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    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Contents</UNITNAME>
    <CNTNTS>
        <AGCY>
            <EAR>
                Agriculture
                <PRTPAGE P="iii"/>
            </EAR>
            <HD>Agriculture Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Forest Service</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Antitrust Division</EAR>
            <HD>Antitrust Division</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Review of Voluntary Agreement Pursuant to the Defense Production Act of 1950, </DOC>
                    <PGS>50049</PGS>
                    <FRDOCBP>2020-18006</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Centers Medicare</EAR>
            <HD>Centers for Medicare &amp; Medicaid Services</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Medicare Program:</SJ>
                <SJDENT>
                    <SJDOC>CY 2021 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; etc., </SJDOC>
                    <PGS>50074-50665</PGS>
                    <FRDOCBP>2020-17127</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Emergency Clearance, </SJDOC>
                    <PGS>50027-50028</PGS>
                    <FRDOCBP>2020-17855</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Civil Rights</EAR>
            <HD>Civil Rights Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Massachusetts Advisory Committee, </SJDOC>
                    <PGS>50002-50003</PGS>
                    <FRDOCBP>2020-17890</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Missouri Advisory Committee, </SJDOC>
                    <PGS>50003</PGS>
                    <FRDOCBP>2020-17880</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>50003-50004</PGS>
                    <FRDOCBP>2020-18049</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Commerce</EAR>
            <HD>Commerce Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Industry and Security Bureau</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>International Trade Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Oceanic and Atmospheric Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Commodity Futures</EAR>
            <HD>Commodity Futures Trading Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Customer Clearing Documentation and Timing of Acceptance for Clearing, </SJDOC>
                    <PGS>50013-50014</PGS>
                    <FRDOCBP>2020-17896</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Process for Review of Swaps for Mandatory Clearing, </SJDOC>
                    <PGS>50012-50013</PGS>
                    <FRDOCBP>2020-17892</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Defense Department</EAR>
            <HD>Defense Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment, </SJDOC>
                    <PGS>50026-50027</PGS>
                    <FRDOCBP>2020-17695</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Women in the Services, </SJDOC>
                    <PGS>50015-50016</PGS>
                    <FRDOCBP>2020-17893</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Reserve Forces Policy Board, </SJDOC>
                    <PGS>50014-50015</PGS>
                    <FRDOCBP>2020-17888</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Education Department</EAR>
            <HD>Education Department</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Waiver and Extension of the Project Periods:</SJ>
                <SJDENT>
                    <SJDOC>American Indian Vocational Rehabilitation Services Program, </SJDOC>
                    <PGS>49965-49967</PGS>
                    <FRDOCBP>2020-18003</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Applications for New Awards:</SJ>
                <SJDENT>
                    <SJDOC>American Indian Vocational Rehabilitation Services Program; Withdrawal, </SJDOC>
                    <PGS>50016-50017</PGS>
                    <FRDOCBP>2020-18004</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Energy Department</EAR>
            <HD>Energy Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Energy Regulatory Commission</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advanced Scientific Computing Advisory Committee, </SJDOC>
                    <PGS>50017</PGS>
                    <FRDOCBP>2020-17918</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Environmental Protection</EAR>
            <HD>Environmental Protection Agency</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Air Quality State Implementation Plans; Approvals and Promulgations:</SJ>
                <SJDENT>
                    <SJDOC>Indiana; Attainment Plan for the Southwest Indiana Sulfur Dioxide Nonattainment Area, </SJDOC>
                    <PGS>49967-49975</PGS>
                    <FRDOCBP>2020-16044</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>50022-50025</PGS>
                    <FRDOCBP>2020-17901</FRDOCBP>
                </DOCENT>
                <SJ>Cross-Media Electronic Reporting:</SJ>
                <SJDENT>
                    <SJDOC>Authorized Program Revision Approval, Kansas, </SJDOC>
                    <PGS>50025</PGS>
                    <FRDOCBP>2020-17818</FRDOCBP>
                </SJDENT>
                <SJ>Requests for Nominations:</SJ>
                <SJDENT>
                    <SJDOC>Toxic Substances Control Act Science Advisory Committee on Chemicals, </SJDOC>
                    <PGS>50020-50022</PGS>
                    <FRDOCBP>2020-17903</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Aviation</EAR>
            <HD>Federal Aviation Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Aspen Avionics, Inc., </SJDOC>
                    <PGS>49944-49947</PGS>
                    <FRDOCBP>2020-17902</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Aviat Aircraft Inc., </SJDOC>
                    <PGS>49962-49965</PGS>
                    <FRDOCBP>2020-17904</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Bell Helicopter Textron Canada Limited Helicopters, </SJDOC>
                    <PGS>49941-49944</PGS>
                    <FRDOCBP>2020-17779</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Continental Aerospace Technologies, Inc. (Type Certificate previously held by Continental Motors, Inc.) Reciprocating Engines, </SJDOC>
                    <PGS>49954-49957</PGS>
                    <FRDOCBP>2020-17874</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Pacific Aerospace Limited Airplanes, </SJDOC>
                    <PGS>49947-49952</PGS>
                    <FRDOCBP>2020-17864</FRDOCBP>
                      
                    <FRDOCBP>2020-17865</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Rolls-Royce Deutschland Ltd and Co KG (Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines, </SJDOC>
                    <PGS>49959-49961</PGS>
                    <FRDOCBP>2020-17822</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Sikorsky Aircraft Corporation Helicopters, </SJDOC>
                    <PGS>49952-49954</PGS>
                    <FRDOCBP>2020-17894</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Viking Air Limited Airplanes, </SJDOC>
                    <PGS>49957-49959</PGS>
                    <FRDOCBP>2020-17900</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Airworthiness Directives:</SJ>
                <SJDENT>
                    <SJDOC>Pratt and Whitney Canada Corp. Turboprop Engines, </SJDOC>
                    <PGS>49981-49983</PGS>
                    <FRDOCBP>2020-17783</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>The Boeing Company Airplanes, </SJDOC>
                    <PGS>49978-49981</PGS>
                    <FRDOCBP>2020-17837</FRDOCBP>
                </SJDENT>
                <SJ>Amendment of Class D and E Airspace:</SJ>
                <SJDENT>
                    <SJDOC>Fallon, NV, </SJDOC>
                    <PGS>49983-49985</PGS>
                    <FRDOCBP>2020-17842</FRDOCBP>
                </SJDENT>
                <SJ>Establishment of Class E airspace:</SJ>
                <SJDENT>
                    <SJDOC>Redding, CA, </SJDOC>
                    <PGS>49985-49986</PGS>
                    <FRDOCBP>2020-17875</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Commercial Space Transportation Advisory Committee, </SJDOC>
                    <PGS>50063-50064</PGS>
                    <FRDOCBP>2020-17898</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Opportunity for Public Comment Equal Land Swap of .64 Acres at Tweed-New Haven Airport, New Haven, CT; Withdrawal, </DOC>
                    <PGS>50064</PGS>
                    <FRDOCBP>2020-17930</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Communications</EAR>
            <HD>Federal Communications Commission</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Promoting Technological Solutions to Combat Contraband Wireless Device Use in Correctional Facilities, </DOC>
                    <PGS>49998-50001</PGS>
                    <FRDOCBP>2020-17335</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Federal Emergency
                <PRTPAGE P="iv"/>
            </EAR>
            <HD>Federal Emergency Management Agency</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Voluntary Agreement under the Defense Production Act:</SJ>
                <SJDENT>
                    <SJDOC>Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic, </SJDOC>
                    <PGS>50035-50040</PGS>
                    <FRDOCBP>2020-18005</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Energy</EAR>
            <HD>Federal Energy Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Application:</SJ>
                <SJDENT>
                    <SJDOC>City of Loveland, </SJDOC>
                    <PGS>50019-50020</PGS>
                    <FRDOCBP>2020-17915</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Review:</SJ>
                <SJDENT>
                    <SJDOC>Northern Natural Gas Co.; Auburn A-Line Abandonment and Capacity Replacement Project, </SJDOC>
                    <PGS>50019</PGS>
                    <FRDOCBP>2020-17917</FRDOCBP>
                </SJDENT>
                <SJ>Filing:</SJ>
                <SJDENT>
                    <SJDOC>PJM Interconnection, LLC, </SJDOC>
                    <PGS>50018-50019</PGS>
                    <FRDOCBP>2020-17914</FRDOCBP>
                </SJDENT>
                <SJ>Request for Comments:</SJ>
                <SJDENT>
                    <SJDOC>Boyne USA, Inc., </SJDOC>
                    <PGS>50017-50018</PGS>
                    <FRDOCBP>2020-17916</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Motor</EAR>
            <HD>Federal Motor Carrier Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Qualification of Drivers; Exemption Applications:</SJ>
                <SJDENT>
                    <SJDOC>Epilepsy and Seizure Disorders, </SJDOC>
                    <PGS>50064-50066</PGS>
                    <FRDOCBP>2020-17824</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Federal Trade</EAR>
            <HD>Federal Trade Commission</HD>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Contact Lens Rule, </DOC>
                    <PGS>50668-50718</PGS>
                    <FRDOCBP>2020-14206</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Fish</EAR>
            <HD>Fish and Wildlife Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Categorical Exclusion:</SJ>
                <SJDENT>
                    <SJDOC>Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Sand Skink and Blue-Tailed Mole Skink, Polk County, FL, </SJDOC>
                    <PGS>50044-50045</PGS>
                    <FRDOCBP>2020-17885</FRDOCBP>
                </SJDENT>
                <SJ>Environmental Assessments; Availability, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Habitat Conservation Plan and Draft Environmental Assessment, </SJDOC>
                    <PGS>50043-50044</PGS>
                    <FRDOCBP>2020-17887</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Food and Drug</EAR>
            <HD>Food and Drug Administration</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <SJ>Physical Medicine Devices:</SJ>
                <SJDENT>
                    <SJDOC>Reclassification of Non-Invasive Bone Growth Stimulators, </SJDOC>
                    <PGS>49986-49994</PGS>
                    <FRDOCBP>2020-17543</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Rapid Response Surveys, </SJDOC>
                    <PGS>50030-50031</PGS>
                    <FRDOCBP>2020-17928</FRDOCBP>
                </SJDENT>
                <SJ>Guidance:</SJ>
                <SJDENT>
                    <SJDOC>Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank, </SJDOC>
                    <PGS>50028-50030</PGS>
                    <FRDOCBP>2020-17909</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Forest</EAR>
            <HD>Forest Service</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Forest Service Handbook:</SJ>
                <SJDENT>
                    <SJDOC>Chapter 30 Law Enforcement; Closures of National Forest System Lands to Hunting, Fishing, or Recreational Shooting, </SJDOC>
                    <PGS>50002</PGS>
                    <FRDOCBP>2020-17661</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>General Services</EAR>
            <HD>General Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment, </SJDOC>
                    <PGS>50026-50027</PGS>
                    <FRDOCBP>2020-17695</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Maximum Per Diem Reimbursement Rates for the Continental United States, </DOC>
                    <PGS>50025-50026</PGS>
                    <FRDOCBP>2020-17938</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Health and Human</EAR>
            <HD>Health and Human Services Department</HD>
            <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>Health Resources and Services Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Institutes of Health</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Health Resources</EAR>
            <HD>Health Resources and Services Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>National Vaccine Injury Compensation Program:</SJ>
                <SJDENT>
                    <SJDOC>List of Petitions Received, </SJDOC>
                    <PGS>50031-50033</PGS>
                    <FRDOCBP>2020-17936</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Homeland</EAR>
            <HD>Homeland Security Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Emergency Management Agency</P>
            </SEE>
            <CAT>
                <HD>RULES</HD>
                <DOCENT>
                    <DOC>Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements; Correction, </DOC>
                    <PGS>49941</PGS>
                    <FRDOCBP>2020-17939</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>President's National Infrastructure Advisory Council, </SJDOC>
                    <PGS>50040-50041</PGS>
                    <FRDOCBP>2020-17940</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Housing</EAR>
            <HD>Housing and Urban Development Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Waivers, Alternative Requirements and Extensions for Community Development Block Grant Disaster Recovery Grantees, </DOC>
                    <PGS>50041-50043</PGS>
                    <FRDOCBP>2020-17886</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Industry</EAR>
            <HD>Industry and Security Bureau</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Additional Protocol to the International Atomic Energy Agency Safeguards, </SJDOC>
                    <PGS>50004</PGS>
                    <FRDOCBP>2020-17919</FRDOCBP>
                </SJDENT>
            </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>Land Management Bureau</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>International Trade Adm</EAR>
            <HD>International Trade Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Antidumping or Countervailing Duty Investigations, Orders, or Reviews:</SJ>
                <SJDENT>
                    <SJDOC>Certain Uncoated Paper from Brazil, </SJDOC>
                    <PGS>50008-50009</PGS>
                    <FRDOCBP>2020-17923</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Citric Acid and Certain Citrate Salts from the People's Republic of China, </SJDOC>
                    <PGS>50009-50010</PGS>
                    <FRDOCBP>2020-17920</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, from the People's Republic of China, </SJDOC>
                    <PGS>50007-50008</PGS>
                    <FRDOCBP>2020-17943</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Crystalline Silicon Photovoltaic Products from the People's Republic of China, </SJDOC>
                    <PGS>50006-50007</PGS>
                    <FRDOCBP>2020-17942</FRDOCBP>
                </SJDENT>
                <SJ>Request for Applicants:</SJ>
                <SJDENT>
                    <SJDOC>United States-Mexico Energy Business Council, </SJDOC>
                    <PGS>50004-50006</PGS>
                    <FRDOCBP>2020-17388</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>International Trade Com</EAR>
            <HD>International Trade Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Investigations; Determinations, Modifications, and Rulings, etc.:</SJ>
                <SJDENT>
                    <SJDOC>Certain Electronic Candle Products and Components Thereof, </SJDOC>
                    <PGS>50048-50049</PGS>
                    <FRDOCBP>2020-17933</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Certain Light-Emitting Diode Products, Fixtures, and Components Thereof, </SJDOC>
                    <PGS>50047-50048</PGS>
                    <FRDOCBP>2020-17931</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Justice Department</EAR>
            <HD>Justice Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Antitrust Division</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Justice Programs Office</P>
            </SEE>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Lodging of Proposed Consent Decree Under the Clean Water Act, </DOC>
                    <PGS>50049-50050</PGS>
                    <FRDOCBP>2020-17879</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>
                Justice Programs
                <PRTPAGE P="v"/>
            </EAR>
            <HD>Justice Programs Office</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Global Justice Information Sharing Initiative Federal Advisory Committee, </SJDOC>
                    <PGS>50050</PGS>
                    <FRDOCBP>2020-17891</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Land</EAR>
            <HD>Land Management Bureau</HD>
            <CAT>
                <HD>PROPOSED RULES</HD>
                <DOCENT>
                    <DOC>Selected Public Lands in Gila, Maricopa, Pima, Pinal and Yavapai Counties, AZ, </DOC>
                    <PGS>49995-49998</PGS>
                    <FRDOCBP>2020-16640</FRDOCBP>
                </DOCENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Authorizing Grazing Use, </SJDOC>
                    <PGS>50045-50046</PGS>
                    <FRDOCBP>2020-17808</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Virtual Wild Horse and Burro Advisory, </SJDOC>
                    <PGS>50046-50047</PGS>
                    <FRDOCBP>2020-17926</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>NASA</EAR>
            <HD>National Aeronautics and Space Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment, </SJDOC>
                    <PGS>50026-50027</PGS>
                    <FRDOCBP>2020-17695</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Credit</EAR>
            <HD>National Credit Union Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Agency Information Collection Activities; Proposals, Submissions, and Approvals, </DOC>
                    <PGS>50050-50051</PGS>
                    <FRDOCBP>2020-17819</FRDOCBP>
                      
                    <FRDOCBP>2020-17857</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Endowment for the Humanities</EAR>
            <HD>National Endowment for the Humanities</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Humanities Panel, </SJDOC>
                    <PGS>50051-50052</PGS>
                    <FRDOCBP>2020-17807</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Foundation</EAR>
            <HD>National Foundation on the Arts and the Humanities</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Endowment for the Humanities</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>National Highway</EAR>
            <HD>National Highway Traffic Safety Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Petition for Decision of Inconsequential Noncompliance:</SJ>
                <SJDENT>
                    <SJDOC>Yamaha Motor Corp., </SJDOC>
                    <PGS>50066-50068</PGS>
                    <FRDOCBP>2020-17905</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Institute</EAR>
            <HD>National Institutes of Health</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Council of Councils, </SJDOC>
                    <PGS>50033</PGS>
                    <FRDOCBP>2020-17907</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Cancer Institute, </SJDOC>
                    <PGS>50033-50034</PGS>
                    <FRDOCBP>2020-17906</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute of Allergy and Infectious Diseases, </SJDOC>
                    <PGS>50034-50035</PGS>
                    <FRDOCBP>2020-17853</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>National Institute on Drug Abuse, </SJDOC>
                    <PGS>50034</PGS>
                    <FRDOCBP>2020-17817</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Oceanic</EAR>
            <HD>National Oceanic and Atmospheric Administration</HD>
            <CAT>
                <HD>RULES</HD>
                <SJ>Fisheries of the Exclusive Economic Zone off Alaska:</SJ>
                <SJDENT>
                    <SJDOC>Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area, </SJDOC>
                    <PGS>49976</PGS>
                    <FRDOCBP>2020-17924</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Several Groundfish Species in the Bering Sea and Aleutian Islands Management Area, </SJDOC>
                    <PGS>49976-49977</PGS>
                    <FRDOCBP>2020-17929</FRDOCBP>
                </SJDENT>
                <SJ>International Fisheries:</SJ>
                <SJDENT>
                    <SJDOC>Pacific Tuna Fisheries; Fishing Restrictions for Silky Shark, Fish Aggregating Devices, and Observer Safety in the Eastern Pacific Ocean, </SJDOC>
                    <PGS>49975-49976</PGS>
                    <FRDOCBP>2020-16730</FRDOCBP>
                </SJDENT>
                <SJ>Takes of Marine Mammals Incidental to Specified Activities:</SJ>
                <SJDENT>
                    <SJDOC>Alaska Liquefied Natural Gas Project in Cook Inlet, </SJDOC>
                    <PGS>50720-50756</PGS>
                    <FRDOCBP>2020-15404</FRDOCBP>
                </SJDENT>
            </CAT>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Evaluation of State Coastal Management Program, </SJDOC>
                    <PGS>50012</PGS>
                    <FRDOCBP>2020-17937</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Taking and Importing of Marine Mammals, </DOC>
                    <PGS>50010-50012</PGS>
                    <FRDOCBP>2020-17934</FRDOCBP>
                      
                    <FRDOCBP>2020-17935</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>National Science</EAR>
            <HD>National Science Foundation</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings; Sunshine Act:</SJ>
                <SJDENT>
                    <SJDOC>National Science Board, </SJDOC>
                    <PGS>50052</PGS>
                    <FRDOCBP>2020-18035</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Nuclear Regulatory</EAR>
            <HD>Nuclear Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Agency Information Collection Activities; Proposals, Submissions, and Approvals:</SJ>
                <SJDENT>
                    <SJDOC>Controlled Unclassified Information Program Challenge Request Process, </SJDOC>
                    <PGS>50053-50054</PGS>
                    <FRDOCBP>2020-17932</FRDOCBP>
                </SJDENT>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Reactor Safeguards, </SJDOC>
                    <PGS>50052-50053</PGS>
                    <FRDOCBP>2020-17922</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Postal Regulatory</EAR>
            <HD>Postal Regulatory Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>New Postal Products, </DOC>
                    <PGS>50054-50055</PGS>
                    <FRDOCBP>2020-17912</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Securities</EAR>
            <HD>Securities and Exchange Commission</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Self-Regulatory Organizations; Proposed Rule Changes:</SJ>
                <SJDENT>
                    <SJDOC>BOX Exchange, LLC, </SJDOC>
                    <PGS>50059-50062</PGS>
                    <FRDOCBP>2020-17828</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Cboe BZX Exchange, Inc., </SJDOC>
                    <PGS>50055-50059</PGS>
                    <FRDOCBP>2020-17823</FRDOCBP>
                </SJDENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Small Business</EAR>
            <HD>Small Business Administration</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, </DOC>
                    <PGS>50062-50063</PGS>
                    <FRDOCBP>2020-17815</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Transportation Department</EAR>
            <HD>Transportation Department</HD>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Aviation Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>Federal Motor Carrier Safety Administration</P>
            </SEE>
            <SEE>
                <HD SOURCE="HED">See</HD>
                <P>National Highway Traffic Safety Administration</P>
            </SEE>
        </AGCY>
        <AGCY>
            <EAR>Unified</EAR>
            <HD>Unified Carrier Registration Plan</HD>
            <CAT>
                <HD>NOTICES</HD>
                <DOCENT>
                    <DOC>Meetings; Sunshine Act, </DOC>
                    <PGS>50068</PGS>
                    <FRDOCBP>2020-18010</FRDOCBP>
                </DOCENT>
            </CAT>
        </AGCY>
        <AGCY>
            <EAR>Veteran Affairs</EAR>
            <HD>Veterans Affairs Department</HD>
            <CAT>
                <HD>NOTICES</HD>
                <SJ>Meetings:</SJ>
                <SJDENT>
                    <SJDOC>Advisory Committee on Structural Safety of Department of Veterans Affairs Facilities, </SJDOC>
                    <PGS>50070-50071</PGS>
                    <FRDOCBP>2020-17840</FRDOCBP>
                </SJDENT>
                <SJDENT>
                    <SJDOC>Advisory Committee on Women Veterans, </SJDOC>
                    <PGS>50068-50069</PGS>
                    <FRDOCBP>2020-17814</FRDOCBP>
                </SJDENT>
                <DOCENT>
                    <DOC>Privacy Act; Systems of Records, </DOC>
                    <PGS>50069-50070</PGS>
                    <FRDOCBP>2020-17945</FRDOCBP>
                </DOCENT>
            </CAT>
        </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>50074-50665</PGS>
                <FRDOCBP>2020-17127</FRDOCBP>
            </DOCENT>
            <HD>Part III</HD>
            <DOCENT>
                <DOC>Federal Trade Commission, </DOC>
                <PGS>50668-50718</PGS>
                <FRDOCBP>2020-14206</FRDOCBP>
            </DOCENT>
            <HD>Part IV</HD>
            <DOCENT>
                <DOC>Commerce Department, National Oceanic and Atmospheric Administration, </DOC>
                <PGS>50720-50756</PGS>
                <FRDOCBP>2020-15404</FRDOCBP>
            </DOCENT>
        </PTS>
        <AIDS>
            <PRTPAGE P="vi"/>
            <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, and notice of recently enacted public laws.</P>
            <P>To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.</P>
        </AIDS>
    </CNTNTS>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <RULES>
        <RULE>
            <PREAMB>
                <PRTPAGE P="49941"/>
                <AGENCY TYPE="F">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <CFR>8 CFR Parts 103, 106, 204, 211, 212, 214, 216, 217, 223, 235, 236, 240, 244, 245, 245a, 248, 264, 274a, 286, 301, 319, 320, 322, 324, 334, 341, 343a, 343b, and 392</CFR>
                <DEPDOC>[CIS No. 2627-18; DHS Docket No. USCIS-2019-0010]</DEPDOC>
                <RIN>RIN 1615-AC18</RIN>
                <SUBJECT>U.S. Citizenship and Immigration Services Fee Schedule and Changes to Certain Other Immigration Benefit Request Requirements</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Citizenship and Immigration Services, DHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On August 3, 2020, the Department of Homeland Security (DHS) published a final rule to amend DHS regulations to adjust certain immigration and naturalization benefit request fees charged by U.S. Citizenship and Immigration Services (USCIS) and make certain other changes. In this rule, we are correcting four technical errors.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective October 2, 2020.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Kika Scott, Chief Financial Officer, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW, Washington, DC 20529-2130, telephone (202) 272-8377.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Need for Correction</HD>
                <P>
                    On August 3, 2020, the Department of Homeland Security published a final rule in the 
                    <E T="04">Federal Register</E>
                     at 85 FR 46788 changing immigration and naturalization benefit request fees charged by U.S. Citizenship and Immigration Services (USCIS), fee exemptions and fee waiver requirements, premium processing time limits, and intercountry adoption processing (FR Doc. 2020-16389). First, in footnote 41 on page 46813, column 1, although the rule was a final rule, it states, “However, DHS proposes changes to the policy in this final rule as explained later in this preamble.” Second, on page 46908, in Table 11, the final rule includes a line item for OMB control number 1615-0122. This control number is not affected by the rule and should be removed from that table. Third, DHS inadvertently, on page 46914, stated that it proposes to amend chapter I of title 8 of the Code of Federal Regulations, although the rule is a final rule. And fourth, in instruction 35, on page 46925, we removed a term from paragraph (k)(1) in 8 CFR 214.11 that does not exist in (k)(1), but exists in (k)(10).
                </P>
                <HD SOURCE="HD2">Correction of Publication</HD>
                <P>Accordingly, the publication on August 3, 2020, at 85 FR 46788, the final rule that was the subject of FR Doc. 2020-16389 is corrected as follows:</P>
                <P>1. On page 46813, column 1, in footnote 41, revise the second to last sentence to read, “However, DHS changes the policy in this final rule as explained later in this preamble.”</P>
                <P>2. On page 46908, in Table 11, remove the row for OMB control number 1615-0122, Immigrant Fee, from the table.</P>
                <AMDPAR>3. On page 46914, in the first column, the words of issuance, “Accordingly, DHS proposes to amend chapter I of title 8 of the Code of Federal Regulations as follows:” are corrected to read, “Accordingly, DHS amends chapter I of title 8 of the Code of Federal Regulations as follows:”</AMDPAR>
                <SECTION>
                    <SECTNO>§ 214.11</SECTNO>
                    <SUBJECT> [Corrected]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="8" PART="214">
                    <AMDPAR>4. On page 46925, in the second column, instruction 35 is corrected to read “Section 214.11 is amended in paragraphs (d)(2)(iii) and (k)(10) by removing “8 CFR 103.7(b)(1)” and adding in its place “8 CFR 106.2.”</AMDPAR>
                </REGTEXT>
                <SIG>
                    <NAME>Chad R. Mizelle,</NAME>
                    <TITLE>Senior Official Performing the Duties of the General Counsel for the Department of Homeland Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17939 Filed 8-13-20; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 9111-97-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-2019-0589; Product Identifier 2017-SW-020-AD; Amendment 39-21215; AD 2020-17-10]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Bell Helicopter Textron Canada Limited Helicopters</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 superseding Airworthiness Directive (AD) 2016-02-06 for Bell Helicopter Textron Canada Limited (Bell) Model 429 helicopters. AD 2016-02-06 required inspecting certain tail rotor (T/R) pitch link bearing bores for corrosion and pitting. AD 2016-02-06 also required a repetitive inspection of the sealant and repeating the inspections for corrosion and pitting if any sealant is missing. This new AD retains the requirements of AD 2016-02-06, expands the applicability, and adds a repetitive inspection. This AD was prompted by an FAA determination that additional part-numbered T/R pitch link assemblies (links) are affected by the same unsafe condition and that an additional repetitive inspection is necessary to address the unsafe condition. The actions of this AD are intended to address an unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 21, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 2, 2016 (81 FR 5367, February 2, 2016).</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this final rule, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone 450-437-2862 or 800-363-8023; fax 450-433-0272; or at 
                        <E T="03">https://www.bellcustomer.com.</E>
                         You may view this referenced service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for 
                        <PRTPAGE P="49942"/>
                        and locating Docket No. FAA-2019-0589.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov in</E>
                     Docket No. FAA-2019-0589; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the Transport Canada AD, any service information that is incorporated by reference, any comments received, and other information. The street address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Scott Franke, Aviation Safety Engineer, International Validation Branch, Aviation and Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817-222-5110; email 
                        <E T="03">scott.franke@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to remove AD 2016-02-06, Amendment 39-18387 (81 FR 5367, February 2, 2016) (“AD 2016-02-06”) and add a new AD. AD 2016-02-06 applied to Bell Model 429 helicopters with a T/R link part number (P/N) 429-012-112-101, -101FM, -103, or -103FM installed. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on August 20, 2019 (84 FR 43085). Since the FAA issued AD 2016-02-06, improved T/R links P/N 429-012-112-111 and -113 were developed, but recurring inspections of the sealant of these T/R links are still necessary because they are subject to the same unsafe condition due to design similarity. Some T/R links P/N 429-012-112-101 and -103 have also been field modified and re-identified as T/R links P/N 429-012-112-111FM and -113FM, and continue to need recurring inspections of the sealant as they are also subject to the same unsafe condition due to design similarity.
                </P>
                <P>The NPRM proposed to continue the requirements of AD 2016-02-06 and add P/Ns 429-012-112-111, -111FM, -113, and -113FM to the applicability. The NPRM also proposed to add use of 10X or higher power magnification to the visual inspection of each cleaned T/R link for pitting and a repetitive 12-month inspection with the corrosion preventative sealant removed.</P>
                <P>Transport Canada, which is the aviation authority for Canada, issued AD No. CF-2016-01R2, dated April 12, 2017 (AD CF-2016-01R2) to clarify the applicable P/Ns, address spare parts, and address parts installed on-condition prior to December 7, 2015. AD CF-2016-01R2 also includes a terminating action for the repetitive inspections.</P>
                <HD SOURCE="HD1">Comments</HD>
                <P>After the NPRM was published, the FAA received comments from one commenter.</P>
                <HD SOURCE="HD1">Request</HD>
                <P>Bell Textron, Inc., commented that this AD omits Bell Helicopter Alert Service Bulletin (ASB) 429-15-16 Rev. B, dated June 15, 2016 (ASB 429-15-16 Rev. B), which was issued after Bell Helicopter ASB 429-15-26, dated December 7, 2015 (ASB 429-15-26). The FAA acknowledges that ASB 429-15-16 Rev. B and ASB 429-15-26 specify procedures for the same part-numbered T/R links. However, the two service information documents address different unsafe conditions, specifically ASB 429-15-16 Rev. B addresses wear and ASB 429-15-26 addresses corrosion. Accordingly, the two different unsafe conditions are addressed in two separate ADs. The unsafe condition of wear (ASB 429-15-16 Rev. B) is addressed in AD 2019-11-05, Amendment 39-19651 (84 FR 26546, June 7, 2019) (“AD 2019-11-05”). The unsafe condition of corrosion (ASB 429-15-26) is addressed in this AD. The FAA did not change this AD based on this comment.</P>
                <P>Bell Textron, Inc., commented that this AD differs from ASB 429-15-16 Rev. B and ASB 429-15-26 by requiring removal of the sealant around the bearing every 12 months and an inspection of the chamfer with a 10X magnifying lens. Bell Textron, Inc., stated that since ASB 429-15-16 Rev. B “requires” a repetitive 50 flight hours inspection of the sealant for pin holes and voids, it does not feel the repetitive 12 month inspection with the sealant removed is necessary. The FAA disagrees. Procedures specified in related service information documents are not required unless mandated by an AD. And while AD 2019-11-05 mandates the repetitive inspection of the sealant condition for pin holes and voids specified in ASB 429-15-16 Rev. B, the FAA determined an inspection with the sealant removed at a longer-term repetitive interval is necessary. Since sealant could become damaged, not maintain seal, or become worn, this more in-depth inspection addresses corrosion and pitting that could build up underneath the sealant. The FAA did not change this AD based on this comment.</P>
                <P>Bell Textron, Inc., commented that not requiring part re-identification makes it more complicated to manage configurations. The FAA does not prohibit re-identifying the T/R links as specified in ASB 429-15-26; however, the FAA determined it unnecessary to require to address the unsafe condition since the repetitive inspections are required for all part-numbered links listed in the applicability. The FAA did not change this AD based on this comment.</P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>
                    The FAA has reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other helicopters of the same type design and that air safety and the public interest require adopting the AD requirements as proposed except for editorial changes. The website URL for Bell and the email address for requesting an alternative method of compliance have changed and have been updated in this final rule. Additionally, the paragraph cross-referencing formatting in the Required Actions paragraph has changed to meet current publication requirements, 
                    <E T="03">e.g.,</E>
                     “(f)(3)(i) and (f)(3)(ii)” has changed to “(f)(3)(i) and (ii)” instead. These editorial changes are consistent with the intent of the proposals in the NPRM and will not increase the economic burden on any operator nor increase the scope of the AD.
                </P>
                <HD SOURCE="HD1">Interim Action</HD>
                <P>The FAA considers this AD to be an interim action. The design approval holder is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, the FAA might consider additional rulemaking.</P>
                <HD SOURCE="HD1">Differences Between This AD and the Transport Canada AD</HD>
                <P>
                    This AD applies to helicopters with certain link P/Ns installed, whereas the Transport Canada AD applies to helicopters with certain serial numbers instead. This AD requires inspecting the bearing bores for any pitting after cleaning the T/R link, while the Transport Canada AD requires inspecting for corrosion after cleaning the T/R link. This AD requires performing the inspections with 10X or higher magnification, while the Transport Canada AD does not specify any magnification. This AD does not require re-identifying the P/N of the 
                    <PRTPAGE P="49943"/>
                    link, whereas the Transport Canada AD does. The Transport Canada AD also provides a terminating action to the repetitive sealant inspection, while this AD does not. This AD also requires a repetitive inspection with the corrosion preventative sealant removed and reapplied, whereas the Transport Canada AD does not.
                </P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed ASB 429-15-26, which advises of reports of corrosion on T/R links between the roll staked lip of bearing P/N 429-312-107-103 and the beveled edge of T/R link P/Ns 429-012-112-101/-103. ASB 429-15-26 specifies inspecting each T/R link bearing bore between the roll staked lip of the bearing outer race and the link bearing bore with 10X magnification for corrosion and if there is corrosion, replacing the link. If there is no corrosion, ASB 429-15-26 specifies cleaning the area and performing a second inspection with 10X magnification for corrosion. If there is corrosion, ASB 429-15-26 specifies replacing the link. If there is no corrosion, ASB 429-15-26 specifies removing the torque stripe, cleaning the area, and applying corrosion preventative sealant. ASB 429-15-26 also specifies re-identifying the P/Ns as 429-012-112-101FM/-103FM. Further, ASB 429-15-26 specifies a repetitive inspection of the sealant and reapplication if the sealant is damaged.</P>
                <P>
                    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 93 helicopters of U.S. Registry. The FAA estimates that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.</P>
                <P>Inspecting the set of T/R links (eight bearings) for corrosion takes about one work-hour for an estimated cost of $85 per helicopter and $7,905 for the U.S. fleet per inspection cycle. Cleaning and inspecting the set of T/R links for pitting takes about one work-hour for an estimated cost of $85 per helicopter. Replacing a T/R link requires no additional work-hours after the inspection and required parts cost $2,739 for an estimated replacement cost of $2,739 per T/R link. Removing the torque stripe, cleaning, and applying sealant to the set of T/R links takes about one work-hour with a negligible parts cost for an estimated cost of $85 per helicopter. Inspecting the sealant on a set of T/R links takes about one work-hour for an estimated cost of $85 per helicopter and $7,905 for the U.S. fleet per inspection cycle.</P>
                <P>According to Bell Helicopter's service information, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage by Bell Helicopter. Accordingly, the FAA has included all costs in this cost estimate.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA has 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. Will not affect intrastate aviation in Alaska, 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>
                <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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by:</AMDPAR>
                    <AMDPAR>a. Removing Airworthiness Directive (AD) 2016-02-06, Amendment 39-18387 (81 FR 5367, February 2, 2016); and</AMDPAR>
                    <AMDPAR>b. Adding the following new AD:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2020-17-10 Bell Helicopter Textron Canada Limited:</E>
                             Amendment 39-21215; Docket No. FAA-2019-0589; Product Identifier 2017-SW-020-AD.
                        </FP>
                        <HD SOURCE="HD1">(a) Applicability</HD>
                        <P>This AD applies to Bell Helicopter Textron Canada Limited Model 429 helicopters with a tail rotor (T/R) pitch link assembly (link) part number (P/N) 429-012-112-101, -101FM, -103, -103FM, -111, -111FM, -113, or -113FM installed, certificated in any category.</P>
                        <HD SOURCE="HD1">(b) Unsafe Condition</HD>
                        <P>This AD defines the unsafe condition as failure of a T/R link. This condition could result in loss of T/R flight control and subsequent loss of control of the helicopter.</P>
                        <HD SOURCE="HD1">(c) Affected ADs</HD>
                        <P>This AD replaces AD 2016-02-06, Amendment 39-18387 (81 FR 5367, February 2, 2016).</P>
                        <HD SOURCE="HD1">(d) Effective Date</HD>
                        <P>This AD becomes effective September 21, 2020.</P>
                        <HD SOURCE="HD1">(e) Compliance</HD>
                        <P>You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.</P>
                        <HD SOURCE="HD1">(f) Required Actions</HD>
                        <P>(1) For T/R link P/N 429-012-112-101 and -103, within 10 hours time-in-service (TIS):</P>
                        <P>(i) Remove each T/R link. Prior to cleaning the T/R link bearing bores, using 10X or higher power magnification, inspect each T/R link bearing bore for aluminum oxide corrosion extruding from between the roll staked lip of the bearing outer race and the link bearing bore. Aluminum oxide corrosion appears as a white crystalline material in contrast with the black finish and any accumulated soot. An example of this corrosion is shown in Figure 1 of Bell Helicopter Alert Service Bulletin 429-15-26, dated December 7, 2015 (ASB 429-15-26).</P>
                        <P>(ii) If there is any aluminum oxide corrosion, replace the T/R link before further flight.</P>
                        <P>
                            (iii) If there is no aluminum oxide corrosion, clean each T/R link bearing bore with isopropyl alcohol, and using 10X or higher power magnification, inspect each cleaned T/R link for pitting.
                            <PRTPAGE P="49944"/>
                        </P>
                        <P>(A) If there is any pitting, replace the T/R link before further flight.</P>
                        <P>(B) If there is no pitting, apply corrosion preventative sealant by following the Accomplishment Instructions, paragraph 5. of Part I, of ASB 429-15-26.</P>
                        <P>(2) For all T/R link P/Ns listed in paragraph (a) of this AD, within 50 hours TIS, and thereafter at intervals not to exceed 50 hours TIS, using 10X or higher power magnification, inspect each T/R link bearing bore for missing corrosion preventative sealant. If any corrosion preventative sealant is missing, perform the actions in paragraphs (f)(3)(i) and (ii) of this AD before further flight.</P>
                        <P>(3) For all T/R link P/Ns listed in paragraph (a) of this AD, within 12 months since date of manufacture, except if paragraphs (f)(1)(i) through (iii) of this AD have already been done for T/R link P/N 429-012-112-101 or -103 within the last 12 months and except if paragraph (f)(3)(i) and (ii) of this AD have already been done for T/R link P/N 429-012-112-101FM, -103FM, -111, -111FM, -113, or -113FM within the last 12 months; and thereafter for all T/R link P/Ns listed in paragraph (a) of this AD at intervals not to exceed 12 months:</P>
                        <P>(i) Remove each T/R link; and</P>
                        <P>(ii) Remove all corrosion preventative sealant, and perform the actions in paragraphs (f)(1)(i) through (iii) of this AD.</P>
                        <P>(4) After the effective date of this AD:</P>
                        <P>(i) Do not install T/R link P/N 429-012-112-101 or -103 on any helicopter before complying with the actions in paragraphs (f)(1)(i) through (iii) of this AD.</P>
                        <P>(ii) Do not install T/R link P/N 429-012-112-101FM, 103FM, -111, 111FM, -113, or -113FM on any helicopter before complying with the actions in paragraph (f)(2) of this AD.</P>
                        <HD SOURCE="HD1">(g) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            (1) The Manager, International Validation Branch, FAA, may approve AMOCs for this AD. Send your proposal to: Scott Franke, Aviation Safety Engineer, International Validation Branch, Aviation and Rotorcraft Unit, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone 817-222-5110; email 
                            <E T="03">scott.franke@faa.gov.</E>
                        </P>
                        <P>(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, the FAA suggests that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.</P>
                        <HD SOURCE="HD1">(h) Additional Information</HD>
                        <P>
                            The subject of this AD is addressed in Transport Canada AD No. CF-2016-01R2, dated April 12, 2017. You may view the Transport Canada AD on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             in Docket No. FAA-2019-0589.
                        </P>
                        <HD SOURCE="HD1">(i) Subject</HD>
                        <P>Joint Aircraft Service Component (JASC) Code: 6400, Tail Rotor System.</P>
                        <HD SOURCE="HD1">(j) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(3) The following service information was approved for IBR on February 2, 2016 (81 FR 5367, February 2, 2016).</P>
                        <P>(i) Bell Helicopter Alert Service Bulletin 429-15-26, dated December 7, 2015.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (4) For service information identified in this AD, contact Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J1R4; telephone 450-437-2862 or 800-363-8023; fax 450-433-0272; or at 
                            <E T="03">https://www.bellcustomer.com.</E>
                        </P>
                        <P>(5) You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call 817-222-5110.</P>
                        <P>
                            (6) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on August 10, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17779 Filed 8-14-20; 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-2020-0723; Project Identifier AD-2020-00586-Q; Amendment 39-21192; AD 2020-16-08]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Aspen Avionics, Inc.</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; correction.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The FAA is correcting an airworthiness directive (AD) that published in the 
                        <E T="04">Federal Register</E>
                        . The AD applies to certain Aspen Avionics, Inc., Evolution Flight Display (EFD) EFD1000 Emergency Backup Display, EFD1000 Multi-Function Display, and EFD1000 Primary Flight Display systems installed on various airplanes. As published, the docket number and product identifier in the Comments Invited section of the preamble are incorrect. This document corrects that error. In all other respects, the original document remains the same; however, for clarity, the FAA is publishing the entire rule in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This correction is effective August 17, 2020. The effective date of AD 2020-16-08 remains August 17, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0723; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mahmood Shah, Aerospace Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; phone: 817-222-5133; fax: 817-222-5960; email: 
                        <E T="03">mahmood.shah@faa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    As published, AD 2020-16-08, Amendment 39-21192 (85 FR 45990, July 31, 2020) (“AD 2020-16-08”), applies to certain Aspen Avionics, Inc., EFD1000 Emergency Backup Display, EFD1000 Multi-Function Display, and EFD1000 Primary Flight Display systems installed on various airplanes. AD 2020-16-08 imposes operating restrictions to flight under visual flight rules (VFR) and prohibits night operations to allow safe operation in the event of a loss of flight display functionality.
                    <PRTPAGE P="49945"/>
                </P>
                <HD SOURCE="HD1">Need for the Correction</HD>
                <P>As published, the docket number and product identifier in the first paragraph of the Comments Invited section of the preamble are incorrect. The paragraph incorrectly references Docket Number “FAA-2020-0711” and Product Identifier “MCAI-2020-00719-A,” instead of Docket No. FAA-2020-0723 and Product Identifier AD-2020-00586-Q.</P>
                <P>
                    Although no other part of the preamble or regulatory information has been corrected, for clarity, the FAA is publishing the entire rule in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <P>The effective date of this AD remains August 17, 2020.</P>
                <HD SOURCE="HD1">Related Service Information</HD>
                <P>The FAA reviewed Aspen Operator Advisory OA2020-01, dated March 3, 2020. This document advises operators of the automatic reset event and provides recommended operating limitations.</P>
                <P>The FAA also reviewed Aspen Service Bulletin Number: SB2020-01, dated April 1, 2020. This document provides instructions for updating the EFD software to correct the automatic reset issue. This AD does not apply to airplanes that are compliant with this service information.</P>
                <HD SOURCE="HD1">Good Cause for Adoption Without Prior Notice</HD>
                <P>Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq.) authorizes agencies to dispense with notice and comment procedures for rules when the agency for “good cause” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Section 553(d)(3) of the APA requires that agencies publish a rule not less than 30 days before its effective date, except as otherwise provided by the agency for good cause found and published with the rule.</P>
                <P>Since this action only corrects the docket number and product identifier in the preamble, the FAA finds that notice and public comment under 5 U.S.C. 553(b) is unnecessary. For the same reason, the FAA finds that good cause exists under 5 U.S.C. 553(d) for making this rule effective in less than 30 days.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include the Docket Number FAA-2020-0723 and Product Identifier AD-2020-00586-Q at the beginning of your comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this final rule.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Mahmood Shah, Aerospace Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.</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 Correction</HD>
                <P>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:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Corrected]</SUBJECT>
                </SECTION>
                <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">2020-16-08 Aspen Avionics, Inc.:</E>
                             Amendment 39-21192; Docket No. FAA-2020-0723; Project Identifier AD-2020-00586-Q.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This AD is effective August 17, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>(1) This AD applies to Aspen Avionics, Inc., Evolution Flight Display (EFD) EFD1000 Primary Flight Display part number (P/N) 910-00001-011, EFD1000 Multi-Function Display P/N 910-00001-012, and EFD1000 Emergency Backup Display P/N 910-00001-017 units that meet both conditions in paragraphs (c)(1)(i) and (ii) of this AD.</P>
                        <P>(i) Software version 2.10 or 2.10.1 is installed;</P>
                        <P>(ii) Independent attitude, altitude, and airspeed back-up instruments are not installed.</P>
                        <P>(2) These flight display units may be installed on, but are not limited to, the following airplanes, certificated in any category:</P>
                        <P>(i) Aermacchi S.p.A. Model S.205-18/F, S.205-18/R, S.205-20/F, S.205-20/R, S.205-22/R, S.208, and S.208A airplanes;</P>
                        <P>(ii) Aeronautica Macchi S.p.A. Model AL 60 (previously designated as Model LASA 60), AL 60-B, AL 60-C5, and AL 60-F5 airplanes;</P>
                        <P>(iii) Aerostar Aircraft Corporation Model PA-60-600 (Aerostar 600), PA-60-601 (Aerostar 601), PA-60-601P (Aerostar 601P), and PA-60-602P (Aerostar 602P) airplanes;</P>
                        <P>(iv) Alexandria Aircraft, LLC (type certificate previously held by Bellanca, Inc.), Model 14-19, 14-19-2, 14-19-3, 14-19-3A, 17-30, 17-30A, 17-31, 17-31A, 17-31ATC, and 17-31TC airplanes;</P>
                        <P>(v) American Champion Aircraft Corp. Model 402, 7ECA, 7GCAA, 7GCBC, 7KCAB, 8GCBC, and 8KCAB airplanes;</P>
                        <P>(vi) CEAPR (type certificate previously held by APEX) Model CAP 10 B airplanes;</P>
                        <P>(vii) Cirrus Design Corporation Model SR20 and SR22 airplanes;</P>
                        <P>(viii) Commander Aircraft Corporation (type certificate previously held by CPAC, Inc.) Model 112, 112B, 112TC, 112TCA, 114, 114A, 114B, and 114TC airplanes;</P>
                        <P>(ix) Consolidated Vultee Aircraft Corporation, Stinson Division Model V-77 (Army AT-19) airplanes;</P>
                        <P>(x) Cougar Aircraft Corporation (type certificate previously held by SOCATA, S.A.) Model GA-7 airplanes;</P>
                        <P>(xi) Diamond Aircraft Industries Inc. Model DA20-A1 and DA20-C1 airplanes;</P>
                        <P>(xii) Diamond Aircraft Industries Inc. (type certificate previously held by Diamond Aircraft Industries GmbH) Model DA 40 and DA 40 F airplanes;</P>
                        <P>(xiii) Discovery Aviation, Inc. (type certificate previously held by Liberty Aerospace Incorporated), Model XL-2 airplanes;</P>
                        <P>
                            (xiv) Dynac Aerospace Corporation Model Aero Commander 100, Aero Commander 100A, Aero Commander 100-180, Volaire 10, and Volaire 10A airplanes;
                            <PRTPAGE P="49946"/>
                        </P>
                        <P>(xv) EADS-PZL “Warszawa-Okeçie” S.A. (type certificate previously held by Panstwowe Zaklady Lotnicze) Model PZL-104 WILGA 80, PZL-104M WILGA 2000, PZL-104MA WILGA 2000, PZL-KOLIBER 150A, and PZL-KOLIBER 160A airplanes;</P>
                        <P>(xvi) Extra Flugzeugproduktions- und Vertriebs- GmbH (type certificate previously held by Extra Flugzeugbau GmbH) Model EA 300, EA 300/L, EA 300/S, EA 300/200, and EA 300/LC airplanes;</P>
                        <P>(xvii) Frakes Aviation Model G-44 (Army OA-14, Navy J4F-2), G-44A, and SCAN Type 30 airplanes;</P>
                        <P>(xviii) FS 2003 Corporation (type certificate previously held by The New Piper Aircraft, Inc.) Model PA-12 and PA-12S airplanes;</P>
                        <P>(xix) GROB Aircraft AG (type certificate previously held by GROB Aerospace GmbH i.l.) Model G115, G115A, G115B, G115C, G115C2, G115D, G115D2, G115EG, and G120A airplanes;</P>
                        <P>(xx) Helio Aircraft, LLC, Model H-250, H-295 (USAF U-10D), H-391 (USAF YL-24), H-391B, H-395 (USAF L-28A and U-10B), H-395A, H-700, H-800, HST-550, HST-550A (USAF AU-24A), and HT-295 airplanes;</P>
                        <P>(xxi) Interceptor Aviation Inc. (type certificate previously held by Interceptor Aircraft Corporation) Model 200, 200A, 200B, 200C, 200D, and 400 airplanes;</P>
                        <P>(xxii) Lockheed Martin Aeronautics Company Model 402-2 airplanes;</P>
                        <P>(xxiii) Maule Aerospace Technology, Inc. (type certificate previously held by Maule Aircraft Corporation), Model Bee Dee M-4, M-4, M-4C, M-4S, M-4T, M-4-180C, M-4-180S, M-4-180T, M-4-210, M-4-210C, M-4-210S, M-4-210T, M-4-220, M-4-220C, M-4-220S, M-4-220T, M-5-180C, M-5-200, M-5-210C, M-5-210TC, M-5-220C, M-5-235C, M-6-180, M-6-235, M-7-235, M-7-235A, M-7-235B, M-7-235C, M-7-260, M-7-260C, M-7-420A, M-7-420AC, M-8-235, MT-7-235, MT-7-260, MT-7-420, MX-7-160, MX-7-160C, MX-7-180, MX-7-180A, MX-7-180AC, MX-7-180B, MX-7-180C, MX-7-235, MX-7-420, MXT-7-160, MXT-7-180, and MXT-7-180A airplanes;</P>
                        <P>(xxiv) Mooney Aircraft Corporation Model M22 airplanes;</P>
                        <P>(xxv) Mooney International Corporation (type certificate previously held by Mooney Aviation Company, Inc.) Model M20, M20A, M20B, M20C, M20D, M20E, M20F, M20G, M20J, M20K, M20L, M20M, M20R, M20S, M20TN, M20U, and M20V airplanes;</P>
                        <P>(xxvi) Pacific Aerospace Ltd. (type certificate previously held by Found Aircraft Canada, Inc.) Model FBA-2C, FBA-2C1, and FBA-2C2 airplanes;</P>
                        <P>(xxvii) Pilatus Aircraft Ltd. Model PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/350-H1, PC-6/350-H2, PC6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1-H2, PC-6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes;</P>
                        <P>(xxviii) Piper Aircraft, Inc. (type certificate previously held by The New Piper Aircraft, Inc.), Model PA-18, PA-18 “105” (Special), PA-18 “125” (Army L-21A), PA-18 “135” (Army L-21B), PA-18 “150,” PA-18A, PA-18A “135,” PA-18A “150,” PA-18AS “125,” PA-18AS “135,” PA-18AS “150,” PA-18S, PA-18S “105” (Special), PA-18S “125,” PA-18S “135,” PA-18S “150,” PA-19 (Army L-18C), PA-19S, PA-20, PA-20 “115,” PA-20 “135,” PA-20S, PA-20S “115,” PA-20S “135,” PA-22, PA-22-108, PA-22-135, PA-22-150, PA-22-160, PA-22S-135, PA-22S-150, PA-22S-160, PA-23, PA-23-160, PA-23-235, PA-23-250, PA-24, PA-24-250, PA-24-260, PA-24-400, PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-201T, PA-28-235, PA-28-236, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, PA-28RT-201T, PA-28S-160, PA-28S-180, PA-30, PA-32-260, PA-32-300, PA-32-301, PA-32-301FT, PA-32-301T, PA-32-301XTC, PA-32R-300, PA-32R-301 (HP), PA-32R-301 (SP), PA-32R-301T, PA-32RT-300, PA-32RT-300T, PA-32S-300, PA-34-200, PA-34-200T, PA-34-220T, PA-39, PA-40, PA-44-180, PA-44-180T, PA-46-310P, and PA-46-350P airplanes;</P>
                        <P>(xxix) Polskie Zaklady Lotnicze Spolka zo.o. (type certificate previously held by PZL MIELEC) Model PZL M26 01 airplanes;</P>
                        <P>(xxx) Revo, Incorporated Model Colonial C-1, Colonial C-2, Lake LA-4, Lake LA-4A, Lake LA-4P, Lake LA-4-200, and Lake Model 250 airplanes;</P>
                        <P>(xxxi) Robert E. Rust, Jr. (type certificate previously held by Robert E. Rust), Model DHC-1 Chipmunk Mk 21, DHC-1 Chipmunk Mk 22, and DHC-1 Chipmunk Mk 22A airplanes;</P>
                        <P>(xxxii) Sierra Hotel Aero, Inc. (type certificate previously held by Navion Aircraft LLC), Model Navion (Army L-17A), Navion A (Army L-17B and L-17C), Navion B, Navion D, Navion E, Navion F, Navion G, and Navion H airplanes;</P>
                        <P>(xxxiii) Slingsby Aviation Ltd. Model T67M260 and T67M260-T3A airplanes;</P>
                        <P>(xxxiv) SOCATA (type certificate previously held by Socata Groupe Aerospatiale) Model MS 880B, MS 885, MS 892A-150, MS 892E-150, MS 893A, MS 893E, MS 894A, MS 894E, Rallye 100S, Rallye 150ST, Rallye 150T, Rallye 235C, Rallye 235E, TB 9, TB 10, TB 20, TB 21, and TB 200 airplanes;</P>
                        <P>(xxxv) Spartan Aircraft Company Model 7W (Army UC-71) airplanes;</P>
                        <P>(xxxvi) SST FLUGTECHNIK GmbH Model EA 400 and EA 400-500 airplanes;</P>
                        <P>(xxxvii) Swift Museum Foundation, Inc. (type certificate previously held by Univair Aircraft Corporation), Model GC-1A and GC-1B airplanes;</P>
                        <P>(xxxviii) Symphony Aircraft Industries Inc. (type certificate previously held by Ostmecklenburgische Flugzeugbau GmbH), Model OMF-100-160 and SA 160 airplanes;</P>
                        <P>(xxxix) Textron Aviation Inc. (type certificate previously held by Cessna Aircraft Company) Model 120, 140, 140A, 150, 150A, 150B, 150C, 150D, 150E, 150F, 150G, 150H, 150J, 150K, 150L, 150M, 152, 170, 170A, 170B, 172, 172A, 172B, 172C, 172D, 172E, 172F (USAF T-41A), 172G, 172H (USAF T-41A), 172I, 172K, 172L, 172M, 172N, 172P, 172Q, 172R, 172RG, 172S, 175, 175A, 175B, 175C, 177, 177A, 177B, 177RG, 180, 180A, 180B, 180C, 180D, 180E, 180F, 180G, 180H, 180J, 180K, 182, 182A, 182B, 182C, 182D, 182E, 182F, 182G, 182H, 182J, 182K, 182L, 182M, 182N, 182P, 182Q, 182R, 182S, 182T, 185, 185A, 185B, 185C, 185D, 185E, 206, 206H, 207, 207A, 210, 210A, 210B, 210C, 210D, 210E, 210F, 210G, 210H, 210J, 210K, 210L, 210M, 210N, 210R, 210-5 (205), 210-5A (205A), 310, 310A (USAF U-3A), 310B, 310C, 310D, 310E (USAF U-3B), 310F, 310G, 310H, 310I, 310J, 310J-1, 310K, 310L, 310N, 310P, 310Q, 310R, 320, 320A, 320B, 320C, 320D, 320E, 320F, 320-1, 335, 336, 337, 337A, 337B, 340, 340A, A150K, A150L, A150M, A152, A185E, A185F, E310H, E310J, LC40-550FG, LC41-550FG, LC42-550FG, P172D, P206, P206A, P206B, P206C, P206D, P206E, P210N, P210R, R172E (USAF T-41B, USAF T-41C and D), R172F (USAF T-41D), R172G (USAF T-41C and D), R172H (USAF T-41D), R172J, R172K, R182, T182, T182T, T206H, T207, T207A, T210F, T210G, T210H, T210J, T210K, T210L, T210M, T210N, T210R, T303, T310P, T310Q, T310R, TP206A, TP206B, TP206C, TP206D, TP206E, TR182, TU206A, TU206B, TU206C, TU206D, TU206E, TU206F, TU206G, U206, U206A, U206B, U206C, U206D, U206E, U206F, and U206G airplanes;</P>
                        <P>(xl) Textron Aviation Inc. (type certificate previously held by Beechcraft Corporation), Model 19A, 23, 35, 35R, 35-33, 35-A33, 35-B33, 35-C33, 35-C33A, 36, 45 (YT-34), 50 (L-23A), 56TC, 58, 58A, 58P, 58PA, 58TC, 58TCA, 76, 95, 95-55, 95-A55, 95-B55, 95-B55A, 95-B55B (T-42), 95-C55, 95-C55A, A23, A23A, A23-19, A23-24, A24, A24R, A35, A36, A36TC, A45 (T-34A, B-45), A56TC, B19, B23, B24R, B35, B36TC, B50 (L-23B), B95, B95A, C23, C24R, C35, C50, D35, D45 (T-34B), D50 (L-23E), D50A, D50B, D50C, D50E, D50E-5990, D55, D55A, D95A, E33, E33A, E33C, E35, E50 (L-23D, RL-23D), E55, E55A, E95, F33, F33A, F33C, F35, F50, G33, G35, G50, H35, H50, J35, J50, K35, M19A, M35, N35, P35, S35, V35, V35A, and V35B airplanes;</P>
                        <P>(xli) The Boeing Company (type certificate previously held by Rockwell International) Model AT-6 (SNJ-2), AT-6A (SNJ-3), AT-6B, AT-6C (SNJ-4), AT-6D (SNJ-5), AT-6F (SNJ-6, SNJ-7), BC-1A, and T-6G airplanes;</P>
                        <P>(xlii) The King's Engineering Fellowship (TKEF) Model 44 airplanes;</P>
                        <P>(xliii) The Waco Aircraft Company Model YMF airplanes;</P>
                        <P>(xliv) Topcub Aircraft, Inc., Model CC18-180 and CC18-180A airplanes;</P>
                        <P>(xlv) True Flight Holdings LLC (type certificate previously held by Tiger Aircraft LLC) Model AA-1, AA-1A, AA-1B, AA-1C, AA-5, AA-5A, AA-5B, and AG-5B airplanes;</P>
                        <P>(xlvi) Twin Commander Aircraft LLC (type certificate previously held by Twin Commander Aircraft Corporation) Model 500, 520, 560, and 560A airplanes;</P>
                        <P>(xlvii) Univair Aircraft Corporation Model 108, 108-1, 108-2, 108-3, and 108-5 airplanes;</P>
                        <P>(xlviii) Viking Air Limited (type certificate previously held by Bombardier Inc. and deHavilland Inc.) Model DHC-2 Mk. I, DHC-2 Mk. II, and DHC-2 Mk. III airplanes;</P>
                        <P>
                            (xlix) Vulcanair S.p.A. (type certificate previously held by Partenavia Costruzioni Aeronautiche S.p.A.) Model AP68TP-300 “Spartacus,” AP68TP-600 “Viator,” P.68, P.68 “Observer,” P.68 “Observer 2,” P.68B, P.68C, P.68C-TC, and P.68TC “Observer” airplanes;
                            <PRTPAGE P="49947"/>
                        </P>
                        <P>(l) WSK PZL Mielec and OBR SK Mielec Model PZL M20 03 airplanes;</P>
                        <P>(li) W.Z.D. Enterprises Inc. (type certificate previously held by JGS Properties, LLC) Model 11A and 11E airplanes;</P>
                        <P>(lii) Zenair Ltd. Model CH2000 airplanes; and</P>
                        <P>(liii) Zlin Aircraft a.s. (type certificate previously held by Moravan a.s.) Model Z-143L and Z-242L airplanes.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 3410, FLIGHT ENVIRONMENT DATA; 3420, ATTITUDE AND DIRECTION DATA SYSTEM.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by an automatic reset occurring when the display internal monitor detects a potential fault causing intermittent loss of airspeed, attitude, and altitude information during flight. The FAA is issuing this AD to address the software interacting with a graphics processing chip defect. The unsafe condition, if not addressed, could result in intermittent loss of airspeed, attitude, and altitude information during flight with consequent loss of airplane control.</P>
                        <HD SOURCE="HD1">(f) Compliance</HD>
                        <P>Comply with this AD within the compliance times specified, unless already done.</P>
                        <HD SOURCE="HD1">(g) Required Actions</HD>
                        <P>(1) Before further flight, revise the limitations section of the airplane flight manual (AFM) for your airplane by inserting a copy of this AD or by making a pen and ink change to add: “Operation under Instrument Flight Rules (IFR) or night Visual Flight Rules (VFR) is prohibited.”</P>
                        <P>(2) The action required by paragraph (g)(1) of this AD may be performed by the owner/operator (pilot) holding at least a private pilot certificate and must be entered into the aircraft records showing compliance with this AD in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR 91.417(a)(2)(v). The record must be maintained as required by 14 CFR 91.417. This authority is not applicable to aircraft being operated under 14 CFR part 119.</P>
                        <HD SOURCE="HD1">(h) Special Flight Permit</HD>
                        <P>Special flight permits are prohibited.</P>
                        <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>(1) The Manager, Fort Worth ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j).</P>
                        <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                        <HD SOURCE="HD1">(j) Related Information</HD>
                        <P>
                            For more information about this AD, contact Mahmood Shah, Aerospace Engineer, Fort Worth ACO Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; phone: 817-222-5133; fax: 817-222-5960; email: 
                            <E T="03">mahmood.shah@faa.gov</E>
                            .
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on August 11, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17902 Filed 8-14-20; 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-2020-0717; Product Identifier 2019-CE-038-AD; Amendment 39-21196; AD 2020-16-12]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Pacific Aerospace Limited 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; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is adopting a new airworthiness directive (AD) for Pacific Aerospace Limited Model 750XL airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as inadvertent fuel shut-off to the engine during the operation of the flaps due to the fuel and flap control levers being located too closely together. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 8, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of September 8, 2020.</P>
                    <P>The FAA must receive comments on this AD by October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        For service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email: 
                        <E T="03">pacific@aerospace.co.nz</E>
                        ; internet: 
                        <E T="03">https://www.aerospace.co.nz.</E>
                         You may view this referenced service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for Docket No. FAA-2020-0717.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0717; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mike Kiesov, Aerospace Engineer, FAA, General Aviation &amp; Rotorcraft Section, International Validation Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4144; fax: (816) 329-4090; email: 
                        <E T="03">mike.kiesov@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Discussion</HD>
                <P>The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD DCA/750XL/39, dated September 5, 2019 (referred to after this as “the MCAI”), to correct an unsafe condition for Pacific Aerospace Limited Model 750XL airplanes. The MCAI states:</P>
                <EXTRACT>
                    <P>
                        DCA/750XL/39 with effective date 5 September 2019 is prompted by the findings of an accident investigation. The report recommended that an effective lock mechanism should be introduced for the fuel condition lever in order to prevent inadvertent fuel shut-off to the engine during the operation of the flaps, as the fuel and flap control levers are closely located.
                        <PRTPAGE P="49948"/>
                    </P>
                    <P>Pacific Aerospace Mandatory Service Bulletin (MSB) PACSB/XL/111 issue 1, dated 18 June 2019 introduces a fuel condition lever inspection and instructions to adjust the position of the fuel condition lever to ensure it rests against the left hand side of the control guide slot when selected to the ground idle position.</P>
                </EXTRACT>
                <FP>
                    You may examine the MCAI on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0717.
                </FP>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Pacific Aerospace Mandatory Service Bulletin PACSB/XL/111, Issue 1, dated June 18, 2019. The service information contains procedures for inspecting and adjusting the position of the fuel condition lever relative to the control guide, which assists in prevention of inadvertent movement of the power lever into the cutoff position if ground idle is selected. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination and Requirements of the AD</HD>
                <P>This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this AD because it evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">FAA's Determination of the Effective Date</HD>
                <P>An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because of several reported engine failures on these airplanes due to inadvertent movement of the power lever into the cutoff position if ground idle is selected. Engine failure could result in loss of airplane control. The risk assessment received by the FAA, and reconfirmed in July of 2020, indicates that urgent action is required. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include the Docket Number FAA-2020-0717 and Product Identifier 2019-CE-038-AD at the beginning of your comments. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact we receive about this final rule.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD will affect 22 products of U.S. registry. The FAA also estimates that it will take 1 work-hour per product to comply with the inspection requirement of this AD. The average labor rate is $85 per work-hour.</P>
                <P>Based on these figures, the FAA estimates the cost of this AD on U.S. operators to be $1,870, or $85 per product.</P>
                <P>In addition, the FAA estimates that any necessary follow-on actions will take 4 work-hours and require parts costing $20, for a cost of $360 per product. The FAA has no way of determining the number of products that may need these actions.</P>
                <P>According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in our cost estimate.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA 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:
                    <PRTPAGE P="49949"/>
                </P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866, and</P>
                <P>(2) Will not affect intrastate aviation in Alaska.</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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2020-16-12 Pacific Aerospace Limited:</E>
                             Amendment 39-21196; Docket No. FAA-2020-0717; Product Identifier 2019-CE-038-AD.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This airworthiness directive (AD) becomes effective September 8, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to Pacific Aerospace Limited Model 750XL airplanes, serial numbers 101 through 216, 220, 8001, and 8002, certificated in any category.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Air Transport Association of America (ATA) Code 76: Engine Controls.</P>
                        <HD SOURCE="HD1">(e) Reason</HD>
                        <P>This AD was prompted by inadvertent fuel shut-off to the engine during the operation of the flaps, due to the fuel and flap control levers being located too closely together. The FAA is issuing this AD to adjust the position of the fuel condition lever relative to the control guide, which will prevent inadvertent movement of the power lever into the cutoff position if ground idle is selected and result in engine failure and loss of airplane control.</P>
                        <HD SOURCE="HD1">(f) Actions and Compliance</HD>
                        <P>Unless already done, within the next 30 days after September 8, 2020 (the effective date of this AD), inspect the position of the fuel condition lever by following the Accomplishment Instructions, paragraph 2(1), of Pacific Aerospace Mandatory Service Bulletin PACSB/XL/111, Issue 1, dated June 18, 2019 (MSB PACSB/XL/111). If the fuel condition lever is not positioned against the left side of the control guide slot in the ground idle position, before further flight, adjust the fuel condition level position by following the Accomplishment Instructions, paragraph 2(3), of MSB PACSB/XL/111.</P>
                        <HD SOURCE="HD1">(g) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            The Manager, Small Airplane General Aviation &amp; Rotorcraft Section, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, General Aviation &amp; Rotorcraft Section, International Validation Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4144; fax: (816) 329-4090; email: 
                            <E T="03">mike.kiesov@faa.gov.</E>
                             Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
                        </P>
                        <HD SOURCE="HD1">(h) Related Information</HD>
                        <P>
                            Refer to mandatory continuing airworthiness information (MCAI) CAA AD No. DCA/750XL/39, dated September 5, 2019, for related information. You may examine the MCAI on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for and locating Docket No. FAA-2020-0717.
                        </P>
                        <HD SOURCE="HD1">(i) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Pacific Aerospace Mandatory Service Bulletin PACSB/XL/111, Issue 1, dated June 18, 2019.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (3) For Pacific Aerospace Limited service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; phone: +64 7843 6144; fax: +64 7843 6134; email: 
                            <E T="03">pacific@aerospace.co.nz</E>
                            ; internet: 
                            <E T="03">https://www.aerospace.co.nz.</E>
                        </P>
                        <P>
                            (4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for locating Docket No. FAA-2020-0717.
                        </P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                              
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on August 5, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17865 Filed 8-14-20; 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-2020-0716; Product Identifier 2019-CE-009-AD; Amendment 39-21191; AD 2020-16-07]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Pacific Aerospace Limited 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; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is adopting a new airworthiness directive (AD) for Pacific Aerospace Limited Model 750XL airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as nose landing gear (NLG) and main landing gear (MLG) attachment bolts without dual retaining devices. The FAA is issuing this AD to require actions to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 8, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of September 8, 2020.</P>
                    <P>The FAA must receive comments on this AD by October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                        <PRTPAGE P="49950"/>
                    </P>
                    <P>
                        For service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; telephone: +64 7 843 6144; facsimile: +64 7 843 6134; email: 
                        <E T="03">pacific@aerospace.co.nz;</E>
                         internet: 
                        <E T="03">https://www.aerospace.co.nz.</E>
                         You may view this referenced service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for Docket No. FAA-2020-0716.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0716; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this AD, the regulatory evaluation, any comments received, and other information. The street address for Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4144; fax: (816) 329-4090; email: 
                        <E T="03">mike.kiesov@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Discussion</HD>
                <P>The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD DCA/750XL/32B, dated February 7, 2019 (referred to after this as “the MCAI”), to correct an unsafe condition for Pacific Aerospace Limited Model 750XL airplanes. In its notification of the MCAI, the CAA states:</P>
                <EXTRACT>
                    <P>DCA/750XL/32B with effective date 7 February 2019 is prompted by several reports of finding loose nose landing gear attachment lock nuts and pal nuts. This [CAA] AD revised to mandate Pacific Aerospace Mandatory Service Bulletin (MSB) PACSB/XL/105 issue 4, dated 19 December 2018, which introduces alternate bolts for [part number] P/N NAS6606D63 and NAS6606D68.</P>
                </EXTRACT>
                <P>The MCAI is part of an extensive evaluation and investigation by the New Zealand CAA on the Pacific Aerospace Model 750XL. The unsafe condition results from a production quality issue where the MLG and NLG attachment bolts may not have the required dual retaining devices installed. Therefore, the MCAI requires an inspection of the MLG and the NLG. The NLG requires the installation of a castellated nyloc locking nut and a split pin. The MLG requires the inspection and installation of Palnuts on any attachment bolts that do not have a Palnut installed. This condition, if not detected and corrected, could lead to failure of the NLG and MLG.</P>
                <P>
                    You may examine the MCAI on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0716.
                </P>
                <HD SOURCE="HD1">Differences Between the MCAI and This AD</HD>
                <P>The MCAI allows a licensed pilot rated for this airplane to do daily visual inspections of the nose landing gear lower bolts and clamp for security for up to 165 hours time-in-service until the terminating corrective action is performed. The FAA's regulations do not allow pilots to perform maintenance, which includes inspections, on U.S.-certificated airplanes. Therefore, this AD does not include the daily inspection requirement and requires a shorter compliance time for the terminating corrective action to address the unsafe condition in a timely manner.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Pacific Aerospace Mandatory Service Bulletin PACSB/XL/105, Issue 4, dated December 19, 2018. The service information contains procedures for inspecting the NLG lower bolts and clamp for security, replacing the NLG locking nut and Palnut with a castellated nyloc locking nut and split pin, and inspecting the MLG attachment bolts and installing Palnuts as necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Other Related Information</HD>
                <P>The FAA also reviewed Pacific Aerospace Drawing BOL6603 THRU 6620, dated December 19, 2018. This drawing contains additional information related to fabrication of the required part number bolts for the NLG.</P>
                <HD SOURCE="HD1">FAA's Determination and Requirements of the AD</HD>
                <P>This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this AD because it evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.</P>
                <HD SOURCE="HD1">FAA's Determination of the Effective Date</HD>
                <P>An unsafe condition exists that requires the immediate adoption of this AD. The risk assessment received by the FAA, and reconfirmed in July of 2020, indicates that urgent action is required. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because without the required dual retaining devices, the NLG and the MLG could fail and result in reduced control on the ground and lead to a runway excursion. Because this AD does not include the daily inspections, the FAA finds that compliance is necessary within 20 hours time-in-service or 30 days, whichever occurs first, to address the unsafe condition. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, the FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include the Docket Number FAA-2020-0716 and Product Identifier 2019-CE-009-AD at the beginning of your comments. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact we receive about this final rule.
                    <PRTPAGE P="49951"/>
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD will affect 22 products of U.S. registry. The FAA also estimates that it would take about 5 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $20 per product.</P>
                <P>Based on these figures, the FAA estimates the cost of the AD on U.S. operators to be $9,790, or $445 per product.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA 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, and</P>
                <P>(2) Will not affect intrastate aviation in Alaska.</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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2020-16-07 Pacific Aerospace Limited:</E>
                             Amendment 39-21191; Docket No. FAA-2020-0716; Product Identifier 2019-CE-009-AD.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This airworthiness directive (AD) becomes effective September 8, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to Pacific Aerospace Limited Model 750XL airplanes, serial numbers (S/Ns) up to and including 216, 220, 8001, and 8002, certificated in any category.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Air Transport Association of America (ATA) Code 32: Landing Gear.</P>
                        <HD SOURCE="HD1">(e) Reason</HD>
                        <P>This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as nose landing gear (NLG) and main landing gear (MLG) attachment bolts without dual retaining devices. The FAA is issuing this AD to prevent the NLG and MLG attachment bolts from detaching, which if not corrected could lead to failure of the landing gear.</P>
                        <HD SOURCE="HD1">(f) Actions and Compliance</HD>
                        <P>Unless already done, comply with this AD within 20 hours time-in-service after September 8, 2020 (the effective date of this AD) or within 30 days after September 8, 2020 (the effective date of this AD), whichever occurs first.</P>
                        <P>(1) Replace each NLG upper and lower attachment lock nut and Palnut with castellated nyloc locking nuts and spring/split pins by following steps 6 and 8 in Part B-Accomplishment Instructions (Nose Landing Gear) of Pacific Aerospace Mandatory Service Bulletin PACSB/XL/105, Issue 4, dated December 19, 2018 (PACSB/XL/105, Issue 4).</P>
                        <P>(2) For airplanes with a S/N up to and including 185, except S/N 177 and except airplanes with modification PAC/XL/0448: inspect the upper and lower attachment bolts on both MLGs for the installation of Palnuts (four on each MLG) as depicted in figure 6 in Part C—Accomplishment Instructions (Main Landing Gear) of PACSB/XL/105, Issue 4.</P>
                        <P>(i) If Palnuts are installed in all eight locations (four on each MLG), no further action is required.</P>
                        <P>(ii) If a Palnut is not installed on an MLG attachment bolt, before further flight, check the torque of the attachment bolt and install a Palnut by following steps 5 through 7 in Part C-Accomplishment Instructions (Main Landing Gear) of PACSB/XL/105, Issue 4.</P>
                        <HD SOURCE="HD1">(g) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            The Manager, Small Airplane Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Mike Kiesov, Aerospace Engineer, FAA, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4144; fax: (816) 329-4090; email: 
                            <E T="03">mike.kiesov@faa.gov.</E>
                             Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
                        </P>
                        <HD SOURCE="HD1">(h) Related Information</HD>
                        <P>
                            Refer to MCAI Civil Aviation Authority AD No. DCA/750XL/32B, dated February 7, 2019, for related information. You may also refer to Pacific Aerospace Drawing BOL6603 THRU 6620, Issue A1, dated December 19, 2018, for additional information related to this AD. You may examine the MCAI on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for and locating Docket No. FAA-2020-0716.
                            <PRTPAGE P="49952"/>
                        </P>
                        <HD SOURCE="HD1">(i) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Pacific Aerospace Mandatory Service Bulletin PACSB/XL/105, Issue 4, dated December 19, 2018.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (3) For Pacific Aerospace Limited service information identified in this AD, contact Pacific Aerospace Limited, Airport Road, Hamilton, Private Bag 3027, Hamilton 3240, New Zealand; phone: +64 7843 6144; fax: +64 7843 6134; email: 
                            <E T="03">pacific@aerospace.co.nz;</E>
                             internet: 
                            <E T="03">https://www.aerospace.co.nz.</E>
                        </P>
                        <P>
                            (4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for and locating Docket No. FAA-2020-0716.
                        </P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on July 29, 2020.</DATED>
                    <NAME>Gaetano A. Sciortino,</NAME>
                    <TITLE>Deputy Director for Strategic Initiatives, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17864 Filed 8-14-20; 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-2019-1115; Project Identifier 2018-SW-065-AD; Amendment 39-21203; AD 2020-16-19]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Sikorsky Aircraft Corporation Helicopters</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 Sikorsky Aircraft Corporation (Sikorsky) Model S-92A helicopters. This AD was prompted by two incidents of erroneous low oil pressure caution cockpit indications and unintended actuation of the main gearbox (MGB) auto bypass valve. This AD requires installing auxiliary circuit breaker modification (MOD) kits and inserting a Rotorcraft Flight Manual (RFM) Supplement into the existing RFM for your helicopter. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 21, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 21, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this final rule, contact your local Sikorsky Field Representative or Sikorsky's Service Engineering Group at Sikorsky Aircraft Corporation, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-946-4337 (1-800-Winged-S); email 
                        <E T="03">wcs_cust_service_eng.gr-sik@lmco.com.</E>
                         Operators may also log on to the Sikorsky 360 website at 
                        <E T="03">https://www.sikorsky360.com.</E>
                         You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call 817-222-5110. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2019-1115.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2019-1115; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Michael Schwetz, Aviation Safety Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; telephone 781-238-7761; email 
                        <E T="03">michael.schwetz@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Sikorsky Model S-92A helicopters, serial number (S/N) 920006 through 920304 inclusive and S/N 920311 through 920314 inclusive. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on February 18, 2020 (85 FR 8771). The NPRM was prompted by two incidents of erroneous low oil pressure caution cockpit indications and unintended actuation of the MGB auto bypass valve caused by unintended popping of the M XMSN OIL WARN circuit breaker during flight. The root cause of this circuit breaker popping is unknown. When this circuit breaker trips, the following cautions will display “MGB PUMP 1 FAIL, MGB PUMP 2 FAIL, MGB OIL HOT, MGB MAN COOL, MGB OIL PRES.” With the MGB auto bypass valve actuated, the MGB BYPASS caution will not annunciate. For the given conditions, the appropriate action for the crew is “land as soon as possible” in accordance with the RFM Emergency Procedures. The erroneous indications conflicting with correct gauge readings may overwhelm the flight crew, resulting in a forced landing of the helicopter.
                </P>
                <P>To address this unsafe condition, Sikorsky developed MOD kits based on helicopter S/N to introduce a separate circuit breaker for the MGB last jet pressure switch. These MOD kits specify reworking the overhead panel to install new clips and brackets, circuit breaker wiring harnesses, wiring MODs, the auxiliary circuit breaker panel, and the M XMSN PRESS SWITCH circuit breaker. Accordingly, the NPRM proposed to require installing MOD kits and inserting an RFM Supplement into the existing RFM for your helicopter. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA gave the public the opportunity to participate in developing this final rule. The FAA received comments from one commenter. The following presents the comments received on the NPRM and the FAA's response to the comments.</P>
                <HD SOURCE="HD1">Request</HD>
                <P>The commenter expressed concern about the compliance time of 400 hours time-in-service (TIS), described it as a substantial amount of time, and suggested operators fix the problem immediately. The commenter did not provide a technical rationale for the FAA to review.</P>
                <P>
                    The FAA disagrees that a shorter compliance time is required to correct the unsafe condition. In determining that a compliance time of 400 hours TIS mitigates the risk to an acceptable level, the FAA considered factors including Sikorsky service information, the scope of the required actions in this AD, and 
                    <PRTPAGE P="49953"/>
                    the scheduled maintenance for Sikorsky Model S-92A helicopters.
                </P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>The FAA reviewed Sikorsky Special Service Instructions No. 92-121, dated October 26, 2017 (SSI 92-121). This service information describes procedures for installing an auxiliary circuit breaker panel MOD kit and M XMSN PRESS SWITCH circuit breaker MOD kit based on helicopter S/N.</P>
                <P>The FAA also reviewed RFM Supplement No. 45, Revision No. 2, Sikorsky Model S-92A, Part 1, dated April 27, 2017 (S-92A RFMS 45, Part 1, Revision 2). This service information specifies operating limitations, preflight checks, normal and emergency procedures, and malfunction information for helicopters with Avionics Management System version 7.1 or 8.0 with the MGB OIL OUT warning activated, pump failure indicating system, MGB auto bypass, and M XMSN PRESS SWITCH circuit breaker installed.</P>
                <P>
                    This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Other Related Service Information</HD>
                <P>The FAA reviewed Sikorsky S-92 Helicopter Alert Service Bulletin 92-63-037, Revision A, dated March 1, 2018. This service information contains planning information pertaining to the auxiliary circuit breaker panel and M XMSN PRESS SWITCH circuit breaker MOD kits, accomplishing SSI 92-121, and inserting S-92A RFMS 45, Part 1, Revision 2 into the helicopter cockpit.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 36 helicopters of U.S. registry. Labor costs are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.</P>
                <P>Modifying helicopters S/N 920006 through 920296 inclusive will take about 48 work-hours and parts will cost about $1,618 for an estimated cost of $5,698 per helicopter and $182,336 for the U.S. fleet size of 32 helicopters.</P>
                <P>Modifying helicopters S/N 920297 through 920304 inclusive and S/N 920311 through 920314 inclusive will take about 2 work-hours and parts will cost about $65 for an estimated cost of $235 per helicopter and $940 for the U.S. fleet size of 4 helicopters.</P>
                <P>Revising the RFM will take about 0.5 work-hour for an estimated cost of $43 per helicopter and $1,548 for the U.S. fleet.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>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) Will not affect intrastate aviation in Alaska, 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>
                <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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <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 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">2020-16-19 Sikorsky Aircraft Corporation:</E>
                             Amendment 39-21203; Docket No. FAA-2019-1115; Project Identifier 2018-SW-065-AD.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This AD is effective September 21, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to Sikorsky Aircraft Corporation Model S-92A helicopters, serial number (S/N) 920006 through 920304 inclusive and S/N 920311 through 920314 inclusive, certificated in any category.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Joint Aircraft System Component (JASC) Code: 6340, Rotor Drive Indicating System.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by two incidents of erroneous low oil pressure caution cockpit indications and unintended actuation of the main gearbox (MGB) auto bypass valve. The FAA is issuing this AD to prevent the M XMSM OIL WARN circuit breaker from presenting erroneous cautions when tripped. The unsafe condition, if not addressed, could result in erroneous low oil pressure caution cockpit indication, unintended actuation of the MGB auto bypass valve, increased oil temperature, conflicting indications, and forced landing of the helicopter.</P>
                        <HD SOURCE="HD1">(f) Compliance</HD>
                        <P>Comply with this AD within the compliance times specified, unless already done.</P>
                        <HD SOURCE="HD1">(g) Required Actions</HD>
                        <P>Within 400 hours time-in-service:</P>
                        <P>(1) For helicopters S/N 920006 through 920296 inclusive:</P>
                        <P>(i) Install Modification (MOD) Kit Clips and Brackets part number (P/N) 92070-20115-015 by following the Instructions, paragraph B. of Sikorsky Special Service Instructions No. 92-121, dated October 26, 2017 (SSI 92-121).</P>
                        <P>(ii) Install the first portion of MOD Kit Auxiliary Circuit Breaker Panel P/N 92070-55075-011 by following the Instructions, paragraph C. of Sikorsky SSI 92-121.</P>
                        <P>(iii) Install MOD Kit Left Hand (LH) Cockpit Auxiliary Power Unit P/N 92070-55096-012 by following the Instructions, paragraph D. of Sikorsky SSI 92-121.</P>
                        <P>
                            (iv) Install MOD Kit LH Cabin Auxiliary Power Unit P/N 92070-55096-013 by following the Instructions, paragraph E. of Sikorsky SSI 92-121.
                            <PRTPAGE P="49954"/>
                        </P>
                        <P>(v) Install MOD Kit LH Top Deck FLD P/N 92070-55096-016 by following the Instructions, paragraph F. of Sikorsky SSI 92-121.</P>
                        <P>(vi) Install MOD Kit MGB XMSN P/N 92070-55096-017 by following the Instructions, paragraph G. of Sikorsky SSI 92-121.</P>
                        <P>(vii) Install the completion portion of MOD Kit Auxiliary Circuit Break Panel P/N 92070-55075-011 by following the Instructions, paragraph H. of Sikorsky SSI 92-121.</P>
                        <P>(viii) Install MOD Kit Auxiliary Cabin Panel Faceplate P/N 92070-55075-012 by following the Instructions, paragraph J. of Sikorsky SSI 92-121.</P>
                        <P>(2) For helicopters S/N 920297 through 920304 inclusive and S/N 920311 through 920314 inclusive:</P>
                        <P>(i) Modify the auxiliary circuit breaker panel and transmission harness by following the Instructions, paragraph I. of Sikorsky SSI 92-121.</P>
                        <P>(ii) Install MOD Kit Auxiliary Cabin Panel Faceplate P/N 92070-55075-012 by following the Instructions, paragraph J. of Sikorsky SSI 92-121.</P>
                        <P>(3) Insert a copy of the Rotorcraft Flight Manual (RFM) Supplement No. 45, Revision No. 2, Sikorsky Model S-92A, Part 1, dated April 27, 2017, into the existing RFM for your helicopter.</P>
                        <HD SOURCE="HD1">(h) Credit for Previous Actions</HD>
                        <P>Completion of the Accomplishment Instructions of Sikorsky S-92 Helicopter Alert Service Bulletin 92-63-037, Revision A, dated March 1, 2018, before the effective date of this AD is considered acceptable for compliance with the actions required by paragraph (g) of this AD.</P>
                        <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>(1) The Manager, Boston ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD.</P>
                        <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                        <HD SOURCE="HD1">(j) Related Information</HD>
                        <P>
                            For more information about this AD, contact Michael Schwetz, Aviation Safety Engineer, Boston ACO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; telephone 781-238-7761; email 
                            <E T="03">michael.schwetz@faa.gov.</E>
                        </P>
                        <HD SOURCE="HD1">(k) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Sikorsky Special Service Instructions No. 92-121, dated October 26, 2017.</P>
                        <P>(ii) Rotorcraft Flight Manual Supplement No. 45, Revision No. 2, Sikorsky Model S-92A, Part 1, dated April 27, 2017.</P>
                        <P>
                            (3) For Sikorsky Aircraft Corporation service information identified in this AD, contact your local Sikorsky Field Representative or Sikorsky's Service Engineering Group at Sikorsky Aircraft Corporation, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-946-4337 (1-800-Winged-S); email 
                            <E T="03">wcs_cust_service_eng.gr-sik@lmco.com.</E>
                             Operators may also log on to the Sikorsky 360 website at 
                            <E T="03">https://www.sikorsky360.com.</E>
                        </P>
                        <P>(4) You may view this service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call 817-222-5110.</P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on July 30, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17894 Filed 8-14-20; 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-2020-0222; Project Identifier AD-2019-00116-E; Amendment 39-21195; AD 2020-16-11]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Continental Aerospace Technologies, Inc. (Type Certificate Previously Held by Continental Motors, Inc.) Reciprocating Engines</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 all Continental Aerospace Technologies, Inc. model GTSIO-520-C, GTSIO-520-D, GTSIO-520-H, GTSIO-520-K, GTSIO-520-L, GTSIO-520-M, GTSIO-520-N, IO-550-G, IO-550-N, IO-550-P, IO-550-R, IOF-550-N, IOF-550-P, IOF-550-R, TSIO-520-BE, TSIO-550-A, TSIO-550-B, TSIO-550-C, TSIO-550-E, TSIO-550-G, TSIO-550-K, TSIO-550-N, TSIOF-550-D, TSIOF-550-J, TSIOF-550-K, and TSIOF-550-P reciprocating aviation gasoline (AvGas) engines with a certain cross-flow cylinder assembly installed. This AD was prompted by reports of in-flight engine failures due to fractured cross-flow cylinder assemblies. This AD requires visual inspection and, depending on the results of the inspection, modification or replacement of the cross-flow cylinder assembly. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 21, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of September 21, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this final rule, contact Continental Aerospace Technologies, Inc., 2039 South Broad Street, Mobile, Alabama 36615; phone: 251-436-8299; website: 
                        <E T="03">http://www.continentalmotors.aero.</E>
                         You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2020-0222.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0222; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Boyce Jones, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: 404-474-5535; fax: 404-474-5606; email: 
                        <E T="03">boyce.jones@faa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Continental Aerospace 
                    <PRTPAGE P="49955"/>
                    Technologies, Inc. model GTSIO-520-C, GTSIO-520-D, GTSIO-520-H, GTSIO-520-K, GTSIO-520-L, GTSIO-520-M, GTSIO-520-N, IO-550-G, IO-550-N, IO-550-P, IO-550-R, IOF-550-N, IOF-550-P, IOF-550-R, TSIO-520-BE, TSIO-550-A, TSIO-550-B, TSIO-550-C, TSIO-550-E, TSIO-550-G, TSIO-550-K, TSIO-550-N, TSIOF-550-D, TSIOF-550-J, TSIOF-550-K, and TSIOF-550-P reciprocating AvGas engines with a certain cross-flow cylinder assembly installed. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on April 17, 2020 (85 FR 21336). The NPRM was prompted by reports of in-flight engine failures due to fractured cross-flow cylinder assemblies. The NPRM proposed to require visual inspection of the cross-flow cylinder assembly and, depending on the results of the inspection, modification or replacement of the cross-flow cylinder assembly. The FAA is issuing this AD to address the unsafe condition on these products.
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comment received on the NPRM and the FAA's response to the comment.</P>
                <HD SOURCE="HD1">Request To Revise Compliance</HD>
                <P>An individual commenter requested that the FAA revise the beginning of paragraph (g)(2), Required Actions, of this AD from “If the engine has 500 engine operating hours or greater on the effective date of this AD . . .” to “If the engine has 500 engine operating hours or greater after the effective date of this AD . . .” The commenter reasoned that the AD, as written, could allow aircraft operated exclusively under 14 CFR part 91 with fewer than 500 engine operating hours on the effective date of the AD to fly for an unlimited number of engine operating hours until the next annual inspection, as the 100-hour inspection is not required for part 91 operations.</P>
                <P>The FAA partially agrees. The FAA agrees that part 91 operators may fly their aircraft for an unlimited number of engine operating hours between annual inspections. Historically, the typical part 91 operator flies fewer than 100 engine operating hours per year, however. The FAA has reviewed the specific scenario outlined by the commenter and evaluated it against the associated risk assessment. The FAA disagrees with the commenter's request to revise the language in paragraph (g)(2), Required Actions, of this AD. Any aircraft with an affected engine, regardless of how they are being operated, must comply within the compliance times contained in the Required Actions section of this AD. All affected engines with fewer than 500 engine operating hours on the effective date of this AD must perform the visual inspection of the cross-flow cylinder assembly at the next 100-hour inspection or the next annual inspection, depending on aircraft operation. All affected engines with 500 engine operating hours or greater on the effective date of this AD must perform the visual inspection of the cross-flow cylinder assembly at the next maintenance event, not to exceed 50 engine operating hours, after the effective date of the AD. The FAA did not change this AD.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed except for minor editorial changes. The FAA has determined that these minor changes:</P>
                <P>• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and</P>
                <P>• Do not add any additional burden upon the public than was already proposed in the NPRM.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Continental Aerospace Technologies, Inc. Mandatory Service Bulletin (MSB) 18-08, Revision B, dated January 13, 2020. The MSB describes procedures for inspection, modification, or replacement of the cross-flow cylinder assembly. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 4,000 engines installed on airplanes of U.S. registry.</P>
                <P>The FAA estimates the following costs to comply with this AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s75,r75,12,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Visual inspection of the cross-flow cylinder assembly</ENT>
                        <ENT>2 work-hours × $85 per hour = $170</ENT>
                        <ENT>$0</ENT>
                        <ENT>$170</ENT>
                        <ENT>$680,000</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary modification or replacement of the cross-flow cylinder assembly that would be required based on the results of the visual inspection. The FAA has no way of determining the number of cross-flow cylinder assemblies that might need this modification or replacement:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s75,r75,12,12">
                    <TTITLE>On-Condition Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per 
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Modify the cross-flow cylinder assembly</ENT>
                        <ENT>1 work-hour × $85 per hour = $85</ENT>
                        <ENT>$0</ENT>
                        <ENT>$85</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Replace the cross-flow cylinder assembly</ENT>
                        <ENT>11.5 work-hours × $85 per hour = $977.50</ENT>
                        <ENT>1,933.28</ENT>
                        <ENT>2,910.78</ENT>
                    </ROW>
                </GPOTABLE>
                <P>According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in our cost estimate.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>
                    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, 
                    <PRTPAGE P="49956"/>
                    section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
                </P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>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) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would 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>
                <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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <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">2020-16-11 Continental Aerospace Technologies, Inc. (Type Certificate previously held by Continental Motors, Inc.):</E>
                             Amendment 39-21195; Docket No. FAA-2020-0222; Project Identifier AD-2019-00116-E.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This AD is effective September 21, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to Continental Aerospace Technologies, Inc. (Type Certificate previously held by Continental Motors, Inc.) model GTSIO-520-C, GTSIO-520-D, GTSIO-520-H, GTSIO-520-K, GTSIO-520-L, GTSIO-520-M, GTSIO-520-N, IO-550-G, IO-550-N, IO-550-P, IO-550-R, IOF-550-N, IOF-550-P, IOF-550-R, TSIO-520-BE, TSIO-550-A, TSIO-550-B, TSIO-550-C, TSIO-550-E, TSIO-550-G, TSIO-550-K, TSIO-550-N, TSIOF-550-D, TSIOF-550-J, TSIOF-550-K, and TSIOF-550-P reciprocating aviation gasoline (AvGas) engines, originally manufactured, rebuilt, or modified with a cross-flow cylinder assembly replacement, on or after November 1, 2014, and with a cross-flow cylinder assembly, part number (P/N) 658538, 658540, 658542, 658591, 658595, 658613, 658624, 658539, 658541, 658590, 658594, 658603, 658623, or 658630, installed.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Joint Aircraft System Component (JASC) Code 8530, Reciprocating Cylinder Section.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by reports of in-flight engine failures due to fractured cross-flow cylinder assemblies. The FAA is issuing this AD to prevent failure of the engine. The unsafe condition, if not addressed, could result in failure of the engine, in-flight shutdown, and forced landing.</P>
                        <HD SOURCE="HD1">(f) Compliance</HD>
                        <P>Comply with this AD within the compliance times specified, unless already done.</P>
                        <HD SOURCE="HD1">(g) Required Actions</HD>
                        <P>(1) If the engine has fewer than 500 engine operating hours on the effective date of this AD, no later than the next scheduled 100-hour inspection or next scheduled annual inspection after the effective date of this AD, whichever is applicable based on the type of aircraft operation, perform a visual inspection of the cross-flow cylinder assembly using paragraphs III.1 through III.3, Action Required, of Continental Aerospace Technologies, Inc. Mandatory Service Bulletin (MSB) 18-08, Revision B, dated January 13, 2020 (“Continental Aerospace Technologies MSB18-08B”).</P>
                        <P>(i) If the radius corner angle of the cross-flow cylinder assembly shows casting flash build-up or a sharp radius edge, modify the cross-flow cylinder assembly using paragraphs III.4 through III.8, Action Required, of Continental Aerospace Technologies MSB 18-08B; or</P>
                        <P>(ii) If a fissure, crack or physical damage is identified, remove the cross-flow cylinder assembly and replace with a part eligible for installation.</P>
                        <P>(2) If the engine has 500 engine operating hours or greater on the effective date of this AD, at the next maintenance event after the effective date of this AD, not to exceed 50 engine operating hours after the effective date of this AD, perform a visual inspection of the cross-flow cylinder assembly using paragraphs III.1 through III.3, Action Required, of Continental Aerospace Technologies MSB18-08B.</P>
                        <P>(i) If the radius corner angle of the cross-flow cylinder assembly shows casting flash build-up or a sharp radius edge, modify the cross-flow cylinder assembly using paragraphs III.4 through III.8, Action Required, of Continental Aerospace Technologies MSB 18-08B; or</P>
                        <P>(ii) If a fissure, crack or physical damage is identified, remove the cross-flow cylinder assembly and replace with a part eligible for installation.</P>
                        <HD SOURCE="HD1">(h) Installation Prohibition</HD>
                        <P>After the effective date of this AD, do not install any cross-flow cylinder assembly having a P/N identified in paragraph (c) of this AD on any affected engine unless the cross-flow cylinder assembly has been visually inspected and modified using paragraph III, Action Required, of Continental Aerospace Technologies MSB18-08B.</P>
                        <HD SOURCE="HD1">(i) No Reporting Requirement</HD>
                        <P>The reporting requirement in paragraph III, Action Required, of Continental Aerospace Technologies MSB18-08B is not required by this AD.</P>
                        <HD SOURCE="HD1">(j) Definitions</HD>
                        <P>(1) For the purpose of this AD, “the next maintenance event” is the next scheduled 100-hour/annual inspection, overhaul, or the next time the airplane enters maintenance for a non-engine issue, whichever occurs first.</P>
                        <P>(2) For the purpose of this AD, “modify the cross-flow cylinder assembly” is the removal of the casting material build-up by blending the cross-flow cylinder assembly radius corner.</P>
                        <HD SOURCE="HD1">(k) Credit for Previous Actions</HD>
                        <P>You may take credit for the visual inspection and modification that is required by paragraph (g) of this AD, if the inspection or modification was performed before the effective date of this AD using Continental Motors Aircraft Engine Service Bulletin 18-08, Revision A, dated January 11, 2019.</P>
                        <HD SOURCE="HD1">(l) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>(1) The Manager, Atlanta ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (m) of this AD.</P>
                        <P>
                            (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
                            <PRTPAGE P="49957"/>
                        </P>
                        <HD SOURCE="HD1">(m) Related Information</HD>
                        <P>
                            For more information about this AD, contact Boyce Jones, Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia 30337; phone: 404-474-5535; fax: 404-474-5606; email: 
                            <E T="03">boyce.jones@faa.gov.</E>
                        </P>
                        <HD SOURCE="HD1">(n) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Continental Aerospace Technologies, Inc. Mandatory Service Bulletin 18-08, Revision B, dated January 13, 2020.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (3) For Continental Aerospace Technologies, Inc. service information identified in this AD, contact Continental Aerospace Technologies, Inc., 2039 South Broad Street, Mobile, Alabama 36615; phone: 251-436-8299; website: 
                            <E T="03">http://www.continentalmotors.aero.</E>
                        </P>
                        <P>(4) You may view this service information at FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759.</P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on August 4, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17874 Filed 8-14-20; 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-2019-0045; Product Identifier 2018-CE-027-AD; Amendment 39-21199; AD 2020-16-15]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Viking Air Limited Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), Department of Transportation (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 Viking Air Limited Models DHC-2 Mk. I and DHC-2 Mk. III airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracks reported on the forward and aft float strut wire pull fittings. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 21, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of September 21, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may examine the AD docket on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2019-0045; or in person at Docket Operations, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        For service information identified in this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (800) 663-8444; fax: (250) 656-0673; email: 
                        <E T="03">technical.support@vikingair.com;</E>
                         internet: 
                        <E T="03">https://www.vikingair.com/support/service-bulletins.</E>
                         You may view this referenced service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for Docket No. FAA-2019-0045.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2019-0045; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the notice of proposed rulemaking (NPRM), the regulatory evaluation, any comments received, and other information. The street address for Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Aziz Ahmed, Aerospace Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 287-7329; fax: (516) 794-5531; email: 
                        <E T="03">aziz.ahmed@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    The FAA issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to Viking Air Limited Models DHC-2 Mk. I and DHC-2 Mk. III airplanes. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on February 11, 2019 (84 FR 3131). The NPRM proposed to correct an unsafe condition for the specified products and was based on AD Number CF-2018-10, dated April 18, 2018 (referred to after this as “the MCAI”), issued by Transport Canada, which is the aviation authority for Canada. The MCAI states:
                </P>
                <EXTRACT>
                    <P>Cracks have been reported on the Forward and Aft float strut wire pull fittings on DHC-2 Mk. I aeroplanes equipped with the 5600 lb gross weight increase kit installed in accordance with STC SA92-63 or SA00299NY and on DHC-2 Mk. III aeroplanes equipped with the 6000 lb gross weight increase kit installed in accordance with STC SA91-18 or SA945NE. An investigation found that the forward and aft wire pull fittings (P/N VALTBS1245-1/-2 and P/N VALTBS1244-1, respectively) are prone to stress corrosion cracking at low cycles/hours.</P>
                    <P>Failure of these wire pull fittings will reduce the strength of the float undercarriage below the required structural capability and could result in a failure of the undercarriage causing the aeroplane to tip over and be submerged.</P>
                    <P>Therefore this [Transport Canada] AD requires that the forward and aft wire pull fittings be replaced with P/N VALTBS1245-3/-4 and P/N VALTBS1244-3/-4 (LH/RH) fittings respectively. These fittings are geometrically similar to the legacy fittings and are made of a different aluminum alloy that is less susceptible to stress corrosion cracking.</P>
                    <P>In addition to replacing the fittings, it is necessary to implement a recurring visual inspection of the fittings to assure continuing airworthiness. </P>
                </EXTRACT>
                <P>
                    The MCAI can be found in the AD docket on the internet at: 
                    <E T="03">https://www.regulations.gov/docket?D=FAA-2019-0045.</E>
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA gave the public the opportunity to participate in developing this AD. The following presents the comment received on the NPRM and the FAA's response.</P>
                <HD SOURCE="HD1">Request To Remove the Repetitive Inspection</HD>
                <P>
                    Christopher Campbell requested the FAA remove the 110-hour repetitive inspection requirement. The commenter stated the unsafe condition is eliminated by the requirement to 
                    <PRTPAGE P="49958"/>
                    replace the affected part. Also, the commenter reasoned that because repetitive inspections are already required at each 100-hour and annual inspection by Appendix D to Part 43, Advisory Circular (AC) 43.13, AC 20-106, the manufacturer's maintenance manual, and the float manufacturer's inspection requirements, the repetitive inspections in the NPRM are unnecessary and burdensome. The commenter stated that if the replacement wire pulls are not strong enough to last 110 hours without cracking, then the FAA should address this at the manufacturing level and not in the field.
                </P>
                <P>The FAA does not agree. Although 14 CFR 43.15 and Appendix D to Part 43 do require that 100-hour and annual inspections include an inspection of floats for insecure attachment and obvious defects, this AD requires a specific inspection of the wire pull fittings. Also, while an operator may incorporate into its maintenance program the inspections in the advisory circulars and manufacturer maintenance manuals referenced by the commenter, not all operators are required to do so. In order for these inspections to become mandatory, and to correct the unsafe conditions identified in the NPRM, the FAA must issue an AD. The compliance times as proposed should allow the inspections to be conducted concurrently with scheduled maintenance, thereby minimizing the costs on operators.</P>
                <P>The FAA did not change this AD based on this comment.</P>
                <HD SOURCE="HD1">Changes to the Final Rule</HD>
                <P>The FAA has revised the applicability of this AD to include airplanes with fitting part number VALTBS1244-3 or VALTBS1244-4, to clarify that replacing the fittings is not terminating action for the repetitive inspections in the AD. The FAA also made some minor editorial changes.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. The FAA has determined that these minor changes:</P>
                <P>• Are consistent with the proposal in the NPRM for correcting the unsafe condition; and</P>
                <P>• Do not increase any burden upon the public than was already proposed in the NPRM.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Viking DHC-2 Beaver Service Bulletin No. V2/003, Revision NC, dated November 28, 2012, for Model DCH-2 Mk. I airplanes; and Viking DHC-2T Beaver Service Bulletin No. V2/002, Revision A, dated September 12, 2011, for Model DCH-2 Mk. III airplanes. This service information contains procedures for replacing the forward and aft float strut wire pull fittings and specifies implementing repetitive visual inspections of the fittings. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Differences Between This AD and the MCAI</HD>
                <P>The MCAI requires returning cracked fittings to Viking, and this AD does not. The MCAI also prohibits installing an affected wire pull fitting on any airplane, and this AD does not.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD will affect 136 products of U.S. registry. The FAA also estimates that replacing the fittings will take about 12 work-hours at an average labor rate of $85 per work-hour and required parts will cost about $2,741. Based on these figures, the FAA estimates a cost of $3,761 per airplane and $511,496 for the U.S. operator fleet.</P>
                <P>Inspecting the fittings will take about .5 work-hour for an estimated cost of $42.50 per airplane and $5,780 for the U.S. fleet, per inspection cycle.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA 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 this AD:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Will not affect intrastate aviation in Alaska, 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>
                <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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES </HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended] </SUBJECT>
                </SECTION>
                <REGTEXT TITLE="14" PART="39">
                    <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive:</AMDPAR>
                    <EXTRACT>
                        <FP SOURCE="FP-2">
                            <E T="04">2020-16-15 Viking Air Limited:</E>
                             Amendment 39-21199; Docket No. FAA-2019-0045; Product Identifier 2018-CE-027-AD.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This airworthiness directive (AD) becomes effective September 21, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to the following Viking Air Limited airplanes, certificated in any category:</P>
                        <P>(1) Model DHC-2 Mk. I airplanes altered by Supplemental Type Certificate (STC) SA92-63 or SA00299NY with a float strut wire pull fitting part number (P/N) VALTBS1245-1, P/N VALTBS1245-2, P/N VALTBS1244-1, P/N VALTBS1244-3, or P/N VALTBS1244-4; and</P>
                        <P>
                            (2) Model DHC-2 Mk. III airplanes altered by STC SA91-18 or SA945NE with a float strut wire pull fitting P/N VALTBS1245-1, P/N VALTBS1245-2, P/N VALTBS1244-1, P/N VALTBS1244-3, or P/N VALTBS1244-4.
                            <PRTPAGE P="49959"/>
                        </P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Air Transport Association of America (ATA) Code 53: Fuselage.</P>
                        <HD SOURCE="HD1">(e) Reason</HD>
                        <P>This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as cracks reported on the forward and aft float strut wire pull fittings. The FAA is issuing this AD to prevent failure of the wire pull fittings, which could reduce the strength of the float undercarriage below the required structural capability, resulting in a failure of the undercarriage causing the airplane to tip over and submerge.</P>
                        <HD SOURCE="HD1">(f) Actions and Compliance</HD>
                        <P>Unless already done, do the following actions.</P>
                        <P>(1) Within 90 days after August 17, 2020 (the effective date of this AD):</P>
                        <P>(i) Replace each forward wire pull fitting P/N VALTBS1245-1 and P/N VALTBS1245-2 with P/N VALTBS1245-3 Left Hand (LH) or P/N VALTBS1245-4 Right Hand (RH) by following the Accomplishment Instructions, paragraphs A.1. through A.8., of Viking DHC-2 Beaver Service Bulletin No. V2/003, Revision NC, dated November 28, 2012 (Viking SB No. V2/003); or Viking DHC-2T Beaver Service Bulletin No. V2/002, Revision A, dated September 12, 2011 (Viking SB No. V2/002, Revision A), as applicable to your model airplane.</P>
                        <P>(ii) Within 110 hours time-in-service (TIS) after the replacement of the forward wire pull fittings and thereafter at intervals not to exceed 110 hours TIS, visually inspect each forward wire pull fitting for corrosion and cracks. If there is any corrosion or a crack, before further flight, replace the fitting with fitting P/N VALTBS1245-3 (LH) or P/N VALTBS1245-4 (RH).</P>
                        <P>(2) Within 180 days after August 17, 2020 (the effective date of this AD):</P>
                        <P>(i) Replace each aft wire pull fitting P/N VALTBS1244-1 with P/N VALTBS1244-3 (LH) or P/N VALTBS1244-4 (RH) by following the Accomplishment Instructions, paragraphs B.1. through B.8., of Viking SB No. V2/003 or Viking SB No. V2/002, Revision A, as applicable to your model airplane.</P>
                        <P>(ii) Within 110 hours TIS after the replacement of the aft wire pull fittings and thereafter at intervals not to exceed 110 hours TIS, visually inspect each aft wire pull fitting for corrosion and cracks. If there is any corrosion or a crack, before further flight, replace the fitting with fitting P/N VALTBS1244-3 (LH) or P/N VALTBS1244-4 (RH).</P>
                        <HD SOURCE="HD1">(g) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>The Manager, Small Airplane Standards Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Aziz Ahmed, Aerospace Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone: (516) 287-7329; fax: (516) 794-5531; email:. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.</P>
                        <HD SOURCE="HD1">(h) Related Information</HD>
                        <P>
                            Refer to MCAI Transport Canada AD Number CF-2018-10, dated April 18, 2018, for related information. The MCAI can be found in the AD docket on the internet at: 
                            <E T="03">https://www.regulations.gov/docket?D=FAA-2019-0045.</E>
                        </P>
                        <HD SOURCE="HD1">(i) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Viking DHC-2 Beaver Service Bulletin No. V2/003, Revision NC, dated November 28, 2012.</P>
                        <P>(ii) Viking DHC-2T Beaver Service Bulletin No. V2/002, Revision A, dated September 12, 2011.</P>
                        <P>
                            (3) For service information identified in this AD, contact Viking Air Limited Technical Support, 1959 De Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; telephone: (North America) (800) 663-8444; fax: (250) 656-0673; email: 
                            <E T="03">technical.support@vikingair.com;</E>
                             internet: 
                            <E T="03">https://www.vikingair.com/support/service-bulletins.</E>
                        </P>
                        <P>
                            (4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. In addition, you can access this service information on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for and locating Docket No. FAA-2019-0045.
                        </P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on August 4, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17900 Filed 8-14-20; 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-2020-0265; Project Identifier MCAI-2019-00131-E; Amendment 39-21201; AD 2020-16-17]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Rolls-Royce Deutschland Ltd &amp; Co KG (Type Certificate Previously Held by Rolls-Royce plc) Turbofan Engines</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 all Rolls-Royce Deutschland Ltd. &amp; Co KG (RRD) Trent XWB-75, Trent XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan engines. This AD was prompted by reports of a lack of weld fusion on the resistance welding during manufacturing, which could result in air leakage through the low-pressure turbine (LPT) rear support seal panel assembly (“LPT seal panel”). This AD requires replacement of the LPT seal panel. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 21, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of September 21, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        For service information identified in this final rule, contact Rolls-Royce Deutschland Ltd. &amp; Co KG, Eschenweg 11, 15827 Blankenfelde-Mahlow, Germany; phone: +49 (0) 33 708 6 0; email: 
                        <E T="03">https://www.rolls-royce.com/contact-us.aspx.</E>
                         You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2020-0265.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0265; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, 
                    <PRTPAGE P="49960"/>
                    the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The address for Docket Operations is U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Stephen Elwin, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7236; fax: 781-238-7199; email: 
                        <E T="03">stephen.l.elwin@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all RRD Trent XWB-75, Trent XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan engines. The NPRM published in the 
                    <E T="04">Federal Register</E>
                     on March 30, 2020 (85 FR 17513). The NPRM was prompted by reports of a lack of weld fusion on the resistance welding during manufacturing, which could result in air leakage through the LPT seal panel. The NPRM proposed to require replacement of the LPT seal panel. The FAA is issuing this AD to address the unsafe condition on these products.
                </P>
                <P>The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2019-0071, dated March 28, 2019 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:</P>
                <EXTRACT>
                    <P>The affected parts, as defined in this [EASA] AD, are static parts, located behind the intermediate pressure (IP) turbine 2 disc, forming a seal between the IP and LP cavities through an interface with the rotating IP flying seal. It was recently determined that, on certain affected parts, insufficient fusion was achieved on the resistance welding during manufacturing.</P>
                    <P>This condition, if not corrected, could lead to air leakage through the LP seal panel, affecting the service lives of the IP turbine 2 and LP turbine 1 discs, possibly resulting in premature disc failure and high energy uncontained debris release from the engine, with consequent damage to, and reduced control of, the aeroplane.</P>
                    <P>To address this potential unsafe condition, Rolls-Royce identified the affected parts and published the NMSB, providing instructions to replace these affected parts.</P>
                    <P>For the reason described above, this [EASA] AD requires replacement of affected parts during a qualified shop visit.</P>
                </EXTRACT>
                <P>
                    You may obtain further information by examining the MCAI in the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0265.
                </P>
                <HD SOURCE="HD1">Comments</HD>
                <P>The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.</P>
                <HD SOURCE="HD1">Request To Revise Definition of Module 51</HD>
                <P>Delta Air Lines, Inc. (DAL) requested that the definition of “module 51” in paragraph (h) of this AD be revised to “intermediate pressure turbine module.” DAL reasoned that the RRD Trent XWB Engine Manual and Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin (NMSB) Trent XWB 72-AJ994, Revision 2, dated August 29, 2019, both refer to module 51 as the intermediate-pressure turbine (IPT) module and refer to module 52 as the LPT module. Therefore, revising this definition would alleviate confusion.</P>
                <P>The FAA agrees and revised the definition of module 51 to read, “For the purpose of this AD, `module 51' is the IPT module.”</P>
                <HD SOURCE="HD1">Support for the AD</HD>
                <P>The Air Line Pilots Association, International, expressed support for the AD as written.</P>
                <HD SOURCE="HD1">Conclusion</HD>
                <P>The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. The FAA has determined that these minor changes:</P>
                <P>• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and</P>
                <P>• Do not add any additional burden upon the public than was already proposed in the NPRM.</P>
                <P>The FAA has also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.</P>
                <HD SOURCE="HD1">Service Information Incorporated by Reference Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed RR Alert NMSB Trent XWB 72-AJ994, Revision 2, dated August 29, 2019. The Alert NMSB describes procedures for removing and replacing the LPT seal panel. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 26 engines installed on airplanes of U.S. registry.</P>
                <P>The FAA estimates the following costs to comply with this AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Replace the LPT seal panel</ENT>
                        <ENT>1 work-hour × $85 per hour = $85</ENT>
                        <ENT>$282,890</ENT>
                        <ENT>$282,975</ENT>
                        <ENT>$7,357,350</ENT>
                    </ROW>
                </GPOTABLE>
                <P>According to the manufacturer, all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all costs in our cost estimate.</P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>
                    The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or 
                    <PRTPAGE P="49961"/>
                    develop on products identified in this rulemaking action.
                </P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>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 this AD:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Would not affect intrastate aviation in Alaska, and</P>
                <P>(3) Would 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>
                <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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <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">2020-16-17 Rolls-Royce Deutschland Ltd &amp; Co KG (Type Certificate previously held by Rolls-Royce plc):</E>
                             Amendment 39-21201; Docket No. FAA-2020-0265; Project Identifier MCAI-2019-00131-E.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This AD is effective September 21, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to all Rolls-Royce Deutschland Ltd. &amp; Co KG (Type Certificate previously held by Rolls-Royce plc) Trent XWB-75, Trent XWB-79, Trent XWB-79B, and Trent XWB-84 model turbofan engines.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Joint Aircraft System Component (JASC) Code 7250, Turbine Section.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by reports of a lack of weld fusion on the resistance welding during manufacturing, which could result in air leakage through the low-pressure turbine (LPT) rear support seal panel assembly (“LPT seal panel”) causing a life reduction to the intermediate-pressure turbine (IPT) 2 and LPT 1 disks. The FAA is issuing this AD to prevent failure of the IPT 2 and LPT 1 disks. The unsafe condition, if not addressed, could result in uncontained debris release, damage to the engine, and damage to the airplane.</P>
                        <HD SOURCE="HD1">(f) Compliance</HD>
                        <P>Comply with this AD within the compliance times specified, unless already done.</P>
                        <HD SOURCE="HD1">(g) Required Actions</HD>
                        <P>During the next qualified shop visit after the effective date of this AD, or during the current shop visit, if, on the effective date of this AD, the engine or module 51 is in a qualified shop visit, remove the affected LPT seal panel from service and replace it with a part eligible for installation in accordance with the Accomplishment Instructions, paragraph 3.A., of Rolls-Royce plc Alert Non-Modification Service Bulletin (NMSB) Trent XWB 72-AJ994, Revision 2, dated August 29, 2019.</P>
                        <HD SOURCE="HD1">(h) Definitions</HD>
                        <P>(1) For the purpose of this AD, a “qualified shop visit” is a Level 4 (Overhaul) or Level 3 (Refurbishment) shop visit of an affected engine with an affected LPT seal panel installed, or Level 2 shop visit (Check and Repair) of module 51 with an affected LPT seal panel installed.</P>
                        <P>(2) For the purpose of this AD, “module 51” is the IPT module.</P>
                        <P>(3) For the purpose of this AD, an “affected LPT seal panel” is LPT rear support seal panel assembly, identified as catalogue serial number (CSN) 72512301890, with a serial number (S/N) listed in Appendix 1 of RR Alert NMSB Trent XWB 72-AJ994, Revision 2, dated August 29, 2019. This appendix additionally lists the module 51 S/N and engine S/N in which these panels were originally installed.</P>
                        <P>(4) For the purpose of this AD, a “part eligible for installation” is a LPT seal panel, CSN 72512301890, with a S/N not listed in Appendix 1 of RR Alert NMSB Trent XWB 72-AJ994, Revision 2, dated August 29, 2019.</P>
                        <HD SOURCE="HD1">(i) Credit for Previous Actions</HD>
                        <P>You may take credit for replacement of the LPT seal panel requirements of paragraph (g) of this AD if you performed the replacement before the effective date of this AD using RR Alert NMSB Trent XWB 72-AJ994, Revision 1, dated November 15, 2018, or Initial Issue, dated September 5, 2018.</P>
                        <HD SOURCE="HD1">(j) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>
                            (1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ECO Branch, send it to the attention of the person identified in paragraph (k)(1) of this AD. You may email your request to: 
                            <E T="03">ANE-AD-AMOC@faa.gov.</E>
                        </P>
                        <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                        <HD SOURCE="HD1">(k) Related Information</HD>
                        <P>
                            (1) For more information about this AD, contact Stephen Elwin, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7236; fax: 781-238-7199; email: 
                            <E T="03">stephen.l.elwin@faa.gov.</E>
                        </P>
                        <P>
                            (2) Refer to European Union Aviation Safety Agency AD 2019-0071, dated March 28, 2019, for more information. You may examine the EASA AD in the AD docket on the internet at 
                            <E T="03">https://www.regulations.gov</E>
                             by searching for and locating Docket No. FAA-2020-0265.
                        </P>
                        <HD SOURCE="HD1">(l) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Rolls-Royce plc (RR) Alert Non-Modification Service Bulletin Trent XWB 72-AJ994, Revision 2, dated August 29, 2019.</P>
                        <P>(ii) [Reserved]</P>
                        <P>(3) For RR service information identified in this AD, contact Rolls-Royce Deutschland Ltd &amp; Co KG, Eschenweg 11, Blankenfelde-Mahlow, Germany; phone: 9 011 49 03370860.</P>
                        <P>(4) You may view this service information at FAA, Airworthiness Products Section, Operational Safety Branch, 1200 District Avenue, Burlington, MA 01803. For information on the availability of this material at the FAA, call 781-238-7759.</P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">http://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on July 29, 2020.</DATED>
                    <NAME>Gaetano A. Sciortino,</NAME>
                    <TITLE>Deputy Director for Strategic Initiatives, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17822 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <PRTPAGE P="49962"/>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2020-0715; Project Identifier AD-2020-00484-A; Amendment 39-21190; AD 2020-16-06]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Aviat Aircraft Inc.</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA is adopting a new airworthiness directive (AD) for all Aviat Aircraft Inc. Models A-1, A-1A, A-1B, A-1C-180, and A-1C-200 airplanes.</P>
                    <P>This AD requires repetitive inspections of the forward horizontal stabilizer support assembly and the rear horizontal stabilizer support tube and reporting information to the FAA. This AD was prompted by field reports of complete failure of both the forward support assembly and the rear support tube due to fatigue. The FAA is issuing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This AD is effective September 1, 2020.</P>
                    <P>The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of September 1, 2020.</P>
                    <P>The FAA must receive comments on this AD by October 1, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        For service information identified in this final rule, contact Aviat Aircraft Inc., Al Humbert, 672 South Washington Street, Afton, WY, 83110, United States; phone: (307) 885-3151; email: 
                        <E T="03">dmir@aviataircraft.com;</E>
                         internet: 
                        <E T="03">https://aviataircraft.com.</E>
                         You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2020-0715.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0715; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this final rule, any comments received, and other information. The street address for the Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Mark Dalrymple, Aerospace Engineer, Denver ACO Branch, FAA, 26805 E. 68th Avenue, Denver, CO 80249; phone: (303) 342-1090; email: 
                        <E T="03">mark.dalrymple@faa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Discussion</HD>
                <P>The FAA received three field reports from Aviat Aircraft Inc. of complete failure of the rear horizontal stabilizer inboard support tube. The first incident, discovered during a scheduled inspection, occurred in 2005, and the second incident, discovered while the airplane was being re-skinned, occurred in 2009. The third incident was discovered during a pre-flight inspection in 2012 and included a complete failure of the forward horizontal stabilizer inboard support assembly. Failure analysis of both parts from the 2012 incident concluded they failed due to fatigue. In addition to these complete failures of the rear support tube, the FAA received two field reports from Aviat Aircraft Inc. of cracks in the rear support tube, discovered during inspections, in 2005 and 2013. Aviat Aircraft Inc. subsequently issued Service Bulletin No. 28, Revision A, dated April 2, 2015, which requires a one-time inspection of the rear stabilizer inboard support tube in response to the multiple reports of failures and cracks.</P>
                <P>In addition to the 2012 incident, which involved a failure of both supports, the FAA received two other field reports from Aviat Aircraft Inc. of complete failure of the forward horizontal stabilizer inboard support assembly, one in 2000 and one in 2019. In the first incident, the failure occurred during ground handling after flight. In the second incident the failure was discovered while the aircraft was being placed in a hanger.</P>
                <P>Failure of either the forward or rear support transfers loads to the other support, increasing the likelihood that both could fail. This condition, if not addressed, could result in stabilizer departure and loss of airplane control.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Aviat Aircraft Inc. Service Bulletin No. 28, Revision A, dated April 2, 2015 (Aviat SB No. 28, Revision A). This service information contains procedures for inspecting and repairing the rear stabilizer support tube. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>The FAA is issuing this AD because it evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">AD Requirements</HD>
                <P>This AD requires inspection for cracks and replacement if necessary of the forward horizontal stabilizer support assembly. This AD also requires inspecting the rear horizontal stabilizer support tube for corrosion and damage and repair if necessary. This AD also requires reporting the inspection results to the FAA.</P>
                <HD SOURCE="HD1">FAA's Justification and Determination of the Effective Date</HD>
                <P>
                    An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because FAA risk assessment indicates there is an unacceptable short-term risk of developing fatigue cracks through 25 percent of the cross sectional area of the rear support tube on airplanes that have engaged in tow operations. In addition, further FAA risk assessment indicates there is an unacceptable short-term risk of developing fatigue cracks through 25 
                    <PRTPAGE P="49963"/>
                    percent of the cross sectional area of the forward support assembly on all airplanes. In the majority of known incidents at either location, the support failed completely. Failure of either the forward or rear support transfers loads to the other support, increasing the likelihood that both could fail, which has occurred in one known incident. A combined failure of both the forward and rear supports could result in stabilizer departure and loss of airplane control. Therefore, the FAA finds good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, the FAA finds that good cause exists for making this amendment effective in less than 30 days.
                </P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No.FAA-2020-0715; Product Identifier AD-2020-00484-A” at the beginning of your comments. The FAA will consider all comments received by the closing date and may amend this proposed AD because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact we receive about this final rule.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Mark Dalrymple, Aerospace Engineer, Denver ACO Branch, FAA, 26805 E. 68th Avenue, Denver, CO 80249. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.</P>
                <P>
                    The FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact we receive about this AD.
                </P>
                <HD SOURCE="HD1">Differences Between This AD and the Service Information</HD>
                <P>The service information only applies to certain serial numbers of the airplane models identified in this AD, while this AD applies to all serial numbers of Aviat Aircraft Inc. Model A-1, A-1A, A-1B, A-1C-180, and A-1C-200 airplanes. The service information only requires inspecting the rear stabilizer support tube, while this AD requires inspecting the forward stabilizer support assembly in addition to the rear stabilizer support tube. The service information only requires a one-time inspection, while this AD requires both initial and repetitive inspections.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this AD affects 941 airplanes of U.S. registry.</P>
                <P>The FAA estimates the following costs to comply with this AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s75,r50,12,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Inspect forward horizontal stabilizer inboard support assembly for cracks</ENT>
                        <ENT>1 work-hour × $85.00 per hour = $85.00</ENT>
                        <ENT>$25.00</ENT>
                        <ENT>$110.00</ENT>
                        <ENT>$103,510.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Inspect rear horizontal stabilizer inboard support tube weld joints for corrosion and damage</ENT>
                        <ENT>0.5 work-hour × $85.00 per hour = $42.50</ENT>
                        <ENT>0.00</ENT>
                        <ENT>42.50</ENT>
                        <ENT>39,992.50</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The FAA estimates the following costs to do any necessary repairs or replacements that would be required based on the results of the inspection. The FAA has no way of determining the number of airplanes that might need these replacements:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s75,r50,12,12">
                    <TTITLE>On-Condition Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Replace forward horizontal stabilizer support tube</ENT>
                        <ENT>2 work-hours × $85.00 per hour = $170.00</ENT>
                        <ENT>$296.00</ENT>
                        <ENT>$466.00</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Repair rear horizontal stabilizer support tube weld joints and install new support tube insert</ENT>
                        <ENT>4.5 work-hours × $85.00 per hour = $382.50</ENT>
                        <ENT>163.00</ENT>
                        <ENT>545.50</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Report if cracks are found</ENT>
                        <ENT>0.5 work-hour × $85.00 per hour = $42.50</ENT>
                        <ENT>0.00</ENT>
                        <ENT>42.50</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Paperwork Reduction Act</HD>
                <P>
                    A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately .5 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing and reviewing the collection of information. All 
                    <PRTPAGE P="49964"/>
                    responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.
                </P>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act</HD>
                <P>The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>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, and</P>
                <P>(2) Will not affect intrastate aviation in Alaska.</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>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 39—AIRWORTHINESS DIRECTIVES</HD>
                </PART>
                <REGTEXT TITLE="14" PART="39">
                    <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>
                <SECTION>
                    <SECTNO>§ 39.13</SECTNO>
                    <SUBJECT> [Amended]</SUBJECT>
                </SECTION>
                <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">2020-16-06 Aviat Aircraft Inc.:</E>
                             Amendment 39-21190; Docket No. FAA-2020-0715; Project Identifier AD-2020-00484-A.
                        </FP>
                        <HD SOURCE="HD1">(a) Effective Date</HD>
                        <P>This AD is effective September 1, 2020.</P>
                        <HD SOURCE="HD1">(b) Affected ADs</HD>
                        <P>None.</P>
                        <HD SOURCE="HD1">(c) Applicability</HD>
                        <P>This AD applies to Aviat Aircraft Inc., Models A-1, A-1A, A-1B, A-1C-180, and A-1C-200 airplanes, all serial numbers, certificated in any category.</P>
                        <HD SOURCE="HD1">(d) Subject</HD>
                        <P>Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 5510, Horizontal Stabilizer Structure.</P>
                        <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                        <P>This AD was prompted by reports of complete failure of the forward horizontal stabilizer support assembly due to fatigue in combination with complete failure of the rear horizontal stabilizer support tube due to fatigue. The FAA is issuing this AD to prevent cracking of the forward and rear inboard supports, which could result in failure of the stabilizer supports, detachment of the stabilizer, and loss of airplane control.</P>
                        <HD SOURCE="HD1">(f) Compliance</HD>
                        <P>Comply with this AD within the compliance times specified, unless already done.</P>
                        <HD SOURCE="HD1">(g) Inspection and Repair</HD>
                        <P>For airplanes with 400 or more hours time-in-service (TIS), do the following inspection within 30 days after September 1, 2020 (the effective date of this AD) or within 20 hours TIS after September 1, 2020 (the effective date of this AD), whichever occurs first. For airplanes with less than 400 hours TIS, do the following inspections within 30 days after accumulating 400 hours TIS or within 20 hours TIS after accumulating 400 hours TIS, whichever occurs first. After the initial inspection, repeat the inspections at intervals not to exceed 12 months or 100 hours TIS, whichever occurs first.</P>
                        <P>(1) Below and just aft of the horizontal stabilizer leading edge, remove each inspection hole cover if installed, or cut out the inside of each inspection ring if not cut out, on both sides of the fuselage. You do not need to remove the stabilizer support assembly. Locate the forward horizontal stabilizer support assembly. Using a light and a mirror or a borescope, inspect the stabilizer support assembly for cracks in the large tube portion of the assembly. Pay particular attention to the toe of the welded bushings where the stabilizer support assembly is bolted to the fuselage frame.</P>
                        <P>(i) If no cracks are found, install inspection hole cover, part number (P/N) 61659 and mounting screws, P/N 59146.</P>
                        <P>(ii) If any cracks are found, before further flight, replace the stabilizer support assembly with the same part-numbered part, either P/N 35086-501 or P/N 38086-501 as applicable. Replace both self-locking nuts with self-locking nuts that have zero hours TIS. Replacing the forward stabilizer support assembly requires removal and reinstallation of other horizontal stabilizer components. Replace all self-locking nuts with self-locking nuts that have zero hours TIS upon reinstallation of these components.</P>
                        <P>(2) Inspect the rear horizontal stabilizer support tube weld joints for corrosion and damage in accordance with the Instructions, steps 1.a. and 1.b., of Aviat Aircraft Inc. Service Bulletin No. 28, Revision A, dated April 2, 2015. If there is any corrosion or damage on a weld joint, before further flight, repair the weld joint and install a repair tube inside the stabilizer support tube as depicted in the figure on page 3 of Aviat Aircraft Inc.</P>
                        <P>Service Bulletin No. 28, Revision A, dated April 2, 2015. Repairing the rear horizontal stabilizer support tube requires removal and reinstallation of other horizontal stabilizer components. Replace all self-locking nuts with self-locking nuts that have zero hours TIS upon reinstallation of these components.</P>
                        <HD SOURCE="HD1">(h) Reporting Requirement</HD>
                        <P>If a crack is found during any inspection required by paragraph (g) of this AD, within 10 days, report the following information to the FAA at the address listed in paragraph (l) of this AD:</P>
                        <P>(1) Aircraft Make and Model</P>
                        <P>(2) Aircraft N-number</P>
                        <P>(3) Aircraft Serial Number</P>
                        <P>(4) Total hours TIS</P>
                        <P>(5) Total takeoff and landing cycles (if known)</P>
                        <P>(6) Aircraft used for Tow operations? Yes or No</P>
                        <P>(7) If the Aircraft is used for Tow operations, report heaviest Glider Max Gross takeoff weight or banner maximum weight.</P>
                        <P>(8) Describe the crack location(s) and report the length of the crack(s) in the forward horizontal stabilizer support assembly, rear horizontal stabilizer support tube, or both.</P>
                        <HD SOURCE="HD1">(i) Special Flight Permit</HD>
                        <P>In accordance with 14 CFR 39.23, special flight permits are prohibited.</P>
                        <HD SOURCE="HD1">(j) Paperwork Reduction Act Burden Statement</HD>
                        <P>
                            A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a 
                            <PRTPAGE P="49965"/>
                            collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to be approximately .5 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.
                        </P>
                        <HD SOURCE="HD1">(k) Alternative Methods of Compliance (AMOCs)</HD>
                        <P>(1) The Manager, Denver ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (l) of this AD.</P>
                        <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                        <HD SOURCE="HD1">(l) Related Information</HD>
                        <P>
                            For more information about this AD, contact Mark Dalrymple, Aerospace Engineer, Denver ACO Branch, FAA, 26805 E. 68th Avenue, Denver, CO 80249; phone: (303) 342-1090; email: 
                            <E T="03">mark.dalrymple@faa.gov</E>
                            .
                        </P>
                        <HD SOURCE="HD1">(m) Material Incorporated by Reference</HD>
                        <P>(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.</P>
                        <P>(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.</P>
                        <P>(i) Aviat Aircraft Inc. Service Bulletin No. 28, Revision A, dated April 2, 2015.</P>
                        <P>(ii) [Reserved]</P>
                        <P>
                            (3) For Aviat Aircraft Inc. service information identified in this AD, contact Aviat Aircraft Inc., Al Humbert, 672 South Washington Street, Afton, WY 83110, United States; phone: (307) 885-3151; email: 
                            <E T="03">dmir@aviataircraft.com</E>
                            ; internet: 
                            <E T="03">https://aviataircraft.com.</E>
                        </P>
                        <P>(4) You may view this service information at FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call 816-329-4148.</P>
                        <P>
                            (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email: 
                            <E T="03">fedreg.legal@nara.gov,</E>
                             or go to: 
                            <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                        </P>
                    </EXTRACT>
                </REGTEXT>
                <SIG>
                    <DATED>Issued on July 28, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17904 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <CFR>34 CFR Part 75 and Chapter III</CFR>
                <SUBJECT>Final Waiver and Extension of the Project Periods for the American Indian Vocational Rehabilitation Services Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Special Education and Rehabilitative Services (OSERS), Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final waiver and extension of project periods.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Education (Department) waives the requirements in the Education Department General Administrative Regulations that generally prohibit project periods exceeding five years and project period extensions involving the obligation of additional Federal funds. The waiver and extension enable 29 American Indian Vocational Rehabilitation Services (AIVRS) projects under Catalog of Federal Domestic Assistance (CFDA) number 84.250K to receive funding for an additional period, not beyond September 30, 2021.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The waiver and extension of the project periods are effective August 17, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        August Martin, U.S. Department of Education, 400 Maryland Avenue SW, Room 5064A, Potomac Center Plaza, Washington, DC 20202-1800. Telephone: 202-245-7410. Email: 
                        <E T="03">August.Martin@ed.gov.</E>
                    </P>
                    <P>If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>Under section 121(a) of the Rehabilitation Act of 1973, as amended (the Act), the purpose of the AIVRS program is to provide grants to the governing bodies of Indian Tribes located on Federal and State reservations (and consortia of such governing bodies) to pay 90 percent of the costs of vocational rehabilitation (VR) services, including culturally appropriate services, to American Indians with disabilities who reside on or near Federal or State reservations, consistent with each eligible individual's strengths, resources, priorities, concerns, abilities, capabilities, interests, and informed choice, so that each individual may prepare for, and engage in, high-quality employment that will increase opportunities for economic self-sufficiency.</P>
                <P>
                    In fiscal year (FY) 2015, the Department published in the 
                    <E T="04">Federal Register</E>
                     (80 FR 18606) a notice inviting applications (NIA) announcing the grant competition for the AIVRS program under CFDA 84.250K. The Department funded 29 applications for a 60-month period that will expire as of September 30, 2020. Any AIVRS grantee seeking a new five-year grant award would typically apply and compete in a new grant competition during their fifth and final year of funding.
                </P>
                <P>
                    On March 9, 2020, the Department published in the 
                    <E T="04">Federal Register</E>
                     (85 FR 13636) an NIA for the FY 2020 AIVRS competition, CFDA 84.250N (2020 NIA). Any new Tribes seeking an AIVRS grant along with the grantees whose grants are expiring on September 30, 2020 would need to submit an application in response to the FY 2020 NIA in order to receive an award that would start on October 1, 2020.
                </P>
                <P>
                    At roughly the same time as the Department published the FY 2020 NIA, in early spring 2020, the effects of the COVID-19 pandemic began to be felt in the United States. American Indian reservations experienced and continue to experience high rates of COVID-19 infections. Many of the entities eligible for AIVRS grants across the country took actions to limit the spread of COVID-19 by requiring their non-essential personnel to shelter at home. We have been informed that many AIVRS personnel who continue to shelter-in-place at home to avoid exposure to COVID-19 have limited access to the necessary technology to telework, such as personal computers, Wi-Fi, or internet availability to connect to workplace servers or workplace resources, and we assume that would also be true of personnel who do not currently receive a grant but would be eligible to apply. This limits their ability to access the information needed to prepare a quality application for the FY 2020 AIVRS competition. In addition, we have been notified that some of the programs attempting to develop grant applications have had difficulty acquiring the Tribal resolutions needed 
                    <PRTPAGE P="49966"/>
                    to submit an application for Federal funding or working with the Tribes' administration, including the authorized representatives needed to approve, sign, and submit applications in 
                    <E T="03">Grants.gov</E>
                    .
                </P>
                <P>
                    On May 20, 2020, the Department published a notice in the 
                    <E T="04">Federal Register</E>
                     (85 FR 30690) extending the application deadline for the AIVRS program competition (84.250N) to June 26, 2020. However, given the ongoing and, for some Tribes, escalating cases of COVID-19 and the continuing challenges resulting from the pandemic, the situation for the Tribes has not improved, and the 30-day extension has not been sufficient to address these circumstances.
                </P>
                <P>
                    Therefore, in a notice published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                    <E T="03">,</E>
                     the Department is withdrawing the FY 2020 NIA and cancelling the FY 2020 CFDA 84.250N competition. At the same time here, under its authority to make certain AIVRS grants effective for more than 60 months under section 121(b)(3) of the Act, the Department is waiving the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, and extending the project period, as well as waiving the requirements in 34 CFR 75.261(a) and (c)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. The waivers and extension will enable the Department to provide additional funds to 29 projects under CFDA 84.250K for an additional period, not beyond September 30, 2021.
                </P>
                <P>This action allows the 29 AIVRS grantees to submit a request for continuation funding in FY 2020 based on their prior fiscal year's continuation award and certification from each grantee that they have the capacity to continue activities and wish to continue to receive additional funds. However, decisions regarding each grantee's annual continuation award will be based on the program narrative, budget, budget narrative, and prior program performance report submitted by each of these 29 AIVRS grantees and on the requirements of 34 CFR 75.253. Any activities to be carried out during the year of continuation award would have to be consistent with, or be a logical extension of, the scope, goals, and objectives of each grantee's application as approved following the 2015 AIVRS competition. The FY 2015 AIVRS NIA will continue to govern each grantee's project during the extension year. These current AIVRS grantees may contact their RSA project officer regarding their request for a continuation award in FY 2020 for a project period through FY 2021.</P>
                <HD SOURCE="HD1">Final Waivers and Extensions</HD>
                <P>For these reasons, the Department does not believe that it is in the public interest to run a new competition for the AIVRS program, CFDA 84.250N, in FY 2020. Given the challenges in Indian country due to the COVID-19 pandemic, extending the end dates of the 29 AIVRS projects currently in their fifth year will allow for more efficient use of the funding and avoid any interruption in services that might result from waiting one year to hold a competition for new five-year AIVRS grant projects in FY 2021. Through that competition the Department intends to make funds available for all eligible applicants, including the 29 AIVRS grantees funded in FY 2015 and the 13 AIVRS grantees funded in FY 2016, whose grants will be expiring on September 30, 2021.</P>
                <P>For these reasons, the Department waives the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, as well as the requirements in 34 CFR 75.261(a) and (c)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. This waiver allows the Department to issue a one-time FY 2020 continuation award to each of the 29 AIVRS projects currently funded under CFDA 84.250K estimated as follows:</P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s200,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Grantee name</CHED>
                        <CHED H="1">Amount</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Confederated Tribes and Bands of the Yakama Nation</ENT>
                        <ENT>$453,200</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lower Muskogee Creek Nation</ENT>
                        <ENT>405,200</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">The Cherokee Nation</ENT>
                        <ENT>605,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Confederated Tribes of the Colville Reservation</ENT>
                        <ENT>464,144</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Samish Indian Nation</ENT>
                        <ENT>310,206</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Inupiat Community of the Arctic Slope</ENT>
                        <ENT>505,778</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Confederated Tribes of the Umatilla Indian Reservation</ENT>
                        <ENT>392,956</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Prairie Band of Potawatomi Nation</ENT>
                        <ENT>300,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hopi Tribe</ENT>
                        <ENT>484,469</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hannahville Indian Community</ENT>
                        <ENT>397,270</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Kawerak, Inc</ENT>
                        <ENT>424,496</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Saint Regis Mohawk Tribe</ENT>
                        <ENT>406,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Confederated Salish and Kootenai Tribes</ENT>
                        <ENT>521,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chippewa Cree Tribe of the Rocky Boy Reservation</ENT>
                        <ENT>412,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">The Coeur D'alene Tribe</ENT>
                        <ENT>444,109</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Confederated Tribes of Siletz Indians</ENT>
                        <ENT>384,442</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cook Inlet Tribal Council, Inc</ENT>
                        <ENT>628,858</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Stillaguamish Tribe of Indians of Washington</ENT>
                        <ENT>575,947</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Moapa Band Paiute</ENT>
                        <ENT>365,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Association of Village Council Presidents, Inc</ENT>
                        <ENT>473,104</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cheyenne River Sioux Tribe</ENT>
                        <ENT>384,587</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">United Houma Nation, Inc</ENT>
                        <ENT>499,086</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Laguna Department of Education</ENT>
                        <ENT>450,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Northern Cheyenne Tribe</ENT>
                        <ENT>375,000</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Eastern Shoshone Tribe</ENT>
                        <ENT>490,368</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Tohono O'odham Nation</ENT>
                        <ENT>450,723</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Standing Rock Sioux Tribe</ENT>
                        <ENT>521,823</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Central Council of Tlingit and Haida Indian Tribes of Alaska</ENT>
                        <ENT>556,369</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lower Elwha Tribal Community</ENT>
                        <ENT>323,430</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="49967"/>
                <HD SOURCE="HD1">Waiver of Notice and Comment Rulemaking and Delayed Effective Date Under the Administrative Procedure Act</HD>
                <P>Under the Administrative Procedure Act (APA) (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, the APA provides that an agency is not required to conduct notice and comment rulemaking when the agency, for good cause, finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(B)).</P>
                <P>
                    Generally, the “good cause” exception to notice and comment rulemaking under the APA, see 5 U.S.C. 553(b)(3)(B), is to be “narrowly construed and only reluctantly countenanced.” 
                    <E T="03">Tennessee Gas Pipeline Co.</E>
                     v. 
                    <E T="03">FERC,</E>
                     969 F.2d 1141, 1144 (D.C. Cir. 1992) (
                    <E T="03">quoting New Jersey</E>
                     v. 
                    <E T="03">EPA,</E>
                     626 F.2d 1038, 1045 (D.C. Cir. 1980)). The exception excuses notice and comment in emergency situations, 
                    <E T="03">Am. Fed'n of Gov't Employees</E>
                     v. 
                    <E T="03">Block,</E>
                     655 F.2d 1153, 1156 (D.C. Cir. 1981), or where delay could result in serious harm. 
                    <E T="03">See Hawaii Helicopter Operators Ass'n</E>
                     v. 
                    <E T="03">FAA,</E>
                     51 F.3d 212, 214 (9th Cir. 1995).
                </P>
                <P>The COVID-19 pandemic struck during the second half of Federal FY 2020 and, as explained earlier, created a situation where the Tribes were dealing with such overwhelmingly trying circumstances that the Department determined that, with their resources and attention diverted to addressing concerns created by the pandemic, it would be too difficult for them to submit applications for the AIVRS grants scheduled to be awarded this year in a timely manner. For this reason, it became necessary for the Department to extend the grants awarded under CFDA 84.250K for an additional year. There is insufficient time left in FY 2020 to adopt these waivers and extensions of the project periods through notice and comment rulemaking and to make the continuation awards to the 29 expiring AIVRS grants. Failure to extend the existing AIVRS grants under CFDA 84.250K for an additional year would result in an interruption of essential services to the American Indians with disabilities who rely on them. In addition, the Department is unique among Federal agencies in that it must go through notice and comment rulemaking under the APA to make its grants. The exception in the APA exempting grants from notice and comment generally does not apply to the Department. 5 U.S.C. 553(a)(2); 20 U.S.C. 1232(d). In short, in the unusual circumstances here, notice and comment rulemaking is both impracticable and not in the public interest.</P>
                <P>The APA also requires that a substantive rule must be published at least 30 days before its effective date, except as otherwise provided for good cause (5 U.S.C. 553(d)(3)). Given that it is not possible to run an effective AIVRS competition this year, it is crucial that the funded grantees under CFDA 84.250K continue to provide services through all of FY 2021. A delayed effective date would be contrary to public interest by prolonging uncertainty about the continuation of VR services provided to American Indians with disabilities living on or near a reservation. Therefore, the Department waives the delayed effective date provision for good cause.</P>
                <HD SOURCE="HD1">Regulatory Flexibility Act Certification</HD>
                <P>The Regulatory Flexibility Act does not apply to this rulemaking because there is good cause to waive notice and comment rulemaking under 5 U.S.C. 553.</P>
                <HD SOURCE="HD1">Paperwork Reduction Act of 1995</HD>
                <P>This waiver and extension of the project periods does not contain any information collection requirements.</P>
                <HD SOURCE="HD1">Intergovernmental Review</HD>
                <P>These programs are not subject to Executive Order 12372 and the regulations in 34 CFR part 79.</P>
                <P>
                    <E T="03">Accessible Format:</E>
                     Individuals with disabilities can obtain this document in an accessible format (
                    <E T="03">e.g.,</E>
                     braille, large print, audiotape, or compact disc) on request to the contact person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <P>
                    <E T="03">Electronic Access to This Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</E>
                     At this site you can view this document, as well as all other documents of this Department published in the 
                    <E T="04">Federal Register</E>
                    , in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <SIG>
                    <NAME>Mark Schultz,</NAME>
                    <TITLE>Commissioner, Rehabilitation Services Administration, Delegated the authority to perform the functions and duties of the Assistant Secretary for the Office of Special Education and Rehabilitative Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-18003 Filed 8-13-20; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <CFR>40 CFR Part 52</CFR>
                <DEPDOC>[EPA-R05-OAR-2015-0700; FRL-10012-09-Region 5]</DEPDOC>
                <SUBJECT>Air Plan Approval; Indiana; Attainment Plan for the Southwest Indiana Sulfur Dioxide Nonattainment Area</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Environmental Protection Agency (EPA) is approving as a State Implementation Plan (SIP) revision to the Southwest Indiana-related elements of an Indiana submission to EPA dated October 2, 2015, as supplemented on November 15, 2017 and September 18, 2019. EPA concludes that Indiana has appropriately demonstrated that the plan provides for attainment of the 2010 sulfur dioxide (SO
                        <E T="52">2</E>
                        ) primary National Ambient Air Quality Standard (NAAQS) in the Southwest Indiana area by the applicable attainment date and that the plan meets the other applicable requirements under the Clean Air Act.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective on September 16, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2015-0700. All documents in the docket are listed on the 
                        <E T="03">www.regulations.gov</E>
                         website. Although listed in the index, some information is not publicly available, 
                        <E T="03">i.e.,</E>
                         Confidential Business Information (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 through 
                        <E T="03">www.regulations.gov,</E>
                         or please contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section for additional availability information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        John Summerhays at EPA Region 5, Attainment Planning and Maintenance 
                        <PRTPAGE P="49968"/>
                        Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6067, 
                        <E T="03">summerhays.john@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Summary of EPA's Notices of Proposed Rulemaking</HD>
                <P>
                    Following the promulgation in 2010 of a 1-hour primary SO
                    <E T="52">2</E>
                     NAAQS, on August 5, 2013, at 78 FR 47191, EPA designated an area in Southwest Indiana that included a township in each of Daviess and Pike Counties, Indiana as nonattainment for this NAAQS, in conjunction with designating three other areas in Indiana and multiple areas in other states as nonattainment. On October 2, 2015, the Indiana Department of Environmental Management (“Indiana”) submitted plans addressing all four of its SO
                    <E T="52">2</E>
                     nonattainment areas. EPA has taken separate action on Indiana's plans for its other nonattainment areas: EPA published final action on plans for the Indianapolis and Terre Haute areas on March 22, 2019, at 84 FR 10692, and published final action on the plan for the Morgan County area on September 23, 2019, at 84 FR 49659.
                </P>
                <P>In addition to its October 2, 2015 submittal, Indiana made a supplemental submittal on November 15, 2017, providing clarifications on its inventory procedures and other elements of its four nonattainment plans. EPA published a proposed rule proposing to approve three of these plans (for the Southwest Indiana, Indianapolis, and Terre Haute areas) on August 15, 2018, at 83 FR 40487.</P>
                <P>In response to that proposed rule, EPA received comments objecting to, among other things, the manner in which Indiana calculated an adjustment to the level of the 30-day average limit for Indianapolis Power and Light's Petersburg power plant (IP&amp;L-Petersburg or “the facility”). These comments prompted Indiana to recalculate the adjustment factor used to determine the appropriate limits for this facility, resulting in the adoption of revised limits and submittal of these revised limits on September 18, 2019. Indiana also provided an email on November 19, 2019 clarifying the interrelationship between the commissioner's order containing the revised limits and the provisions in Indiana regulations, both of which Indiana requested be incorporated into the Indiana SIP.</P>
                <P>On February 24, 2020, at 85 FR 10350, EPA published a supplementary proposed rule addressing Indiana's revised plan. This action evaluated Indiana's revised 30-day average limits and the recalculated adjustment factor used to determine those limits. The original submittal relied on modeling to determine 1-hour emission limits that would provide for attainment (expressed in pounds per million British Thermal Units (MMBTU), known as critical emission rates), and imposed 30-day average limits determined by multiplying these 1-hour rates by 80 percent. Indiana's reevaluation concluded that a more appropriate adjustment factor was 68 percent. Indiana made no change to its modeling; its revised 30-day average limits reflect only this change in adjustment factor. Therefore, the supplemental proposed rule solicited comments only on this change to Indiana's plan.</P>
                <HD SOURCE="HD1">II. Comments</HD>
                <P>In response to its proposed rule of August 15, 2018, EPA received relevant comments from Sierra Club addressing the reliance on 30-day average emission limits for Indianapolis Power and Light's Petersburg power plant (IP&amp;L-Petersburg). EPA also received two anonymous comments that address subjects outside the scope of our proposed action, do not explain (or provide a legal basis for) how the proposed action should differ in any way, and make no specific mention of the substantive aspects of the proposed action. Consequently, these comments are not germane to this rulemaking and require no further response. EPA received no comments on its supplemental proposed rule of February 24, 2020.</P>
                <P>As noted above, Sierra Club had numerous comments on the calculation of the adjustment factor used to determine the original 30-day average limits, which resulted in Indiana recalculating the adjustment factor and adopting revised limits, and which EPA then discussed in a supplemental notice of proposed rulemaking (NPRM). Consequently, some of Sierra Club's comments on the original Indiana submittal are either moot or have been subject to an additional solicitation of comments in light of the additional relevant available information. EPA received no comments on this supplemental NPRM. The following responses to Sierra Club's comments will identify the extent to which comments on specific aspects of Indiana's calculations of 30-day average limits for IP&amp;L-Petersburg are still germane.</P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club notes the health effects from exposure to SO
                    <E T="52">2</E>
                     “in even very short time periods—such as five minutes.” Sierra Club expresses concern that IP&amp;L-Petersburg's 30-day average limit will allow spikes in emissions that cause spikes in concentrations sufficient to yield violations of the 1-hour air quality standard.
                </P>
                <P>
                    <E T="03">Response:</E>
                     EPA believes that Indiana's establishment of a 30-day average limit at a lower level than the 1-hour limit indicated to be necessary by modeling will avoid some of the exceedances that would be expected with emissions constantly at the modeled level, such that the net effect of Indiana's lower, longer term average limit is to have similar air quality as would be expected with a 1-hour limit. Further discussion of this topic is provided below in response to more detailed comments. Sierra Club properly focuses on whether Indiana's plan provides for attainment of the 1-hour standard, and not on the shorter term (
                    <E T="03">e.g.,</E>
                     five minutes) exposures that the standard is designed in part to address. Nevertheless, EPA notes that suitably adjusted long term limits can be expected to provide adequate mitigation of even the shorter (sub-hour) exposures to SO
                    <E T="52">2</E>
                    , for the same reasons that such limits suitably address the 1-hour standard.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club observes that EPA's April 2014 guidance 
                    <SU>1</SU>
                    <FTREF/>
                     acknowledges that EPA historically has required averaging times consistent with the averaging time of the standard, and specifically stated that EPA would not approve plans relying solely on 30-day average limits. Sierra Club cites other EPA statements that short term standards must be addressed with short term average limits. Sierra Club equates a 30-day average limit to a 720-hour average limit, and states that a 720-hour limit would not sufficiently limit hourly emissions to protect against violations of the air quality standard “unless it was shown through air dispersion modeling that the maximum uncontrolled hourly emissions from a source” would not result in violation of the standard. Sierra Club notes that Table 8-1 of EPA's modeling guideline “requires modeling for short term [standards] be based on the allowable emissions over the averaging time of the [standard].” Sierra Club asserts that “the maximum allowable hourly emission rate is difficult to predict from a 30-day average limit.”
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         See “Guidance for 1-Hour SO
                        <E T="52">2</E>
                         Nonattainment Area SIP Submissions,” available at 
                        <E T="03">https://www.epa.gov/sites/production/files/2016-06/documents/20140423guidance_nonattainment_sip.pdf.</E>
                    </P>
                </FTNT>
                <P>
                    <E T="03">Response:</E>
                     The EPA statements that Sierra Club cites predate the 2014 guidance, and thus reflect a time when EPA had not yet conducted the analyses and completed evaluation of methods 
                    <PRTPAGE P="49969"/>
                    for formulating longer term average limits that would provide for attainment of a 1-hour air quality standard. Now that EPA has completed this work, the 2014 guidance, for purposes of implementing the 2010 SO
                    <E T="52">2</E>
                     NAAQS, supersedes prior guidance on the topic.
                </P>
                <P>
                    Sierra Club cites the requirement in EPA's modeling guideline 
                    <SU>2</SU>
                    <FTREF/>
                     to model the allowable emission rate based on a short term limitation, but does not address the guidance in appendix A of EPA's 2014 guidance (entitled “Modeling Guidance for Nonattainment Areas”), which states that notwithstanding the orientation of Table 8-1 toward short term emission limits, “current guidance . . . provides that after the state determines the 1-hour limit that would be necessary to provide for attainment, any longer term limit should be established at a level that is sufficiently lower to provide comparable stringency. Thus, in cases where a state wishes to apply a longer term average limit, the attainment analysis would be based not on the level of the longer term limit but rather on the level of the corresponding 1-hour emission limit.” 
                    <E T="03">See</E>
                     page A-79 of EPA's 2014 guidance. This recommended approach avoids the unnecessary burden of defining an ensemble of variable emissions that may be considered to reflect allowable emissions and the burden of conducting a modeling analysis with such an inventory. Instead, EPA recommends relying on standard modeling approaches, as if a short-term limit were to be established. For reasons described in the guidance and described in more detail in the August 15, 2018 NPRM, EPA believes that a longer term limit that is determined to have comparable stringency to the corresponding 1-hour limit (generally, by applying an adjustment factor computed according to recommended methods) will yield comparable air quality (
                    <E T="03">i.e.,</E>
                     comparable assurance that the standard will not be violated) as the 1-hour limit. For that reason, and for ease of implementation, EPA does not believe that an assessment of the range of emissions expected upon compliance with a long-term limit or an assessment of the associated air quality is warranted or necessary.
                </P>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         Title 40 Code of Federal Regulations part 51 appendix W, entitled “Guideline on Air Quality Models.”
                    </P>
                </FTNT>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club asserts that “ambient air quality conditions can be rendered unsafe by as few as four hours of elevated emissions over the course of a year.”
                </P>
                <P>
                    <E T="03">Response:</E>
                     Indiana, by imposing a 30-day average limit on IP&amp;L-Petersburg's emissions determined in accordance with EPA's guidance, allows a small number of occasions to have emissions above the critical emissions value but requires most occasions to have emissions well below this level, indeed requiring emissions on average to be 32 percent below the critical emissions value. In modeling constant emissions, as in routine modeling to assess whether a particular set of 1-hour emissions limits would provide for attainment, one makes no assessment of the impact of emissions sometimes being higher and other times being lower than the constant emission level. Sierra Club addresses only the occasions with higher emissions, noting their potential to result in exceedances beyond those expected with emissions always at the critical emissions value, thereby yielding a violation of the standard. However, Sierra Club does not address the impact of emissions generally being well below the critical emissions value. Thus, Sierra Club does not consider the likelihood that the more numerous occasions of emissions well below the critical emissions value, mandated by the downward adjusted longer term average emissions limit, would result in avoiding some of the exceedances that would be expected with emissions always at the critical emissions value. EPA does not dispute Sierra Club's contention that occasions with emissions above the critical emissions value create added risk of exceedances of the air quality standard (if these occasions occur when the meteorology is conducive toward high concentrations at locations where violations might occur), but Sierra Club does not dispute or otherwise address EPA's contention that other occasions with emissions well below the critical emissions value, which the downward adjusted 30-day average limit requires to occur often, can be expected to yield a compensating reduction in the frequency of concentrations above the level of the standard. As explained in the NPRM, EPA believes that the net effect of a properly downward adjusted longer-term limit is comparable to the effect of a corresponding 1-hour emission limit and provides equally for attainment.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club asserts that Indiana's modeling analysis, which does not directly assess emissions allowed by a long-term average emission limit, is contrary to the regulatory requirements in 40 CFR 51.112(a). Separately, Sierra Club objects to EPA's assertion that the plan need not provide “absolute certainty that attainment will in fact occur” and that the plan need only provide “an adequate level of confidence of prospective [attainment of the standard].” Sierra Club quotes from Clean Air Act section 172(c)(1), that attainment plans “
                    <E T="03">shall</E>
                     provide for attainment of the national primary ambient air quality standards.” [Emphasis in comments.] Sierra Club concludes that “EPA has much more responsibility than just ensuring a plan provides ‘an adequate level of confidence’ ” of attainment.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The requirement in 40 CFR 51.112(a) is that “[e]ach plan must demonstrate that the measures, rules, and regulations contained in it are adequate to provide for the timely attainment and maintenance of the national standard that it implements.” In this case, Indiana has conducted modeling to identify 1-hour emission limits that would provide for attainment. Indiana then provided an analysis of the degree of adjustment needed for 30-day average limits to be comparably stringent to those 1-hour limits, and Indiana adopted these 30-day average limits. Because Indiana has conducted a suitable analysis of appropriate 1-hour limits and suitably analyzed and adopted the 30-day average limits that are comparably stringent, EPA believes that Indiana has suitably demonstrated that the 30-day average limits in its plan are adequate to provide for timely attainment of the SO
                    <E T="52">2</E>
                     standard, thereby satisfying the requirement of 40 CFR 51.112(a).
                </P>
                <P>Sierra Club has accurately quoted the requirement in the Clean Air Act for attainment plans to provide for attainment. Evidently Sierra Club believes that this requirement would have been met with 1-hour limits, despite the possibility that future violations might occur if, for example, future meteorology differs in unforeseeable ways from the historic meteorology analyzed in planning. EPA believes that the 30-day average limits adopted by Indiana provide comparable assurance of attainment as would have been provided by the 1-hour limits that Indiana would otherwise have relied on, and thus equally as well satisfy the requirement that, in all reasonably foreseeable circumstances, the plan provides for attainment.</P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club believes that the modeling analysis in appendix B of EPA's 2014 guidance does not suffice to demonstrate that 30-day average limits at IP&amp;L-Petersburg or elsewhere can protect against violations of the SO
                    <E T="52">2</E>
                     standard as well as 1-hour limits. Sierra Club believes that the appendix B analysis, by assuming a fixed distribution among stacks at the facility and assuming no changes in stack parameters pursuant to the addition of 
                    <PRTPAGE P="49970"/>
                    emission controls, does not properly address the multi-stack situation at IP&amp;L-Petersburg. Sierra Club objects further that the analysis in appendix B, by using an inventory of how the source would actually emit under a 30-day average limit, is not comparable to an analysis using the maximum permissible emissions under a 1-hour emission limit.
                </P>
                <P>
                    <E T="03">Response:</E>
                     The differences between the plant modeled for appendix B (Canadys) and IP&amp;L-Petersburg are not persuasive reasons to believe that the results found for Canadys would not also apply to IP&amp;L-Petersburg. There is no question that modeling to identify suitable 1-hour emission limits must be done on a source-specific basis, considering the site-specific configurations of stacks, stack parameters (reflecting any influence of controls on those stack parameters), and other source-specific factors such as meteorology, terrain, and dimensions of nearby buildings. However, appendix B reflects a premise that a source-specific critical emission value (
                    <E T="03">i.e.,</E>
                     a candidate value for a 1-hour emission limit) has been identified. Appendix B addresses instead whether a 30-day average limit that reflects an adjustment in accordance with appendix C of EPA's guidance can be expected to result in attainment as well as imposition of a 1-hour limit at the critical emission value. The two scenarios addressed in appendix B (with and without a scrubber) reflect adjustment factors of 68 percent and 69 percent, respectively. Thus, the issue being addressed by appendix B is whether a 30-day average limit reflecting such adjustments (determined based on a source-specific measure of variability) can be expected to ensure attainment as well as the corresponding 1-hour limit. EPA believes that this comparison between air quality with an adjusted 30-day average limit and air quality with the corresponding 1-hour limit applies to a broad range of circumstances. In particular, EPA believes that longer term limits established in accordance with EPA's guidance can provide for comparable air quality as the analogous 1-hour limits for a broad range of plants with various numbers of stacks, with various stack parameters, and with a broad range in the absolute magnitude of the 1-hour limits that are necessary to assure attainment.
                </P>
                <P>
                    Sierra Club is correct that the modeling described in appendix B for emissions in compliance with 30-day average limits is not directly comparable to the modeling that was done in establishing a suitable 1-hour limit. As Sierra Club notes, modeling for the 30-day average limit scenarios reflected the expected distribution of emissions in compliance with such a limit, inherently reflecting a margin of compliance that sources routinely have at most times, whereas the modeling for the 1-hour limit scenarios reflected no such margin of compliance (
                    <E T="03">i.e.,</E>
                     these runs reflected emissions always at the 1-hour limit).
                </P>
                <P>To address this comment, EPA performed additional analyses designed to identify emission profiles with average emissions equal to the presumptive 30-day average limit and to estimate the air quality that would result. These analyses are described in detail in a document entitled “Supplemental Assessment of the Air Quality Consequences of Applying Adjusted Long Term Average Emission Limits,” which is included in the docket for this action.</P>
                <P>
                    The emission profiles used in this supplemental assessment were generally based on the actual emissions variations found in the 30-day periods having 99th percentile level average emissions. Profiles were developed for two plants with limits established in recent attainment plans for 2010 SO
                    <E T="52">2</E>
                     nonattainment areas: IP&amp;L-Petersburg (Unit 3) and Cardinal (Unit 1), a comparably large power plant in Jefferson County, Ohio. In each case, the analyses used data for a suitable period (3 years for IP&amp;L-Petersburg and 5 years for Cardinal) during which the sources were complying with the attainment-level emission limit adopted by the state. Calculations were performed in accordance with appendix C of the 2014 guidance to determine the 99th percentile 30-day average emission rates and to determine appropriate adjustment factors to be applied in determining 30-day average emission limits. These calculations were performed separately on a pound per hour basis and on a pound per MMBTU basis, supporting identification of two actual emission profiles for each plant, one reflecting emission variations in the 30-day period with approximately the 99th percentile pound per hour value and one reflecting emission variations in the 30-day period with approximately the 99th percentile pound per MMBTU value. Since the analysis used the modeling information for a separate plant (Canadys), the analyses used the critical emission value identified in that modeling. Allowable emissions (as a 30-day average) were calculated by multiplying this critical emission value by the applicable adjustment factor. Allowable emission profiles were then developed by scaling the actual emission profiles to the allowable level, 
                    <E T="03">i.e.,</E>
                     multiplying the emissions for each hour times the ratio of the allowable emissions against the average emissions in the actual profile, as well as by substituting the allowable emission value for any time the plant was not operating in the actual profile period. These allowable emission profiles were applied repeatedly, in the first 30 days and every successive 30 days, with the result that every 30-day period in the 5-year analysis had average emissions equal to the allowable emissions level.
                </P>
                <P>One of these profiles, namely for the 99th percentile pound per MMBTU profile at IP&amp;L-Petersburg, included a brief period with exceptionally high emissions, reflecting minimal if any flue gas desulfurization. Based on the uniqueness of these emissions during this timeframe, EPA does not believe that such a profile, recurring every 30 days, is a realistic representation of emission variations that routinely occur. The supplemental assessment document identified above provides further rationale for treating this as an unrepresentative profile, including evidence that such exceptional emissions are much more rare in practice, engineering reasons that such operation is prone to be damaging to the plant, and policy reasons that recurring occasions of exceptionally high emissions would be contrary to guidance to minimize the frequency and magnitude of occasions with emissions above the critical emissions value. Therefore, for this assessment, EPA replaced that profile with a profile based on emissions for the 30-day period with approximately the 98th percentile 30-day average pound per MMBTU value.</P>
                <P>
                    The results of this assessment are shown in Table 1. For each of the four profiles, the resulting air quality is somewhat below the air quality standard. Since these profiles reflect allowable emissions at all times, these results may be compared to the results of modeling allowable emissions under the corresponding 1-hour limit (
                    <E T="03">i.e.,</E>
                     modeling emissions constantly at the critical emission value). Thus, this assessment supports a conclusion similar to the conclusion from appendix B, that establishment of a long term average emissions limit estimated to have comparable stringency to the corresponding 1-hour emission limit (calculated in accordance with the guidance in A C) can be expected to result in comparable air quality, and that such a limit provides comparable assurance of attainment.
                    <PRTPAGE P="49971"/>
                </P>
                <GPOTABLE COLS="2" OPTS="L2,p7,7/8,i1" CDEF="s25,12">
                    <TTITLE>Table 1—Design Values Estimated for Each Emission Profile</TTITLE>
                    <BOXHD>
                        <CHED H="1">Profile</CHED>
                        <CHED H="1">
                            Design value
                            <LI>
                                (µg/m 
                                <SU>3</SU>
                                 (ppb))
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Cardinal #/hour</ENT>
                        <ENT>181.2 (69.2)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Cardinal #/MMBTU</ENT>
                        <ENT>190.6 (72.8)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Petersburg #/hour</ENT>
                        <ENT>156.3 (59.7)</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Petersburg 98th %-ile #/MMBTU</ENT>
                        <ENT>190.5 (72.7)</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club asserts that “[n]either Indiana nor EPA evaluated the reasonably available control measures that could be utilized” at IP&amp;L-Petersburg. Sierra Club highlights a consultant's evaluation of such measures at this plant, as reported to the Indiana Utility Regulatory Commission. Sierra Club identifies several of the measures identified in this consultant's evaluation, and states that “EPA cannot justify allowing a 30-day average limit . . . without considering all reasonably available control measures.”
                </P>
                <P>
                    <E T="03">Response:</E>
                     EPA guidance for implementing the SO
                    <E T="52">2</E>
                     NAAQS advises that a plan that provides for attainment may be considered to have implemented all reasonably available control measures. EPA believes that the 30-day average limits in Indiana's plan provide for attainment as well as would have been provided by 1-hour limits. Therefore, EPA believes that use of these 30-day average limits does not create a need for requirements for specific control measures (beyond the requirements inherent in the emission limit) that would not apply with the use of 1-hour limits. While the measures evaluated in the consultant's report may be useful approaches for the company to comply with Indiana's emission limits, EPA does not believe that approval of Indiana's plan should be contingent on Indiana adopting requirements for any of these specific measures.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club objects that Indiana “did not conduct a unit-specific analysis in determining emissions variability.” Sierra Club believes that Indiana is not justified in evaluating emissions variability only for the FGD stack 
                    <SU>3</SU>
                    <FTREF/>
                     for Unit 2, rather than examining variability of emissions for all four units at IP&amp;L-Petersburg and including emissions from the bypass stacks (as applicable at Units 1 and 2). Sierra Club notes, in particular, that neither the 30-day average limits nor any other requirement will ensure that emissions from the bypass stacks will not occur. Sierra Club notes that the units differ significantly, as they use scrubbers of different vintages and these scrubbers have been upgraded recently, so that Indiana may not assume that the variability of the FGD stack emissions at Unit 2 in the period from 2006 to 2010 is representative of either the variability of emissions of the other three units at that time or of the variability of emissions that can be expected for any of the four units once the units meet the proposed SIP limits. Sierra Club thus implies that the data Indiana used are not appropriate for determining the degree of adjustment warranted for all four units for an attainment plan for this area.
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The “FGD stack” refers to the stack that vents emissions from the unit's control device, and thus represents controlled emissions. The bypass stack vents the emissions from the unit when the control device is not controlling emissions properly.
                    </P>
                </FTNT>
                <P>
                    <E T="03">Response:</E>
                     In response to this comment, Indiana provided further explanation of its reliance on data from the Unit 2 FGD stack, namely that these data, by exclusively reflecting controlled emissions and reflecting more stable control equipment operation than Unit 1, provide the best data set for representing the distribution of emissions for all four units once Indiana's limits take effect. An extensive discussion of Indiana's rationale is provided in the February 24, 2020 supplemental NPRM, on which Sierra Club did not comment. Furthermore, additional analyses of variability at all four units at IP&amp;L-Petersburg that were described in the supplemental NPRM provide additional support for EPA's belief that the 2006 to 2010 data for the Unit 2 FGD stack provide an appropriate data base for anticipating the variability that has in fact occurred in the time after Indiana's limits took effect. In absence of comments on this additional explanation, EPA maintains that Indiana's adjustment factor, based on 2006 to 2010 data for the FGD stack at Unit 2, is appropriate.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club notes that EPA's guidance recommends that variability analyses be based on “‘an adequately robust data’ with at least `3 to 5 years of stable data (without changes that significantly altered emissions variability)'.” Sierra Club believes that the data set for IP&amp;L-Petersburg's Unit 2 FGD stack does not meet these criteria. Sierra Club notes significant variability from year to year in the maximum 30-day average emissions (in pounds per hour) and emission rate (in pounds per MMBTU), which was permissible given the absence of a constraining emission limit. Sierra Club further notes that the emissions from the Unit 2 FGD stack were below Indiana's proposed 30-day average proposed SIP limit for two of the five years included in Indiana's analysis, yet even in those years those emissions (not including bypass stack emissions) exceeded the critical mass emissions value in 82 and 99 hours (in 2007 and 2008, respectively).
                </P>
                <P>
                    <E T="03">Response:</E>
                     The February 24, 2020 supplemental NPRM addresses most of these comments. In particular, the supplemental action provided additional rationale for the use of historic data from the Unit 2 FGD stack for assessing the expected variability of emissions at all four units at IP&amp;L-Petersburg, and the supplemental action described EPA's analysis of more recent data that help confirm Indiana's forecast of variability and that indicate that the three units that are complying with the revised limits are emitting above the critical emissions value less than one percent of the time. Because EPA received no comments on this supplemental action, EPA considers the supplemental information to address these comments on the initial NPRM.
                </P>
                <P>The supplemental NPRM did not address the portion of this comment that argued that year-to-year variability in emissions, expressed in terms of year-to-year variations in the maximum 30-day average pound per hour and pound per MMBTU, is too great to consider the 2006 to 2010 period to be a period of stable operation with respect to emissions from the Unit 2 FGD stack. That portion of the comment is addressed here.</P>
                <P>
                    The purpose of the relevant portion of EPA's guidance is to determine variability based on a data set that best reflects the degree of variability that can be expected once the facility complies with the limits in the plan. A data set with significant changes in control levels (
                    <E T="03">e.g.,</E>
                     two years of uncontrolled emissions and two years of well controlled emissions) would either (at the 99th percentile level) be dominated by the two years of uncontrolled emissions data or give a distorted picture of variability, thus giving results that are either insufficiently robust or misleading.
                </P>
                <P>
                    However, Sierra Club has made no argument that the control regime for the Unit 2 emissions that are vented through the FGD stack changed during the 2006 to 2010 period. Instead, Sierra Club is effectively arguing that routine operation of the control equipment during that period results in significant variations in emissions from year to year. EPA expects year-to-year differences in plant operations, and indeed EPA seeks to include that variability in its recommended approach to assessing the appropriate degree of adjustment of longer-term limits. Indeed, EPA's analysis of post-control data described in the supplemental NPRM suggests that the multi-year variability of current 
                    <PRTPAGE P="49972"/>
                    emissions is similar to the multi-year variability of Unit 2 FGD stack emissions in 2006 to 2010. “Stable operation” cannot be defined as operation without year-to-year variations; such a definition would defeat the purpose of forecasting the variability in emissions that can be expected into the future once the SIP control strategy is implemented. If anything, Sierra Club's comment highlights the importance of using the entirety of a multi-year data base (EPA recommends at least three to five years) for determining the relative stringency of a long term average limit as compared to a 1-hour limit, for a period with a stable control regime such as was the case here.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club objects that Indiana did not evaluate whether limits with an intermediate averaging period (
                    <E T="03">e.g.,</E>
                     24 hours) might be more appropriate or whether supplemental limitations on peak hourly emissions might be warranted. Sierra Club provided statistics for each of the four units on the number of days since the limits took effect (using data from January 1, 2017 to June 30, 2018) during which at least one hour exceeded the critical emission rate, despite the four units all complying with Indiana's 30-day average emission limits. For Units 1 through 4 during that one and one half year period, Sierra Club noted 63 days, 138 days, 9 days, and 22 days, respectively, with at least one hour having more emissions than the unit's critical emissions value, representing respectively 11.5 percent, 25.3 percent, 1.7 percent, and 4.0 percent of the days in that period. Sierra Club further notes eight hours during which total SO
                    <E T="52">2</E>
                     emissions exceeded the sum of the four units' critical emissions values (in approximate terms, a plant-wide critical emissions value). Sierra Club concludes that Indiana's 30-day average limits cannot be considered comparably stringent to 1-hour limits at the critical emissions value, that modeling of the critical emissions value does not suffice to demonstrate that the 30-day average limits provide for attainment, and that supplemental limits must be imposed to assure that “actual occurrences of hourly emission rates above the critical emissions values will only occur on `rare' occasions.”
                </P>
                <P>
                    <E T="03">Response:</E>
                     EPA's initial NPRM concluded that Indiana's 30-day average limits appeared to be sufficiently stringent to constrain hourly emissions to be only rarely above the critical emissions values, without the need for supplemental limits. The same logic would suggest that the use of limits with an intermediate averaging time such as 24 hours is also not necessary to assure that hours with emissions above the critical emissions value will be rare.
                </P>
                <P>
                    EPA's initial NPRM reported the results of an examination of five years of data from Unit 2 from before Indiana's limits took effect, noting that the unit exceeded the 30-day average limit for about seven percent of the averages and that the unit exceeded the critical emissions value for about six percent of the hours. Sierra Club uses a data set for 18 months starting when Indiana's limits took effect, which is a data set that is more indicative of operation in accordance with the limits in Indiana's plan. Sierra Club also examined data for all four units. Finally, EPA's supplemental NPRM, on which Sierra Club did not comment, reviewed the data for a 30-month period starting when Indiana's limits took effect. Specifically, for this 30-month period, Units 1, 3, and 4 complied with their revised 30-day average limits and had hourly emissions above the critical emissions value (
                    <E T="03">i.e.,</E>
                     the modeled mass emissions in pounds per hour) for 0.9 percent, 0.1 percent, and 0.4 percent of the hours, respectively. Unit 2 exceeded its revised limit 17 percent of the 30-day averages, while exceeding the critical emission value 3 percent of the time. This suggests that the necessary improvements in scrubber efficiency at Unit 2 would likely yield a percentage of hours with emissions above the critical emission value that is similar to the percentages found for the three units that are already complying with limits. In absence of comments on this information, EPA continues to believe that Indiana's 30-day average limits are sufficient to constrain emissions to be only rarely above the critical emissions value, even without supplemental limits or limits set with a shorter averaging time.
                </P>
                <P>
                    <E T="03">Comment:</E>
                     Sierra Club noted that Indiana determined its 30-day average limits on emission levels (in pounds per hour) on the basis of an adjustment factor calculated to reflect variability of emission rates (in pounds per MMBTU), to which Sierra Club objected as being inappropriate and contrary to EPA guidance.
                </P>
                <P>
                    <E T="03">Response:</E>
                     EPA agrees that the variability of emission levels is prone to be different from the variability of emission rates, and Sierra Club is correct that EPA guidance recommends determining and applying separate adjustment factors for these two types of limits. Indiana's amended plan, including revised emission rate limits, no longer includes 30-day average mass emission level limits.
                    <SU>4</SU>
                    <FTREF/>
                     EPA's supplemental NPRM provided EPA's review of this and other revisions Indiana made, and EPA received no comments on the revisions or on the review provided in its supplemental action. Thus, this comment is now moot.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Indiana has provided modeling demonstrating that attainment is assured by a limit corresponding to the “critical emission rate” (which may be defined as the pound per MMBTU rate that at maximum load suffices to provide for attainment), and so Indiana's plan provides for attainment without need for an additional limit on pounds of emissions per hour.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">III. EPA's Final Action</HD>
                <P>
                    EPA is approving Indiana's SIP submission for the Southwest Indiana SO
                    <E T="52">2</E>
                     nonattainment area, which Indiana submitted to EPA on October 2, 2015 and supplemented on June 7, 2017, November 15, 2017, and September 18, 2019, and clarified on November 19, 2019. This SO
                    <E T="52">2</E>
                     nonattainment plan included Indiana's attainment demonstration for this area. The nonattainment plan also addressed requirements for emission inventories, reasonably available control technology/reasonably available control measures, reasonable further progress, and contingency measures. Indiana has previously addressed requirements regarding nonattainment area new source review.
                    <SU>5</SU>
                    <FTREF/>
                     EPA has determined that Indiana's SO
                    <E T="52">2</E>
                     nonattainment plan for Southwest Indiana meets the applicable requirements of Clean Air Act sections 110, 172, 191, and 192.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         As noted in the NPRM, EPA approved Indiana's nonattainment new source review rules on October 7, 1994 (94 FR 24838).
                    </P>
                </FTNT>
                <P>
                    Underpinning Indiana's attainment plan for Southwest Indiana are three rules and a Commissioner's Order. The rule that is most pertinent to this action is Indiana Administrative Code, Title 326, Rule 7-4-15 (326 IAC 7-4-15), entitled “Pike County sulfur dioxide emission limitations”, effective January 1, 2017, which provides 1-hour emission limits for IP&amp;L-Petersburg and the Frank E. Ratts facility and provide the terms under which IP&amp;L may switch between being subject to the 1-hour limits in the rule and the 30-day average limits in the Commissioner's order. Two other rules, namely 326 IAC 7-1.1-3 (“Compliance date”) and 326 IAC 7-2-1 (“Reporting requirements; methods to determine compliance”), are also pertinent to the Marion, Morgan, and Vigo County nonattainment plans and were approved in the context of action on the Marion and Vigo County action (
                    <E T="03">See</E>
                     84 FR 10692, published March 22, 2019.) As a result of this action, the SIP will include Pike County limits (in 
                    <PRTPAGE P="49973"/>
                    addition to previously approved limits for Marion, Morgan and Vigo Counties) as well as the implementing provisions in 326 IAC 7-1.1-3 and 326 IAC 7-2-1, and no reapproval of these implementing provisions and indeed no SIP revision is needed for these implementing provisions to govern the implementation of the Pike County limits, as Indiana intended.
                    <SU>6</SU>
                    <FTREF/>
                     In accordance with Indiana's request, EPA is approving paragraphs a, b, d, and e of 326 IAC 7-4-15. EPA is also approving Commissioner's Order Number 2019-2, issued on July 31, 2019 and effective on August 18, 2019. Indiana did not request approval of 326 IAC 7-4-15(c), because these 30-day average limits have been superseded by the 30-day average limits in Commissioner's Order. As discussed in the supplemental NPRM, EPA is following Indiana's interpretation that compliance with the limits in the Commissioner's Order substitute for and supersede the limits in 326 IAC 7-4-15(c), and accordingly that the provisions of 326 IAC 7-4-15(d) describe how 30-day average emission rates are to be calculated to determine compliance with the limits in the Commissioner's Order, and that the provisions of 326 IAC 7-4-15(e) set the terms under which IP&amp;L may elect to switch whether they must meet the 1-hour emission limits in 326 IAC 7-4-15(a) or the 30-day average limits in the Commissioner's Order.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         To avoid any potential for confusion, EPA wishes to note that the compliance deadline for the limits in the commissioner's order is specified in the commissioner's order and not in 326 IAC 7-1.1-3.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">IV. Incorporation by Reference</HD>
                <P>
                    In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of an Indiana regulation described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available through 
                    <E T="03">www.regulations.gov,</E>
                     and at the EPA Region 5 Office (please contact the applicable person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the Clean Air Act as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation.
                    <SU>7</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         62 FR 27968 (May 22, 1997).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">V. Statutory and Executive Order Reviews</HD>
                <P>Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:</P>
                <P>• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);</P>
                <P>• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;</P>
                <P>
                    • Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>
                    • Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 
                    <E T="03">et seq.</E>
                    );
                </P>
                <P>• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);</P>
                <P>• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);</P>
                <P>• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);</P>
                <P>• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);</P>
                <P>• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and</P>
                <P>• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).</P>
                <P>In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).</P>
                <P>
                    The Congressional Review Act, 5 U.S.C. 801 
                    <E T="03">et seq.,</E>
                     as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the 
                    <E T="04">Federal Register</E>
                    . A major rule cannot take effect until 60 days after it is published in the 
                    <E T="04">Federal Register</E>
                    . This action is not a “major rule” as defined by 5 U.S.C. 804(2).
                </P>
                <P>Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 16, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 40 CFR Part 52</HD>
                    <P>Environmental protection, Air pollution control, Incorporation by Reference, Reporting and recordkeeping requirements, Sulfur oxides.</P>
                </LSTSUB>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        42 U.S.C. 7401 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: July 16, 2020.</DATED>
                    <NAME>Kurt Thiede,</NAME>
                    <TITLE>Regional Administrator, Region 5.</TITLE>
                </SIG>
                <P>For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:</P>
                <PART>
                    <PRTPAGE P="49974"/>
                    <HD SOURCE="HED">PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS</HD>
                </PART>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>1. The authority citation for part 52 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>
                            42 U.S.C. 7401 
                            <E T="03">et seq.</E>
                        </P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="40" PART="52">
                    <AMDPAR>2. In § 52.770:</AMDPAR>
                    <AMDPAR>a. In paragraph (c) amend the table by adding an entry for “7-4-15” under “Article 7. Sulfur Dioxide Rules,” “Rule 4. Emission Limitations and Requirements by County”;</AMDPAR>
                    <AMDPAR>b. In paragraph (d) amend the table by adding an entry at the end with a CO date of “7/31/2019” for “IP&amp;L-Petersburg”; and</AMDPAR>
                    <AMDPAR>
                        c. In paragraph (e) amend the table by adding an entry for “Southwest Indiana 2010 Sulfur Dioxide (SO
                        <E T="52">2</E>
                        ) Attainment Plan” after the entry for “Ozone (8-Hour, 1997): South Bend-Elkhart, IN (Elkhart and St. Joseph Counties)”.
                    </AMDPAR>
                    <P>The additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 52.770 </SECTNO>
                        <SUBJECT>Identification of plan.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="xs60,r50,12,r50,r50">
                            <TTITLE>EPA—Approved Indiana Regulations</TTITLE>
                            <BOXHD>
                                <CHED H="1">Indiana citation</CHED>
                                <CHED H="1">Subject</CHED>
                                <CHED H="1">
                                    Indiana
                                    <LI>effective</LI>
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval date</CHED>
                                <CHED H="1">Notes</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Article 7. Sulfur Dioxide Rules</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW RUL="s">
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW EXPSTB="04" RUL="s">
                                <ENT I="21">
                                    <E T="02">Rule 4. Emission Limitations and Requirements by County</E>
                                </ENT>
                            </ROW>
                            <ROW EXPSTB="00">
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">7-4-15</ENT>
                                <ENT>Pike County sulfur dioxide emission limitations</ENT>
                                <ENT>10/5/2015</ENT>
                                <ENT>
                                    8/17/2020, [insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>Only (a), (b), (d), and (e). EPA is approving a commissioner's order in place of (c).</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                        <P>(d) * * *</P>
                        <GPOTABLE COLS="5" OPTS="L1,i1" CDEF="xs60,r50,12,r50,r50">
                            <TTITLE>EPA—Approved Indiana Nonregulatory and Quasi-Regulatory Provisions</TTITLE>
                            <BOXHD>
                                <CHED H="1">CO date</CHED>
                                <CHED H="1">Title</CHED>
                                <CHED H="1">SIP rule</CHED>
                                <CHED H="1">EPA approval</CHED>
                                <CHED H="1">Explanation</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">7/31/2019</ENT>
                                <ENT>IP&amp;L-Petersburg</ENT>
                                <ENT>7-4-15</ENT>
                                <ENT>
                                    8/17/2020, [insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                                <ENT>30-day average limits.</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                        <P>(e) * * *</P>
                        <GPOTABLE COLS="4" OPTS="L1,i1" CDEF="s100,12,r100,xs60">
                            <TTITLE>EPA—Approved Indiana Nonregulatory and Quasi-Regulatory Provisions</TTITLE>
                            <BOXHD>
                                <CHED H="1">Title</CHED>
                                <CHED H="1">
                                    Indiana
                                    <LI>date</LI>
                                </CHED>
                                <CHED H="1">EPA approval</CHED>
                                <CHED H="1">Explanation</CHED>
                            </BOXHD>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                            <ROW>
                                <ENT I="01">
                                    Southwest Indiana 2010 Sulfur Dioxide (SO
                                    <E T="0732">2</E>
                                    ) Attainment Plan
                                </ENT>
                                <ENT>10/2/15</ENT>
                                <ENT>
                                    8/17/2020, [insert 
                                    <E T="02">Federal Register</E>
                                     citation]
                                </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="22"> </ENT>
                            </ROW>
                            <ROW>
                                <ENT I="28">*         *         *         *         *         *         *</ENT>
                            </ROW>
                        </GPOTABLE>
                        <STARS/>
                    </SECTION>
                </REGTEXT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-16044 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>
                BILLING CODE 6560-50-P
                <PRTPAGE P="49975"/>
            </BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Parts 216 and 300</CFR>
                <DEPDOC>[Docket No. 200728-0201]</DEPDOC>
                <RIN>RIN 0648-BJ23</RIN>
                <SUBJECT>International Fisheries; Pacific Tuna Fisheries; Fishing Restrictions for Silky Shark, Fish Aggregating Devices, and Observer Safety in the Eastern Pacific Ocean</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>Final rule; date of effectiveness for collection-of-information requirements.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        NMFS announces approval by the Office of Management and Budget (OMB) of collection-of-information requirements contained in regulations published in a final rule on May 18, 2020. The final rule implements three resolutions adopted by the Members of the Inter-American Tropical Tuna Commission (IATTC) in 2018 and 2019: Resolution C-19-01 (
                        <E T="03">Amendment to Resolution C-18-05 on the Collection and Analyses of Data on Fish-Aggregating Devices</E>
                        ); Resolution C-19-05 (
                        <E T="03">Amendment to the Resolution C-16- 06 Conservation Measures for Shark Species, with Special Emphasis on the Silky Shark (Carcharhinus falciformis), for the Years 2020 and 2021</E>
                        ); and Resolution C-18-07 (
                        <E T="03">Resolution on Improving Observer Safety at Sea: Emergency Action Plan</E>
                        ). The final rule also implements a resolution adopted by Parties to the Agreement on the International Dolphin Conservation Program (AIDCP): Resolution A-18-03 (
                        <E T="03">On Improving Observer Safety At Sea: Emergency Action Plan</E>
                        ). The intent of this final rule is to inform the public of the effectiveness of the collection-of information requirements associated with silky shark reporting, fish aggregating device (FAD) reporting, and observer reporting included in the final rule.
                    </P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This final rule is effective August 17, 2020. The amendments to §§ 216.24, 300.22(a)(3)(i), 300.24(ff), (gg), (hh), 300.27(f), and 300.29 published at 85 FR 29666 (May 18, 2020) are effective on August 17, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Copies of supporting documents are available via the Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov,</E>
                         docket NOAA-NMFS-2019-0149, or contact Rachael Wadsworth, NMFS WCR SFD, 7600 Sand Point Way NE, Building 1, Seattle, WA 98115, or 
                        <E T="03">WCR.HMS@noaa.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Rachael Wadsworth, NMFS at 562-980-4036.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    NMFS implemented decisions of the IATTC and AIDCP in the eastern Pacific Ocean under the authority of the Tuna Conventions Act (16 U.S.C. 951 
                    <E T="03">et seq.</E>
                    ) and the Marine Mammal Protection Act (16 U.S.C. 1361 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>NMFS issued a final rule to implement three IATTC Resolutions and one AIDCP Resolution on silky shark, data collection for FADs, and observer safety. The rule applies to U.S. commercial fishing vessels that fish for tuna or tuna-like species in the IATTC Convention Area. The IATTC Convention Area is defined as waters of the eastern Pacific Ocean within the area bounded by the west coast of the Americas and by 50° N latitude, 150° W longitude, and 50° S latitude.</P>
                <P>
                    The final rule was published in the 
                    <E T="04">Federal Register</E>
                     on May 18, 2020 (85 FR 29666), and associated regulations are found at 50 CFR parts 216 and 300. The requirements of that final rule related to the retention prohibition on silky shark caught on longline vessels became effective June 17, 2020, and the remaining amendments that included collection-of-information requirements were delayed. OMB approved the collection-of-information requirements for the remaining amendments contained in the final rule on June 12, 2020, under OMB Control Number 0648-0214 and 0648-0148. Accordingly, this final rule announces the approval and effective date of those remaining amendments related to FAD, silky shark, and observer safety collection-of-information requirements found in Subpart C of 50 CFR parts 216 and 300.
                </P>
                <HD SOURCE="HD1">Classification</HD>
                <HD SOURCE="HD2">Administrative Procedure Act</HD>
                <P>
                    Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and opportunity for public comment for this action because notice and comment would be unnecessary and contrary to the public interest. This action simply provides notice of OMB's approval of the reporting requirements at issue, which has already occurred, and renders those requirements effective. Thus, this action does not involve any further exercise of agency discretion by NMFS or OMB. Moreover, the public has had prior notice and the opportunity to comment on the collection-of-information requirements. NMFS published the proposed rule in the 
                    <E T="04">Federal Register</E>
                     (85 FR 4250; January 24, 2020), with comments accepted until February 24, 2020. NMFS received one comment during the comment period. This comment was outside the scope of the action and is not relevant to this rule. The final rule was published on May 18, 2020 (85 FR 29666), and indicated that this final rule would be published announcing the effective date for the revised reporting requirements upon OMB approval.
                </P>
                <P>There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date for the collection-of information requirements. This final rule relieves some of the reporting requirements for captains of purse seine vessels, allows NMFS to collect data related to silky shark regulations, and implements reporting requirements intended to improve observer safety at sea. In addition, the final rule is necessary for the United States to satisfy its obligations as a member of the IATTC and Party to the AIDCP. Accordingly, waiver of the 30-day delay in effective date is necessary to improve compliance with the requirements of the IATTC and AIDCP, the failure of which would be contrary to the public interest.</P>
                <HD SOURCE="HD2">Executive Order 12866</HD>
                <P>This final rule has been determined to be not significant for purposes of Executive Order 12866.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>This final rule contains collection of-information requirements subject to the Paperwork Reduction Act (PRA) and which OMB approved under OMB Control Number 0648-0214 and 0648-0148 on June 12, 2020.</P>
                <P>
                    Specifically, captains of U.S. purse seine vessels are only required to collect FAD data (OMB Control No. 0648-0148) when an observer is not onboard, and captains are still required to provide the observer with the FAD identification number. The public reporting burden for these requirements is estimated to average 1 minute per form. The requirement to report silky shark surrendered or donated is also estimated to average 1 minute per form, and the reporting related to observer safety on purses seine vessels is estimated to average 5 minutes per reporting incident. Public reporting burden for amendments to the supporting 
                    <PRTPAGE P="49976"/>
                    statement for the Pacific Islands Region Logbook Family of Forms (OMB Control No. 0648-0214) for reporting related to observer safety on longline vessels is estimated to average 5 minutes per reporting incident. These estimates include time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
                </P>
                <P>Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection-of-information subject to the requirements of the PRA, unless that collection-of-information displays a currently valid OMB control number.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1361 
                        <E T="03">et seq.</E>
                         and 16 U.S.C. 951 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: July 28, 2020.</DATED>
                    <NAME>Samuel D. Rauch III,</NAME>
                    <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-16730 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 200227-0066; RTID 0648-XA383]</DEPDOC>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Reallocation of Pacific Cod in the Bering Sea and Aleutian Islands Management Area</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>Temporary rule; reallocation.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>NMFS is reallocating the projected unused amount of Pacific cod from vessels using jig gear and catcher vessels greater than or equal to 60 feet (18.3 meters (m)) length overall (LOA) using hook-and-line gear to catcher vessels less than 60 feet (18.3 m) length overall using hook-and-line or pot gear in the Bering Sea and Aleutian Islands (BSAI) management area. This action is necessary to allow the 2020 total allowable catch (TAC) of Pacific cod to be harvested.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective August 14, 2020, through 2400 hours, Alaska local time (A.l.t.), December 31, 2020.</P>
                </EFFDATE>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Krista Milani, 907-581-2062.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.</P>
                <P>The 2020 Pacific cod TAC specified for vessels using jig gear in the BSAI is 1,278 metric tons (mt) as established by the final 2020 and 2021 harvest specifications for groundfish in the BSAI (85 FR 13553, March 9, 2020) and reallocation (85 FR 4601, January 27, 2020).</P>
                <P>The 2020 Pacific cod TAC specified for catcher vessels greater than or equal to 60 feet (18.3 m) LOA using hook-and-line gear in the BSAI is 277 mt as established by the final 2020 and 2021 harvest specifications for groundfish in the BSAI (85 FR 13553, March 9, 2020).</P>
                <P>The 2020 Pacific cod TAC allocated to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear in the BSAI is 3,433 mt as established by final 2020 and 2021 harvest specifications for groundfish in the BSAI (85 FR 13553, March 9, 2020) and reallocation (85 FR 4601, January 27, 2020).</P>
                <P>
                    The Administrator, Alaska Region, NMFS, (Regional Administrator) has determined that jig vessels will not be able to harvest 1,100 mt of the 2020 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(
                    <E T="03">1</E>
                    ) and catcher vessels greater than or equal to 60 feet (18.3 m) LOA using hook-and-line gear will not be able to harvest 274 mt of the 2020 Pacific cod TAC allocated to those vessels under § 679.20(a)(7)(ii)(A)(
                    <E T="03">3</E>
                    ).
                </P>
                <P>Therefore, in accordance with § 679.20(a)(7)(iv)(C), NMFS apportions 1,100 mt of Pacific cod from the jig gear apportionment to the annual amount specified for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear. Also, in accordance with § 679.20(a)(7)(iii)(A), NMFS reallocates 274 mt from the catcher vessels greater than or equal to 60 feet (18.3 m) LOA using hook-and-line gear apportionment to the annual amount specified for catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.</P>
                <P>The harvest specifications for 2020 Pacific cod included in final 2020 and 2021 harvest specifications for groundfish in the BSAI (85 FR 13553, March 9, 2020) and reallocation (85 FR 4601, January 27, 2020) are revised as follows: 178 mt to vessels using jig gear, 3 mt to catcher vessels greater than or equal to 60 feet (18.3 m) LOA using hook-and-line gear, and 4,807 mt to catcher vessels less than 60 feet (18.3 m) LOA using hook-and-line or pot gear.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.</P>
                <P>Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would allow for harvests that exceed the originally specified apportionment of the Pacific cod TAC.</P>
                <P>NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 7, 2020.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Kelly Denit,</NAME>
                    <TITLE>Director, Office of Sustainable Fisheries, National Marine Fisheries Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17924 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
        <RULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <CFR>50 CFR Part 679</CFR>
                <DEPDOC>[Docket No. 200227-0066; RTID 0648-XA385]</DEPDOC>
                <SUBJECT>Fisheries of the Exclusive Economic Zone Off Alaska; Several Groundfish Species in the Bering Sea and Aleutian Islands Management Area</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>Temporary rule; apportionment of reserves; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        NMFS apportions amounts of the non-specified reserve to the initial total allowable catch (ITAC) of Aleutian Islands (AI) Greenland turbot, AI trawl sablefish, Bering Sea (BS) trawl 
                        <PRTPAGE P="49977"/>
                        sablefish, Bering Sea and Eastern Aleutian Islands (BS/EAI) blackspotted/rougheye rockfish, Bering Sea and Aleutian Islands (BSAI) Alaska plaice, BSAI Kamchatka flounder, BSAI octopuses, and BSAI “other flatfish”. This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the BSAI management area.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Effective August 14, 2020, through 2400 hrs, Alaska local time, December 31, 2020. Comments must be received at the following address no later than 4:30 p.m., Alaska local time, August 31, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit your comments, identified by docket number NOAA-NMFS-2019-0074, by either of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Electronic Submission:</E>
                         Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to 
                        <E T="03">https://www.regulations.gov/docket?D=NOAA-NMFS-2019-0074</E>
                         click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         NMFS may not consider comments if they are sent by any other method, to any other address or individual, or received after the comment period ends. All comments received are a part of the public record and NMFS will post the comments for public viewing on 
                        <E T="03">www.regulations.gov</E>
                         without change. All personal identifying information (
                        <E T="03">e.g.,</E>
                         name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender is publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Steve Whitney, 907-586-7228.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the BSAI Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.</P>
                <P>The 2020 ITAC of AI Greenland turbot was established as 149 metric tons (mt), the 2020 ITAC of AI trawl sablefish was established as 433 mt, the 2020 ITAC of BS trawl sablefish was established as 791 mt, the 2020 ITAC of BS/EAI blackspotted/rougheye rockfish was established as 72 mt, the 2020 ITAC of BSAI Alaska plaice was established as 14,450 mt, the 2020 ITAC of BSAI Kamchatka flounder was established as 5,780 mt, the 2020 ITAC of BSAI octopuses was established as 234, and the 2020 ITAC of BSAI “other flatfish” was established as 3,400 mt by the final 2020 and 2021 harvest specifications for groundfish of the BSAI (85 FR 13553, March 9, 2020). In accordance with § 679.20(a)(3) the Regional Administrator, Alaska Region, NMFS, has reviewed the most current available data and finds that the ITACs for AI Greenland turbot, AI trawl sablefish, BS trawl sablefish, BS/EAI blackspotted/rougheye rockfish, BSAI Alaska plaice, BSAI Kamchatka flounder, BSAI octopuses, and BSAI “other flatfish” need to be supplemented from the non-specified reserve to promote efficiency in the utilization of fishery resources in the BSAI and allow fishing operations to continue.</P>
                <P>Therefore, in accordance with § 679.20(b)(3), NMFS apportions from the non-specified reserve of groundfish to ITACs in the BSAI management area as follows: 550 mt to AI Greenland turbot, 38 mt to AI trawl sablefish, 70 mt to BS trawl sablefish, 40 mt to BS/EAI blackspotted/rougheye rockfish, 3,000 mt to BSAI Alaska plaice, 800 mt to BSAI Kamchatka flounder, 450 mt to BSAI octopuses, and 200 mt to BSAI “other flatfish.” These apportionments are consistent with § 679.20(b)(1)(i) and do not result in overfishing of any target species because the revised ITACs and total allowable catches (TACs) are equal to or less than the specifications of the acceptable biological catch in the final 2020 and 2021 harvest specifications for groundfish in the BSAI (85 FR 13553, March 9, 2020).</P>
                <P>The harvest specification for the 2020 ITACs and TACs included in the harvest specifications for groundfish in the BSAI are revised as follows: 699 mt for AI Greenland turbot, 471 mt for AI trawl sablefish, 861 mt for BS trawl sablefish, 112 mt for BS/EAI blackspotted/rougheye rockfish, 17,450 mt for BSAI Alaska plaice, 6,580 mt for BSAI Kamchatka flounder, 684 mt for BSAI octopuses, and 3,600 mt for BSAI “other flatfish.</P>
                <HD SOURCE="HD1">Classification</HD>
                <P>NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.</P>
                <P>Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the apportionment of the non-specified reserves of groundfish to the AI Greenland turbot, AI trawl sablefish, BS trawl sablefish, BS/EAI blackspotted/rougheye rockfish, BSAI Alaska plaice, BSAI Kamchatka flounder, BSAI octopuses, and BSAI “other flatfish”. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 7, 2020.</P>
                <P>
                    Under § 679.20(b)(3)(iii), interested persons are invited to submit written comments on this action (see 
                    <E T="02">ADDRESSES</E>
                    ) until August 31, 2020.
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P>
                        16 U.S.C. 1801 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Kelly Denit,</NAME>
                    <TITLE>Director, Office of Sustainable Fisheries, National Marine Fisheries Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17929 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </RULE>
    </RULES>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <PRORULES>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="49978"/>
                <AGENCY TYPE="F">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2020-0689; Product Identifier 2020-NM-060-AD]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; The Boeing Company Airplanes</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to supersede Airworthiness Directive (AD) 2013-18-08, which applies to certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. AD 2013-18-08 requires repetitive inspections for cracking of certain upper and lower skin panels of the fuselage, and of the fuselage skin along certain chem-milled lines, and corrective actions if necessary. AD 2013-18-08 also includes a terminating action for the repetitive inspections of certain modified or repaired areas only. Since the FAA issued AD 2013-18-08, there have been reports of additional cracking in certain horizontal and vertical chem-milled step locations outside of those identified in AD 2013-18-08. This proposed AD would continue to require repetitive inspections for cracking of the fuselage skin along certain chem-milled lines and applicable on-condition actions, and would expand the inspection area. This AD would continue to provide terminating action for repetitive inspections of certain modified or repaired areas. This proposed AD would also add airplanes to the applicability. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by October 1, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</E>
                         You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating Docket No. FAA-2020-0689.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0689; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, any comments received, and other information. The street address for Docket Operations) is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        James Guo, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5357; fax: 562-627-5210; email: 
                        <E T="03">james.guo@faa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2020-0689; Product Identifier 2020-NM-060-AD” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this NPRM because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about this proposed AD.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to the person identified in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                </P>
                <HD SOURCE="HD1">Discussion</HD>
                <P>
                    Fatigue damage can occur locally, in small areas or structural design details, or globally, in widespread areas. Multiple-site damage is widespread damage that occurs in a large structural element such as a single rivet line of a lap splice joining two large skin panels. Widespread damage can also occur in 
                    <PRTPAGE P="49979"/>
                    multiple elements such as adjacent frames or stringers. Multiple-site damage and multiple-element damage cracks are typically too small initially to be reliably detected with normal inspection methods. Without intervention, these cracks will grow, and eventually compromise the structural integrity of the airplane. This condition is known as widespread fatigue damage (WFD). It is associated with general degradation of large areas of structure with similar structural details and stress levels. As an airplane ages, WFD will likely occur, and will certainly occur if the airplane is operated long enough without any intervention.
                </P>
                <P>The FAA's WFD final rule (75 FR 69746, November 15, 2010) became effective on January 14, 2011. The WFD rule requires certain actions to prevent structural failure due to WFD throughout the operational life of certain existing transport category airplanes and all of these airplanes that will be certificated in the future. For existing and future airplanes subject to the WFD rule, the rule requires that DAHs establish a limit of validity (LOV) of the engineering data that support the structural maintenance program. Operators affected by the WFD rule may not fly an airplane beyond its LOV, unless an extended LOV is approved.</P>
                <P>The WFD rule (75 FR 69746, November 15, 2010) does not require identifying and developing maintenance actions if the DAHs can show that such actions are not necessary to prevent WFD before the airplane reaches the LOV. Many LOVs, however, do depend on accomplishment of future maintenance actions. As stated in the WFD rule, any maintenance actions necessary to reach the LOV will be mandated by ADs through separate rulemaking actions.</P>
                <P>In the context of WFD, this action is necessary to enable DAHs to propose LOVs that allow operators the longest operational lives for their airplanes, and still ensure that WFD will not occur. This approach allows for an implementation strategy that provides flexibility to DAHs in determining the timing of service information development (with FAA approval), while providing operators with certainty regarding the LOV applicable to their airplanes.</P>
                <P>The FAA issued AD 2013-18-08, Amendment 39-17581 (78 FR 60660, October 2, 2013) (“AD 2013-18-08”), for certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. AD 2013-18-08 requires repetitive inspections for cracking of certain upper and lower skin panels of the fuselage, and of the fuselage skin along certain chem-milled lines, and corrective actions if necessary. AD 2013-18-08 also includes a terminating action for the repetitive inspections of certain modified or repaired areas only. The FAA issued AD 2013-18-08 to address fatigue cracking of the skin panels, which could result in sudden fracture and failure of the skin panels of the fuselage, and consequent rapid decompression of the airplane.</P>
                <HD SOURCE="HD1">Actions Since AD 2013-18-08 Was Issued</HD>
                <P>Since the FAA issued AD 2013-18-08, there have been reports of additional cracking in the horizontal and vertical chem-milled step locations outside of those identified in AD 2013-18-08. The cracking was caused by fatigue from hoop stress and higher than expected bending stresses across the chem-milled steps. The FAA has determined that the repetitive inspections must be expanded to include these areas and that additional airplanes are subject to the unsafe condition.</P>
                <HD SOURCE="HD1">Related Service Information Under 1 CFR Part 51</HD>
                <P>
                    The FAA reviewed Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020. This service information describes procedures for repetitive detailed and non-destructive tests (NDTs) (including external medium frequency eddy current (MFEC), external magneto optical imaging (MOI), external c-scan, external sliding probe, external high frequency eddy current (HFEC), external low frequency eddy current (LFEC), internal ultrasonic phased array (UTPA), or internal ultrasonic); inspections for cracking of the fuselage skin along all horizontal and vertical chem-milled locations with a history of cracking between stations (STAs) 259.5 and 1016; and applicable on-condition actions. On-condition actions include repair; LFEC inspections of certain repairs for cracking; detailed inspections of certain repairs for cracking and loose, missing, or damaged fasteners; replacement of loose, missing, or damaged fasteners; and preventative modifications. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>The FAA is proposing this AD because the agency evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements</HD>
                <P>
                    Although this proposed AD does not explicitly restate the requirements of AD 2013-18-08, this proposed AD would retain certain requirements of AD 2013-18-08. Those requirements are referenced in the service information identified previously, which, in turn, is referenced in paragraph (g) of this proposed AD. This proposed AD would expand the area for the existing inspections for cracking of the fuselage skin along all horizontal and vertical chem-milled locations and add airplanes to the applicability. This proposed AD would also require accomplishment of the actions identified as “RC” (required for compliance) in the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, described previously. For information on the procedures, see this service information at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0689.
                </P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this proposed AD affects 141 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="s50,r100,12,r100">
                    <TTITLE>Estimated Costs for Required Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">Cost per product</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Inspections</ENT>
                        <ENT>Up to 165 work-hours × $85 per hour = $14,025 per inspection cycle</ENT>
                        <ENT>$0</ENT>
                        <ENT>Up to $1,977,525 per inspection cycle.</ENT>
                    </ROW>
                </GPOTABLE>
                <PRTPAGE P="49980"/>
                <P>The FAA estimates the following costs to do any necessary corrective actions that would be required based on the results of the proposed inspections. The FAA has no way of determining the number of aircraft that might need these corrective actions:</P>
                <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s100,12C,r50">
                    <TTITLE>Estimated Costs of On-Condition Actions</TTITLE>
                    <BOXHD>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">Cost per product</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Up to 185 work-hours × $85 per hour = $15,725</ENT>
                        <ENT>$ *</ENT>
                        <ENT>Up to $15,725.</ENT>
                    </ROW>
                    <TNOTE>* The FAA has received no definitive data that would enable providing parts costs for the on-condition actions specified in this proposed AD.</TNOTE>
                </GPOTABLE>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA has determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 the proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Will not affect intrastate aviation in Alaska, 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>
                <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">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <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>
                <AMDPAR>2. The FAA amends § 39.13 by removing Airworthiness Directive (AD) 2013-18-08, Amendment 39-17581 (78 FR 60660, October 2, 2013), and adding the following new AD:</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">The Boeing Company:</E>
                         Docket No. FAA-2020-0689; Product Identifier 2020-NM-060-AD.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments on this AD action by October 1, 2020.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>This AD replaces AD 2013-18-08, Amendment 39-17581 (78 FR 60660, October 2, 2013) (“AD 2013-18-08”).</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>This AD applies to The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020.</P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Air Transport Association (ATA) of America Code 53, Fuselage.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by reports of additional cracking in the horizontal and vertical chem-milled step locations outside of those identified in AD 2013-18-08. The FAA is issuing this AD to address fatigue cracking of the skin panels, which could result in sudden fracture and failure of the skin panels of the fuselage, and consequent rapid decompression of the airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Required Actions for Group 1 Through 25 Airplanes</HD>
                    <P>For airplanes identified as Group 1 through 25 in Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, except as specified in paragraph (h) of this AD: At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020. Actions identified as terminating action in Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, terminate the applicable required actions of this AD, provided the terminating action is done in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020.</P>
                    <HD SOURCE="HD1">(h) Exceptions to Service Information Specifications</HD>
                    <P>(1) Where Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, uses the phrase “the original issue date of this service bulletin,” this AD requires using “the effective date of this AD.”</P>
                    <P>(2) Where Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, specifies contacting Boeing for repair instructions, this AD requires doing the repair before further flight using a method approved in accordance with the procedures specified in paragraph (j) of this AD.</P>
                    <HD SOURCE="HD1">(i) Required Actions for Group 26 Airplanes</HD>
                    <P>For airplanes identified as Group 26 in Alert Service Bulletin 737-53A1346, dated March 27, 2020: Within 120 days after the effective date of this AD, inspect the fuselage skin along certain chem-milled lines for cracks, using a method approved in accordance with the procedures specified in paragraph (j) of this AD.</P>
                    <HD SOURCE="HD1">(j) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to: 
                        <E T="03">9-ANM-LAACO-AMOC-Requests@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                    <P>
                        (3) An AMOC that provides an acceptable level of safety may be used for any repair, 
                        <PRTPAGE P="49981"/>
                        modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
                    </P>
                    <P>(4) AMOCs approved previously for AD 2013-18-08 are approved as AMOCs for the corresponding provisions of Boeing Alert Service Bulletin 737-53A1346, dated March 27, 2020, that are required by paragraph (g) of this AD.</P>
                    <P>(5) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(5)(i) and (ii) of this AD apply.</P>
                    <P>(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.</P>
                    <P>(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.</P>
                    <HD SOURCE="HD1">(k) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact James Guo, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5357; fax: 562-627-5210; email: 
                        <E T="03">james.guo@faa.gov.</E>
                    </P>
                    <P>
                        (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual &amp; Data Services (C&amp;DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet 
                        <E T="03">https://www.myboeingfleet.com.</E>
                         You may view this referenced service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on August 6, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17837 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 39</CFR>
                <DEPDOC>[Docket No. FAA-2020-0692; Project Identifier MCAI-2019-00140-E]</DEPDOC>
                <RIN>RIN 2120-AA64</RIN>
                <SUBJECT>Airworthiness Directives; Pratt &amp; Whitney Canada Corp. Turboprop Engines</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The FAA proposes to adopt a new airworthiness directive (AD) for all Pratt &amp; Whitney Canada Corp. PT6A-34, -34B, -34AG, -114, and -114A model turboprop engines. This proposed AD was prompted by several reports of low-time fractures of compressor turbine (CT) blades resulting in loss of power or in-flight shutdown of the engine. This proposed AD would require replacement of certain CT vanes. This proposed AD would also require removal from service of certain CT blades when these blades have been operated with certain CT vanes. The FAA is proposing this AD to address the unsafe condition on these products.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The FAA must receive comments on this proposed AD by October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12 140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Examining the AD Docket</HD>
                <P>
                    You may examine the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0692; or in person at Docket Operations between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this NPRM, the mandatory continuing airworthiness information (MCAI), any comments received, and other information. The street address for Docket Operations is listed above. Comments will be available in the AD docket shortly after receipt.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Barbara Caufield, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7146; fax: 781-238-7199; email: 
                        <E T="03">barbara.caufield@faa.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>
                    The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the 
                    <E T="02">ADDRESSES</E>
                     section. Include “Docket No. FAA-2020-0692; Project Identifier MCAI-2019-00140-E” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this NPRM because of those comments.
                </P>
                <P>
                    Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to 
                    <E T="03">https://www.regulations.gov,</E>
                     including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact we received about this proposal.
                </P>
                <HD SOURCE="HD1">Confidential Business Information</HD>
                <P>
                    Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Barbara Caufield, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
                    <PRTPAGE P="49982"/>
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>Transport Canada, which is the aviation authority for Canada, has issued Canada AD CF 2019-30R1, dated December 17, 2019 (referred to after this as “the MCAI”), to address the unsafe condition on these products. The MCAI states:</P>
                <EXTRACT>
                    <P>There have been several reported events of low time CT blade fractures resulting in power loss/In-flight shutdown (IFSD) on post P&amp;WC Service Bulletin (SB) 1669 configured PT6A-114 engines, featuring new CMSX-6 CT blades. In addition, relatively low time failures of Non-P&amp;WC CT blades have also been reported on PT6A-34 and -114 series engines.</P>
                    <P>In service data shows that these low time failures were reported on engines that had CT vanes installed that were repaired in accordance with repair specification number STI 72-50-254 held by Southwest Turbine Inc. (STI). Most of the affected engines are installed on single-engine powered aeroplanes and some events have resulted in the loss of the aeroplane and fatalities.</P>
                    <P>Dimensional checks and operational testing of the subject STI repaired CT vane removed from an incident engine, revealed that it did not conform to the engine manufacturer's CT vane type design criteria. The noted variations and features in the STI repaired CT vane can cause airflow distortion and subsequent aerofoil excitation of the CT blades resulting in High Cycle Fatigue (HCF) failure of the CT blades. Test data indicates that the stress levels induced in CT blades by the adverse effect of subject airflow distortion exceeds the design requirements for CMSX-6 CT blades.</P>
                    <P>An IFSD or loss of power on a single-engine powered aeroplane under certain conditions can lead to an unsafe condition as seen in some past events. AD CF-2019-30 was issued on 19 August 2019 to address the potential hazard of power loss/IFSD as a result of CT blade failures on engines with CT vanes installed that were repaired in accordance with repair specification number STI 72-50-254.</P>
                    <P>This AD revision, CF-2019-30R1, is issued to update the background information and to clarify the affected P&amp;WC CT blade Part Numbers (P/Ns).</P>
                </EXTRACT>
                <P>
                    You may obtain further information by examining the MCAI in the AD docket on the internet at 
                    <E T="03">https://www.regulations.gov</E>
                     by searching for and locating Docket No. FAA-2020-0692.
                </P>
                <HD SOURCE="HD1">FAA's Determination</HD>
                <P>This product has been approved by the aviation authority of Canada and is approved for operation in the United States. Pursuant to our bilateral agreement with Canada, they have notified us of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this NPRM because we evaluated all the relevant information provided by Transport Canada and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.</P>
                <HD SOURCE="HD1">Proposed AD Requirements</HD>
                <P>This proposed AD would require replacement of certain CT vanes. This proposed AD would also require removal from service of certain CT blades when these blades have been operated with certain CT vanes.</P>
                <HD SOURCE="HD1">Costs of Compliance</HD>
                <P>The FAA estimates that this proposed AD affects 907 engines installed on airplanes of U.S. registry. The FAA estimates that 63 engines will need to replace the CT vanes and CT blades.</P>
                <P>The FAA estimates the following costs to comply with this proposed AD:</P>
                <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r50,12,12,12">
                    <TTITLE>Estimated Costs</TTITLE>
                    <BOXHD>
                        <CHED H="1">Action</CHED>
                        <CHED H="1">Labor cost</CHED>
                        <CHED H="1">Parts cost</CHED>
                        <CHED H="1">
                            Cost per
                            <LI>product</LI>
                        </CHED>
                        <CHED H="1">
                            Cost on U.S.
                            <LI>operators</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Remove and replace certain CT vanes</ENT>
                        <ENT>16 work-hours × $85 per hour = $1,360</ENT>
                        <ENT>$115,789</ENT>
                        <ENT>$117,149</ENT>
                        <ENT>$7,380,387</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Remove and replace CMSX-6 CT blade set</ENT>
                        <ENT>16 work-hours × $85 per hour = $1,360</ENT>
                        <ENT>90,271</ENT>
                        <ENT>91,631</ENT>
                        <ENT>5,772,753</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.</P>
                <P>The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.</P>
                <HD SOURCE="HD1">Regulatory Findings</HD>
                <P>The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 this proposed regulation:</P>
                <P>(1) Is not a “significant regulatory action” under Executive Order 12866,</P>
                <P>(2) Will not affect intrastate aviation in Alaska, 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>
                <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">The Proposed Amendment</HD>
                <P>Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:</P>
                <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>
                <AMDPAR>2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):</AMDPAR>
                <EXTRACT>
                    <FP SOURCE="FP-2">
                        <E T="04">Pratt &amp; Whitney Canada Corp.:</E>
                         Docket No. FAA-2020-0692; Project Identifier MCAI-2019-00140-E.
                    </FP>
                    <HD SOURCE="HD1">(a) Comments Due Date</HD>
                    <P>The FAA must receive comments by October 1, 2020.</P>
                    <HD SOURCE="HD1">(b) Affected ADs</HD>
                    <P>None.</P>
                    <HD SOURCE="HD1">(c) Applicability</HD>
                    <P>
                        This AD applies to all Pratt &amp; Whitney Canada Corp. PT6A-34, -34B, -34AG,  -114, and -114A model turboprop engines.
                        <PRTPAGE P="49983"/>
                    </P>
                    <HD SOURCE="HD1">(d) Subject</HD>
                    <P>Joint Aircraft System Component (JASC) Code 7250, Turbine Section.</P>
                    <HD SOURCE="HD1">(e) Unsafe Condition</HD>
                    <P>This AD was prompted by several reports of low-time fractures of compressor turbine (CT) blades resulting in loss of power or in-flight shutdown of the engine. The FAA is issuing this AD to prevent failure of the CT blade. The unsafe condition, if not addressed, could result in failure of the engine, in-flight shutdown, and loss of the airplane.</P>
                    <HD SOURCE="HD1">(f) Compliance</HD>
                    <P>Comply with this AD within the compliance times specified, unless already done.</P>
                    <HD SOURCE="HD1">(g) Required Actions</HD>
                    <P>(1) Within 250 flight hours (FHs) or 270 days after the effective date of this AD, whichever occurs first:</P>
                    <P>(i) Remove from service any CT vane repaired in accordance with Southwest Turbine Inc. (STI) repair specification STI-72-50-254 and replace with a non-STI-repaired CT vane.</P>
                    <P>(ii) Remove from service any CMSX-6 CT blade that has been operated on an affected engine with a CT vane repaired in accordance with STI repair specification STI-72-50-254.</P>
                    <P>(2) [Reserved]</P>
                    <HD SOURCE="HD1">(h) Installation Prohibition</HD>
                    <P>After the effective date of this AD, do not install on any engine a CT vane that was repaired in accordance with repair specification STI-72-50-254.</P>
                    <HD SOURCE="HD1">(i) Alternative Methods of Compliance (AMOCs)</HD>
                    <P>
                        (1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ECO Branch, send it to the attention of the person identified in paragraph (j)(1) of this AD. You may email your request to: 
                        <E T="03">ANE-AD-AMOC@faa.gov.</E>
                    </P>
                    <P>(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.</P>
                    <HD SOURCE="HD1">(j) Related Information</HD>
                    <P>
                        (1) For more information about this AD, contact Barbara Caufield, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7146; fax: 781-238-7199; email: 
                        <E T="03">barbara.caufield@faa.gov</E>
                        .
                    </P>
                    <P>
                        (2) Refer to Transport Canada AD CF 2019-30R1, dated December 17, 2019, for more information. You may examine the Transport Canada AD in the AD docket on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by searching for and locating it in Docket No. FAA-2020-0692.
                    </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued on August 10, 2020.</DATED>
                    <NAME>Lance T. Gant,</NAME>
                    <TITLE>Director, Compliance &amp; Airworthiness Division, Aircraft Certification Service.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17783 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2020-0741; Airspace Docket No. 19-AWP-79]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Amendment of Class D and E Airspace; Fallon, NV</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to modify Class E airspace at Fallon NAS (Voorhis Field) Airport, by revoking the Class E airspace designated as an extension to a Class D or Class E surface area. This action also proposes to modify the Class E airspace extending upward from 700 feet above the surface. Further, this action proposes to modify the Class E airspace extending upward from 1,200 feet above the surface. Lastly, this action proposes numerous administrative amendments to the airspaces' legal descriptions. This action would ensure the safety and management of instrument flight rules (IFR) operations at the airport.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2020-0741; Airspace Docket No. 19-AWP-79, at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order 7400.11D, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11D at NARA, email 
                        <E T="03">fedreg.legal@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Matthew Van Der Wal, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3695.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would amend the Class D and Class E airspace at Fallon NAS (Voorhis Field) Airport, Fallon, NV, to support IFR operations at the airport.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2020-0741; Airspace Docket No. 19-AWP-79”. The postcard will be date/time stamped and returned to the commenter.</P>
                <P>
                    All communications received before the specified closing date for comments will be considered before taking action 
                    <PRTPAGE P="49984"/>
                    on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
                </P>
                <HD SOURCE="HD1">Availability of NPRMs</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at
                    <E T="03"> https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the 
                    <E T="02">ADDRESSES</E>
                     section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace designated as an extension to a Class D or Class E surface area. This airspace is not required and should be revoked.</P>
                <P>This action also proposes to modify Class E airspace extending upward from 700 feet above the surface. This area is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. This airspace area would be described as follows: That airspace extending upward from 700 feet above the surface within an 8-mile radius of the airport, and within 2.5 miles each side of the 143° bearing from the airport, extending from the 8-mile radius to 11.5 miles southeast of the airport, and within 2.5 miles each side of the 270° bearing from the airport, extending from the 8-mile radius to 11.5 miles west of the airport, and within 2.5 miles each side of the 327° bearing from the airport, extending from the 8-mile radius to 11.5 miles northwest of Fallon NAS (Voorhis Field) Airport.</P>
                <P>Further, this action proposes to modify Class E airspace extending upward from 1,200 feet above the surface. This area is designed to contain IFR aircraft transitioning to/from the terminal and en route environments. This airspace area would be described as follows: That airspace extending upward from 1,200 feet above the surface within a 30-mile radius of the Fallon NAS (Van Voorhis Field) Airport.</P>
                <P>Lastly, this action proposes numerous administrative amendments to the airspaces' legal descriptions. To match the FAA database, the geographic coordinates in the Class D and Class E2 text headers for Fallon NAS (Voorhis Field) Airport and Fallon Municipal Airport should be updated. For Fallon NAS (Voorhis Field) Airport the coordinates should be lat. 39°25′04″ N, long. 118°41′55″ W. For Fallon Municipal Airport the coordinates should be lat. 39°29′57″ N, long. 118°44′56″ W. The last two sentences in the Class D and Class E surface area legal descriptions contain incorrect verbiage, the sentences should be updated to “This Class D (or E, as appropriate) airspace area is effective during the specific dates and times established, in advance, by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.” For the Class E airspace areas extending upward from 700 feet or more above the surface, the Fallon Navy TACAN and Mustang VORTAC are not required to define these airspace areas. The TACAN, VORTAC, all radials, and distances from the navigational aids should be removed from the airspace descriptions.</P>
                <P>Class D, E2, E4, and E5 airspace designations are published in paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</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, is non-controversial, and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 5000 Class D Airspace.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AWP NV D Fallon, NV [Amended]</HD>
                    <FP SOURCE="FP-2">Fallon NAS (Van Voorhis Field) Airport, NV</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°25′04″ N, long. 118°41′55″ W)</FP>
                    <FP SOURCE="FP-2">
                        Fallon Municipal Airport, NV
                        <PRTPAGE P="49985"/>
                    </FP>
                    <FP SOURCE="FP1-2">(Lat. 39°29′57″ N, long. 118°44′56″ W)</FP>
                    <P>That airspace extending upward from the surface to and including 6,400 feet MSL within a 5.5-mile radius of Fallon NAS (Van Voorhis Field) Airport, excluding that airspace within a 1-mile radius of Fallon Municipal Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.</P>
                    <HD SOURCE="HD2">Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AWP NV E2 Fallon, NV [Amended]</HD>
                    <FP SOURCE="FP-2">Fallon NAS (Van Voorhis Field) Airport, NV</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°25′04″ N, long. 118°41′55″ W)</FP>
                    <FP SOURCE="FP-2">Fallon Municipal Airport, NV</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°29′57″ N, long. 118°44′56″ W)</FP>
                    <P>That airspace extending upward from the surface within a 5.5-mile radius of Fallon NAS (Van Voorhis Field) Airport, excluding that airspace within a 1-mile radius of Fallon Municipal Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.</P>
                    <HD SOURCE="HD2">Paragraph 6004 Class E Airspace Areas Designated as an Extension to a Class D or Class E Surface Area.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AWP NV E4 Fallon NAS, NV [Revoked]</HD>
                    <FP SOURCE="FP-2">Fallon NAS (Van Voorhis Field), NV</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°25′00″ N, long. 118°42′04″ W)</FP>
                    <FP SOURCE="FP-2">Fallon Navy TACAN</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°25′01″ N, long. 118°42′18″ W)</FP>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AWP NV E5 Fallon, NV [Amended]</HD>
                    <FP SOURCE="FP-2">Fallon NAS (Van Voorhis Field) Airport, NV</FP>
                    <FP SOURCE="FP1-2">(Lat. 39°25′04″ N, long. 118°41′55″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within an 8-mile radius of the airport, and within 2.5 miles each side of the 143° bearing from the airport, extending from the 8-mile radius to 11.5 miles southeast of the airport, and within 2.5 miles each side of the 270° bearing from the airport, extending from the 8-mile radius to 11.5 miles west of the airport, and within 2.5 miles each side of the 327° bearing from the airport, extending from the 8-mile radius to 11.5 miles northwest of the airport; and that airspace extending upward from 1,200 feet above the surface within a 30-mile radius of the Fallon NAS (Van Voorhis Field) Airport.</P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Seattle, Washington, on August 11, 2020.</DATED>
                    <NAME>B.G. Chew,</NAME>
                    <TITLE>Acting Group Manager, Operations Support Group, Western Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17842 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <CFR>14 CFR Part 71</CFR>
                <DEPDOC>[Docket No. FAA-2020-0707; Airspace Docket No. 18-AWP-28]</DEPDOC>
                <RIN>RIN 2120-AA66</RIN>
                <SUBJECT>Proposed Establishment of Class E Airspace; Redding, CA</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed rulemaking (NPRM).</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This action proposes to establish Class E airspace, extending upward from 700 feet above the surface, at Benton Field Airport. This action would ensure the safety and management of IFR operations at the airport.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1-800-647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2020-0707; Airspace Docket No. 18-AWP-28, at the beginning of your comments. You may also submit comments through the internet at 
                        <E T="03">https://www.regulations.gov.</E>
                    </P>
                    <P>
                        FAA Order 7400.11D, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at 
                        <E T="03">https://www.faa.gov/air_traffic/publications/.</E>
                         For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11D at NARA, email 
                        <E T="03">fedreg.legal@nara.gov</E>
                         or go to 
                        <E T="03">https://www.archives.gov/federal-register/cfr/ibr-locations.html.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Matthew Van Der Wal, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-3695.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority for This Rulemaking</HD>
                <P>The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would establish Class E airspace at Benton Field Airport, Redding, CA, to support instrument flight rules (IFR) operations at the airport.</P>
                <HD SOURCE="HD1">Comments Invited</HD>
                <P>Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Persons wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2020-0707; Airspace Docket No. 18-AWP-28”. The postcard will be date/time stamped and returned to the commenter.</P>
                <P>All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.</P>
                <HD SOURCE="HD1">Availability of NPRMs</HD>
                <P>
                    An electronic copy of this document may be downloaded through the internet at 
                    <E T="03">https://www.regulations.gov.</E>
                     Recently published rulemaking documents can also be accessed through the FAA's web page at
                    <E T="03"> https://www.faa.gov/air_traffic/publications/airspace_amendments/.</E>
                </P>
                <P>
                    You may review the public docket containing the proposal, any comments 
                    <PRTPAGE P="49986"/>
                    received, and any final disposition in person in the Dockets Office (see the 
                    <E T="02">ADDRESSES</E>
                     section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198.
                </P>
                <HD SOURCE="HD1">Availability and Summary of Documents for Incorporation by Reference</HD>
                <P>
                    This document proposes to amend FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the 
                    <E T="02">ADDRESSES</E>
                     section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
                </P>
                <HD SOURCE="HD1">The Proposal</HD>
                <P>The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by establishing Class E airspace, extending upward from 700 feet above the surface, at Benton Field Airport. This area is designed to contain IFR departures to 1,200 feet above the surface and IFR arrivals descending below 1,500 feet above the surface. This airspace area would be described as follows: That airspace extending upward from 700 feet above the surface within a 3.3-mile radius of the airport, and within 4 miles east and 2.3 miles west of the 002° bearing from the airport, extending from 2.5 miles north of the airport to 12.4 miles north of the airport, and within 2.7 miles each side of the 176° bearing from the airport, extending from the 3.3-mile radius to 10.8 miles south of Benton Field Airport.</P>
                <P>Class E5 airspace designations are published in paragraph 6005 of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.</P>
                <P>FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.</P>
                <HD SOURCE="HD1">Regulatory Notices and Analyses</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, is non-controversial, and unlikely to result in adverse or negative comments. 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. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.</P>
                <HD SOURCE="HD1">Environmental Review</HD>
                <P>This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 14 CFR Part 71</HD>
                    <P>Airspace, Incorporation by reference, Navigation (air).</P>
                </LSTSUB>
                <HD SOURCE="HD1">The Proposed Amendment</HD>
                <P>Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS</HD>
                </PART>
                <AMDPAR>1. The authority citation for 14 CFR part 71 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority:</HD>
                    <P> 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.</P>
                </AUTH>
                <SECTION>
                    <SECTNO>§ 71.1 </SECTNO>
                    <SUBJECT>[Amended]</SUBJECT>
                </SECTION>
                <AMDPAR>2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, is amended as follows:</AMDPAR>
                <EXTRACT>
                    <HD SOURCE="HD2">Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth.</HD>
                    <STARS/>
                    <HD SOURCE="HD1">AWP CA E5 Redding, CA</HD>
                    <FP SOURCE="FP-2">Benton Field Airport, CA</FP>
                    <FP SOURCE="FP1-2">(Lat. 40°34′25″ N, long. 122°24′26″ W)</FP>
                    <P>That airspace extending upward from 700 feet above the surface within a 3.3-mile radius of the airport, and within 4 miles east and 2.3 miles west of the 002° bearing from the airport, extending from 2.5 miles north of the airport to 12.4 miles north of the airport, and within 2.7 miles each side of the 176° bearing from the airport, extending from the 3.3-mile radius to 10.8 miles south of Benton Field Airport. </P>
                </EXTRACT>
                <SIG>
                    <DATED>Issued in Seattle, Washington, on August 10, 2020.</DATED>
                    <NAME>B.G. Chew,</NAME>
                    <TITLE>Acting Group Manager, Operations Support Group, Western Service Center.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17875 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <CFR>21 CFR Part 890</CFR>
                <DEPDOC>[Docket No. FDA-2020-N-1053]</DEPDOC>
                <SUBJECT>Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Proposed amendment; proposed order; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA) is proposing to reclassify non-invasive bone growth stimulators, postamendments class III devices (product codes LOF and LPQ), into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification with the name “non-invasive bone growth stimulators” along with the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these devices will no longer be required to submit a premarket approval application (PMA), but are subject to premarket notification (510(k)) requirements and general and special controls.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit either electronic or written comments on the proposed order by October 16, 2020. Please see section XII of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments as follows. Please note that late, 
                        <PRTPAGE P="49987"/>
                        untimely filed comments will not be considered. Electronic comments must be submitted on or before October 16, 2020. The 
                        <E T="03">https://www.regulations.gov</E>
                         electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of October 16, 2020. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
                    </P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal Rulemaking Portal:</E>
                      
                    <E T="03">https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2020-N-1053 for “Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators.” Received comments, those filed in a timely manner (see 
                    <E T="02">ADDRESSES</E>
                    ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jesse Muir, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4508, Silver Spring, MD 20993, 240-402-6679, 
                        <E T="03">Jesse.Muir@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Background—Regulatory Authorities</HD>
                <P>The Federal Food, Drug, and Cosmetic Act (FD&amp;C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&amp;C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (general controls and special controls), and class III (general controls and premarket approval).</P>
                <P>Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices) are automatically classified by section 513(f)(1) of the FD&amp;C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until: (1) FDA reclassifies the device into class I or II or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&amp;C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&amp;C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807), subpart E, of the regulations.</P>
                <P>A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&amp;C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&amp;C Act. Section 513(f)(3) of the FD&amp;C Act provides that FDA acting by administrative order, can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.</P>
                <P>
                    Reevaluation of the data previously presented before the Agency is an appropriate basis for subsequent action, where the reevaluation is made in light of newly available regulatory authority (see 
                    <E T="03">Bell</E>
                     v. 
                    <E T="03">Goddard,</E>
                     366 F.2d 177, 181 (7th Cir. 1966); 
                    <E T="03">Ethicon, Inc.</E>
                     v. 
                    <E T="03">FDA,</E>
                     762 F. Supp. 382, 388-391 (D.D.C. 1991)) or in light of changes in “medical science” (
                    <E T="03">Upjohn</E>
                     v. 
                    <E T="03">Finch,</E>
                     422 F.2d 944, 951 (6th Cir. 1970)). Whether data before the Agency are old or new, the “new information” to support reclassification under 513(f)(3) must be “valid scientific evidence”, as defined in section 513(a)(3) of the FD&amp;C Act and § 860.7(c)(2) (21 CFR 860.7(c)(2)). (See, 
                    <E T="03">e.g., General Medical Co.</E>
                     v. 
                    <E T="03">FDA,</E>
                     770 F.2d 214 (D.C. Cir. 1985); 
                    <E T="03">Contact Lens Assoc.</E>
                     v. 
                    <E T="03">FDA,</E>
                     766 F.2d 592 (D.C. Cir. 
                    <PRTPAGE P="49988"/>
                    1985), cert. denied, 474 U.S. 1062 (1986).)
                </P>
                <P>
                    FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&amp;C Act and § 860.7(c)(2), in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, 
                    <E T="03">e.g.,</E>
                     the contents of a pending PMA (see section 520(c) of the FD&amp;C Act (21 U.S.C. 360j(c)). Section 520(h)(4) of the FD&amp;C Act provides that FDA may use, for reclassification of a device, certain information in a PMA 6 years after the application has been approved (Ref. 1). This includes information from clinical and preclinical tests or studies that demonstrate the safety or effectiveness of the device, but does not include descriptions of methods of manufacture or product composition and other trade secrets.
                </P>
                <P>
                    In accordance with section 513(f)(3) of the FD&amp;C Act, FDA is issuing this proposed order to reclassify non-invasive bone growth stimulator devices, postamendments class III devices, into class II (special controls), subject to premarket notification because FDA believes the standard in section 513(a)(1)(B) of the FD&amp;C Act is met as there is sufficient information to establish special controls, which in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         In December 2019, FDA began adding the term “Proposed amendment” to the “ACTION” caption for these documents, typically styled “Proposed order”, to indicate that they “propose to amend” the Code of Federal Regulations. This editorial change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act (44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and parts 21 and 22), and the Document Drafting Handbook.
                    </P>
                </FTNT>
                <P>Section 510(m) of the FD&amp;C Act provides that a class II device may be exempted from the premarket notification requirements under section 510(k) of the FD&amp;C Act, if the Agency determines that premarket notification is not necessary to reasonably assure the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to reasonably assure the safety and effectiveness of non-invasive bone growth stimulator devices. Therefore, the Agency does not intend to exempt these proposed class II devices from premarket notification (510(k)) submission as provided under section 510(m) of the FD&amp;C Act.</P>
                <HD SOURCE="HD1">II. Regulatory History of Non-Invasive Bone Growth Stimulator Devices</HD>
                <P>In accordance with section 513(f)(1) of the FD&amp;C Act, non-invasive bone growth stimulator devices were automatically classified into class III because they were not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and have not been found substantially equivalent to a device placed in commercial distribution after May 28, 1976, which was subsequently classified or reclassified into class II or class I. Therefore, the device is subject to PMA requirements under section 515 of the FD&amp;C Act (21 U.S.C. 360e).</P>
                <P>Accordingly, on November 6, 1979, FDA approved a PMA for the Bio Osteogen System 204 (P790002) (Ref. 2). Since that time, five additional original PMAs have been approved for non-invasive bone growth stimulators (P850007, P850022, P900009, P910066, and P030034). On February 9, 2005, FDA received a reclassification petition dated February 7, 2005, submitted by RS Medical Corporation, requesting that FDA reclassify certain non-invasive bone growth stimulators from class III to class II (Ref. 3). As stated in the Notice of Panel Recommendation discussed further below, “the petition was submitted under section 513(e) of the act but FDA . . . review[ed] the petition under section 513(f)(3) of the act because that section contain[ed] the appropriate procedures for reclassification of postamendments devices” (72 FR 1951 at 1952, January 17, 2007). FDA requested additional information and the petitioner amended the petition on November 30, 2005 (“amended petition”). In accordance with the FD&amp;C Act and regulations, FDA referred the petition, as amended, to the FDA Advisory Committee, specifically the Orthopaedic and Rehabilitation Devices Panel (“the 2006 Panel”) for its recommendations on the requested reclassification.</P>
                <P>On June 2, 2006, the 2006 Panel deliberated on the information in RS Medical's petition; the presentations made by RS Medical, FDA, and members of the public; and their own experience with certain non-invasive bone growth stimulators (Ref. 4).</P>
                <P>The 2006 Panel identified the following risks to health associated with non-invasive bone growth stimulators: Electric shock; burn; skin irritation and/or allergic reaction; inconsistent or ineffective treatment; adverse interaction with electrical implants; adverse interactions with internal/external fixation devices; and biological risks. The 2006 Panel did not specifically address risks associated with ultrasound-based devices, as these were outside the scope of RS Medical's petition; however, as discussed below, based upon FDA's review of information since the Panel meeting, the risks identified with ultrasound-based devices, along with their reported benefits, are comparable to those of non-invasive bone growth stimulators incorporating other modalities.</P>
                <P>
                    The majority of the 2006 Panel recommended that non-invasive bone growth stimulators should be retained in class III because there was insufficient information in the petition by RS Medical to establish that special controls in conjunction with general controls would provide a reasonable assurance of the safety and effectiveness of the device. Specifically, the Panel recommended that the proposed special controls by RS Medical were sufficient to control for the risk of electric shock, burn, skin irritation, and/or allergic reaction; adverse interaction with electrical implants; adverse interactions with internal/external fixation devices; and biological risks. However, the Panel believed that there was insufficient evidence presented by RS Medical to control for the risk of inconsistent or ineffective treatment because there is a lack of knowledge about how waveform characteristics (
                    <E T="03">e.g.,</E>
                     pulse duration, amplitude, power, frequency), including potential modifications to the device, affect the clinical response to treatment. The Panel requested additional clinical data and/or special controls, which was not adequately devised by the petitioner, to control for the risk of inconsistent or ineffective treatment.
                </P>
                <P>
                    FDA concurred with the 2006 Panel's recommendation, and similarly believed that RS Medical's petition was inadequate in that FDA had concerns about the petitioner's proposed special controls to control the risk of inconsistent or ineffective treatment. In the 
                    <E T="04">Federal Register</E>
                     of January 17, 2007 (72 FR 1951), FDA published a Notice of Panel Recommendations (“the 2007 Notice”), as referenced above.
                </P>
                <P>In a letter dated April 2, 2007, RS Medical requested that its petition be withdrawn (Ref. 5). On July 10, 2007, FDA granted RS Medical's request for withdrawal of the petition and did not take any further action on the petition (Ref. 6). FDA has not received any subsequent petition requesting reclassification of these devices.</P>
                <P>
                    Subsequently, as part of the Center for Devices and Radiological Health's 2014-2015 strategic priority, “Strike the Right Balance Between Premarket and Postmarket Data Collection,” a 
                    <PRTPAGE P="49989"/>
                    retrospective review of all PMA product codes with active PMAs approved prior to 2010 was conducted to determine whether, based on our current understanding of the technology, certain devices could be reclassified (down-classified). On April 29, 2015, FDA published a document in the 
                    <E T="04">Federal Register</E>
                     identifying certain product codes as potential candidates for reclassification (80 FR 23798), including non-invasive bone growth stimulators under product codes LOF and LPQ, from class III to class II (Ref. 7). One comment was received in response to this proposal for reclassification of LOF and LPQ; this comment did not support FDA's intention to reclassify these devices, citing the concerns discussed during the 2006 Panel. This comment was considered in development of this proposed order. Note that invasive bone growth stimulators, designated under product code LOE, are outside the scope of this proposed reclassification. As noted in the 2006 Panel, invasive bone growth stimulator devices have added risks compared to non-invasive bone growth stimulators, and therefore would require a separate classification discussion. Furthermore, invasive bone growth stimulators were also considered as a part of the aforementioned PMA retrospective review and FDA determined that these devices should remain as class III (Ref. 8). Therefore, FDA will continue to regulate invasive bone growth stimulators as a class III device, subject to PMA requirements.
                </P>
                <P>While RS Medical's petition inadequately addressed all of the risks associated with non-invasive bone growth stimulators for reclassification, FDA is, on its own initiative, proposing to reclassify these devices from class III to class II, and believes that sufficient information exists to establish special controls, as identified in this proposed order, that, together with general controls, can provide a reasonable assurance of safety and effectiveness for this device type. Additionally, RS Medical in its petition excluded use of these devices as an adjunct to cervical fusion surgery in patients at high risk for nonfusion, as well as for use in congenital pseudarthrosis. Based upon the review of the evidence and FDA's ability to establish special controls, FDA believes these indications that have been approved for currently marketed non-invasive bone growth stimulator devices should be included in this proposed reclassification.</P>
                <HD SOURCE="HD1">III. Device Description</HD>
                <P>
                    Non-invasive bone growth simulators, currently designated under product codes LOF and LPQ, are typically composed of a waveform generator and transducer (
                    <E T="03">e.g.,</E>
                     coils, electrodes, and/or ultrasound transducers). Patient-contacting surfaces include the transducers, lead wires, and the device outer casing.
                </P>
                <P>
                    Non-invasive bone growth stimulators utilize an electrical component to produce an output electrical, magnetic, or ultrasonic waveform that is delivered to a treatment site via a non-invasively applied transducer (
                    <E T="03">e.g.,</E>
                     electromagnetic coil or ultrasound transducer) or electrodes (
                    <E T="03">e.g.,</E>
                     capacitor plates). The device also incorporates an internal means to monitor the output waveform and delivery of treatment, and to provide visual and/or audible alarms to alert the user of improper device function. The induced electrical and/or magnetic fields are generated using one of the following modalities:
                </P>
                <P>• Capacitive coupling (CC), in which a pair of electrodes are placed on the skin such that a current can be driven across the target site;</P>
                <P>• pulsed electromagnetic fields (PEMF), in which a modulated electromagnetic field is generated near the treatment site though an external coil; or</P>
                <P>• combined magnetic fields (CMF), in which a coil generates a combination of a static and pulsed magnetic field near the treatment site.</P>
                <P>The ultrasonic waveform is generated using:</P>
                <P>• Low intensity pulsed ultrasound (LIPUS), in which pulsed ultrasonic signals are generated using ultrasonic transducers.</P>
                <P>The non-invasive nature of the device obviates the need for sterile components; however, patient-contacting surfaces should be capable of being cleaned as needed and biocompatibility must be ensured.</P>
                <P>Non-invasive bone growth stimulators are generally intended to promote osteogenesis as adjunct to primary treatments for fracture fixation or spinal fusion. The indications for use for this device type depend on the specific device characteristics, but have included:</P>
                <P>• Treatment of an established non-union secondary to trauma of the appendicular system,</P>
                <P>• treatment of congenital pseudarthrosis,</P>
                <P>• treatment of failed fusions of the appendicular system,</P>
                <P>• early treatment of certain fresh fractures, and</P>
                <P>• as an adjunct to lumbar or cervical spinal fusion.</P>
                <P>In addition, non-invasive bone growth stimulators are currently prescription use only devices under § 801.109 (21 CFR 801.109).</P>
                <HD SOURCE="HD1">IV. Proposed Reclassification</HD>
                <P>In accordance with section 513(f)(3) of the FD&amp;C Act and 21 CFR part 860, subpart C, FDA is proposing to reclassify non-invasive bone growth stimulator devices under product codes LOF and LPQ from class III into class II. This includes devices that generate electrical or magnetic fields using CC, PEMF, and CMF, and ultrasonic signals.</P>
                <P>FDA believes that there is sufficient information available by way of FDA's accumulated experience with these devices from review of premarket submissions, peer-reviewed literature, medical device reports (MDRs), and recalls to understand the risks associated with these devices to establish special controls that effectively mitigate the risks to health identified in section V. In this proposed order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&amp;C Act that, together with general controls, would provide a reasonable assurance of the safety and effectiveness for non-invasive bone growth stimulators to be in class II. Absent the special controls identified in this proposed order, general controls applicable to this device type are insufficient to provide reasonable assurance of safety and effectiveness of the device.</P>
                <P>
                    FDA is proposing to create a classification regulation for non-invasive bone growth stimulators, which would include devices designated under product codes LOF and LPQ. Under this proposed order, if finalized, a non-invasive bone growth stimulator will be identified as a prescription device. As such, the prescription device must satisfy prescription labeling requirements (see § 801.109, 
                    <E T="03">Prescription devices</E>
                    ). Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&amp;C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of § 801.109 are met. In this proposed order, if finalized, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&amp;C Act that, together with general controls, will provide a reasonable assurance of the safety and effectiveness for non-invasive bone growth stimulator devices.
                </P>
                <P>
                    Section 510(m) of the FD&amp;C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&amp;C Act if FDA determines that premarket notification is not necessary 
                    <PRTPAGE P="49990"/>
                    to provide reasonable assurance of the safety and effectiveness of the device. For non-invasive bone growth stimulators, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, FDA does not propose to exempt these proposed class II devices from 510(k) requirements. If this order is finalized, persons who intend to market this type of device would need to submit to FDA a 510(k) and receive clearance prior to marketing the device.
                </P>
                <HD SOURCE="HD1">V. Risks to Health</HD>
                <P>Based on available information for non-invasive bone growth stimulators, including the 2005 reclassification petition request from RS Medical Corp, input from the 2006 Panel, data in PMA applications P030034, P850022/S009, and P910066/S011 available to FDA under section 520(h)(4) of the FD&amp;C Act, published literature, and postmarket experience associated with use of these devices, FDA identifies the following risks to health associated with non-invasive bone growth stimulators:</P>
                <P>
                    a. 
                    <E T="03">Failure or delay of osteogenesis—</E>
                    A patient could receive ineffective treatment, contributing to failure or delay of osteogenesis that may lead to clinical symptoms (
                    <E T="03">e.g.,</E>
                     pain) and the need for surgical interventions. Ineffective treatment could be a result of various circumstances (
                    <E T="03">e.g.,</E>
                     inadequate therapeutic signal output or device malfunction or misuse).
                </P>
                <P>
                    b. 
                    <E T="03">Burn—</E>
                    A patient or health care professional could be burned from the use and operation of the device. This could be a result of various circumstances including device malfunction (
                    <E T="03">e.g.,</E>
                     electrical fault) or misuse of the device (
                    <E T="03">e.g.,</E>
                     use while sleeping).
                </P>
                <P>
                    c. 
                    <E T="03">Electrical shock</E>
                    —A patient or health care professional could be shocked from the use and operation of the device. This could be a result of various circumstances including device malfunction (
                    <E T="03">e.g.,</E>
                     electrical fault) or misuse of the device (
                    <E T="03">e.g.,</E>
                     use of alternating current source during treatment).
                </P>
                <P>
                    d. 
                    <E T="03">Electromagnetic interference (EMI)—</E>
                    A patient with electrically powered implants (such as cardiac pacemakers, cardiac defibrillators, and neurostimulators) could experience an adverse interaction with the implanted electrical device via EMI or radiofrequency interference.
                </P>
                <P>
                    e. 
                    <E T="03">Adverse tissue reaction—</E>
                    A patient could experience skin irritation and/or allergic reaction associated with the use and operation of the device via the use of non-biocompatible device materials.
                </P>
                <P>
                    f. 
                    <E T="03">Adverse interaction with internal/external fixation devices—</E>
                    The signal output could be impacted by certain metallic internal or external fixation devices leading to inadequate treatment signals, device malfunction, or tissue damage.
                </P>
                <P>
                    g. 
                    <E T="03">Adverse biologic effects—</E>
                    A patient may experience adverse biologic effects resulting from prolonged exposure to the treatment signal via biologic interaction with the treatment signal at a cellular level. Excessive energy transmission could cause tissue damage or aberrant tissue behavior if signal output parameters exceed established safety thresholds.
                </P>
                <P>
                    The risks to health identified within this proposed order are consistent with those identified in the 2005 reclassification petition, as amended. The 2006 Panel agreed with these identified risks; however, in some cases the risk or accompanying description was reworded for clarity in this proposed order (
                    <E T="03">e.g.,</E>
                     “inconsistent treatment or ineffective treatment” is described in terms of risk to health, which may entail “failure or delay in osteogenesis”). Also, the risk of adverse biologic effects previously specified risks of carcinogenicity, genotoxicity, mutagenicity, and teratological effects. The petitioner notes in the amended petition that “. . . the evidence points to lack of genotoxic, carcinogenic, and teratologic potential of the subject waveforms,” which is corroborated by the lack of such reports identified in the literature. Although FDA similarly has found a lack of such reports, it considers this risk more generally as potential deleterious effects at the tissue or cellular level due to signal output parameters that exceed established safety thresholds.
                </P>
                <HD SOURCE="HD1">VI. Summary of Reasons for Reclassification</HD>
                <P>FDA believes that non-invasive bone growth stimulator devices, which are intended to promote osteogenesis as an adjunct to primary treatments for fracture fixation or spinal fusion, should be reclassified from class III to class II and that there is sufficient information to establish special controls for the risks identified in section V which, in addition to general controls, can provide reasonable assurance of safety and effectiveness.</P>
                <P>Specifically, FDA proposes to require clinical performance data as a special control to address the risk of failure or delay of osteogenesis. FDA review of the literature suggests a high variability of treatment efficacy, depending on therapeutic signal and anatomic location. This would also address the main concern cited by the 2006 Panel and FDA with RS Medical's proposal, which led to the recommendation to retain non-invasive bone growth stimulators in class III, and various comments received in response to the 2007 Notice.</P>
                <P>
                    FDA's proposal would require that clinical performance of any non-invasive bone growth stimulator device be evaluated in support of the intended use. Rather than prescribe specific study requirements, FDA's proposal would allow for flexibility in study design and the level of clinical evidence needed by taking into consideration certain parameters, 
                    <E T="03">e.g.,</E>
                     the intended use, treatment population, and technological characteristics of the device, including any similarities between the device and legally marketed predicate device, as appropriate.
                </P>
                <HD SOURCE="HD1">VII. Summary of Data Upon Which the Reclassification Is Based</HD>
                <P>The available evidence demonstrates that there are probable health benefits derived from the use of these devices, and that the nature and incidence of risks are well known so that special controls can be established to adequately mitigate the risks to health. FDA is proposing a single device class for non-invasive bone growth stimulators, considering that FDA did not identify any unique risks associated with the different modalities included in this proposed order. FDA has considered and analyzed the following: Data in PMA applications P030034, P850022/S009, and P910066/S011 available to FDA under section 520(h)(4) of the FD&amp;C Act; information presented at the 2006 Panel concerning RS Medical's petition to down-classify certain non-invasive bone growth stimulators (Ref. 3) and the 2007 Notice; peer-reviewed articles that discussed the use of, as well as the probable benefits and risks of these devices; reported adverse events identified through a search of FDA's Medical Device Reporting (MDR) system; and a review of any recalls associated with these devices through a search of FDA's Medical Device Recall database.</P>
                <P>
                    In accordance with the “6-year rule” described in section 520(h)(4) of the FD&amp;C Act, FDA considered data contained in three original PMAs or supplements, P030034, P850022/S009, and P910066/S011, approved for non-invasive bone growth stimulators (Refs. 9 to 11). These PMAs/supplements include three different device modalities: A PEMF device (P030034), a CC device (P850022/S009), and a CMF device (P910066/S011). In review of the reported clinical data in the summary of 
                    <PRTPAGE P="49991"/>
                    safety and effectiveness data documents (SSEDs), the studies conducted in support of these devices include a total study size of 831 enrolled subjects. The adverse event profile for the devices in each study were similar to the control group, with a similar distribution of event types. With regards to benefit, the clinical data reported in the SSEDs demonstrate an improved rate of bone fusion compared to placebo controls, with an 83.6 percent vs. 68.6 percent fusion rate at 6 months in P030034 (cervical spine), an 85 percent vs. 75 percent clinical success shown in P850022/S009 (lumbar spine), and a 67 percent vs. 43 percent fusion rate at 9 months in P910066/S011 (lumbar spine).
                </P>
                <P>Further, FDA performed a literature review to evaluate data related to non-invasive bone growth stimulator devices, including studies up to the date of the 2006 Panel, as well as any new clinical information published since the 2006 Panel.</P>
                <P>Literature published at the time of the 2006 Panel includes a 1953 seminal paper on the use of electrical signals to stimulate bone formation by Yasuda, that reported bone formation in rabbits exposed to direct current (DC) stimulation (Ref. 12). In the following decades, other researchers expanded on this finding in animal and clinical models. In a canine study, a DC stimulation was shown to cause complete ossification of the femoral medullary canal (Ref. 13). The first clinical case report demonstrated that electrical stimulation could treat a non-union fracture (Ref. 14). An early publication regarding the effects of DC stimulation on spinal fusion was published by Dwyer (Ref. 15). Another early clinical study published by Becker, et al. showed successful fracture fusion with a success rate of 77 percent (Ref. 16).</P>
                <P>In the 1990s and early 2000s, several literature articles were identified assessing the effects of non-invasive bone growth stimulators on various anatomic locations. These studies generally included various therapeutic modalities (magnitude, frequency, duration, etc.) and demonstrated varying results regarding the efficacy of these treatments. In two studies of PEMF devices, Basset and Schink-Ascani (Ref. 17) found a 72 percent fusion rate in patients with congenital pseudarthrosis of the tibia, and in a study of non-unions of the scaphoid, Adams, et al. (Ref. 18) reported a fusion rate of 69 percent, as a followup to an earlier study that found a fusion rate of 80 percent. When looking at the rate of compliance of PEMF devices as a factor of effectiveness, Garland, et al. (Ref. 19) found that fusion rates ranged from 35.7 percent to 80 percent, depending on how often the devices were used. In studies of CC devices, fusion rates in long bones varied from 60 percent (Ref. 20), 68.8 percent (Ref. 21), and 72.7 percent (Ref. 22), to no difference between treatment and a placebo-treated group in a study by Fourie and Bowerbank (Ref. 23). While there was a large range of observed efficacies, there was no reporting of treatment-related adverse events. These reported variabilities in efficacy and low adverse event rates were consistent with the findings by the 2006 Panel.</P>
                <P>
                    FDA performed a systematic review of published literature to identify any new clinical findings since the 2006 Panel. FDA identified 14 papers that included a combination of retrospective and prospective studies. For studies that assessed medical or insurance claims databases, radiographs were not always available to determine actual fusion. Instead, results were presented in terms of 
                    <E T="03">healing rate</E>
                     based on patient records or reported outcomes. When radiographs were available and analyzed to assess union, results were reported as 
                    <E T="03">fusion rate.</E>
                </P>
                <P>Phillips, et al. (Ref. 24) looked at registry data of 2,370 subjects who were treated with OL1000 (DJO), a CMF device, at various fracture sites and reported an average healing rate of 75.1 percent (ranging from 57.2 percent in the humerus to 89.7 percent in the finger phalanx). DeVries, et al. (Ref. 25) also evaluated the OL1000 device in a retrospective analysis of 144 subjects, finding a fusion rate of 57.1 percent in tibiotalocalcaneal fusions of the ankle.</P>
                <P>With respect to LIPUS, Zura, et al. (Refs. 26 and 27) published two papers evaluating subjects in the Exogen (Bioventus) Post Market Registry. One of the studies assessed how various patient risk factors affected healing rate in 4,190 subjects. The study demonstrated an overall healing rate of 95.7 percent, and in another single arm study of 767 subjects, showed a healing rate varying from 81.8 percent to 87.9 percent depending on fracture site. Nolte, et al. (Ref. 28) evaluated the Exogen registry in conjunction with a medical claims database to examine metatarsal fractures and reported a healing rate of 97.4 percent overall, while Elvey, et al. (Ref. 29) evaluated 26 cases with use of Exogen in hand and wrist non-unions, and found a fusion rate of 54 percent to 58 percent. In two smaller studies of the Exogen device, Majeed, et al. (Ref. 30) and Mizra, et al. (Ref. 31) both evaluated foot and ankle fractures and found 78.7 percent and 67 percent fusion rate in a 47 and 18 patient study, respectively. Biglari (Ref. 32) also performed an observational study using the Exogen device and found a much lower fusion rate of 32.8 percent in 60 subjects having existing non-unions of various long bones.</P>
                <P>For PEMF devices, a retrospective study by Coric, et al. (Ref. 33) on the effects of the CervicalStim (Orthofix) device on 593 subjects showed a 73.2 percent fusion rate in the cervical spine at 6 months. In a single arm prospective study by Assiotis, et al. (Ref. 34), a 77.3 percent fusion rate in the tibia was demonstrated with use of the Physiostim (Orthofix). Murray and Pethica (Ref. 35) performed a 1,382-subject retrospective study of use of the EBI device (Zimmer Biomet) for non-unions of the scaphoid, tibia, and fibula, and while an assessment of healing rates was not performed, the data showed reduction in time to healing between 35 percent and 40 percent when the device was used as prescribed.</P>
                <P>In addition, two randomized control studies on PEMF devices were conducted by Foley, et al. (Ref. 36) and by Streit, et al. (Ref. 37). Foley evaluated 323 subjects using the Orthofix CervicalStim device in cervical fusion and found an 83.6 percent fusion rate in the treatment group compared to a 68.6 percent fusion rate in the control group, with no difference in pain scores or adverse events between groups. Streit, et al. performed a small, eight subject clinical study using the EBI device to treat non-unions of the fifth metatarsal and found the time to fusion was reduced on average from 14.7 weeks to 8.9 weeks with the use of the device.</P>
                <P>
                    In summary, FDA's literature review resulted in findings that are consistent with available clinical data from PMA submissions. These studies suggest that there are probable benefits to the use of these devices; however, differences in methodology, including differences in devices used, treatment waveform and frequency, patient populations, as well as anatomic location, could have had significant effects on reported device effectiveness, which ranged from 32.8 percent to 97.4 percent. Regarding safety, the findings from these studies demonstrate that the devices are relatively safe as the adverse event profile associated with these devices using various modalities was similar to controls. Overall, the studies involved 10,566 subjects (including control subjects), with only a single report of a serious adverse event (Biglari, Ref. 32); however, a direct link to the use of the device could not be established for this event.
                    <PRTPAGE P="49992"/>
                </P>
                <P>Further, a search of FDA's MDR database was conducted to identify all adverse events submitted to FDA up to October 31, 2019, for devices approved under product codes LOF and LPQ. The results of the identified reports are consistent with the risk profiles identified in both PMA applications and literature that were reviewed. FDA's search yielded a total of 270 unique MDRs. The most frequently reported events were categorized as “skin reaction/issue” (n = 187) followed by “pain” (n = 59) and “device functional issue” (n = 21). A review of the adverse events regarding skin reactions found that a majority were due to irritation from the electrode adhesive or ultrasound gel used. There was no apparent difference in risk profile across the various device modalities, though the risk of skin irritation was primarily observed in the skin-contacting devices (due to the electrodes in the CC device and the gel in the LIPUS device). For cases where followup was described, patients recovered when treatment was discontinued. In addition, 11 reports of “mass/tumor” were identified; however, the nature of the relationship between the mass/tumor to the device was unrelated or unclear. Based upon FDA's assessment of other systematic reviews of these devices, no other reports of mass/tumors have been identified (Refs. 38 to 42).</P>
                <P>Finally, a search of FDA's Medical Device Recall database was conducted. No recalls were found when searching the database for devices under product code LOF. Two class 2 recalls were reported for devices under product code LPQ; specifically, there was a recall for the Exogen Express Bone Healing System and a recall for the Exogen 4000+ Ultrasound Bone Healing System. Both were posted on August 4, 2009, and initiated by the manufacturer because of problems with the transducer, which may have resulted in a reduced ultrasound output. These recalls were terminated on November 18, 2010. These recall events reflect the risks to health identified in section V, and FDA believes the special controls proposed, in addition to general controls, can effectively mitigate the risks identified.</P>
                <HD SOURCE="HD1">VIII. Proposed Special Controls</HD>
                <P>Table 1 outlines the risks to health identified in section V and the corresponding mitigation measures proposed to reasonably assure safety and effectiveness, which are discussed in more detail below.</P>
                <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s100,r100">
                    <TTITLE>Table 1—Risks to Health and Mitigation Measures for Non-Invasive Bone Growth Stimulators</TTITLE>
                    <BOXHD>
                        <CHED H="1">Identified risk to health</CHED>
                        <CHED H="1">Mitigation measures</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Failure or delay of osteogenesis</ENT>
                        <ENT>
                            Clinical performance data.
                            <LI>Non-clinical performance testing.</LI>
                            <LI>Software verification, validation, and hazard analysis.</LI>
                            <LI>Labeling.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Burn</ENT>
                        <ENT>
                            Non-clinical performance testing.
                            <LI>Electrical safety testing.</LI>
                            <LI>Labeling.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Electrical shock</ENT>
                        <ENT>
                            Electrical safety testing.
                            <LI>Labeling.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Electromagnetic interference</ENT>
                        <ENT>
                            Electromagnetic compatibility (EMC) testing.
                            <LI>Labeling.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Adverse tissue reaction</ENT>
                        <ENT>
                            Biocompatibility evaluation.
                            <LI>Labeling.</LI>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Adverse interaction with internal/external fixation devices</ENT>
                        <ENT>Labeling.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Adverse biological effects</ENT>
                        <ENT>
                            Non-clinical performance testing.
                            <LI>Software verification, validation, and hazard analysis.</LI>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    The risk of failure or delay of osteogenesis is clinically significant. To mitigate this risk, FDA proposes that manufacturers provide clinical performance data to demonstrate that the device yields positive outcomes (
                    <E T="03">e.g.,</E>
                     fusion of the non-union) in accordance with its intended use. Further, FDA proposes non-clinical performance testing to demonstrate that the device performs as intended under anticipated conditions of use to achieve the identified successful clinical performance characteristics. This would include verification and validation of critical performance characteristics, including characterization of the designed outputs of the device as well as the outputs that are delivered to the patient, thermal safety and reliability testing, reliability testing consistent with the expected device use-life, and validation that signal characteristics are within safe physiologic limits. Also, FDA proposes appropriate software verification, validation, and hazard analysis to ensure that any device software performs as intended. Lastly, FDA proposes labeling to provide appropriate instructions (
                    <E T="03">e.g.,</E>
                     duration, frequency of use) to the end user.
                </P>
                <P>To mitigate the risk of skin burns, FDA proposes non-clinical performance testing of the device to verify and validate critical performance characteristics, demonstrate thermal safety and reliability, validate that signal characteristics are within safe physiologic limits, and demonstrate reliability of the device consistent with its expected use-life. FDA also proposes electrical safety testing to minimize the risk of thermal burns to the patient, and specific instructions regarding proper usage and specific warnings associated with the risk of burns.</P>
                <P>To mitigate electrical shocks, FDA proposes electrical safety testing to minimize the risk of shock to the patient. Furthermore, FDA proposes labeling provisions, including instructions on appropriate usage and maintenance, and specific warnings regarding electrical shock.</P>
                <P>To mitigate electromagnetic interference, FDA proposes electromagnetic compatibility testing and labeling to minimize the risk of adverse interaction with other electronic devices such as implanted electronic devices.</P>
                <P>To mitigate the risk of adverse tissue reactions, FDA proposes a biocompatibility evaluation to ensure that the materials used in patient-contacting components of the device are safe for skin contact and labeling that includes warnings against use on compromised skin or when there are known sensitivities, as well as instructions on appropriate cleaning of any reusable components.</P>
                <P>
                    To mitigate the risk of adverse interaction with internal/external fixation devices, FDA proposes labeling, 
                    <PRTPAGE P="49993"/>
                    specifically inclusion of appropriate warnings for patients with implanted internal/external devices.
                </P>
                <P>To mitigate the risk of adverse biologic effects, FDA proposes non-clinical performance testing to verify and validate critical performance characteristics of the device, demonstrate thermal safety and reliability, validate safety of the signal by reference to known biological safety limits, and demonstrate reliability of the device over the expected use-life. Furthermore, FDA proposes software verification, validation, and hazard analysis.</P>
                <P>If this reclassification is finalized, non-invasive bone growth stimulators will be reclassified into class II and would be subject to premarket notification (510(k)) requirements under § 807.81. As discussed below, the intent is for the reclassification to be codified in 21 CFR 890.5870. Firms submitting a 510(k) for non-invasive bone growth stimulators will be required to comply with the particular mitigation measures set forth in the special controls. Adherence to the special controls, in addition to the general controls, is necessary to provide a reasonable assurance of the safety and effectiveness of these devices.</P>
                <HD SOURCE="HD1">IX. Analysis of Environmental Impact</HD>
                <P>The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.</P>
                <HD SOURCE="HD1">X. Paperwork Reduction Act of 1995</HD>
                <P>FDA tentatively concludes that this proposed order contains no new collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required. This proposed order refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.</P>
                <HD SOURCE="HD1">XI. Codification of Orders</HD>
                <P>Under section 513(f)(3) of the FD&amp;C Act, FDA may issue final orders to reclassify devices. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as newly codified orders. Therefore, under section 513(f)(3), in the proposed order, we are proposing to codify non-invasive bone growth stimulators in the new 21 CFR 890.5870, under which non-invasive bone growth stimulators would be reclassified from class III to class II.</P>
                <HD SOURCE="HD1">XII. Proposed Effective Date</HD>
                <P>
                    FDA proposes that any final order based on this proposal become effective 30 days after the date of its publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD1">XIII. References</HD>
                <P>
                    The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see 
                    <E T="02">ADDRESSES</E>
                    ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at 
                    <E T="03">https://www.regulations.gov.</E>
                     References without asterisks are not on public display at 
                    <E T="03">https://www.regulations.gov</E>
                     because they have copyright restriction. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the 
                    <E T="04">Federal Register</E>
                    , but websites are subject to change over time.
                </P>
                <EXTRACT>
                    <P>
                        1. *Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997, available at 
                        <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-section-216-food-and-drug-administration-modernization-act-1997-guidance-industry-and-fda.</E>
                    </P>
                    <P>
                        2. *P790002 Approval available at: 
                        <E T="03">https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P790002.</E>
                    </P>
                    <P>
                        3. *RS Medical Corporation Reclassification Petition, available at 
                        <E T="03">https://wayback.archive-it.org/7993/20170405072021/https://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4224b1-06-TabB-RSMEDICAL-Petition.pdf.</E>
                    </P>
                    <P>
                        4. *FDA's Orthopaedic and Rehabilitation Devices Panel transcript and other meeting materials for the June 2, 2006, meeting are available at: 
                        <E T="03">https://wayback.archive-it.org/7993/20170403222246/https://www.fda.gov/ohrms/dockets/ac/cdrh06.html#orthopaedic.</E>
                    </P>
                    <P>
                        5. *Letter from RS Medical requesting withdrawal of petition, available at 
                        <E T="03">https://www.regulations.gov/document?D=FDA-2005-P-0052-0007.</E>
                    </P>
                    <P>
                        6. *FDA letter granting RS Medical's withdrawal request, available at 
                        <E T="03">https://www.regulations.gov/document?D=FDA-2005-P-0052-0006.</E>
                    </P>
                    <P>
                        7. *First Cohort of Results of the 2014-2015 Strategic Priority: Strike the Right Balance Between Premarket and Postmarket Data Collection (April 2015), available at 
                        <E T="03">https://www.fda.gov/media/91437/download.</E>
                    </P>
                    <P>
                        8. *Second and Final Cohort of Results of the 2014-2015 Strategic Priority: Strike the Right Balance Between Premarket and Postmarket Data Collection (August 2016), available at 
                        <E T="03">https://www.fda.gov/media/99822/download.</E>
                    </P>
                    <P>
                        9. *P030034 Summary of Safety and Effectiveness, available at 
                        <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030034B.pdf.</E>
                    </P>
                    <P>
                        10. *P850022/S009 Summary of Safety and Effectiveness, available at 
                        <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf/P850022S009B.pdf.</E>
                    </P>
                    <P>
                        11. *P910066/S011 Summary of Safety and Effectiveness, available at 
                        <E T="03">https://www.accessdata.fda.gov/cdrh_docs/pdf/P910066S011B.pdf.</E>
                    </P>
                    <P>
                        12. Yasuda, I., “The Classic: Fundamental Aspects of Fracture Treatment.” 
                        <E T="03">J. Kyoto Med. Soc.,</E>
                         4:395-406, 1953.
                    </P>
                    <P>
                        13. Bassett, C.A., R.J. Pawluk, and R.O. Becker, “Effects of Electric Currents on Bone In Vivo.” 
                        <E T="03">Nature,</E>
                         204: 652-654, 1964.
                    </P>
                    <P>
                        14. Friedenberg, Z.B., M.C. Harlow, and C.T. Brighton, “Healing of Nonunion of the Medial Malleolus by Means of Direct Current: A Case Report.” 
                        <E T="03">The Journal of Trauma,</E>
                         11(10):883-885, 1971.
                    </P>
                    <P>
                        15. Dwyer, A.F., “The Use of Electrical Current Stimulation in Spinal Fusion.” 
                        <E T="03">The Orthopedic Clinics of North America,</E>
                         6(1):265-273, 1975.
                    </P>
                    <P>
                        16. Becker, R.O., J.A. Spadaro, and A.A. Marino, “Clinical Experiences With Low Direct Current Stimulation of Bone Growth.” 
                        <E T="03">Clinical Orthopaedics and Related Research</E>
                        , 124:75-83, 1977.
                    </P>
                    <P>
                        17. Bassett, C.A. and M. Schink-Ascani, “Long-Term Pulsed Electromagnetic Field (PEMF) Results in Congenital Pseudarthrosis.” 
                        <E T="03">Calcified Tissue International</E>
                        , 49(3):216-220, 1991.
                    </P>
                    <P>
                        18. Adams, B.D., G.K. Frykman, and J. Taleisnik, “Treatment of Scaphoid Nonunion With Casting and Pulsed Electromagnetic Fields: A Study Continuation.” 
                        <E T="03">The Journal of Hand Surgery</E>
                        , 17(5):910-914, 1992.
                    </P>
                    <P>
                        19. Garland, D.E., B. Moses, and W. Salyer, “Long-Term Follow-up of Fracture Nonunions Treated With PEMFs.” 
                        <E T="03">Contemporary Orthopaedics,</E>
                         22(3):295-302, 1991.
                    </P>
                    <P>
                        20. Scott, G. and J.B. King, “A Prospective, Double-Blind Trial of Electrical Capacitive Coupling in the Treatment of Non-Union of Long Bones.” 
                        <E T="03">The Journal of Bone and Joint Surgery. American volume,</E>
                         76(6):820-826, 1994.
                    </P>
                    <P>
                        21. Abeed, R.I., M. Naseer, and E.W. Abel, “Capacitively Coupled Electrical Stimulation Treatment: Results from Patients With Failed Long Bone Fracture Unions.” 
                        <E T="03">Journal of Orthopaedic Trauma</E>
                        , 12(7):510-513, 1998.
                    </P>
                    <P>
                        22. Zamora-Navas, P., A. Borras Verdera, R. Antelo Lorenzo, et al., “Electrical Stimulation of Bone Nonunion With the 
                        <PRTPAGE P="49994"/>
                        Presence of a Gap.” 
                        <E T="03">Acta Orthopaedica Belgica</E>
                        , 61(3):169-176, 1995.
                    </P>
                    <P>
                        23. Fourie, J.A. and P. Bowerbank, “Stimulation of Bone Healing in New Fractures of the Tibial Shaft Using Interferential Currents.” 
                        <E T="03">Physiotherapy Research International</E>
                        , 2(4):255-268, 1997.
                    </P>
                    <P>
                        24. Philips, M., J. Baumhauer, S. Sprague, et al., “Use of Combined Magnetic Field Treatment for Fracture Nonunion.” 
                        <E T="03">Journal of Long Term Effects of Medical Implants</E>
                        , 26(3):277-284, 2016.
                    </P>
                    <P>
                        25. DeVries, J.G., G.C. Berlet, and C.F. Hyer, “Union Rate of Tibiotalocalcaneal Nails With Internal or External Bone Stimulation.” 
                        <E T="03">Foot and Ankle International</E>
                        , 33(11):969-978, 2012.
                    </P>
                    <P>
                        26. Zura, R., S. Mehta, G.J. Della Rocca, et al., “A Cohort Study of 4,190 Patients Treated With Low-Intensity Pulsed Ultrasound (LIPUS): Findings in the Elderly Versus All Patients.” 
                        <E T="03">BioMed Central Musculoskeletal Disorders</E>
                        , 16:45, 2015.
                    </P>
                    <P>
                        27. Zura, R., G.J. Della Rocca, S. Mehta, et al., “Treatment of Chronic (&gt;1 Year) Fracture Nonunion: Heal Rate in a Cohort of 767 Patients Treated With Low-Intensity Pulsed Ultrasound (LIPUS).” 
                        <E T="03">Injury</E>
                        , 46(10):2036-2041, 2015.
                    </P>
                    <P>
                        28. Nolte, P., R. Anderson, E. Strauss, et al., “Heal Rate of Metatarsal Fractures: A Propensity-Matching Study of Patients Treated With Low-Intensity Pulsed Ultrasound (LIPUS) vs. Surgical and Other Treatments.” 
                        <E T="03">Injury</E>
                        , 47(11):2584-2590, 2016.
                    </P>
                    <P>
                        29. Elvey, M.H., R. Miller, K.S. Khor, et al., “The Use of Low-Intensity Pulsed Ultrasound in Hand and Wrist Nonunions.” 
                        <E T="03">Journal of Plastic Surgery and Hand Surgery</E>
                        , 1-6, 2019 (published online ahead of print, November 26, 2019).
                    </P>
                    <P>
                        30. Majeed, H., T. Karim, J. Davenport, et al., “Clinical and Patient-Reported Outcomes Following Low Intensity Pulsed Ultrasound (LIPUS, Exogen) for Established Post-Traumatic and Post-Surgical Nonunion in the Foot and Ankle.” 
                        <E T="03">Foot and Ankle Surgery</E>
                        , S1268-7731(19)30072-4, 2019 (published online ahead of print, May 19, 2019).
                    </P>
                    <P>
                        31. Mizra, Y.H., K.H. Teoh, D. Golding, et al., “Is There a Role for Low Intensity Pulsed Ultrasound (LIPUS) in Delayed or Nonunion Following Arthrodesis in Foot and Ankle Surgery?” 
                        <E T="03">Foot and Ankle Surgery,</E>
                         25(6):842-848, 2019.
                    </P>
                    <P>
                        32. Biglari, B., T.M. Yildirim, T. Swing, et al., “Failed Treatment of Long Bone Nonunions With Low Intensity Pulsed Ultrasound.” 
                        <E T="03">Archives of Orthopaedic and Trauma Surgery,</E>
                         136(8):1121-1134, 2016.
                    </P>
                    <P>
                        33. Coric, D., D.E. Bullard, V.V. Patel, et al., “Pulsed Electromagnetic Field Stimulation May Improve Fusion Rates in Cervical Arthrodesis in High-Risk Populations.” 
                        <E T="03">Bone and Joint Research,</E>
                         7(2):124-130, 2018.
                    </P>
                    <P>
                        34. Assiotis, A., N.P. Sachinis, and B.E. Chalidis, “Pulsed Electromagnetic Fields for the Treatment of Tibial Delayed Unions and Nonunions. A Prospective Clinical Study and Review of the Literature.” 
                        <E T="03">Journal of Orthopaedic Surgery and Research,</E>
                         7:24, 2012.
                    </P>
                    <P>
                        35. Murray, H.B. and B.A. Pethica, “A Follow-up Study of the In-Practice Results of Pulsed Electromagnetic Field Therapy in the Management of Nonunion Fractures.” 
                        <E T="03">Orthopaedic Research and Reviews,</E>
                         8:67-72, 2016.
                    </P>
                    <P>
                        36. Foley, K.T., T.E. Mroz, P.M. Arnold, et al., “Randomized, Prospective, and Controlled Clinical Trial of Pulsed Electromagnetic Field Stimulation for Cervical Fusion.” 
                        <E T="03">Spine Journal,</E>
                         8(3):436-442, 2008.
                    </P>
                    <P>
                        37. Streit, A., B.C. Watson, J.D. Granata, et al., “Effect on Clinical Outcome and Growth Factor Synthesis With Adjunctive Use of Pulsed Electromagnetic Fields for Fifth Metatarsal Nonunion Fracture: A Double-Blind Randomized Study.” 
                        <E T="03">Foot and Ankle International,</E>
                         37(9):919-923, 2016.
                    </P>
                    <P>
                        38. Aleem, I.S., I. Aleem, N. Evaniew, et al., “Efficacy of Electrical Stimulators for Bone Healing: A Meta-Analysis of Randomized Sham-Controlled Trials.” 
                        <E T="03">Science Reports,</E>
                         6:31724, 2016.
                    </P>
                    <P>
                        39. Behrens, S.B., M.E. Deren, and K O. Monchik, “A Review of Bone Growth Stimulation for Fracture Treatment.” 
                        <E T="03">Current Orthopedic Practice,</E>
                         24(1):84-91, 2013.
                    </P>
                    <P>
                        40. Griffin, X.L., M.L. Costa, N. Parsons, et al., “Electromagnetic Field Stimulation for Treating Delayed Union or Non-Union of Long Bone Fractures in Adults.” 
                        <E T="03">The Cochrane Database of Systematic Reviews,</E>
                         4:CD008471, 2011.
                    </P>
                    <P>
                        41. Griffin, X.L., N. Smith, N. Parsons, et al., “Ultrasound and Shockwave Therapy for Acute Fractures in Adults.” 
                        <E T="03">The Cochrane Database of Systematic Reviews,</E>
                         2:CD008579, 2012.
                    </P>
                    <P>
                        42. Hannemann, P.F., E.H.H. Mommers, J.P.M. Schots, et al., “The Effects of Low-Intensity Pulsed Ultrasound and Pulsed Electromagnetic Fields Bone Growth Stimulation in Acute Fractures: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.” 
                        <E T="03">Archives of Orthopaedic and Trauma Surgery,</E>
                         134(8):1093-1106, 2014.
                    </P>
                </EXTRACT>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 21 CFR Part 890</HD>
                    <P>Medical devices.</P>
                </LSTSUB>
                <P>Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 890 be amended as follows:</P>
                <PART>
                    <HD SOURCE="HED">PART 890—PHYSICAL MEDICINE DEVICES</HD>
                </PART>
                <AMDPAR>1. The authority citation for part 890 continues to read as follows:</AMDPAR>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        21 U.S.C. 351, 360, 360c, 360e, 360j, 360
                        <E T="03">l,</E>
                         371.
                    </P>
                </AUTH>
                <AMDPAR>2. Add § 890.5870 to subpart F to read as follows:</AMDPAR>
                <SECTION>
                    <SECTNO>§ 890.5870 </SECTNO>
                    <SUBJECT>Non-invasive bone growth stimulator.</SUBJECT>
                    <P>
                        (a) 
                        <E T="03">Identification.</E>
                         A non-invasive bone growth stimulator provides stimulation through electrical, magnetic, or ultrasonic fields. The device is for prescription use and is intended to be used externally to promote osteogenesis as an adjunct to primary treatments for fracture fixation or spinal fusion.
                    </P>
                    <P>
                        (b) 
                        <E T="03">Classification.</E>
                         Class II (special controls). The special controls for this device are:
                    </P>
                    <P>(1) Clinical performance data must support the intended use of the device.</P>
                    <P>(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be provided:</P>
                    <P>(i) Verification and validation of critical performance characteristics of the device, including characterization of the designed outputs of the device as well as the outputs that are delivered to the patient.</P>
                    <P>(ii) Thermal safety and thermal reliability testing.</P>
                    <P>(iii) Validation that signal characteristics are within safe physiologic limits.</P>
                    <P>(iv) Reliability testing consistent with the expected use-life of the device.</P>
                    <P>(3) Patient-contacting components of the device must be demonstrated to be biocompatible.</P>
                    <P>(4) Performance data must demonstrate the electrical safety and electromagnetic compatibility of the device.</P>
                    <P>(5) Appropriate software verification, validation, and hazard analysis must be performed.</P>
                    <P>(6) Labeling for the device must include the following:</P>
                    <P>(i) Warning against use on compromised skin or when there are known sensitivities;</P>
                    <P>(ii) Appropriate warnings for patients with implanted medical devices;</P>
                    <P>(iii) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;</P>
                    <P>(iv) A clear description of the device;</P>
                    <P>(v) Instructions on appropriate usage, duration, and frequency of use;</P>
                    <P>(vi) Instructions for maintenance and safe disposal;</P>
                    <P>(vii) Instructions for appropriate cleaning of any reusable components;</P>
                    <P>(viii) Specific warnings regarding user burns, electrical shock, and skin irritation; and</P>
                    <P>(ix) The risks and benefits associated with use of the device.</P>
                </SECTION>
                <SIG>
                    <DATED>Dated: August 4, 2020.</DATED>
                    <NAME>Lauren K. Roth,</NAME>
                    <TITLE>Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17543 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <PRTPAGE P="49995"/>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <CFR>43 CFR Part 8365</CFR>
                <DEPDOC>[LLAZP00000.L122000000.DF0000.LXSSA3610000]</DEPDOC>
                <SUBJECT>Notice of Proposed Supplementary Rules for Selected Public Lands in Gila, Maricopa, Pima, Pinal and Yavapai Counties, AZ</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of proposed supplementary rules.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Bureau of Land Management (BLM) is proposing supplementary rules on selected public lands administered by the Hassayampa and Lower Sonoran Field Offices. These rules are needed in order to protect public health and safety and to reduce user conflicts within developed recreation areas (or sites), including recreational shooting sports sites. In compliance with the John D. Dingell, Jr. Conservation, Management, and Recreation Act (Dingell Act), notice is hereby given that for public safety, one of the proposed supplementary rules would close public lands within the designated Hazardous Exclusion Area at each recreational shooting sports site to public entry, including entry for hunting, fishing, and recreational shooting activities. These proposed closures are necessary to ensure public safety adjacent to shooting facilities.</P>
                </SUM>
                <EFFDATE>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested parties may submit written comments regarding the proposed supplementary rules no later than October 16, 2020.</P>
                </EFFDATE>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments by any of the following methods:</P>
                    <P>
                         BLM National Environmental Policy Act website: 
                        <E T="03">https://go.usa.gov/xmfVv.</E>
                    </P>
                    <P>
                          
                        <E T="03">Mail:</E>
                         BLM, Phoenix District Office, Attention: Tyler Lindsey, 21605 North 7th Avenue, Phoenix, AZ 85027.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        John (Jake) Szympruch, District Chief Law Enforcement Ranger at email: 
                        <E T="03">jszympru@blm.gov;</E>
                         Lane Cowger, Hassayampa Field Office Manager at email: 
                        <E T="03">lcowger@blm.gov;</E>
                         or Edward J. Kender, Lower Sonoran Field Office Manager at email: 
                        <E T="03">ekender@blm.gov;</E>
                         or at 623-580-5500. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact one of the above individuals. The FRS is available 24 hours a day, 7 days a week, to leave a message or question. You will receive a reply during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Comment Procedures</HD>
                <HD SOURCE="HD2">General Notice Comments on Proposed Supplementary Rules</HD>
                <P>
                    You may mail comments to Tyler Lindsey, or comment directly online at the addresses listed above (See 
                    <E T="02">ADDRESSES</E>
                    ). Written comments on the proposed supplementary rules should be specific, confined to issues pertinent to the proposed rules, and should explain the reason for any recommended change. Where possible, comments should reference the specific section or paragraph of the proposal that the commenter is addressing. The BLM is not obligated to consider, or include in the Administrative Record for the final supplementary rules, comments delivered to an address other than those listed above (See 
                    <E T="02">ADDRESSES</E>
                    ) or comments that the BLM receives after the close of the comment period (See 
                    <E T="02">DATES</E>
                    ), unless they are postmarked or electronically dated before the deadline.
                </P>
                <HD SOURCE="HD3">Comments on Proposed Closure</HD>
                <P>Under the Dingell Act (16 U.S.C. 7913 (b)(2)(A)), and in compliance with 43 CFR 8364.1, the BLM is required to consider public comments when closures are proposed and would affect hunting, fishing, and recreational shooting on public lands. Within developed recreation areas where the primary purpose is recreational shooting, a designated Hazardous Exclusion Area where errant/ricochet projectiles could potentially land has been delineated based on geospatial review of topographic features and in coordination with the Arizona Game and Fish Department. Each Hazardous Exclusion Area proposed for closure is the smallest area required for public safety adjacent to shooting facilities and would remain closed for as long as the recreational shooting sports site is available for public use. Proposed supplementary rule 13 would prohibit entry into the Hazardous Exclusion Areas.</P>
                <P>
                    This notice announces the beginning of the 60-day comment period for the proposed closure of public lands within Hazardous Exclusion Areas to all entry, whereby comments on impacts to hunting, fishing, and recreational shooting are being accepted by the BLM. Following the public comment period, the BLM will respond in a reasonable manner to the comments received, will explain how significant issues were resolved, and will issue a final decision on the proposed closure made available online at: 
                    <E T="03">https://go.usa.gov/xmfVv.</E>
                </P>
                <P>
                    Comments, including names, street addresses, and other contact information for respondents, will be available for public review at the Phoenix District Office, 21605 North 7th Avenue, Phoenix, AZ 85027, listed in 
                    <E T="02">ADDRESSES</E>
                    , during regular business hours (8 a.m. to 4:30 p.m., Monday through Friday, except Federal holidays). Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>These proposed supplementary rules are necessary for the protection of public lands and resources and for the protection, well-being, and health and safety of those using public lands. Proposed supplementary rules 1 through 4 would apply to existing developed recreation areas throughout the Phoenix District Office, and to future developed recreation areas. The rest of the proposed supplementary rules would apply only to the recreational shooting sports sites and any future recreational shooting sports sites within the district.</P>
                <P>In January 2020, the BLM Phoenix District Office approved the construction of five recreational shooting sports sites (Baldy Mountain, Box Canyon, Church Camp Road, Narramore Road, and Saddleback Mountain) in the Recreational Shooting Sports Project Final Environmental Assessment (EA). The EA was in conformance with the two applicable land use plans, the Bradshaw-Harquahala Approved Resource Management Plan and Record of Decision (Bradshaw-Harquahala RMP (BLM 2010)) and the Lower Sonoran Approved Resource Management Plan and Record of Decision (Lower Sonoran RMP (BLM 2012)). As a result of improvements, each site would meet the “developed recreation site and area” definition found in 43 Code of Federal Regulations (CFR) 8360.0-5. Existing rules associated with developed recreation sites and areas (43 CFR 8365) would apply in addition to these proposed supplementary rules.</P>
                <P>
                    To promote safe use and operation of each site, supplementary rules of conduct would be needed to manage behavior. Within developed recreation areas established for recreational 
                    <PRTPAGE P="49996"/>
                    shooting sports, the discharge of firearms would be allowed where authorized (see 43 CFR 8365.2-5). Each recreation area would be posted with appropriate signage at access points. Immediately adjacent to shooting facilities (facility area) would be a designated Hazardous Exclusion Area. Each Hazardous Exclusion Area is required for public safety and would be enclosed within a perimeter fence. Given the complexity of the terrain and uncertainties about where the actual fence line will be constructed, the BLM estimates 539 acres of public lands would be closed to public entry, as depicted on maps found at 
                    <E T="03">https://go.usa.gov/xmfVv.</E>
                     The combination of the shooting facility area and the Hazardous Exclusion Area defines the boundary of the recreational shooting sports site. Appropriate warning signage would be installed and maintained.
                </P>
                <HD SOURCE="HD1">III. Discussion of Proposed Supplementary Rules</HD>
                <P>Proposed supplementary rules 1 through 4 would apply to all developed recreation areas and sites within the Phoenix District boundary. In addition to supplementary rules 1 through 4, supplementary rules 5 through 16 would apply within recreational shooting sports sites.</P>
                <P>
                    <E T="03">Supplementary Rule 1</E>
                     would prevent activities that would impede access to or through areas (or sites). The proposed rule is similar to an existing rule for National Forest System roads and trails found at 36 CFR 261.12(d)).
                </P>
                <P>
                    <E T="03">Supplementary Rule 2</E>
                     would prevent improper disposal of pet waste, in a manner consistent with Pima County Code 7.29.030, which requires responsible storage and disposal of solid waste, and provides for hygiene, health, and safety for users.
                </P>
                <P>
                    <E T="03">Supplementary Rule 3</E>
                     would address user conduct in a manner consistent with Arizona Revised Statue (ARS) 13-2904 describing “Disorderly conduct.”
                </P>
                <P>
                    <E T="03">Supplementary Rule 4</E>
                     would combine existing regulations to protect wildlife, livestock, and vegetation from recreational shooting within developed recreation areas and sites.
                </P>
                <P>
                    <E T="03">Supplementary Rule 5</E>
                     would limit the potential for personal property to be left behind by the public, unless authorized. The existing rule for developed recreation sites or areas found at 43 CFR 8365.2-3 limits leaving personal property to 24 hours or less in developed picnic day-use areas or 72 hours or less in developed camping areas. The proposed rule would be more restrictive and is needed to address recreational shooting sports sites specifically.
                </P>
                <P>
                    <E T="03">Supplementary Rule 6</E>
                     would prohibit firearm discharge while any individual is in front of the designated firing line to protect public, contractor, volunteer, and BLM employee safety.
                </P>
                <P>
                    <E T="03">Supplementary Rule 7</E>
                     would address drug and/or alcohol related concerns within recreational shooting sports sites for the purpose of public health and safety. Existing supplementary rules only address underage drinking and open containers of alcohol while operating or riding on/in motor vehicles.
                </P>
                <P>
                    <E T="03">Supplementary Rule 8</E>
                     would establish hours of operation for recreational shooting sports sites in the operating plans. Site hours would be posted at the site and on the agency's website and would depend on time of year and type of use. Flexibility in operating times are needed to appropriately enforce times of use.
                </P>
                <P>
                    <E T="03">Supplementary Rule 9</E>
                     would prohibit climbing on buildings or structures, unless authorized, to protect public safety.
                </P>
                <P>
                    <E T="03">Supplementary Rule 10</E>
                     would limit the use of targets, as established through the operating plan and as posted at each site, for the purpose of managing shooting related waste.
                </P>
                <P>
                    <E T="03">Supplementary Rule 11</E>
                     would restrict the public from impeding recreational target shooting and provide the ability to manage sites for their intended use.
                </P>
                <P>
                    <E T="03">Supplementary Rule 12</E>
                     would limit the use of ammunition as established through the operating plan, and as posted at each site and on the agency's website, for the purpose of promoting safe shooting practices and managing shooting related waste.
                </P>
                <P>
                    <E T="03">Supplementary Rule 13</E>
                     would prohibit access into the Hazardous Exclusion Areas to avoid projectile or ricochet concerns and promote public safety. The Hazardous Exclusion Areas will be posted with appropriate signage.
                </P>
                <P>
                    <E T="03">Supplementary Rule 14</E>
                     would restrict the direction of firearm discharge into appropriate backstops to reduce resource damage and to protect public, contractor, volunteer, and BLM employee safety.
                </P>
                <P>
                    <E T="03">Supplementary Rule 15</E>
                     would establish site capacity user limits through the operating plan and as posted. The limiting of the number of users would provide for user safety.
                </P>
                <P>
                    <E T="03">Supplementary Rule 16</E>
                     would align with a local shooting range policy by stating that children under the age of 16 must be accompanied by a responsible adult within the recreational shooting sports site for the purpose of promoting safety.
                </P>
                <HD SOURCE="HD1">IV. Procedural Matters</HD>
                <HD SOURCE="HD2">Executive Orders 12866 and 13563, Regulatory Planning and Review</HD>
                <P>These proposed supplementary rules are not a significant regulatory action and are not subject to review by the Office of Management and Budget under Executive Order 12866. These proposed supplementary rules would not have an effect of $100 million or more on the economy.</P>
                <P>These proposed supplementary rules would establish rules for recreational shooting sports sites to protect public health and safety and avoid user conflicts. These proposed supplementary rules would 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. These proposed supplementary rules would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. These proposed supplementary rules do not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the right or obligations of their recipients, nor do these rules raise novel legal or policy issues. These proposed supplementary rules protect resources and human health and safety, and enable BLM law enforcement personnel to efficiently enforce, where appropriate, regulations pertaining to unlawful usage of a recreation area (or site) in a manner consistent with state and local laws, ordinances, regulations, or orders on public lands.</P>
                <HD SOURCE="HD2">Clarity of the Supplementary Rules</HD>
                <P>Executive Order 12866 requires each agency to write regulations that are simple and easy to understand. The BLM invites your comments on how to make these proposed supplementary rules easier to understand, including answers to questions such as the following:</P>
                <P>(1) Are the requirements in the proposed supplementary rules clearly stated?</P>
                <P>(2) Do the proposed supplementary rules contain technical language or jargon that interferes with their clarity?</P>
                <P>(3) Does the format of the proposed supplementary rules (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?</P>
                <P>(4) Would the proposed supplementary rules be easier to understand if they were divided into more (but shorter) sections?</P>
                <P>
                    (5) Is the description of the proposed supplementary rules in the 
                    <PRTPAGE P="49997"/>
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                     section of this preamble helpful to your understanding of the proposed supplementary rules? How could this description be more helpful in making the proposed supplementary rules easier to understand?
                </P>
                <P>
                    Please send any comments you have on the clarity of the proposed supplementary rules to an address specified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD2">National Environmental Policy Act (NEPA)</HD>
                <P>The BLM prepared an EA and found that these proposed supplementary rules do not constitute a major Federal action significantly affecting the quality of the human environment under Section 102(2)(C) of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4332(2)(C). The BLM completed a 30-day scoping period and a 15-day public review of the draft EA in 2019.</P>
                <P>
                    The BLM completed the EA to analyze the construction and operation of the recreational shooting sports sites which included the proposed supplementary rules. The Decision Record for this EA was signed in January 2020. The BLM has placed the EA and associated documents in the administrative record at the addresses specified in the 
                    <E T="02">ADDRESSES</E>
                     section.
                </P>
                <HD SOURCE="HD2">Regulatory Flexibility Act</HD>
                <P>
                    Congress enacted the Regulatory Flexibility Act of 1980 (RFA), as amended, 5 U.S.C. 601, 
                    <E T="03">et seq.,</E>
                     to ensure that Government regulations do not unnecessarily or disproportionately burden small entities. The RFA requires a regulatory flexibility analysis if a rule has a significant economic impact, either detrimental or beneficial, on a substantial number of small entities. These proposed supplementary rules do not pertain specifically to commercial or governmental entities of any size but contain rules to protect the health and safety of the public and reduce user conflicts on public lands within the Hassayampa and Lower Sonoran Field Office areas. Therefore, the BLM has determined, under the RFA, that these proposed supplementary rules do not have a significant economic impact on a substantial number of small entities.
                </P>
                <HD SOURCE="HD2">Small Business Regulatory Enforcement Fairness Act</HD>
                <P>These proposed supplementary rules do not constitute “major rules” as defined at 5 U.S.C. 804(2). These proposed supplementary rules are intended to manage behavior and establish rules of conduct in developed recreation areas (or sites) within the Hassayampa and Lower Sonoran Field Office areas. These proposed supplementary rules would have no effect on business, commercial, or industrial use of the public lands.</P>
                <HD SOURCE="HD2">Unfunded Mandates Reform Act</HD>
                <P>
                    These proposed supplementary rules do not impose an unfunded mandate on state, local, or tribal governments or the private sector of more than $100 million per year, nor do the proposed supplementary rules have a significant or unique effect on state, local, or tribal governments or the private sector. The proposed supplementary rules do not require anything of state, local, or tribal governments. Therefore, the BLM is not required to prepare a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531, 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <HD SOURCE="HD2">Executive Order 12630, Governmental Actions and Interference With Constitutionally Protected Property Rights (Takings)</HD>
                <P>These proposed supplementary rules do not represent a government action capable of interfering with constitutionally protected property rights. These proposed supplementary rules do not address property rights in any form and do not cause the impairment of anyone's property rights. Therefore, the BLM has determined that these proposed supplementary rules do not cause a taking of private property or require further discussion of takings implications under this executive order.</P>
                <HD SOURCE="HD2">Executive Order 13132, Federalism</HD>
                <P>These proposed supplementary rules would not have a substantial, direct effect on the states, on the relationship between the Federal government and the states, or on the distribution of power and responsibilities among the various levels of government. These proposed supplementary rules apply in only one state, Arizona, and do not address jurisdictional issues involving the Arizona State government. Therefore, in accordance with Executive Order 13132, the BLM has determined that these proposed supplementary rules do not have sufficient federalism implications to warrant preparation of a Federalism Assessment.</P>
                <HD SOURCE="HD2">Executive Order 12988, Civil Justice Reform</HD>
                <P>Under Executive Order 12988, the BLM has determined that these proposed supplementary rules would not unduly burden the judicial system and that the rules meet the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.</P>
                <HD SOURCE="HD2">Executive Order 13175, Consultation and Coordination With Indian Tribal Governments</HD>
                <P>In accordance with Executive Order 13175, the BLM has found that these proposed supplementary rules do not include policies that have tribal implications and would have no bearing on trust lands or on lands for which title is held in fee status by Indian tribes or U.S. Government-owned lands managed by the Bureau of Indian Affairs. Since these proposed supplementary rules do not change BLM policy and do not involve Indian reservation lands or resources, we have determined that the government-to-government relationships remain unaffected. These proposed supplementary rules affect developed recreation areas (or sites), including recreational shooting sports sites on public lands managed by the BLM Hassayampa and Lower Sonoran Field Offices.</P>
                <HD SOURCE="HD2">Executive Order 13352, Facilitation of Cooperative Conservation</HD>
                <P>Under Executive Order 13352, the BLM has determined that these proposed supplementary rules would not impede the facilitation of cooperative conservation. These proposed supplementary rules would take appropriate account of, and consider the interests of, persons with ownership or other legally recognized interests in land or other natural resources; properly accommodate local participation in the Federal decision-making process; and provide that the programs, projects, and activities are consistent with protecting public health and safety.</P>
                <HD SOURCE="HD2">Information Quality Act</HD>
                <P>In developing these proposed supplementary rules, the BLM did not conduct or use a study, experiment, or survey requiring peer review under the Information Quality Act (Section 515 of Pub. L. 106-554).</P>
                <HD SOURCE="HD2">Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use</HD>
                <P>The proposed supplementary rules do not constitute a significant energy action since they have no impact on energy supplies, production, or consumption, and have no connection with energy policy.</P>
                <HD SOURCE="HD2">Paperwork Reduction Act</HD>
                <P>
                    These proposed supplementary rules do not contain information collection requirements that the Office of Management and Budget must approve 
                    <PRTPAGE P="49998"/>
                    under the Paperwork Reduction Act, 44 U.S.C. 3501, 
                    <E T="03">et seq.</E>
                </P>
                <HD SOURCE="HD1">Proposed Supplementary Rules</HD>
                <HD SOURCE="HD2">Author</HD>
                <P>The principal author of these proposed supplementary rules is Tyler Lindsey, Project Manager, Phoenix District Office, Bureau of Land Management.</P>
                <P>For the reasons stated in the preamble, and under the authority for supplementary rules at 43 U.S.C. 1740 and 43 CFR 8365.1-6, the Arizona State Director, BLM, proposes to establish the following supplementary rules for all BLM developed recreation sites and areas, in addition to supplementary rules specific to recreational shooting sports sites, within the Phoenix District boundary, Arizona, to read as follows:</P>
                <HD SOURCE="HD2">Definitions</HD>
                <P>
                    <E T="03">Developed recreation sites and areas,</E>
                     as defined by 43 CFR 8360.0-5(c), means sites and areas that contain structures of capital improvements primarily used by the public for recreation purposes.
                </P>
                <P>
                    <E T="03">Hazardous Exclusion Area</E>
                     means a designated area within a recreational shooting sports site where errant/ricochet projectiles could potentially land.
                </P>
                <P>
                    <E T="03">Recreational shooting sports site</E>
                     means a developed recreation site or area meeting the definition found at 43 CFR 8360.0-5(c) and where the primary purpose is recreational shooting.
                </P>
                <HD SOURCE="HD2">Rules and Prohibited Acts Within Developed Recreation Sites and Areas</HD>
                <P>(1) You must not block, restrict, place signs, create a hazardous condition, or otherwise interfere with the use of a road, gate, or other legal access to and/or through a developed recreation site or area boundary.</P>
                <P>(2) You must pick up and properly dispose of pet excrement.</P>
                <P>(3) You must not engage in disorderly conduct as described in Arizona Revised Statute 13-2904.</P>
                <P>(4) You must not shoot at wildlife, livestock, or vegetation.</P>
                <HD SOURCE="HD2">Rules and Prohibited Acts Within Recreational Shooting Sports Sites</HD>
                <P>In addition to the preceding supplementary rules, the following rules would apply within a recreational shooting sports site:</P>
                <P>(5) You must not leave any personal property unattended within a site.</P>
                <P>(6) You must not discharge a firearm while an individual is past the designated firing line.</P>
                <P>(7) You must not use, possess, consume, or be under the influence of alcohol or controlled substances.</P>
                <P>(8) You must not use a site during the restricted times outlined in the operating plan, posted at each site, and listed on the agency's website.</P>
                <P>(9) You must not climb on any buildings or structures, occupied or unoccupied.</P>
                <P>(10) You must only use authorized targets as outlined in the operating plan and as posted at each site.</P>
                <P>(11) You must not enter a site for any purpose other than activities associated with recreational shooting.</P>
                <P>(12) You must only use authorized ammunition as outlined in the operating plan, posted at each site, and listed on the agency's website.</P>
                <P>(13) You must not enter the Hazardous Exclusion Areas.</P>
                <P>(14) You must discharge a firearm only from a designated firing line and into developed backstops and berms.</P>
                <P>(15) You must not exceed the maximum occupancy posted at each site.</P>
                <P>(16) Children under 16 must be accompanied by a responsible adult while in a site.</P>
                <HD SOURCE="HD2">Exemptions</HD>
                <P>The following persons would be exempt from the proposed supplementary rules: Any Federal, state, local, and/or military employee acting within the scope of their duties; members of any organized rescue or fire-fighting force performing an official duty; and persons, agencies, municipalities, or companies holding an existing special-use permit or written authorization from an authorized officer and operating within the scope of their permit or authorization.</P>
                <HD SOURCE="HD2">Penalties</HD>
                <P>On public lands under section 303(a) of the Federal Land Policy and Management Act of 1976 (43 U.S.C. 1733(a) and 43 CFR 8360.0-7), any person who violates any of these supplementary rules may be tried before a United States Magistrate and fined no more than $1,000, imprisoned for no more than 12 months, or both. Such violations may also be subject to enhanced fines provided for by 18 U.S.C. 3571.</P>
                <SIG>
                    <NAME>Raymond Suazo,</NAME>
                    <TITLE>Bureau of Land Management, State Director, Arizona.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-16640 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-32-P</BILCOD>
        </PRORULE>
        <PRORULE>
            <PREAMB>
                <AGENCY TYPE="N">FEDERAL COMMUNICATIONS COMMISSION</AGENCY>
                <CFR>47 CFR Part 20</CFR>
                <DEPDOC>[GN Docket No. 13-111, DA 20-791, FRS 16977]</DEPDOC>
                <SUBJECT>Promoting Technological Solutions To Combat Contraband Wireless Device Use in Correctional Facilities</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 Wireless Telecommunications Bureau (Bureau) seeks to refresh the record on the proposals and questions raised in the Further Notice of Proposed Rulemaking (
                        <E T="03">Further Notice</E>
                        ) in GN Docket No. 13-111, FCC 17-25, released on March 24, 2017, and invite additional comment on the successes and ongoing challenges of currently employed solutions and those under further review and development.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested parties may file comments on or before September 16, 2020; and reply comments on or before October 1, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by GN Docket No. 13-111, by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Electronic Filers:</E>
                         Comments may be filed electronically using the internet by accessing the ECFS: 
                        <E T="03">http://www.fcc.gov/ecfs/.</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Paper Filers:</E>
                         Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.
                    </P>
                    <P>Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.</P>
                    <P>• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.</P>
                    <P>• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.</P>
                    <P>
                        • Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. 
                        <PRTPAGE P="49999"/>
                        See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020), 
                        <E T="03">https://www.fcc.gov/document/fcc-closes-headquarters-open-window-and-changes-hand-delivery-policy.</E>
                    </P>
                    <P>
                        <E T="03">People with Disabilities.</E>
                         To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to 
                        <E T="03">fcc504@fcc.gov</E>
                         or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         Melissa Conway, 
                        <E T="03">Melissa.Conway@fcc.gov,</E>
                         of the Wireless Telecommunications Bureau, Mobility Division, (202) 418-2887.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This is a summary of the Bureau's Public Notice in Docket No. 13-111, DA 20-791, released July 28, 2020. The complete text of the document is available for viewing via the Commission's ECFS website by entering the docket number, GN Docket No. 13-111.</P>
                <HD SOURCE="HD1">Ex Parte Rules</HD>
                <P>
                    This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's 
                    <E T="03">ex parte</E>
                     rules. Persons making 
                    <E T="03">ex parte</E>
                     presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral 
                    <E T="03">ex parte</E>
                     presentations are reminded that memoranda summarizing the presentation must: (1) List all persons attending or otherwise participating in the meeting at which the 
                    <E T="03">ex parte</E>
                     presentation was made; and (2) summarize all data presented and arguments made during the presentation.
                </P>
                <P>
                    If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda, or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during 
                    <E T="03">ex parte</E>
                     meetings are deemed to be written 
                    <E T="03">ex parte</E>
                     presentations and must be filed consistent with section 1.1206(b) of the Commission's rules. In proceedings governed by section 1.49(f) of the rules or for which the Commission has made available a method of electronic filing, written 
                    <E T="03">ex parte</E>
                     presentations and memoranda summarizing oral 
                    <E T="03">ex parte</E>
                     presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (
                    <E T="03">e.g.,</E>
                     .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's 
                    <E T="03">ex parte</E>
                     rules.
                </P>
                <P>
                    In the document, the Bureau seeks to refresh the record in this proceeding that addresses the serious threat of contraband wireless device use by inmates in correctional facilities. Developing a more comprehensive and current record will facilitate an evaluation of potential next steps necessary to eliminate this challenging public safety problem. Through its March 2017 
                    <E T="03">Further Notice</E>
                     (82 FR 22780) and Report and Order (
                    <E T="03">R&amp;O</E>
                    ), the Commission streamlined the authorization process for contraband wireless device interdiction systems in correctional facilities by eliminating certain filing requirements and providing for immediate approval of lease applications filed to operate these systems. In the 
                    <E T="03">Further Notice,</E>
                     the Commission sought further comment on a process for wireless providers to disable wireless devices identified as contraband, on whether to require advanced notice of wireless provider network changes to solutions providers to maintain system effectiveness, and on the viability of other technological solutions.
                </P>
                <P>
                    Since the release of the 
                    <E T="03">R&amp;O</E>
                     and 
                    <E T="03">Further Notice,</E>
                     the Commission has conducted substantial outreach and encouraged stakeholder cooperation in deploying effective technologies. Evolving wireless technologies and wireless provider networks have necessitated adjustments in the deployment and maintenance of contraband interdiction systems. Stakeholders, including wireless providers, contraband device interdiction solutions providers, and corrections officials, have gained meaningful experience using various tools to combat contraband wireless devices. The Bureau's goal is to leverage these experiences to better facilitate the nationwide deployment of legal and cost-effective contraband interdiction systems. The Bureau encourages commenters to be as specific as possible when addressing the below issues.
                </P>
                <P>First, the Bureau seeks to refresh the record on all aspects of the proposed Commission process that would require the disabling of contraband wireless devices by wireless providers following identification. As contraband wireless device use in correctional facilities continues to be a threat to public safety, despite continued voluntary efforts to mitigate the problem, would adoption of a rule-based disabling approach be a more effective, wide-scale solution? The Bureau seeks additional comment on the specifics of the proposed disabling rules. CTIA, the Wireless Association (CTIA), recently reported to the Commission that it has been working successfully, along with its members companies, on processes in various states using a model court order, and that wireless providers are in fact ceasing service to contraband devices pursuant to court orders they have obtained. Therefore, the Bureau also seeks additional comment on specific successes and failures associated with obtaining and executing court orders in the various states where this approach has been pursued. How many contraband devices have been disabled pursuant to court orders, and in what jurisdictions? Has the process been overly burdensome or costly and are there jurisdictions where court orders cannot be obtained and why not? CTIA also claims that the approach of disabling contraband devices added to the Stolen Phone Database is working. The Bureau invites comment from all stakeholders on the effectiveness of using this database to disable contraband wireless devices and render them unusable across multiple wireless provider networks. The Bureau would welcome comment on specific advantages or disadvantages associated with this approach.</P>
                <P>
                    Second, the Bureau seeks to refresh the record on requiring notification to solutions providers of wireless provider system technical changes, recognizing that lack of timely notice of wireless provider system upgrades can render contraband interdiction systems ineffective. What is the current state of communications between wireless providers seeking to upgrade networks and solutions providers that must react to network changes? Have increased coordination efforts substantially improved the ability of solutions providers to ensure effective contraband interdiction system deployments, or is Commission action appropriate to facilitate enhanced communications? CTIA indicates it has developed a Managed Access System Stakeholder Checklist that emphasizes the need for vendors, corrections officials, and wireless providers to establish points of contact to enhance stakeholder 
                    <PRTPAGE P="50000"/>
                    communication and coordination on the deployment of future spectrum bands. Are stakeholders using the Checklist and taking into consideration, in particular, the technical recommendations? If not, why not? Are financial considerations a factor? Are there additional issues that should be added to the Checklist, and is there any action the Commission could take to facilitate its implementation? Would further standardization of best practices involving notification of network changes be beneficial? If so, what type of notice, and what additional best practices should be included? Relatedly, the Bureau also seeks comment on the ability of wireless providers to configure their networks and make system changes to avoid the need for major contraband interdiction system upgrades. If these network configurations are achievable, the Bureau seeks comment on whether wireless providers would, as a matter of best practices, implement them in areas proximate to correctional facilities or, alternatively, compensate solutions providers to make contraband interdiction systems upgrades required to adjust to wireless provider network technical changes that significantly impact contraband interdiction system effectiveness. The Bureau understands that this approach has been adopted internationally and seeks specific comment on whether it has been successful.
                </P>
                <P>
                    Third, the Bureau invites further comment on other technological solutions addressed in the 
                    <E T="03">Further Notice,</E>
                     including quiet zones, network-based solutions, and beacon technology. The Bureau seeks to refresh the record on any developments for these and any other technological solutions, and the regulatory steps the Commission should take to facilitate the development and deployment of these new technologies. The Bureau requests focused comment on the state of carrier network solutions, or the concept of “geofencing” in the contraband wireless device context. The Bureau seeks to update the record on whether there have been technical developments making such an approach a feasible solution to identifying the location of, and ultimately terminating, contraband wireless devices. The Bureau seeks comment on whether the Commission should require wireless providers to not exceed a specific signal strength in the proximity of a correctional facility, or to minimize or remove service-quality signals entirely in the proximity of a facility. For example, should the Commission require a wireless provider to treat the walls of a correctional facility (or some subset of such facilities) the same as the edge of the license areas? The Bureau also seeks to refresh the record on what network modifications, if any, would be required to track and identify contraband devices on carrier networks to a sufficient degree of location accuracy, and at what cost. Should the Commission require wireless carriers to use existing and future network capabilities to accomplish detection and disabling of contraband devices? What advances in location technology could enable carriers to accurately locate contraband devices in correctional facilities for disabling? Are there technical, privacy, legal, or other considerations that are relevant to this approach?
                </P>
                <P>Fourth, the Bureau notes that the evolution of wireless technology from 2G to widespread 3G/4G and ultimately 5G deployments requires continued managed access system upgrades to maintain long-term effectiveness. The Bureau understands that many managed access system solutions depend largely on forcing contraband devices from 3G/4G to 2G services, which carriers are rapidly phasing out, and current network security issues can prevent these systems from capturing calls made from 5G phones. In April 2019, CTIA and the Association of State Correctional Administrators submitted a Task Force Status Report that described next generation managed access system solutions as “MAS Evolved.” The report recommended that wireless providers establish roaming agreements with solutions providers for network security reasons to enable newer generation services on managed access system networks. The Bureau understands that a key feature of a MAS Evolved solution involves use of roaming agreements allowing a MAS Evolved system to block calls by preventing authentication on the network, and enabling newer generation services on managed access system networks where calls are captured without forcing the devices down to 2G.</P>
                <P>The Bureau seeks comment on how this approach can be more effective, less complex, easier to manage, and less costly to implement when compared to a more traditional managed access system deployment. If full roaming partners, can solutions providers leverage their small cell deployments to create a virtual fence and enhance the ability to identify and block contraband phones? Would this approach lead to a greater diversity in types and areas of contraband interdiction system deployments? What steps can the Commission take to facilitate the widespread implementation of MAS Evolved as a solution? The Bureau seeks comment on how the wireless providers are working with vendors to promote MAS Evolved and how the Commission can support these efforts. Would a standardized template roaming agreement improve the effectiveness of MAS deployments and encourage expansion? The Bureau seeks focused comment on the status of the development and execution of roaming agreements in order to promote MAS Evolved solutions. The Bureau requests that commenters be specific regarding how many states and how many correctional facilities have been involved in testing or deploying MAS Evolved solutions. In addition to the execution of roaming agreements, are there other approaches that could be developed by the wireless providers and/or the vendors to add features or services and help defray the cost of MAS deployments and operations? Are there specific approaches or other examples of which the Commission should be aware? How can the Commission further support these efforts? Are there specific steps the Commission can take to help coordinate stakeholder efforts? Are there other voluntary actions that stakeholders have taken in order to promote MAS Evolved?</P>
                <P>Fifth, given the development of newer technologies and applications for addressing contraband device use, the Bureau seeks comment on whether the leasing rules adopted in 2017 remain effective in facilitating spectrum use agreements between wireless providers and solutions providers. Should the Commission revise these rules or implement further streamlining initiatives in its secondary markets processes? The Bureau recognizes that, for budgetary reasons, some correctional facilities are seeking more mobile solutions with less reliance on permanent fixed deployments. Should the Commission amend its rules or update its licensing policies/databases to better accommodate these newer solutions and if so, how?</P>
                <P>
                    Sixth, the Bureau notes that the Commission has not pursued regulatory action on jamming technologies by state or local entities given the prohibition against willful or malicious interference in section 333 of the Communications Act, as amended. The Bureau recognizes that limited testing of jamming technologies has occurred with federal oversight, consistent with the statute, and the Commission continues to support efforts to obtain more data on this type of solution when tested in authorized environments. As a 
                    <PRTPAGE P="50001"/>
                    substantial number of corrections officials continue to seek a “jamming” solution or its equivalent, the Bureau does seek comment, however, on the potential for wireless providers to voluntarily deploy base stations in the vicinity of a correctional facility that would, in effect, result in the blocking of their own signals in all or part of a correctional facility, thereby not resulting in a violation of section 333. Would such a solution be feasible in certain areas of the country and at what cost? Wireless providers presumably have all relevant information about the radiofrequency signal environment surrounding a correctional facility they serve. Accordingly, would this type of wireless provider-driven approach alleviate concerns regarding difficulties in coordinating communications with third party solutions providers and the associated need for contraband interdiction system upgrades?
                </P>
                <SIG>
                    <FP>Federal Communications Commission.</FP>
                    <NAME>Amy Brett,</NAME>
                    <TITLE>Chief of Staff, Competition and Infrastructure Policy Division, Wireless Telecommunications Bureau.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17335 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6712-01-P</BILCOD>
        </PRORULE>
    </PRORULES>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Notices</UNITNAME>
    <NOTICES>
        <NOTICE>
            <PREAMB>
                <PRTPAGE P="50002"/>
                <AGENCY TYPE="F">DEPARTMENT OF AGRICULTURE</AGENCY>
                <SUBAGY>Forest Service</SUBAGY>
                <SUBJECT>Forest Service Handbook 5309.11, Chapter 30 Law Enforcement: Public Notice and Comment for Closures of National Forest System Lands to Hunting, Fishing, or Recreational Shooting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Forest Service, Agriculture (USDA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability for public comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Agriculture (USDA), United States Forest Service (Forest Service), is issuing directives implementing the public notice and comment requirements for issuance of orders that temporarily or permanently close National Forest System lands to hunting, fishing, or recreational shooting, except in an emergency.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received in writing by September 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The proposed directive may be reviewed at and comments may be submitted electronically to 
                        <E T="03">https://cara.ecosystem-management.org/Public/CommentInput?project=ORMS-2312.</E>
                         Written comments may be mailed to Jamie Schwartz, National Program Manager, Shooting Sports, Recreation, Heritage, and Volunteer Resources, 201 14th Street SW, Washington, DC 20024. All timely received comments, including names and addresses, will be placed in the record and will be available for public inspection at 
                        <E T="03">https://cara.ecosystem-management.org/Public/ReadingRoom?project=ORMS-2312.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jamie Schwartz, National Program Manager, Shooting Sports, 202-205-1589 or 
                        <E T="03">james.schwartz@usda.gov.</E>
                         Individuals using telecommunication devices for the deaf may call the Federal Information Relay Service at 800-877-8339 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Forest Service has determined that the definition of emergency contained in this proposed directive formulates a standard, criteria, or guideline applicable to Forest Service programs and is therefore subject to public notice and comment under 36 CFR 216. Newly enacted section 4103 of the John D. Dingell, Jr., Conservation, Management, and Recreation Act, Public Law 116-9, Title IV (section 4103), requires the Forest Service to provide advance notice of an opportunity for public comment as well as an opportunity for public comment before permanently or temporarily closing any National Forest Service lands to hunting, fishing, or recreational shooting, except in an emergency. The Forest Service is issuing directives in Law Enforcement and Investigations Handbook 5309.11, Chapter 30, that re-designate existing section 34 as section 35 and add a new section 34 to implement section 4103. New section 34 defines the term “emergency” for purposes of section 4103. The Forest Service has determined that the definition of “emergency” contained in the directives formulates a standard, criterion, or guideline applicable to a Forest Service program and is therefore publishing that definition for public comment under 36 CFR part 216. The Forest Service is seeking public comment only on the definition of “emergency”. The Forest Service has determined that the remaining provisions in the directive do not formulate standards, criteria, or guidelines applicable to a Forest Service program and therefore are not subject to the notice and comment requirements under 36 CFR 216.</P>
                <P>
                    After the public comment period closes, the Forest Service will consider timely comments that are within the scope of the proposed definition of emergency in the development of the final directive. A notice of the final directive, including a response to timely comments, will be posted on the Forest Service's web page at 
                    <E T="03">https://www.fs.fed.us/about-agency/regulations-policies/comment-on-directives.</E>
                </P>
                <SIG>
                    <NAME>Tina Johnna Terrell,</NAME>
                    <TITLE>Associate Deputy Chief, National Forest System.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17661 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3411-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Notice of Public Meeting of the Massachusetts Advisory Committee</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Announcement of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Massachusetts Advisory Committee to the Commission will convene by conference call on Wednesday, August 26, 2020 at 12:30 p.m. (EDT). The purpose of the meeting is to continue its work on water accessibility in Massachusetts.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Wednesday, August 26, 2020 at 12:30 p.m. (EDT).</P>
                    <P>
                        <E T="03">Public Call-In Information:</E>
                         1-800-353-6461; conference ID: 4756247.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Evelyn Bohor at 
                        <E T="03">ero@usccr.gov</E>
                         or by phone at 202-376-7533.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Interested members of the public may listen to the discussion by calling the following toll-free conference call-in numbers: 1-800-353-6461; conference ID: 4756247. Please be advised that before placing them into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free conference call-in number.</P>
                <P>
                    Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference 
                    <PRTPAGE P="50003"/>
                    call-in numbers: 1-800-353-6461; conference ID: 4756247.
                </P>
                <P>
                    Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be emailed to Evelyn Bohor at 
                    <E T="03">ero@usccr.gov.</E>
                     Persons who desire additional information may contact the Eastern Regional Office at (202) 376-7533.
                </P>
                <P>
                    Records and documents discussed during the meeting will be available for public viewing as they become available at this FACA link, click the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Eastern Regional Office, as they become available, both before and after the meetings. Persons interested in the work of this advisory committee are advised to go to the Commission's website, 
                    <E T="03">www.usccr.gov,</E>
                     or to contact the Eastern Regional Office at the above phone numbers, email or street address.
                </P>
                <P>
                    <E T="03">Agenda:</E>
                     Wednesday, August 26, 2020 at 12:30 p.m. (EDT)
                </P>
                <FP SOURCE="FP-2">1. Welcome and Open</FP>
                <FP SOURCE="FP-2">2. Web Briefing on Water Project</FP>
                <FP SOURCE="FP-2">3. Open Comment</FP>
                <FP SOURCE="FP-2">4. Next Steps</FP>
                <FP SOURCE="FP-2">5. Adjourn</FP>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>David Mussatt,</NAME>
                    <TITLE>Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17890 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">COMMISSION ON CIVIL RIGHTS</AGENCY>
                <SUBJECT>Notice of Public Meeting of the Missouri Advisory Committee To Discuss the Pending Briefings on the State's Response to the Pandemic Caused by the Novel Corona Virus Known as COVID-19</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>U.S. Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Announcement of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Missouri Advisory Committee (Committee) will hold a meeting on Thursday, August 27, 2020 at 12:00 p.m. (Central) for the purpose of discussing the proposal for the study on Covid-19 and voting.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will be held on Thursday, August 27, 2020 at 12:00 p.m. (Central).</P>
                    <P>
                        <E T="03">Public Call Information:</E>
                         Dial: (800) 353-6461, Conference ID: 5004921.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Barreras, DFO, at 
                        <E T="03">dbarreras@usccr.gov</E>
                         or 312-353-8311.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Members of the public can listen to the discussion. This meeting is available to the public through the following call-in number: 800-353-6461, conference ID: 7139252. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. 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 conference ID number.</P>
                <P>
                    Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 230 S Dearborn Street, Suite 2120, Chicago, IL 60604. They may also be faxed to the Commission at (312) 353-8324 or emailed to David Barreras at 
                    <E T="03">dbarreras@usccr.gov.</E>
                     Persons who desire additional information may contact the Midwestern Regional Office at (312) 353-8311.
                </P>
                <P>
                    Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via 
                    <E T="03">www.facadatabase.gov</E>
                     under the Commission on Civil Rights, Missouri Advisory Committee link (
                    <E T="03">https://facadatabase.gov/committee/committee.aspx?cid=258&amp;aid=17</E>
                    ). Persons interested in the work of this Committee are directed to the Commission's website, 
                    <E T="03">http://www.usccr.gov,</E>
                     or may contact the Midwestern Regional Office at the above email or street address.
                </P>
                <HD SOURCE="HD1">Agenda</HD>
                <FP SOURCE="FP-2">Welcome and Roll Call</FP>
                <FP SOURCE="FP-2">Panel Presentations</FP>
                <FP SOURCE="FP-2">Questions and Answer Period</FP>
                <FP SOURCE="FP-2">Public Comment</FP>
                <FP SOURCE="FP-2">Adjournment</FP>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>David Mussatt,</NAME>
                    <TITLE>Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17880 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">CIVIL RIGHTS COMMISSION</AGENCY>
                <SUBJECT>Sunshine Act Meeting Notice</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>United States Commission on Civil Rights.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Commission public business meeting.</P>
                </ACT>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Friday August 21, 2020, 12 p.m. ET.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Zakee Martin: 202-376-7700; 
                        <E T="03">publicaffairs@usccr.gov.</E>
                    </P>
                </FURINF>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Meeting to take place by telephone and open to the public by telephone: 1-877-238-4695, Conference ID 873-1601. Computer assisted real-time transcription (CART) will be provided. The web link to access CART (in English) on Friday August 21, 2020, is 
                        <E T="03">https://www.streamtext.net/player?event=USCCR.</E>
                         Please note that CART is text-only translation that occurs in real time during the meeting and is not an exact transcript.
                    </P>
                </ADD>
                <HD SOURCE="HD1">Meeting Agenda</HD>
                <FP SOURCE="FP-2">I. Approval of Agenda</FP>
                <FP SOURCE="FP-2">II. Closed Session</FP>
                <P>A closed session may occur during this business meeting for an unlimited duration.</P>
                <P>
                    <E T="03">Entering Closed Session:</E>
                     The telephone line will remain open while the Commissioners meet in closed session. If you enter the Commission meeting during the closed session, the telephone operator will inform you of the Commission meeting status. Announcements will be made by the telephone operation periodically every 5 to 7 minutes. An announcement will be made at the end of the closed session announcing the reconvening of the Commission meeting and providing the time the meeting will resume.
                </P>
                <FP SOURCE="FP-2">III. Business Meeting</FP>
                <FP SOURCE="FP1-2">
                    A. Presentation by Diane Citrino, Chair of Ohio Advisory Committee on the Committee's report, 
                    <E T="03">
                        Education Funding and Civil Rights 
                        <PRTPAGE P="50004"/>
                        in Ohio
                    </E>
                </FP>
                <FP SOURCE="FP1-2">
                    B. Presentation by Alvina Earnhart, Chair of Colorado Advisory Committee on the Committee's report, 
                    <E T="03">Citizenship Delayed: Civil Rights and Voting Rights Implications of the Backlog in Citizenship and Naturalization Applications</E>
                </FP>
                <FP SOURCE="FP1-2">C. Discussion and vote on Commission Advisory Committees</FP>
                <FP SOURCE="FP1-2">• Vermont Advisory Committee</FP>
                <FP SOURCE="FP1-2">• Idaho Advisory Committee</FP>
                <FP SOURCE="FP1-2">• Kansas Advisory Committee</FP>
                <FP SOURCE="FP1-2">
                    D. Discussion and vote on the Commission's report, 
                    <E T="03">Navigating Voting During the COVID-19 Pandemic: Considerations in Access for Minority Voters</E>
                </FP>
                <FP SOURCE="FP1-2">E. Discussion and vote on amendment to Administrative Instruction 5-9, Advisory Committee Member Conduct Policy</FP>
                <FP SOURCE="FP1-2">F. Discussion and vote on Commission project planning for Fiscal Years 2021 and 2022</FP>
                <FP SOURCE="FP1-2">G. Discussion and vote on Commission statement on the passing of C.T. Vivian</FP>
                <FP SOURCE="FP1-2">H. Management and Operations</FP>
                <FP SOURCE="FP1-2">• Staff Director's Report</FP>
                <FP SOURCE="FP-2">III. Adjourn Meeting.</FP>
                <SIG>
                    <DATED>Dated: August 13, 2020.</DATED>
                    <TITLE>David Mussatt, Supervisory Chief, Regional Programs Unit.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-18049 Filed 8-13-20; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>Bureau of Industry and Security</SUBAGY>
                <SUBJECT>Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Additional Protocol to the U.S.—International Atomic Energy Agency Safeguards</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Industry and Security, Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Information Collection, request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>To ensure consideration, comments regarding this proposed information collection must be received on or before October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Interested persons are invited to submit comments by email to Mark Crace, IC Liaison, Bureau of Industry and Security, at 
                        <E T="03">mark.crace@bis.doc.gov</E>
                         or to 
                        <E T="03">PRAcomments@doc.gov.</E>
                         Please reference OMB Control Number 0694-0135 in the subject line of your comments. Do not submit Confidential Business Information or otherwise sensitive or protected information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Requests for additional information or specific questions related to collection activities should be directed to Mark Crace, IC Liaison, Bureau of Industry and Security, phone 202-482-8093 or by email at 
                        <E T="03">mark.crace@bis.doc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Abstract</HD>
                <P>The Additional Protocol requires the United States to submit declaration forms to the International Atomic Energy Agency (IAEA) on a number of commercial nuclear and nuclear-related items, materials, and activities that may be used for peaceful nuclear purposes, but also would be necessary elements for a nuclear weapons program. These forms provides the IAEA with information about additional aspects of the U.S. commercial nuclear fuel cycle, including: Mining and milling of nuclear materials; buildings on sites of facilities selected by the IAEA from the U.S. Eligible Facilities List; nuclear-related equipment manufacturing, assembly, or construction; import and export of nuclear and nuclear-related items and materials; and research and development. The Protocol also expands IAEA access to locations where these activities occur in order to verify the form data.</P>
                <HD SOURCE="HD1">II. Method of Collection</HD>
                <P>Submitted electronically or in paper form.</P>
                <HD SOURCE="HD1">III. Data</HD>
                <P>
                    <E T="03">OMB Control Number:</E>
                     0694-0135.
                </P>
                <P>
                    <E T="03">Form Number(s):</E>
                     AP-1 through AP-17, and AP-A through AP-Q.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Regular submission, extension of a current information collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Business or other for-profit organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     500.
                </P>
                <P>
                    <E T="03">Estimated Time per Response:</E>
                     23 minutes to 6 hours.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     920.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Cost to Public:</E>
                     5,400.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Mandatory.
                </P>
                <P>
                    <E T="03">Legal Authority:</E>
                     Additional Protocol Implementation Act (Title II of Pub. L. 109-401), Executive Order (E.O.) 13458.
                </P>
                <HD SOURCE="HD1">IV. Request for Comments</HD>
                <P>We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.</P>
                <P>Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <SIG>
                    <NAME>Sheleen Dumas,</NAME>
                    <TITLE>Department PRA Clearance Officer, Office of the Chief Information Officer, Commerce Department.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17919 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-33-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <SUBJECT>Notice of Request for Applicants for Appointment to the United States-Mexico Energy Business Council</SUBJECT>
                <DATE>June 24, 2020.</DATE>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>International Trade Administration, Department of Commerce.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        In 2016, agencies of the Governments of the United States and Mexico established the U.S.-Mexico Energy Business Council (the 
                        <PRTPAGE P="50005"/>
                        “Council”). This notice announces 10 membership opportunities for appointment as U.S. representatives to the U.S. Section of the Council for a term beginning in October 2020 and ending in October 2022.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>All applications must be received by the Office of North America by 5:00 p.m. Eastern Standard Time (EST) on September 16, 2020. Applications received after that date will be considered only if vacancies have not already been filled.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Please submit applications to David Olsen, International Trade Specialist, Office of North America, U.S. Department of Commerce by email only at 
                        <E T="03">David.Olsen@trade.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Olsen, Office of North America, U.S. Department of Commerce, telephone: (202) 809-7233, email: 
                        <E T="03">David.Olsen@trade.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The U.S. Department of Commerce, the U.S. Department of Energy, the Ministry of Economy of the United Mexican States, and the Ministry of Energy of the United Mexican States established the Council in March 2016. The objective of the Council is to bring together representatives of the respective energy industries of the United States and Mexico to discuss issues of mutual interest, particularly ways to strengthen the economic and commercial ties between energy industries in the two countries, and communicate actionable, non-binding recommendations to the U.S. and Mexican Governments.  Since 2016, Council members have participated in public-private sector dialogue to highlight the importance of the United States-Mexico energy relationship, share priorities for the energy sector, and identify opportunities for collaboration. As part of this dialogue, Council members have drafted binational recommendations on topics of mutual interest, including energy security, cross-border energy projects, power planning and integration, workforce development, and the U.S.-Mexico-Canada Agreement (USMCA).  For more information, please consult the Terms of Reference of the Council (copy and paste link into browser): 
                    <E T="03">https://legacy.trade.gov/hled/documents/Signed%20US-MEX%20Energy%20Business%20Council%20Terms%20(May%202016%20-%20English).pdf.</E>
                </P>
                <HD SOURCE="HD1">Participation Requirements</HD>
                <P>
                    The Department of Commerce is seeking applicants for membership on the U.S. Section of the Council. Each applicant must be a senior representative (
                    <E T="03">e.g.,</E>
                     Chief Executive Officer, Vice President, Regional Manager, Senior Director, or holder of a similar position) of a U.S.-owned or controlled individual company, trade association, or private sector organization that is incorporated in and has its main headquarters in the United States and whose activities include a focus on the manufacture, production, commercialization, and/or trade in goods and services for the energy industry in Mexico. Each applicant must also be a U.S. citizen, or otherwise legally authorized to work in the United States and be able to travel to Mexico or locations in the United States to attend Council meetings, as well as U.S. Section and Committee meetings. In addition, the applicant may not be a registered foreign agent under the Foreign Agents Registration Act of 1938, as amended. Applications for membership in the U.S. Section by eligible individuals, including applications by current U.S. Section members for reappointment, will be evaluated on the following criteria:
                </P>
                <FP SOURCE="FP-1">—A demonstrated strong interest in Mexico and its economic development, including as applicable either through exports or investment.</FP>
                <FP SOURCE="FP-1">—The ability to offer to the work of the Council a broad perspective and business experience specific to the energy industry.</FP>
                <FP SOURCE="FP-1">—The ability to address cross-cutting issues that affect the entity's entire energy industry sub-sector, including the oil and gas, renewable energy, electricity, nuclear energy, and energy efficiency.</FP>
                <FP SOURCE="FP-1">—The ability to dedicate organizational resources to initiate and be responsible for activities in which the Council will be active.</FP>
                <P>U.S. Section members will also be selected on the basis of who is best qualified to carry out the objectives of the Council to:</P>
                <FP SOURCE="FP-1">—Promote increased two-way investment in the energy industry;</FP>
                <FP SOURCE="FP-1">—Promote two-way trade in goods and services produced by and used in the energy industry;</FP>
                <FP SOURCE="FP-1">—Promote the development of binational value chains in the production of goods and services in the energy sector;</FP>
                <FP SOURCE="FP-1">—Promote the development of modern energy infrastructure and bolster energy efficiency and security;</FP>
                <FP SOURCE="FP-1">—Foster an enabling environment for the rapid development, deployment, and integration of new energy industry technologies—including clean renewable energy technologies—into the marketplace;</FP>
                <FP SOURCE="FP-1">—Improve competitiveness through innovation and entrepreneurship in the energy industry, to include the promotion of technology exchanges and research partnerships; and</FP>
                <FP SOURCE="FP-1">—Partner in skills development to create solutions in training and education to address evolving energy industry workforce needs.</FP>
                <P>In selecting members of the U.S. Section, the U.S. Government selection committee, composed of representatives from the Department of Commerce and the Department of Energy, will attempt to ensure that the Section represents a cross-section of small, medium-sized, and large firms.</P>
                <HD SOURCE="HD1">Fees and Expenses</HD>
                <P>U.S. Section members will receive no compensation for their participation in Council-related activities. They shall not be considered as special government employees. Individual U.S. Section members will be responsible for all travel and related expenses associated with their participation in the Council, including attendance at Committee and Section meetings. Only appointed U.S. Section members may participate in Council meetings; substitutes and alternates may not be designated. U.S. Section members are expected to serve for two-year terms but may be reappointed.</P>
                <HD SOURCE="HD1">Timeframe for Recruitment and Application</HD>
                <P>
                    To apply for membership in the U.S. Section, please submit the following information to David Olsen, International Trade Specialist, by email at 
                    <E T="03">David.Olsen@trade.gov</E>
                     by September 16, 2020:
                </P>
                <FP SOURCE="FP-1">—Name(s) and title(s) of the applicant;</FP>
                <FP SOURCE="FP-1">—Name and address of the headquarters of the entity that employs the applicant;</FP>
                <FP SOURCE="FP-1">—Location of incorporation or establishment;</FP>
                <FP SOURCE="FP-1">—Size of the represented entity, in terms of annual sales and number of employees;</FP>
                <FP SOURCE="FP-1">—As applicable, the size of the entity's export trade, investment, and nature of operations or interest in Mexico; and</FP>
                <FP SOURCE="FP-1">—A brief statement of why the applicant should be considered, including information about the applicant's ability to initiate and be responsible for activities in which the Council will be active.</FP>
                <P>
                    All applicants will be notified of whether they have been selected once the application window closes and 
                    <PRTPAGE P="50006"/>
                    selection of U.S. Section members has been made. Applications received after September 16, 2020 will be considered only if vacancies have not already been filled.
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        The Act of February 14, 1903, as amended (15 U.S.C. 1512 
                        <E T="03">et seq.;</E>
                         15 U.S.C. 171 
                        <E T="03">et seq.</E>
                        ), to foster, promote, and develop the foreign and domestic commerce of the United States. Section 2 of Reorganization Plan no. 3 of 1979, which assigns to the Secretary of Commerce responsibility for major nonagricultural international trade functions of the United States, including export development.
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 4, 2020.</DATED>
                    <NAME>David Olsen,</NAME>
                    <TITLE>International Trade Specialist, Office of North America.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17388 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-HE-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-570-011]</DEPDOC>
                <SUBJECT>Crystalline Silicon Photovoltaic Products From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Countervailing Duty Administrative Review and Notice of Amended Final Results of Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On August 4, 2020, the United States Court of International Trade (the Court) entered final judgment sustaining the final results of remand redetermination pursuant to court order by the Department of Commerce (Commerce) pertaining to the 2014-2015 countervailing duty (CVD) administrative review of the order on crystalline silicon photovoltaic products (solar products) from the People's Republic of China (China). Commerce is notifying the public that the final judgment in this case is not in harmony with Commerce's final results in the 2014-2015 administrative review of solar products from China, and that Commerce is amending the final results.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable August 14, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Caitlin Monks, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2670.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On September 12, 2017, Commerce published its final results of the 2014-2015 administrative review of solar products.
                    <SU>1</SU>
                    <FTREF/>
                     Commerce reached affirmative determinations for mandatory respondent Changzhou Trina Solar Energy Co., Ltd. and its cross-owned affiliates (collectively, Trina Solar), as well as numerous other producers and exporters not selected for individual review. On November 30, 2018, the Court remanded aspects of the 
                    <E T="03">Final Results</E>
                     to Commerce for further consideration.
                    <SU>2</SU>
                    <FTREF/>
                     The Court remanded Commerce's determinations as regards to the Export Buyer's Credit Program and inclusion of Comtrade data in calculating the world market price for aluminum extrusions and solar glass.
                    <SU>3</SU>
                    <FTREF/>
                     In its first remand redetermination, issued in April 2019,
                    <SU>4</SU>
                    <FTREF/>
                     Commerce provided additional explanation and evidence for its determinations, but the Court continued to find them unsupported by substantial evidence and remanded them a second time.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Crystalline Silicon Photovoltaic Products from the People's Republic of China: Final Results of Countervailing Duty Administrative Review, and Partial Rescission of Countervailing Duty Administrative Review; 2014-2015,</E>
                         82 FR 42792 (September 12, 2017) (
                        <E T="03">Final Results</E>
                        ), and accompanying Issues and Decision Memorandum.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. et al.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 18-167 (November 30, 2018).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                         at 16.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. et al.</E>
                         v. 
                        <E T="03">United States,</E>
                         Court of International Trade Consolidated Court No. 17-00246, “Final Results of Redetermination Pursuant to Court Remand,” dated April 24, 2019.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 19-143 (November 18, 2019).
                    </P>
                </FTNT>
                <P>
                    In its second remand redetermination, issued in February 2020,
                    <SU>6</SU>
                    <FTREF/>
                     Commerce explained that, although it continues to believe that it is not possible to verify whether respondents used the Export Buyer's Credit Program without the cooperation of the Government of China (GOC), it found the program not used, under protest, to comply with the Court's order.
                    <SU>7</SU>
                    <FTREF/>
                     Commerce also solicited additional information for the solar glass benchmark, and selected data from PV Insights consistent with Commerce's preference for product-specific monthly data.
                    <SU>8</SU>
                    <FTREF/>
                     For aluminum extrusions, Commerce used the more product-specific annual data from IHS exclusively rather than averaging them with less specific monthly Comtrade data, consistent with the Court's order.
                    <SU>9</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. and SolarWorld Americas, Inc.</E>
                         v. 
                        <E T="03">United States,</E>
                         Consol. Court No. 17-00246; Slip Op. 19-143 (November 18, 2019), “Final Results of Redetermination Pursuant to Court Remand,” dated February 28, 2020 (Second Remand Redetermination).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Id.</E>
                         at 7-8.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">Id.</E>
                         at 9-10.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                         at 8-9.
                    </P>
                </FTNT>
                <P>
                    The Court sustained Commerce's second remand in full.
                    <SU>10</SU>
                    <FTREF/>
                     Specifically, the Court found that Commerce's determinations regarding the Export Buyer's Credit Program, as well as the aluminum extrusions and solar glass benchmarks, complied with the options the Court provided in its remand opinion.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. and SolarWorld Americas, Inc.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 20-109 (August 4, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">Id.</E>
                         at 3-6 (Export Buyer's Credit Program) and 7-13 (benchmarks for aluminum extrusions and solar glass).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Timken Notice</HD>
                <P>
                    In its decision in 
                    <E T="03">Timken,</E>
                    <SU>12</SU>
                    <FTREF/>
                     as clarified by 
                    <E T="03">Diamond Sawblades,</E>
                    <SU>13</SU>
                    <FTREF/>
                     the Court of Appeals for the Federal Circuit held that, pursuant to section 516A(c) of the Tariff Act of 1930, as amended (the Act), Commerce must publish a notice of court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The Court's August 4, 2020, judgment constitutes a final decision of that court that is not in harmony with Commerce's 
                    <E T="03">Final Results.</E>
                     This notice is published in fulfillment of the publication requirements of 
                    <E T="03">Timken.</E>
                     Accordingly, Commerce will continue suspension of liquidation of subject merchandise pending expiration of the period of appeal or, if appealed, pending a final and conclusive court decision.
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See Timken Co.</E>
                         v. 
                        <E T="03">United States,</E>
                         893 F.2d 337 (Fed. Cir. 1990) (
                        <E T="03">Timken</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">See Diamond Sawblades Mfrs. Coalition</E>
                         v. 
                        <E T="03">United States,</E>
                         626 F.3d 1374 (Fed. Cir. 2010).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Amended Final Results</HD>
                <P>
                    Because there is now a final court decision, Commerce is amending the 2017 
                    <E T="03">Final Results</E>
                     with respect to Trina Solar and all other producers and exporters subject to this review. The revised total subsidy rates for these companies for the period June 10, 2014 through December 31, 2015 are as follows: 
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See</E>
                         Second Remand Redetermination at 20-21.
                    </P>
                </FTNT>
                <PRTPAGE P="50007"/>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="s250,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Exporter or producer</CHED>
                        <CHED H="1">
                            Subsidy rate 
                            <LI>(percent </LI>
                            <LI>
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Changzhou Trina Solar Energy Co., Ltd. and its Cross-Owned Affiliates 
                            <SU>15</SU>
                        </ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chint Solar (Zhejiang) Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hefei JA Solar Technology Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Perlight Solar Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Risen Energy Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Shanghai JA Solar Technology Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Shenzhen Sungold Solar Co., Ltd</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Sunny Apex Development Limited</ENT>
                        <ENT>3.72</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">
                    Amended
                    <FTREF/>
                     Cash Deposit Rates
                </HD>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See Final Results,</E>
                         82 FR at 42793. Cross-owned affiliates are: Trina Solar Limited; Trina Solar (Changzhou) Science &amp; Technology Co., Ltd.; Yancheng Trina Solar Energy Technology Co., Ltd.; Changzhou Trina Solar Yabang Energy Co., Ltd.; Hubei Trina Solar Energy Co., Ltd.; Turpan Trina Solar Energy Co., Ltd.; and Changzhou Trina PV Ribbon Materials Co., Ltd.
                    </P>
                </FTNT>
                <P>
                    Commerce will issue revised cash deposit instructions to U.S. Customs and Border Protection for all firms above that do not have a superseding cash deposit rate (
                    <E T="03">e.g.,</E>
                     from a subsequent administrative review). For such firms, the revised cash deposit rates will be the rates indicated above, effective August 14, 2020.
                </P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1) and 777(i)(1) of the Act.</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Jeffrey I. Kessler,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17942 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[C-570-980]</DEPDOC>
                <SUBJECT>Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled Into Modules, From the People's Republic of China: Notice of Court Decision Not in Harmony With Final Results of Countervailing Duty Administrative Review and Notice of Amended Final Results of Review</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On August 4, 2020, the United States Court of International Trade (the Court) entered final judgment sustaining the final results of remand redetermination pursuant to court order by the Department of Commerce (Commerce) pertaining to the 2014 countervailing duty (CVD) administrative review of the order on crystalline silicon photovoltaic cells, whether or not assembled into modules (solar cells), from the People's Republic of China (China). Commerce is notifying the public that the final judgment in this case is not in harmony with Commerce's final results in the 2014 administrative review of solar cells from China, and that Commerce is amending the final results.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable August 14, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Caitlin Monks, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-2670.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On July 17, 2017, Commerce published its final results of the 2014 administrative review of solar cells.
                    <SU>1</SU>
                    <FTREF/>
                     Commerce reached affirmative determinations for mandatory respondents Canadian Solar Manufacturing (Changshu) Inc. and its cross-owned affiliates (collectively, Canadian Solar) and Changzhou Trina Solar Energy Co., Ltd. and its cross-owned affiliates (collectively, Trina Solar), as well as numerous other producers and exporters not selected for individual review. On November 30, 2018, the Court remanded aspects of the 
                    <E T="03">Final Results</E>
                     to Commerce for further consideration.
                    <SU>2</SU>
                    <FTREF/>
                     The Court remanded Commerce's determinations as regards to the Export Buyer's Credit Program, the inclusion of Comtrade data in calculating the world market price for aluminum extrusions and solar glass, Commerce's decision to revert to a tier-two benchmark in determining the price for polysilicon without considering a respondent's proffered evidence, and the finding that the provision of electricity constitutes a specific and thus countervailable subsidy.
                    <SU>3</SU>
                    <FTREF/>
                     In its first remand redetermination, issued in April 2019,
                    <SU>4</SU>
                    <FTREF/>
                     Commerce provided additional explanation and evidence for its determinations, but the Court continued to find them unsupported by substantial evidence and remanded them a second time.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled into Modules, from the People's Republic of China: Final Results of Countervailing Duty Administrative Review, and Partial Rescission of Countervailing Duty Administrative Review; 2014,</E>
                         82 FR 32678 (July 17, 2017) (
                        <E T="03">Final Results</E>
                        ), and accompanying Issues and Decision Memorandum (IDM), as amended by 
                        <E T="03">Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled into Modules, from the People's Republic of China: Amended Final Results of Countervailing Duty Administrative Review,</E>
                         82 FR 46760 (October 6, 2017) (
                        <E T="03">Amended Final Results</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. et al.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 18-166 (November 30, 2018).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         
                        <E T="03">Id.</E>
                         at 44.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd. et al.</E>
                         v. 
                        <E T="03">United States,</E>
                         Court of International Trade Consolidated Court No. 17-00198, “Final Results of Redetermination Pursuant to Court Remand,” dated April 24, 2019.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 19-137 (November 8, 2019) (
                        <E T="03">Second Remand Order</E>
                        ).
                    </P>
                </FTNT>
                <P>
                    In its second remand redetermination, issued in February 2020,
                    <SU>6</SU>
                    <FTREF/>
                     Commerce explained that, although it continues to believe that it is not possible to verify whether respondents used the Export Buyer's Credit Program without the cooperation of the Government of China (GOC), it found the program not used, under protest, to comply with the Court's order.
                    <SU>7</SU>
                    <FTREF/>
                     Commerce also solicited additional information for the solar glass benchmark, and selected data from PV Insights consistent with Commerce's preference for product specific monthly data.
                    <SU>8</SU>
                    <FTREF/>
                     For aluminum extrusions, Commerce used the more product-specific annual data from IHS exclusively rather than averaging them with less specific monthly Comtrade data, consistent with the Court's order.
                    <FTREF/>
                    <SU>9</SU>
                      
                    <PRTPAGE P="50008"/>
                    For polysilicon, Commerce placed additional information on the record that supported its finding that the solar grade polysilicon market in China is distorted by government involvement.
                    <SU>10</SU>
                    <FTREF/>
                     Finally, Commerce found, based on adverse facts available, that the provision of electricity for less-than-adequate remuneration is a regionally specific subsidy program, based on the GOC's failure to explain the variation in electricity prices between provinces.
                    <SU>11</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         Consol. Court No. 17-00198; Slip Op. 19-137 (November 8, 2019), “Final Results of Redetermination Pursuant to Court Remand,” dated February 28, 2020 (Second Remand Redetermination).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         
                        <E T="03">Id.</E>
                         at 11-12.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         
                        <E T="03">Id.</E>
                         at 13-14.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         
                        <E T="03">Id.</E>
                         at 12-13.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">Id.</E>
                         at 14-22.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">Id.</E>
                         at 22-24.
                    </P>
                </FTNT>
                <P>
                    The Court sustained Commerce's second remand redetermination in full.
                    <SU>12</SU>
                    <FTREF/>
                     Specifically, the Court found that Commerce's determinations regarding the Export Buyer's Credit Program, as well as the aluminum extrusions and solar glass benchmarks, complied with the options the Court provided in the 
                    <E T="03">Second Remand Order.</E>
                    <SU>13</SU>
                    <FTREF/>
                     For polysilicon, the Court explained that Commerce reasonably identified further evidence supporting its finding of market distortion.
                    <SU>14</SU>
                    <FTREF/>
                     Finally, the Court found that Commerce appropriately identified the missing information and facts that, when combined with an adverse inference, supported finding that the provision of electricity is regionally specific.
                    <SU>15</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See Changzhou Trina Solar Energy Co., Ltd.</E>
                         v. 
                        <E T="03">United States,</E>
                         Slip Op. 20-108 (August 4, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         
                        <E T="03">Id.</E>
                         at 4-8 (Export Buyer's Credit Program) and 8-14 (benchmarks for aluminum extrusions and solar glass).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">Id.</E>
                         at 14-18.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">Id.</E>
                         at 18-25.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Timken Notice</HD>
                <P>
                    In its decision in 
                    <E T="03">Timken,</E>
                    <SU>16</SU>
                    <FTREF/>
                     as clarified by 
                    <E T="03">Diamond Sawblades,</E>
                    <SU>17</SU>
                    <FTREF/>
                     the Court of Appeals for the Federal Circuit held that, pursuant to section 516A(c) of the Tariff Act of 1930, as amended (the Act), Commerce must publish a notice of court decision that is not “in harmony” with a Commerce determination and must suspend liquidation of entries pending a “conclusive” court decision. The Court's August 4, 2020, judgment constitutes a final decision of that court that is not in harmony with Commerce's 
                    <E T="03">Final Results</E>
                     and 
                    <E T="03">Amended Final Results.</E>
                     This notice is published in fulfillment of the publication requirements of 
                    <E T="03">Timken.</E>
                     Accordingly, Commerce will continue suspension of liquidation of subject merchandise pending expiration of the period of appeal or, if appealed, pending a final and conclusive court decision.
                </P>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         
                        <E T="03">See Timken Co.</E>
                         v. 
                        <E T="03">United States,</E>
                         893 F.2d 337 (Fed. Cir. 1990) (
                        <E T="03">Timken</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See Diamond Sawblades Mfrs. Coalition</E>
                         v. 
                        <E T="03">United States,</E>
                         626 F.3d 1374 (Fed. Cir. 2010).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Amended Final Results</HD>
                <P>
                    Because there is now a final court decision, Commerce is amending the 
                    <E T="03">Amended Final Results</E>
                     with respect to Canadian Solar, Trina Solar, and all other producers and exporters subject to this review. The revised total subsidy rates for Canadian Solar and Trina Solar for the period January 1, 2014 through December 31, 2014 are as follows: 
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         
                        <E T="03">See</E>
                         Second Remand Redetermination at 48.
                    </P>
                    <P>
                        <SU>19</SU>
                         
                        <E T="03">See Final Results,</E>
                         82 FR at 32680. Cross-owned affiliates are: Canadian Solar Inc.; Canadian Solar Manufacturing (Luoyang) Inc.; CSI Cells Co., Ltd.; CSI Solar Power (China) Inc.; CSI Solartronics (Changshu) Co., Ltd.; CSI Solar Technologies Inc.; and CSI Solar Manufacture Inc.
                    </P>
                    <P>
                        <SU>20</SU>
                         
                        <E T="03">Id.</E>
                         Cross-owned affiliates are: Trina Solar Limited; Trina Solar (Changzhou) Science &amp; Technology Co., Ltd.; Yancheng Trina Solar Energy Technology Co., Ltd.; Changzhou Trina Solar Yabang Energy Co., Ltd.; Hubei Trina Solar Energy Co., Ltd.; Turpan Trina Solar Energy Co., Ltd.; and Changzhou Trina PV Ribbon Materials Co., Ltd.
                    </P>
                </FTNT>
                <GPOTABLE COLS="2" OPTS="L2,tp0,p7,7/8,i1" CDEF="s25,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Exporter or producer</CHED>
                        <CHED H="1">
                            Subsidy rate 
                            <LI>(percent </LI>
                            <LI>
                                <E T="03">ad valorem</E>
                                )
                            </LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">
                            Canadian Solar Manufacturing (Changshu) Inc. and its Cross-Owned Affiliates 
                            <SU>19</SU>
                        </ENT>
                        <ENT>7.36</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">
                            Changzhou Trina Solar Energy Co., Ltd. and its Cross-Owned Affiliates 
                            <SU>20</SU>
                        </ENT>
                        <ENT>5.97</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">BYD (Shangluo) Industrial Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Chint Solar (Zhejiang) Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ET Solar Energy Limited</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">ET Solar Industry Limited</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Hangzhou Sunny Energy Science and Technology Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Jiawei Solarchina Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Jiawei Solarchina (Shenzhen) Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Lightway Green New Energy Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Luoyang Suntech Power Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Ningbo Qixin Solar Electrical Appliance Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Shanghai BYD Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Shenzhen Topray Solar Co. Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Systemes Versilis, Inc</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Taizhou BD Trade Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">tenKsolar (Shanghai) Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Toenergy Technology Hangzhou Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Wuxi Suntech Power Co., Ltd</ENT>
                        <ENT>6.44</ENT>
                    </ROW>
                </GPOTABLE>
                <HD SOURCE="HD1">Amended Cash Deposit Rates</HD>
                <P>
                    Commerce will issue revised cash deposit instructions to U.S. Customs and Border Protection for all firms above that do not have a superseding cash deposit rate (
                    <E T="03">e.g.,</E>
                     from a subsequent administrative review). For such firms, the revised cash deposit rates will be the rates indicated above, effective August 14, 2020.
                </P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1) and 777(i)(1) of the Act.</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Jeffrey I. Kessler,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17943 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-351-842]</DEPDOC>
                <SUBJECT>Certain Uncoated Paper From Brazil: Partial Rescission of Antidumping Duty Administrative Review; 2019-2020</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Commerce (Commerce) is partially rescinding the administrative review of the antidumping duty order on certain uncoated paper (uncoated paper) from Brazil for the period of review (POR) March 1, 2019 through February 29, 2020.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable August 17, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Jerry Huang, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4047.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On March 2, 2020, Commerce published a notice of opportunity to request an administrative review of the antidumping duty order on uncoated paper from Brazil.
                    <SU>1</SU>
                    <FTREF/>
                     Pursuant to requests from interested parties, Commerce initiated an administrative review with respect to three companies, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).
                    <SU>2</SU>
                    <FTREF/>
                     Subsequent to the initiation of the administrative review, the petitioners 
                    <SU>3</SU>
                    <FTREF/>
                     timely withdrew their request for an administrative review of two companies, as discussed below. No 
                    <PRTPAGE P="50009"/>
                    other party requested an administrative review of these companies.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity to Request Administrative Review,</E>
                         85 FR 12267 (March 2, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Initiation of Antidumping and Countervailing Duty Administrative Reviews,</E>
                         85 FR 26931 (May 6, 2020) (Initiation Notice).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Collectively, the petitioners are: Domtar Corporation, P.H. Glatfelter Company, Packaging Corporation of America, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO, CLC.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Partial Rescission of Administrative Review</HD>
                <P>
                    Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if the party that requested a review withdraws its request within 90 days of the date of publication of the notice of initiation. The request for an administrative review of the following companies was withdrawn within 90 days of the date of publication of the 
                    <E T="03">Initiation Notice:</E>
                     International Paper do Brasil Ltda. and International Paper Exportadora Ltda.
                    <SU>4</SU>
                    <FTREF/>
                     As a result, Commerce is rescinding this review with respect to these two companies, in accordance with 19 CFR 351.213(d)(1). The review will continue with respect to Suzano S.A.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Petitioners' Letter, “Uncoated Paper From Brazil/Partial Withdrawal Of Request For Administrative Review Of The Antidumping Order,” dated July 28, 2020.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">See Initiation Notice,</E>
                         85 FR at 26933.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Assessment</HD>
                <P>Commerce will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse for consumption, in accordance with 19 CFR 351.212(c)(l)(i). Commerce intends to issue appropriate assessment instructions to CBP 15 days after publication of this notice.</P>
                <HD SOURCE="HD1">Notification to Importers</HD>
                <P>This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.</P>
                <HD SOURCE="HD1">Notification Regarding Administrative Protective Orders</HD>
                <P>This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(l) of the Act, and 19 CFR 351.213(d)(4).</P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>James Maeder,</NAME>
                    <TITLE>Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17923 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>International Trade Administration</SUBAGY>
                <DEPDOC>[A-570-937]</DEPDOC>
                <SUBJECT>Citric Acid and Certain Citrate Salts From the People's Republic of China: Final Results of Second Expedited Sunset Review of Antidumping Duty Order</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Enforcement and Compliance, International Trade Administration, Department of Commerce.</P>
                </AGY>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>As a result of this sunset review, the Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on citric acid and certain citrate salts from the People's Republic of China (China) would be likely to lead to a continuation or recurrence of dumping, at the levels identified in the “Final Results of Sunset Review” section of this notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicable August 17, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Thomas Martin or Zachary Shaykin, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3936 or (202) 482-2638, respectively.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On May 29, 2009, Commerce published in the 
                    <E T="04">Federal Register</E>
                     a notice of the AD order on citric acid and certain citrate salts from China.
                    <SU>1</SU>
                    <FTREF/>
                     On May 1, 2020, Commerce published its initiation of the second sunset review of the 
                    <E T="03">Order,</E>
                     pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).
                    <SU>2</SU>
                    <FTREF/>
                     On May 18, 2020, Commerce received a timely and complete notice of intent to participate in the sunset review in relation to the order on subject merchandise from China from domestic interested parties 
                    <SU>3</SU>
                    <FTREF/>
                     within the deadline specified in 19 CFR 351.218(d)(1)(i).
                    <SU>4</SU>
                    <FTREF/>
                     The domestic interested parties claimed interested party status pursuant to section 771(9)(C) of the Act as manufacturers in the United States of the domestic like product.
                    <SU>5</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See Citric Acid and Certain Citrate Salts from Canada and the People's Republic of China: Antidumping Duty Orders,</E>
                         74 FR 25703 (May 29, 2009) (
                        <E T="03">Order</E>
                        ).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         
                        <E T="03">See Initiation of Five-Year (Sunset) Reviews,</E>
                         85 FR 25386 (May 1, 2020).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The domestic interested parties are Archer Daniels Midland Company; Cargill, Incorporated; and Tate &amp; Lyle Ingredients Americas LLC (collectively, domestic interested parties).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Domestic Interested Parties' Letter, “Second Five-Year (`Sunset') Review Of Antidumping And Countervailing Duty Orders On Citric Acid And Certain Citrate Salts from the People's Republic of China: Domestic Industry's Notice Of Intent To Participate,” dated May 18, 2020.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         
                        <E T="03">Id.</E>
                         at 2.
                    </P>
                </FTNT>
                <P>
                    On June 1, 2020, the domestic interested parties filed a timely and adequate substantive response within the deadline specified in 19 CFR 351.218(d)(3)(i).
                    <SU>6</SU>
                    <FTREF/>
                     Commerce did not receive substantive responses from any respondent interested party with respect to the 
                    <E T="03">Order</E>
                     covered by this sunset review. As a result, pursuant to section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted an expedited (120-day) sunset review of the 
                    <E T="03">Order.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         
                        <E T="03">See</E>
                         Domestic Interested Parties' Letter, “Second Five-Year (`Sunset') Review Of Antidumping Duty Order On Citric Acid And Certain Citrate Salts from the People's Republic of China: Domestic Industry's Substantive Response,” dated June 1, 2020.
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Scope of the Order</HD>
                <P>
                    The scope of the order includes all grades and granulation sizes of citric acid, sodium citrate, and potassium citrate in their unblended forms, whether dry or in solution, and regardless of packaging type. The scope also includes blends of citric acid, sodium citrate, and potassium citrate; as well as blends with other ingredients, such as sugar, where the unblended form(s) of citric acid, sodium citrate, and potassium citrate constitute 40 percent or more, by weight, of the blend. The scope of the order also includes all forms of crude calcium citrate, including dicalcium citrate monohydrate, and tricalcium citrate tetrahydrate, which are intermediate products in the production of citric acid, sodium citrate, and potassium citrate. The scope of the order does not include calcium citrate that satisfies the 
                    <PRTPAGE P="50010"/>
                    standards set forth in the United States Pharmacopeia and has been mixed with a functional excipient, such as dextrose or starch, where the excipient constitutes at least 2 percent, by weight, of the product. The scope of the order includes the hydrous and anhydrous forms of citric acid, the dihydrate and anhydrous forms of sodium citrate, otherwise known as citric acid sodium salt, and the monohydrate and monopotassium forms of potassium citrate. Sodium citrate also includes both trisodium citrate and monosodium citrate, which are also known as citric acid trisodium salt and citric acid monosodium salt, respectively. Citric acid and sodium citrate are classifiable under 2918.14.0000 and 2918.15.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), respectively. Potassium citrate and crude calcium citrate are classifiable under 2918.15.5000 and 3824.90.9290 of the HTSUS, respectively. Blends that include citric acid, sodium citrate, and potassium citrate are classifiable under 3824.90.9290 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope is dispositive.
                </P>
                <HD SOURCE="HD1">Analysis of Comments Received</HD>
                <P>
                    A complete discussion of all issues raised in this sunset review, including the likelihood of continuation or recurrence of dumping in the event of revocation of the 
                    <E T="03">Order</E>
                     and the magnitude of the margins likely to prevail if the 
                    <E T="03">Order</E>
                     were to be revoked, is provided in the Issues and Decision Memorandum. A list of the topics discussed in the Issues and Decision Memorandum is attached as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at 
                    <E T="03">https://access.trade.gov.</E>
                     In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at 
                    <E T="03">https://enforcement.trade.gov/frn/.</E>
                     The signed and electronic versions of the Issues and Decision Memorandum are identical in content.
                </P>
                <HD SOURCE="HD1">Final Results of Sunset Review</HD>
                <P>
                    Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the 
                    <E T="03">Order</E>
                     on citric acid and certain citrate salts from China would be likely to lead to a continuation or recurrence of dumping, and that the magnitude of the dumping margins likely to prevail is up to 156.87 percent.
                </P>
                <HD SOURCE="HD1">Notification Regarding Administrative Protective Orders</HD>
                <P>This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under an APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials, or conversion to judicial protective orders, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.</P>
                <HD SOURCE="HD1">Notification to Interested Parties</HD>
                <P>We are issuing and publishing these final results and notice in accordance with sections 751(c), 752(c), and 777(i)(1) of the Act, and 19 CFR 351.218(f)(3).</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Jeffrey I. Kessler,</NAME>
                    <TITLE>Assistant Secretary for Enforcement and Compliance.</TITLE>
                </SIG>
                <HD SOURCE="HD1">Appendix</HD>
                <EXTRACT>
                    <HD SOURCE="HD1">List of Topics Discussed in the Issues and Decision Memorandum</HD>
                    <FP SOURCE="FP-2">I. Summary</FP>
                    <FP SOURCE="FP-2">II. Background</FP>
                    <FP SOURCE="FP-2">III. Scope of the Order</FP>
                    <FP SOURCE="FP-2">IV. History of the Order</FP>
                    <FP SOURCE="FP-2">V. Legal Framework</FP>
                    <FP SOURCE="FP-2">VI. Discussion of the Issues</FP>
                    <FP SOURCE="FP1-2">A. Likelihood of Continuation or Recurrence of Dumping</FP>
                    <FP SOURCE="FP1-2">B. Magnitude of the Dumping Margins Likely To Prevail</FP>
                    <FP SOURCE="FP-2">VII. Final Results of Sunset Review</FP>
                    <FP SOURCE="FP-2">VIII. Recommendation</FP>
                </EXTRACT>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17920 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-DS-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XA298]</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; 5-year affirmative findings for Ecuador, Guatemala, Mexico, and Spain.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The NMFS Assistant Administrator (Assistant Administrator) has issued new 5-year affirmative findings for the Governments of Ecuador, Guatemala, Mexico, and Spain (referred to hereafter as “The Nations”) under the Marine Mammal Protection Act (MMPA). This affirmative finding will allow importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP) by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. NMFS bases the affirmative finding determination on reviews of documentary evidence submitted by the Government of The Nations and of information obtained from the Inter-American Tropical Tuna Commission (IATTC).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>These affirmative findings are effective for the 5-year period of April 1, 2020, through March 31, 2025.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Justin Greenman, West Coast Region, National Marine Fisheries Service, 501 W Ocean Blvd., Suite 4200, Long Beach, CA 90802. Phone: 562-980-3264. Email: 
                        <E T="03">justin.greenman@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The MMPA, 16 U.S.C. 1361 
                    <E T="03">et seq.,</E>
                     allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP from a nation with jurisdiction over purse seine vessels with carrying capacity greater than 400 short tons that harvest tuna in the ETP only if the nation has an “affirmative finding” issued by the NMFS Assistant Administrator. 
                    <E T="03">See</E>
                     section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B); 
                    <E T="03">see also</E>
                     50 CFR 216.24(f)(6)(i). If requested by the government of such a nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government, the IATTC, or the Department of State.
                </P>
                <P>
                    The affirmative finding process requires that the harvesting nation is meeting its obligations under the AIDCP and its obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS reviews the affirmative finding and determines whether the harvesting nation continues to meet the requirements. A nation may provide information related to compliance with AIDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to 
                    <PRTPAGE P="50011"/>
                    NMFS to annually renew 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, thereby diminishing the effectiveness of the AIDCP.</P>
                <P>As a part of the affirmative finding process set forth in 50 CFR 216.24(f)(8), the Assistant Administrator considered documentary evidence submitted by the Governments of The Nations and obtained from the IATTC and has determined that The Nations have met the MMPA's requirements to receive an affirmative finding.</P>
                <P>After consultation with the Department of State, the Assistant Administrator issued a 5-year affirmative finding to The Nations, allowing the importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. Issuance of an affirmative finding for The Nations does not affect implementation of an intermediary nation embargo under 50 CFR 216.24(f)(9), which applies to exports from a nation that exports to the United States yellowfin tuna or yellowfin tuna products that was subject to a ban on importation into the United States under section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B). Ecuador, Guatemala, Mexico, and Spain's affirmative findings are effective for the 5-year period of April 1, 2020, through March 31, 2025, subject to subsequent annual reviews by NMFS.</P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Chris Oliver,</NAME>
                    <TITLE>Assistant Administrator for Fisheries, National Marine Fisheries Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17935 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <DEPDOC>[RTID 0648-XA299]</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; affirmative finding annual renewals for Colombia, El Salvador, and Peru.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The NMFS Assistant Administrator (Assistant Administrator) has completed an affirmative finding annual renewal for the Governments of Colombia, El Salvador, and Peru (referred to hereafter as “The Nations”) under the Marine Mammal Protection Act (MMPA). These affirmative findings will continue to allow the importation into the United States of yellowfin tuna and yellowfin tuna products harvested in the eastern tropical Pacific Ocean (ETP) for 1 year in compliance with the Agreement on the International Dolphin Conservation Program (AIDCP) by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. NMFS bases the affirmative finding annual renewals on reviews of documentary evidence submitted by the Governments of The Nations and of information obtained from the Inter-American Tropical Tuna Commission (IATTC).</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>These affirmative finding annual renewals are effective for the 1-year period of April 1, 2020, through March 31, 2021.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Justin Greenman, West Coast Region, National Marine Fisheries Service, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802. Phone: 562-980-3264. Email: 
                        <E T="03">justin.greenman@noaa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The MMPA, 16 U.S.C. 1361 
                    <E T="03">et seq.,</E>
                     allows for importation into the United States of yellowfin tuna harvested by purse seine vessels in the ETP from a nation with jurisdiction over purse seine vessels with carrying capacity greater than 400 short tons that harvest tuna in the ETP only if the nation has an “affirmative finding” issued by the NMFS Assistant Administrator. 
                    <E T="03">See</E>
                     Section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B); 
                    <E T="03">see also</E>
                     50 CFR 216.24(f)(6)(i). If requested by the government of such a nation, the Assistant Administrator will determine whether to make an affirmative finding based upon documentary evidence provided by the government, the IATTC, or the Department of State.
                </P>
                <P>The affirmative finding process requires that the harvesting nation is meeting its obligations under the AIDCP and its obligations of membership in the IATTC. Every 5 years, the government of the harvesting nation must request a new affirmative finding and submit the required documentary evidence directly to the Assistant Administrator. On an annual basis, NMFS must determine whether the harvesting nation continues to meet the requirements of their 5-year affirmative finding. NMFS does this by reviewing the documentary evidence from the last year. A nation may provide information related to compliance with AIDCP and IATTC measures directly to NMFS on an annual basis or may authorize the IATTC to release the information to NMFS to annually renew 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, thereby diminishing the effectiveness of the AIDCP.</P>
                <P>As a part of the affirmative finding process set forth in 50 CFR 216.24(f)(8), for this annual renewal, the Assistant Administrator considered documentary evidence submitted by the Governments of The Nations and obtained from the IATTC and has determined that The Nations have met the MMPA's requirements to receive affirmative finding annual renewals.</P>
                <P>After consultation with the Department of State, the Assistant Administrator issued affirmative finding annual renewals to The Nations, allowing the continued importation into the United States of yellowfin tuna and products derived from yellowfin tuna harvested in the ETP by purse seine vessels operating under The Nations' jurisdiction or exported from The Nations. Issuance of affirmative finding annual renewals for The Nations does not affect implementation of an intermediary nation embargo under 50 CFR 216.24(f)(9), which applies to exports from a nation that exports to the United States yellowfin tuna or yellowfin tuna products that was subject to a ban on importation into the United States under section 101(a)(2)(B) of the MMPA, 16 U.S.C. 1371(a)(2)(B).</P>
                <P>These affirmative finding annual renewals for The Nations are for the 1-year period of April 1, 2020, through March 31, 2021. The Nations' individual 5-year affirmative findings, which have varying start and end dates, remain valid. Colombia's 5-year affirmative finding will remain valid through March 31, 2024, El Salvador's 5-year affirmative finding will remain valid through March 31, 2023, and Peru's 5-year affirmative finding will remain valid through March 31, 2022, subject to subsequent annual reviews by NMFS.</P>
                <SIG>
                    <PRTPAGE P="50012"/>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Chris Oliver,</NAME>
                    <TITLE>Assistant Administrator for Fisheries, National Marine Fisheries Service. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17934 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-22-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                <SUBJECT>Evaluation of State Coastal Management Program; Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office for Coastal Management (OCM), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting and opportunity to comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management will hold a public meeting to solicit comments on the performance evaluation of the Florida Coastal Management Program.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>NOAA will consider all written comments received by October 2, 2020. The virtual public meeting will be held on Wednesday September 23, 2020 at 12:00 p.m. EDT.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments on the coastal management program NOAA intends to evaluate by emailing Susie Holst Rice, Evaluator, NOAA Office for Coastal Management, at 
                        <E T="03">Susie.Holst@noaa.gov.</E>
                         Comments that the Office for Coastal Management receives are considered part of the public record and may be publicly accessible. Any personal identifying information (
                        <E T="03">e.g.,</E>
                         name, address) submitted voluntarily by the sender may also be publicly accessible. NOAA will accept anonymous comments.
                    </P>
                    <P>To participate in the public meeting Wednesday, September 23, 2020 at 12:00 p.m. EDT, registration is required two hours in advance by 10:00 a.m. EDT.</P>
                    <P>
                        <E T="03">Registration: http://noaacsc.adobeconnect.com/floridacmppublicmeeting/event/event_info.html.</E>
                         You may participate online or by phone. If you would like to provide comment during the public meeting, please select “yes” during the online registration. The line-up of speakers will be based on the date and time of registration.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Susie Holst Rice, Evaluator, NOAA Office for Coastal Management by email at 
                        <E T="03">Susie.Holst@noaa.gov</E>
                         or by phone at (240) 533-0730. Copies of the previous evaluation findings, coastal management program's 2016-2020 Assessment and Strategy and reserve's management plan and site profile may be viewed and downloaded on the internet at 
                        <E T="03">http://coast.noaa.gov/czm/evaluations.</E>
                         A copy of the evaluation notification letter and most recent progress reports may be obtained upon request by contacting Susie Holst Rice.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Section 312 of the Coastal Zone Management Act (CZMA) requires NOAA to conduct periodic evaluations of federally approved state coastal programs. The process includes one or more public meetings, consideration of written public comments, and consultations with interested Federal, state, and local agencies and members of the public. For the evaluation of the Florida Coastal Management Program, NOAA will consider the extent to which the state has met the national objectives, adhered to the management program approved by the Secretary of Commerce, and adhered to the terms of financial assistance under the CZMA. When the evaluation is completed, NOAA's Office for Coastal Management will place a notice in the 
                    <E T="04">Federal Register</E>
                     announcing the availability of the Final Evaluation Findings.
                </P>
                <SIG>
                    <NAME>Keelin Kuipers,</NAME>
                    <TITLE>Deputy Director, Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17937 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 3510-JE-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">COMMODITY FUTURES TRADING COMMISSION</AGENCY>
                <SUBJECT>Agency Information Collection Activities: Notice of Intent To Renew Collection; 3038-0097, Process for Review of Swaps for Mandatory Clearing</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commodity Futures Trading Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Commodity Futures Trading Commission (“Commission” or “CFTC”) is announcing an opportunity for public comment on the proposed renewal of a collection of certain information by the agency. Under the Paperwork Reduction Act (“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. This notice solicits comments on reporting and recordkeeping requirements relating to information management requirements for derivatives clearing organizations.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by OMB Control No. 3038-0097 by any of the following methods:</P>
                    <P>
                        • The Agency's website, at 
                        <E T="03">http://comments.cftc.gov/.</E>
                         Follow the instructions for submitting comments through the website.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Same as Mail above.
                    </P>
                    <P>
                        Please submit your comments using only one method and identify that it is for the renewal of Collection Number 3038-0097. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to 
                        <E T="03">http://www.cftc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Megan Wallace, Senior Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-5150; email: 
                        <E T="03">mwallace@cftc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA, 44 U.S.C. 3501 
                    <E T="03">et seq.,</E>
                     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 and includes agency requests 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, the Commission is publishing notice of the proposed extension of the collection of information listed below. 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.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Part 39, Process for Review of Swaps for Mandatory Clearing (OMB Control No. 3038-0097). This is a 
                    <PRTPAGE P="50013"/>
                    request for extension and revision of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Commodity Exchange Act and Commission regulations require a derivatives clearing organization (“DCO”) that wishes to accept a swap for clearing to be eligible to clear the swap and to submit the swap to the Commission for a determination as to whether the swap is required to be cleared. Commission Regulation 39.5 sets forth the process for these submissions. The Commission will use the information in this collection to determine whether a DCO that wishes to accept a swap for clearing is eligible to clear the swap and whether the swap should be required to be cleared.
                </P>
                <P>With respect to the collection of information, the CFTC invites comments on:</P>
                <P>• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;</P>
                <P>• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and</P>
                <P>
                    • Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in section 145.9 of the Commission's regulations.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         17 CFR 145.9.
                    </P>
                </FTNT>
                <P>
                    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from 
                    <E T="03">http://www.cftc.gov</E>
                     that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the Information Collection Request will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.
                </P>
                <P>
                    <E T="03">Burden Statement:</E>
                     The respondent burden for this collection is estimated to be as follows:
                </P>
                <P>
                    <E T="03">Respondents/Affected Entities:</E>
                     Derivatives clearing organizations.
                </P>
                <P>
                    <E T="03">Estimated Number of Respondents:</E>
                     15.
                </P>
                <P>
                    <E T="03">Annual Submission by Each Respondent:</E>
                     1.
                </P>
                <P>
                    <E T="03">Total Annual Responses:</E>
                     15.
                </P>
                <P>
                    <E T="03">Estimated Average Burden Hours per Respondent:</E>
                     40.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     600.
                </P>
                <P>There is no capital cost associated with this collection.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Robert Sidman,</NAME>
                    <TITLE>Deputy Secretary of the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17892 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">COMMODITY FUTURES TRADING COMMISSION</AGENCY>
                <SUBJECT>Agency Information Collection Activities: Notice of Intent To Renew Collection  3038-0092, Customer Clearing Documentation and Timing of Acceptance for Clearing</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Commodity Futures Trading Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Commodity Futures Trading Commission (“Commission” or “CFTC”) is announcing an opportunity for public comment on the extension of the collection of certain information by the agency. Under the Paperwork Reduction Act (“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. This notice solicits comments on the obligation to maintain records related to clearing documentation between the customer and the customer's clearing member.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be submitted on or before October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments, identified by OMB Control No. 3038-0092 by any of the following methods:</P>
                    <P>
                        • The Agency's website, at 
                        <E T="03">http://comments.cftc.gov/.</E>
                         Follow the instructions for submitting comments through the website.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery/Courier:</E>
                         Same as Mail above.
                    </P>
                    <P>
                        Please submit your comments using only one method. All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to 
                        <E T="03">http://www.cftc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Megan Wallace, Senior Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-5150; email: 
                        <E T="03">mwallace@cftc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA, 44 U.S.C. 3501 
                    <E T="03">et seq.,</E>
                     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 and includes agency requests 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, the Commission is publishing notice of the proposed extension of the collection of information listed below. 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.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Customer Clearing Documentation and Timing of Acceptance for Clearing (OMB Control No. 3038-0092). This is a request for extension and revision of a currently approved information collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 4d(c) of the Commodity Exchange Act (“CEA”), as amended by the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”), directs the Commission to require futures commission merchants (“FCMs”) to implement conflict of interest procedures that address such issues the Commission determines to be appropriate. Similarly, section 4s(j)(5) of the CEA, as added by the Dodd-Frank Act, requires swap dealers (“SDs) and major swap participants (“MSPs”) to 
                    <PRTPAGE P="50014"/>
                    implement conflict of interest procedures that address such issues the Commission determines to be appropriate. Section 4s(j)(5) also requires SDs and MSPs to ensure that any persons providing clearing activities or making determinations as to accepting clearing customers are separated by appropriate informational partitions from persons whose involvement in pricing, trading, or clearing activities might bias their judgment or contravene the core principle of open access. Section 4s(j)(6) of the CEA prohibits a SD or MSP from adopting any process or taking any action that results in any unreasonable restraint on trade or imposes any material anticompetitive burden on trading or clearing, unless necessary or appropriate to achieve the purposes of the Act. Section 2(h)(1)(B)(ii) of the CEA requires that derivatives clearing organization (“DCOs) rules provide for the nondiscriminatory clearing of swaps executed bilaterally or through an unaffiliated designated contract market or swap execution facility.
                </P>
                <P>To address these provisions, the Commission promulgated regulations that prohibit arrangements involving FCMs, SDs, MSPs, and DCOs that would (a) disclose to an FCM, SD, or MSP the identity of a customer's original executing counterparty (§§ 1.72(a), 23.608(a), and 39.12(a)(1)(vi)); (b) limit the number of counterparties with whom a customer may enter into a trade (§§ 1.72(b), 23.608(b), and 39.12(a)(1)(vi)); (c) restrict the size of the position a customer may take with any individual counterparty, apart from an overall credit limit for all positions held by the customer at the FCM (§§ 1.72(c), 23.608(c), and 39.12(a)(1)(vi)); (d) impair a customer's access to execution of a trade on terms that have a reasonable relationship to the best terms available (§§ 1.72(d), 23.608(d), and 39.12(a)(1)(vi)); or (e) prevent compliance with specified time frames for acceptance of trades into clearing set forth in 1.74(b), 23.610(b), or 39.12(b)(7) (§§ 1.72(e), 23.608(e), and 39.12(a)(1)(vi)). Additionally, the Commission requires, through regulation 39.12(b)(7)(i)(B), DCOs to coordinate with clearing members to establish prompt processing of trades. Regulations 1.74(a) and 23.610(a) require reciprocal coordination by FCMs, SDs, and MSPs that are clearing members.</P>
                <P>Under the above regulations, SDs, MSPs, FCMs, and DCOs are required to develop and maintain written customer clearing documentation and trade processing procedures. Maintenance of contracts, policies, and procedures is prudent business practice. All SDs, MSPs, FCMs, and DCOs maintain documentation consistent with these regulations. The regulations are crucial both for effective risk management and for the efficient operation of trading venues among SDs, MSPs, FCMs, and DCOs. Each of these entities has a general recordkeeping obligation for these requirements under the Commission's regulations (§ 39.20 for DCOs; § 23.606 for SDs and MSPs; and § 1.73 for FCMs).</P>
                <P>As discussed further below, the information collection burden arising from the regulations primarily is restricted to the costs associated with the affected registrants' obligation to maintain records related to clearing documentation between the customer and the customer's clearing member, and trade processing procedures between DCOs and FCMs, SDs, and MSPs. The information collection obligations are necessary to implement certain provisions of the CEA, including ensuring that registrants exercise effective risk management and for the efficient operation of trading venues among swap dealers, major swap participants, futures commission merchants, and derivatives clearing organizations.</P>
                <P>With respect to the collection of information, the CFTC invites comments on:</P>
                <P>• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;</P>
                <P>• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;</P>
                <P>• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and</P>
                <P>
                    • Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses.
                </P>
                <P>
                    You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in section 145.9 of the Commission's regulations.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         17 CFR 145.9.
                    </P>
                </FTNT>
                <P>
                    The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from 
                    <E T="03">http://www.cftc.gov</E>
                     that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the Information Collection Request will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.
                </P>
                <P>
                    <E T="03">Burden Statement:</E>
                     The Commission is revising its estimate of the burden for this collection, which include 107 Swap Dealers, Major Swap Participants, 61 Futures Commission Merchants, and 15 Derivatives Clearing Organizations. The respondent burden for this collection is estimated to be as follows:
                </P>
                <P>
                    <E T="03">Respondents/Affected Entities:</E>
                     183.
                </P>
                <P>
                    <E T="03">Estimated Average Burden Hours per Respondent:</E>
                     40.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     7,320.
                </P>
                <P>
                    <E T="03">Frequency of collection:</E>
                     Daily, annual, and as needed.
                </P>
                <P>There are no capital costs or operating and maintenance costs associated with this collection.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Robert Sidman,</NAME>
                    <TITLE>Deputy Secretary of the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17896 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6351-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF DEFENSE</AGENCY>
                <SUBAGY>Office of the Secretary</SUBAGY>
                <SUBJECT>Reserve Forces Policy Board; Notice of Federal Advisory Committee Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD). </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Federal Advisory Committee meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Reserve Forces Policy (RFPB) will take place.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The RFPB will hold an open meeting to the public on Wednesday, September 9, 2020 from 8:55 a.m. to 12:55 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The RFPB meeting will be online using Microsoft Teams CVR and Teleconference line. To participate in 
                        <PRTPAGE P="50015"/>
                        the meeting, see the Meeting Accessibility section for instructions.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Alexander Sabol, (703) 681-0577 (Voice), 703-681-0002 (Facsimile), 
                        <E T="03">Alexander.J.Sabol.Civ@Mail.Mil</E>
                         (Email). Mailing address is Reserve Forces Policy Board, 5113 Leesburg Pike, Suite 601, Falls Church, VA 22041. Website: 
                        <E T="03">http://rfpb.defense.gov/</E>
                        . The most up-to-date changes to the meeting agenda can be found on the website and the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.</P>
                <P>
                    <E T="03">Purpose of the Meeting:</E>
                     The purpose of the meeting is to obtain, review, and evaluate information related to strategies, policies, and practices designed to improve and enhance the capabilities, efficiency, and effectiveness of the Reserve Components (RC).
                </P>
                <P>
                    <E T="03">Agenda:</E>
                     The RFPB will hold an open online meeting to the public on Wednesday, September 9, 2020 from 8:55 a.m. to 12:55 p.m. The meeting will consist of remarks to the RFPB from the following invited speakers: The Under Secretary of Defense for Personnel and Readiness will discuss the Total Force mix in a time of flat budgets, the Total Force integration policy, and current issues with the Services' recruiting; the National, and Public Service National Commission on Military, National, and Public Service will discuss the findings of facts and recommendations presented in the commission's final report to the President; the Secretary of the U.S. Air Force will discuss RC access and equipment interoperability demands to fulfill the National Defense Strategy, challenges in accounting for fully burdened Active and Reserve manpower costs in force structure decisions, and ensuring the Space Force's ability to expand in wartime with a RC structure; the Director of the Army National Guard will provide an update on the Army National Guard's readiness and vision for the future; the Commanding General, District of Columbia National Guard will discuss the DC National Guard's role in supporting Civil Authorities within the District; the Acting Assistant Secretary of Defense for Manpower and Reserve Affairs will discuss the FY 2021 National Defense Authorization Act legislations; and the Chief of National Guard Bureau will discuss the state of the National Guard and recent National Guard missions.
                </P>
                <P>
                    <E T="03">Meeting Accessibility:</E>
                     Pursuant to 5 U.S.C. 552b, as amended and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, the meeting is open online to the public from 8:55 a.m. to 12:55 p.m. Persons desiring to participate in the meeting online or by phone are required to submit their name, organization, email and telephone contact information to COL Robert D'Alto at 
                    <E T="03">robert.r.dalto.mil@mail.mil</E>
                     not later than Friday, September 4, 2020. Specific instructions, both for online or teleconference participation in the meeting, will be provided by reply email. The meeting agenda will be available prior to the meeting on the Board's website at: 
                    <E T="03">http://rfpb.defense.gov/.</E>
                </P>
                <P>
                    <E T="03">Written Statements:</E>
                     Pursuant to section 10(a)(3) of the FACA and 41 CFR 102-3.105(j) and 102-3.140, interested persons may submit written statements to the RFPB about its approved agenda or at any time on the RFPB's mission. Written statements should be submitted to the RFPB's Designated Federal Officer (DFO) at the address, email, or facsimile number listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section. If statements pertain to a specific topic being discussed at the planned meeting, then these statements must be submitted no later than five (5) business days prior to the meeting in question. Written statements received after this date may not be provided to or considered by the RFPB until its next meeting. The DFO will review all timely submitted written statements and provide copies to all the RFPB members before the meeting that is the subject of this notice. Please note that since the RFPB operates in accordance with the provisions of the FACA, all submitted comments and public presentations will be treated as public documents and will be made available for public inspection, including, but not limited to, being posted on the RFPB's website.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Aaron T. Siegel,</NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17888 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 5001-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF DEFENSE </AGENCY>
                <SUBAGY>Office of the Secretary </SUBAGY>
                <SUBJECT>Defense Advisory Committee on Women in the Services; Notice of Federal Advisory Committee Meeting </SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P> Under Secretary of Defense for Personnel and Readiness, Department of Defense (DoD). </P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P> Notice of Federal Advisory Committee meeting. </P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P> The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place. </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P> Day 1—Open to the public Tuesday, September 1, 2020 from 9:00 a.m. to 12:00 p.m. Day 2—Open to the public Wednesday, September 2, 2020 from 9:00 a.m. to 12:30 p.m.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held by videoconference. Participant access information will be provided after registering. (Pre-meeting registration is required. See guidance in 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                        , “Meeting Accessibility”). 
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                         COL Elaine Freeman, (571) 447-8151 (Voice), 
                        <E T="03">roelene.e.freeman.mil@mail.mil</E>
                         (Email). Website: 
                        <E T="03">https://dacowits.defense.gov.</E>
                        The most up-to-date changes to the meeting agenda can be found on the website. 
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P> This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.</P>
                <P>
                    <E T="03">Availability of Materials for the Meeting:</E>
                     Additional information, including the agenda or any updates to the agenda, is available at the DACOWITS website, 
                    <E T="03">https://dacowits.defense.gov/.</E>
                     Materials presented in the meeting may also be obtained on the DACOWITS website. 
                    <E T="03">Purpose of the Meeting:</E>
                     The purpose of the meeting is for the DACOWITS to receive written information and briefings on topics related to the recruitment, retention, employment, integration, well-being, and treatment of women in the Armed Forces of the United States. 
                    <E T="03">Agenda:</E>
                     Tuesday, September 1, 2020, from 9:00 a.m. to 12:00 p.m.—Welcome, Introductions, and Announcements; Request for Information Status Update; and Briefings and DACOWITS discussion. 
                    <PRTPAGE P="50016"/>
                    Wednesday, September 2, 2020, from 9:00 a.m. to 12:30 p.m.—Welcome, Introductions and Announcements; Awards Ceremony; and Committee Voting Session on 2020 Recommendations.
                </P>
                <P>
                    <E T="03">Meeting Accessibility:</E>
                     Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public from 9:00 a.m. to 12:00 p.m. on September 1, 2020 and 9:00 a.m. to 12:30 p.m. on September 2, 2020. The meeting will be held by videoconference. The number of participants is limited and is on a first-come basis. All members of the public who wish to participate must register by contacting DACOWITS at 
                    <E T="03">osd.pentagon.ousd-p-r.mbx.dacowits@mail.mil</E>
                     or by contacting Mr. Robert Bowling at (703) 380-0116 no later than Monday, August 24, 2020. Once registered, the web address and/or audio number will be provided.
                </P>
                <P>
                    <E T="03">Special Accommodations:</E>
                     Individuals requiring special accommodations to access the public meeting should contact Mr. Robert Bowling at (703) 380-0116 no later than Monday, August 24, 2020 so that appropriate arrangements can be made. 
                    <E T="03">Written Statements:</E>
                     Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the FACA, interested persons may submit a written statement to the DACOWITS. Individuals submitting a written statement must submit their statement no later than 5:00 p.m., Monday, August 24, 2020 to Mr. Robert Bowling (703) 380-0116 (Voice) or to 
                    <E T="03">osd.pentagon.ousd-p-r.mbx.dacowits@mail.mil</E>
                     (Email). If a statement is not received by Monday, August 24, 2020, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the Committee during this quarterly business meeting. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee. 
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Aaron T. Siegel, </NAME>
                    <TITLE>Alternate OSD Federal Register Liaison Officer, Department of Defense. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17893 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 5001-06-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF EDUCATION</AGENCY>
                <SUBJECT>Withdrawal of Notice Inviting Applications and Cancellation of the Competition for the American Indian Vocational Rehabilitation Services Program</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Special Education and Rehabilitative Services (OSERS), Department of Education.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Department of Education (Department) withdraws the notice inviting applications (NIA) and cancels the competition for the fiscal year (FY) 2020 American Indian Vocational Rehabilitation Services (AIVRS) program under Catalog of Federal Domestic Assistance (CFDA) number 84.250N. The Department intends to announce a new competition in FY 2021.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The withdrawal and cancellation of the document published on March 9, 2020 (85 FR 13636) is effective August 17, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        August Martin, U.S. Department of Education, 400 Maryland Avenue SW, Room 5064A, Potomac Center Plaza, Washington, DC 20202-1800. Telephone: 202-245-7410. Email: 
                        <E T="03">August.Martin@ed.gov.</E>
                    </P>
                    <P>If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Background</HD>
                <P>Under section 121(a) of the Rehabilitation Act of 1973, as amended (the Act), the purpose of the AIVRS program is to provide grants to the governing bodies of Indian Tribes located on Federal and State reservations (and consortia of such governing bodies) to pay 90 percent of the costs of vocational rehabilitation (VR) services, including culturally appropriate services, to American Indians with disabilities who reside on or near Federal or State reservations, consistent with each eligible individual's strengths, resources, priorities, concerns, abilities, capabilities, interests, and informed choice, so that each individual may prepare for, and engage in, high-quality employment that will increase opportunities for economic self-sufficiency.</P>
                <P>
                    On March 9, 2020, the Department published in the 
                    <E T="04">Federal Register</E>
                     (85 FR 13636) an NIA for the FY 2020 AIVRS competition, CFDA 84.250N, 
                    <E T="03">Grants.gov</E>
                     opportunity number ED-GRANTS-030920-001.
                </P>
                <P>At roughly the same time, the COVID-19 pandemic began to affect the United States. American Indian reservations experienced and continue to experience a high rate of COVID-19 infections. Many of the entities eligible for AIVRS grants across the country took actions to limit the spread of COVID-19 by requiring their non-essential personnel to shelter at home. We have been informed that many AIVRS personnel who continue to shelter-in-place at home to avoid exposure to COVID-19 have limited access to the necessary technology to telework, such as personal computers, Wi-Fi, or internet availability to connect to workplace servers or workplace resources, and we assume that would also be true of personnel who do not currently receive a grant but would be eligible to apply. This limits their ability to access the information needed to prepare a quality application for the FY 2020 AIVRS competition.</P>
                <P>
                    In addition, we have been notified that some of the programs attempting to develop grant applications have had difficulty acquiring the Tribal resolutions needed to submit an application for Federal funding or working with the Tribes' administration, including the authorized representatives needed to approve, sign, and submit applications in 
                    <E T="03">Grants.gov</E>
                    .
                </P>
                <P>
                    On May 20, 2020, the Department published a notice in the 
                    <E T="04">Federal Register</E>
                     (85 FR 30690) extending the deadline for the transmittal of applications for the AIVRS program competition (84.250N) to June 26, 2020. However, given the ongoing and, for some Tribes, escalating cases of COVID-19 and the continuing challenges resulting from the pandemic, the 30-day extension has not been sufficient to address these circumstances. Therefore, the Department is withdrawing the NIA and cancelling the FY 2020 AIVRS CFDA 84.250N grant competition.
                </P>
                <P>
                    In order to allow for continuity of services for the AIVRS program, the Department is, through a document published elsewhere in this issue of the 
                    <E T="04">Federal Register</E>
                    <E T="03">,</E>
                     extending the project period and waiving the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, as well as waiving the requirements in 34 CFR 75.261(a) and (c)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. The extension and waivers will enable the Department to provide additional funds to the current 29 projects under CFDA 84.250K, which were awarded in 
                    <PRTPAGE P="50017"/>
                    FY 2015 and will expire as of September 30, 2020. With the additional funds, the Department will also be able to extend those grants to September 30, 2021.
                </P>
                <P>The Department intends to announce a new AIVRS grant competition for five-year grants in FY 2021. Through that competition the Department intends to make funds available for all eligible applicants, including the 29 AIVRS grantees funded in FY 2015 and the 13 AIVRS grantees funded in FY 2016, whose grants will be expiring on September 30, 2021.</P>
                <HD SOURCE="HD1">Intergovernmental Review</HD>
                <P>These programs are not subject to Executive Order 12372 and the regulations in 34 CFR part 79.</P>
                <P>
                    <E T="03">Accessible Format:</E>
                     Individuals with disabilities can obtain this document in an accessible format (
                    <E T="03">e.g.,</E>
                     braille, large print, audiotape, or compact disc) on request to the contact person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <P>
                    <E T="03">Electronic Access to This Document:</E>
                     The official version of this document is the document published in the 
                    <E T="04">Federal Register</E>
                    . You may access the official edition of the 
                    <E T="04">Federal Register</E>
                     and the Code of Federal Regulations at 
                    <E T="03">www.govinfo.gov.</E>
                     At this site you can view this document, as well as all other documents of this Department published in the 
                    <E T="04">Federal Register</E>
                    <E T="03">,</E>
                     in text or Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.
                </P>
                <P>
                    You may also access documents of the Department published in the 
                    <E T="04">Federal Register</E>
                     by using the article search feature at 
                    <E T="03">www.federalregister.gov.</E>
                     Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.
                </P>
                <SIG>
                    <NAME>Mark Schultz,</NAME>
                    <TITLE>Commissioner, Rehabilitation Services Administration, Delegated the authority to perform the functions and duties of the Assistant Secretary for the Office of Special Education and Rehabilitative Services.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-18004 Filed 8-13-20; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 4000-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF ENERGY</AGENCY>
                <SUBJECT>Advanced Scientific Computing Advisory Committee</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Science, Department of Energy.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of open meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This notice announces a meeting of the Advanced Scientific Computing Advisory Committee (ASCAC). Federal Advisory Committee Act requires that public notice of these meetings be announced in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Thursday, September 24, 2020; 11:00 a.m. to 3:00 p.m. EDT, and Friday, September 25, 2020; 11:00 a.m. to 3:00 p.m. EDT.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Teleconference: Remote attendance of the Advanced Scientific Computing Advisory Committee meeting will be possible via Zoom. Instructions will be posted on the Advanced Scientific Computing Advisory Committee website at: 
                        <E T="03">https://science.energy.gov/ascr/ascac/,</E>
                         prior to the meeting and can also be obtained by contacting Christine Chalk by email at 
                        <E T="03">christine.chalk@science.doe.gov,</E>
                         or by phone at (301) 903-7486.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Christine Chalk, Office of Advanced Scientific Computing Research; SC-31/Germantown Building; U.S. Department of Energy; 1000 Independence Avenue SW; Washington, DC 20585-1290; Telephone (301) 903-7486; 
                        <E T="03">christine.chalk@science.doe.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Purpose of the Committee:</E>
                     The purpose of the committee is to provide advice and guidance on a continuing basis to the Office of Science and to the Department of Energy on scientific priorities within the field of advanced scientific computing research.
                </P>
                <P>
                    <E T="03">Purpose of the Meeting:</E>
                     This meeting is the semi-annual meeting of the Committee.
                </P>
                <P>
                    <E T="03">Tentative Agenda:</E>
                </P>
                <FP SOURCE="FP-1">• View from Washington</FP>
                <FP SOURCE="FP-1">• View from Germantown</FP>
                <FP SOURCE="FP-1">• Update on Exascale project activities</FP>
                <FP SOURCE="FP-1">• Report from Subcommittee on 40 years of investments by the Department of Energy in advanced computing and networking</FP>
                <FP SOURCE="FP-1">• Report from AI Subcommittee</FP>
                <FP SOURCE="FP-1">• Technical presentations</FP>
                <FP SOURCE="FP-1">• Public Comment (10-minute rule)</FP>
                <P>
                    The meeting agenda includes an update on the budget, accomplishments and planned activities of the Advanced Scientific Computing Research program and the exascale computing project; an update from the Office of Science; technical presentations from funded researchers; updates from subcommittees and there will be an opportunity for comments from the public. The meeting will conclude at 3:00 p.m. EDT on September 25, 2020. Agenda updates and presentations will be posted on the ASCAC website prior to the meeting: 
                    <E T="03">https://science.osti.gov/ascr/ascac.</E>
                </P>
                <P>
                    <E T="03">Public Participation:</E>
                     The meeting is open to the public. Individuals and representatives of organizations who would like to offer comments and suggestions may do so during the meeting. Approximately 30 minutes will be reserved for public comments. Time allotted per speaker will depend on the number who wish to speak but will not exceed 10 minutes. The Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Those wishing to speak should submit your request at least five days before the meeting. Those not able to attend the meeting or who have insufficient time to address the committee are invited to send a written statement to Christine Chalk, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585, email to 
                    <E T="03">Christine.Chalk@science.doe.gov.</E>
                </P>
                <P>
                    <E T="03">Minutes:</E>
                     The minutes of this meeting will be available within 90 days on the Advanced Scientific Computing website at: 
                    <E T="03">https://science.osti.gov/ascr/ascac.</E>
                </P>
                <SIG>
                    <DATED>Signed in Washington, DC, on August 12, 2020.</DATED>
                    <NAME>LaTanya Butler,</NAME>
                    <TITLE>Deputy Committee Management Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17918 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6450-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Project No. 3409-032]</DEPDOC>
                <SUBJECT>Boyne USA, Inc.; Notice Soliciting Scoping Comments</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.</P>
                <P>
                    a. 
                    <E T="03">Type of Application:</E>
                     Subsequent License.
                </P>
                <P>
                    b. 
                    <E T="03">Project No.:</E>
                     P-3409-032.
                </P>
                <P>
                    c. 
                    <E T="03">Date filed:</E>
                     January 31, 2020.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     Boyne USA, Inc.
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Boyne River Hydroelectric Project (Boyne River Project).
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     The existing project is located on the Boyne River in Boyne Valley Township, Charlevoix County, Michigan.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act 16 U.S.C. 791(a)-825(r).
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Randall Sutton, Boyne Mountain Resort Area Manager, Boyne USA, Inc. P.O. Box 19 Boyne Falls, MI 49713; (231) 549-6076; 
                    <E T="03">rsutton@boynemountain.com.</E>
                    <PRTPAGE P="50018"/>
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     Patrick Ely at 
                    <E T="03">patrick.ely@ferc.gov</E>
                     or (202) 502-8570.
                </P>
                <P>
                    j. 
                    <E T="03">Deadline for filing scoping comments:</E>
                     September 10, 2020.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file scoping comments using the Commission's eFiling system at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx.</E>
                     Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at 
                    <E T="03">https://ferconline.ferc.gov/QuickComment.aspx.</E>
                     You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov,</E>
                     (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P-3409-032.
                </P>
                <P>The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>k. This application is not ready for environmental analysis at this time.</P>
                <P>
                    l. 
                    <E T="03">Project Description:</E>
                     The Boyne River Project consists of a reservoir with a gross storage capacity of 356 acre-feet and a surface area of 68 acres at a pool elevation of 636.8 feet National Geodetic Vertical Datum 1988. The project includes: (a) An existing 610-foot-long by 30-foot-high (left) earth-fill dam embankment and a 180-foot-long by 18-foot-high (right) earth-fill dam embankment; (b) a 132-foot-long by 50 to 72-foot-wide by 12-foot-deep concrete lined headrace channel; (c) a 35-foot-long concrete fixed crest spillway that discharges to a transverse collection gallery, and a 77-foot-long by 5-foot-diameter concrete discharge pipe that carries flow from the collection gallery to a stilling basin; (d) a 20-foot-long by 8.3-foot-wide to 16-foot-wide by 4-foot-deep stilling basin; (e) 6-foot wide by 7-foot 9-inches high sluice gate spillway; (f) a 72-foot-long by 5-foot-diameter concrete pipe that carries the flow from the sluice gate spillway to the stilling basin; (g) a 74-foot-long steel penstock consisting of two 5-foot-diameter and one 7-foot-diameter sections; (h) a 75-foot-long by 18-inch-diameter steel pipes that make up the auxiliary spillway; (i) a 715-foot long by 100-foot-wide emergency overflow spillway area; and (j) a 24-foot-long by 24-foot-wide concrete powerhouse with a single 250-kilowatt propeller turbine. The project also consists of a 100-foot-long, 2400-volt underground transmission line connected to a pole-mounted transformer and a 2.34-mile-long, 7.2/12.5-kilovolt overhead transmission line from the pole-mounted transformer to the Boyne Mountain Resort side of the Consumers Energy utility primary metering cabinet. The last 1,300 feet +/− at the Boyne Mountain Resort end is also buried. The project generates about 661 megawatt-hours annually.
                </P>
                <P>
                    m. In addition to publishing the full text of this notice in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this notice, as well as other documents in the proceeding (
                    <E T="03">e.g.,</E>
                     scoping document) via the internet through the Commission's Home Page (
                    <E T="03">http://www.ferc.gov</E>
                    ) using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document (P-3409). At this time, the Commission has suspended access to the Commission's Public Reference Room due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID-19) issued by the President on March 13, 2020. For assistance, contact FERC at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or call toll-free, (886) 208-3673 or (202) 502-8659 (TTY).
                </P>
                <P>
                    n. You may also register online at 
                    <E T="03">https://ferconline.ferc.gov/FERCOnline.aspx</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, contact FERC Online Support.
                </P>
                <P>o. Scoping Process.</P>
                <P>The Commission staff intends to prepare a single Environmental Assessment (EA) for the project in accordance with the National Environmental Policy Act. The EA will consider both site-specific and cumulative environmental impacts and reasonable alternatives to the proposed action.</P>
                <P>At this time, we do not anticipate holding on-site public or agency scoping meetings. Instead, we are soliciting your comments and suggestions on the preliminary list of issues and alternatives to be addressed in the EA, as described in scoping document 1 (SD1), issued August 11, 2020.</P>
                <P>
                    Copies of the SD1 outlining the subject areas to be addressed in the EA were distributed to the parties on the Commission's mailing list and the applicant's distribution list. Copies of SD1 may be viewed on the web at 
                    <E T="03">http://www.ferc.gov</E>
                     using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, call 1-866-208-3676 or for TTY, (202) 502-8659.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17916 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. EL19-58-003]</DEPDOC>
                <SUBJECT>PJM Interconnection, LLC; Notice of Filing</SUBJECT>
                <P>
                    Take notice that on August 5, 2020, PJM Interconnection, LLC submitted a filing in compliance with the Federal Energy Regulatory Commission's (Commission) Order on Proposed Tariff Revisions and Operating Agreement Revisions, in the above captioned proceeding, on May 21, 2020.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">PJM Interconnection, L.L.C.,</E>
                         171 FERC 61,153 (2020) (May 21 Order).
                    </P>
                </FTNT>
                <P>Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.</P>
                <P>
                    The Commission encourages electronic submission of protests and interventions in lieu of paper using the eFiling link at 
                    <E T="03">http://www.ferc.gov.</E>
                     Persons unable to file electronically 
                    <PRTPAGE P="50019"/>
                    should submit an original and 5 copies of the protest or intervention to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
                </P>
                <P>
                    In addition to publishing the full text of this document in the 
                    <E T="04">Federal Register</E>
                    , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page (
                    <E T="03">http://www.ferc.gov</E>
                    ) using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. At this time, the Commission has suspended access to Commission's Public Reference Room, due to the proclamation declaring a National Emergency concerning the Novel Coronavirus Disease (COVID-19), issued by the President on March 13, 2020. For assistance, contact FERC at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                     or call toll-free, (886) 208-3676 or TYY, (202) 502-8659.
                </P>
                <P>
                    <E T="03">Comment Date:</E>
                     5:00 p.m. Eastern Time on August 26, 2020.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17914 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[Docket No. CP20-479-000]</DEPDOC>
                <SUBJECT>Northern Natural Gas Company; Notice of Schedule for Environmental Review of The 2021 Auburn A-Line Abandonment and Capacity Replacement Project</SUBJECT>
                <P>On June 11, 2020, Northern Natural Gas Company (Northern) filed an application in Docket No. CP20-479-000 requesting abandonment authorization and a Certificate of Public Convenience and Necessity pursuant to Section 7(b) and 7(c) of the Natural Gas Act to abandon, construct, and operate certain natural gas pipeline facilities in Lancaster, Otoe, Johnson, and Nemaha counties, Nebraska. The proposed project is known as the 2021 Auburn A-Line Abandonment and Capacity Replacement Project (Project), and Northern states it would modernize Northern's pipeline system, improve reliability, and enable safer long-term operation of the system.</P>
                <P>On June 25, 2020, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Project.</P>
                <HD SOURCE="HD1">Schedule for Environmental Review</HD>
                <FP SOURCE="FP-1">Issuance of EA December 11, 2020</FP>
                <FP SOURCE="FP-1">90-day Federal Authorization Decision Deadline March 11, 2021</FP>
                <P>If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.</P>
                <HD SOURCE="HD1">Project Description</HD>
                <P>Northern proposes to abandon in-place 31.7 miles of 4- to 6-inch-diameter A-line in Lancaster, Otoe, Johnson, and Nemaha counties, Nebraska. In addition, Northern proposes to construct and operate about 4.4 miles of new 8-inch-diameter pipeline and install a launcher and a regulation station in Lancaster and Otoe counties, Nebraska.</P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    On July 24, 2020, the Commission issued a 
                    <E T="03">Notice of Intent to Prepare an Environmental Assessment for the Proposed 2021 Auburn A-Line Abandonment and Capacity Replacement Project and Request for Comments on Environmental Issues</E>
                     (NOI). The NOI was sent to affected landowners; federal, state, and local government agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. All substantive comments will be addressed in the EA.
                </P>
                <HD SOURCE="HD1">Additional Information</HD>
                <P>
                    In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to 
                    <E T="03">https://www.ferc.gov/ferc-online/overview</E>
                     to register for eSubscription.
                </P>
                <P>
                    Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
                    <E T="03">www.ferc.gov</E>
                    ). Using the eLibrary link, select General Search from the eLibrary menu, enter the selected date range and Docket Number excluding the last three digits (
                    <E T="03">i.e.,</E>
                     CP20-479), and follow the instructions. For assistance with access to eLibrary, the helpline can be reached at (866) 208-3676, TTY (202) 502-8659, or at 
                    <E T="03">FERCOnlineSupport@ferc.gov.</E>
                     The eLibrary link on the FERC website also provides access to the texts of formal documents issued by the Commission, such as orders, notices, and rule makings.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17917 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF ENERGY</AGENCY>
                <SUBAGY>Federal Energy Regulatory Commission</SUBAGY>
                <DEPDOC>[ Project No. 2829-012]</DEPDOC>
                <SUBJECT>City of Loveland; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests</SUBJECT>
                <P>Take notice that the following hydroelectric application has been filed with the Federal Energy Regulatory Commission and is available for public inspection:</P>
                <P>
                    a. 
                    <E T="03">Application Type:</E>
                     License Amendment.
                </P>
                <P>
                    b. 
                    <E T="03">Project No:</E>
                     2829-012.
                </P>
                <P>
                    c. 
                    <E T="03">Date Filed:</E>
                     July 29, 2020.
                </P>
                <P>
                    d. 
                    <E T="03">Applicant:</E>
                     City of Loveland, Colorado.
                </P>
                <P>
                    e. 
                    <E T="03">Name of Project:</E>
                     Loveland Hydroelectric Project.
                </P>
                <P>
                    f. 
                    <E T="03">Location:</E>
                     Big Thompson River, in Larimer County, Colorado.
                </P>
                <P>
                    g. 
                    <E T="03">Filed Pursuant to:</E>
                     Federal Power Act, 16 U.S.C. 791a-825r.
                </P>
                <P>
                    h. 
                    <E T="03">Applicant Contact:</E>
                     Christine Schraeder, City of Loveland, Colorado, 200 North Wilson Avenue, Loveland, CO 80537; phone (970) 962-3587.
                </P>
                <P>
                    i. 
                    <E T="03">FERC Contact:</E>
                     David Rudisail at (202) 502-6376, or 
                    <E T="03">david.rudisail@ferc.gov.</E>
                </P>
                <P>
                    j. 
                    <E T="03">Deadline for filing comments, motions to intervene, and protests:</E>
                     September 11, 2020.
                </P>
                <P>
                    The Commission strongly encourages electronic filing. Please file motions to intervene, protests, and comments using the Commission's eFiling system at 
                    <E T="03">http://www.ferc.gov/docs-filing/efiling.asp.</E>
                     Commenters can submit brief comments up to 6,000 characters, 
                    <PRTPAGE P="50020"/>
                    without prior registration, using the eComment system at 
                    <E T="03">http://www.ferc.gov/docs-filing/ecomment.asp.</E>
                     You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support at 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                    , (866) 208-3676 (toll free), or (202) 502-8659 (TTY). In lieu of electronic filing, you may submit a paper copy. Submissions sent via the U.S. Postal Service must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426. Submissions sent via any other carrier must be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland 20852. The first page of any filing should include docket number P-2829-012. Comments emailed to Commission staff are not considered part of the Commission record.
                </P>
                <P>The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.</P>
                <P>
                    k. 
                    <E T="03">Description of Request:</E>
                     The City of Loveland has requested to amend its license to allow the following activities: restoration of the river channel and floodplain in the area formerly impacted by Idylwilde Dam and reservoir and; reconstruction of the parking lot along the Big Thompson River, formerly known as Idywilde Recreation Area.
                </P>
                <P>
                    l. 
                    <E T="03">Locations of the Application:</E>
                     This filing may also be viewed on the Commission's website at 
                    <E T="03">http://www.ferc.gov</E>
                     using the eLibrary link. Enter the docket number excluding the last three digits in the docket number field to access the document. You may also register online at 
                    <E T="03">http://www.ferc.gov/docs-filing/esubscription.asp</E>
                     to be notified via email of new filings and issuances related to this or other pending projects. For assistance, call 1-866-208-3676 or email 
                    <E T="03">FERCOnlineSupport@ferc.gov</E>
                    , for TTY, call (202) 502-8659. Agencies may obtain copies of the application directly from the applicant.
                </P>
                <P>m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.</P>
                <P>
                    n. 
                    <E T="03">Comments, Protests, or Motions to Intervene:</E>
                     Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214, respectively. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
                </P>
                <P>
                    o. 
                    <E T="03">Filing and Service of Documents:</E>
                     Any filing must (1) bear in all capital letters the title COMMENTS, PROTEST, or MOTION TO INTERVENE as applicable; (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person commenting, protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, motions to intervene, or protests must set forth their evidentiary basis. Any filing made by an intervenor must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 385.2010.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Kimberly D. Bose,</NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17915 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6717-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPPT-2020-0135; FRL-10013-62]</DEPDOC>
                <SUBJECT>TSCA Science Advisory Committee on Chemicals; Request for Nominations; Extension of Nomination and Public Comment Periods</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Environmental Protection Agency (EPA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice; extension of nomination and public comment periods.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>On March 20, 2020, the Environmental Protection Agency (EPA) invited the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA), Science Advisory Committee on Chemicals (SACC). On April 15, 2020, a federal district court vacated the grants policy articulated in EPA's 2017 federal advisory committee membership directive. In light of that intervening decision, EPA is extending the nomination and public comment periods to receive additional nominees and input on prospective candidates for the SACC. Please note that all prior nominations and comments will be considered by EPA and do not need to be resubmitted.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P/>
                    <P>
                        <E T="03">Nominations:</E>
                         To be considered for appointment to the SACC nominations must be received on or before September 1, 2020. Late nominations will not be considered.
                    </P>
                    <P>
                        <E T="03">Comments:</E>
                         Public comments on prospective candidates for membership on the SACC must be received within 30 days of EPA posting of an updated List of Candidates. The availability of the list and the due date for public comments will be announced through the Office of Chemical Safety and Pollution Prevention (OCSPP)'s listservs.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Nominations:</E>
                         Submit your nominations, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0135, by email to 
                        <E T="03">knott.steven@epa.gov.</E>
                    </P>
                    <P>
                        <E T="03">Comments:</E>
                         Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2020-0135, to the Federal eRulemaking Portal: 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
                    </P>
                    <P>
                        Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at 
                        <E T="03">http://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Steven M. Knott, MS, Designated Federal Officer (DFO), Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: (202) 564-0103; email address: 
                        <E T="03">knott.steven@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. General Information</HD>
                <P>
                    EPA is extending the nomination and public comment periods to receive additional nominees and input on prospective candidates to be considered for appointment to the SACC. The purpose of the SACC is to provide independent advice and expert 
                    <PRTPAGE P="50021"/>
                    consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of issues relating to implementation of TSCA. EPA anticipates appointing multiple SACC members over the next year. Sources in addition to this solicitation may be utilized to solicit nominations and identify candidates. Current members of the SACC are eligible for reappointment during this period. Therefore, the appointments completed over the next year may include a mix of newly appointed and reappointed members. As additional background, the biographies of current SACC members are available on the TSCA SACC website at 
                    <E T="03">https://www.epa.gov/tsca-peer-review/members-science-advisory-committee-chemicals.</E>
                </P>
                <P>
                    EPA previously solicited nominations for the SACC in the 
                    <E T="04">Federal Register</E>
                     of March 20, 2020 (85 FR 16095; FRL-10006-50), requesting such nominations be submitted such that they were received on or before April 20, 2020. On April 15, 2020, the U.S. District Court for the Southern District of New York (SDNY) vacated Section 1 of EPA's 2017 federal advisory committee membership directive (2017 Directive), which announced “a requirement that no member of an EPA federal advisory committee be currently in receipt of EPA grants.” As a result of the vacatur, Section 1 is no longer in effect and EPA is following the relevant policies as they existed before the 2017 Directive. However, because EPA was still seeking nominations when the SDNY vacated Section 1, EPA is reopening the SACC's membership solicitations and accepting further nominations and public comments.
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>
                    The SACC is a federal advisory committee, established in December 2016 pursuant to TSCA section 2625(o), and chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix 2. EPA established the SACC to provide independent advice and recommendations to the EPA Administrator on the scientific basis for risk assessments, methodologies, and approaches relating to implementation of TSCA. The SACC members serve as Special Government Employees (SGEs) or Regular Government Employees (RGEs). The SACC expects to meet approximately 4 to 6 times per year, or as needed and approved by the DFO. Meetings may be virtual (
                    <E T="03">e.g.,</E>
                     held via telephone and webcast) or they may be held in the Washington, DC, metropolitan area.
                </P>
                <P>In January 2017, the EPA Administrator appointed 18 members to the SACC. After further consideration of the objectives and scope of SACC activities, EPA decided to increase the membership of the SACC, and in March 2018, completed additional appointments resulting in a total of 26 members. Subsequently, some SACC members either resigned or declined to serve extended appointments. Currently, there are 19 SACC members, all with membership terms that will expire over the next year.</P>
                <P>To date, SACC members and ad hoc reviewers have provided their expertise and knowledge on the first draft chemical risk evaluations. These individuals have dedicated an incredible amount of time to provide EPA with thoughtful and important recommendations for improving the risk evaluations. At times, SACC members were working on multiple chemical evaluations while also preparing for and participating in peer review meetings and writing reports. EPA greatly appreciates the dedication and commitment to service of the SACC members.</P>
                <P>Given the foundation provided by the SACC recommendations from peer reviews of the first 10 chemical risk evaluations, EPA is exploring different ways to use the SACC's expertise for providing independent advice and expert consultation. The Agency is considering requesting that the SACC review significant, cross-cutting science issues on exposure, risk, and modeling, similar to how the Agency uses the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Scientific Advisory Panel (SAP) for health and safety issues related to pesticides. Therefore, EPA may not ask the SACC to peer review every single draft risk evaluation for the next 20 high priority chemicals. With this prospective change in the scope of SACC activities, EPA anticipates appointing approximately 15 members to the SACC by March 2021.</P>
                <HD SOURCE="HD1">III. Nominations</HD>
                <P>
                    EPA values and welcomes diversity and encourages nominations of women and men of all racial and ethnic groups. Any interested person or organization may nominate qualified persons to be considered for appointment to this advisory committee. Individuals also may self-nominate. Nominations should be submitted in accordance with the instructions under 
                    <E T="02">ADDRESSES</E>
                    .
                </P>
                <P>Nominations should include candidates who have demonstrated high levels of competence, knowledge, and expertise in scientific/technical fields relevant to chemical safety and risk assessment. In particular, the nominees should include representation of the following disciplines, including, but not limited to: Human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically-based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.</P>
                <P>
                    EPA requests that nominations include the following information: Current contact information for the nominee (including the nominee's name, organization, current business address, email address, and daytime telephone number); the disciplinary and specific areas of expertise of the nominee; the nominee's curriculum vitae; and a biographical sketch of the nominee developed using the template available at 
                    <E T="03">https://www.epa.gov/tsca-peer-review/science-advisory-committee-chemicals-basic-information.</E>
                     Persons having questions about the nomination process should contact the DFO listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <P>
                    The names and biographical sketches of all interested and available candidates will be added to an updated List of Candidates that will be posted in the docket at 
                    <E T="03">http://www.regulations.gov</E>
                     and a link to this document will be provided on the SACC website at 
                    <E T="03">http://www.epa.gov/tsca-peer-review.</E>
                     Please note that no interested and available candidates will be excluded from the list based on prescreening using the selection criteria described in the next section. The availability of the list will be announced through the Office of Chemical Safety and Pollution Prevention (OCSPP)'s listservs. You may subscribe to these listservs at the following website: 
                    <E T="03">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.</E>
                     Public comments on the List of Candidates will be accepted for 30 days from the date the updated list is posted. Public comments should be submitted in accordance with the instructions under 
                    <E T="02">ADDRESSES</E>
                    . The public will be requested to provide relevant information or other documentation on nominees that the EPA should consider in evaluating candidates.
                </P>
                <HD SOURCE="HD1">IV. Selection Criteria</HD>
                <P>
                    In addition to scientific expertise, in selecting members, EPA will consider the differing perspectives and the breadth of collective experience needed to address EPA's charge to the SACC, as well as the following:
                    <PRTPAGE P="50022"/>
                </P>
                <P>
                    • Background and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (
                    <E T="03">e.g.,</E>
                     geographical location; social and cultural backgrounds; and professional affiliations);
                </P>
                <P>• Skills and experience working on committees and advisory panels including demonstrated ability to work constructively and effectively in a committee setting;</P>
                <P>• Absence of financial conflicts of interest or the appearance of a loss of impartiality;</P>
                <P>• Willingness to commit adequate time for the thorough review of materials provided to the committee; and</P>
                <P>• Availability to participate in committee meetings.</P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        15 U.S.C. 2625 
                        <E T="03">et seq.;</E>
                         5 U.S.C. Appendix 2 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: August 10, 2020.</DATED>
                    <NAME>Hayley Hughes,</NAME>
                    <TITLE>Director, Office of Science Coordination and Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17903 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[EPA-HQ-OPP-2017-0628, EPA-HQ-OPP-2015-0715, EPA-HQ-OPP-2017-0440, EPA-HQ-OPP-2017-0687, EPA-HQ-OPP-2017-0619, EPA-HQ-OPP-2016-0108, and EPA-HQ-OPP-2016-0630; FRL-10010-29]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Proposed Renewal of Seven Existing Information Collection Requests (ICRs) Undergoing Consolidation; Comment Request</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>In compliance with the Paperwork Reduction Act (PRA), this document announces that EPA is planning to submit renewal requests for seven currently approved Information Collection Requests (ICRs) to the Office of Management and Budget (OMB). The seven renewal ICRs, which are identified in Unit IV. by their corresponding titles, EPA ICR numbers, OMB Control numbers, and related docket identification (ID) numbers, are being consolidated under a separate but parallel effort. To ensure continuity of the approved collection activities, EPA did not make any changes to the currently approved ICRs for the purpose of these renewals. As required by the PRA, before submitting these ICRs to OMB for review and approval, EPA is soliciting comments on specific aspects of the information collection activities that are summarized in this document. The ICRs and accompanying material are available for public review and comment in the relevant dockets identified in this document for each ICR.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Submit your comments, identified by the docket identification (ID) number for the corresponding ICR as identified in Unit IV. of this document, using the following method:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal: http://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
                    </P>
                    <P>
                        Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit 
                        <E T="03">https://www.epa.gov/dockets.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Carolyn Siu, Field and External Affairs Division, 7650P, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (703) 347-0159; email address: 
                        <E T="03">siu.carolyn@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. What information is EPA particularly interested in?</HD>
                <P>Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), EPA specifically solicits comments and information to enable it to:</P>
                <P>1. Evaluate 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.</P>
                <P>2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.</P>
                <P>3. Enhance the quality, utility, and clarity of the information to be collected.</P>
                <P>
                    4. 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 technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.
                </P>
                <HD SOURCE="HD1">II. What should I consider when I prepare my comments for EPA?</HD>
                <P>You may find the following suggestions helpful for preparing your comments:</P>
                <P>1. Explain your views as clearly as possible and provide specific examples.</P>
                <P>2. Describe any assumptions that you used.</P>
                <P>3. Provide copies of any technical information and/or data you used that support your views.</P>
                <P>4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.</P>
                <P>
                    5. Submit your comments by the deadline identified under 
                    <E T="02">DATES</E>
                    .
                </P>
                <P>6. In the subject line on the first page of your response, identify the docket ID number that is assigned to the ICR action. You may also provide the ICR title and related EPA and OMB numbers. For the ICRs that are the subject of this notice, please refer to the information in Unit IV.</P>
                <HD SOURCE="HD1">III. What do I need to know about the PRA?</HD>
                <P>
                    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to PRA approval unless it displays a currently valid OMB control number. The OMB control numbers for the EPA regulations in title 40 of the Code of Federal Regulations (CFR), after appearing in the preamble of the final rule, are further displayed either by publication in the 
                    <E T="04">Federal Register</E>
                     or by other appropriate means, such as on the related collection instruments or form, if applicable. The display of OMB control numbers for certain EPA regulations is consolidated in a list at 40 CFR 9.1.
                </P>
                <P>As used in the PRA context, burden is defined in 5 CFR 1320.3(b).</P>
                <HD SOURCE="HD1">IV. Which ICRs are being renewed?</HD>
                <P>
                    EPA is planning to submit the seven ICR renewal requests to OMB for review and approval under PRA that are identified in this unit, which provides 
                    <PRTPAGE P="50023"/>
                    the ICR titles and corresponding ICR, OMB and docket ID numbers. This unit also provides a brief summary of the information collection activity and the Agency's estimated burden and costs. The Supporting Statement for each ICR, a copy of which is available in the corresponding docket, provides a more detailed explanation of the collection activities and the Agency's estimates.
                </P>
                <P>Please note that EPA intends to request the renewal of the ICRs without any substantive changes to what is currently approved because these seven ICRs are being consolidated in a separate effort. Ensuring the continuity of the existing approvals during the consolidation these ICRs is an administrative action that is intended to focus EPA and the public on the consolidation. EPA will announce and seek comment on the consolidated ICR later this summer.</P>
                <HD SOURCE="HD2">A. Docket ID Number EPA-HQ-OPP-2017-0628</HD>
                <P>
                    <E T="03">Title:</E>
                     Experimental Use Permits (EUPs) for Pesticides.
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 0276.17.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0040.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on February 28, 2021.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The information collection provides EPA with the data necessary to determine whether to issue an experimental use permit (EUP) under section 5 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA requires that before a pesticide product may be distributed or sold in the U.S., it must be registered by EPA. However, FIFRA section 5 authorizes EPA to issue an EUP to allow pesticide companies to temporarily ship pesticide products for experimental use for the purpose of gathering data necessary to support the application for registration of a pesticide product. In general, EUPs are issued either for a pesticide not registered with the Agency or for a new use of a registered pesticide.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to range between 32.8-147 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include Pesticide and other Agricultural Chemical Manufacturing.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     31.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     567 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $37,497. This includes an estimated burden cost of $37,497 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">B. Docket ID Number EPA-HQ-OPP-2015-0715</HD>
                <P>
                    <E T="03">Title:</E>
                     Tolerance Petitions for Pesticides on Food or Feed Crops and New Food Use Inert Ingredients.
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 0597.13.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0024.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on April 30, 2022.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The use of pesticides to increase crop production often results in pesticide residues in or on the crop. To protect public health from unsafe pesticide residues, EPA sets limits on the nature and level of residues permitted pursuant to section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA). A pesticide may not be used on food or feed crops unless the Agency has established a tolerance (maximum residue limit) for the pesticide residues on that crop or established an exemption from the requirement to have a tolerance.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to range between 1,726-1,739 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include individuals or entities engaged in activities related to the registration of a pesticide product and establishments primarily engaged in administrative management and general management consulting services.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     165.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     285,128 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $27,475,223. This includes an estimated burden cost of $27,475,223 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">C. Docket ID Number EPA-HQ-OPP-2017-0440</HD>
                <P>
                    <E T="03">Title:</E>
                     Plant-Incorporated Protectants; CBI Substantiation and Adverse Effects Reporting.
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 1693.10.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0142.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on February 28, 2021.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     EPA is responsible for the regulation of pesticides as authorized by FIFRA. Prior to EPA granting a registration, the manufacturer of the pesticide must demonstrate to the Agency that the use of the pesticide product will not result in any unreasonable adverse effects to humans or the environment. EPA is also responsible under FFDCA for establishing a tolerance or exemption from the requirement of a tolerance for pesticide residues on food or feed.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to average 7.0-21.5 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include pesticides and other agricultural chemical manufacturing, research and development in the physical, engineering, and life sciences, biological products (except diagnostic) manufacturing, colleges, universities, and professional schools, farm supplies wholesalers, flower, nursery stock, and florists' supplies (wholesalers).
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     25.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     518 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $41,892. This includes an estimated burden cost of $41,892 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">D. Docket ID Number EPA-HQ-OPP-2017-0687</HD>
                <P>
                    <E T="03">Title:</E>
                     Submission of Unreasonable Adverse Effects Information under FIFRA Section 6(a)(2).
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 1204.14.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0039.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on February 28, 2021.
                    <PRTPAGE P="50024"/>
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     FIFRA section 6(a)(2) requires pesticide registrants to submit information to the Agency which may be relevant to the balancing of the risks and benefits of a pesticide product. The statute requires the registrant to submit any factual information that it acquires regarding adverse effects associated with its pesticidal products, and it is up to the Agency to determine whether or not that factual information constitutes an unreasonable adverse effect. In order to limit the amount of less meaningful information that might be submitted to the Agency, the EPA has limited the scope of factual information that the registrant must submit. The Agency's regulations at 40 CFR part 159 provide a detailed description of the reporting obligations of registrants under FIFRA section 6(a)(2).
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2.37-3.00 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include those in pesticide and other agricultural chemical manufacturing.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     1,452.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     301,118 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $ 19,999,815. This includes an estimated burden cost of $19,999,815 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">E. Docket ID Number EPA-HQ-OPP-2017-0619</HD>
                <P>
                    <E T="03">Title:</E>
                     Pesticide Program Public Sector Collections (FIFRA Sections 18 &amp; 24(c)).
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 2311.04.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0182.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on February 28, 2021.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This ICR covers the paperwork burden under the PRA that is associated with two types of pesticide registration requests made by States, U.S. Territories, or Federal agencies. Specifically, this ICR covers emergency exemption requests, which allow for an unregistered use of a pesticide, and State registrations of a pesticide use to meet a special local need (SLN). FIFRA section 18 authorizes EPA to grant emergency exemptions to States, U.S. Territories, and Federal agencies to allow an unregistered use of a pesticide for a limited time if EPA determines that emergency conditions exist. FIFRA Section 18 requests include unregistered pesticide use exemptions for specific agricultural, public health, quarantine and crisis purposes. FIFRA Section 24(c) authorizes any particular State to register additional uses of a federally registered pesticide for distribution and use within that state to meet a SLN.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to average 39-99 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include States and Federal government agencies and pesticide, fertilizer, and other agricultural chemical manufacturing.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     283.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     25,753 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $1,829,103. This includes an estimated burden cost of $1,829,103 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">F. Docket ID Number EPA-HQ-OPP-2016-0108</HD>
                <P>
                    <E T="03">Title:</E>
                     Notice of Supplemental Distribution of a Registered Pesticide Product.
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 0278.13.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0044.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on October 31, 2021.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This information collection activity notifies the EPA of supplemental distribution of registered pesticide products. As mandated by FIFRA, as amended, EPA is responsible for the regulation of pesticides. FIFRA section 3(e) (7 U.S.C. 136a(e)) allows pesticide products with the same formulation, label claims, and manufacturer as a registered product to be distributed under the same registration as the basic product. Pesticide registrants may distribute or sell registered pesticides under a different product name in addition to the registered name, or under a different entity's name and address. Such distribution and sale is termed “supplemental distribution” and the product is termed a “distributor product.” EPA requires pesticide registrants who enter into supplemental distribution agreements with other companies to submit EPA Form 8570-5, Notice of Supplemental Distribution of a Registered Pesticide Product. Supplemental registrations are only an extension of a currently federally registered pesticide product.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.32 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include those in pesticide and other agricultural chemical manufacturing.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     1,885.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     603 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $54,463. This includes an estimated burden cost of $54,463 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD2">G. Docket ID Number EPA-HQ-OPP-2016-0630</HD>
                <P>
                    <E T="03">Title:</E>
                     Compliance Requirement for Child-Resistant Packaging.
                </P>
                <P>
                    <E T="03">ICR number:</E>
                     EPA ICR No. 0616.13.
                </P>
                <P>
                    <E T="03">OMB control number:</E>
                     OMB Control No. 2070-0052.
                </P>
                <P>
                    <E T="03">ICR status:</E>
                     The approval for this ICR is scheduled to expire on November 30, 2021.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     This information collection program is designed to provide EPA with assurances that the packaging of pesticide products sold and distributed to the general public in the United States meets standards set forth by the Agency pursuant to FIFRA. Registrants must certify to the Agency that the pesticide packaging or device regulated by this Act meets these standards.
                </P>
                <P>
                    <E T="03">Burden statement:</E>
                     The annual public reporting and recordkeeping burden for this collection of information is estimated to average 3,535 hours per response. The ICR, a copy of which is available in the docket, provides a detailed explanation of this estimate, which is only briefly summarized here:
                    <PRTPAGE P="50025"/>
                </P>
                <P>
                    <E T="03">Respondents/Affected entities:</E>
                     Entities potentially affected by this ICR include pesticide and other agricultural chemical manufacturing, other chemical and allied products merchant wholesalers, exterminating and pest control services.
                </P>
                <P>
                    <E T="03">Estimated total number of potential respondents:</E>
                     31.
                </P>
                <P>
                    <E T="03">Frequency of response:</E>
                     On occasion.
                </P>
                <P>
                    <E T="03">Estimated total annual burden hours:</E>
                     3,535 hours.
                </P>
                <P>
                    <E T="03">Estimated total annual costs:</E>
                     $249,292. This includes an estimated burden cost of $249,292 and an estimated cost of $0 for non-burden hour paperwork costs, 
                    <E T="03">e.g.,</E>
                     investment or maintenance and operational costs.
                </P>
                <P>
                    <E T="03">Changes in the estimates from the last approval:</E>
                     There are no changes in the estimates.
                </P>
                <HD SOURCE="HD1">V. What is the next step in the process for these ICRs?</HD>
                <P>
                    EPA will consider the comments received and amend the individual ICRs as appropriate before submitting the final ICR packages to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
                    <E T="04">Federal Register</E>
                     document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of these ICRs to OMB and the opportunity for the public to submit additional comments for OMB consideration. If you have any questions about any of these ICRs or the approval process in general, please contact the person listed under 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    .
                </P>
                <AUTH>
                    <HD SOURCE="HED">Authority: </HD>
                    <P>
                        44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                    </P>
                </AUTH>
                <SIG>
                    <DATED>Dated: July 31, 2020.</DATED>
                    <NAME>Alexandra Dapolito Dunn,</NAME>
                    <TITLE>Assistant Administrator, Office of Chemical Safety and Pollution Prevention.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17901 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">ENVIRONMENTAL PROTECTION AGENCY</AGENCY>
                <DEPDOC>[FRL-10013-58-OMS]</DEPDOC>
                <SUBJECT>Cross-Media Electronic Reporting: Authorized Program Revision Approval, State of Kansas</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>This notice announces the Environmental Protection Agency's (EPA) approval of the State of Kansas's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>EPA approves the authorized program revisions/modifications as of August 17, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Shirley M. Miller, U.S. Environmental Protection Agency, Office of Information Management, Mail Stop 2824T, 1200 Pennsylvania Avenue NW, Washington, DC 20460, (202) 566-2908, 
                        <E T="03">miller.shirley@epa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the 
                    <E T="04">Federal Register</E>
                     (70 FR 59848) and codified as part 3 of title 40 of the CFR. CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of CROMERR requires that state, tribal or local government agencies that receive, or wish to begin receiving, electronic reports under their EPA-authorized programs must apply to EPA for a revision or modification of those programs and obtain EPA approval. Subpart D provides standards for such approvals based on consideration of the electronic document receiving systems that the state, tribe, or local government will use to implement the electronic reporting. Additionally, § 3.1000(b) through (e) of 40 CFR part 3, subpart D provides special procedures for program revisions and modifications to allow electronic reporting, to be used at the option of the state, tribe or local government in place of procedures available under existing program-specific authorization regulations. An application submitted under the subpart D procedures must show that the state, tribe or local government has sufficient legal authority to implement the electronic reporting components of the programs covered by the application and will use electronic document receiving systems that meet the applicable subpart D requirements.
                </P>
                <P>
                    On December 3, 2019, the Kansas Department of Health and Environment (KDHE) submitted an application titled KEIMS (Kansas Environmental Information Management System) for revisions/modifications to its EPA-approved programs under title 40 CFR to allow new electronic reporting. EPA reviewed KDHE's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Kansas's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 122, 125, 240-249, 260-270, 272-279, 280, and EPCRA Sections 302-304, 311-313 is being published in the 
                    <E T="04">Federal Register</E>
                    :
                </P>
                <FP SOURCE="FP-1">
                    <E T="03">Part 123:</E>
                     EPA-Administered Permit Programs: the National Pollutant Discharge Elimination System (NPDES) Reporting under CFR 122 &amp; 125
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Part 239:</E>
                     Requirements for State Permit Program Determination of Adequacy (RCRA Subtitle C) Reporting under CFR 240-259
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Part 271:</E>
                     Requirements for Authorization of State Hazardous Waste Programs (RCRA Subtitle C) Reporting under CFR 260-270, 272-279
                </FP>
                <FP SOURCE="FP-1">
                    <E T="03">Part 281:</E>
                     Technical Standards and Corrective Action Requirements for Owners and Operators of Underground Storage Tanks (UST) Reporting under CFR 280
                </FP>
                <FP SOURCE="FP-1">Emergency Planning and Community Right-to-Know Act (SARA Title 111/CRTK) Reporting under EPCRA Sections 302-304, 311-313</FP>
                <FP SOURCE="FP-1">KDHE was notified of EPA's determination to approve its application with respect to the authorized programs listed above.</FP>
                <SIG>
                    <DATED>Dated: August 10, 2020.</DATED>
                    <NAME>Jennifer Campbell,</NAME>
                    <TITLE>Acting Director, Office of Information Management. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17818 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6560-50-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">GENERAL SERVICES ADMINISTRATION</AGENCY>
                <DEPDOC>[Notice-MA-2020-10; Docket No. 2020-0002; Sequence No. 27]</DEPDOC>
                <SUBJECT>Maximum Per Diem Reimbursement Rates for the Continental United States</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Government-wide Policy (OGP), General Services Administration (GSA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of GSA Per Diem Bulletin FTR 21-01, Fiscal Year (FY) 2021 CONUS per diem reimbursement rates.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The GSA FY 2021 per diem reimbursement rates review has resulted in lodging and meal allowance changes for certain locations within CONUS to provide for reimbursement of Federal employees' subsistence expenses while on official travel.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Applicability Date:</E>
                         This notice applies to travel performed on or after 
                        <PRTPAGE P="50026"/>
                        October 1, 2020, through September 30, 2021.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For clarification of content, contact Ms. Jill Denning, Program Analyst, Office of Government-wide Policy, Office of Asset and Transportation Management, at 202-208-7642, or by email at 
                        <E T="03">travelpolicy@gsa.gov.</E>
                         Please cite Notice of GSA Per Diem Bulletin FTR 21-01.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    The CONUS per diem reimbursement rates prescribed in Bulletin 21-01 may be found at 
                    <E T="03">https://www.gsa.gov/perdiem.</E>
                     GSA bases the maximum lodging allowance rates on the average daily rate that the lodging industry reports to an independent organization. If a maximum lodging allowance rate and/or a meals and incidental expenses (M&amp;IE) per diem reimbursement rate is insufficient to meet necessary expenses in any given location, Federal executive agencies can request that GSA review that location. Please review questions six and seven of GSA's per diem Frequently Asked Questions page at 
                    <E T="03">https://www.gsa.gov/perdiem</E>
                     for more information on the special review process. In addition, the Federal Travel Regulation (FTR) allows for actual expense reimbursement as provided in §§ 301-11.300 through 301-11.306.
                </P>
                <P>For FY 2021, one new non-standard area (NSA) location was added for Albuquerque, New Mexico (Bernalillo County). The standard CONUS lodging rate will remain unchanged at $96. The M&amp;IE reimbursement rate tiers were also unchanged for FY 2021. The standard CONUS M&amp;IE rate remains at $55, and the M&amp;IE NSA tiers remain at $56-$76.</P>
                <P>
                    Notices published periodically in the 
                    <E T="04">Federal Register</E>
                     now constitute the only notification of revisions in CONUS per diem reimbursement rates to agencies, other than the changes posted on the GSA website.
                </P>
                <SIG>
                    <NAME>Jessica Salmoiraghi,</NAME>
                    <TITLE>Associate Administrator,Office of Government-wide Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17938 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-14-P</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. 9000-0201; Docket No. 2020-0053; Sequence No. 6]</DEPDOC>
                <SUBJECT>Information Collection; Prohibition on Contracting With Entities Using Certain Telecommunications and Video Surveillance Services or Equipment (FAR Case 2019-009)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</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 and request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, and the Office of Management and Budget (OMB) regulations, DoD, GSA, and NASA invite the public to comment on an extension of information collection 9000-0201 concerning representations and reporting associated with implementation of Federal Acquisition Regulation (FAR) rule 2019-009, Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment. OMB authorized information collection 9000-0201 as an emergency collection. DoD, GSA, and NASA propose that OMB extend its approval for use for three additional years beyond the current expiration date.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>DoD, GSA, and NASA will consider all comments received by October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        DoD, GSA, and NASA invite interested persons to submit comments on this collection through 
                        <E T="03">http://www.regulations.gov</E>
                         and follow the instructions on the site. This website provides the ability to type short comments directly into the comment field or attach a file for lengthier comments. If there are difficulties submitting comments, contact the GSA Regulatory Secretariat Division at 202-501-4755 or 
                        <E T="03">GSARegSec@gsa.gov.</E>
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All items submitted must cite Information Collection 9000-0201, Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment (FAR Case 2019-009). Comments received generally will be posted without change to 
                        <E T="03">regulations.gov,</E>
                         including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check 
                        <E T="03">regulations.gov,</E>
                         approximately two-to-three days after submission to verify posting.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        FAR Policy at telephone 202-969-4075, or 
                        <E T="03">farpolicy@gsa.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">A. OMB Control Number, Title, and Any Associated Form(s)</HD>
                <P>9000-0201, Prohibition on Contracting with Entities Using Certain Telecommunications and Video Surveillance Services or Equipment (FAR Case 2019-009).</P>
                <HD SOURCE="HD1">B. Need and Uses</HD>
                <P>This information collection supports implementation of subparagraph (a)(1)(B) of Section 889 of the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year 2019 (Pub. L. 115-232). DoD, GSA, and NASA published an interim rule (FAR Case 2019-009) at 85 FR 42665 on July 14, 2020 to implement section 889(a)(1)(B) of the NDAA. This section prohibits executive agencies from entering into, or extending or renewing, a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, on or after August 13, 2020, unless an exception applies or a waiver has been granted.</P>
                <P>This requirement is implemented in the Federal Acquisition Regulation (FAR) through the provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment and the clause at FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.</P>
                <P>Information collected under the provision at 52.204-24 will be used to identify if an offeror uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system, and their intended use in order to determine whether the prohibition applies.</P>
                <P>
                    Information collected under the clause at FAR 52.204-25 will consist of reports from contractors who have identified, post-award, the use of any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical 
                    <PRTPAGE P="50027"/>
                    technology as part of any system, and requires a disclosure that will be used by agency personnel to identify and consult with legal counsel and the program office on next steps regarding the prohibited equipment or services.
                </P>
                <P>If the Government seeks a waiver from the prohibition, the offeror will be required to provide a full and complete laydown of the presences of covered telecommunications or video surveillance equipment or services in the entity's supply chain, a phase-out plan to eliminate such covered telecommunications equipment or services from the offeror's systems, and any other information necessary for the agency to process the waiver.</P>
                <HD SOURCE="HD1">C. Annual Burden</HD>
                <P>The annual public reporting burden for this collection of information is estimated as follows:</P>
                <P>
                    <E T="03">Agency:</E>
                     DoD, GSA, and NASA.
                </P>
                <P>
                    <E T="03">Type of Information Collection:</E>
                     New Collection.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.
                </P>
                <P>
                    <E T="03">FAR Clause:</E>
                     52.204-24.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private Sector—Business.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     102,792.
                </P>
                <P>
                    <E T="03">Average Responses per Respondents:</E>
                     378.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     38,854,291.
                </P>
                <P>
                    <E T="03">Average Time (for both positive and negative representations) per Response:</E>
                     3 hours.
                </P>
                <P>
                    <E T="03">Total Annual Time Burden:</E>
                     116,562,873.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DoD, GSA, and NASA.
                </P>
                <P>
                    <E T="03">Type of Information Collection:</E>
                     New Collection.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.
                </P>
                <P>
                    <E T="03">FAR Clause:</E>
                     52.204-25.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private Sector—Business.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     5,140.
                </P>
                <P>
                    <E T="03">Average Responses per Respondents:</E>
                     5.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     25,700.
                </P>
                <P>
                    <E T="03">Average Time per Response:</E>
                     3 hours.
                </P>
                <P>
                    <E T="03">Total Annual Time Burden:</E>
                     77,100.
                </P>
                <P>
                    <E T="03">Agency:</E>
                     DoD, GSA, and NASA.
                </P>
                <P>
                    <E T="03">Type of Information Collection:</E>
                     New Collection.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Waiver from Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.
                </P>
                <P>
                    <E T="03">FAR Clause:</E>
                     52.204-25.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private Sector—Business.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Respondents:</E>
                     20,000.
                </P>
                <P>
                    <E T="03">Average Responses per Respondents:</E>
                     1.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Responses:</E>
                     20,000.
                </P>
                <P>
                    <E T="03">Average Time per Response:</E>
                     160 hours.
                </P>
                <P>
                    <E T="03">Total Annual Time Burden:</E>
                     3,200,000.
                </P>
                <P>The public reporting burden for this collection of information consists of a representation to identify whether an offeror uses covered telecommunications equipment or services for each offer as required by 52.204-24 and reports of identified use of covered telecommunications equipment or services as required by 52.204-25. The representation at 52.204-24 is estimated to average 3 hours per response to review the prohibitions, research the source of the product or service, and complete the additional detailed disclosure, if applicable. Reports required by 52.204-25 are estimated to average 3 hours per response, including the time for reviewing definitions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the report.</P>
                <P>If the Government seeks a waiver from the prohibition, the offeror will be required to provide a full and complete laydown of the presences of covered telecommunications or video surveillance equipment or services in the entity's supply chain and a phase-out plan to eliminate such covered telecommunications equipment or services from the offeror's systems. There is no way to estimate the total number of waivers at this time. For the purposes of complying with the PRA analysis, the FAR Council estimates 20,000 waivers; however there is no data for the basis of this estimate. This estimate may be higher or lower once the rule is in effect.</P>
                <HD SOURCE="HD1">D. Public Comments</HD>
                <P>DoD, GSA, and NASA invite comments on: whether the proposed collection of information is necessary for the proper performance of the functions of Federal Government acquisitions, including whether the information will have practical utility; the accuracy of the estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.</P>
                <P>
                    <E T="03">Obtaining Copies:</E>
                     Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing 
                    <E T="03">GSARegSec@gsa.gov.</E>
                     Please cite OMB Control No. 9000-0201, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (FAR Case 2019-009).
                </P>
                <SIG>
                    <NAME>William Clark,</NAME>
                    <TITLE>Director, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17695 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 6820-EP-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                <DEPDOC>[Document Identifier CMS-10751]</DEPDOC>
                <SUBJECT>Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Centers for Medicare &amp; Medicaid Services, HHS</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Centers for Medicare and Medicaid Services (CMS) is requesting that a new information collection request (ICR) associated with the Temporary Policy on 2020 Premium Credits Associated with the COVID-19 Public Health Emergency be processed under the emergency clearance process. Due to agencies inability to update CMS systems for IRS reporting purposes in time for tax season if the normal non-emergency clearance procedures are followed, an emergency clearance is requested. Once the emergency information collection request is approved, CMS plans to seek public comments during the required 60-day and 30-day notice and comment periods associated with obtaining a standard (non-emergency) OMB approval. The use of normal clearance procedures will not allow CMS to update its enrollment data timely and is therefore is reasonably likely to prevent accurate and timely distribution of 1095-A tax forms to affected consumers. Health Insurance Exchanges furnish Form 1095-A to individuals to allow them to reconcile the credit on their returns with advance payments of the premium 
                        <PRTPAGE P="50028"/>
                        tax credit (APTC) and file an accurate tax return.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P> Comments must be received by August 24, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted within 10 days in any one of the following ways:</P>
                    <P>
                        1. 
                        <E T="03">Electronically.</E>
                         You may send your comments electronically to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.
                    </P>
                    <P>
                        2. 
                        <E T="03">By regular mail.</E>
                         You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number __, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.
                    </P>
                    <P>To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:</P>
                    <P>
                        1. Access CMS' website address at 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>William Parham at (410) 786-4669.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    Under the PRA, Federal agencies are required to publish notice in the 
                    <E T="04">Federal Register</E>
                     concerning each proposed ICR. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this ICR including the necessity and utility of the proposed ICR for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
                </P>
                <HD SOURCE="HD1">Contents</HD>
                <P>
                    This notice sets out a summary of the use and burden associated with the following ICR. More detailed information can be found in the collection's supporting statement and associated materials (see 
                    <E T="02">ADDRESSES</E>
                    ).
                </P>
                <HD SOURCE="HD1">CMS-10751 Collection of Premium Credit Data Related to COVID-19 Emergency</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. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public: Submit reports, keep records, or provide information to a third party. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment.</P>
                <HD SOURCE="HD1">Information Collection</HD>
                <P>
                    1. 
                    <E T="03">Type of Information Collection Request:</E>
                     New collection (Request for a new OMB control number); 
                    <E T="03">Title of Information Collection:</E>
                     Collection of Premium Credit Data Related to COVID-19 Emergency; 
                    <E T="03">Use:</E>
                     The reporting requirements and data collection in the implementing regulations for the Exchanges and QHP issuers, 45 CFR parts 155 and 156, address the minimum requirements that Qualified Health Plan (QHP) issuers must meet in order to comply with provisions in the Affordable Care Act with respect to participation in the Federally-facilitated Exchange (FFE) or a State-based Exchange (SBE). CMS currently has authority under CMS-10592/OMB Control Number: 0938-1341 to collect enrollment reconciliation data from QHP issuers. However, in light of the urgent need to help individuals and small employers experiencing economic hardship to maintain continuous coverage through the COVID-19 public health emergency, CMS is adopting a policy of relaxed enforcement with respect to 45 CFR 156.80(d), 45 CFR 156.210(a), and 155.400(e) and (g) to allow QHP issuers, on a temporary basis, to offer premium credits for 2020 coverage. Internal Revenue Service (IRS) regulations require that Exchanges accurately report enrollee premiums to the IRS and to enrollees on the annual 1095-A tax form.
                </P>
                <P>To comply with existing reporting requirements, QHP issuers in states with a FFE or State-based Exchange on the Federal Platform (SBE-FP) that offer these premium credits must notify CMS of the parameters of these credits using the attached template. QHP issuers offering premium credits in a state with an SBE that relies on its own eligibility and enrollment system will follow any requirements established by the SBE for reporting planned temporary premium credits. QHP issuers must submit the attached template to notify CMS of all planned temporary premium credits for FFE or SBE-FP plans no later than October 1, 2020, regardless of the month(s) to which the credit will be applied. To ensure proper allocation of Advance Payments of the Premium Tax Credit (APTC) to the portion of premium that covers essential health benefits, CMS will adjust premium and APTC amounts in its enrollment data. CMS will also report to the IRS the premium and APTC changes in the issuer-submitted template for purposes of reconciliation to premium tax credits. In accordance with the implementing regulations of the PRA at 5 CFR 1320.13, CMS is requesting emergency processing for this ICR because it cannot reasonably comply with normal clearance procedures. Upon OMB approval of this emergency clearance request, CMS will follow the normal clearance procedures.</P>
                <P>
                    <E T="03">Form Number:</E>
                     CMS-10751 (OMB control number: 0938-NEW); Frequency: One-time collection; 
                    <E T="03">Affected Public:</E>
                     Business or other for-profits and Not-for-profit institutions; 
                    <E T="03">Number of Respondents:</E>
                     175; 
                    <E T="03">Total Annual Responses:</E>
                     1; 
                    <E T="03">Total Annual Hours:</E>
                     175. (For policy questions regarding this collection contact Anne Pesto at 410-786-3492.)
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020. </DATED>
                    <NAME>William N. Parham, III,</NAME>
                    <TITLE>Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17855 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4120-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2018-D-0787]</DEPDOC>
                <SUBJECT>Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to the Food and Drug Administration, and Food and Drug Administration Staff; Availability</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and other responsible parties entitled “Civil Money Penalties Relating to the 
                        <E T="03">ClinicalTrials.gov</E>
                         Data Bank; Guidance 
                        <PRTPAGE P="50029"/>
                        for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff.” The guidance provides the current thinking of FDA's medical product Centers—the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health—regarding civil money penalties that may be assessed under the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) for violations of the requirements to submit clinical trial registration and results information to the 
                        <E T="03">ClinicalTrials.gov</E>
                         data bank and certain certifications to FDA.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The announcement of the guidance is published in the 
                        <E T="04">Federal Register</E>
                         on August 17, 2020.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit either electronic or written comments on Agency guidances at any time as follows:</P>
                </ADD>
                <HD SOURCE="HD2">Electronic Submissions</HD>
                <P>Submit electronic comments in the following way:</P>
                <P>
                    • 
                    <E T="03">Federal eRulemaking Portal:</E>
                      
                    <E T="03">https://www.regulations.gov.</E>
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    <E T="03">https://www.regulations.gov</E>
                     will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <P>• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</P>
                <HD SOURCE="HD2">Written/Paper Submissions</HD>
                <P>Submit written/paper submissions as follows:</P>
                <P>
                    • 
                    <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E>
                     Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</P>
                <P>
                    <E T="03">Instructions:</E>
                     All submissions received must include the Docket No. FDA-2018-D-0787 for “Civil Money Penalties Relating to the 
                    <E T="03">ClinicalTrials.gov</E>
                     Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at 
                    <E T="03">https://www.regulations.gov</E>
                     or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
                </P>
                <P>
                    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on 
                    <E T="03">https://www.regulations.gov.</E>
                     Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: 
                    <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E>
                </P>
                <P>
                    <E T="03">Docket:</E>
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    <E T="03">https://www.regulations.gov</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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
                </P>
                <P>You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).</P>
                <P>
                    Submit written requests for single copies of the guidance to the Office of Good Clinical Practice (OGCP), Office of Clinical Policy and Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your requests. See the 
                    <E T="02">SUPPLEMENTARY INFORMATION</E>
                     section for electronic access to the guidance document.
                </P>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Patrick McNeilly, Office of Good Clinical Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-2941.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">I. Background</HD>
                <P>
                    FDA is announcing the availability of a guidance for industry and other responsible parties entitled “Civil Money Penalties Relating to the 
                    <E T="03">ClinicalTrials.gov</E>
                     Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff.” The guidance provides the current thinking of FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health (Center, or collectively Centers), regarding civil money penalties for responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (submitters) who violate applicable FD&amp;C Act (21 U.S.C. 301 
                    <E T="03">et seq.</E>
                    ) prohibitions relating to requirements under section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR part 11, to submit clinical trial registration and results information to the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank and certain certifications to FDA.
                </P>
                <P>
                    The guidance is intended to address several questions. First, the guidance addresses how the Centers may identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank or submitted false or misleading information to the data bank, and whether submitters have failed to submit the certification required by section 402(j)(5)(B) of the PHS Act to FDA or knowingly submitted a false certification to FDA. Second, the guidance addresses the circumstances under which a Center may decide to seek civil money penalties against a responsible party or submitter. Third, 
                    <PRTPAGE P="50030"/>
                    the guidance addresses the procedures that apply when a Center seeks civil money penalties; and fourth, the guidance addresses the civil money penalty amounts that may be assessed for: (1) Failing to submit required clinical trial registration and/or results information to the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank, (2) knowingly submitting false or misleading clinical trial information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA.
                </P>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of September 21, 2018 (83 FR 47926), FDA announced the availability of the draft guidance. FDA received comments on the draft guidance and considered all comments in finalizing this guidance. FDA revised the guidance to clarify that FDA does not intend to include on its Lists of Inspectional Observations, Forms FDA 483, any inspectional observations regarding potential violations relating to the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank; however, information that is collected by an investigator regarding potential violations of such requirements will be included in an Establishment Inspection Report and provided to the relevant Center for further evaluation. The guidance has also been revised to make clear that, in determining whether to seek civil money penalties, FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance. The guidance further explains that FDA intends to post Notices of Noncompliance on its website and to transmit the Notices of Noncompliance to the National Institutes of Health (NIH), so NIH can include the notice regarding noncompliance required under section 402(j)(5)(E) of the PHS Act in the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank. The guidance also provides some limited examples of applicable clinical trials of products that potentially may pose a higher risk to human subjects or applicable clinical trials of products intended to address significant public health need. In addition, editorial changes were made to the guidance to improve clarity. The guidance announced in this notice finalizes the draft guidance dated September 21, 2018.
                </P>
                <P>
                    This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on civil money penalties relating to the 
                    <E T="03">ClinicalTrials.gov</E>
                     data bank. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
                </P>
                <HD SOURCE="HD1">II. Paperwork Reduction Act of 1995</HD>
                <P>This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required.</P>
                <P>However, this guidance refers to previously approved collections of information. This collection of information is subject to review by OMB under the PRA. The collection of information referenced in this guidance is related to information required under section 402(j)(5)(B) of the PHS Act and has been approved under OMB control number 0910-0616.</P>
                <HD SOURCE="HD1">III. Electronic Access</HD>
                <P>
                    Persons with access to the internet may obtain the guidance at either 
                    <E T="03">https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm</E>
                     or 
                    <E T="03">https://www.regulations.gov.</E>
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Lowell J. Schiller,</NAME>
                    <TITLE>Principal Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17909 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <DEPDOC>[Docket No. FDA-2020-N-0257]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit written comments (including recommendations) on the collection of information by September 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0500. Also include the FDA docket number found in brackets in the heading of this document.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
                        <E T="03">PRAStaff@fda.hhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.</P>
                <HD SOURCE="HD1">Food and Drug Administration Rapid Response Surveys</HD>
                <HD SOURCE="HD2">OMB Control Number 0910-0500—Extension</HD>
                <P>Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act) (21 U.S.C. 355) requires that important safety information relating to all human prescription drug products be made available to FDA so that the Agency can take appropriate action to protect the public health when necessary. Section 702 of the FD&amp;C Act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the FD&amp;C Act. Under section 519 of the FD&amp;C Act (21 U.S.C. 360i), FDA is authorized to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions to FDA; to require user facilities to report device-related deaths directly to FDA and to manufacturers; and to report serious injuries to the manufacturer. Section 522 of the FD&amp;C Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct postmarket surveillance of medical devices. Section 705(b) of the FD&amp;C Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate information regarding medical products or cosmetics in situations involving imminent danger to health or gross deception of the consumer. Section 1003(d)(2) of the FD&amp;C Act (21 U.S.C. 393(d)(2)) authorizes the Commissioner of Food and Drugs to implement general powers (including conducting research) to carry out effectively the mission of FDA.</P>
                <P>
                    These sections of the FD&amp;C Act enable FDA to enhance consumer protection from risks associated with medical products usage that are not 
                    <PRTPAGE P="50031"/>
                    foreseen or apparent during the premarket notification and review process. FDA's regulations governing application for Agency approval to market a new drug (21 CFR part 314) and regulations governing biological products (21 CFR part 600) implement these statutory provisions. FDA's regulations governing Agency oversight of Foods, Cosmetics, Dietary Supplements, and Animal Food and Feed (21 CFR parts 70 through 199) also implement these statutory provisions. Currently, FDA monitors medical product related postmarket adverse events via both the mandatory and voluntary MedWatch reporting systems using Forms FDA 3500 and 3500A (OMB control number 0910-0291), electronic Safety Reporting Portal (OMB control number 0910-0645), and the vaccine adverse event reporting system.
                </P>
                <P>FDA is seeking extension of OMB approval to collect vital information via a series of rapid response surveys. Participation in these surveys will be voluntary. This request covers rapid response surveys for community-based healthcare professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other healthcare professionals, patients, consumers, and risk managers working in facilities containing products related to or regulated by FDA. FDA will use the information gathered from these surveys to quickly obtain vital information about medical product risks and interventions to reduce risks so the Agency may take appropriate public health or regulatory action including dissemination of this information as necessary and appropriate.</P>
                <P>FDA projects six emergency risk related surveys per year with a sample of between 50 and 10,000 respondents per survey. FDA also projects a response time of 0.5 hours per response. These estimates are based on the maximum sample size per questionnaire that FDA may be able to obtain by working with healthcare professional organizations. The annual number of surveys was determined by the maximum past number of surveys per year FDA has conducted under this collection.</P>
                <P>Respondents to this collection of information will be identified when additional surveillance data will address a potential public health hazard. For example, respondents could include facilities or professionals that have the most experience in the use of certain FDA-regulated products, foods, cosmetics, dietary supplements, animal food and feed, drugs, tobacco products, etc. Once FDA identifies the need for additional surveillance data to address a potential public health hazard, the appropriate respondents will be identified either through FDA's lists or through the appropriate professional organizations.</P>
                <P>
                    In the 
                    <E T="04">Federal Register</E>
                     of February 5, 2020 (85 FR 6559), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
                </P>
                <P>FDA estimates the burden of this collection of information as follows:</P>
                <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,r50,12">
                    <TTITLE>
                        Table 1—Estimated Annual Reporting Burden 
                        <SU>1</SU>
                    </TTITLE>
                    <BOXHD>
                        <CHED H="1">Activity</CHED>
                        <CHED H="1">Numbers of respondents</CHED>
                        <CHED H="1">Numbers of responses per respondent</CHED>
                        <CHED H="1">Total annual responses</CHED>
                        <CHED H="1">
                            Average burden per
                            <LI>response</LI>
                        </CHED>
                        <CHED H="1">Total hours</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">FDA Rapid Response Survey</ENT>
                        <ENT>10,000</ENT>
                        <ENT>6</ENT>
                        <ENT>60,000</ENT>
                        <ENT>0.5 (30 minutes)</ENT>
                        <ENT>30,000</ENT>
                    </ROW>
                    <TNOTE>
                        <SU>1</SU>
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
                    </TNOTE>
                </GPOTABLE>
                <P>Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.</P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Lowell J. Schiller,</NAME>
                    <TITLE>Principal Associate Commissioner for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17928 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4164-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Health Resources and Services Administration</SUBAGY>
                <SUBJECT>National Vaccine Injury Compensation Program; List of Petitions Received</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        For information about requirements for filing petitions, and the Program in general, contact Lisa L. Reyes, Clerk of Court, United States Court of Federal Claims, 717 Madison Place NW, Washington, DC 20005, (202) 357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857; (301) 443-6593, or visit our website at: 
                        <E T="03">http://www.hrsa.gov/vaccinecompensation/index.html.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 
                    <E T="03">et seq.,</E>
                     provides that those seeking compensation are to file a petition with the United States Court of Federal Claims and to serve a copy of the petition to the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.
                </P>
                <P>
                    A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods 
                    <PRTPAGE P="50032"/>
                    specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.
                </P>
                <P>
                    Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the 
                    <E T="04">Federal Register</E>
                    .” Set forth below is a list of petitions received by HRSA on July 1, 2020, through July 31, 2020. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.
                </P>
                <P>Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:</P>
                <P>1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and</P>
                <P>2. Any allegation in a petition that the petitioner either:</P>
                <P>a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or</P>
                <P>b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.</P>
                <P>
                    In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                    ), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Healthcare Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, Maryland 20857.
                </P>
                <P>The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.</P>
                <SIG>
                    <NAME>Thomas J. Engels,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
                <HD SOURCE="HD1">List of Petitions Filed</HD>
                <FP SOURCE="FP-2">1. Kevin Reilley, Bedford, New Hampshire, Court of Federal Claims No: 20-0798V</FP>
                <FP SOURCE="FP-2">2. Patrick John Coleman, North Bend, Washington, Court of Federal Claims No: 20-0799V</FP>
                <FP SOURCE="FP-2">3. Susan Laracy, Burlington, Massachusetts, Court of Federal Claims No: 20-0800V</FP>
                <FP SOURCE="FP-2">4. Ana Guardiola, Houston, Texas, Court of Federal Claims No: 20-0801V</FP>
                <FP SOURCE="FP-2">5. Joy Holladay on behalf of M.C., Manning, South Carolina, Court of Federal Claims No: 20-0804V</FP>
                <FP SOURCE="FP-2">6. Victor Stock on behalf of Estate of Cynthia Stock, Deceased, Englewood, New Jersey, Court of Federal Claims No: 20-0805V</FP>
                <FP SOURCE="FP-2">7. Ronald Orion, Middletown, New York, Court of Federal Claims No: 20-0806V</FP>
                <FP SOURCE="FP-2">8. Shirley A. Millett, Springboro, Ohio, Court of Federal Claims No: 20-0807V</FP>
                <FP SOURCE="FP-2">9. William C. Herrick, White River Junction, Vermont, Court of Federal Claims No: 20-0809V</FP>
                <FP SOURCE="FP-2">10. Lynn Gustafson, Berkeley, California, Court of Federal Claims No: 20-0810V</FP>
                <FP SOURCE="FP-2">11. Sandra Adkins, Huntington, West Virginia, Court of Federal Claims No: 20-0813V</FP>
                <FP SOURCE="FP-2">12. Erin Lynn Gillaspy, Bridgeton, Missouri, Court of Federal Claims No: 20-0815V</FP>
                <FP SOURCE="FP-2">13. Michelle Han, West Hayward, California, Court of Federal Claims No: 20-0817V</FP>
                <FP SOURCE="FP-2">14. Branislav Grujic, Port Washington, New York, Court of Federal Claims No: 20-0820V</FP>
                <FP SOURCE="FP-2">15. Kimberly Reser, Clayton, Ohio, Court of Federal Claims No: 20-0825V</FP>
                <FP SOURCE="FP-2">16. Cathy Boyd, Pasadena, California, Court of Federal Claims No: 20-0826V</FP>
                <FP SOURCE="FP-2">17. Michael Cervantes, Middletown, Connecticut, Court of Federal Claims No: 20-0827V</FP>
                <FP SOURCE="FP-2">18. Jonathon Bafus, Roseville, California, Court of Federal Claims No: 20-0828V</FP>
                <FP SOURCE="FP-2">19. Noelle Anderson on behalf of C.A., Spring, Texas, Court of Federal Claims No: 20-0830V</FP>
                <FP SOURCE="FP-2">20. Amy M. Kreithen, Pittsburgh, Pennsylvania, Court of Federal Claims No: 20-0833V</FP>
                <FP SOURCE="FP-2">21. Jake Buchma, Unadilla, New York, Court of Federal Claims No: 20-0834V</FP>
                <FP SOURCE="FP-2">22. Corinn Darby on behalf of John R. Darby, Deceased, Portland, Maine, Court of Federal Claims No: 20-0836V</FP>
                <FP SOURCE="FP-2">23. Jennifer Reyes, Freehold Township, New Jersey, Court of Federal Claims No: 20-0839V</FP>
                <FP SOURCE="FP-2">24. Samantha McNair, High Point, North Carolina, Court of Federal Claims No: 20-0840V</FP>
                <FP SOURCE="FP-2">25. Alexei Rodionov, Southampton, Pennsylvania, Court of Federal Claims No: 20-0842V</FP>
                <FP SOURCE="FP-2">26. Janice Dickhardt, Boca Raton, Florida, Court of Federal Claims No: 20-0843V</FP>
                <FP SOURCE="FP-2">27. Kyle Mattox, North Vernon, Indiana, Court of Federal Claims No: 20-0844V</FP>
                <FP SOURCE="FP-2">28. Annette Molina, Holyoke, Massachusetts, Court of Federal Claims No: 20-0845V</FP>
                <FP SOURCE="FP-2">29. Kalee Cambray on behalf of S.C., Milwaukee, Wisconsin, Court of Federal Claims No: 20-0847V</FP>
                <FP SOURCE="FP-2">30. Glenn T. McMahon, Stroudsburg, Pennsylvania, Court of Federal Claims No: 20-0848V</FP>
                <FP SOURCE="FP-2">31. Jan Kelsey, Indianapolis, Indiana, Court of Federal Claims No: 20-0850V</FP>
                <FP SOURCE="FP-2">32. Analicia Guerrero, Edina, Minnesota, Court of Federal Claims No: 20-0851V</FP>
                <FP SOURCE="FP-2">33. Bernadette Moya, Edgewood, New Mexico, Court of Federal Claims No: 20-0854V</FP>
                <FP SOURCE="FP-2">34. Craig Fisher, Phoenix, Arizona, Court of Federal Claims No: 20-0855V</FP>
                <FP SOURCE="FP-2">35. Sally Velez on behalf of N.V., Wrightsville, Pennsylvania, Court of Federal Claims No: 20-0856V</FP>
                <FP SOURCE="FP-2">36. Shirley Vanderford, Frisco, Texas, Court of Federal Claims No: 20-0857V</FP>
                <FP SOURCE="FP-2">37. Clarence Deacon, Newark, Delaware, Court of Federal Claims No: 20-0858V</FP>
                <FP SOURCE="FP-2">38. Amy J. Wolf, Franklin, Wisconsin, Court of Federal Claims No: 20-0861V</FP>
                <FP SOURCE="FP-2">39. Arthur French, East Hampton, New York, Court of Federal Claims No: 20-0862V</FP>
                <FP SOURCE="FP-2">40. Gail Cook, Springfield, Oregon, Court of Federal Claims No: 20-0866V</FP>
                <FP SOURCE="FP-2">41. William Ash, Brooklyn, New York, Court of Federal Claims No: 20-0867V</FP>
                <FP SOURCE="FP-2">42. Shanna Hendrix on behalf of D. H., Phoenix, Arizona, Court of Federal Claims No: 20-0868V</FP>
                <FP SOURCE="FP-2">
                    43. John Birrell-Levine, North Bend, Washington, Court of Federal Claims No: 20-0871V
                    <PRTPAGE P="50033"/>
                </FP>
                <FP SOURCE="FP-2">44. Jeffrey Balch, Chicago, Illinois, Court of Federal Claims No: 20-0872V</FP>
                <FP SOURCE="FP-2">45. Elaine Montana, Boston, Massachusetts, Court of Federal Claims No: 20-0873V</FP>
                <FP SOURCE="FP-2">46. Susan Greenberg-Folkman, Los Ranchos, New Mexico, Court of Federal Claims No: 20-0874V</FP>
                <FP SOURCE="FP-2">47. Wanda Oliver, Boston, Massachusetts, Court of Federal Claims No: 20-0877V</FP>
                <FP SOURCE="FP-2">48. Jerry L. Bailey, Moline, Illinois, Court of Federal Claims No: 20-0878V</FP>
                <FP SOURCE="FP-2">49. Jasmine Dede, Elmont, New York, Court of Federal Claims No: 20-0880V</FP>
                <FP SOURCE="FP-2">50. Domenica Foster, Medford, New Jersey, Court of Federal Claims No: 20-0882V</FP>
                <FP SOURCE="FP-2">51. Eric Simmons, Boston, Massachusetts, Court of Federal Claims No: 20-0884V</FP>
                <FP SOURCE="FP-2">52. Gesdia Kelly, Phoenix, Arizona, Court of Federal Claims No: 20-0885V</FP>
                <FP SOURCE="FP-2">53. Mark Thomas on behalf of Z. T., Loxahatchee, Florida, Court of Federal Claims No: 20-0886V</FP>
                <FP SOURCE="FP-2">54. John Timothy Hamilton, Boston, Massachusetts, Court of Federal Claims No: 20-0887V</FP>
                <FP SOURCE="FP-2">55. Thomas Bierbaum, Edina, Minnesota, Court of Federal Claims No: 20-0888V</FP>
                <FP SOURCE="FP-2">56. Shaun Gladders, New Lenox, Illinois, Court of Federal Claims No: 20-0891V</FP>
                <FP SOURCE="FP-2">57. Kyle Bolick, Omaha, Nebraska, Court of Federal Claims No: 20-0893V</FP>
                <FP SOURCE="FP-2">58. Brandon Robison, Yakima, Washington, Court of Federal Claims No: 20-0896V</FP>
                <FP SOURCE="FP-2">59. Christopher Diane Lewis, Dallas, Texas, Court of Federal Claims No: 20-0898V</FP>
                <FP SOURCE="FP-2">60. Jan Koonce, Boston, Massachusetts, Court of Federal Claims No: 20-0899V</FP>
                <FP SOURCE="FP-2">61. Paula Doze, Boston, Massachusetts, Court of Federal Claims No: 20-0900V</FP>
                <FP SOURCE="FP-2">62. Raymond Balcer, Boston, Massachusetts, Court of Federal Claims No: 20-0901V</FP>
                <FP SOURCE="FP-2">63. James Harkins, Hamilton, Montana, Court of Federal Claims No: 20-0902V</FP>
                <FP SOURCE="FP-2">64. Sapna Patel, Houston, Texas, Court of Federal Claims No: 20-0903V</FP>
                <FP SOURCE="FP-2">65. Russell Ramsey, Oklahoma City, Oklahoma, Court of Federal Claims No: 20-0904V</FP>
                <FP SOURCE="FP-2">66. Allison Romansky, Baltimore, Maryland, Court of Federal Claims No: 20-0907V</FP>
                <FP SOURCE="FP-2">67. Constance Nichols, Watertown, New York, Court of Federal Claims No: 20-0912V</FP>
                <FP SOURCE="FP-2">68. Georgina Ransford, Washington, District of Columbia, Court of Federal Claims No: 20-0914V</FP>
                <FP SOURCE="FP-2">69. Jason Barrow, Washington, District of Columbia, Court of Federal Claims No: 20-0915V</FP>
                <FP SOURCE="FP-2">70. Christopher Dougherty, Washington, District of Columbia, Court of Federal Claims No: 20-0916V</FP>
                <FP SOURCE="FP-2">71. James Kincaid, Washington, District of Columbia, Court of Federal Claims No: 20-0917V</FP>
                <FP SOURCE="FP-2">72. Ashley Nore, Huntsville, Alabama, Court of Federal Claims No: 20-0919V</FP>
                <FP SOURCE="FP-2">73. Tawana T. Morrison, Rochester, New York, Court of Federal Claims No: 20-0921V</FP>
                <FP SOURCE="FP-2">74. Theresa Pistochini, Washington, District of Columbia, Court of Federal Claims No: 20-0922V</FP>
                <FP SOURCE="FP-2">75. Eric Newak, Coer d'Alene, Idaho, Court of Federal Claims No: 20-0923V</FP>
                <FP SOURCE="FP-2">76. Jodi Solem, Washington, District of Columbia, Court of Federal Claims No: 20-0925V</FP>
                <FP SOURCE="FP-2">77. Jodi Solem, Washington, District of Columbia, Court of Federal Claims No: 20-0927V</FP>
                <FP SOURCE="FP-2">78. Ayon Wen-Waldron on behalf of The Estate of Darryl Waldron, Washington, District of Columbia Court of Federal Claims No: 20-0928V</FP>
                <FP SOURCE="FP-2">79. Samantha Ivers, Elk Grove Village, Illinois, Court of Federal Claims No: 20-0929V</FP>
                <FP SOURCE="FP-2">80. Amber Bob on behalf of G. B., Phoenix, Arizona, Court of Federal Claims No: 20-0931V</FP>
                <FP SOURCE="FP-2">81. Ijeoma Chukwudum, Houston, Texas, Court of Federal Claims No: 20-0936V</FP>
                <FP SOURCE="FP-2">82. Carl Carnes, Beverly Hills, California, Court of Federal Claims No: 20-0937V</FP>
                <FP SOURCE="FP-2">83. Mary Ward, Fontana, California, Court of Federal Claims No: 20-0938V</FP>
                <FP SOURCE="FP-2">84. Olivia Renchen, Beverly Hills, California, Court of Federal Claims No: 20-0939V</FP>
                <FP SOURCE="FP-2">85. Darla Conley, Beverly Hills, California,Court of Federal Claims No: 20-0940V</FP>
                <FP SOURCE="FP-2">86. Linda Howard, Dresher, Pennsylvania, Court of Federal Claims No: 20-0941V</FP>
                <FP SOURCE="FP-2">87. Erin Mattheis, Beverly Hills, California, Court of Federal Claims No: 20-0942V</FP>
                <FP SOURCE="FP-2">88. Lillie Johnson, Dresher, Pennsylvania, Court of Federal Claims No: 20-0943V</FP>
                <FP SOURCE="FP-2">89. Theresa Cristoph, Richmond, Virginia, Court of Federal Claims No: 20-0945V</FP>
                <FP SOURCE="FP-2">90. Jessica Mott on behalf of Lola Crawford, New York, New York, Court of Federal Claims No: 20-0947V</FP>
                <FP SOURCE="FP-2">91. Annika Olsen-Santoro, Pasadena, California, Court of Federal Claims No: 20-0948V</FP>
                <FP SOURCE="FP-2">92. Randy Moore, Washington, District of Columbia, Court of Federal Claims No: 20-0949V</FP>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17936 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4165-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>National Institutes of Health</SUBAGY>
                <SUBJECT>Office of the Director, National Institutes of Health Amended; Notice of Meeting</SUBJECT>
                <P>
                    Notice is hereby given of a change in the meeting of the Council of Councils, September 11, 2020, 08:15 a.m. to 04:00 p.m., National Institutes of Health, Natcher Building, Building 45 Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892 which was published in the 
                    <E T="04">Federal Register</E>
                     on December 16, 2019, 84 FR 68467.
                </P>
                <P>
                    The meeting notice is amended to change the open and closed session meeting times as follows: The open session will now be held from 10:15 a.m. to 1:00 p.m. and from 2:15 p.m. to 4:55 p.m. with the closed session held from 1:00 p.m. to 2:00 p.m. This notice is also being amended to change the meeting location from National Institutes of Health, Natcher Building, Building 45 Room D, C1/C2 and G1/G2, 45 Center Drive, Bethesda, MD 20892 to a virtual meeting. The url link to this meeting can be found at: 
                    <E T="03">http://videocast.nih.gov/.</E>
                     Any member of the public may submit written comments no later than 15 days after the meeting.
                </P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Ronald J. Livingston, Jr., </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17907 Filed 8-14-20; 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, notice is hereby given of a meeting of the National Cancer Advisory Board.</P>
                <P>
                    The meeting will be held as a virtual meeting and is open to the public as 
                    <PRTPAGE P="50034"/>
                    indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting should notify the Contact Person listed below in advance of the meeting. The meeting will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
                    <E T="03">http://videocast.nih.gov/</E>
                    ).
                </P>
                <P>A portion of the National Cancer Advisory Board 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 Cancer Advisory Board.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         September 1, 2020.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         1:00 p.m. to 5:45 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         NCAB Subcommittee Meetings—Subcommittee on Planning and Budget; 
                        <E T="03">Ad Hoc</E>
                         Subcommittee on Experimental Therapeutics; 
                        <E T="03">Ad Hoc</E>
                         Subcommittee on Population Science, Epidemiology and Disparities; and 
                        <E T="03">Ad Hoc</E>
                         Subcommittee on Global Cancer Research.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Cancer Institute—Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 (Virtual Meetings).
                    </P>
                    <P>
                        Instructions regarding access to the virtual Subcommittee Meetings will be posted at: 
                        <E T="03">https://deainfo.nci.nih.gov/advisory/ncab/ncabmeetings.htm.</E>
                    </P>
                    <P>
                        <E T="03">Name of Committee:</E>
                         National Cancer Advisory Board.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         September 2, 2020.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         1:00 p.m. to 3:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Director's and Program reports and presentations; business of the Board.
                    </P>
                    <P>
                        <E T="03">Closed:</E>
                         3:30 p.m. to 4:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Cancer Institute—Shady Grove, 9609 Medical Center Drive, Rockville, MD 20850 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Paulette S. Gray, Ph.D., Executive Secretary Division of Extramural Activities, National Cancer Institute—Shady Grove, National Institutes of Health, 9609 Medical Center Drive, 7th Floor, Room 7W444 Bethesda, MD 20892, 240-276-6340, 
                        <E T="03">grayp@mail.nih.gov.</E>
                    </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: NCAB: 
                        <E T="03">https://deainfo.nci.nih.gov/advisory/ncab/ncabmeetings.htm,</E>
                         where an agenda, instructions for accessing the virtual NCAB meetings, and any additional information for the meetings 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: August 12, 2020.</DATED>
                    <NAME>Melanie J. Pantoja,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17906 Filed 8-14-20; 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 Institute on Drug Abuse; Notice of Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Drug Abuse.</P>
                <P>
                    The meeting will be held as a virtual meeting and is open to the public, as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
                    <E T="03">http://videocast.nih.gov/</E>
                    ).
                </P>
                <P>A portion of this 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 Advisory Council on Drug Abuse.
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         September 10, 2020.
                    </P>
                    <P>
                        <E T="03">Closed:</E>
                         11:00 a.m. to 12:15 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Open:</E>
                         12:45 p.m. to 4:30 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         Presentations and other business of the Council.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institutes of Health, National Institute on Drug Abuse, Neurosciences Center Building, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Susan R.B. Weiss, Ph.D., Director, Division of Extramural Research, Office of the Director, National Institute on Drug Abuse, NIH, DHHS, 6001 Executive Boulevard, NSC, Room 5274, MSC 9591, Rockville, MD 20892, 301-443-6487, 
                        <E T="03">sweiss@nida.nih.gov.</E>
                    </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">www.drugabuse.gov/NACDA/NACDAHome.html,</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. 93.277, Drug Abuse Scientist Development Award for Clinicians, Scientist Development Awards, and Research Scientist Awards; 93.278, Drug Abuse National Research Service Awards for Research Training; 93.279, Drug Abuse and Addiction Research Programs, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: August 11, 2020.  </DATED>
                    <NAME>Tyeshia M. Roberson,  </NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17817 Filed 8-14-20; 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 Institute of Allergy and Infectious Diseases; Notice of Closed Meeting</SUBJECT>
                <P>Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, 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 Allergy and Infectious Diseases Special Emphasis Panel; Emergency Awards: Rapid Investigation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19).
                    </P>
                    <P>
                        <E T="03">Date:</E>
                         August 27, 2020.
                        <PRTPAGE P="50035"/>
                    </P>
                    <P>
                        <E T="03">Time:</E>
                         10:00 a.m. to 4:00 p.m.
                    </P>
                    <P>
                        <E T="03">Agenda:</E>
                         To review and evaluate grant applications.
                    </P>
                    <P>
                        <E T="03">Place:</E>
                         National Institute of Allergy and Infectious Diseases, National Institutes of Health 5601 Fishers Lane, Room 3E70 Rockville, MD 20892 (Telephone Conference Call).
                    </P>
                    <P>
                        <E T="03">Contact Person:</E>
                         Mohammed S. Aiyegbo, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health. 5601 Fishers Lane, Room 3E70 Rockville, MD 20852 (301) 761-7106, 
                        <E T="03">mohammed.aiyegbo@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. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS)</FP>
                </EXTRACT>
                <SIG>
                    <DATED>Dated: August 11, 2020. </DATED>
                    <NAME>Tyeshia M. Roberson,</NAME>
                    <TITLE>Program Analyst, Office of Federal Advisory Committee Policy.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17853 Filed 8-14-20; 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>
                <DEPDOC>[Docket ID FEMA-2020-0016]</DEPDOC>
                <SUBJECT>Voluntary Agreement Under Section 708 of the Defense Production Act; Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Emergency Management Agency, Homeland Security (DHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Federal Emergency Management Agency (FEMA) announces the formation of a voluntary agreement under Section 708 of the Defense Production Act for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic. This Notice contains the text of the Voluntary Agreement.</P>
                </SUM>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Harold Lucie, Joint DPA Office, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472-3184, telephone (202) 212-2900, and email 
                        <E T="03">FEMA-DPA@fema.dhs.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    Section 708 of the Defense Production Act (DPA), 50 U.S.C. 4558, allows the President to provide for the formation of voluntary agreements by the private sector to help provide for the national defense. This authority was delegated to the Secretary of Homeland Security generally in section 401 of Executive Order 13603,
                    <SU>1</SU>
                    <FTREF/>
                     “National Defense Resources Preparedness,” and specifically for response to COVID-19 in section 3 of Executive Order 13911,
                    <SU>2</SU>
                    <FTREF/>
                     “Delegating Additional Authority Under the Defense Production Act With Respect to Health and Medical Resources To Respond to the Spread of COVID-19.” The Secretary of Homeland Security has delegated these authorities to the FEMA Administrator in Department of Homeland Security (DHS) Delegation 09052 Rev. 00, “Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency,” (Jan. 3, 2017), and DHS Delegation 09052 Rev. 00.1, “Delegation of Defense Production Act Authority to the Administrator of the Federal Emergency Management Agency” (Apr. 1, 2020), respectively.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         77 FR 16651 (Mar. 22, 2012).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>2</SU>
                         85 FR 18403 (Apr. 1, 2020).
                    </P>
                </FTNT>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    FEMA sought and received approval from the Attorney General, after consultation with the Federal Trade Commission (FTC), to begin consultation with the private sector, as required by Section 708(c)(2). Pursuant to that approval, on May 12, 2020, FEMA posted an announcement of a public meeting and request for comments to develop a Voluntary Agreement in the 
                    <E T="04">Federal Register</E>
                     (85 FR 28031). FEMA held a public meeting on May 21, 2020, and accepted public comments until June 5, 2020.
                    <SU>3</SU>
                    <FTREF/>
                     FEMA received 34 public comments and considered these comments when preparing the Voluntary Agreement.
                    <SU>4</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The original comment period was extended to allow commentators additional time to respond. FEMA posted notices of extension to 
                        <E T="03">www.regulations.gov</E>
                         under the Docket ID for this notice, FEMA-2020-0016.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Available on 
                        <E T="03">www.regulations.gov</E>
                         under Docket ID for this notice.
                    </P>
                </FTNT>
                <P>
                    The Attorney General, in consultation with the Chairman of the Federal Trade Commission, made the required finding that the purpose of the voluntary agreement may not reasonably be achieved through an agreement having less anticompetitive effect or without any voluntary agreement. Pursuant to Sec. 708(f)(1)(B) of the Defense Production Act, the Department of Justice is separately publishing this finding in this issue of the 
                    <E T="04">Federal Register</E>
                     as a notice. The FEMA Administrator, as the Sponsor of the agreement, has certified in writing that the agreement is necessary to help provide for the national defense.
                </P>
                <HD SOURCE="HD1">Text of the Voluntary Agreement, Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic</HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">Preface</FP>
                    <FP SOURCE="FP-2">I. Purpose</FP>
                    <FP SOURCE="FP-2">II. Authorities</FP>
                    <FP SOURCE="FP-2">III. General Provisions</FP>
                    <FP SOURCE="FP1-2">A. Definitions</FP>
                    <FP SOURCE="FP1-2">B. Committee Participation</FP>
                    <FP SOURCE="FP1-2">C. Effective Date and Duration of Participation</FP>
                    <FP SOURCE="FP1-2">D. Withdrawal</FP>
                    <FP SOURCE="FP1-2">E. Plan of Action Activation and Deactivation</FP>
                    <FP SOURCE="FP1-2">F. Rules and Regulations</FP>
                    <FP SOURCE="FP1-2">G. Modification and Amendment</FP>
                    <FP SOURCE="FP1-2">H. Expenses</FP>
                    <FP SOURCE="FP1-2">I. Record Keeping</FP>
                    <FP SOURCE="FP-2">IV. Antitrust Defense</FP>
                    <FP SOURCE="FP-2">V. Terms and Conditions</FP>
                    <FP SOURCE="FP1-2">A. Plan of Action Execution</FP>
                    <FP SOURCE="FP1-2">B. Information Management and Responsibilities</FP>
                    <FP SOURCE="FP1-2">C. Oversight</FP>
                    <FP SOURCE="FP-2">VI. Establishment of the Committee</FP>
                    <FP SOURCE="FP-2">VII. Application and Agreement</FP>
                    <FP SOURCE="FP-2">VIII. Assignment</FP>
                </EXTRACT>
                <HD SOURCE="HD1">Voluntary Agreement, Manufacture and Distribution of Critical Healthcare Resources Necessary To Respond to a Pandemic</HD>
                <HD SOURCE="HD1">Preface</HD>
                <P>
                    Pursuant to section 708 of the Defense Production Act of 1950 (DPA), as amended (50 U.S.C. 4558), the Federal Emergency Management Agency (FEMA) Administrator (Administrator), after consultation with the Secretary of the Department of Health and Human Services (HHS), the Attorney General of the United States (Attorney General), and the Chairman of the Federal Trade Commission (FTC), has developed this Voluntary Agreement (Agreement). This Agreement is intended to maximize the effectiveness of the manufacture and distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between the Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, and allocation and distribution of Critical Healthcare Resources. The activities contemplated by this Agreement are limited to those necessary to respond to a Pandemic, at the sole determination of FEMA. This Agreement affords Participants defenses 
                    <PRTPAGE P="50036"/>
                    to civil and criminal actions brought for violations of antitrust laws when carrying out this Agreement and an appropriate Plan of Action. This Agreement is intended to foster a close working relationship among FEMA, HHS, and the Participants to address national defense needs through cooperative action under the direction and supervision of FEMA. This Agreement, when implemented through a Plan of Action, affords Participants a safe harbor to exchange information, collaborate and adjust commercial operations as to particular products and services, when FEMA determines it necessary for the national defense, and only to the extent necessary for the national defense.
                </P>
                <HD SOURCE="HD1">I. Purpose</HD>
                <P>A pandemic may present conditions that pose a direct threat to the national defense of the United States or its preparedness programs such that, pursuant to DPA section 708(c)(1), an agreement to collectively coordinate, plan and collaborate for the manufacture and distribution of personal protective equipment (PPE), Pharmaceuticals and other Critical Healthcare Resources is necessary for the national defense. This Agreement will maximize the effectiveness of the manufacture and distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between the Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, allocation and distribution of Critical Healthcare Resources. The activities included in this Agreement are limited to those necessary to respond to a Pandemic, at the sole determination, direction, and supervision of FEMA and implemented through Plans of Action.</P>
                <HD SOURCE="HD1">II. Authorities</HD>
                <P>
                    Section 708, Defense Production Act (50 U.S.C. 4558); sections 402(2) &amp; 501(b), Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121-5207); sections 503(b)(2)(B) &amp; 504(a)(10) &amp; (16) of the Homeland Security Act of 2002 (6 U.S.C. 313(b)(2)(B), 314(a)(10) &amp; (16)); sections 201, 301, National Emergencies Act (50 U.S.C. 1601 
                    <E T="03">et seq.</E>
                    ); section 319, Public Health Service Act (42 U.S.C. 247d); Executive Order (E.O.) 13911, 85 FR 18403 (Mar. 27, 2020); Prioritization and Allocation of Certain Scarce or Threatened Health and Medical Resources for Domestic Use, 85 FR 20195 (Apr. 10, 2020). Pursuant to DPA section 708(f)(1)(A), the Administrator certifies that this Agreement is necessary for the national defense.
                </P>
                <HD SOURCE="HD1">III. General Provisions</HD>
                <HD SOURCE="HD2">A. Definitions</HD>
                <HD SOURCE="HD3">Administrator</HD>
                <P>The FEMA Administrator who, as a Presidentially appointed and Senate confirmed official, is the Sponsor of this Agreement. Pursuant to a delegation or redelegation of the functions given to the President by DPA section 708, the Administrator proposes and provides for the development and carrying out of this Agreement. The Administrator is responsible for carrying out all duties and responsibilities required by 50 U.S.C. 4558 and 44 CFR part 332 and for appointing one or more Chairpersons to manage and administer the Committee and any Sub-Committee formed to carry out this Agreement.</P>
                <HD SOURCE="HD3">Agreement</HD>
                <P>The Voluntary Agreement. Participants who have been invited to join and agreed to the terms of this Agreement as described in Section VII below may join the “Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic.”</P>
                <HD SOURCE="HD3">Attendees</HD>
                <P>Subject matter experts, invited by the Chairperson to attend meetings authorized under this Agreement, to provide technical advice or to represent other Government agencies or interested parties. Attendees are not Members of the Committee.</P>
                <HD SOURCE="HD3">Chairperson</HD>
                <P>FEMA senior executive, appointed by the Administrator, to chair the “Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic.” The Chairperson shall be responsible for the overall management and administration of the Committee, this Agreement, and Plans of Action developed under this Agreement while remaining under the supervision of the Administrator; may create one or more Sub-Committees, as approved by the Administrator; shall initiate, or approve in advance, each meeting held to discuss problems, determine policies, recommend actions, and make decisions necessary to carry out this Agreement; and otherwise shall carry out all duties and responsibilities assigned to him. The Administrator may appoint one or more co-Chairpersons to chair the Committee and Sub-Committees, as appropriate.</P>
                <HD SOURCE="HD3">Committee</HD>
                <P>Committee for the Distribution of Healthcare Resources Necessary to Respond to a Pandemic established under this Agreement. Provides Committee Members a forum to maximize the effectiveness of the manufacture and distribution of Critical Healthcare Resources nationwide to respond to a Pandemic through integrated coordination, planning, and identification and development of Plans of Action needed to respond to a pandemic, including making recommendations on the creation of a Plan of Action.</P>
                <HD SOURCE="HD3">Critical Healthcare Resources</HD>
                <P>All categories of health and medical resources for which production and distribution capacity is necessary to respond to a pandemic, including, but not limited to, PPE, Pharmaceuticals, respiratory devices, vaccines, raw materials, supplies, and medical devices.</P>
                <HD SOURCE="HD3">Documents</HD>
                <P>Any information, on paper or in electronic format, including written, recorded, and graphic materials of every kind, in the possession, custody, or control of the Participant.</P>
                <HD SOURCE="HD3">Members</HD>
                <P>Collectively the Chairperson, Representatives, and Participants of the Committee. Jointly responsible for developing all decisions necessary to carry out this Agreement and to develop and execute Plans of Action under this Agreement.</P>
                <HD SOURCE="HD3">Pandemic</HD>
                <P>A Pandemic is defined as an epidemic that has spread to human populations across a large geographic area that is subject to one or more declarations under the National Emergencies Act, the Public Health Service Act, or the Robert T. Stafford Disaster Relief and Emergency Assistance Act, or if the Administrator determines that one or more declarations is likely to occur and the epidemic poses a direct threat to the national defense or its preparedness programs. For example, Coronavirus Disease 2019 (COVID-19).</P>
                <HD SOURCE="HD3">Participant</HD>
                <P>
                    An individual, partnership, corporation, association, or private organization, other than a Federal agency, that has substantive capabilities, resources or expertise to carry out the purpose of this Agreement, that has been specifically invited to participate in this Agreement by the Chairperson, and that has applied and agreed to the 
                    <PRTPAGE P="50037"/>
                    terms of this Agreement in Section VII below. “Participant” includes a corporate or non-corporate entity entering into this Agreement and all subsidiaries and affiliates of that entity in which that entity has 50 percent or more control either by stock ownership, board majority, or otherwise. The Administrator may invite Participants to join this Agreement at any time during its effective period.
                </P>
                <HD SOURCE="HD3">Personal Protective Equipment</HD>
                <P>Objects that provide measures of safety protection for healthcare workers, first responders, critical infrastructure personnel and/or the general public for the response to the Pandemic. These PPE items may include, but are not limited to, face coverings, filtering facepiece respirators, face shields, isolation and surgical gowns, examination and surgical gloves, suits, and foot coverings.</P>
                <HD SOURCE="HD3">Pharmaceuticals</HD>
                <P>All drugs defined under the Food, Drug, and Cosmetic Act, 21 U.S.C. 321(g), including biological products defined under the Public Health Service Act, 42 U.S.C. 262(i).</P>
                <HD SOURCE="HD3">Plan of Action</HD>
                <P>A documented method, pursuant to 50 U.S.C. 4558(b)(2), proposed by FEMA and adopted by invited Participants, to implement this Agreement, through a Sub-Committee focused on a particular Critical Healthcare Resource, or pandemic response workstream or functional area necessary for the national defense.</P>
                <HD SOURCE="HD3">Plan of Action Agreement</HD>
                <P>A separate commitment made by Participants upon invitation and agreement to participate in a Plan of Action. Completing the Plan of Action Agreement confers responsibilities on the Participant consistent with those articulated in the Plan of Action and affords Participants antitrust protections for actions taken consistent with that Plan of Action as described in Section IV below.</P>
                <HD SOURCE="HD3">Point of Care</HD>
                <P>All categories of medical service providers necessary to respond to a pandemic, as determined by the Chairperson after consultation with the Members of the Committee. This may include, but is not limited to, Acute Care, First Responders, Nursing Homes, Private Hospitals, Public Hospitals, Veterans Administration Hospitals, Physician Offices, Dental Offices, Ambulatory Clinics, Pharmacies, Community Health Clinics, Laboratories, and other acute and non-acute care facilities responsible for healthcare.</P>
                <HD SOURCE="HD3">Representatives</HD>
                <P>The representatives the Administrator identifies and invites to the Committee from FEMA, HHS, and other Federal agencies with equities in this Agreement, and empowered to speak on behalf of their agencies' interests. The Attorney General and the Chairman of the FTC, or their delegates, may also attend any meeting as a Representative.</P>
                <HD SOURCE="HD3">Sub-Committee</HD>
                <P>A body formed by the Administrator from select Participants to implement a Plan of Action.</P>
                <HD SOURCE="HD2">B. Committee Participation</HD>
                <P>
                    The Committee established under this Agreement will consist of the (1) Chairperson, (2) Representatives from FEMA, HHS, DOJ, and other Federal agencies with equities in this Agreement, and (3) Participants that have substantive capabilities, resources or expertise to carry out the purpose of this Agreement. Other Attendees—invited by the Chairperson as subject matter experts to provide technical advice or to represent the interests of other Government agencies or interested parties—may also participate in Committee meetings. Collectively, the Chairperson, Representatives and Participants will serve as the Members of the Committee. Public notice will be provided as each Participant joins or withdraws from this Agreement. The list of Participants will be published annually in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD2">C. Effective Date and Duration of Participation</HD>
                <P>This Agreement is effective immediately upon the signature of the Participant or their authorized designees. This Agreement shall remain in effect until terminated in accordance with 44 CFR 332.4, or in any case, it shall be effective no more than five (5) years from the date the requirements of DPA section 708(f)(1) are satisfied as to the initial Voluntary Agreement regarding the manufacture and distribution of critical healthcare resources necessary to respond to a Pandemic, unless otherwise terminated pursuant to DPA section 708(h)(9) and 44 CFR 332.4 or extended as set forth in DPA section 708(f)(2). No action may take place under this Agreement until it is activated, as described in Section III(E.), below.</P>
                <HD SOURCE="HD2">D. Withdrawal</HD>
                <P>Participants may withdraw from this Agreement at any point, subject to the fulfillment of obligations incurred under this Agreement prior to the date this agreement is terminated with regard to such Participant, by giving written notice to the Administrator at least fifteen (15) calendar days prior to the effective date of that Participant's withdrawal. Following receipt of such notice, the Administrator will inform the other Participants of the date of the withdrawal.</P>
                <P>Upon the effective date of the withdrawal, the Participant must cease all activities under this Agreement.</P>
                <HD SOURCE="HD2">E. Plan of Action Activation and Deactivation</HD>
                <P>
                    Upon occurrence of a Pandemic, the Administrator may authorize a Plan of Action and Sub-Committee for one or more specific Pandemic response workstreams, functional areas, or Critical Healthcare Resource national defense needs, 
                    <E T="03">e.g.,</E>
                     a pharmaceuticals plan of action, or a PPE distribution plan of action, or a vaccine plan of action. The Administrator will invite a select group of Participants who are representative of the segment of the industry for which the Plan of Action is intended to participate on the Sub-Committee. The Plan of Action will be activated for each invited Participant when the Participant executes a Plan of Action Agreement. Actions taken by Participants to develop a Plan of Action and actions taken after executing a Plan of Action Agreement to collectively coordinate, plan and collaborate, pursuant to that Plan of Action and as directed and supervised by FEMA, will constitute action taken to develop and carry out this Agreement pursuant to 50 U.S.C. 4558(j).
                </P>
                <P>
                    Sub-Committees will meet only for the purposes specified in this Agreement and as provided for in writing by the Chairperson. They will report directly to the Committee regarding all actions taken by them, and any Plan of Action adopted by a Sub-Committee must be approved first by the Chairperson. A Plan of Action may not become effective unless and until the Attorney General (after consultation with the Chairman of the Federal Trade Commission) finds, in writing, that such purpose(s) of the Plan of Action may not reasonably be achieved through a Plan of Action having less anticompetitive effects or without any Plan of Action and publishes such finding in the 
                    <E T="04">Federal Register</E>
                    . The Chairperson may appoint a Sub-Committee Chairperson to preside over each Sub-Committee as 
                    <PRTPAGE P="50038"/>
                    a delegate of the Chairperson; however, the Chairperson retains responsibility for all Sub-Committees and for administerial and record keeping requirements of any meetings held by such Sub-Committees, including providing public notice as required of any meetings.
                </P>
                <P>When recommended by the Sub-Committee Chairperson, the Administrator will provide notice of a Plan of Action Deactivation. Any actions taken by Participants after the Deactivation date are outside the scope of Plan of Action Agreement and the Section IV antitrust defense is not available.</P>
                <HD SOURCE="HD2">F. Rules and Regulations</HD>
                <P>Participants acknowledge and agree to comply with all provisions of DPA section 708, as amended, and regulations related thereto which are promulgated by FEMA, the Department of Homeland Security, HHS, the Attorney General, and the FTC. FEMA has promulgated standards and procedures pertaining to voluntary agreements in 44 CFR part 332. The Administrator shall inform Participants of new rules and regulations as they are issued.</P>
                <HD SOURCE="HD2">G. Modification and Amendment</HD>
                <P>The Administrator, after consultation with the Attorney General and the Chairman of the FTC, may terminate or modify, in writing, this Agreement or a Plan of Action at any time, and may remove Participants from this Agreement or a Plan of Action at any time. Participants may propose modifications or amendments to this Agreement at any time. The Administrator shall inform Participants of modifications or amendments to this Agreement as they are issued. If a Participant indicates an intent to withdraw from the Agreement due to a modification or amendment of the Agreement, the Participant will not be required to perform actions directed by that modification or amendment.</P>
                <P>The Attorney General, after consultation with the Chairman of the FTC and the Administrator, may terminate or modify, in writing, this Agreement or a Plan of Action at any time, and may remove Participants from this Agreement or a Plan of Action at any time. If the Attorney General decides to use this authority, the Attorney General will notify the Chairperson as soon as possible, who will in turn notify Participants.</P>
                <HD SOURCE="HD2">H. Expenses</HD>
                <P>Participation in this Agreement does not confer funds to Participants, nor does it limit or prohibit any pre-existing source of funds. Unless otherwise specified, all expenses, administrative or otherwise, incurred by Participants associated with participation in this Agreement shall be borne exclusively by the Participants.</P>
                <HD SOURCE="HD2">I. Record Keeping</HD>
                <P>The Chairperson shall have primary responsibility for maintaining records in accordance with 44 CFR part 332, and shall be the official custodian of records related to carrying out this Agreement. Each Participant shall maintain for 5 years all minutes of meetings, transcripts, records, documents, and other data, including any communications with other Participants or with any other member of the Committee, including drafts, related to the carrying out of this Agreement or any Plan of Action or incorporating data or information received in the course of carrying out this Agreement or any Plan of Action. Each Participant agrees to produce to the Administrator, the Attorney General, and the Chairman of the FTC upon request any item that this section requires the Participant to maintain. Any record maintained in accordance with 44 CFR part 332 shall be available for public inspection and copying, unless exempted on the grounds specified in 5 U.S.C. 552(b)(1), (3) or (4) or identified as privileged and confidential information in accordance with DPA section 705(d), and 44 CFR 332.5.</P>
                <HD SOURCE="HD1">IV. Antitrust Defense</HD>
                <P>Under the provisions of DPA subsection 708(j), each Participant in this Agreement shall have available as a defense to any civil or criminal action brought for violation of the antitrust laws (or any similar law of any State) with respect to any action to develop or carry out this Agreement or a Plan of Action, that such action was taken by the Participant in the course of developing or carrying out this Agreement or a Plan of Action, that the Participant complied with the provisions of DPA section 708 and the rules promulgated thereunder, and that the Participant acted in accordance with the terms of this Agreement and any relevant Plan of Action. Except in the case of actions taken to develop this Agreement or a Plan of Action, this defense shall be available only to the extent the Participant asserting the defense demonstrates that the action was specified in, or was within the scope of, this Agreement or a Plan of Action.</P>
                <P>This defense shall not apply to any action occurring after the termination of this Agreement or a Plan of Action. Immediately upon modification of this Agreement or a Plan of Action, no antitrust immunity shall apply to any subsequent action that is beyond the scope of the modified Agreement or Plan of Action. The Participant asserting the defense bears the burden of proof to establish the elements of the defense. The defense shall not be available if the person against whom the defense is asserted shows that the action was taken for the purpose of violating the antitrust laws.</P>
                <HD SOURCE="HD1">V. Terms and Conditions</HD>
                <P>Each Participant agrees to voluntarily collaborate with all Committee Members to recommend Plans of Action and Sub-Committees that will, at the direction of and under the supervision of FEMA, maximize the effectiveness of the manufacture and distribution of Critical Healthcare Resources nationwide to respond to a pandemic by establishing unity of effort between the Participants and the Federal Government for integrated coordination, planning, information sharing with FEMA, and allocation and distribution of Critical Healthcare Resources. These efforts aim to promote efficiency and timeliness to mitigate shortages of Critical Healthcare Resources to respond to a Pandemic and to meet the overall demands of the healthcare and other selected critical infrastructure sectors, along with those demands necessary to continue all-level-of-government mission-essential functions.</P>
                <P>As the sponsoring agency, FEMA will maintain oversight over Committee and Sub-Committee activities and direct and supervise actions taken to carry out this Agreement and subsequent Plans of Action, including by retaining decision-making authority over actions taken pursuant to this Agreement and subsequent Plans of Action to ensure such actions are necessary to address a direct threat to the national defense. The Department of Justice (DOJ) and the Chairman of the FTC will monitor activities of the Committee and Sub-Committees to ensure they execute their responsibilities in a manner consistent with this Agreement having the least anticompetitive effects possible.</P>
                <HD SOURCE="HD2">A. Plan of Action Execution</HD>
                <P>
                    Specific Member obligations and actions to be undertaken will only be provided for in individual Plans of Action, not in the Agreement. Activities taken to develop a Plan of Action or to implement a Plan of Action that has been activated pursuant to section III.E. above will provide Participants the antitrust defense described in section 
                    <PRTPAGE P="50039"/>
                    IV. Each Plan of Action will endeavor to clearly identify the conduct that Participants will undertake in carrying out the Plan of Action and that would be subject to the defense described in Section IV.
                </P>
                <P>Each Plan of Action will describe what information Members will share, as directed by FEMA and under FEMA's supervision. Information will be used to create a common operating picture in furtherance of the Plan of Action's purpose and/or to promote overall situational awareness of Critical Healthcare Resource manufacturing and distribution activities.</P>
                <P>Each Plan of Action, and information gathered pursuant to that plan, will be used to support one or more of the following objectives:</P>
                <P>(1) Facilitate maximum availability of Critical Healthcare Resources to end-users by deconflicting overlapping requirements for the collective Participant customer base;</P>
                <P>(2) Facilitate maximum availability of Critical Healthcare Resources to Members by deconflicting overlapping supply chain demands of Members;</P>
                <P>(3) Facilitate efficient distribution of Critical Healthcare Resources by deconflicting overlapping distribution chain activities of Members;</P>
                <P>(4) Inform where expansion of the manufacture of Critical Healthcare resources is necessary;</P>
                <P>(5) Identify and prioritize Critical Healthcare Resource requirements;</P>
                <P>(6) Validate Critical Healthcare Resource requirements;</P>
                <P>(7) Project future demand for Critical Healthcare Resource requirements.</P>
                <P>(8) Execute a collaborative manufacturing strategy to more efficiently make use of limited resources for key manufacturing lines of effort for Critical Healthcare Resources;</P>
                <P>(9) Collaborate in the voluntary Participant allocation of Critical Healthcare Resources nationwide;</P>
                <P>(10) Cooperate to the fullest extent possible to distribute Critical Healthcare Resources to locations most in need, as identified by FEMA;</P>
                <P>(11) Explore strategies for increased manufacturing of Critical Health Resources in or near the United States;</P>
                <P>(12) Carry out any other activities as determined and directed by FEMA necessary to address the Pandemic's direct threat to the national defense.</P>
                <HD SOURCE="HD2">B. Information Management and Responsibilities</HD>
                <P>FEMA will request only that data and information from Participants that is necessary to meet the objectives of a Plan of Action. Upon signing a Plan of Action Agreement, participants should endeavor to cooperate to the greatest extent possible to share data and information necessary to meet the objectives of the Plan of Action.</P>
                <P>The specific data requested, procedures for sharing that data, and data management and disposition will be tailored for each specific Plan of Action. Where feasible and to the greatest extent possible, FEMA will incorporate the following principles regarding data sharing into each Plan of Action:</P>
                <P>• In general, Participants will not be asked to share competitively sensitive information directly with other Participants. Direct sharing of information among Participants will be requested only when necessary and will be closely supervised by FEMA, including requiring appropriate safeguards regarding participant use and dissemination of other participants' data.</P>
                <P>• If FEMA needs to share information with parties outside the Sub-Committee, FEMA will limit the amount and type of information shared to the greatest extent feasible and permitted by law, while still furthering the objectives of the Plan of Action.</P>
                <P>• Prior to distribution within or outside the Sub-Committee, FEMA will aggregate and anonymize data in such a way that will maximize the effectiveness of the Plan of Action without compromising competitively sensitive information.</P>
                <P>• Pursuant to 5 U.S.C. 552(b)(4) and 44 CFR 332.5, FEMA will withhold from disclosure under the Freedom of Information Act Participant trade secrets and commercial or financial information and will restrict Sub-Committee meeting attendance where necessary to protect trade secrets and commercial or financial information.</P>
                <P>• Any party receiving competitively sensitive information through a Plan of Action shall use such information solely for the purposes outlined in the Plan of Action and take steps, such as imposing firewalls or tracking usage, to ensure such information is not used for any other purpose. Disclosure and use of competitively sensitive information will be limited to the greatest extent possible.</P>
                <P>
                    • At the conclusion of a Participant's involvement in a Plan of Action—due to the deactivation of the Plan of Action or due to the Participant's withdrawal or removal—each Participant will be requested to sequester any and all competitively sensitive information received through participation in the Plan of Action. This sequestration will include the deletion of all competitively sensitive information unless required to be kept pursuant to the Record Keeping requirements as described 
                    <E T="03">supra,</E>
                     Section I, 44 CFR part 332, or any other provision of law.
                </P>
                <HD SOURCE="HD2">C. Oversight</HD>
                <P>The Chairperson is responsible for ensuring the Attorney General, or suitable delegate(s) from DOJ, and the FTC Chairman, or suitable delegate(s) from the FTC, have awareness of activities under this Agreement, including Plan of Action activation, deactivation, and scheduling of meetings. The Attorney General, the FTC Chairman, or their delegates may attend Committee and Sub-Committee meetings and request to be apprised of any activities taken in accordance with activities under this Agreement or a Plan of Action. DOJ or FTC Representatives may request and review any proposed action by the Committee, Sub-Committee or Participants undertaken pursuant to this Agreement or Plan of Action, including the provision of data. If any DOJ or FTC Representative believes any actions proposed or taken are not consistent with relevant antitrust protections provided by the DPA, he or she shall provide warning and guidance to the Committee as soon as the potential issue is identified. If questions arise about the antitrust protections applicable to any particular action, FEMA may request DOJ, in consultation with the FTC, provide an opinion on the legality of the action under relevant DPA antitrust protections.</P>
                <HD SOURCE="HD1">VI. Establishment of the Committee</HD>
                <P>
                    There is established a Committee for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Committee) to provide the Federal Government and the Participants a forum to maximize the effectiveness of the manufacture and distribution of Critical Healthcare Resources nationwide to respond to a Pandemic through integrated coordination, planning, and information sharing with FEMA. A Chairperson designated by the FEMA Administrator will convene and preside over the Committee. The Committee will not be used for widespread or collective exchange of information among members. These activities, if required, shall be done within individual Sub-Committees, and in accordance with an established Plan of Action. The Committee will not be used for contract negotiations or contract discussions between the Participants and the Federal Government; such negotiations or discussions will be in accordance with applicable Federal contracting 
                    <PRTPAGE P="50040"/>
                    policies and procedures. However, this shall not limit any discussion within a Sub-Committee about the operational utilization of existing and potential contracts between the Participants and Representatives when seeking to align their use with overall manufacturing and distribution efforts consistent with this Agreement and a Plan of Action.
                </P>
                <P>The Committee will consist of designated Representatives from FEMA, HHS, other Federal agencies with equities in this Agreement, and each Participant. The Attorney General and Chairman of the FTC, or their delegates, may also join the Committee and attend meetings at their discretion. Attendees may also be invited at the discretion of the Chairperson as subject matter experts, to provide technical advice, or to represent other Government agencies, but will not be considered part of the Committee.</P>
                <P>To the extent necessary to respond to the Pandemic and at the explicit direction of the Chairperson, the Committee Members will provide technical advice to each other as needed, share information collectively, identify and validate places and resources of the greatest need, project future manufacturing and distribution demands, collectively identify and resolve the allocation of scarce resources amongst all necessary public and private sector domestic needs, and as necessary, share vendor, manufacturer and distribution information, and take any other necessary actions to maximize the timely manufacture and distribution of Critical Healthcare Resources as determined necessary by FEMA to respond to the Pandemic. The Chairperson or his or her designee, at the Chairperson's sole discretion, will make decisions on these issues in order to ensure the maximum coordination, efficiency, and effectiveness in the use of Member's resources and will create and execute Plans of Action as needed. All Participants will be invited to open Committee meetings. For selected Committee meetings, attendance may be limited to designated Participants to meet specific operational requirements.</P>
                <P>
                    The Committee Chairperson shall notify the Attorney General, the Chairman of the FTC, Representatives, and Participants of the time, place, and nature of each meeting and of the proposed agenda of each meeting to be held to carry out this Agreement. Additionally, the Chairperson shall provide for publication in the 
                    <E T="04">Federal Register</E>
                     of a notice of the time, place, and nature of each meeting. If a meeting is open, a 
                    <E T="04">Federal Register</E>
                     notice will be published reasonably in advance of the meeting. The Chairman may restrict attendance at meetings only on the grounds outlined by 44 CFR 332.5(c)(1)-(3). If a meeting is closed, a 
                    <E T="04">Federal Register</E>
                     notice will be published within 10 days of the meeting and will include the reasons why the meeting is closed pursuant to 44 CFR 332.3(c)(2).
                </P>
                <P>The Chairperson shall establish the agenda for each meeting, be responsible for adherence to the agenda, and provide for a written summary or other record of each meeting and provide copies of transcripts or other records to FEMA, the Attorney General, the Chairman of the FTC, and all Participants. The Chair shall take necessary actions to protect from public disclosure any data discussed with or obtained from Participants which a Participant has identified as a trade secret or as privileged and confidential in accordance with DPA sections 708(h)(3) and 705(d), or which qualifies for withholding under 44 CFR 332.5.</P>
                <P>The Administrator, in his or her sole discretion and after consultation with the Committee Members, will create Plans of Action and Sub-Committees for specific workstreams or functional areas requiring collective coordination, planning, and collaboration. These Sub-Committees shall be subject to the same rules, regulations and requirements of the Committee and any other rules or requirements deemed necessary by the Chairperson, the Administrator, or the Attorney General, after consultation with the Chairman of the FTC.</P>
                <HD SOURCE="HD1">VII. Application and Agreement</HD>
                <P>
                    The Participant identified below hereby agrees to join in the Federal Emergency Management Agency sponsored Voluntary Agreement entitled Committee for the Manufacture and Distribution of Healthcare Resources Necessary to Respond to a Pandemic (Agreement) and to become a Participant in this Committee. This Agreement will be published in the 
                    <E T="04">Federal Register</E>
                    . This Agreement is authorized under section 708 of the Defense Production Act of 1950, as amended. Regulations governing this Agreement appear at 44 CFR part 332. The applicant, as Participant, agrees to comply with the provisions of section 708 of the Defense Production Act of 1950, as amended, the regulations at 44 CFR part 332, and the terms of this Agreement.
                </P>
                <HD SOURCE="HD1">VIII. Assignment</HD>
                <P>No Participant may assign or transfer this Agreement, in whole or in part, or any protections, rights or obligations hereunder without the prior written consent of the Chairperson. When requested, the Chairperson will respond to written requests for consent within 10 business days of receipt.</P>
                <EXTRACT>
                    <FP SOURCE="FP-DASH"/>
                    <FP>(Company name)</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>(Name of authorized representative)</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>(Signature of authorized representative)</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>(Date)</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>Administrator (Sponsor)</FP>
                    <FP SOURCE="FP-DASH"/>
                    <FP>(Date)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Pete Gaynor,</NAME>
                    <TITLE>Administrator, Federal Emergency Management Agency. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-18005 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9111-19-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF HOMELAND SECURITY</AGENCY>
                <DEPDOC>[Docket No. CISA-2020-0011]</DEPDOC>
                <SUBJECT>Notice of the President's National Infrastructure Advisory Council Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Federal Advisory Committee Act (FACA) meeting; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The President's National Infrastructure Advisory Council (NIAC) will meet remotely via conference call on Thursday, September 17, 2020. This meeting will be open to the public.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P> </P>
                    <P>
                        <E T="03">Meeting Registration:</E>
                         Individual registration to attend the meeting by phone is required and must be received no later than 5:00 p.m. EST on September 14, 2020.
                    </P>
                    <P>
                        <E T="03">Speaker Registration:</E>
                         Individuals may register to speak during the meeting's public comment period. Registration must be received no later than 5:00 p.m. EST on September 14, 2020.
                    </P>
                    <P>
                        <E T="03">Written Comments:</E>
                         To facilitate public participation, CISA invites public comments on the agenda items and any associated briefing materials to be considered by the council at the meeting. Written comments must be received no later than 5:00 p.m. EST on September 7, 2020.
                    </P>
                    <P>
                        <E T="03">NIAC Meeting:</E>
                         The meeting will be held on Thursday, September 17, 2020 from 1:00 p.m.-5:00 p.m. EST. The meeting may close early if the council has completed its business.
                    </P>
                </DATES>
                <ADD>
                    <PRTPAGE P="50041"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will be held remotely via conference call. For access to the conference call bridge, information on services for individuals with disabilities, or to request special assistance to participate, please email 
                        <E T="03">NIAC@cisa.dhs.gov</E>
                         by 5:00 p.m. EST on September 14, 2020.
                    </P>
                    <P>
                        <E T="03">Comments:</E>
                         Written comments may be submitted on the issues to be considered by the NIAC as described in the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section below and any briefing materials for the meeting. Any briefing materials that will be presented at the meeting will be made publicly available 
                        <E T="03">before the meeting</E>
                         at the following website: 
                        <E T="03">https://www.cisa.gov/niac.</E>
                    </P>
                    <P>
                        Comments identified by docket number “
                        <E T="03">CISA-2020-0011”</E>
                         may be submitted by any of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                          
                        <E T="03">www.regulations.gov.</E>
                         Follow the instructions for submitting written comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Email:</E>
                          
                        <E T="03">NIAC@cisa.dhs.gov.</E>
                         Include docket number 
                        <E T="03">CISA-2020-0011</E>
                         in the subject line of the message.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Rachel Liang, Designated Federal Officer, National Infrastructure Advisory Council, Cybersecurity and Infrastructure Security Agency, Department of Homeland Security, 245 Murray Lane, Mail Stop 0612, Arlington, VA 20598-0612.
                    </P>
                    <P>
                        <E T="03">Instructions:</E>
                         All submissions received must include the agency name and docket number for this notice. All written comments received will be posted without alteration at 
                        <E T="03">www.regulations.gov,</E>
                         including any personal information provided. For detailed instructions on sending comments and additional information on participating in the upcoming NIAC meeting, see the “PUBLIC PARTICIPATION” 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 and comments received by the NIAC, go to 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                    <P>
                        A public comment period is scheduled to be held during the meeting from 2:45 p.m.-2:50 p.m. ET. Speakers who wish to participate in the public comment period must register by emailing 
                        <E T="03">NIAC@cisa.dhs.gov.</E>
                         Speakers are requested to limit their comments to three minutes and will speak in order of registration. Please note that the public comment period may end before the time indicated, following the last request for comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        <E T="03">NIAC@cisa.dhs.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The NIAC is established under Section 10 of Executive Order 13231 issued on October 16, 2001. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix (Pub. L. 92-463). The NIAC shall provide the President, through the Secretary of Homeland Security, with advice on the security and resilience of the Nation's critical infrastructure sectors. The NIAC will meet to discuss issues relevant to critical infrastructure security and resilience, as directed by the President.</P>
                <P>The NIAC will meet in an open meeting on September 17, 2020, to discuss the following agenda items.</P>
                <HD SOURCE="HD1">Agenda</HD>
                <FP SOURCE="FP-2">I. Call to Order</FP>
                <FP SOURCE="FP-2">II. Opening Remarks</FP>
                <FP SOURCE="FP-2">III. Workforce and Talent Management Study Update</FP>
                <FP SOURCE="FP-2">IV. COVID-19 Panel Discussion</FP>
                <FP SOURCE="FP-2">V. Critical Infrastructure Command Center Follow-on Analysis Update</FP>
                <FP SOURCE="FP-2">VI. Public Comment</FP>
                <FP SOURCE="FP-2">VII. Closing Remarks</FP>
                <FP SOURCE="FP-2">VIII. Adjournment</FP>
                <HD SOURCE="HD1">Public Participation</HD>
                <HD SOURCE="HD2">Meeting Registration Information</HD>
                <P>
                    Requests to attend via conference call will be accepted and processed in the order in which they are received. Individuals may register to attend the NIAC meeting by phone by sending an email to 
                    <E T="03">NIAC@cisa.dhs.gov.</E>
                </P>
                <HD SOURCE="HD2">Public Comment</HD>
                <P>
                    A public comment period will be held during the meeting from approximately 2:45 p.m.-2:50 p.m. EST. Speakers who wish to comment must register in advance and can do so by emailing 
                    <E T="03">NIAC@cisa.dhs.gov</E>
                     no later than Monday, September 14, 2020, at 5:00 p.m. EST. Speakers are requested to limit their comments to three minutes. Please note that the public comment period may end before the time indicated, following the last call for comments.
                </P>
                <HD SOURCE="HD2">Information on Services for Individuals With Disabilities</HD>
                <P>
                    For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, please contact 
                    <E T="03">NIAC@cisa.dhs.gov by 5:00 p.m. EST on September 14, 2020.</E>
                </P>
                <SIG>
                    <NAME>Rachel Liang,</NAME>
                    <TITLE>Designated Federal Officer, National Infrastructure Advisory Council, Cybersecurity and Infrastructure Security Agency, Department of Homeland Security.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17940 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 9110-9P-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT</AGENCY>
                <DEPDOC>[Docket No. FR-6226-N-01]</DEPDOC>
                <SUBJECT>Waivers, Alternative Requirements and Extensions for Community Development Block Grant Disaster Recovery Grantees</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of the Assistant Secretary for Community Planning and Development, Housing and Urban Development (HUD).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice governs Community Development Block Grant disaster recovery (CDBG-DR) funds awarded under several appropriations. Specifically, this notice provides waivers and establishes alternative requirements and extensions for grants provided pursuant to Public Laws 114-113, 114-223, 114-254, 115-31, 115-56, 115-123, 115-254, and 116-20 in connection with HUD's obligation or use by the recipient of these funds. This notice provides additional flexibility to CDBG-DR grantees as they continue their disaster recovery efforts while also responding to the Coronavirus Disease 2019 (COVID-19) pandemic.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Applicability Date: August 24, 2020.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jessie Handforth Kome, Director, Office of Block Grant Assistance, U.S. Department of Housing and Urban Development, 451 7th Street SW, Room 7282, Washington, DC 20410, telephone number 202-708-3587. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at 800-877- 8339. Facsimile inquiries may be sent to Ms. Kome at 202-708-0033. (Except for the “800” number, these telephone numbers are not toll-free.) Email inquiries may be sent to 
                        <E T="03">disaster_recovery@hud.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">Table of Contents </HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Public Laws 114-113, 114-223, 114-254, 115-31, 115-56, and 115-123 Extensions</FP>
                    <FP SOURCE="FP-2">II. Public Laws 115-254 and 116-20 Extensions</FP>
                    <FP SOURCE="FP-2">III. Citizenship Requirements</FP>
                    <FP SOURCE="FP-2">IV. Environmental Review </FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Public Laws 114-113, 114-223, 114-254, 115-31, 115-56, and 115-123 Extensions</HD>
                <P>
                    The Department has awarded CDBG-DR funds for multiple disasters occurring in 2015, 2016, and 2017 under Public Laws 114-113, 114-223, 114-254, 115-31, 115-56, and 115-123. Those Public Laws authorize the 
                    <PRTPAGE P="50042"/>
                    Secretary to waive or specify alternative requirements for any provision of any statute or regulation that the Secretary administers in connection with HUD's obligation or use by the recipient of these funds (except for requirements related to fair housing, nondiscrimination, labor standards, and the environment). Regulatory waiver authority is also provided by 24 CFR 5.110, 91.600, and 570.5. As required by Public Laws 114-113, 114-223, 114-254, 115-31, 115-56 or 115-123, the waiver and alternative requirement provided herein is based upon a determination by the Secretary that good cause exists and that the waiver and alternative requirement is not inconsistent with the overall purposes of title I of the Housing and Community Development Act of 1974 (HCDA).
                </P>
                <P>
                    HUD has determined that the rapidly emerging needs of states and local governments in responding to the COVID-19 pandemic provides good cause to allow extensions of the CDBG-DR expenditure deadlines established in 
                    <E T="04">Federal Register</E>
                     notices published on June 17, 2016 (paragraph VI.A.24, 81 FR 39687); November 21, 2016 (section II. and paragraph VI.A.24., 81 FR 83254); January 18, 2017 (section II., 82 FR 5591); August 7, 2017 (sections I.E. and III.B., 82 FR 36812); February 9, 2018 (paragraph VI.A.28. and section VII., 83 FR 5844); and August 14, 2018 (section V., 83 FR 40314) (the “Prior Notices”). HUD shall presume the start of the COVID-19 crisis to be January 21, 2020, the date the Centers for Disease Control and Prevention (CDC) confirmed the first case in the United States, unless HUD receives conclusive evidence to the contrary.
                </P>
                <P>These Prior Notices establish an administrative deadline for the timely distribution of funds, requiring each grantee to expend 100 percent of its allocation of CDBG-DR funds on eligible activities within six years. In response to the COVID-19 pandemic, HUD is providing a one-year extension of the previously established expenditure deadline for all grantees that received CDBG-DR funds under Public Laws 114-113, 114-223, 114-254, 115-31, 115-56 or 115-123 for a 2015, 2016, or 2017 disaster. If a grantee determines that an extension is required beyond the one-year extension provided by HUD in this notice, within 90 days of the applicability date of this notice, a grantee must submit a written request to HUD to further extend the expenditure deadline for one additional year (for a maximum total extension of two years).</P>
                <P>Grantees are reminded that the Prior Notices require the grantee to update the projections of expenditures for each grant based on the status of current programs or projects and to reflect any new expenditure deadlines.</P>
                <P>To request the additional one-year extension referenced above, the grantee shall: (a) Indicate how the COVID-19 pandemic has affected the grantee's ability to expend CDBG-DR funds in a timely manner and to meet its original deadline; (b) describe the specific CDBG-DR funded recovery programs, activities, or projects that have slowed as a result of the COVID-19 pandemic and; (c) submit an updated version of its “CDBG-DR Grantee Projections of Expenditures and Outcomes” that provides for the full expenditure of the grant within the expenditure period requested (a maximum total two-year extension is allowed). In its request, the grantee shall also indicate if it previously was identified by HUD as a “slow spender” as of October 2019 or later in the Department's Monthly CDBG-DR Grant Financial Reports for the grant under consideration. If the grantee was identified as a slow spender for the grant under consideration as of October 2019 or later, the grantee must also include an explanation of the causes of its slow expenditures prior to the COVID-19 pandemic and the actions that have been implemented to address those causes. Grantees that have been identified as a slow spender during the above period must also include a description of the concrete steps that it will implement to ensure that its CDBG-DR expenditures will be “on pace” as soon as practicable, and must update its “CDBG-DR Grantee Projections of Expenditures and Outcomes” that was previously submitted to HUD with its action plan. The Department shall establish, as appropriate, a grant condition to require each grantee receiving the additional one-year extension (for a maximum total extension of two years) to comply with expenditure milestones as provided in the revised projections, consistent with the provisions at 2 CFR part 200. The Department may, if warranted, restrict the availability of funds until such time as this or any grant condition is met by individual grantees.</P>
                <P>Grantees are reminded that HUD may, at any time, establish or revise grant conditions based on performance or lack thereof or may pursue remedies based on performance consistent with subpart O of the CDBG regulations (including corrective and remedial actions in 24 CFR 570.910, 570.911, and 570.913) or under subpart I of the CDBG regulations at 24 CFR part 570. Grantees are advised to work with the assigned CPD representative in the development of expenditure extension requests. The Department will periodically publish all revised expenditure deadlines established pursuant to this notice on the HUD website.</P>
                <HD SOURCE="HD1">II. Public Laws 115-254 and 116-20 Extensions</HD>
                <P>
                    The Department has awarded CDBG-DR funds for multiple disasters occurring in 2017, 2018, and 2019 under the Public Laws 115-254 and 116-20. The COVID-19 pandemic, which the President declared as a national emergency on March 13, 2020, disrupted normal government operations that are likely to impede grantees' ability to meet previously established submission deadlines. Therefore, as described below, HUD is exercising its waiver authority to waive and modify submission deadlines published in 
                    <E T="04">Federal Register</E>
                     notices that contain grant requirements for these CDBG-DR funds. Public Laws 115-254 and 116-20 authorize the Secretary to waive or specify alternative requirements for any provision of any statute or regulation that the Secretary administers in connection with HUD's obligation or use by the recipient of these funds (except for requirements related to fair housing, nondiscrimination, labor standards, and the environment).
                </P>
                <P>Waivers and alternative requirements are based upon a determination by the Secretary that good cause exists, and that the waiver or alternative requirement is not inconsistent with the overall purposes of title I of the HCDA. Regulatory waiver authority is also provided by 24 CFR 5.110, 91.600, and 570.5. For the waiver and alternative requirement described herein, the Secretary has determined that good cause exists and that the waiver and alternative requirement is not inconsistent with the overall purposes of title I of the HCDA.</P>
                <P>
                    Section III of the Department's January 27, 2020 
                    <E T="04">Federal Register</E>
                     notice (85 FR 4681) included deadlines for the submission of the initial CDBG-DR action plan, the Financial Management and Grant Compliance certification submission, and the Pre-Award Implementation Plan. The January 27, 2020 notice requires grantees receiving funds for 2018 and 2019 disasters to submit their Pre-Award Implementation Plan and Financial Management and Grant Compliance certification documentation within 60 days of the applicability date of that notice (or together with the submission of the action plan, if earlier) and to submit their initial action plans within 120 days after the applicability date of that 
                    <PRTPAGE P="50043"/>
                    notice. Section III.A. of the same notice required grantees that received an allocation for unmet infrastructure needs for 2017 disasters to submit a substantial amendment to their current action plan no later than 90 days after the applicability date of that notice.
                </P>
                <P>On March 20, 2020, HUD issued a notification to these grantees that extended the above deadlines for an additional 90 days to provide flexibility to CDBG-DR grantees as they also respond to the impacts of the COVID-19 pandemic. On July 24, 2020, HUD amended that notification for only those grantees that received an allocation for unmet infrastructure needs for 2017 disasters, to extend their deadline for submission by an additional 30 days. In order to provide CDBG-DR grantees with additional flexibility in complying with submission deadlines, HUD is amending the January 27, 2020 notice to allow individual grantees to request further extensions, if necessary. Accordingly, HUD is amending section III of the January 27, 2020 notice by replacing the third paragraph of section III in its entirety with the following:</P>
                <P>“To begin expending CDBG-DR funds, the grantee must follow the process outlined in the February 9, 2018 notice (83 FR 5846), unless otherwise amended below:</P>
                <P>• HUD will accept an action plan no later than 210 days after the applicability date of this notice, unless the grantee has requested, and HUD has approved an extension of the submission deadlines below.</P>
                <P>• Within 150 days of the applicability date of this notice (or when the grantee submits its action plan, whichever is earlier), submit documentation for the certification of financial controls and procurement processes and adequate procedures for grant management, as amended in section IV.B.1 of this notice. A grantee that received a certification of its financial controls and procurement processes pursuant to a 2016 or 2017 disaster may request that HUD rely on that certification for purposes of this allocation, provided, however, that grantees shall be required to provide updates to reflect any material changes in the submissions.</P>
                <P>• Within 150 days of the applicability date of this notice (or when the grantee submits its action plan, whichever is earlier), submit documentation for the implementation plan and capacity assessment.</P>
                <P>• Additionally, all funds must be expended within 6 years of the date of obligation as described in section V of this notice.”</P>
                <P>HUD is also amending section III.A. of the January 27, 2020 notice, and will replace that section in its entirety with the following:</P>
                <EXTRACT>
                    <P>Each grantee that received an allocation pursuant to Public Law 115-56 or Public Law 115-123 for 2017 disasters and an additional allocation in this notice for unmet infrastructure needs is required to submit a substantial amendment to its current action plan required by the Prior Notices. The substantial amendment must be submitted no later than 210 days after the applicability date of this notice, unless the grantee has requested, and HUD has approved an extension of its submission deadline. The substantial amendment must include the additional allocation of funds and address the requirements of the Prior Notices, as amended by this notice. Each grantee must follow the applicable substantial amendment process pursuant to section III.B of the August 14, 2018 notice (83 FR 40316). Based on the 2019 Appropriations Act, HUD will condition the availability of these funds for grantees that have entered into alternative procedures under section 428 of the Stafford Act as of the date of enactment of the 2019 Appropriations Act until such grantees have reached a final agreement on all fixed cost estimates within the timeline provided by FEMA.</P>
                </EXTRACT>
                <HD SOURCE="HD1">III. Citizenship Requirements</HD>
                <P>
                    Please note that the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services provides that Immigration Reform and Control Act, 8 U.S.C. 1324a 
                    <E T="03">et seq.</E>
                     prohibits employers from hiring and employing an individual for employment in the U.S. knowing that the individual is not authorized with respect to such employment. This generally applicable law also applies to CDBG grantees and their subrecipients and/or contractors/subcontractors (including relating to employees recruited under Section 3). For more information, please see 
                    <E T="03">https://www.uscis.gov/i-9-central/form-i-9-resources/handbook-for-employers-m-274/10-why-employers-must-verify-employment-authorization-and-identity-of-new-employees</E>
                     and 
                    <E T="03">https://www.uscis.gov/i-9-central/legal-requirements-and-enforcement.</E>
                </P>
                <HD SOURCE="HD1">IV. Environmental Review</HD>
                <P>
                    This Notice provides operating instructions and procedures in connection with activities under 
                    <E T="04">Federal Register</E>
                     documents that have previously been subject to required environmental reviews. Accordingly, under 24 CFR 50.19(c)(4), this Notice is categorically excluded from environmental review under the National Environmental Policy Act (42 U.S.C. 4321, 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>John Gibbs,</NAME>
                    <TITLE>Acting Assistant Secretary for Community Planning and Development.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17886 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4210-67-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <DEPDOC>[Docket No. FWS-R6-ES-2020-0014; FF06E220000-201-FXES11140600000]</DEPDOC>
                <SUBJECT>Habitat Conservation Plan and Draft Environmental Assessment, Keystone XL Pipeline; Incidental Take Permit Application for American Burying Beetle; Tripp County, South Dakota, and Antelope, Boyd, Brown, Cherry, Holt, and Keya Paha Counties, Nebraska</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for public comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We, the Fish and Wildlife Service (Service), announce the availability of documents related to an incidental take permit (ITP) application under the Endangered Species Act of 1973, as amended (ESA). We have received an application from TransCanada Keystone Pipeline, L.P. (Keystone) for a 50-year ITP for take of the federally endangered American burying beetle incidental to otherwise lawful activities associated with its Keystone XL pipeline project in parts of South Dakota and Nebraska. Pursuant to the ESA and the National Environmental Policy Act (NEPA), we announce the availability of Keystone's ITP application, including Keystone's Draft Keystone XL Pipeline American Burying Beetle Habitat Conservation Plan (HCP), and the Service's draft environmental assessment for public review and comment. We provide this notice to seek comments from the public and Federal, Tribal, State, and local governments.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        We will accept comments received or postmarked on or before September 16, 2020. Comments submitted electronically using the Federal eRulemaking Portal (see 
                        <E T="02">ADDRESSES</E>
                        ) must be received by 11:59 p.m. Eastern Standard Time on the closing date. For more information, see 
                        <E T="03">Public Availability of Comments</E>
                        .
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Obtaining documents:</E>
                         You may obtain the documents at 
                        <E T="03">http://www.regulations.gov</E>
                         in Docket Number FWS-R6-ES-2020-0014.
                        <PRTPAGE P="50044"/>
                    </P>
                    <P>
                        <E T="03">Comment submission:</E>
                         You may submit written comments by one of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Internet: http://www.regulations.gov.</E>
                         Search for and submit comments on Docket No. FWS-R6-ES-2020-0014.
                    </P>
                    <P>
                        • 
                        <E T="03">U.S. mail:</E>
                         Public Comments Processing, Attn: Docket No. FWS-R6-ES-2020-0014; U.S. Fish and Wildlife Service Headquarters, MS: PRB/3W, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Drue DeBerry, 303-236-4774 (telephone). Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8339 for TTY assistance.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    We, the Fish and Wildlife Service (Service), announce the availability of documents related to an incidental take permit (ITP) application under the Endangered Species Act of 1973, as amended (ESA 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ). We have received an application from TransCanada Keystone Pipeline, L.P. (Keystone) for a 50-year ITP for take of the federally endangered American burying beetle (
                    <E T="03">Nicrophorus americanus</E>
                    ) incidental to otherwise lawful activities associated with construction, operation, and maintenance of its Keystone XL pipeline project, in Tripp County, South Dakota, and Antelope, Boyd, Brown, Cherry, Holt, Keya Paha Counties, Nebraska. Keystone has proposed a conservation program to minimize and mitigate for the impacts of the incidental take as described in its Draft Keystone XL Pipeline American Burying Beetle Habitat Conservation Plan (HCP). Pursuant to the ESA and the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ), we announce the availability of Keystone's ITP application, including its HCP, and the Service's draft environmental assessment, for public review and comment. We provide this notice to seek comments from the public and Federal, Tribal, State, and local governments.
                </P>
                <HD SOURCE="HD1">Background</HD>
                <P>
                    Section 9 of the ESA (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) and its implementing regulations prohibit the “take” of animal species listed as endangered or threatened. Take is defined under the ESA as to “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect listed animal species, or to attempt to engage in such conduct” (16 U.S.C. 1538). However, under section 10(a) of the ESA, we may issue permits to authorize incidental take of listed species. “Incidental take” is defined by the ESA as take that is incidental to, and not the purpose of, carrying out an otherwise lawful activity.
                </P>
                <HD SOURCE="HD1">Applicant's Proposed Project</HD>
                <P>Keystone is seeking a permit for the incidental take of the federally endangered American burying beetle for a term of 50 years. Incidental take of this species may occur due to construction, operation, and maintenance of the pipeline and associated electric infrastructure. The proposed conservation strategy in the applicant's proposed HCP is designed to avoid, minimize, and mitigate the impacts of the covered activity on the covered species. The biological goals and objectives are to avoid or minimize potential take of American burying beetle and to provide permanent habitat conservation mitigation measures for American burying beetles to offset any unavoidable impacts during construction, operation, and maintenance of the project.</P>
                <P>The HCP provides avoidance and minimization measures, which include measures to minimize impacts prior to construction and restoration of habitat after impacts. The estimated level of American burying beetle take from the project is 551 American burying beetles over the 50-year project duration, which would occur in Tripp County, South Dakota, and Antelope, Boyd, Holt, and Keya Paha Counties, Nebraska. To offset unavoidable impacts to the American burying beetle, Keystone will acquire, protect, and manage a minimum of 1,035 acres of American burying beetle habitat in perpetuity. These mitigation lands are expected to be acquired in Brown and/or Cherry Counties, Nebraska.</P>
                <HD SOURCE="HD1">National Environmental Policy Act</HD>
                <P>The issuance of an ITP triggers the need for compliance with NEPA. We have prepared a draft EA that analyzes the environmental impacts on the human environment resulting from two alternatives: A no-action alternative and the proposed action, and also addresses alternatives that were considered but that were dismissed from further consideration.</P>
                <HD SOURCE="HD1">Next Steps</HD>
                <P>We will evaluate the HCP and comments we receive to determine whether the permit application meets the requirements of section 10(a) of the ESA. We will also evaluate whether issuance of a section 10(a)(1)(B) permit would appreciably reduce the likelihood of survival and recovery of the species in the wild by conducting an intra-Service section 7 consultation. We will use the results of our intra-Service consultation, in combination with the above findings, in our final analysis to determine whether to issue a permit. If the requirements are met, we will issue the permit to the applicant.</P>
                <HD SOURCE="HD1">Public Availability of Comments</HD>
                <P>
                    We will post all public comments and information received electronically or via hardcopy at 
                    <E T="03">http://regulations.gov.</E>
                     All comments received, including names and addresses, will become part of the administrative record and will be available to the public. Before including your address, phone number, electronic mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—will be publicly available. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
                </P>
                <HD SOURCE="HD1">Authority</HD>
                <P>
                    This notice is provided pursuant to section 10(c) of the ESA (16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ) and its implementing regulations (50 CFR 17.22 and 17.32), and the National Environmental Policy Act (42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ) and its implementing regulations (40 CFR 1506.6 and 43 CFR 46.305).
                </P>
                <SIG>
                    <NAME>Nicole Alt,</NAME>
                    <TITLE>Acting Assistant Regional Director, Ecological Services, Mountain-Prairie Region.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17887 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Fish and Wildlife Service</SUBAGY>
                <DEPDOC>[Docket No. FWS-R4-ES-2020-0090; FXES11140400000-178-FF04EF2000]</DEPDOC>
                <SUBJECT>Receipt of Incidental Take Permit Application and Proposed Habitat Conservation Plan for the Sand Skink and Blue-Tailed Mole Skink, Polk County, FL; Categorical Exclusion</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Fish and Wildlife Service, Interior.</P>
                </AGY>
                <ACT>
                    <PRTPAGE P="50045"/>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of availability; request for comments and information.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>We, the Fish and Wildlife Service (Service), announce receipt of an application from Tampa Electric Company (applicant) for an incidental take permit (ITP) under the Endangered Species Act. The applicant requests the ITP to take the federally listed sand skink and blue-tailed mole skink incidental to the construction of an electrical power substation in Polk County, Florida. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and the Service's preliminary determination that this HCP qualifies as “low-effect,” categorically excluded, under the National Environmental Policy Act. To make this determination, we used our environmental action statement and low-effect screening form, both of which are also available for public review.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>We must receive your written comments on or before September 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P/>
                    <P>
                        <E T="03">Obtaining Documents:</E>
                         You may obtain copies of the documents online in Docket No. FWS-R4-ES-2020-0090 at 
                        <E T="03">http://www.regulations.gov.</E>
                    </P>
                    <P>
                        <E T="03">Submitting Comments:</E>
                         If you wish to submit comments on any of the documents, you may do so in writing by any of the following methods:
                    </P>
                    <P>
                        • 
                        <E T="03">Online: http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments on Docket No. FWS-R4-ES-2020-0090.
                    </P>
                    <P>
                        • 
                        <E T="03">U.S. mail:</E>
                         Public Comments Processing, Attn: Docket No. FWS-R4-ES-2020-0090; U.S. Fish and Wildlife Service, MS: PRB/3W, 5275 Leesburg Pike, Falls Church, VA 22041-3803.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Lindsay Nester, by telephone at 772-469-4226 or via email at 
                        <E T="03">lindsay_nester@fws.gov.</E>
                         Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8339 for TTY assistance.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>
                    We, the Fish and Wildlife Service, announce receipt of an application from Tampa Electric Company (applicant) for an incidental take permit (ITP) under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 
                    <E T="03">et seq.</E>
                    ). The applicant requests the ITP to take the federally listed sand skink (
                    <E T="03">Neoseps reynoldsi</E>
                    ) and blue-tailed mole skink (
                    <E T="03">Eumeces egregious lividus</E>
                    ) (skinks) incidental to the construction of an electrical power substation in Polk County, Florida. We request public comment on the application, which includes the applicant's proposed habitat conservation plan (HCP), and on the Service's preliminary determination that this HCP qualifies as “low-effect,” categorically excluded, under the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 
                    <E T="03">et seq.</E>
                    ). To make this determination, we used our environmental action statement and low-effect screening form, which are also available for public review.
                </P>
                <HD SOURCE="HD1">Project</HD>
                <P>Tampa Electric Company requests a 10-year ITP to take skinks through the conversion of approximately 0.233 acres of occupied skink foraging and sheltering habitat incidental to the construction of an electrical power substation located on a 3.13-acre parcel in Section 17, Township 27 South, Range 25 East in Polk County, Florida. The applicant proposes to mitigate for take of the skinks by purchasing credits equivalent to 0.47 acres of skink-occupied habitat from a Service-approved conservation bank in Polk County. The Service would require the applicant to purchase the credits prior to engaging in any phase of the project.</P>
                <HD SOURCE="HD1">Public Availability of Comments</HD>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, be aware that your entire comment, including your personal identifying information, may be made available to the public. While you may request that we withhold your personal identifying information, we cannot guarantee that we will be able to do so.</P>
                <HD SOURCE="HD1">Our Preliminary Determination</HD>
                <P>The Service has made a preliminary determination that the applicant's project, including land clearing, construction of an electrical substation, and the proposed mitigation measure, would individually and cumulatively have a minor or negligible effect on the skinks and the environment. Therefore, we have preliminarily concluded that the ITP for this project would qualify for categorical exclusion, and the HCP would be low effect under our NEPA regulations at 43 CFR 46.205 and 46.210. A low-effect HCP is one that would result in (1) minor or negligible effects on federally listed, proposed, and candidate species and their habitats; (2) minor or negligible effects on other environmental values or resources; and (3) impacts that, when considered together with the impacts of other past, present, and reasonable foreseeable similarly situated projects, would not result in significant cumulative effects to environmental values or resources over time.</P>
                <HD SOURCE="HD1">Next Steps</HD>
                <P>The Service will evaluate the application and the comments to determine whether to issue the requested permit. We will also conduct an intra-Service consultation pursuant to section 7 of the ESA to evaluate the effects of the proposed take. After considering the preceding matters, we will determine whether the permit issuance criteria of section 10(a)(1)(B) of the ESA have been met. If met, the Service will issue ITP number TE77447D-0 to Tampa Electric Company.</P>
                <HD SOURCE="HD1">Authority</HD>
                <P>The Service provides this notice under section 10(c) (16 U.S.C. 1539(c)) of the ESA and NEPA regulation 40 CFR 1506.6.</P>
                <SIG>
                    <NAME>Roxanna Hinzman,</NAME>
                    <TITLE>Field Supervisor, South Florida Ecological Services Office.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17885 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4333-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[20X.LLWO220000.L10200000.PK0000; OMB Control Number 1004-0041]</DEPDOC>
                <SUBJECT>Agency Information Collection Activities; Authorizing Grazing Use</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of information collection; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM) are proposing to renew an information collection.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Interested persons are invited to submit comments on or before October 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Send your comments on this information collection request (ICR) by mail to Chandra Little. U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW, Room 2134LM, Washington, DC 20240; or by email to 
                        <E T="03">cclittle@blm.gov.</E>
                         Please reference Office of Management and Budget (OMB) Control Number 1004-0041 in the subject line of your comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        To request additional information about this ICR, contact Brian Thrift by email at 
                        <E T="03">bthrift@blm.gov,</E>
                         or by telephone at 
                        <PRTPAGE P="50046"/>
                        208-373-3869. Individuals who are hearing or speech impaired may call the Federal Relay Service at 1-800-877-8339 for TTY assistance.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>In accordance with the PRA and its implementing regulations at 5 CFR 1320.8(d)(1), all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.</P>
                <P>As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.</P>
                <P>We are especially interested in public comment addressing the following:</P>
                <P>(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;</P>
                <P>(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;</P>
                <P>(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and</P>
                <P>
                    (4) How might the agency 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 technological collection techniques or other forms of information technology, 
                    <E T="03">e.g.,</E>
                     permitting electronic submission of response.
                </P>
                <P>Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.</P>
                <P>
                    <E T="03">Abstract:</E>
                     The BLM is required by the Taylor Grazing Act (43 U.S.C. 315-315r) and Subchapter IV of the Federal Land Policy and Management Act (43 U.S.C. 1751-1753) to manage domestic livestock grazing on public lands consistent with land use plans, principles of multiple use and sustained yield, and other relevant factors. Compliance with these statutory provisions necessitates collection of information on matters such as permittee and lessee qualifications for a grazing permit or lease, base property used in conjunction with public lands, and the actual use of public lands for domestic livestock grazing. Most permits and leases are in effect for 10 years and are renewable if the BLM determines that the terms and conditions of the expiring permit or lease are being met.
                </P>
                <P>
                    <E T="03">Title of Collection:</E>
                     Authorizing Grazing Use (43 CFR subparts 4110 and 4130).
                </P>
                <P>
                    <E T="03">OMB Control Number:</E>
                     1004-0041.
                </P>
                <P>
                    <E T="03">Form Number:</E>
                     4130-1, 4130-1a, 4130-1b, 4130-3a, 4130-4, and 4130-5.
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Respondents/Affected Public:</E>
                     Any U.S. citizen or validly licensed business may apply for a BLM grazing permit or lease. The BLM administers nearly 18,000 permits and leases for grazing domestic livestock, at least part of the year on public lands.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Respondents:</E>
                     18,010.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Responses:</E>
                     33,810.
                </P>
                <P>
                    <E T="03">Estimated Completion Time per Response:</E>
                     Varies from 10 to 35 minutes, depending on activity.
                </P>
                <P>
                    <E T="03">Total Estimated Number of Annual Burden Hours:</E>
                     7,811.
                </P>
                <P>
                    <E T="03">Respondent's Obligation:</E>
                     Required to obtain or retain a benefit.
                </P>
                <P>
                    <E T="03">Frequency of Collection:</E>
                     The BLM collects the information on Forms 4130-1, 4130-1a, 4130-1b, and 4130-4 on occasion. The BLM collects the information on Forms 4130-3a and 4130-5 annually.
                </P>
                <P>
                    <E T="03">Total Estimated Annual Nonhour Burden Cost:</E>
                     $30,000.
                </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.</P>
                <P>
                    The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
                    <E T="03">et seq.</E>
                    ).
                </P>
                <SIG>
                    <NAME>Chandra Little,</NAME>
                    <TITLE>Regulatory Analyst.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17808 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-84-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF THE INTERIOR</AGENCY>
                <SUBAGY>Bureau of Land Management</SUBAGY>
                <DEPDOC>[LLWO260000.L10600000.PC0000.LXSIADVSBD00.20X]</DEPDOC>
                <SUBJECT>Virtual Wild Horse and Burro Advisory Board Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Bureau of Land Management, Interior.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Wild Horse and Burro Advisory Board (Advisory Board) will hold a virtual public meeting due to public health restrictions.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The Advisory Board will hold a virtual public meeting on Wednesday and Thursday September 23-24, 2020, from 8:00 a.m. to 4:00 p.m. Mountain Time (MT).</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>The virtual meeting will be held via the Zoom Webinar Platform.</P>
                    <P>
                        Written comments pertaining to the meeting and written statements that will be presented to the Advisory Board may be filed in advance of the meeting through the Advisory Board email address at 
                        <E T="03">www.whbadvisoryboard@blm.gov.</E>
                         Please include “Advisory Board Comment” in the subject line of the email.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Dorothea Boothe, Acting Wild Horse and Burro Program Coordinator: telephone: (602) 906-5543, email: 
                        <E T="03">dboothe@blm.gov.</E>
                         Individuals that use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at (800) 877-8339 to contact Ms. Boothe during normal business hours. The FRS is available 24 hours a day, 7 days a week. All responses will be during normal business hours.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>The Advisory Board advises the Secretary of the Interior, the BLM Director, the Secretary of Agriculture, and the Chief of the U.S. Forest Service on matters pertaining to the management and protection of wild, free-roaming horses and burros on the nation's public lands. The Advisory Board operates under the authority of 43 CFR 1784.</P>
                <HD SOURCE="HD1">Advisory Board Public Meeting Agenda</HD>
                <HD SOURCE="HD2">Wednesday, September 23 (8:00 a.m.-4:00 p.m.)</HD>
                <FP SOURCE="FP-1">
                    Advisory Board Administrative Items (8:00 a.m.-10:00 a.m.)
                    <PRTPAGE P="50047"/>
                </FP>
                <FP SOURCE="FP-1">Advisory Board Discussion on the Wild Horse and Burro Report to Congress (10:15 a.m.-12:15 p.m.)</FP>
                <FP SOURCE="FP-1">Public Comment Period (12:45 p.m.-2:45 p.m.)</FP>
                <FP SOURCE="FP-1">Advisory Board Discussion on Fertility Control (3:00 p.m.-4:00 p.m.)</FP>
                <HD SOURCE="HD2">Thursday, September 24 (8:00 a.m.-4:00 p.m.)</HD>
                <FP SOURCE="FP-1">Advisory Board Discussion on Range Conditions and Improvements (8:00 a.m.-10:00 a.m.)</FP>
                <FP SOURCE="FP-1">Public Comment Period (10:30 a.m.-11:30 a.m.)</FP>
                <FP SOURCE="FP-1">Advisory Board Discussion on Burro Management and Draft Recommendations (11:30 a.m.-1:00 p.m.)</FP>
                <FP SOURCE="FP-1">Public Comment Period (1:30 p.m.-2:30 p.m.)</FP>
                <FP SOURCE="FP-1">Advisory Board Discussion and Finalize Recommendations (Board Vote) (2:30 p.m.-4:00 p.m.)</FP>
                <P>Agenda may be subject to change.</P>
                <P>
                    Advisory Board meetings are open to the public in their entirety and will be live streamed at 
                    <E T="03">www.blm.gov/live</E>
                     and through the Zoom Webinar Platform.
                </P>
                <P>
                    The BLM will post the final agenda 2 weeks prior to the meeting online at 
                    <E T="03">www.blm.gov/programs/wild-horse-and-burro/get-involved/advisory-board.</E>
                     The public will have an opportunity to provide verbal comments to the Board during the designated times.
                </P>
                <P>
                    Beyond live captioning, any person(s) with special needs, such as an auxiliary aid, interpreting service, assistive listening device, or materials in an alternate format, must notify Ms. Boothe 2 weeks before the scheduled meeting date. It is important to adhere to the 2-week notice to allow enough time to arrange for the auxiliary aid or special service. Live captioning will be available throughout the event on both the Zoom Webinar Platform and the livestream page at 
                    <E T="03">www.blm.gov/live.</E>
                </P>
                <HD SOURCE="HD1">Public Comment Procedures</HD>
                <P>
                    The BLM welcomes comments from all interested parties. Members of the public will have three opportunities to make statements (audio only) to the Board regarding the Wild Horse and Burro Program on both Wednesday, September 23, from 12:45 p.m. to 2:45 p.m. MT, and on Thursday, September 24, from 10:30 a.m. to 11:30 a.m. MT and from 1:30 p.m. to 2:30 p.m. MT. In order to accommodate all individuals interested in providing comments, please register with BLM 3 days in advance of the meetings. Individuals that have not registered in advance but would like to offer extemporaneous comments will be permitted if time allows. Information on how to register, login, and participate in the virtual meeting will be announced at least 15 days in advance of the meeting on the BLM website at https: 
                    <E T="03">www.blm.gov.</E>
                     Participants using desktops, laptops, smartphones, and other personal digital devices will be able to participate via audio only. Those with phone only access will also be able to participate via a provided phone number and meeting ID. The Advisory Board may limit the length of comments, depending on the number of participants who register in advance. Written comments emailed 3 days prior to the meeting will be provided to the Advisory Board for consideration during the meeting. Please see the 
                    <E T="02">ADDRESSES</E>
                     section earlier for the BLM email address and include “Advisory Board Comment” in the subject line of your email. The BLM will record the entire meeting, including the allotted comment time. Comments should be specific and explain the reason for the recommendation(s). Comments supported by quantitative information, studies, or those that include citations and analysis of applicable laws and regulations are most beneficial and more useful, and likely to assist the decision-making process for the management and protection of wild horses and burros.
                </P>
                <P>Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, the BLM cannot guarantee that it will be able to do so.</P>
                <EXTRACT>
                    <FP>(Authority: 43 CFR 1784.4-2)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Brian St. George,</NAME>
                    <TITLE>Deputy Assistant Director, Resources and Planning.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17926 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4310-84-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 337-TA-1213]</DEPDOC>
                <SUBJECT>Certain Light-Emitting Diode Products, Fixtures, and Components Thereof Institution of Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on July 15, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of IDEAL INDUSTRIES LIGHTING LLC d/b/a Cree Lighting of Durham, North Carolina. A supplement to the complaint was filed on July 20, 2020. The complaint, as supplemented, alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain light-emitting diode products, fixtures, and components thereof by reason of infringement of certain claims of U.S. Patent No. 8,403,531 (“the '531 patent”); U.S. Patent No. 8,596,819 (“the '819 patent”); U.S. Patent No. 8,777,449 (“the '449 patent”); U.S. Patent No. 9,261,270 (“the '270 patent”); and U.S. Patent No. 9,476,570 (“the '570 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and a cease and desist order.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         For help accessing EDIS, please email 
                        <E T="03">EDIS3Help@usitc.gov.</E>
                         Hearing impaired individuals are advised that information on this matter can be obtained 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 at 
                        <E T="03">https://www.usitc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Katherine Hiner, Office of Docket Services, U.S. International Trade Commission, telephone (202) 205-1802.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority:</E>
                     The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2020).
                </P>
                <P>
                    <E T="03">Scope of Investigation:</E>
                     Having considered the complaint, the U.S. International Trade Commission, on August 11, 2020, 
                    <E T="03">ordered that</E>
                    —
                </P>
                <P>
                    (1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a 
                    <PRTPAGE P="50048"/>
                    violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1, 10, 12, 17, 21, and 24-26 of the '531 patent; claims 1, 24-27, 29, 48-50, 52, 57-60, and 65-67 of the '819 patent; claims 1-14 of the '449 patent; claims 1-12 of the '270 patent; and claims 1-24 of the '570 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
                </P>
                <P>(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “LED fixtures for indoor or outdoor applications, and components of such products”;</P>
                <P>(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served: (a) The complainant is: Ideal Industries Lighting LLC, d/b/a Cree Lighting, 4401 Silicon Drive, Durham, North Carolina 27703.</P>
                <P>(4) The respondent is the following entity alleged to be in violation of section 337, and is the party upon which the complaint is to be served: RAB Lighting Inc., 170 Ludlow Avenue, Northvale, NJ 07647. </P>
                <P>(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.</P>
                <P>The Office of Unfair Import Investigations will not participate as a party in this investigation.</P>
                <P>Responses to the complaint and the notice of investigation must be submitted by the named respondent in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16€ and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.</P>
                <P>Failure of the respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.</P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: August 12, 2020.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17931 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7020-02-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">INTERNATIONAL TRADE COMMISSION</AGENCY>
                <DEPDOC>[Investigation No. 337-TA-1212]</DEPDOC>
                <SUBJECT>Certain Electronic Candle Products and Components  Thereof; Institution of Investigation</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>International Trade Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on July 15, 2020, under section 337 of the Tariff Act of 1930, as amended, on behalf of The Sterno Group Companies, LLC of Corona, California and Sterno Home Inc. of Canada. Supplements were filed on July 27 and August 5, 2020. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic candle products and components thereof by reason of infringement of certain claims of U.S. Patent No. 9,068,706 (“the '706 patent”), U.S. Patent No. 10,024,507 (“the '507 patent”), U.S. Patent No. 10,352,517 (“the '517 patent”), and U.S. Patent No. 10,578,264 (“the '264 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainants request that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.</P>
                </SUM>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at 
                        <E T="03">https://edis.usitc.gov.</E>
                         For help accessing EDIS, please email 
                        <E T="03">EDIS3Help@usitc.gov.</E>
                         Hearing impaired individuals are advised  that information on this matter can be obtained 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 at 
                        <E T="03">https://www.usitc.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">Authority:</E>
                     The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2020).
                </P>
                <P>
                    <E T="03">Scope of Investigation:</E>
                     Having considered the complaint, the U.S. International Trade Commission, on August 11, 2020, 
                    <E T="03">ordered that—</E>
                </P>
                <P>(4) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1, 2, 4, 5, 7, and 11-14 of the '706 patent; claims 1, 2, 4, 5, 7, 11-14, and 16 of the '507 patent; claims 1, 3-7, and 9-12 of the '517 patent; and claims 1, 3-6, 14, 16, and 17 of the '264 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;</P>
                <P>(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “artificial flameless candles that simulate a realistic flame effect using LEDs and electronic components”;</P>
                <P>(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:</P>
                <P>(a) The complainants are:</P>
                <PRTPAGE P="50049"/>
                <FP SOURCE="FP-1">The Sterno Group Companies, LLC, 1880 Compton Avenue, Suite 101, Corona, California 92881</FP>
                <FP SOURCE="FP-1">Sterno Home Inc.,  1 Burbidge Street, Suite 101,  Coquitlam, BC V3K 7B2, Canada</FP>
                <P>(4) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:</P>
                <FP SOURCE="FP-1">Shenzhen Liown Electronics Co. Ltd.,  No. 7, Gongye 3rd Road, Shekou, Nanshan District,  Shenzhen, Guangdong, 518067, China</FP>
                <FP SOURCE="FP-1">Luminara Worldwide, LLC,  10911 Valley View Road,  Eden Prairie, MN 55344</FP>
                <FP SOURCE="FP-1">L &amp; L Candle Company, LLC,  621 Lunar Avenue, Brea, California 92821</FP>
                <P>€ The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and</P>
                <P>(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.</P>
                <P>Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainant of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.</P>
                <P>Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.</P>
                <SIG>
                    <P>By order of the Commission.</P>
                    <DATED>Issued: August 12, 2020.</DATED>
                    <NAME>Lisa Barton,</NAME>
                    <TITLE>Secretary to the Commission.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17933 Filed 8-14-20; 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>Notice Pursuant to the Defense Production Act of 1950</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Antitrust Division, U.S. Department of Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of review of voluntary agreement.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is hereby given pursuant to section 708 of the Defense Production Act of 1950 (“DPA”), that the Attorney General finds, with respect to the Voluntary Agreement for the Manufacture and Distribution of Critical Healthcare Resources Necessary to Respond to a Pandemic (“Voluntary Agreement”) proposed by the Federal Emergency Management Agency (“FEMA”), that the purposes of section 708(c)(1) of the DPA may not reasonably be achieved through a voluntary agreement having less anticompetitive effects or without any voluntary agreement. Given this finding, the proposed Voluntary Agreement may become effective following the publication of this notice. FEMA is publishing the text of the proposed Voluntary Agreement elsewhere in this issue of the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </SUM>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Under the DPA, FEMA may enter into agreements with representatives of private industry for the purpose of improving the efficiency with which private firms contribute to the national defense when conditions exist that may pose a direct threat to the national defense or its preparedness. Such arrangements are generally known as “voluntary agreements.” A defense to actions brought under the antitrust laws is available to each participant acting within the scope of a voluntary agreement that has come into force under the DPA.</P>
                <P>The DPA requires that each proposed voluntary agreement be reviewed by the Attorney General prior to becoming effective. If, after consulting with the Chairman of the Federal Trade Commission, the Attorney General finds that the purposes of the DPA's voluntary-agreements provision “may not reasonably be achieved through a voluntary agreement . . . having less anticompetitive effects or without any voluntary agreement,” the agreement may become effective. 50 U.S.C. 4558(f)(1)(B).</P>
                <P>The purpose of the proposed Voluntary Agreement is to support Department of Homeland Security, Department of Health and Human Services (“HHS”), and FEMA contingency requirements to provide medical resources during times of pandemic through procedures agreed upon in advance. The proposed Voluntary Agreement establishes the terms, conditions and procedures under which participants agree voluntarily to contribute and facilitate medical resources production and distribution capacity as requested by FEMA, HHS, and other Federal Government entities. FEMA has certified that the proposed Voluntary Agreement is necessary to provide for the national defense in the event of a pandemic.</P>
                <P>FEMA requested that the Attorney General issue a finding that the proposed Voluntary Agreement satisfies the statutory criteria set forth in 50 U.S.C. 4558(f)(1)(B). The Antitrust Division reviewed the proposed agreement, attended an open meeting of interested persons pursuant to the requirements of 44 CFR 332.2, and consulted with the Chairman of the Federal Trade Commission as to the competitive effect of the proposed agreement. On July 31, 2020, by letter to Peter Gaynor, FEMA Administrator, William P. Barr, Attorney General, issued a finding, pursuant to 50 U.S.C. 4558(f)(1)(B), that the purposes of the DPA's voluntary-agreements provision “may not reasonably be achieved through a voluntary agreement . . . having less anticompetitive effects or without any voluntary agreement.”</P>
                <SIG>
                    <NAME>David G.B. Lawrence,</NAME>
                    <TITLE>Chief, Competition Policy &amp; Advocacy Section.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-18006 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-11-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBJECT>Notice of Lodging of Proposed Consent Decree Under the Clean Water Act</SUBJECT>
                <P>
                    On August 5, 2020, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Colorado in the lawsuit entitled 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Groendyke Transport Inc.,</E>
                     Civil Action No. 1:20-cv-02311.
                </P>
                <P>
                    This civil action asserts claims for penalties against Groendyke Transport Inc. Groendyke, as the legal successor to Manweiler Transport Company (Transport), for violations of Section 
                    <PRTPAGE P="50050"/>
                    311(b)(3) of the Clean Water Act (CWA), 33 U.S.C. 132l(b)(3), for the unpermitted discharge on August 26, 2016, of petroleum product into or upon navigable waters of the United States and their adjoining shorelines. The Consent Decree requires the defendant to pay a civil penalty of $225,000 to settle the claims against it. In return, the United States will grant Groendyke Transport Inc. a covenant not to sue or take administrative action pursuant to the Clean Water Act for the civil violations alleged in the Complaint, filed simultaneously with the Consent Decree.
                </P>
                <P>
                    The publication of this notice opens a period for public comment on the Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to 
                    <E T="03">United States</E>
                     v. 
                    <E T="03">Groendyke Transport Inc.,</E>
                     D.J. Ref. No. 90-5-1-1-12121. All comments must be submitted no later than thirty (30) days after the publication date of this notice. Comments may be submitted either by email or by mail:
                </P>
                <GPOTABLE COLS="2" OPTS="L2,tp0,i1" CDEF="xs50,r50">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1" O="L">
                            <E T="03">To submit comments:</E>
                        </CHED>
                        <CHED H="1" O="L">
                            <E T="03">Send them to:</E>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">By email</ENT>
                        <ENT>
                            <E T="03">pubcomment-ees.enrd@usdoj.gov.</E>
                        </ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">By mail</ENT>
                        <ENT>Assistant Attorney General, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>
                    During the public comment period, the Consent Decree may be examined and downloaded at this Justice Department website: 
                    <E T="03">https://www.justice.gov/enrd/consent-decrees.</E>
                     We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.
                </P>
                <P>Please enclose a check or money order for $3.75 (25 cents per page reproduction cost) payable to the United States Treasury.</P>
                <SIG>
                    <NAME>Jeffrey Sands,</NAME>
                    <TITLE>Assistant Section Chief, Environmental Enforcement Section, Environment and Natural Resources Division.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17879 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-15-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF JUSTICE</AGENCY>
                <SUBAGY>Office of Justice Programs</SUBAGY>
                <DEPDOC>[OJP (OJP) Docket No. 1784]</DEPDOC>
                <SUBJECT>Meeting of the Global Justice Information Sharing Initiative Federal Advisory Committee</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Office of Justice Programs (OJP), Justice.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        This is an announcement of a meeting of the Global Justice Information Sharing Initiative (Global) Federal Advisory Committee (GAC) to discuss the Global Initiative, as described at 
                        <E T="03">www.it.ojp.gov/global.</E>
                         This meeting will provide an update on existing projects as well as the status of priorities for the FY20 Fiscal Year.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>The meeting will take place on Thursday, September 17, 2020, from 9:00 a.m. ET to 4:30 p.m. ET.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The meeting will take place via video conference. See 
                        <E T="02">Supplementary Information</E>
                         for registration and access information.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Tracey Trautman, Global Designated Federal Official (DFO), Bureau of Justice Assistance, Office of Justice Programs, 810 7th Street, Washington, DC 20531; Phone (202) 305-1491 [note: this is not a toll-free number]; Email: 
                        <E T="03">tracey.trautman@ojp.usdoj.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This meeting is open to the public via Zoom for Government, but prior registration is required. Members of the public who wish to attend this meeting must register with Ms. Tracey Trautman at the above address at least (7) days in advance of the meeting. Registrations will be accepted on a space available basis. Access to the meeting will not be allowed without registration.</P>
                <P>Anyone requiring special accommodations should notify Ms. Trautman at least seven (7) days in advance of the meeting.</P>
                <P>
                    <E T="03">Purpose:</E>
                     The GAC will act as the focal point for justice information systems integration activities in order to facilitate the coordination of technical, funding, and legislative strategies in support of the Administration's justice priorities.
                </P>
                <P>The GAC will guide and monitor the development of the Global information sharing concept. It will advise the Acting Director of the Bureau of Justice Assistance; the Principal Deputy Assistant Attorney General, OJP; the Attorney General; the President (through the Attorney General); and local, state, tribal, and federal policymakers in the executive, legislative, and judicial branches. The GAC will also advocate for strategies for accomplishing a Global information sharing capability.</P>
                <P>Interested persons whose registrations have been accepted may be permitted to participate in the discussions at the discretion of the meeting chairman and with approval of the DFO.</P>
                <SIG>
                    <NAME>Tracey Trautman,</NAME>
                    <TITLE>Global DFO, Principal Deputy Director, Bureau of Justice Assistance, Office of Justice Programs, U.S. Department of Justice.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17891 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4410-18-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL CREDIT UNION ADMINISTRATION</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Credit Union Administration (NCUA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Credit Union Administration (NCUA), as part of a continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the following extension of a currently approved collection, as required by the Paperwork Reduction Act of 1995.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Written comments should be received on or before September 16, 2020 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Copies of the submission may be obtained by contacting Mackie Malaka at (703) 548-2704, emailing 
                        <E T="03">PRAComments@ncua.gov,</E>
                         or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">OMB Number:</E>
                     3133-0117.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Designation of Low Income Status, 12 CFR part 701.34(a).
                </P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     The Federal Credit Union Act (12 U.S.C. 1752(5)) authorizes the NCUA Board to define low-income members so that credit unions with a membership serving predominantly 
                    <PRTPAGE P="50051"/>
                    low-income members can benefit from certain statutory relief and receive assistance from the Community Development Revolving Loan Fund. To utilize this authority, a credit union must receive a low-income designation from NCUA as defined in NCUA's regulations at 12 CFR 701.34. NCUA uses the information from credit unions to determine whether they meet the criteria for the low-income designation.
                </P>
                <P>This is an extension of an emergency revision that incorporated a procedural change for credit unions, in qualifying for low-income designation status, to include military personnel in the low-income designation calculation.</P>
                <P>
                    <E T="03">Affected Public:</E>
                     Not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     443.
                </P>
                <SIG>
                    <P>By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on August 11, 2020.</P>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Mackie I. Malaka,</NAME>
                    <TITLE>NCUA PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17857 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7535-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NATIONAL CREDIT UNION ADMINISTRATION</AGENCY>
                <SUBJECT>Submission for OMB Review; Comment Request</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Credit Union Administration (NCUA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Credit Union Administration (NCUA) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 on or after the date of publication of this notice.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments should be received on or before September 16, 2020 to be assured of consideration.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Copies of the submission may be obtained by contacting Dawn Wolfgang at (703) 548-2279, emailing 
                        <E T="03">PRAComments@ncua.gov,</E>
                         or viewing the entire information collection request at 
                        <E T="03">www.reginfo.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">OMB Number:</E>
                     3133-0154.
                </P>
                <P>
                    <E T="03">Title:</E>
                     Prompt Corrective Action, 12 CFR 702 (Subparts A-D).
                </P>
                <P>
                    <E T="03">Abstract:</E>
                     Section 216 of the Federal Credit Union Act (12 U.S.C. 1790d) mandates prompt corrective action (PCA) requirements for federally insured credit unions (FICUs) that become less than well capitalized. Section 216 requires the NCUA Board to (1) adopt, by regulation, a system of prompt corrective action to restore the net worth of inadequately capitalized FICUs; and (2) develop an alternative system of prompt corrective action for new credit unions that carries out the purpose of PCA while allowing an FICU reasonable time to build its net worth to an adequately capitalized level. The purpose of PCA is to resolve the problems of FICUs at the least possible long-term loss to the National Credit Union Share Insurance Fund (NCUSIF).
                </P>
                <P>This is an extension of emergency revisions to the PCA that provide regulatory relief in response to COVID-19. The waiver requirement for each quarterly transfer made from undivided earning to its regular reserve account until well capitalized was temporary suspended for adequately capitalized credit unions and a FICU that becomes undercapitalized may submit a significantly simpler Net Worth Restoration Plan to NCUA.</P>
                <P>
                    <E T="03">Type of Review:</E>
                     Extension of a currently approved collection.
                </P>
                <P>
                    <E T="03">Affected Public:</E>
                     Private Sector: Not-for-profit institutions.
                </P>
                <P>
                    <E T="03">Estimated Total Annual Burden Hours:</E>
                     569.
                </P>
                <P>By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on August 11, 2020.</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Dawn D. Wolfgang,</NAME>
                    <TITLE>NCUA PRA Clearance Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17819 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7535-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES</AGENCY>
                <SUBAGY>National Endowment for the Humanities</SUBAGY>
                <SUBJECT>Meeting of Humanities Panel</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Endowment for the Humanities; National Foundation on the Arts and the Humanities.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of Meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Endowment for the Humanities (NEH) will hold nineteen meetings, by videoconference, of the Humanities Panel, a federal advisory committee, during September 2020. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and the Humanities Act of 1965.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        See 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         for meeting dates. The meetings will open at 8:30 a.m. and will adjourn by 5 p.m. on the dates specified below.
                    </P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW, Room 4060, Washington, DC 20506; (202) 606-8322; 
                        <E T="03">evoyatzis@neh.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meetings:</P>
                <FP SOURCE="FP-2">
                    1. 
                    <E T="03">Date:</E>
                     September 1, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of History, for the Digital Projects for the Public: Discovery Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    2. 
                    <E T="03">Date:</E>
                     September 1, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of Computational Analysis, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.</P>
                <FP SOURCE="FP-2">
                    3. 
                    <E T="03">Date:</E>
                     September 1, 2020
                </FP>
                <P>This video meeting—the first of two on this date—will discuss applications for the Humanities Initiatives at Colleges and Universities grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    4. 
                    <E T="03">Date:</E>
                     September 1, 2020
                </FP>
                <P>This video meeting—the second of two on this date—will discuss applications for the Humanities Initiatives at Colleges and Universities grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    5. 
                    <E T="03">Date:</E>
                     September 2, 2020
                </FP>
                <P>This video meeting will discuss applications on the topics of Games and VR, for the Digital Projects for the Public: Production Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    6. 
                    <E T="03">Date:</E>
                     September 2, 2020
                </FP>
                <P>This video meeting will discuss applications on the topics of Arts and Media Studies, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.</P>
                <FP SOURCE="FP-2">
                    7. 
                    <E T="03">Date:</E>
                     September 2, 2020
                </FP>
                <PRTPAGE P="50052"/>
                <P>This video meeting will discuss applications for the Humanities Initiatives at Colleges and Universities grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    8. 
                    <E T="03">Date:</E>
                     September 3, 2020
                </FP>
                <P>This video meeting will discuss applications for the Humanities Initiatives at Tribal Colleges and Universities grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    9. 
                    <E T="03">Date:</E>
                     September 3, 2020
                </FP>
                <P>This video meeting will discuss applications on the topics of Pedagogy and Community Engagement, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.</P>
                <FP SOURCE="FP-2">
                    10. 
                    <E T="03">Date:</E>
                     September 3, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of U.S. History, for the Digital Projects for the Public: Production Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    11. 
                    <E T="03">Date:</E>
                     September 4, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of Scholarly Communications, for the Digital Humanities Advancement Grants program, submitted to the Office of Digital Humanities.</P>
                <FP SOURCE="FP-2">
                    12. 
                    <E T="03">Date:</E>
                     September 8, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of Historic Sites, for the Digital Projects for the Public: Discovery Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    13. 
                    <E T="03">Date:</E>
                     September 8, 2020
                </FP>
                <P>This video meeting—the first of two on this date—will discuss applications for the Humanities Initiatives at Hispanic-Serving Institutions grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    14. 
                    <E T="03">Date:</E>
                     September 8, 2020
                </FP>
                <P>This video meeting—the second of two on this date—will discuss applications for the Humanities Initiatives at Hispanic-Serving Institutions grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    15. 
                    <E T="03">Date:</E>
                     September 9, 2020
                </FP>
                <P>This video meeting will discuss applications on the topics of Arts and Culture, for the Digital Projects for the Public: Discovery Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    16. 
                    <E T="03">Date:</E>
                     September 9, 2020
                </FP>
                <P>This video meeting—the first of two on this date—will discuss applications for the Humanities Initiatives at Hispanic-Serving Institutions grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    17. 
                    <E T="03">Date:</E>
                     September 9, 2020
                </FP>
                <P>This video meeting—the second of two on this date—will discuss applications for the Humanities Initiatives at Hispanic-Serving Institutions grant program, submitted to the Division of Education Programs.</P>
                <FP SOURCE="FP-2">
                    18. 
                    <E T="03">Date:</E>
                     September 10, 2020
                </FP>
                <P>This video meeting will discuss applications on the topic of Urban History, for the Digital Projects for the Public: Production Grants program, submitted to the Division of Public Programs.</P>
                <FP SOURCE="FP-2">
                    19. 
                    <E T="03">Date:</E>
                     September 11, 2020
                </FP>
                <P>This video meeting will discuss applications on the topics of Arts and Culture, for the Digital Projects for the Public: Production Grants program, submitted to the Division of Public Programs.</P>
                <P>Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee Meetings dated April 15, 2016.</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Caitlin Cater,</NAME>
                    <TITLE>Attorney-Advisor, National Endowment for the Humanities. </TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17807 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7536-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NATIONAL SCIENCE FOUNDATION</AGENCY>
                <SUBJECT>Sunshine Act Meeting; National Science Board</SUBJECT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The National Science Board's Committee on National Science and Engineering Policy (SEP), pursuant to NSF regulations, the National Science Foundation Act, as amended, and the Government in the Sunshine Act, hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Friday, August 21, 2020 at 3:30-4:30 p.m. EDT.</P>
                </DATES>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE:</HD>
                    <P>
                        This meeting will be held by videoconference through the National Science Foundation. An audio link will be available for the public. Contact the Board Office 24 hours before the teleconference to request the public audio link at 
                        <E T="03">nationalsciencebrd@nsf.gov.</E>
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS:</HD>
                    <P>Open.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P>Chair's opening remarks; discussion and recommendation of the narrative outlines for the SEI 2022 thematic reports on academic research &amp; development, and K-12 education.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION:</HD>
                    <P>
                        Point of contact for this meeting is: Chris Blair, 
                        <E T="03">cblair@nsf.gov,</E>
                         703-292-7000. To listen to this teleconference, members of the public must send an email to 
                        <E T="03">nationalsciencebrd@nsf.gov</E>
                         at least 24 hours prior to the teleconference. The National Science Board Office will send requesters a link to the audio. Meeting information and updates (time, place, subject matter or status of meeting) may be found at 
                        <E T="03">http://www.nsf.gov/nsb/meetings/notices.jsp#sunshine.</E>
                         Please refer to the National Science Board website 
                        <E T="03">www.nsf.gov/nsb</E>
                         for additional information.
                    </P>
                </PREAMHD>
                <SIG>
                    <NAME>Chris Blair,</NAME>
                    <TITLE>Executive Assistant to the National Science Board Office.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-18035 Filed 8-13-20; 4:15 pm]</FRDOC>
            <BILCOD>BILLING CODE 7555-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">NUCLEAR REGULATORY COMMISSION </AGENCY>
                <SUBJECT>678th Meeting of the Advisory Committee on Reactor Safeguards (ACRS)</SUBJECT>
                <P>In accordance with the purposes of Sections 29 and 182b of the Atomic Energy Act (42 U.S.C. 2039, 2232b), the Advisory Committee on Reactor Safeguards (ACRS) will hold meetings on September 10-12, 2020. As part of the coordinated government response to combat the COVID-19 public health emergency, the Committee will conduct virtual meetings. The public will be able to participate in any open sessions via 1-866-822-3032, pass code 8272423#.</P>
                <HD SOURCE="HD1">Thursday, September 10, 2020</HD>
                <P>
                    <E T="03">9:30 a.m.-9:35 a.m.: Opening Remarks by the ACRS Chairman</E>
                     (Open)—The ACRS Chairman will make opening remarks regarding the conduct of the meeting.
                </P>
                <P>
                    <E T="03">9:35 a.m.-11:00 a.m.: Staff White Paper on 10 CFR part 53 Advanced Notice of Proposed Rulemaking</E>
                     (Open)—The Committee will have presentations and discussion with the U.S. Nuclear Regulatory Commission (NRC) staff regarding the subject topic.
                </P>
                <P>
                    <E T="03">
                        11:15 a.m.-1:30 p.m.: GEH Topical Report NEDC-3391P, “BWRX-300 
                        <PRTPAGE P="50053"/>
                        Reactor Vessel and Overpressure Protection”
                    </E>
                     (Open/Closed)—The Committee will have presentations and discussion with GEH and the NRC staff regarding the subject topic. [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <P>
                    <E T="03">2:30 p.m.-4:00 p.m.: Topical Report ANP-10337, Supplement 1, “Deformer Spacer Grid Element”</E>
                     (Open/Closed)—The Committee will have presentations and discussion with the NRC staff regarding the subject topic. [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <P>
                    <E T="03">4:15 p.m.-6:15 p.m.: Preparation of ACRS Reports</E>
                     (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <HD SOURCE="HD1">Friday, September 11, 2020</HD>
                <P>
                    <E T="03">9:30 a.m.-10:30 a.m.: Future ACRS Activities/Report of the Planning and Procedures Subcommittee and Reconciliation of ACRS Comments and Recommendations/Preparation of Reports</E>
                     (Open/Closed)—The Committee will hear discussion of the recommendations of the Planning and Procedures Subcommittee regarding items proposed for consideration by the Full Committee during future ACRS meetings, and/or proceed to preparation of reports as determined by the Chairman. [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C. 552b(c)(2) and (6), a portion of this meeting may be closed to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACRS, and information the release of which would constitute a clearly unwarranted invasion of personal privacy.] [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <P>
                    <E T="03">10:30 a.m.-12:30 p.m.: Future Focused Research Projects</E>
                     (Open)—The Committee will have presentations and discussion with the NRC staff regarding the subject topic.
                </P>
                <P>
                    <E T="03">1:30 p.m.-6:00 p.m.: Preparation of ACRS Reports</E>
                     (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [Note: Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <HD SOURCE="HD1">Saturday, September 12, 2020</HD>
                <P>
                    <E T="03">9:30 a.m.-2:00 p.m.: Preparation of ACRS Reports</E>
                     (Open/Closed)—The Committee will continue its discussion of proposed ACRS reports. [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C 552b(c)(4), a portion of this session may be closed in order to discuss and protect information designated as proprietary.]
                </P>
                <P>
                    [
                    <E T="04">Note:</E>
                     Pursuant to 5 U.S.C. 552b(c)(2) and (6), portions of this meeting may be closed to discuss organizational and personnel matters that relate solely to internal personnel rules and practices of the ACRS, and information the release of which would constitute a clearly unwarranted invasion of personal privacy.]
                </P>
                <P>
                    Procedures for the conduct of and participation in ACRS meetings were published in the 
                    <E T="04">Federal Register</E>
                     on June 13, 2019 (84 FR 27662). In accordance with those procedures, oral or written views may be presented by members of the public, including representatives of the nuclear industry. Persons desiring to make oral statements should notify Quynh Nguyen, Cognizant ACRS Staff and the Designated Federal Official (Telephone: 301-415-5844, Email: 
                    <E T="03">Quynh.Nguyen@nrc.gov</E>
                    ), 5 days before the meeting, if possible, so that appropriate arrangements can be made to allow necessary time during the meeting for such statements. In view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with the Cognizant ACRS staff if such rescheduling would result in major inconvenience.
                </P>
                <P>An electronic copy of each presentation should be emailed to the Cognizant ACRS Staff at least one day before meeting.</P>
                <P>In accordance with Subsection 10(d) of Public Law 92-463 and 5 U.S.C. 552b(c), certain portions of this meeting may be closed, as specifically noted above. Use of still, motion picture, and television cameras during the meeting may be limited to selected portions of the meeting as determined by the Chairman. Electronic recordings will be permitted only during the open portions of the meeting.</P>
                <P>
                    ACRS meeting agendas, meeting transcripts, and letter reports are available through the NRC Public Document Room (PDR) at 
                    <E T="03">pdr.resource@nrc.gov,</E>
                     or by calling the PDR at 1-800-397-4209, or from the Publicly Available Records System component of NRC's Agencywide Documents Access and Management System (ADAMS) which is accessible from the NRC website at 
                    <E T="03">https://www.nrc.gov/reading-rm/adams.html</E>
                     or 
                    <E T="03">https://www.nrc.gov/reading-rm/doc-collections/#ACRS/</E>
                </P>
                <P>Video teleconferencing service is available for observing open sessions of ACRS meetings. Those wishing to use this service should contact Thomas Dashiell, ACRS Audio Visual Technician (301-415-7907), between 7:30 a.m. and 3:45 p.m. (Eastern Time), 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: August 12, 2020. </DATED>
                    <NAME>Russell E. Chazell,</NAME>
                    <TITLE>Federal Advisory Committee Management Officer, Office of the Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17922 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">NUCLEAR REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[NRC-2019-0239]</DEPDOC>
                <SUBJECT>Information Collection: NRC CUI Program Challenge Request Process</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Nuclear Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of submission to the Office of Management and Budget; request for comment.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a proposed collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, “NRC CUI Program Challenge Request Process.”</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Submit comments by September 16, 2020. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to 
                        <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E>
                         Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David Cullison, NRC Clearance Officer, 
                        <PRTPAGE P="50054"/>
                        U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                        <E T="03">INFOCOLLECTS.Resource@nrc.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Obtaining Information and Submitting Comments</HD>
                <HD SOURCE="HD2">A. Obtaining Information</HD>
                <P>Please refer to Docket ID NRC-2019-0239 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:</P>
                <P>
                    • 
                    <E T="03">Federal Rulemaking Website:</E>
                     Go to 
                    <E T="03">https://www.regulations.gov</E>
                     and search for Docket ID NRC-2019-0239. A copy of the collection of information and related instructions may be obtained without charge by accessing Docket ID NRC-2019-0239 on this website.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Agencywide Documents Access and Management System (ADAMS):</E>
                     You may obtain publicly-available documents online in the ADAMS Public Documents collection at 
                    <E T="03">https://www.nrc.gov/reading-rm/adams.html.</E>
                     To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room reference staff at 1-800-397-4209, 301-415-4737, or by email to 
                    <E T="03">pdr.resource@nrc.gov.</E>
                     A copy of the collection of information and related instructions may be obtained without charge by accessing ADAMS Accession No. ML19317D847. The supporting statement and NRC Controlled Unclassified Information (CUI) Program Challenge Request Form is available in ADAMS under Accession No. ML20118D025.
                </P>
                <P>
                    • 
                    <E T="03">NRC's Clearance Officer:</E>
                     A copy of the collection of information and related instructions may be obtained without charge by contacting the NRC's Clearance Officer, David Cullison, Office of the Chief Information Officer, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2084; email: 
                    <E T="03">INFOCOLLECTS.Resource@NRC.GOV.</E>
                </P>
                <HD SOURCE="HD2">B. Submitting Comments</HD>
                <P>
                    The NRC cautions you not to include identifying or contact information in comment submissions that you do not want to be publicly disclosed in your comment submission. All comment submissions are posted at 
                    <E T="03">https://www.regulations.gov</E>
                     and entered into ADAMS. Comment submissions are not routinely edited to remove identifying or contact information.
                </P>
                <P>If you are requesting or aggregating comments from other persons for submission to the OMB, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that comment submissions are not routinely edited to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.</P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the NRC recently submitted a proposed collection of information to OMB for review entitled, “NRC CUI Program Challenge Request.” The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.</P>
                <P>
                    The NRC published a 
                    <E T="04">Federal Register</E>
                     notice with a 60-day comment period on this information collection on April 17, 2020, 85 FR 21475.
                </P>
                <P>
                    1. 
                    <E T="03">The title of the information collection:</E>
                     NRC CUI Program Challenge Request.
                </P>
                <P>
                    2. 
                    <E T="03">OMB approval number:</E>
                     3150-XXXX.
                </P>
                <P>
                    3. 
                    <E T="03">Type of submission:</E>
                     New.
                </P>
                <P>
                    4. 
                    <E T="03">The form number if applicable:</E>
                     N/A.
                </P>
                <P>
                    5. 
                    <E T="03">How often the collection is required or requested:</E>
                     On occasion.
                </P>
                <P>
                    6. 
                    <E T="03">Who will be required or asked to respond:</E>
                     Authorized holders, including any individual or organization who has been provided with CUI and has a lawful government purpose to possess CUI.
                </P>
                <P>
                    7. 
                    <E T="03">The estimated number of annual responses:</E>
                     12.
                </P>
                <P>
                    8. 
                    <E T="03">The estimated number of annual respondents:</E>
                     12.
                </P>
                <P>
                    9. 
                    <E T="03">An estimate of the total number of hours needed annually to comply with the information collection requirement or request:</E>
                     18.
                </P>
                <P>
                    10. 
                    <E T="03">Abstract:</E>
                     The NRC CUI Program Challenge Request Process, also referred to as the “CUI Challenge Request Process” in this document, provides the process used for NRC CUI authorized holders to challenge the designation of information that has been marked as CUI as improperly or incorrectly designated. “Authorized holder” includes any individual or organization who has been provided with CUI and has a lawful government purpose to possess the information. Any authorized holder who believes that the designation of specific information as CUI is improper or incorrect, or who believes they have received unmarked CUI, may use this process to formally notify the NRC CUI Senior Agency Official (SAO). The process also allows for the NRC CUI SAO and CUI Program Manager to process such requests and to issue a Final Decision from the CUI SAO.
                </P>
                <P>11. The CUI Challenge Request Process is not intended to be used to address all disagreements regarding the proper designation of CUI. Authorized holders are encouraged to seek or utilize less formal means when resolving internal good faith disputes over the proper designation of information as CUI, such as discussion with the creator or designator of the information in dispute. Where resolution cannot be achieved through less formal means, the CUI challenge request process is available.</P>
                <P>The CUI Challenge Request Process does not supersede any obligations under law or NRC policy to report information spills.</P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <P>For the Nuclear Regulatory Commission.</P>
                    <NAME>David C. Cullison,</NAME>
                    <TITLE>NRC Clearance Officer,Office of the Chief Information Officer.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17932 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7590-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">POSTAL REGULATORY COMMISSION</AGENCY>
                <DEPDOC>[Docket Nos. MC2020-216 and CP2020-244; Docket Nos. MC2020-217 and CP2020-245]</DEPDOC>
                <SUBJECT>New Postal Products</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Postal Regulatory Commission.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        <E T="03">Comments are due:</E>
                         August 19, 2020.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Submit comments electronically via the Commission's Filing Online system at 
                        <E T="03">http://www.prc.gov.</E>
                         Those who cannot submit comments electronically should contact the person identified in the 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                         section by telephone for advice on filing alternatives.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>David A. Trissell, General Counsel, at 202-789-6820.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">
                    SUPPLEMENTARY INFORMATION:
                    <PRTPAGE P="50055"/>
                </HD>
                <HD SOURCE="HD1">Table of Contents</HD>
                <EXTRACT>
                    <FP SOURCE="FP-2">I. Introduction</FP>
                    <FP SOURCE="FP-2">II. Docketed Proceeding(s)</FP>
                </EXTRACT>
                <HD SOURCE="HD1">I. Introduction</HD>
                <P>The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.</P>
                <P>Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.</P>
                <P>
                    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
                    <E T="03">http://www.prc.gov</E>
                    ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301.
                    <SU>1</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         
                        <E T="03">See</E>
                         Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).
                    </P>
                </FTNT>
                <P>The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3030, and 39 CFR part 3040, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3040, subpart B. Comment deadline(s) for each request appear in section II.</P>
                <HD SOURCE="HD1">II. Docketed Proceeding(s)</HD>
                <P>
                    1. 
                    <E T="03">Docket No(s).:</E>
                     MC2020-216 and CP2020-244; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Express Contract 81 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     August 11, 2020; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Kenneth R. Moeller; 
                    <E T="03">Comments Due:</E>
                     August 19, 2020.
                </P>
                <P>
                    2. 
                    <E T="03">Docket No(s).:</E>
                     MC2020-217 and CP2020-245; 
                    <E T="03">Filing Title:</E>
                     USPS Request to Add Priority Mail Contract 649 to Competitive Product List and Notice of Filing Materials Under Seal; 
                    <E T="03">Filing Acceptance Date:</E>
                     August 11, 2020; 
                    <E T="03">Filing Authority:</E>
                     39 U.S.C. 3642, 39 CFR 3040.130 through 3040.135, and 39 CFR 3035.105; 
                    <E T="03">Public Representative:</E>
                     Kenneth R. Moeller; 
                    <E T="03">Comments Due:</E>
                     August 19, 2020.
                </P>
                <P>
                    This Notice will be published in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <NAME>Erica A. Barker, </NAME>
                    <TITLE>Secretary.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17912 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 7710-FW-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-89525; File No. SR-CboeBZX-2020-065]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Fees Schedule</SUBJECT>
                <DATE>August 11, 2020.</DATE>
                <P>
                    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
                    <SU>1</SU>
                    <FTREF/>
                     and Rule 19b-4 thereunder,
                    <SU>2</SU>
                    <FTREF/>
                     notice is hereby given that on August 4, 2020, Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the Exchange. 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>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>Cboe BZX Exchange, Inc. (the “Exchange” or “BZX”) is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend its Fee Schedule. The text of the proposed rule change is provided in Exhibit 5.</P>
                <P>
                    The text of the proposed rule change is also available on the Exchange's website (
                    <E T="03">http://markets.cboe.com/us/equities/regulation/rule_filings/bzx/</E>
                    ), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.
                </P>
                <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>
                    The Exchange proposes to amend its fee schedule for its equity options platform (“BZX Options”).
                    <SU>3</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         The Exchange initially filed the proposed fee changes on July 31, 2020 (SR-CboeBZX-2020-062). On August 4, 2020, the Exchange withdrew that filing and submitted this filing.
                    </P>
                </FTNT>
                <P>
                    The Exchange first notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of 16 options venues to which market participants may direct their order flow. Based on publicly available information, no single options exchange has more than 17% of the market share and currently the Exchange represents only approximately 8% of the market share.
                    <SU>4</SU>
                    <FTREF/>
                     Thus, in such a low-concentrated and highly competitive market, no single options exchange, including the Exchange, possesses significant pricing power in the execution of option order flow. The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue to reduce use of certain categories of products, in response to fee changes. Accordingly, competitive forces constrain the Exchange's transaction fees, and market participants can readily trade on competing venues if they deem pricing levels at those other venues to 
                    <PRTPAGE P="50056"/>
                    be more favorable. The Exchange's fee schedule sets forth standard rebates and rates applied per contract, which varies depending on the Member's Capacity (Customer, Firm, Market Maker, etc.), whether the order adds or removes liquidity, and whether the order is in Penny or Non-Penny Pilot Securities. Additionally, in response to the competitive environment, the Exchange also offers tiered pricing which provides Members opportunities to qualify for higher rebates or reduced fees where certain volume criteria and thresholds are met. Tiered pricing provides an incremental incentive for Members to strive for higher tier levels, which provides increasingly higher benefits or discounts for satisfying increasingly more stringent criteria.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         
                        <E T="03">See</E>
                         Cboe Global Markets U.S. Options Market Month-to-Date Volume Summary (July 27, 2020), available at 
                        <E T="03">https://markets.cboe.com/us/options/market_statistics/.</E>
                    </P>
                </FTNT>
                <P>
                    For example, the Exchange currently offers five NBBO Setter Tiers under footnote 7 of the Fee Schedule which provide additional rebates between $0.01 and $0.05 per contract for qualifying orders which establish a new NBBO and yield fee code PM or PN,
                    <SU>5</SU>
                    <FTREF/>
                     where a Member meets certain liquidity thresholds. Under the current NBBO Setter Tiers, a Member may receive an additional rebate where the Member has an ADAV 
                    <SU>6</SU>
                    <FTREF/>
                     in Non-Customer orders, or Firm/Market Maker/Away MM orders greater or equal to a specified percentage of OCV.
                    <SU>7</SU>
                    <FTREF/>
                     The Exchange now proposes to amend the criteria in NBBO Setter Tiers 2 through 5 by increasing, in each, a percentage of ADV into average OCV within existing criteria and also adding to Tier 5 a new, additional criteria that that a Member must meet to receive the existing additional rebate. The Exchange notes that the proposed changes do not alter the current rebates provided under NBBO Setter Tiers 2 through 5.
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         Orders yielding fee code PM are Market Maker orders that add liquidity in Penny Pilot Securities and are offered a rebate of $0.29, and orders yielding fee code PN are Away Market Maker orders that add liquidity in Penny Pilot Securities and are offered a rebate of $0.26.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         “ADAV” means average daily added volume calculated as the number of contracts added, per day.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         “OCC Customer Volume” or “OCV” means the total equity and ETF options volume that clears in the Customer range at the Options Clearing Corporation (“OCC”) for the month for which the fees apply, excluding volume on any day that the Exchange experiences an Exchange System Disruption and on any day with a scheduled early market close.
                    </P>
                </FTNT>
                <P>
                    Specifically, Tier 2 currently provides an additional rebate of $0.02 for a Member's qualifying orders (
                    <E T="03">i.e.,</E>
                     that yield fee code PM or PN and establish a new NBBO) for Members that have (1) an ADAV in Non-Customer orders greater than or equal to 0.40% of average OCV, and (2) an ADAV in Firm/Market Maker/Away Market Maker (MM) orders that establish a new NBBO greater than or equal to 0.05% of average OCV. Tier 3 currently provides an additional rebate of $0.03 for qualifying orders for Members that have (1) an ADAV in Non-Customer orders greater than or equal to 0.75% of average OCV, and (2) an ADAV in Firm/Market Maker/Away MM orders that establish a new NBBO greater than or equal to 0.05% of average OCV. Tier 4 currently provides an additional rebate of $0.04 for qualifying orders for Members that have (1) an ADAV in Non-Customer orders greater than or equal to 1.80% of average OCV, (2) an ADAV in Non-Customer Non-Penny orders greater than or equal to 0.20% of average OCV, and (3) an ADAV in Firm/Market Maker/Away MM orders that establish a new NBBO greater than or equal to 0.05% of average OCV. Tier 5 currently provides an additional rebate of $0.05 for qualifying orders for Member that have (1) an ADAV in Non-Customer orders greater than or equal to 3.00% of average OCV, and (2) Member has an ADAV in Firm/Market Maker/Away MM orders that establish a new NBBO greater than or equal to 0.05% of average OCV. The Exchange notes that prong 2 of Tiers 2, 3, and 5 and prong 3 of Tier 4 (as well as prong 2 of Tier 1 which is not being amended) provide the same criteria. The proposed change updates these criteria in each tier to instead become incrementally more difficult. The proposed criteria in Tier 2 requires that a Member have an has an ADAV in Firm/Market Maker/Away MM orders that establish a new NBBO greater than or equal to 0.15% of average OCV, in Tier 3 requires a threshold greater than or equal to 0.30% of average OCV, in Tier 4 requires a threshold of greater than or equal to 0.50% of average OCV, and in Tier 5 requires a threshold of 0.80% of average OCV. In addition to this, the proposed change amends the criteria in prong 1 of Tier 5 to decrease the threshold of Non-Customer orders over average OCV from 3.00% to 2.55% and adopts an additional criteria in Tier 5, a new prong 2 (current prong 2 will become prong 3), which requires an ADAV in Non-Customer Non-Penny orders greater than or equal to 0.25% of average OCV. The proposed increases in Firm/Market Maker/Away MM order ADAV that establish a new NBBO as a percentage of average OCV in Tiers 2 through 5 are intended to incrementally increase the level of difficulty in achieving each of these tiers, thus, incentivizing Members to increase their overall order flow to the Exchange by encouraging those Members to strive for the different, incrementally more difficult tier criteria under the proposed tiers to receive the additional rebates. The proposed additional prong of criteria in Tier 5 is also designed to incrementally increase the level of difficulty in achieving Tier 5, while the proposed decrease in the threshold of ADAV over average OCV in prong 1 is designed to balance the entirety of Tier 5's difficulty in light of the proposed additional criteria, incentivizing Members to continue to submit Non-Customer orders to the Exchange's Order Book.
                </P>
                <P>The Exchange believes that the proposed fee changes are overall designed to incentivize more Firm, Market Maker, and Away Market Maker add volume order flow to establish a new NBBO as well as overall Non-Customer add volume order flow to the Exchange. Increased add volume order flow, particularly by liquidity providers, contributes to a deeper, more liquid market, which, in turn, provides for increased execution opportunities and thus overall enhanced price discovery and price improvement opportunities on the Exchange. As such, this benefits all Members by contributing towards a robust and well-balanced market ecosystem, offering additional flexibility for all investors to enjoy cost savings, supporting the quality of price discovery, promoting market transparency and improving investor protection.</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
                    <SU>8</SU>
                    <FTREF/>
                     in general, and furthers the objectives of Section 6(b)(4),
                    <SU>9</SU>
                    <FTREF/>
                     in particular, as it is designed to provide for the equitable allocation of reasonable dues, fees and other charges among its Members and issuers and other persons using its facilities. The Exchange also believes that the proposed rule change is consistent with the objectives of Section 6(b)(5) 
                    <SU>10</SU>
                    <FTREF/>
                     requirements that the rules of an exchange be 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 regulating, clearing, settling, processing information with respect to, and facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system, and, in general, to protect 
                    <PRTPAGE P="50057"/>
                    investors and the public interest, and, particularly, is not designed to permit unfair discrimination between customers, issuers, brokers, or dealers.
                </P>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78f.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78f(b)(4).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         15 U.S.C. 78f.(b)(5).
                    </P>
                </FTNT>
                <P>As described above, the Exchange operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. The proposed rule change reflects a competitive pricing structure designed to incentivize market participants to direct their order flow to the Exchange, which the Exchange believes would enhance market quality to the benefit of all Members.</P>
                <P>
                    In particular, the Exchange believes the proposed tiers are reasonable because they amend existing opportunities in a manner that incentivizes increased Non-Customer (which would include, where applicable, Firm, Market Maker, and Away MM specifically) order flow via incrementally more challenging criteria in order to receive the same additional rebates on a Member's qualifying orders. The Exchange notes that volume-based incentives and discounts have been widely adopted by exchanges,
                    <SU>11</SU>
                    <FTREF/>
                     including the Exchange,
                    <SU>12</SU>
                    <FTREF/>
                     and are reasonable, equitable and non-discriminatory because they are open to all Members on an equal basis and provide additional benefits or discounts that are reasonably related to (i) the value to an exchange's market quality and (ii) associated higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns. Additionally, as noted above, the Exchange operates in a highly competitive market. The Exchange is only one of several options venues to which market participants may direct their order flow, and it represents a small percentage of the overall market. Competing options exchanges offer similar tiered pricing structures to that of the Exchange, including schedules of rebates and fees that apply based upon Members achieving certain volume and/or growth thresholds.
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         
                        <E T="03">See e.g.,</E>
                         NYSE Arca Options Fee Schedule, Firm and Broker Dealer Penny Posting Credit Tiers, and Non-Customer Non-Penny Posting Credit Tiers.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         
                        <E T="03">See e.g.,</E>
                         The Exchange's Fee Schedule, Footnote 4, NBBO Setter Tiers.
                    </P>
                </FTNT>
                <P>Moreover, the Exchange believes the amended NBBO Setter Tiers are a reasonable means to encourage Members to increase their liquidity on the Exchange, specifically their Non-Customer add volume order flow. The Exchange believes that modifying existing criteria in Tiers 2 through 5 to be incrementally more difficult to achieve, as opposed to the current fixed criteria pursuant to the same prong in each tier, and adopting an additional prong of criteria in Tier 5 are reasonable modifications of existing criteria because they are designed to incrementally increase the difficulty in achieving these tiers, thereby incentivizing Members to increase their overall add volume order flow, and particularly, to strive to establish new NBBOs. This benefits all market participants by incentivizing continuous display of and opportunity to execute at the best prices, and by incentivizing overall additional liquidity, which signals other market participants to take the additional execution opportunities provided by such liquidity. This overall increase in activity deepens the Exchange's liquidity pool, offers additional cost savings, supports the quality of price discovery, promotes market transparency and improves market quality, for all investors. The Exchange also notes that it is reasonable to decrease the threshold of ADAV as a percentage average OCV in prong 1 of Tier 5 in order to balance the ultimate level of difficult in achieving the tier with the added proposed prong of criteria that a Member must meet to achieve the current rebate.</P>
                <P>Further, the Exchange believes that the proposed rule changes are reasonable as they represent proportional increases in difficulty per adjacent tiers and the criteria thresholds appropriately reflect the incremental difficulty to achieve the existing rebates that increase with each ascending tier. For example, the Exchange proposes to simultaneously increase the ADAV thresholds of Firm/Market Maker/Away MM orders that establish a new NBBO in each of Tier 2, 3, 4, and 5 in a manner that poses a step up in difficulty per each ascending tier to achieve the current ascending rebates per each tier. The Exchange also believes that the proposed change to Tier 5 in adding another prong of criteria, as well as tempering the difficulty posed by the added prong by decreasing the threshold of ADAV over average OCV in an existing prong, appropriately balances the step up in difficulty from Tier 4 to Tier 5. The Exchange again notes that the proposed rule changes do not alter the amount of any of the current rebates in place.</P>
                <P>The Exchange believes that the proposal represents an equitable allocation of fees and is not unfairly discriminatory because all Members will be eligible for the proposed tier and the corresponding additional rebate will apply uniformly to all Members that reach the proposed tier criteria. That is, the proposed tiers are designed as an incentive to any and all Members interested in meeting the tier criteria to submit additional order flow to the Exchange and each will receive the proposed additional rebate if the tier criteria is met.</P>
                <P>The Exchange believes that the proposal represents an equitable allocation of rebates and is not unfairly discriminatory because all Members will continue to be eligible for NBBO Setter Tiers 2 through 5, as amended. The proposed changes to the tiers' criteria are designed as an incentive to any and all Members interested in meeting the tier criteria to submit additional Non-Customer orders (with opportunities to achieve such tiers via criteria for Firm/Market Maker/Away MM orders) to the Exchange. Each will have the opportunity to submit the requisite order flow and will receive the applicable existing rebate if the tier criteria are met. Without having a view of activity on other markets and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would definitely result in any Members qualifying for the proposed tiers. While the Exchange has no way of predicting with certainty how the proposed tiers will impact Member activity, the Exchange anticipates that approximately at least three Members will be able to compete for and achieve the amended criteria in each of Tier 2 and Tier 3, and at least one Member will be able to compete for and achieve the amended criteria in each of Tier 4 and Tier 5. The Exchange anticipates that the tiers will particularly include liquidity providers, such as traditional Market Makers, and wholesale or consolidator firms that mainly make markets for retail orders, each providing distinct types of order flow to the Exchange to the benefit of all market participants. The Exchange also notes that the proposed tiers will not adversely impact any Member's pricing or their ability to qualify for other rebate tiers. Rather, should a Member not meet the proposed criteria for a tier, the Member will merely not receive the corresponding additional rebate. Furthermore, the existing rebate and fees will continue to uniformly apply to all Members that meet the required criteria, as amended, per each respective tier.</P>
                <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 intramarket or intermarket competition that is not 
                    <PRTPAGE P="50058"/>
                    necessary or appropriate in furtherance of the purposes of the Act. Rather, as discussed above, the Exchange believes that the proposed change would encourage the submission of additional liquidity to a public exchange, thereby promoting market depth, price discovery and transparency and enhancing order execution opportunities for all Members. As a result, the Exchange believes that the proposed change furthers the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.” 
                    <SU>13</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         Securities Exchange Act Release No. 51808, 70 FR 37495, 37498-99 (June 29, 2005) (S7-10-04) (Final Rule).
                    </P>
                </FTNT>
                <P>The Exchange believes the proposed rule change does not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the proposed change applies to all Members equally in that all Members are eligible to achieve the tiers' proposed criteria, have a reasonable opportunity to meet the tiers' proposed criteria and will all receive the existing rebates if such criteria is met. Overall, the proposed change is designed to attract additional Non-Customer (including, where applicable, specifically Firm/Market Maker/Away MM) order flow to the Exchange. The Exchange believes that the modified tier criteria would incentivize market participants to strive to increase such order flow to the Exchange to meet the proposed criteria and, as a result, provide for deeper levels of liquidity, increasing trading opportunities for other market participants, thus signaling further trading activity, ultimately incentivizing more overall order flow and improving price transparency on the Exchange. Greater overall order flow and pricing transparency benefits all market participants on the Exchange by generally providing continuous trading opportunities, enhancing market quality, and continuing to encourage Members to send orders, thereby contributing towards a robust and well-balanced market ecosystem, which benefits all market participants.</P>
                <P>
                    Next, the Exchange believes the proposed rule change does not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. As previously discussed, the Exchange operates in a highly competitive market. Members have numerous alternative venues that they may participate on and director their order flow, including 15 other options exchanges and off-exchange venues. Additionally, the Exchange represents a small percentage of the overall market. Based on publicly available information, no single options exchange has more than 17% of the market share.
                    <SU>14</SU>
                    <FTREF/>
                     Therefore, no exchange possesses significant pricing power in the execution of option order flow. Indeed, participants can readily choose to send their orders to other exchange and off-exchange venues if they deem fee levels at those other venues to be more favorable. Moreover, the Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.” 
                    <SU>15</SU>
                    <FTREF/>
                     The fact that this market is competitive has also long been recognized by the courts. In NetCoalition v. Securities and Exchange Commission, the D.C. Circuit stated as follows: “[n]o one disputes that competition for order flow is `fierce.' . . . As the SEC explained, `[i]n the U.S. national market system, buyers and sellers of securities, and the broker-dealers that act as their order-routing agents, have a wide range of choices of where to route orders for execution'; [and] `no exchange can afford to take its market share percentages for granted' because `no exchange possesses a monopoly, regulatory or otherwise, in the execution of order flow from broker dealers'. . . .”.
                    <SU>16</SU>
                    <FTREF/>
                     Accordingly, the Exchange does not believe its proposed fee change imposes any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
                </P>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         
                        <E T="03">See supra</E>
                         note 3.
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 51808 (June 9, 2005), 70 FR 37496, 37499 (June 29, 2005).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         NetCoalition v. SEC, 615 F.3d 525, 539 (D.C. Cir. 2010) (quoting Securities Exchange Act Release No. 59039 (December 2, 2008), 73 FR 74770, 74782-83 (December 9, 2008) (SR-NYSEArca-2006-21)).
                    </P>
                </FTNT>
                <HD SOURCE="HD2">C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others</HD>
                <P>The Exchange neither solicited nor received comments on the proposed rule change.</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) of the Act 
                    <SU>17</SU>
                    <FTREF/>
                     and paragraph (f) of Rule 19b-4 
                    <SU>18</SU>
                    <FTREF/>
                     thereunder. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend 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. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or disapproved.
                </P>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         17 CFR 240.19b-4(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 email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number SR-CboeBZX-2020-065 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File Number SR-CboeBZX-2020-065. This file number should be included on the subject line if email 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 website (
                    <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 website viewing and printing in the Commission's Public 
                    <PRTPAGE P="50059"/>
                    Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeBZX-2020-065 and should be submitted on or before September 8, 2020.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>19</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17823 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">SECURITIES AND EXCHANGE COMMISSION</AGENCY>
                <DEPDOC>[Release No. 34-89520; File No. SR-BOX-2020-33]</DEPDOC>
                <SUBJECT>Self-Regulatory Organizations; BOX Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Rule 16000 Series, the Exchange's Compliance Rule Regarding the National Market System Plan Governing the Consolidated Audit Trail To Be Consistent With an Amendment to the CAT NMS Plan Recently Approved by the Commission</SUBJECT>
                <DATE>August 11, 2020.</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 August 5, 2020, BOX Exchange LLC (the “Exchange”) 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 the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule 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>
                <HD SOURCE="HD1">I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change</HD>
                <P>
                    The Exchange proposes to amend the Rule 16000 Series, the Exchange's compliance rule (“Compliance Rule”) regarding the National Market System Plan Governing the Consolidated Audit Trail (the “CAT NMS Plan” or “Plan”) 
                    <SU>3</SU>
                    <FTREF/>
                     to be consistent with an amendment to the CAT NMS Plan recently approved by the Commission. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's internet website at 
                    <E T="03">http://boxoptions.com.</E>
                </P>
                <FTNT>
                    <P>
                        <SU>3</SU>
                         Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth in the Compliance Rule.
                    </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, the self-regulatory organization 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 self-regulatory organization 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 purpose of this proposed rule change is to amend the Rule 16000 Series, the Compliance Rule regarding the CAT NMS Plan, to be consistent with an amendment to the CAT NMS Plan recently approved by the Commission.
                    <SU>4</SU>
                    <FTREF/>
                     The Commission approved an amendment to the CAT NMS Plan to amend the requirements for Firm Designated IDs in four ways: (1) To prohibit the use of account numbers as Firm Designated IDs for trading accounts that are not proprietary accounts; (2) to require that the Firm Designated ID for a trading account be persistent over time for each Industry Member so that a single account may be tracked across time within a single Industry Member; (3) to permit the use of relationship identifiers as Firm Designated IDs in certain circumstances; and (4) to permit the use of entity identifiers as Firm Designated IDs in certain circumstances (the “FDID Amendment”). As a result, the Exchange proposes to amend the definition of “Firm Designated ID” in Rule 16010 to reflect the changes to the CAT NMS Plan regarding the requirements for Firm Designated IDs.
                </P>
                <FTNT>
                    <P>
                        <SU>4</SU>
                         Securities Exchange Act Release No. 89397 (July 24, 2020) (
                        <E T="04">Federal Register</E>
                         pending).
                    </P>
                </FTNT>
                <P>Rule 16010(r) defines the term “Firm Designated ID” to mean “a unique identifier for each trading account designated by Industry Members for purposes of providing data to the Central Repository, where each such identifier is unique among all identifiers from any given Industry Member for each business date.”</P>
                <HD SOURCE="HD3">(1) Prohibit Use of Account Numbers</HD>
                <P>The Exchange proposes to amend the definition of “Firm Designated ID” in Rule 16010(r) to provide that Industry Members may not use account numbers as the Firm Designated ID for trading accounts that are not proprietary accounts. Specifically, the Exchange proposes to add the following to the definition of a Firm Designated ID: “provided, however, such identifier may not be the account number for such trading account if the trading account is not a proprietary account.”</P>
                <HD SOURCE="HD3">(2) Persistent Firm Designated ID</HD>
                <P>
                    The Exchange also proposes to amend the definition of “Firm Designated ID” in Rule 16010(r) to require a Firm Designated ID assigned by an Industry Member to a trading account to be persistent over time, not for each business day.
                    <SU>5</SU>
                    <FTREF/>
                     To effect this change, the Exchange proposes to amend the definition of “Firm Designated ID” in Rule 16010(r) to add “and persistent” after “unique” and delete “for each business date” so that the definition of “Firm Designated ID” would read, in relevant part, as follows:
                </P>
                <FTNT>
                    <P>
                        <SU>5</SU>
                         If an Industry Member assigns a new account number or entity identifier to a client or customer due to a merger, acquisition or some other corporate action, then the Industry Member should create a new Firm Designated ID to identify the new account identifier/relationship identifier/entity identifier in use at the Industry Member for the entity. In addition, if a previously assigned Firm Designated ID is no longer in use by an Industry Member (
                        <E T="03">e.g.,</E>
                         if the trading account associated with the Firm Designated ID has been closed), then an Industry Member may reuse the Firm Designated ID for another trading account. The Plan Processor will maintain a history of the use of each Firm Designated ID, including, for example, the effective dates of the Firm Designated ID with respect to each associated trading account.
                    </P>
                </FTNT>
                <EXTRACT>
                    <P>a unique and persistent identifier for each trading account designated by Industry Members for purposes of providing data to the Central Repository . . . where each such identifier is unique among all identifiers from any given Industry Member.</P>
                </EXTRACT>
                <HD SOURCE="HD3">(3) Relationship Identifiers</HD>
                <P>
                    The FDID Amendment also permits an Industry Member to provide a relationship identifier as the Firm 
                    <PRTPAGE P="50060"/>
                    Designated ID, rather than an identifier that represents a trading account, in certain scenarios in which an Industry Member does not have an account number available to its order handling and/or execution system at the time of order receipt (
                    <E T="03">e.g.,</E>
                     certain institutional accounts, managed accounts, accounts for individuals). In such scenarios, the trading account structure may not be available when a new order is first received from a client and, instead, only an identifier representing the client's trading relationship is available. In these limited instances, the Industry Member may provide an identifier used by the Industry Member to represent the client's trading relationship with the Industry Member instead of an account number.
                </P>
                <P>
                    When a trading relationship is established at a broker-dealer for clients, the broker-dealer typically creates a parent account, under which additional subaccounts are created. However, in some cases, the broker-dealer establishes the parent relationship for a client using a relationship identifier as opposed to an actual parent account. The relationship identifier could be any of a variety of identifiers, such as a short name for a relevant individual or institution. This relationship identifier is established prior to any trading for the client. If a relationship identifier has been established rather than a parent account, and an order is placed on behalf of the client, any executed trades will be kept in a firm account (
                    <E T="03">e.g.,</E>
                     a facilitation or average price account) until they are allocated to the proper subaccount(s), 
                    <E T="03">i.e.,</E>
                     the accounts associated with the parent relationship identifier connecting them to the client.
                </P>
                <P>Relationship identifiers are used in circumstances in which the account structure is not available to the trading system at the time of order placement. The clients have established accounts prior to the trade that satisfy relevant regulatory obligations for opening accounts, such as Know Your Customer and other customer obligations. However, the order receipt workflows operate using relationship identifiers, not accounts.</P>
                <P>For Firm Designated ID purposes, as with an identifier for a trading account, the relationship identifier must be persistent over time. The relationship identifier also must be unique among all identifiers from any given Industry Member. With these requirements, a single relationship could be tracked across time within a single Industry Member using the Firm Designated ID. In addition, the relationship identifier must be masked as the relationship identifier could be a name or otherwise provide an indication as to the identity of the relationship. The masking requirement would avoid potentially revealing the identity of the relationship.</P>
                <P>An example of the use of a relationship identifier as a Firm Designated ID would be as follows: Suppose that Big Fund Manager is known in Industry Member A's systems as “BFM1.” When an order is placed by Big Fund Manager, the order is tagged to BFM1. Industry Member A could use a masked version of BFM1 in place of the Firm Designated ID representing a trading account when reporting a new order from Big Fund Manager instead of the account numbers to which executed shares/contracts will be allocated at a later time via a booking or other system. Similarly, another example of the use of a relationship identifier as a Firm Designated ID would involve an individual in place of the Big Fund Manager in the above example.</P>
                <P>In accordance with the FDID Amendment, the Exchange proposes to amend the definition of a “Firm Designated ID” in Rule 16010(r) to permit Industry Members to provide a relationship identifier as the Firm Designated ID as described above. Specifically, the Exchange proposes to amend the definition of “Firm Designated ID” in Rule 16010(r) to state that a Firm Designated ID means, in relevant part, “a unique and persistent relationship identifier when an Industry Member does not have an account number available to its order handling and/or execution system at the time of order receipt, provided, however, such identifier must be masked.”</P>
                <HD SOURCE="HD3">(4) Entity Identifiers</HD>
                <P>The FDID Amendment also permits Industry Members to provide an entity identifier, rather than an identifier that represents a trading account, when an employee of the Industry Member is exercising discretion over multiple client accounts and creates an aggregated order for which a trading account number of the Industry Member is not available at the time of order origination. An entity identifier is an identifier of the Industry Member that represents the firm discretionary relationship with the client rather than a firm trading account.</P>
                <P>The scenarios in which a firm uses an entity identifier are comparable to when a firm uses a relationship identifier (as described above) except the entity identifier represents the Industry Member rather than a client. As with relationship identifiers, entity identifiers are used in circumstances in which the account structure is not available to the trading system at the time of order placement. In this workflow, the Industry Member's order handling and/execution system does not have an account number at the time of order origination. The relevant clients that will receive an allocation of the execution have established accounts prior to the trade that satisfy relevant regulatory obligations for opening accounts, such as Know Your Customer and other customer obligations. However, the order origination workflows operate using entity identifiers, not accounts.</P>
                <P>For Firm Designated ID purposes, as with the identifier for a trading account or a relationship, the entity identifier must be persistent over time. The entity identifier also must be unique among all identifiers from any given Industry Member. Each Industry Member must make its own risk determination as to whether it believes it is necessary to mask the entity identifier when using an entity identifier to report the Firm Designated ID to CAT.</P>
                <P>An example of the use of an entity identifier as a Firm Designated ID would be when Industry Member 1 has an employee that is a registered representative that has discretion over several client accounts held at Industry Member 1. The registered representative places an order that he will later allocate to individual client accounts. At the time the order is placed, the trading system only knows it involves a representative of Industry Member 1 and it does not have a specific trading account that could be used for Firm Designated ID reporting. Therefore, Industry Member 1 could report IM1, its entity identifier, as the FDID with the new order.</P>
                <P>In accordance with the FDID Amendment, the Exchange proposes to amend the definition of “Firm Designated ID” in Rule 16010(r) to permit the use of an entity identifier as a Firm Designated ID as described above. Specifically, the Exchange proposes to amend the definition of a “Firm Designated ID” in Rule 16010(r) to state that a Firm Designated ID means, in relevant part, “a unique and persistent entity identifier when an employee of an Industry Member is exercising discretion over multiple client accounts and creates an aggregated order for which a trading account number of the Industry Member is not available at the time of order origination.”</P>
                <HD SOURCE="HD3">2. Statutory Basis</HD>
                <P>
                    The Exchange believes that the proposal is consistent with the 
                    <PRTPAGE P="50061"/>
                    requirements of Section 6(b) of the Act,
                    <SU>6</SU>
                    <FTREF/>
                     in general, and Section 6(b)(5) of the Act,
                    <SU>7</SU>
                    <FTREF/>
                     which require, among other things, that the Exchange's rules must be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest, and Section 15A(b)(9) of the Act,
                    <SU>8</SU>
                    <FTREF/>
                     Section 6(b)(8) of the Act,
                    <SU>9</SU>
                    <FTREF/>
                     which requires that the Exchange's rules not impose any burden on competition that is not necessary or appropriate.
                </P>
                <FTNT>
                    <P>
                        <SU>6</SU>
                         15 U.S.C. 78f(b).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>7</SU>
                         15 U.S.C. 78f(b)(5).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>8</SU>
                         15 U.S.C. 78o-3(b)(9) [sic].
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>9</SU>
                         15 U.S.C. 78f(b)(8)
                    </P>
                </FTNT>
                <P>
                    The Exchange believes that this proposal is consistent with the Act because it is consistent with, and implements, a recent amendment to the CAT NMS Plan, and is designed to assist the Exchange and its Industry Members in meeting regulatory obligations pursuant to the Plan. In approving the Plan, the SEC noted that the Plan “is necessary and appropriate in the public interest, for the protection of investors and the maintenance of fair and orderly markets, to remove impediments to, and perfect the mechanism of a national market system, or is otherwise in furtherance of the purposes of the Act.” 
                    <SU>10</SU>
                    <FTREF/>
                     To the extent that this proposal implements the Plan, and applies specific requirements to Industry Members, the Exchange believes that this proposal furthers the objectives of the Plan, as identified by the SEC, and is therefore consistent with the Act.
                </P>
                <FTNT>
                    <P>
                        <SU>10</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 79318 (November 15, 2016), 81 FR 84696, 84697 (November 23, 2016).
                    </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 result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange notes that the proposed rule changes are consistent with a recent amendment to the CAT NMS Plan, and are designed to assist the Exchange in meeting its regulatory obligations pursuant to the Plan. The Exchange also notes that the FDID Amendment will apply equally to all Industry Members that trade NMS Securities and OTC Equity Securities. In addition, all national securities exchanges and FINRA are proposing this amendment to their Compliance Rules. Therefore, this is not a competitive rule filing, and, therefore, it does not impose a 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>The Exchange has neither solicited nor received comments on the proposed rule change.</P>
                <HD SOURCE="HD1">III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action</HD>
                <P>
                    The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act 
                    <SU>11</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6) thereunder.
                    <SU>12</SU>
                    <FTREF/>
                     Because the proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative prior to 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, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 
                    <SU>13</SU>
                    <FTREF/>
                     and Rule 19b-4(f)(6)(iii) thereunder.
                    <SU>14</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>11</SU>
                         15 U.S.C. 78s(b)(3)(A)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>12</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>13</SU>
                         15 U.S.C. 78s(b)(3)(A).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>14</SU>
                         17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii) requires the Exchange to give the Commission written notice of the Exchange's 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, or such shorter time as designated by the Commission. The Exchange has satisfied this requirement.
                    </P>
                </FTNT>
                <P>
                    A proposed rule change filed under Rule 19b-4(f)(6) 
                    <SU>15</SU>
                    <FTREF/>
                     normally does not become operative prior to 30 days after the date of the filing. However, pursuant to Rule 19b-4(f)(6)(iii),
                    <SU>16</SU>
                    <FTREF/>
                     the Commission may designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange has asked the Commission to waive the 30-day operative delay so that the proposal may become operative upon filing. The Commission believes that waiver of the 30-day operative delay is consistent with the protection of investors and the public interest because it implements an amendment to the CAT NMS Plan approved by the Commission.
                    <SU>17</SU>
                    <FTREF/>
                     Accordingly, the Commission hereby waives the 30-day operative delay and designates the proposal operative upon filing.
                    <SU>18</SU>
                    <FTREF/>
                </P>
                <FTNT>
                    <P>
                        <SU>15</SU>
                         17 CFR 240.19b-4(f)(6).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>16</SU>
                         17 CFR 240.19b-4(f)(6)(iii).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>17</SU>
                         
                        <E T="03">See</E>
                         Securities Exchange Act Release No. 89397 (July 24, 2020) (
                        <E T="04">Federal Register</E>
                         publication pending).
                    </P>
                </FTNT>
                <FTNT>
                    <P>
                        <SU>18</SU>
                         For purposes only of waiving the 30-day operative delay, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation. 
                        <E T="03">See</E>
                         15 U.S.C. 78c(f).
                    </P>
                </FTNT>
                <P>At any time within 60 days of the filing of this proposed rule change, the Commission summarily may temporarily suspend 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. If the Commission takes such action, the Commission will institute proceedings to determine whether the proposed rule change should be approved or 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 email to 
                    <E T="03">rule-comments@sec.gov.</E>
                     Please include File Number SR-BOX-2020-33 on the subject line.
                </P>
                <HD SOURCE="HD2">Paper Comments</HD>
                <P>• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.</P>
                <FP>
                    All submissions should refer to File Number SR-BOX-2020-33. This file number should be included on the subject line if email 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 website (
                    <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 website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal 
                    <PRTPAGE P="50062"/>
                    office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-BOX-2020-33, and should be submitted on or before September 8, 2020.
                </FP>
                <SIG>
                    <P>
                        For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
                        <SU>19</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             17 CFR 200.30-3(a)(12).
                        </P>
                    </FTNT>
                    <NAME>J. Matthew DeLesDernier,</NAME>
                    <TITLE>Assistant Secretary.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17828 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8011-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">SMALL BUSINESS ADMINISTRATION </AGENCY>
                <RIN>RIN 3245-AH31</RIN>
                <SUBJECT>Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Small Business Administration.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of technical amendment; request for comment request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Small Business Administration is amending the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs Policy Directive to clarify that successor-in-interest entities are eligible to receive phase III awards.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        These revisions to the SBIR/STTR Policy Directive take effect on October 1, 2020, without further action, unless significant adverse comment is received by September 16, 2020. If significant adverse comment is received, SBA will publish a timely withdrawal of the notice in the 
                        <E T="04">Federal Register</E>
                        .
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        You may submit comments, identified by number SBA-2020-XXXX through the Federal eRulemaking Portal: 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the instructions for submitting comments.
                    </P>
                    <P>
                        SBA will post all comments on 
                        <E T="03">www.regulations.gov.</E>
                         Please do not submit confidential business information (CBI) as defined in the User Notice at 
                        <E T="03">www.regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Jennifer Shieh at (202) 205-6817 or 
                        <E T="03">Jennifer.shieh@sba.gov.</E>
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Executive Summary</HD>
                <P>The mission of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs is to engage small business concerns (SBCs) to support scientific excellence and technological innovation through the investment of Federal research and research and development (R/R&amp;D) funding in critical American priorities to build a strong national economy. Both programs follow a three-phase process throughout the Federal Government to solicit proposals and award funding agreements for R/R&amp;D: Phase I, Phase II, and Phase III.</P>
                <P>The Small Business Act (the Act) requires that the Small Business Administration (SBA) issue a policy directive setting forth guidance to the Federal Agencies participating in the SBIR and STTR programs (Participating Agencies). The SBIR and STTR (SBIR/STTR) Policy Directive outlines how agencies must generally conduct their programs. Each Participating Agency, however, may tailor its program to meet the needs of the individual Agency, as long as the general principles of the program set forth in the Act and directive are followed. Therefore, when incorporating SBIR/STTR policy into agency-specific regulations and procedures, Participating Agencies may develop and apply processes needed to implement the policy effectively; however, no Participating Agency may develop and apply policies, directives, or clauses, that contradict, weaken, or conflict with the policy as stated in the directive.</P>
                <P>SBA reviews its Policy Directive regularly to determine areas that need updating and further clarification. It has come to SBA's attention that the language in section 6(a)(5) requires clarification to confirm for Participating Agencies and applicants that successor-in-interest entities are eligible to receive phase III SBIR/STTR awards. Section 6(a) of the Policy Directive addresses eligibility to receive SBIR/STTR awards. Paragraph (5) of this section specifically relates to the eligibility of entities that have received a novated award, a similarly-revised award, or are successor-in-interest entities. SBA is clarifying this paragraph in order to confirm the Agency's long-standing interpretation that permits successor-in-interest entities to receive phase III SBIR/STTR awards.</P>
                <HD SOURCE="HD1">II. Amendment</HD>
                <HD SOURCE="HD2">Section 6—Eligibility and Application (Proposal) Requirements</HD>
                <P>
                    The Small Business Act describes the three-phase nature of the programs. The first phase (phase I) award generally does not exceed $150,000 and is intended to fund the determination of the technical and scientific merit, and feasibility of ideas that appear to have commercial potential. 
                    <E T="03">See</E>
                     15 U.S.C. 638(e)(4)(A). The second phase (phase II) award generally does not exceed $1,000,000 and is intended to further develop proposals with commercial potential. 
                    <E T="03">See id.</E>
                     at § 638(e)(4)(B). The final third phase award (phase III) is defined, as follows:
                </P>
                <EXTRACT>
                    <P>
                        (C) where appropriate, a third phase for work that 
                        <E T="03">derives from, extends, or completes efforts made under prior funding agreements under the SBIR program</E>
                        —
                    </P>
                    <P>(i) in which commercial applications of SBIR-funded research or research and development are funded by non-Federal sources of capital or, for products or services intended for use by the Federal Government, by follow-on non-SBIR Federal funding awards; or</P>
                    <P>(ii) for which awards from non-SBIR Federal funding sources are used for the continuation of research or research and development that has been competitively selected using peer review or merit-based selection procedures;</P>
                </EXTRACT>
                <FP>15 U.S.C. 638(e)(4)(C) (emphasis added). One way that an SBC has achieved commercialization is through a phase III award.</FP>
                <P>A major feature of the SBIR/STTR programs, and incentive for SBC participation, is that the Government receives a limited rights license in data developed under an SBIR/STTR award, which fosters a competitive advantage for the SBC, as opposed to potential larger competitors, to achieve commercialization. The Government's limited rights license in SBIR/STTR data, combined with the statutory requirement for Participating Agencies to pursue phase III awards on a non-competitive basis with the SBC that performed prior SBIR/STTR awards, is a central aspect of the program.</P>
                <P>
                    The SBIR/STTR programs are intended to economically assist SBCs performing R/R&amp;D work by creating an advantage for those firms to receive Government funding at the early often riskiest stage, from an investment perspective, through commercialization. This intention may be hindered if the SBC's rights and interests in SBIR/STTR data cannot be assigned through a merger or sale with another business concern, along with the attendant incentives for non-competitive phase III awards. Such a policy interpretation would create inefficiencies in the marketplace and discourage valuations and transactions among businesses that may otherwise allow for greater investment in new ideas and products.
                    <PRTPAGE P="50063"/>
                </P>
                <P>Consistent with the statutory purposes and policy goals of the program, a firm may be considered a successor-in-interest and receive a subsequent SBIR/STTR award. An entity may be considered a successor-in-interest, if it has secured the transfer of: (1) All the small business concern's assets; or (2) the entire portion of the assets involved in performing the award. Examples of such transactions include, but are not limited to: (1) Sale of these assets with a provision for assuming liabilities; (2) transfer of these assets incident to a merger or corporate consolidation; and (3) incorporation of a proprietorship or partnership, or formation of a partnership. Further, to be considered a successor-in-interest, the firm must meet any applicable eligibility requirements. If performance of the funding agreement is complete prior to the transfer of assets, an entity may be considered a successor-in-interest without a novation. If the transfer of assets occurs during performance of the funding agreement, the awardee should verify with the awarding agency whether a novation is necessary.</P>
                <P>Section 6(a)(5) of the Policy Directive provides, only as an example, that a phase III award can be made when the previous SBIR/STTR awardee has received a phase I or phase II award, or been novated one of those awards. This was never intended to be an exclusive list of all scenarios where an SBIR/STTR award could be made to a firm other than the recipient of a prior phase I or phase II award.</P>
                <P>SBA amends the second sentence of section 6(a) of the Policy Directive to clarify SBA's long-standing intent regarding the eligibility of successor-in-interest entities to receive phase III awards. Currently, the first two sentences of this paragraph read as follows: “An SBIR/STTR Awardee may include, and SBIR/STTR work may be performed by, those identified via a `novated' or `successor in interest' or similarly-revised Funding Agreement. For example, in order to receive a Phase III award, the Awardee must have either received a prior Phase I or Phase II award or been novated a Phase I or Phase II award (or received a revised Phase I or Phase II award if a grant or cooperative grant).” SBA changes “must” to “may” in the second sentence and adds “successor-in-interest” to the list of possible eligible entities at the end of the sentence. This would not be a change in policy, but rather, a clarification of existing policy.</P>
                <P>This clarification is necessary to provide confidence to Participating Agencies and applicants that entities that acquire access to the relevant SBIR/STTR data developed pursuant to prior SBIR/STTR awards, may be eligible to receive a phase III award as a successor-in-interest without novation if the performance of the prior SBIR/STTR award is complete.</P>
                <HD SOURCE="HD2">Notice of Clarification of Phase III Eligibility in the Policy Directive for the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Programs</HD>
                <HD SOURCE="HD3">To: The SBIR and STTR Program Managers</HD>
                <HD SOURCE="HD3">Subject: SBIR/STTR Policy Directive</HD>
                <P>
                    1. 
                    <E T="03">Purpose.</E>
                     The Small Business Administration (SBA) is updating its Small Business Innovation Research and Small Business Technology Transfer Research (SBIR/STTR) Policy Directives to clarify SBA's current policy that successor-in-interest entities are eligible to receive phase III SBIR/STTR awards.
                </P>
                <P>
                    2. 
                    <E T="03">Authority.</E>
                     The Small Business Act (15 U.S.C. 638(j) and (p)) requires the SBA Administrator to issue an SBIR and STTR program Policy Directive for the general conduct of the programs.
                </P>
                <P>
                    3. 
                    <E T="03">Procurement Regulations.</E>
                     There are no procurement regulations created by this proposed clarification.
                </P>
                <P>
                    4. 
                    <E T="03">Personnel Concerned.</E>
                     This SBIR/STTR Policy Directive serves as guidance for all Federal Government personnel who are involved in the administration of the SBIR and STTR programs, issuance and management of funding agreements or contracts pursuant to the programs, and/or the establishment of goals for small business concerns in research or research and development acquisition or grants.
                </P>
                <P>
                    5. 
                    <E T="03">Originator.</E>
                     SBA's Office of Investment and Innovation.
                </P>
                <P>
                    This amendment to the SBIR/STTR Policy Directive will be effective on the date shown in the 
                    <E T="02">DATES</E>
                     section unless SBA receives any significant adverse comments on or before the deadline for comments set forth in the 
                    <E T="02">DATES</E>
                     section. Significant adverse comments are comments that provide strong justifications why the clarifying amendment to the PD should not be adopted as written or should be changed further. SBA does not expect to receive any significant adverse comments because the amendment does not change SBA's or Participating Agencies' interpretation of existing policy, and continues to confer the intended incentive for SBIR/STTR awardee successor-in-interest entities. Implementation of this change will benefit the public by ensuring that the plain language interpretation of the SBIR/STTR Policy Directive is consistent with SBA's policy intent. If SBA receives any significant adverse comments, SBA will publish a notice in the 
                    <E T="04">Federal Register</E>
                     withdrawing this notice before the effective date.
                </P>
                <P>
                    6. 
                    <E T="03">Date.</E>
                     Public comments on the proposed amendments to the Policy Directive must be submitted within 30 days following publication in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <SIG>
                    <P>Authorized By:</P>
                    <NAME>Jovita Carranza,</NAME>
                    <TITLE>Administrator.</TITLE>
                </SIG>
                <P>SBA revises section 6(a)(5) of the SBIR/STTR Policy Directive as follows:</P>
                <HD SOURCE="HD1">6. Eligibility and Application (Proposal) Requirements</HD>
                <HD SOURCE="HD2">
                    (a) 
                    <E T="03">Eligibility Requirements</E>
                </HD>
                <P>(1) * * *</P>
                <STARS/>
                <P>
                    (5) 
                    <E T="03">Novated/Successor in Interested/Revised Funding Agreements.</E>
                     An SBIR/STTR Awardee may include, and SBIR/STTR work may be performed by, those identified via a “novated” or “successor in interest” or similarly-revised Funding Agreement. For example, a phase III Awardee may have either received a prior Phase I or Phase II award or been novated a Phase I or Phase II award (or received a revised Phase I or Phase II award if a grant or cooperative grant) or be a successor-in-interest entity. * * *
                </P>
                <STARS/>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17815 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8026-03-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <SUBJECT>Commercial Space Transportation Advisory Committee: Notice of Public Meeting</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration, Department of Transportation.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of public meeting.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>This notice announces a meeting of the Commercial Space Transportation Advisory Committee for September 14, 2020.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        The September 14, 2020 meeting will be held from 8:45 a.m. to 3:30 p.m. Requests to attend the meeting must be received by September 4, 2020. Requests for accommodations to a disability must be received by September 4, 2020. Requests to speak during the meeting must be submitted by September 4, 2020 to DOT and include a written copy of their remarks. Requests to submit 
                        <PRTPAGE P="50064"/>
                        written materials to be reviewed during the meeting must be received by DOT no later than September 4, 2020.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        The September 14, 2020 meeting will be an internet-only meeting. No physical meeting is planned. Instructions on how to attend the meeting, copies of meeting minutes and a detailed agenda will be posted on the COMSTAC website at: 
                        <E T="03">https://www.faa.gov/space/additional_information/comstac/.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        James Hatt, Designated Federal Officer, U.S. Department of Transportation, at 
                        <E T="03">james.a.hatt@faa.gov.</E>
                         Any committee related request should be sent to the person listed in this section.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Background</HD>
                <P>The Commercial Space Transportation Advisory Committee was created under the Federal Advisory Committee Act (FACA), in accordance with Public Law 92-463. Since its inception, industry-led COMSTAC has provided information, advice, and recommendations to the U.S. Department of Transportation through FAA regarding technology, business, and policy issues relevant to oversight of the U.S. commercial space transportation sector.</P>
                <HD SOURCE="HD1">II. Proposed Agenda</HD>
                <FP SOURCE="FP-1">A. Review of Taskers Assigned at the Previous Meeting</FP>
                <FP SOURCE="FP-1">B. Assignment of New Taskers to COMSTAC</FP>
                <FP SOURCE="FP-1">C. Public Comment</FP>
                <HD SOURCE="HD1">III. Public Participation</HD>
                <P>
                    The meeting listed in this notice will be open to the public. The US Department of Transportation is committed to providing equal access to this meeting for all participants. If you need alternative formats or services because of a disability, such as sign language, interpretation, or other ancillary aids, please contact the person listed in the 
                    <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                     section.
                </P>
                <P>There will be at least thirty minutes allotted for oral comments from members of the public joining a COMSTAC meeting. To accommodate as many speakers as possible, the time for each commenter may be limited. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration, as well as the name, address, and organizational affiliation of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the FAA Office of Commercial Space Transportation may conduct a lottery to determine the speakers. Speakers are requested to submit a written copy of their prepared remarks for inclusion in the meeting records and for circulation to COMSTAC members. All prepared remarks submitted on time will be accepted and considered as part of the record. Any member of the public may present a written statement to the committee at any time.</P>
                <SIG>
                    <DATED>Issued in Washington, DC, this 17th day of August 2020.</DATED>
                    <NAME>James A. Hatt,</NAME>
                    <TITLE>Designated Federal Officer, Commercial Space Transportation Advisory Committee, Federal Aviation Administration, Department of Transportation.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17898 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-13-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Aviation Administration</SUBAGY>
                <SUBJECT>Notice of Opportunity for Public Comment Equal Land Swap of .64 Acres at Tweed-New Haven Airport, New Haven, CT Withdrawal</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Aviation Administration (FAA), Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Withdrawal of notice.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Notice is being given that the FAA is withdrawing a Notice of Opportunity for Public Comment for the City of New Haven, CT to exchange a .64 acre parcel of land with an adjacent land owner of equal size and value at Tweed-New Haven Regional Airport. The exchange of land will provide the airport with the necessary land to build an extension of a parallel taxiway and vehicle service road that will serve the end of Runway 20. A 
                        <E T="04">Federal Register</E>
                         notice is not required for this specific action. The Notice, Document Number: 2020-17150, 85 FR 47838, Page 47838, was published in the 
                        <E T="04">Federal Register</E>
                         on August 6, 2020 and is currently on public inspection.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Comments must be received on or before September 3, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may send comments using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov,</E>
                         and follow the instructions on providing comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         202-493-2251.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver to mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
                    </P>
                    <P>
                        Interested persons may inspect the request and supporting documents by contacting the FAA at the address listed under 
                        <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                        .
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Mr. Jorge E. Panteli, Compliance and Land Use Specialist, Federal Aviation Administration New England Region Airports Division, 1200 District Avenue, Burlington, Massachusetts 01803. Telephone: 781-238-7618.</P>
                    <SIG>
                        <DATED>Issued in Burlington, Massachusetts, on August 12, 2020.</DATED>
                        <NAME>Julie Seltsam-Wilps,</NAME>
                        <TITLE>Deputy Director, ANE-600.</TITLE>
                    </SIG>
                </FURINF>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17930 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>Federal Motor Carrier Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. FMCSA-2013-0444; FMCSA-2014-0212; FMCSA-2015-0321; FMCSA-2018-0051; FMCSA-2018-0052; FMCSA-2018-0053]</DEPDOC>
                <SUBJECT>Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Federal Motor Carrier Safety Administration (FMCSA), DOT.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of renewal of exemptions; request for comments.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>FMCSA announces its decision to renew exemptions for nine individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have “no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.” The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before September 16, 2020.</P>
                </DATES>
                <ADD>
                    <PRTPAGE P="50065"/>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>You may submit comments identified by the Federal Docket Management System (FDMS) Docket No. FMCSA-2013-0444, Docket No. FMCSA-2014-0212, Docket No. FMCSA-2015-0321, Docket No. FMCSA-2018-0051, Docket No. FMCSA-2018-0052, or Docket No. FMCSA-2018-0052 using any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Federal eRulemaking Portal:</E>
                         Go to 
                        <E T="03">http://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Docket Operations; U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal Holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Fax:</E>
                         (202) 493-2251.
                    </P>
                    <P>
                        To avoid duplication, please use only one of these four methods. See the “Public Participation” portion of the 
                        <E T="02">SUPPLEMENTARY INFORMATION</E>
                         section for instructions on submitting comments.
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001, 
                        <E T="03">fmcsamedical@dot.gov,</E>
                         FMCSA, Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224, Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., ET, Monday through Friday, except Federal holidays. If you have questions regarding viewing or submitting material to the docket, contact Docket Operations, (202) 366-9826.
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <HD SOURCE="HD1">I. Public Participation</HD>
                <HD SOURCE="HD2">A. Submitting Comments</HD>
                <P>If you submit a comment, please include the docket number for this notice (Docket No. FMCSA-2013-0444, FMCSA-2014-0212, FMCSA-2015-0321, FMCSA-2018-0051, FMCSA-2018-0052, or FMCSA-2018-0052), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.</P>
                <P>
                    To submit your comment online, go to 
                    <E T="03">http://www.regulations.gov,</E>
                     put the docket number, FMCSA-2013-0444, FMCSA-2014-0212, FMCSA-2015-0321, FMCSA-2018-0051, FMCSA-2018-0052, or FMCSA-2018-0052, in the keyword box, and click “Search.” When the new screen appears, click on the “Comment Now!” button and type your comment into the text box on the following screen. Choose whether you are submitting your comment as an individual or on behalf of a third party and then submit.
                </P>
                <P>
                    If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
                    <FR>1/2</FR>
                     by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the facility, please enclose a stamped, self-addressed postcard or envelope.
                </P>
                <P>FMCSA will consider all comments and material received during the comment period.</P>
                <HD SOURCE="HD2">B. Viewing Documents and Comments</HD>
                <P>
                    To view comments, as well as any documents mentioned in this notice as being available in the docket, go to 
                    <E T="03">http://www.regulations.gov.</E>
                     Insert the docket number, FMCSA-2013-0444, FMCSA-2014-0212, FMCSA-2015-0321, FMCSA-2018-0051, FMCSA-2018-0052, or FMCSA-2018-0052, in the keyword box, and click “Search.” Next, click the “Open Docket Folder” button and choose the document to review. If you do not have access to the internet, you may view the docket online by visiting Docket Operations in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To be sure someone is there to help you, please call (202) 366-9317 or (202) 366-9826 before visiting Docket Operations.
                </P>
                <HD SOURCE="HD2">C. Privacy Act</HD>
                <P>
                    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to 
                    <E T="03">www.regulations.gov,</E>
                     as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at 
                    <E T="03">www.transportation.gov/privacy.</E>
                </P>
                <HD SOURCE="HD1">II. Background</HD>
                <P>Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption from the FMCSRs for no longer than a 5-year period if it finds such exemption would likely achieve a level of safety that is equivalent to, or greater than, the level that would be achieved absent such exemption. The statute also allows the Agency to renew exemptions at the end of the 5-year period. FMCSA grants medical exemptions from the FMCSRs for a 2-year period to align with the maximum duration of a driver's medical certification.</P>
                <P>The physical qualification standard for drivers regarding epilepsy found in 49 CFR 391.41(b)(8) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause the loss of consciousness or any loss of ability to control a CMV.</P>
                <P>
                    In addition to the regulations, FMCSA has published advisory criteria 
                    <SU>1</SU>
                    <FTREF/>
                     to assist medical examiners (MEs) in determining whether drivers with certain medical conditions are qualified to operate a CMV in interstate commerce.
                </P>
                <FTNT>
                    <P>
                        <SU>1</SU>
                         These criteria may be found in APPENDIX A TO PART 391—MEDICAL ADVISORY CRITERIA, section H. 
                        <E T="03">Epilepsy:</E>
                         § 391.41(b)(8), paragraphs 3, 4, and 5, which is available on the internet at 
                        <E T="03">https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.</E>
                    </P>
                </FTNT>
                <P>The nine individuals listed in this notice have requested renewal of their exemptions from the epilepsy and seizure disorders prohibition in § 391.41(b)(8), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable 2-year period.</P>
                <HD SOURCE="HD1">III. Request for Comments</HD>
                <P>Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b), FMCSA will take immediate steps to revoke the exemption of a driver.</P>
                <HD SOURCE="HD1">IV. Basis for Renewing Exemptions</HD>
                <P>
                    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the nine applicants has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition. The nine drivers in this notice remain in good standing with the 
                    <PRTPAGE P="50066"/>
                    Agency, have maintained their medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous 2-year exemption period. In addition, for Commercial Driver's License (CDL) holders, the Commercial Driver's License Information System and the Motor Carrier Management Information System are searched for crash and violation data. For non-CDL holders, the Agency reviews the driving records from the State Driver's Licensing Agency. These factors provide an adequate basis for predicting each driver's ability to continue to safely operate a CMV in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each renewal applicant for a period of 2 years is likely to achieve a level of safety equal to that existing without the exemption.
                </P>
                <P>In accordance with 49 U.S.C. 31136(e) and 31315(b), the following groups of drivers received renewed exemptions in the month of August and are discussed below. As of August 1, 2020, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following eight individuals have satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:</P>
                <FP SOURCE="FP-1">Brian Checkley (NJ)</FP>
                <FP SOURCE="FP-1">Steven Ford (WI)</FP>
                <FP SOURCE="FP-1">Paul Gomez (CA)</FP>
                <FP SOURCE="FP-1">Thomas Ork (NY)</FP>
                <FP SOURCE="FP-1">Milton Tatham (NV)</FP>
                <FP SOURCE="FP-1">Phillip Moore (CT)</FP>
                <FP SOURCE="FP-1">Joshua Thomas (MN)</FP>
                <FP SOURCE="FP-1">Troy Nichols (TX)</FP>
                <P>The drivers were included in docket number FMCSA-2013-0444, FMCSA-2015-0321, FMCSA-2018-0051, FMCSA-2018-0052, and FMCSA-2018-0052. Their exemptions are applicable as of August 1, 2020, and will expire on August 1, 2022.</P>
                <P>As of August 28, 2020, and in accordance with 49 U.S.C. 31136(e) and 31315(b), the following individual has satisfied the renewal conditions for obtaining an exemption from the epilepsy and seizure disorders prohibition in the FMCSRs for interstate CMV drivers:</P>
                <FP SOURCE="FP-1">Terry Hamby (NC)</FP>
                <P>This driver was included in docket number FMCSA-2014-0212. The exemption is applicable as of August 28, 2020, and will expire on August 28, 2022.</P>
                <HD SOURCE="HD1">V. Conditions and Requirements</HD>
                <P>The exemptions are extended subject to the following conditions: (1) Each driver must remain seizure-free and maintain a stable treatment during the 2-year exemption period; (2) each driver must submit annual reports from their treating physicians attesting to the stability of treatment and that the driver has remained seizure-free; (3) each driver must undergo an annual medical examination by a certified ME, as defined by § 390.5; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy of his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).</P>
                <HD SOURCE="HD1">VI. Preemption</HD>
                <P>During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.</P>
                <HD SOURCE="HD1">VII. Conclusion</HD>
                <P>Based on its evaluation of the nine exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the epilepsy and seizure disorders prohibition in § 391.41(b)(8). In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption will be valid for 2 years unless revoked earlier by FMCSA.</P>
                <SIG>
                    <NAME>Larry W. Minor,</NAME>
                    <TITLE>Associate Administrator for Policy.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17824 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-EX-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF TRANSPORTATION</AGENCY>
                <SUBAGY>National Highway Traffic Safety Administration</SUBAGY>
                <DEPDOC>[Docket No. NHTSA-2020-0034; Notice 1]</DEPDOC>
                <SUBJECT>Yamaha Motor Corporation, U.S.A., Receipt of Petition for Decision of Inconsequential Noncompliance</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Receipt of petition.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        Yamaha Motor Corporation, U.S.A., (Yamaha) has determined that certain model year (MY) 2019 Yamaha NIKEN motorcycles do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 122, 
                        <E T="03">Motorcycle Brake Systems.</E>
                         Yamaha filed a noncompliance report dated February 26, 2020. Yamaha subsequently petitioned NHTSA on May 28, 2020, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This notice announces receipt of Yamaha's petition.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>Send comments on or before September 16, 2020.</P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:</P>
                    <P>
                        • 
                        <E T="03">Mail:</E>
                         Send comments by mail addressed to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
                    </P>
                    <P>
                        • 
                        <E T="03">Hand Delivery:</E>
                         Deliver comments by hand to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m. except for Federal holidays.
                    </P>
                    <P>
                        • 
                        <E T="03">Electronically:</E>
                         Submit comments electronically by logging onto the Federal Docket Management System (FDMS) website at 
                        <E T="03">https://www.regulations.gov.</E>
                         Follow the online instructions for submitting comments.
                    </P>
                    <P>• Comments may also be faxed to (202) 493-2251.</P>
                    <P>
                        Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to 
                        <E T="03">https://www.regulations.gov,</E>
                         including any personal information provided.
                    </P>
                    <P>
                        All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and 
                        <PRTPAGE P="50067"/>
                        supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
                    </P>
                    <P>
                        When the petition is granted or denied, notice of the decision will also be published in the 
                        <E T="04">Federal Register</E>
                         pursuant to the authority indicated at the end of this notice.
                    </P>
                    <P>
                        All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at 
                        <E T="03">https://www.regulations.gov</E>
                         by following the online instructions for accessing the docket. The docket ID number for this petition is shown in the heading of this notice.
                    </P>
                    <P>
                        DOT's complete Privacy Act Statement is available for review in a 
                        <E T="04">Federal Register</E>
                         notice published on April 11, 2000 (65 FR 19477-78).
                    </P>
                </ADD>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P/>
                <P>
                    <E T="03">I. Overview:</E>
                     Yamaha has determined that certain MY 2019 Yamaha NIKEN motorcycles do not fully comply with the requirements of paragraph S5.1.7 of FMVSS No. 122, 
                    <E T="03">Motorcycle Brake Systems</E>
                     (49 CFR 571.122). Yamaha filed a noncompliance report dated February 26, 2020, pursuant to 49 CFR part 573, 
                    <E T="03">Defect and Noncompliance Responsibility and Reports.</E>
                     Yamaha subsequently petitioned NHTSA on May 28, 2020, for an exemption from the notification and remedy requirements of 49 U.S.C. Chapter 301 on the basis that this noncompliance is inconsequential as it relates to motor vehicle safety, pursuant to 49 U.S.C. 30118(d) and 30120(h) and 49 CFR part 556, 
                    <E T="03">Exemption for Inconsequential Defect or Noncompliance.</E>
                </P>
                <P>This notice of receipt of Yamaha's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.</P>
                <P>
                    <E T="03">II. Motorcycles Involved:</E>
                     Approximately 278 MY 2019 Yamaha NIKEN motorcycles manufactured between August 1, 2018, and July 31, 2019, are potentially involved.
                </P>
                <P>
                    <E T="03">III. Noncompliance:</E>
                     Yamaha explains that the noncompliance is that the subject motorcycles do not comply with the requirement for class 3-5 motorcycle braking systems, as specified in paragraph S5.1.7 in FMVSS No. 122. Specifically, due to the motorcycles being classified as a category 3-5 motorcycle rather than a 3-3 motorcycle, the motorcycles lack the required trike parking brake and integrated rear brake system.
                </P>
                <P>
                    <E T="03">IV. Rule Requirements:</E>
                     Paragraph S5.1.7 of FMVSS No. 122 includes the requirements relevant to this petition. Each category 3-5 motorcycle shall be equipped with: (a) A parking brake system; and (b) a foot actuated service brake system which operates the brakes on all wheels by way of either (1) a split service brake system; or (2) a combined brake system (CBS) and a secondary brake system, which may be the parking brake system.
                </P>
                <P>
                    <E T="03">V. Background:</E>
                     NHTSA contacted Yamaha on February 16, 2020 and informed the company that the agency's position is that the subject motorcycles did not meet the definition of a traditional two-wheeled motorcycle. While Yamaha maintained that the proximity of the two front wheels to each other indicated that the Niken was a two wheeled motorcycle, NHTSA classifies the product as a three wheeled trike, and as such, the Niken does not possess the required trike parking brake and integrated rear brake system.
                </P>
                <P>
                    <E T="03">VI. Summary of Yamaha's Petition:</E>
                     The following views and arguments presented in this section, VI. Summary of Yamaha's Petition, are the views and arguments provided by Yamaha. They have not been evaluated by the Agency and do not reflect the views of the Agency. Yamaha described the subject noncompliance and stated their belief that the noncompliance is inconsequential as it relates to motor vehicle safety.
                </P>
                <P>In support of its petition, Yamaha submitted the following reasoning:</P>
                <P>1. NHTSA stated that their contract test laboratory was unable to complete compliance testing because the NIKEN lacked two “requirements”: (1) Parking brake and (2) foot brake actuating on all wheels. Yamaha independently conducted the relevant compliance testing and the test results demonstrate that the NIKEN substantially satisfies the “requirements” detailed below:</P>
                <P>a. Parking Brake: Requirements for a parking brake are presumably in place to keep a vehicle from unwanted movement while in a parked condition, such as on a slope. However, traditional two-wheeled and narrow-twin-front-wheeled motorcycles cannot stand unsupported; they simply fall over. Should a traditional motorcycle be parked on a slope (up-hill or down) on the side stand, it is a customary for the rider to park in-gear, locking the vehicle against movement. Likewise, by adapting this standard practice, the NIKEN can be parked on a slope (up-hill or down) on the side-stand just as a rider of a traditional two wheeled motorcycle would be. In an effort to emulate the test environment, the brake system was conditioned, and the engine was disconnected (placed in neutral) in accordance with paragraph S6.8; the NIKEN was placed on the test surface on the vehicle's main stand. According to requirements in FMVSS No. 122, the Laden vehicle shall be held stationary for 5 minutes, both in an up-hill and down-hill configuration at the required 18% (10.2°) gradient for 5 minutes. The NIKEN, exceeds this requirement.</P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s50,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">
                            Standard 18%
                            <LI>(10.2°)</LI>
                        </CHED>
                        <CHED H="1">Up-hill</CHED>
                        <CHED H="1">Down-hill</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">NIKEN on Main Stand</ENT>
                        <ENT>12.0°</ENT>
                        <ENT>
                            11.8°
                            <SU>0</SU>
                        </ENT>
                    </ROW>
                </GPOTABLE>
                <P>It should be noted that approximately 70% of NIKENs currently in use have main stands, the balance have only side stands. Yamaha genuine accessory Main Stands could be added to those without quite easily.</P>
                <P>
                    b. Foot brake actuating on all wheels: Likewise, NHTSA testing staff was unable to complete the testing of braking performance of the “split or CBS” system, as the NIKEN utilizes the conventional separate (independently controlled) front and rear braking system found on most similar sport-performance type motorcycles. When Yamaha tested the NIKEN's all-wheel, anti-lock brake system, Yamaha found that the brake system, in a laden condition, met NHTSA's single actuated brake control test. The NIKEN, in a laden condition, met the requirements with the rear brake alone and, likewise, when tested with the front brake alone, the NIKEN exceeded the standard test requirements and stopping distances. In the lightly loaded condition, the NIKEN exceeded the braking target by a mere 30 cm. However, when the user-induced front brake is combined with the NIKEN's rear brake system, typical of motorcycle rider brake application, this vehicle exceeds NHTSA requirements by considerable margin.
                    <PRTPAGE P="50068"/>
                </P>
                <GPOTABLE COLS="7" OPTS="L2,tp0,i1" CDEF="s25,r25,12,12,12,12,12">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1"> </CHED>
                        <CHED H="1"> </CHED>
                        <CHED H="1">
                            Mass
                            <LI>(kg)</LI>
                        </CHED>
                        <CHED H="2">Front</CHED>
                        <CHED H="2">Rear</CHED>
                        <CHED H="2">Total</CHED>
                        <CHED H="1">
                            Target
                            <LI>(m)</LI>
                        </CHED>
                        <CHED H="1">
                            Result
                            <LI>(m)</LI>
                        </CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">Rear</ENT>
                        <ENT>Lightly loaded</ENT>
                        <ENT>170.7</ENT>
                        <ENT>181.9</ENT>
                        <ENT>352.6</ENT>
                        <ENT>33.7</ENT>
                        <ENT>34.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="22"> </ENT>
                        <ENT>Laden</ENT>
                        <ENT>171.1</ENT>
                        <ENT>289.8</ENT>
                        <ENT>460.9</ENT>
                        <ENT>33.7</ENT>
                        <ENT>31.0</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">Front</ENT>
                        <ENT>Laden</ENT>
                        <ENT>171.1</ENT>
                        <ENT>289.8</ENT>
                        <ENT>460.9</ENT>
                        <ENT>61.4</ENT>
                        <ENT>25.8</ENT>
                    </ROW>
                </GPOTABLE>
                <P>Results show that the NIKEN substantially meets the performance criteria for brake performance without the Split or CBS braking system, while providing riders the more active control and better brake feel they expect from a performance sport machine.</P>
                <P>2. It is the belief of Yamaha that the information described above satisfies the intent of 49 CFR part 573 and that the operator can safety operate the vehicle. The NIKEN was designed to perform and react similarly to a traditional two-wheeled motorcycle primarily for experienced, enthusiast riders, and provides the safety features and performance that these riders expect from a motorcycle.</P>
                <P>Yamaha concluded by expressing the belief that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.</P>
                <P>NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject motorcycles that Yamaha no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant motorcycles under their control after Yamaha notified them that the subject noncompliance existed.</P>
                <EXTRACT>
                    <FP>(Authority: 49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8)</FP>
                </EXTRACT>
                <SIG>
                    <NAME>Otto G. Matheke III,</NAME>
                    <TITLE>Director, Office of Vehicle Safety Compliance.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17905 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-59-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">UNIFIED CARRIER REGISTRATION PLAN</AGENCY>
                <SUBJECT>Sunshine Act Meeting Notice; Unified Carrier Registration Plan Board Subcommittee Meeting</SUBJECT>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>August 20, 2020, from Noon to 2 p.m., Eastern time.</P>
                </DATES>
                <PREAMHD>
                    <HD SOURCE="HED">PLACE: </HD>
                    <P>
                        This meeting will be accessible via conference call and via Zoom Meeting and Screenshare. Any interested person may call (i) 1-929-205-6099 (U.S. Toll) or 1-669-900-6833 (U.S. Toll) or (ii) 1-877-853-5247 (U.S. Toll Free) or 1-888-788-0099 (U.S. Toll Free), Meeting ID: 978 5932 8076, to listen and participate in this meeting. The website to participate via Zoom Meeting and Screenshare is 
                        <E T="03">https://kellen.zoom.us/j/97859328076.</E>
                    </P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">STATUS:</HD>
                    <P>This meeting will be open to the public.</P>
                </PREAMHD>
                <PREAMHD>
                    <HD SOURCE="HED">MATTERS TO BE CONSIDERED:</HD>
                    <P>The Unified Carrier Registration Plan Education and Training Subcommittee (the “Subcommittee”) will continue its work in developing and implementing the Unified Carrier Registration Plan and Agreement. The subject matter of this meeting will include:</P>
                </PREAMHD>
                <HD SOURCE="HD1">Proposed Agenda</HD>
                <HD SOURCE="HD2">I. Call to Order—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will welcome attendees, call the meeting to order, call roll for the Subcommittee, confirm whether a quorum is present, and facilitate self-introductions.</P>
                <HD SOURCE="HD2">II. Verification of Publication of Meeting Notice—UCR Executive Director</HD>
                <P>
                    The UCR Executive Director will verify the publication of the meeting notice on the UCR website and distribution to the UCR contact list via email followed by the subsequent publication of the notice in the 
                    <E T="04">Federal Register</E>
                    .
                </P>
                <HD SOURCE="HD2">III. Review and Approval of Subcommittee Agenda and Setting of Ground Rules—Subcommittee Chair</HD>
                <HD SOURCE="HD3">For Discussion and Possible Subcommittee Action</HD>
                <P>The Subcommittee Agenda will be reviewed and the Subcommittee will consider adoption.</P>
                <HD SOURCE="HD3">Ground Rules</HD>
                <P>Subcommittee action only to be taken in designated areas on agenda.</P>
                <HD SOURCE="HD2">IV. Approval of Minutes From May 14, 2020 Meeting—Subcommittee Chair</HD>
                <HD SOURCE="HD3">For Discussion and Possible Subcommittee Action</HD>
                <P>Draft minutes from the May 14, 2020 Education and Training Subcommittee meeting via teleconference will be reviewed. The Subcommittee will consider action to approve.</P>
                <HD SOURCE="HD2">V. Discuss Needed Future Training Modules—Subcommittee Chair</HD>
                <P>The Subcommittee will discuss and provide comments on needed future education and training modules.</P>
                <HD SOURCE="HD2">VI. Discuss Priority of Training Modules To Be Developed—Subcommittee Chair</HD>
                <P>The Subcommittee will discuss and rank by development priority needed future education and training modules.</P>
                <HD SOURCE="HD2">VII. Other Items—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will call for any other items the committee members would like to discuss.</P>
                <HD SOURCE="HD2">VIII. Adjournment—Subcommittee Chair</HD>
                <P>The Subcommittee Chair will adjourn the meeting.</P>
                <P>
                    The agenda will be available no later than 5 p.m. Eastern time, August 11, 2020 at: 
                    <E T="03">https://plan.ucr.gov.</E>
                </P>
                <PREAMHD>
                    <HD SOURCE="HED">CONTACT PERSON FOR MORE INFORMATION:</HD>
                    <P>
                        Elizabeth Leaman, Chair, Unified Carrier Registration Plan Board of Directors, (617) 305-3783, 
                        <E T="03">eleaman@board.ucr.gov.</E>
                    </P>
                </PREAMHD>
                <SIG>
                    <NAME>Alex B. Leath,</NAME>
                    <TITLE>Chief Legal Officer, Unified Carrier Registration Plan.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-18010 Filed 8-13-20; 11:15 am]</FRDOC>
            <BILCOD>BILLING CODE 4910-YL-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Advisory Committee on Women Veterans, Notice of Meeting</SUBJECT>
                <P>
                    The Department of Veterans Affairs (VA) gives notice under the Federal 
                    <PRTPAGE P="50069"/>
                    Advisory Committee Act that the Advisory Committee on Women Veterans will conduct a virtual site visit on September 21-24, 2020, with the Veterans Integrated Service Network (VISN) 22: Desert Pacific Healthcare Network and the Southern Arizona VA Health Care System (SAVAHCS) in Tucson, AZ. The meetings will begin and end as follows:
                </P>
                <GPOTABLE COLS="3" OPTS="L2,tp0,i1" CDEF="s75,r75,r75">
                    <TTITLE> </TTITLE>
                    <BOXHD>
                        <CHED H="1">Date</CHED>
                        <CHED H="1">Time</CHED>
                        <CHED H="1">Location</CHED>
                    </BOXHD>
                    <ROW>
                        <ENT I="01">September 21, 2020</ENT>
                        <ENT>8:30 a.m.-3:45 p.m. Pacific Standard Time (PST)</ENT>
                        <ENT>See WebEx link and call-in information below.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">September 22, 2020</ENT>
                        <ENT>8:30 a.m.-2 p.m. (PST)</ENT>
                        <ENT>See WebEx link and call-in information below.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">September 23, 2020</ENT>
                        <ENT>8 a.m.-3:30 p.m. (PST)</ENT>
                        <ENT>See WebEx link and call-in information below.</ENT>
                    </ROW>
                    <ROW>
                        <ENT I="01">September 24, 2020</ENT>
                        <ENT>8:30 a.m.-9:30 a.m. (PST)</ENT>
                        <ENT>See WebEx link and call-in information below.</ENT>
                    </ROW>
                </GPOTABLE>
                <P>The purpose of the Committee is to advise the Secretary of Veterans Affairs regarding the needs of women Veterans with respect to health care, rehabilitation, compensation, outreach and other programs and activities administered by VA designed to meet such needs. The Committee makes recommendations to the Secretary regarding such programs and activities.</P>
                <P>On Monday, September 21, the agenda includes briefings on: VISN 22 facilities/programs/demographics; women Veterans services; SAVAHCS and its strategic partnerships; SAVAHCS's women Health program; the breast and cervical cancer screening program; SAVAHCS's Native American Veterans Program and Indian Health Services sharing Agreements; LGBT and transgender programs; SAVAHCS's health care training programs; primary care community based outpatient clinics; and the THRIVE program.</P>
                <P>On Tuesday, September 22, the agenda includes briefings on: The Arizona Department of Veteran Services and how it collaborates with VA; mental health services; the Transition Care Management program; the Office of Tribal and Government Relations; health care for homeless Veterans; gynecology service and reproductive health programs. From 2:30-4:00 p.m., the Committee will observe a women Veterans town hall meeting for women Veterans in Arizona, hosted by the SAVAHCS.</P>
                <P>On Wednesday, September 23, the agenda includes briefings on: SAVAHCS's Comprehensive Compensation and Pension program; readjustment counseling; prosthetic services; inpatient services; telehealth; research and medical affiliations; the Phoenix Regional Office; rural health; and the National Cemetery Phoenix National Cemetery of Arizona. On Thursday, September 24, the committee will conduct an out-briefing with leadership from SAVAHCS, Phoenix Regional Office and the National Cemetery Phoenix National Cemetery of Arizona. The meeting sessions and town hall meeting are open to the public.</P>
                <P>The agenda will include overview briefings on programs and services for Arizona's women Veterans from VISN 22, SAVAHCS, the Phoenix Regional Office, National Cemetery of Arizona, the Office of Tribal Government Relations, and the Arizona Department of Veterans Services.</P>
                <P>
                    No time will be allocated at this meeting for receiving oral presentations from the public. Interested parties should provide written comments for review by the Committee to Ms. Shannon L. Middleton at 
                    <E T="03">00W@mail.va.gov.</E>
                     Any member of the public who wishes to participate in the virtual site visit may use the following WebEx link (for September 21-23 only): 
                    <E T="03">https://veteransaffairs.WebEx.com/webappng/sites/veteransaffairs/meeting/download/236670d5436a47bc95047e1bb8f45ae5?siteurl=veteransaffairs&amp;MTID=mafac92e107678c58f9c9abdb003b0d5a.</E>
                     Meeting number (access code): 199 257 9839; meeting password: CZyzrUe*633. To join by phone: 1-404-397-1596; access code: 1992579839##.
                </P>
                <P>
                    For September 24 (only), please use the following information below: 
                    <E T="03">https://veteransaffairs.WebEx.com/webappng/sites/veteransaffairs/meeting/download/244e7a4df0ce4c1ea406615b409796f7?siteurl=veteransaffairs&amp;MTID=m8df485138357baa5bcede9e6e8fab356.</E>
                     Meeting number (access code): 199 156 9644; meeting password: wU3DhjRV$77. To join by phone: 1-404-397-1596; access code: 1991569644##.
                </P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Jelessa M. Burney,</NAME>
                    <TITLE>Federal Advisory Committee Management Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17814 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Privacy Act of 1974; System of Records</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Department of Veterans Affairs (VA).</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Notice of a new matching program.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>The Department of Veterans Affairs (VA) provides notice that the VA intends to renew a computer matching agreement with the Social Security Administration (SSA). This disclosure provides VA with data to update the master records of VA applicants and beneficiaries, including Veterans and survivors, and their eligible dependent(s) who are receiving income-dependent benefits. This disclosure also provides VA with data to determine the continued eligibility of those receiving income-dependent benefits and those beneficiaries who are receiving disability compensation at the 100 percent rate because of unemployability, and allow VA to adjust or discontinue benefits accordingly.</P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>
                        Comments on this matching program must be received no later than September 16, 2020. If no public comment is received during the period allowed for comment or unless otherwise published in the 
                        <E T="04">Federal Register</E>
                         by VA, the new matching program will become effective September 16, 2020. This matching program will begin on September 15, 2020, and end on March 14, 2022 with the option to renew an additional twelve months to March 14, 2023.
                    </P>
                </DATES>
                <ADD>
                    <HD SOURCE="HED">ADDRESSES:</HD>
                    <P>
                        Written comments may be submitted through 
                        <E T="03">www.Regulations.gov;</E>
                         by mail or hand-delivery to Director, Regulation Policy and Management (00REG), Department of Veterans Affairs, 810 Vermont Ave. NW, Room 1064, Washington, DC 20420; or by fax to (202) 273-9026 (not a toll-free number). Comments should indicate that they are submitted in response to “COMPUTER MATCHING AGREEMENT (CMA) BETWEEN THE DEPARTMENT VETERANS AFFAIRS (VA) AND THE SOCIAL SECURITY ADMINISTRATION #1050 (SSA).” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8:00 a.m. and 4:30 p.m., 
                        <PRTPAGE P="50070"/>
                        Monday through Friday (except holidays). Please call (202) 461-4902 for an appointment. (This is not a toll-free number.) In addition, comments may be viewed online at 
                        <E T="03">www.Regulations.gov.</E>
                    </P>
                </ADD>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>Bryant Coleman, Program Analyst, Pension and Fiduciary Service (21P), Department of Veterans Affairs, 810 Vermont Ave NW, Washington, DC 20420, (202) 461-8394.</P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>This disclosure will provide VA with data to update the master records of VA applicants and beneficiaries, including Veterans and survivors, and their eligible dependent(s) who are receiving income-dependent benefits. This disclosure will also provide VA with data to determine the continued eligibility of those receiving income-dependent benefits and those beneficiaries who are receiving disability compensation at the 100 percent rate because of unemployability, and allow VA to adjust or discontinue benefits accordingly.</P>
                <P>Legal authority for the disclosures under this agreement is 38 U.S.C. 5106, which requires Federal agencies to furnish VA with information the VA Secretary may request for determining eligibility for or the amount of VA benefits.</P>
                <P>SSA will disclose to VA the necessary tax return information from the MEF, last fully published at 71 FR 1819 (January 11, 2006), and amended at 78 FR 40542. SSA will disclose to VA data from Master Files of Social Security Number (SSN) Holders and SSN Applications (the Enumeration System), 60-0058, last fully published at 75 FR 82121 (December 29, 2010), and amended at 78 FR 40542 (July 5, 2013) and 79 FR 8780 (February 13, 2014).</P>
                <P>In accordance with the Privacy Act, 5 U.S.C. 552a(o)(2) and (r), copies of the agreement are being sent to both Houses of Congress and to the Office of Management and Budget. This notice is provided in accordance with the provisions of Privacy Act of 1974 as amended by Public Law 100-503.</P>
                <P>
                    <E T="03">Participating Agencies:</E>
                     The Social Security Administration (SSA).
                </P>
                <P>
                    <E T="03">Authority for Conducting the Matching Program:</E>
                     The Privacy Act, 5 U.S.C 552a, and 38 U.S.C 5106 authorize VA to enter into this CMA with SSA.
                </P>
                <P>
                    <E T="03">Purpose(s):</E>
                     This disclosure will provide VA with data to update the master records of VA applicants and beneficiaries, including Veterans and survivors, and their eligible dependent(s) who are receiving income-dependent benefits. This disclosure will also provide VA with data to determine the continued eligibility of those receiving income-dependent benefits and those beneficiaries who are receiving disability compensation at the 100 percent rate because of unemployability, and allow VA to adjust or discontinue benefits accordingly.
                </P>
                <P>
                    <E T="03">Categories of Individuals:</E>
                     Veterans and beneficiaries who apply for VA income benefits.
                </P>
                <P>
                    <E T="03">Categories of Records:</E>
                     VA will provide SSA with an electronic file in a format defined by SSA that contains the SSN, name, date of birth, and report year for each applicant, beneficiary, and eligible dependent(s) for whom tax return information is being requested. SSA will verify the SSNs furnished by VA using the Enumeration System. If the SSN of the VA applicant, beneficiary, or dependent(s) submitted to SSA verifies, SSA will return a response to VA that includes earnings data (employer identification and addresses, wage amounts from Form W-2, and earnings amounts from self-employment), SSN verification code, verified SSN, death indicator, annual total wages, and earnings report type on the record subject. If the SSN of the VA applicant, beneficiary, or dependent(s) submitted to SSA fails to verify, SSA will return a response to VA indicating that the SSN did not verify.
                </P>
                <P>
                    <E T="03">System(s) of Records:</E>
                     SSA will disclose to VA the necessary tax return information from the MEF, last fully published at 71 FR 1819 (January 11, 2006), and amended at 78 FR 40542. SSA will disclose to VA data from Master Files of Social Security Number (SSN) Holders and SSN Applications (the Enumeration System), 60-0058, last fully published at 75 FR 82121 (December 29, 2010), and amended at 78 FR 40542 (July 5, 2013) and 79 FR 8780 (February 13, 2014). VA will match the SSA data with data in its system of records (SOR) entitled “Compensation, Pension, Education, and Vocational Rehabilitation and Employment Records-VA (58VA21/22/28),” republished with updated name at 74 FR 14865 (April 1, 2009) and last amended at 77 FR 42593 (July 19, 2012).
                </P>
                <HD SOURCE="HD1">Signing Authority</HD>
                <P>The Senior Agency Official for Privacy, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Joseph S. Stenaka, Department of Veterans Affairs Chief Privacy Officer, approved this document on July 21, 2020 for publication.</P>
                <SIG>
                    <DATED>Dated: August 12, 2020.</DATED>
                    <NAME>Amy L. Rose,</NAME>
                    <TITLE>Program Analyst, VA Privacy Service, Office of Information Security, Office of Information and Technology, Department of Veterans Affairs.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. 2020-17945 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
        <NOTICE>
            <PREAMB>
                <AGENCY TYPE="S">DEPARTMENT OF VETERANS AFFAIRS</AGENCY>
                <SUBJECT>Advisory Committee on Structural Safety of Department of Veterans Affairs Facilities, Notice of Meeting</SUBJECT>
                <P>The Department of Veterans Affairs (VA) gives notice that a virtual meeting of the Advisory Committee on Structural Safety of Department of Veterans Affairs Facilities will be held on September 10, 2020. The meeting is open to the public.</P>
                <P>The purpose of the Committee is to advise the Secretary of Veterans Affairs on matters of structural safety in the construction and remodeling of VA facilities and to recommend standards for use by VA in the construction and alteration of its facilities.</P>
                <P>On September 10, the Committee will receive appropriate briefings and presentations on current seismic, natural hazards, and fire safety issues that are particularly relevant to facilities owned and leased by the Department. The Committee will also discuss appropriate structural and fire safety recommendations for inclusion in VA's construction standards.</P>
                <PRTPAGE P="50071"/>
                <P>
                    No time will be allocated for receiving oral presentations from the public. However, the Committee will accept written comments. Comments should be emailed to Donald Myers, Director, Facilities Standards Service, Office of Construction &amp; Facilities Management (003C2B), Department of Veterans Affairs, at 
                    <E T="03">Donald.Myers@va.gov.</E>
                     In the communication, writers must identify themselves and state the organization, association, or person(s) they represent. For any members of the public that wish to attend virtually, they may use the WebEx link: 
                    <E T="03">https://veteransaffairs.webex.com/veteransaffairs/j.php?MTID=mbd9d601e89be75c8061a0292096e9128,</E>
                     password: VAStrucSaf$ep10, or join via phone at: 404-397-1596, access code: 199 507 0680.
                </P>
                <P>Those seeking additional information or wishing to attend should contact Mr. Myers at the email address noted above or phone at 202-632-5388.</P>
                <SIG>
                    <DATED>Dated: August 11, 2020.</DATED>
                    <NAME>Jelessa M. Burney,</NAME>
                    <TITLE>Federal Advisory Committee Management Officer.</TITLE>
                </SIG>
            </PREAMB>
            <FRDOC>[FR Doc. 2020-17840 Filed 8-14-20; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 8320-01-P</BILCOD>
        </NOTICE>
    </NOTICES>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Proposed Rules</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="50073"/>
            <PARTNO>Part II</PARTNO>
            <AGENCY TYPE="P"> Department of Health and Human Services</AGENCY>
            <SUBAGY> Centers for Medicare &amp; Medicaid Services</SUBAGY>
            <HRULE/>
            <CFR>42 CFR Parts 410, 414 et al.</CFR>
            <TITLE>Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Proposed Rule</TITLE>
        </PTITLE>
        <PRORULES>
            <PRORULE>
                <PREAMB>
                    <PRTPAGE P="50074"/>
                    <AGENCY TYPE="S">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                    <SUBAGY>Centers for Medicare &amp; Medicaid Services</SUBAGY>
                    <CFR>42 CFR Parts 410, 414, 415, 423, 424, and 425</CFR>
                    <DEPDOC>[CMS-1734-P]</DEPDOC>
                    <RIN>RIN 0938-AU10</RIN>
                    <SUBJECT>Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; and Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy</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>Proposed rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>This major proposed rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>
                            To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on October 5, 2020. (See the 
                            <E T="02">SUPPLEMENTARY INFORMATION</E>
                             section of this proposed rule for a list of provisions open for comment.)
                        </P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>In commenting, please refer to file code CMS-1734-P.</P>
                        <P>Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed).</P>
                        <P>
                            1. 
                            <E T="03">Electronically.</E>
                             You may submit electronic comments on this regulation to 
                            <E T="03">http://www.regulations.gov.</E>
                             Follow the “Submit a comment” instructions.
                        </P>
                        <P>
                            2. 
                            <E T="03">By regular mail.</E>
                             You may mail written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1734-P, P.O. Box 8016, Baltimore, MD 21244-8016.
                        </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 express or overnight mail.</E>
                             You may send written comments to the following address ONLY: Centers for Medicare &amp; Medicaid Services, Department of Health and Human Services, Attention: CMS-1734-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P/>
                        <P>Jamie Hermansen, (410) 786-2064, for any issues not identified below.</P>
                        <P>Michael Soracoe, (410) 786-6312, for issues related to practice expense, work RVUs, conversion factor, and specialty-specific impacts of PFS proposals.</P>
                        <P>Larry Chan, (410) 786-6864, for issues related to potentially misvalued services under the PFS.</P>
                        <P>Emily Yoder, (410) 786-1804, Donta Henson, (410) 786-1947, and Patrick Sartini, (410) 786-9252, for issues related to telehealth and other services involving communications technology.</P>
                        <P>Liane Grayson, (410) 786-6583, for issues related to care management services and remote physiologic monitoring services.</P>
                        <P>Emily Yoder, (410) 786-1804, Christiane LaBonte, (410) 786-7237, Ann Marshall, (410) 786-3059, and Patrick Sartini, (410) 786-9252, for issues related to payment for office/outpatient evaluation and management visits.</P>
                        <P>Christiane LaBonte, (410) 786-7237, for issues related to teaching physician services.</P>
                        <P>Roberta Epps, (410) 786-4503, and Regina Walker-Wren, (410) 786-9160, for issues related to supervision of diagnostic tests.</P>
                        <P>Ann Marshall, (410) 786-3059, for issues related to incident to pharmacist services.</P>
                        <P>Pamela West, (410) 786-2302, for issues related to therapy services.</P>
                        <P>Sarah Leipnik, (410) 786-3933, for issues related to medical record documentation.</P>
                        <P>Lindsey Baldwin, (410) 786-1694 and Terry Simananda, (410) 786-8144, for issues related to Medicare coverage of opioid use disorder treatment services furnished by opioid treatment programs.</P>
                        <P>Laura Ashbaugh, (410) 786-1113, for issues related to Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions.</P>
                        <P>Joseph Schultz, (410) 786-2656, for issues related to opioid treatment program provider enrollment regulation updates for institutional claim submissions.</P>
                        <P>Lisa Parker, (410) 786-4949, for issues related to RHCs and FQHCs, primary care management services, and the FQHC market basket.</P>
                        <P>Rachel Katonak, (410) 786-8564, for issues related to comprehensive screenings for seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act).</P>
                        <P>David Koppel, (303) 844-2883, or Elizabeth LeBreton, (202) 615-3816, for issues related to the Medicaid Promoting Interoperability Program.</P>
                        <P>Fiona Larbi, (410) 786-7224, for issues related to the Medicare Shared Savings Program (Shared Savings Program) Quality performance standard and quality reporting requirements.</P>
                        <P>
                            Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, or 
                            <E T="03">SharedSavingsProgram@cms.hhs.gov,</E>
                             for issues related to Shared Savings Program beneficiary assignment and repayment mechanism requirements.
                        </P>
                        <P>Cheryl Gilbreath, (410) 786-5919, for issues related to home infusion therapy benefit.</P>
                        <P>Heather Hostetler, (410) 786-4515, for issues related to removal of selected national coverage determinations.</P>
                        <P>Joella Roland, (410) 786-7638, for issues related to requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan.</P>
                        <P>Edmund Kasaitis, (410) 786-0477, for issues related to Part B drug payment and Food Drug &amp; Cosmetic Act section 505(b)(2) drug products.</P>
                        <P>Elizabeth Holland, (410) 786-1309, for issues related to updates to certified electronic health record technology due to the 21st Century Cures Act.</P>
                        <P>Julia Venanzi, (410) 786-1471, for issues related to the Hospital Inpatient Quality Reporting (IQR) Program</P>
                        <P>
                            Irina Akelaitis, (410) 786-4602, for issues related to HCPCS Level II codes.
                            <PRTPAGE P="50075"/>
                        </P>
                        <P>Amanda Rhee, (410) 786-3888, for the Medicare Diabetes Prevention Program (MDPP) expanded model emergency policy.</P>
                        <P>Molly MacHarris, (410) 786-4461, for inquiries related to Merit-based Incentive Payment System (MIPS).</P>
                        <P>Brittany LaCouture, (410) 786-0481, for inquiries related to Alternative Payment Models (APMs).</P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <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. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: 
                        <E T="03">http://regulations.gov.</E>
                         Follow the search instructions on that website to view public comments.
                    </P>
                    <P>
                        <E T="03">Addenda Available Only Through the Internet on the CMS Website:</E>
                         The PFS Addenda along with other supporting documents and tables referenced in this proposed rule are available on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.</E>
                         Click on the link on the left side of the screen titled, “PFS Federal Regulations Notices” for a chronological list of PFS 
                        <E T="04">Federal Register</E>
                         and other related documents. For the CY 2021 PFS proposed rule, refer to item CMS-1734-P. Readers with questions related to accessing any of the Addenda or other supporting documents referenced in this proposed rule and posted on the CMS website identified above should contact Jamie Hermansen at (410) 786-2064.
                    </P>
                    <P>
                        <E T="03">CPT (Current Procedural Terminology) Copyright Notice:</E>
                         Throughout this proposed rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2019 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
                    </P>
                    <HD SOURCE="HD1">I. Executive Summary</HD>
                    <HD SOURCE="HD2">A. Purpose</HD>
                    <P>This major proposed rule proposes to revise payment polices under the Medicare PFS and makes other policy changes, including proposals to implement certain provisions of the Bipartisan Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (the SUPPORT Act) (Pub. L. 115-271, October 24, 2018), related to Medicare Part B payment. In addition, this proposed rule includes provisions related to other payment policy changes that are addressed in section III. of this proposed rule.</P>
                    <HD SOURCE="HD3">1. Summary of the Major Provisions</HD>
                    <P>The statute requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work; practice expense (PE); and malpractice (MP) expense. In addition, the statute requires that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas.</P>
                    <P>In this major proposed rule, we are proposing to establish RVUs for CY 2021 for the PFS to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This proposed rule also includes discussions and provisions regarding several other Medicare Part B payment policies.</P>
                    <P>Specifically, this proposed rule addresses:</P>
                    <FP SOURCE="FP-1">• Practice Expense RVUs (section II.B.)</FP>
                    <FP SOURCE="FP-1">• Potentially Misvalued Services Under the PFS (section II.C.)</FP>
                    <FP SOURCE="FP-1">• Telehealth and Other Services Involving Communications Technology (section II.D.)</FP>
                    <FP SOURCE="FP-1">• Care Management Services and Remote Physiologic Monitoring Services (section II.E.)</FP>
                    <FP SOURCE="FP-1">• Refinements to Values for Certain Services to Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability during the COVID-19 Pandemic (section II.F.)</FP>
                    <FP SOURCE="FP-1">• Scopes of Practice and Related Issues (section II.G.)</FP>
                    <FP SOURCE="FP-1">• Valuation of Specific Codes (section II.H.)</FP>
                    <FP SOURCE="FP-1">• Modifications related to Medicare Coverage for Opioid Use Disorder (OUD) Services Furnished by Opioid Treatment Programs (OTPs) (section II.I.)</FP>
                    <FP SOURCE="FP-1">• Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions, and a Comment Solicitation on Payment for Specimen Collection for Covid-19 Tests (section III.A.)</FP>
                    <FP SOURCE="FP-1">• Opioid Treatment Program Provider Enrollment Regulation Updates for Institutional Claim Submissions (section III.B.)</FP>
                    <FP SOURCE="FP-1">• Payment for Primary Care Management Services in RHCs and FQHCs (section III.C.)</FP>
                    <FP SOURCE="FP-1">• Changes to the Federally Qualified Health Center Prospective Payment System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising of the FQHC Market Basket (section III.D.)</FP>
                    <FP SOURCE="FP-1">• Comprehensive Screenings for Seniors: Section 2002 of the Substance Use-Disorder Prevention that Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) (section III.E.)</FP>
                    <FP SOURCE="FP-1">• Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs) (section III.F.)</FP>
                    <FP SOURCE="FP-1">• Medicare Shared Savings Program (section III.G.)</FP>
                    <FP SOURCE="FP-1">• Notification of Infusion Therapy Options Available Prior to Furnishing Home Infusion Therapy Services (section III.H.)</FP>
                    <FP SOURCE="FP-1">• Modifications to Quality Reporting Requirements and Comment Solicitation on Modifications to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2020 (section III.I.)</FP>
                    <FP SOURCE="FP-1">• Proposal to Remove Selected National Coverage Determinations (section III.J.)</FP>
                    <FP SOURCE="FP-1">• Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan (section III.K.)</FP>
                    <FP SOURCE="FP-1">• Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act (section III.L.)</FP>
                    <FP SOURCE="FP-1">• Updates to Certified Electronic Health Record Technology due to the 21st Century Cures Act Final Rule (section III.M.)</FP>
                    <FP SOURCE="FP-1">• Proposal to Establish New Code Categories (section III.N.)</FP>
                    <FP SOURCE="FP-1">• Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy (section III.O.)</FP>
                    <FP SOURCE="FP-1">• CY 2021 Updates to the Quality Payment Program (section IV.)</FP>
                    <FP SOURCE="FP-1">• Planned 30-day Delayed Effective Date for the Final Rule (section V.)</FP>
                    <FP SOURCE="FP-1">• Collection of Information Requirements (section VI.)</FP>
                    <FP SOURCE="FP-1">• Response to Comments (section VII.)</FP>
                    <FP SOURCE="FP-1">
                        • Regulatory Impact Analysis (section VIII.)
                        <PRTPAGE P="50076"/>
                    </FP>
                    <HD SOURCE="HD3">2. Summary of Costs and Benefits</HD>
                    <P>
                        We have determined that this proposed rule is economically significant. For a detailed discussion of the economic impacts, 
                        <E T="03">see</E>
                         section VIII. of this proposed rule.
                    </P>
                    <HD SOURCE="HD3">3. Waiver of the 60-Day Delayed Effective Date for the Final Rule</HD>
                    <P>The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that has now been detected in more than 190 locations internationally, including in all 50 States and the District of Columbia. The virus has been named “SARS CoV 2” and the disease it causes has been named “Coronavirus disease 2019” (abbreviated “COVID-19”).</P>
                    <P>Due to the significant devotion of resources to the COVID-19 response, as discussed in section V. of the preamble of this proposed rule, we are hereby waiving the 60-day delay in the effective date of the final rule, and replacing it with a 30-day delay in the effective date of the final rule.</P>
                    <HD SOURCE="HD1">II. Provisions of the Proposed Rule for the PFS</HD>
                    <HD SOURCE="HD2">A. Background</HD>
                    <P>
                        Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, practice expense (PE), and malpractice (MP), which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the relative value units (RVUs) into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final rule published in the November 25, 1991 
                        <E T="04">Federal Register</E>
                         (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.
                    </P>
                    <P>We note that throughout this proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for the services they furnish to Medicare beneficiaries.</P>
                    <HD SOURCE="HD3">1. Development of the RVUs</HD>
                    <HD SOURCE="HD3">a. Work RVUs</HD>
                    <P>The work RVUs established for the initial fee schedule, which was implemented on January 1, 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 under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the federal government, and obtained input from numerous physician specialty groups.</P>
                    <P>As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or similar codes, and magnitude estimation. More information on these issues is available in that rule.</P>
                    <HD SOURCE="HD3">b. Practice Expense RVUs</HD>
                    <P>Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended by section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding MP expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.</P>
                    <P>Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA ’97) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA ’97 provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.</P>
                    <P>We established the resource-based PE RVUs for each physicians' service in the November 2, 1998 final rule (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 PFS final rule with comment period (76 FR 73033).</P>
                    <P>Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some resource costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those specific facility resource costs is not made under the PFS.</P>
                    <P>
                        Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) 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 to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 
                        <PRTPAGE P="50077"/>
                        25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the 
                        <E T="04">Federal Register</E>
                         (65 FR 65376) as part of a November 1, 2000 final rule. The PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended the period during which we would accept these supplemental data through March 1, 2005.
                    </P>
                    <P>In the CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed for CY 2010. In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.</P>
                    <HD SOURCE="HD3">c. Malpractice RVUs</HD>
                    <P>Section 4505(f) of the BBA ’97 amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' MP insurance premium data from all the states, the District of Columbia, and Puerto Rico.</P>
                    <HD SOURCE="HD3">d. Refinements to the RVUs</HD>
                    <P>Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed 5-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.</P>
                    <P>Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.</P>
                    <P>In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.</P>
                    <P>In addition to the 5-year reviews, beginning for CY 2009, CMS and the RUC identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, that require the agency to periodically identify, review and adjust values for potentially misvalued codes.</P>
                    <HD SOURCE="HD3">e. Application of Budget Neutrality to Adjustments of RVUs</HD>
                    <P>As described in section VII. of this proposed rule, the Regulatory Impact Analysis, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.</P>
                    <HD SOURCE="HD3">2. Calculation of Payments Based on RVUs</HD>
                    <P>To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP in an area compared to the national average costs for each component. Please refer to the CY 2020 PFS final rule for a discussion of the last GPCI update (84 FR 62615 through 62623).</P>
                    <P>RVUs are converted to dollar amounts through the application of a CF, which is calculated based on a statutory formula by CMS' Office of the Actuary (OACT). The formula for calculating the Medicare PFS payment amount for a given service and fee schedule area can be expressed as:</P>
                    <FP SOURCE="FP-2">Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU MP × GPCI MP)] × CF</FP>
                    <HD SOURCE="HD3">3. Separate Fee Schedule Methodology for Anesthesia Services</HD>
                    <P>Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia CF, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate CF for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.</P>
                    <HD SOURCE="HD2">B. Determination of PE RVUs</HD>
                    <HD SOURCE="HD3">1. Overview</HD>
                    <P>Practice expense (PE) is the portion of the resources used in furnishing a service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages, but excluding MP expenses, as specified in section 1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.</P>
                    <HD SOURCE="HD3">2. Practice Expense Methodology</HD>
                    <HD SOURCE="HD3">a. Direct Practice Expense</HD>
                    <P>
                        We determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work relative value units under the PFS and proposed changes to the PE methodology CY 2007 PFS proposed 
                        <PRTPAGE P="50078"/>
                        notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
                    </P>
                    <HD SOURCE="HD3">b. Indirect Practice Expense per Hour Data</HD>
                    <P>We use survey data on indirect PEs incurred per hour worked, in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs paid under the PFS using a survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. We used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.</P>
                    <P>When we began using the PPIS data in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.</P>
                    <P>Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.</P>
                    <P>Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments beginning in CY 2007. Neither IDTFs, nor independent labs, participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.</P>
                    <P>Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.</P>
                    <P>We also do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend the PPIS data with Medicare-recognized specialty data.</P>
                    <P>
                        Previously, we established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file titled “CY 2021 PFS Proposed Rule PE/HR” on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                    </P>
                    <P>As noted above, we have established PE/HR values for various specialties without SMS or PPIS survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. On this note, stakeholders have raised concerns regarding the appropriate specialty crosswalk used for home PT/INR monitoring services. These services are currently classified under the independent diagnostic testing facilities specialty for PE/HR purposes, due to a lack of survey data for these services, and stakeholders have suggested to CMS that this specialty does not reflect the indirect costs associated with furnishing these services. Stakeholders have raised concerns that the practice pattern of PT/INR monitoring services are markedly different from that of the dominant parent specialty as most of the services are furnished remotely and require long-term relationship with beneficiaries similar to chronic therapy. Stakeholders also stated that this is a unique request due to the lack of home PT/INR monitoring supplier involvement in the last PPIS, and that payments for these services are derived from previously used supplemental survey data from the Association for Quality Imaging (AQI), blended with supplementary survey data from the American College of Radiology (ACR)—neither of which reflect indirect cost inputs for home PT/INR monitoring.</P>
                    <P>Therefore, we are soliciting comment from the public regarding the most accurate specialty crosswalk to use for indirect PE when it comes to home PT/INR monitoring services. We are seeking information on any additional costs associated with these services that are not reflected in our currently assigned PE/HR for independent diagnostic testing facilities, as well as which specialties would best capture these costs through the use of a crosswalk.</P>
                    <HD SOURCE="HD3">c. Allocation of PE to Services</HD>
                    <P>To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.</P>
                    <HD SOURCE="HD3">(1) Direct Costs</HD>
                    <P>The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing each of the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.</P>
                    <HD SOURCE="HD3">(2) Indirect Costs</HD>
                    <P>We allocate the indirect costs at the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion. The general approach to developing the indirect portion of the PE RVUs is as follows:</P>
                    <P>
                        • For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. That is, the initial indirect allocator is 
                        <PRTPAGE P="50079"/>
                        calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00).
                    </P>
                    <P>• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.</P>
                    <P>• Then, we incorporate the specialty-specific indirect PE/HR data into the calculation. In our example, if, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.</P>
                    <HD SOURCE="HD3">(3) Facility and Nonfacility Costs</HD>
                    <P>For procedures that can be furnished in a physician's office, as well as in a facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, we establish two PE RVUs: Facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, the facility PE RVUs are generally lower than the nonfacility PE RVUs.</P>
                    <HD SOURCE="HD3">(4) Services With Technical Components and Professional Components</HD>
                    <P>Diagnostic services are generally comprised of two components: A professional component (PC); and a technical component (TC). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)</P>
                    <HD SOURCE="HD3">(5) PE RVU Methodology</HD>
                    <P>
                        For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746). We also direct readers to the file titled “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</E>
                        . This file contains a table that illustrates the calculation of PE RVUs as described in this proposed rule for individual codes.
                    </P>
                    <HD SOURCE="HD3">(a) Setup File</HD>
                    <P>First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data calculated from the surveys.</P>
                    <HD SOURCE="HD3">(b) Calculate the Direct Cost PE RVUs</HD>
                    <P>Sum the costs of each direct input.</P>
                    <P>
                        <E T="03">Step 1:</E>
                         Sum the direct costs of the inputs for each service.
                    </P>
                    <P>
                        <E T="03">Step 2:</E>
                         Calculate the aggregate pool of direct PE costs for the current year. We set the aggregate pool of PE costs equal to the product of the ratio of the current aggregate PE RVUs to current aggregate work RVUs and the projected aggregate work RVUs.
                    </P>
                    <P>
                        <E T="03">Step 3:</E>
                         Calculate the aggregate pool of direct PE costs for use in ratesetting. This is the product of the aggregate direct costs for all services from Step 1 and the utilization data for that service.
                    </P>
                    <P>
                        <E T="03">Step 4:</E>
                         Using the results of Step 2 and Step 3, use the CF to calculate a direct PE scaling adjustment to ensure that the aggregate pool of direct PE costs calculated in Step 3 does not vary from the aggregate pool of direct PE costs for the current year. Apply the scaling adjustment to the direct costs for each service (as calculated in Step 1).
                    </P>
                    <P>
                        <E T="03">Step 5:</E>
                         Convert the results of Step 4 to a RVU scale for each service. To do this, divide the results of Step 4 by the CF. Note that the actual value of the CF used in this calculation does not influence the final direct cost PE RVUs as long as the same CF is used in Step 4 and Step 5. Different CFs would result in different direct PE scaling adjustments, but this has no effect on the final direct cost PE RVUs since changes in the CFs and changes in the associated direct scaling adjustments offset one another.
                    </P>
                    <HD SOURCE="HD3">(c) Create the Indirect Cost PE RVUs</HD>
                    <P>Create indirect allocators.</P>
                    <P>
                        <E T="03">Step 6:</E>
                         Based on the survey data, calculate direct and indirect PE percentages for each physician specialty.
                    </P>
                    <P>
                        <E T="03">Step 7:</E>
                         Calculate direct and indirect PE percentages at the service level by taking a weighted average of the results of Step 6 for the specialties that furnish the service. Note that for services with TCs and PCs, the direct and indirect percentages for a given service do not vary by the PC, TC, and global service.
                    </P>
                    <P>
                        We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. We finalized a policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we instead use the expected specialty that we identify on a list developed based on medical review and input from expert stakeholders. We display this list of expected specialty assignments as part of the annual set of data files we make available as part of notice and comment rulemaking and consider recommendations from the RUC and 
                        <PRTPAGE P="50080"/>
                        other stakeholders on changes to this list on an annual basis. Services for which the specialty is automatically assigned based on previously finalized policies under our established methodology (for example, “always therapy” services) are unaffected by the list of expected specialty assignments. We also finalized in the CY 2018 PFS final rule (82 FR 52982 through 59283) a policy to apply these service-level overrides for both PE and MP, rather than one or the other category.
                    </P>
                    <P>
                        <E T="03">Step 8:</E>
                         Calculate the service level allocators for the indirect PEs based on the percentages calculated in Step 7. The indirect PEs are allocated based on the three components: The direct PE RVUs; the clinical labor PE RVUs; and the work RVUs.
                    </P>
                    <P>For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.</P>
                    <P>There are two situations where this formula is modified:</P>
                    <P>• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs + work RVUs.</P>
                    <P>• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: Indirect PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.</P>
                    <P>
                        (
                        <E T="03">Note:</E>
                         For global services, the indirect PE allocator is based on both the work RVUs and the clinical labor PE RVUs. We do this to recognize that, for the PC service, indirect PEs would be allocated using the work RVUs, and for the TC service, indirect PEs would be allocated using the direct PE RVUs and the clinical labor PE RVUs. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.)
                    </P>
                    <P>For presentation purposes, in the examples in the download file titled “Calculation of PE RVUs under Methodology for Selected Codes”, the formulas were divided into two parts for each service.</P>
                    <P>• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).</P>
                    <P>• The second part is either the work RVU, clinical labor PE RVU, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).</P>
                    <P>Apply a scaling adjustment to the indirect allocators.</P>
                    <P>
                        <E T="03">Step 9:</E>
                         Calculate the current aggregate pool of indirect PE RVUs by multiplying the result of step 8 by the average indirect PE percentage from the survey data.
                    </P>
                    <P>
                        <E T="03">Step 10:</E>
                         Calculate an aggregate pool of indirect PE RVUs for all PFS services by adding the product of the indirect PE allocators for a service from Step 8 and the utilization data for that service.
                    </P>
                    <P>
                        <E T="03">Step 11:</E>
                         Using the results of Step 9 and Step 10, calculate an indirect PE adjustment so that the aggregate indirect allocation does not exceed the available aggregate indirect PE RVUs and apply it to indirect allocators calculated in Step 8.
                    </P>
                    <P>Calculate the indirect practice cost index.</P>
                    <P>
                        <E T="03">Step 12:</E>
                         Using the results of Step 11, calculate aggregate pools of specialty-specific adjusted indirect PE allocators for all PFS services for a specialty by adding the product of the adjusted indirect PE allocator for each service and the utilization data for that service.
                    </P>
                    <P>
                        <E T="03">Step 13:</E>
                         Using the specialty-specific indirect PE/HR data, calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the work time for the service, and the specialty's utilization for the service across all services furnished by the specialty.
                    </P>
                    <P>
                        <E T="03">Step 14:</E>
                         Using the results of Step 12 and Step 13, calculate the specialty-specific indirect PE scaling factors.
                    </P>
                    <P>
                        <E T="03">Step 15:</E>
                         Using the results of Step 14, calculate an indirect practice cost index at the specialty level by dividing each specialty-specific indirect scaling factor by the average indirect scaling factor for the entire PFS.
                    </P>
                    <P>
                        <E T="03">Step 16:</E>
                         Calculate the indirect practice cost index at the service level to ensure the capture of all indirect costs. Calculate a weighted average of the practice cost index values for the specialties that furnish the service. (
                        <E T="03">Note:</E>
                         For services with TCs and PCs, we calculate the indirect practice cost index across the global service, PCs, and TCs. Under this method, the indirect practice cost index for a given service (for example, echocardiogram) does not vary by the PC, TC, and global service.)
                    </P>
                    <P>
                        <E T="03">Step 17:</E>
                         Apply the service level indirect practice cost index calculated in Step 16 to the service level adjusted indirect allocators calculated in Step 11 to get the indirect PE RVUs.
                    </P>
                    <HD SOURCE="HD3">(d) Calculate the Final PE RVUs</HD>
                    <P>
                        <E T="03">Step 18:</E>
                         Add the direct PE RVUs from Step 5 to the indirect PE RVUs from Step 17 and apply the final PE budget neutrality (BN) adjustment. The final PE BN adjustment is calculated by comparing the sum of steps 5 and 17 to the proposed aggregate work RVUs scaled by the ratio of current aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in the PFS account for the fact that certain specialties are excluded from the calculation of PE RVUs but included in maintaining overall PFS budget neutrality. (See “Specialties excluded from ratesetting calculation” later in this proposed rule.)
                    </P>
                    <P>
                        <E T="03">Step 19:</E>
                         Apply the phase-in of significant RVU reductions and its associated adjustment. Section 1848(c)(7) of the Act specifies that for services that are not new or revised codes, if the total RVUs for a service for a year would otherwise be decreased by an estimated 20 percent or more as compared to the total RVUs for the previous year, the applicable adjustments in work, PE, and MP RVUs shall be phased in over a 2-year period. In implementing the phase-in, we consider a 19 percent reduction as the maximum 1-year reduction for any service not described by a new or revised code. This approach limits the year one reduction for the service to the maximum allowed amount (that is, 19 percent), and then phases in the remainder of the reduction. To comply with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure that the total RVUs for all services that are not new or revised codes decrease by no more than 19 percent, and then apply a relativity adjustment to ensure that the total pool of aggregate PE RVUs remains relative to the pool of work and MP RVUs. For a more detailed description of the methodology for the phase-in of significant RVU changes, we refer readers to the CY 2016 PFS final rule with comment period (80 FR 70927 through 70931).
                    </P>
                    <HD SOURCE="HD3">(e) Setup File Information</HD>
                    <P>
                        • 
                        <E T="03">Specialties excluded from ratesetting calculation:</E>
                         For the purposes of calculating the PE and MP RVUs, we exclude certain specialties, such as certain NPPs paid at a percentage of the PFS and low-volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="480">
                        <PRTPAGE P="50081"/>
                        <GID>EP17AU20.001</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>
                        • Crosswalk 
                        <E T="03">certain low volume physician specialties:</E>
                         Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
                    </P>
                    <P>
                        • Physical 
                        <E T="03">therapy utilization:</E>
                         Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
                    </P>
                    <P>
                        • 
                        <E T="03">Identify professional and technical services not identified under the usual TC and 26 modifiers:</E>
                         Flag the services that are PC and TC services but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
                    </P>
                    <P>
                        • 
                        <E T="03">Payment modifiers:</E>
                         Payment modifiers are accounted for in the creation of the file consistent with current payment policy as implemented in claims processing. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier. Similarly, for those services to which volume adjustments are made to account for the payment modifiers, time adjustments are applied as well. For time adjustments to surgical services, the intraoperative portion in the work time file is used; where it is not present, the intraoperative percentage from the payment files used by contractors to process Medicare claims is used instead. Where neither is available, we use the payment adjustment ratio to adjust the time accordingly. Table 2 details the manner in which the modifiers are applied.
                    </P>
                    <GPH SPAN="3" DEEP="251">
                        <PRTPAGE P="50082"/>
                        <GID>EP17AU20.002</GID>
                    </GPH>
                    <P>We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPRs). We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.</P>
                    <P>For anesthesia services, we do not apply adjustments to volume since we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.</P>
                    <P>
                        • Work
                        <E T="03"> RVUs:</E>
                         The setup file contains the work RVUs from this proposed rule.
                    </P>
                    <HD SOURCE="HD3">(6) Equipment Cost per Minute</HD>
                    <P>The equipment cost per minute is calculated as:</P>
                    <FP SOURCE="FP-2">(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + interest rate) ‸ life of equipment)))) + maintenance)</FP>
                    <EXTRACT>
                        <FP SOURCE="FP-2">Where:</FP>
                        <FP SOURCE="FP-2">minutes per year = maximum minutes per year if usage were continuous (that is, usage = 1); generally 150,000 minutes.</FP>
                        <FP SOURCE="FP-2">
                            usage = variable, 
                            <E T="03">see</E>
                             discussion below in this proposed rule.
                        </FP>
                        <FP SOURCE="FP-2">price = price of the particular piece of equipment.</FP>
                        <FP SOURCE="FP-2">life of equipment = useful life of the particular piece of equipment.</FP>
                        <FP SOURCE="FP-2">maintenance = factor for maintenance; 0.05.</FP>
                        <FP SOURCE="FP-2">
                            interest rate = variable, 
                            <E T="03">see</E>
                             discussion below in this proposed rule.
                        </FP>
                    </EXTRACT>
                    <P>
                        <E T="03">Usage:</E>
                         We currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment, for which we use a 90 percent assumption as required by section 1848(b)(4)(C) of the Act.
                    </P>
                    <P>
                        <E T="03">Useful Life:</E>
                         In the CY 2005 PFS final rule we stated that we updated the useful life for equipment items primarily based on the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” guidelines (69 FR 66246). The most recent edition of these guidelines was published in 2018. This reference material provides an estimated useful life for hundreds of different types of equipment, the vast majority of which fall in the range of 5 to 10 years, and none of which are lower than 2 years in duration. We believe that the updated editions of this reference material remain the most accurate source for estimating the useful life of depreciable medical equipment.
                    </P>
                    <P>We note that stakeholders including the RUC, specialty societies, and other commenters suggested a useful life of less than 1 year for several of the new equipment items for CY 2021, and as low as three months in one case. We have rarely, if ever, received requests for equipment useful life of less than one year in duration and note that these very short useful life durations are significantly lower than anything in our current equipment database, and if finalized would represent major outliers when compared to the rest of the equipment. Table 3 details the distribution of useful life durations of the equipment currently in our database:</P>
                    <GPH SPAN="3" DEEP="109">
                        <PRTPAGE P="50083"/>
                        <GID>EP17AU20.003</GID>
                    </GPH>
                    <P>As Table 3 demonstrates, the vast majority of equipment items have a useful life duration of 5 to 10 years, and only 4 out of the 777 equipment codes have a useful life duration of less than 3 years. We also note that due to the formula used to calculate the equipment cost per minute, decreasing the useful life of any equipment item from 5 years to 3 months has the same effect as increasing the price of the equipment 20 times over. In other words, decreasing the useful life from 5 years to 0.25 years has the same multiplicative effect as increasing the price of the equipment from $5,000 to 100,000 due to the formula listed above. Since we currently do not have any equipment items in our database with a useful life of less than one year, we are proposing a clarification on how to address these cases.</P>
                    <P>We disagree that assigning a useful life at these very short durations would be typical for new equipment, especially in light of the data provided by the AHA's “Estimated Useful Lives of Depreciable Hospital Assets” reference. The equipment life durations listed in Table 3 were finalized over the last 15 years through the use of this reference material. We have concerns that assigning very low useful life durations to equipment items would fail to maintain relativity with other equipment on the PFS, effectively assigning a much higher price than other equipment items with more typical useful life durations. We believe that equipment items with very low useful life durations represent outlier cases that are not handled appropriately by the current equipment methodology and which we seek to clarify through this rulemaking. We also note that the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. Our current equipment formula is not designed to address cases in which equipment is replaced multiple times per year, and we believe that applying a multi-year depreciation in these situations would not be reflective of market pricing. We do not believe that items which are replaced on a monthly basis can be accurately priced using a formula which assumes they will be in use for years at a time, and that the use of such a formula would distort relativity with the overwhelming majority of equipment items which are in use for 5-10 years.</P>
                    <P>Therefore, we proposing to treat equipment life durations of less than 1 year as having a duration of 1 year for the purpose of our equipment price per minute formula. We believe that this is the most accurate way to incorporate these short equipment life durations within the framework of our current methodology. In the rare cases where items are replaced every few months, we believe that it is more accurate to treat these items as disposable supplies with a fractional supply quantity as opposed to equipment items with very short equipment life durations. For example, we are proposing to establish the EECP compression equipment package (SD341) and the EECP electrical equipment package (SD342) as disposable supplies instead of equipment items as described in the Valuation of Specific Codes (section II.H. of this proposed rule) portion of the preamble. We expect these situations to occur only rarely, and we will evaluate them on an individual case-by-case basis. Our criteria will be based on whether or not the item in question could be more accurately classified as a disposable supply while maintaining overall relativity within our PE methodology. We welcome additional comments from stakeholders regarding the subject of useful life durations for new equipment items with unique useful life durations as described above and any additional suggestions on alternative ways to incorporate these items into our methodology or potential wider changes to the equipment cost per minute formula more broadly.</P>
                    <P>
                        • 
                        <E T="03">Maintenance:</E>
                         This factor for maintenance was finalized in the CY 1998 PFS final rule with comment period (62 FR 33164). As we previously stated in the CY 2016 PFS final rule with comment period (80 FR 70897), we do not believe the annual maintenance factor for all equipment is precisely 5 percent, and we concur that the current rate likely understates the true cost of maintaining some equipment. We also believe it likely overstates the maintenance costs for other equipment. When we solicited comments regarding sources of data containing equipment maintenance rates, commenters were unable to identify an auditable, robust data source that could be used by CMS on a wide scale. We do not believe that voluntary submissions regarding the maintenance costs of individual equipment items would be an appropriate methodology for determining costs. As a result, in the absence of publicly available datasets regarding equipment maintenance costs or another systematic data collection methodology for determining a different maintenance factor, we are not proposing a variable maintenance factor for equipment cost per minute pricing as we do not believe that we have sufficient information at present. We continue to investigate potential avenues for determining equipment maintenance costs across a broad range of equipment items.
                    </P>
                    <P>
                        • 
                        <E T="03">Interest Rate:</E>
                         In the CY 2013 PFS final rule with comment period (77 FR 68902), we updated the interest rates used in developing an equipment cost per minute calculation (
                        <E T="03">see</E>
                         77 FR 68902 for a thorough discussion of this issue). The interest rate was based on the Small Business Administration (SBA) maximum interest rates for different categories of loan size (equipment cost) and maturity (useful life). The Interest rates are listed in Table 4.
                    </P>
                    <GPH SPAN="3" DEEP="109">
                        <PRTPAGE P="50084"/>
                        <GID>EP17AU20.004</GID>
                    </GPH>
                    <P>We are not proposing any changes to the equipment interest rates for CY 2021.</P>
                    <HD SOURCE="HD3">3. Changes to Direct PE Inputs for Specific Services</HD>
                    <P>
                        This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2020 direct PE input public use files, which are available on the CMS website under downloads for the CY 2020 PFS final rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html</E>
                        .
                    </P>
                    <HD SOURCE="HD3">a. Standardization of Clinical Labor Tasks</HD>
                    <P>As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640 through 67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and post service periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this level of detail would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the detailed information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe that setting and maintaining such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.</P>
                    <P>In the CY 2016 PFS final rule with comment period (80 FR 70901), we solicited comments on the appropriate standard minutes for the clinical labor tasks associated with services that use digital technology. After consideration of comments received, we finalized standard times for clinical labor tasks associated with digital imaging at 2 minutes for “Availability of prior images confirmed”, 2 minutes for “Patient clinical information and questionnaire reviewed by technologist, order from physician confirmed and exam protocoled by radiologist”, 2 minutes for “Review examination with interpreting MD”, and 1 minute for “Exam documents scanned into PACS” and “Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue.” In the CY 2017 PFS final rule (81 FR 80184 through 80186), we finalized a policy to establish a range of appropriate standard minutes for the clinical labor activity, “Technologist QCs images in PACS, checking for all images, reformats, and dose page.” These standard minutes will be applied to new and revised codes that make use of this clinical labor activity when they are reviewed by us for valuation. We finalized a policy to establish 2 minutes as the standard for the simple case, 3 minutes as the standard for the intermediate case, 4 minutes as the standard for the complex case, and 5 minutes as the standard for the highly complex case. These values were based upon a review of the existing minutes assigned for this clinical labor activity; we determined that 2 minutes is the duration for most services and a small number of codes with more complex forms of digital imaging have higher values. We also finalized standard times for a series of clinical labor tasks associated with pathology services in the CY 2016 PFS final rule with comment period (80 FR 70902). We do not believe these activities would be dependent on number of blocks or batch size, and we believe that the finalized standard values accurately reflect the typical time it takes to perform these clinical labor tasks.</P>
                    <P>
                        In reviewing the RUC-recommended direct PE inputs for CY 2019, we noticed that the 3 minutes of clinical labor time traditionally assigned to the “Prepare room, equipment and supplies” (CA013) clinical labor activity were split into 2 minutes for the “Prepare room, equipment and supplies” activity and 1 minute for the “Confirm order, protocol exam” (CA014) activity. We proposed to maintain the 3 minutes of clinical labor time for the “Prepare room, equipment and supplies” activity and remove the clinical labor time for the “Confirm order, protocol exam” activity wherever we observed this pattern in the RUC-recommended direct PE inputs. Commenters explained in response that when the new version of the PE worksheet introduced the activity codes for clinical labor, there was a need to translate old clinical labor tasks into the new activity codes, and that a prior clinical labor task was split into two of the new clinical labor activity codes: CA007 (“Review patient clinical extant information and questionnaire”) in the preservice period, and CA014 (“Confirm order, protocol exam”) in the service period. Commenters stated that the same clinical labor from the old PE worksheet was now divided into the CA007 and CA014 activity codes, with a standard of 1 minute for each activity. We agreed with commenters that we would finalize the RUC-recommended 2 minutes of clinical labor time for the CA007 activity code and 1 minute for the CA014 activity code in situations where this was the case. However, when reviewing the clinical labor for the reviewed codes affected by this issue, we found that several of the codes did not include this old clinical labor task, and we also noted that several of the reviewed codes that contained the CA014 clinical labor activity code did 
                        <PRTPAGE P="50085"/>
                        not contain any clinical labor for the CA007 activity. In these situations, we continue to believe that in these cases the 3 total minutes of clinical staff time would be more accurately described by the CA013 “Prepare room, equipment and supplies” activity code, and we finalized these clinical labor refinements. For additional details, we direct readers to the discussion in the CY 2019 PFS final rule (83 FR 59463 and 59464).
                    </P>
                    <P>Following the publication of the CY 2020 PFS proposed rule, a commenter expressed concern with the published list of common refinements to equipment time. The commenter stated that these refinements were the formulaic result of the applying refinements to the clinical labor time and did not constitute separate refinements; the commenter requested that CMS no longer include these refinements in the table published each year. In the CY 2020 PFS final rule, we agreed with the commenter that that these equipment time refinements did not reflect errors in the equipment recommendations or policy discrepancies with the RUC's equipment time recommendations. However, we believed that it was important to publish the specific equipment times that we were proposing (or finalizing in the case of the final rule) when they differed from the recommended values due to the effect that these changes can have on the direct costs associated with equipment time. Therefore, we finalized the separation of the equipment time refinements associated with changes in clinical labor into a separate table of refinements. For additional details, we direct readers to the discussion in the CY 2020 PFS final rule (84 FR 62584).</P>
                    <P>
                        Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning with its recommendations for CY 2019, the RUC has mandated the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations will help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database. As we did in previous calendar years, to facilitate rulemaking for CY 2021, we are continuing to display two versions of the Labor Task Detail public use file: One version with the old listing of clinical labor tasks, and one with the same tasks crosswalked to the new listing of clinical labor activity codes. These lists are available on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                    </P>
                    <HD SOURCE="HD3">b. Equipment Recommendations for Scope Systems</HD>
                    <P>During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.</P>
                    <P>To promote appropriate relativity among the services and facilitate the transparency of our review process, during the review of the recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope, the associated video system, and any scope accessories that might be typical as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems and accessories that are used with scopes.</P>
                    <HD SOURCE="HD3">(1) Scope Equipment</HD>
                    <P>Beginning in the CY 2017 PFS proposed rule (81 FR 46176 through 46177), we proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose input prices for these equipment items through future rulemaking.</P>
                    <P>We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. We did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we noted we could consider proposing to apply to other codes in future rulemaking. We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.</P>
                    <P>
                        We did not make further changes to existing scope equipment in CY 2017 to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals in the CY 2018 PFS proposed rule (82 FR 33961 through 33962) to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We considered creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We 
                        <PRTPAGE P="50086"/>
                        stated our belief that the variation between these scopes was not significant enough to warrant maintaining these distinctions, and we believed that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.
                    </P>
                    <P>After considering the comments on the CY 2018 PFS proposed rule, we did not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we supported the recommendation from the commenters to create scope equipment codes on a per-specialty basis for six categories of scopes as applicable, including the addition of a new sixth category of multi-channeled flexible video scopes. Our goal was to create an administratively simple scheme that would be easier to maintain and help to reduce administrative burden. In 2018, the RUC convened a Scope Equipment Reorganization Workgroup to incorporate feedback from expert stakeholders with the intention of making recommendations to us on scope organization and scope pricing. Since the workgroup was not convened in time to submit recommendations for the CY 2019 PFS rulemaking cycle, we delayed proposals for any further changes to scope equipment until CY 2020 in order to incorporate the feedback from the aforementioned workgroup.</P>
                    <HD SOURCE="HD3">(2) Scope Video System</HD>
                    <P>We proposed in the CY 2017 PFS proposed rule (81 FR 46176 through 46177) to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule (81 FR 80188). We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. In the CY 2018 PFS final rule (82 FR 52991 through 52993), we outlined, but did not finalize, a proposal to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. We also described a proposal to increase the price of the scope video system by $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.). With the addition of the LED light (equipment code EQ382 at a price of $1,915), the updated total price of the scope video system would be set at $36,306.</P>
                    <P>We did not finalize this updated pricing to the scope video system in CY 2018, but we did propose and finalize the updated pricing for CY 2019 to $36,306 along with changing the name of the ES031 equipment item to “scope video system (monitor, processor, digital capture, cart, printer, LED light)” to reflect the fact that the use of the ES031 scope video system is not limited to endoscopy procedures.</P>
                    <HD SOURCE="HD3">(3) Scope Accessories</HD>
                    <P>We understand that there may be other accessories associated with the use of scopes. We finalized a proposal in the CY 2017 PFS final rule (81 FR 80188) to separately price any scope accessories outside the use of the scope video system, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.</P>
                    <HD SOURCE="HD3">(4) Scope Proposals for CY 2020</HD>
                    <P>The Scope Equipment Reorganization Workgroup organized by the RUC submitted detailed recommendations to CMS for consideration in the CY 2020 rule cycle, describing 23 different types of scope equipment, the HCPCS codes associated with each scope type, and a series of invoices for scope pricing. Based on the recommendations from the workgroup, we proposed to establish 23 new scope equipment codes. For the eight new scope equipment items where we received submitted invoices for pricing, we proposed to replace the existing scopes with the new scope equipment at the same amount of equipment time. This scope replacement involved approximately 100 HCPCS codes in total and was detailed in a table published in the CY 2020 proposed rule (84 FR 40495 through 40498). We noted that we did not receive pricing information along with the workgroup recommendations for the other 15 new scope equipment items. Therefore, although we proposed to establish new equipment codes for these scopes, we did not propose to replace existing scope equipment with the new equipment items as we did for the other eight new scope equipment items for CY 2020.</P>
                    <P>Following the publication of the CY 2020 PFS proposed rule, commenters provided additional information regarding pricing for the new scope equipment and their associated HCPCS codes. Based on this information provided by the commenters, we finalized a price for eight additional new scope equipment items and finalized the replacement of the existing scopes with the new scope equipment at the same amount of equipment time for approximately two dozen additional HCPCS codes (84 FR 62593 through 62595). Table 5 lists the CY 2020 finalized price for the new scope equipment codes:</P>
                    <GPH SPAN="3" DEEP="312">
                        <PRTPAGE P="50087"/>
                        <GID>EP17AU20.005</GID>
                    </GPH>
                    <P>We noted that although we updated the scope equipment pricing for CY 2020 such that the ES087 and ES089 scopes shared the same price with the ES088 scope, and the ES090 scope shared the same price with the ES085 scope, we did not mean to suggest that these scopes that shared pricing were identical with one another. We assigned the same price to these scopes because they replaced the same current scope equipment codes, and because we did not have individual pricing information for them. We remain open to the submission of additional invoices to establish individual pricing for these scopes, and we continue to welcome more data to help identify pricing for the remaining seven scope equipment codes that still lack invoices.</P>
                    <HD SOURCE="HD3">(5) Scope Proposals for CY 2021</HD>
                    <P>We did not receive further recommendations from the Scope Equipment Reorganization Workgroup organized by the RUC following the publication of the CY 2020 final rule. However, we did receive invoices associated with the pricing of the scope video system (monitor, processor, digital capture, cart, printer, LED light) (ES031) equipment item as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We previously finalized a price of $36,306 for the ES031 equipment based on the sum of component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, $1,750 for the cart, $1,915 for the LED light, and $1,000 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.) We received 37 invoices associated with the components of the ES031 scope video system, which averaged out to prices of $21,988.89 for the processor, $16,175.87 for the digital capture device, $6,987.56 for the monitor, $7,922.80 for the printer, $4,945.45 for the cart, and $12,652.82 for the LED light. Based on the sum of these component prices, we are proposing to update the price the ES031 scope video system equipment to $70,673.38. We are not proposing to include an additional $1,000 to cover the expense of miscellaneous small equipment as the products listed on the component invoices indicated that cost of cables were already included in this significantly higher equipment pricing. We are soliciting additional comments from stakeholders regarding the pricing of the full ES031 scope equipment system as well as its components.</P>
                    <P>
                        As part of our market-based supply and equipment pricing transition, we finalized a policy in CY 2019 to phase in any updated pricing established during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, even if invoices are provided as part of the formal review of a code family (83 FR 59473 through 59475). Because the ES031 scope equipment system is utilized by more than 250 HCPCS codes, we are proposing to transition this pricing increase over the remaining two years of the pricing update, such that the CY 2021 equipment price will be $53,489.69 before moving to its destination price of $70,673.38 in CY 2022. We note that this transition policy also applies to the price of the suction machine (Gomco) (EQ235) equipment, which, although it is not a scope, is utilized by approximately 360 HCPCS codes, and therefore, is another example of this pricing transition policy. We are proposing to transition the EQ235 pricing increase over the remaining 2 years of the pricing update, such that the CY 2021 equipment price will be $1,981.66 before moving to its destination price of $ $3,195.85 in CY 2022. As we stated previously, this 
                        <PRTPAGE P="50088"/>
                        policy is intended to minimize any potential disruptive effects during the pricing transition period due to the high number of services that make use of these very common supply and equipment items included in 100 or more HCPCS codes.
                    </P>
                    <P>We also received invoices for the colonoscopy videoscope (ES033) and gastroscopy videoscopy (ES034) as part of the review of the Esophagogastroduodenoscopy (EGD) with Biopsy and the Colonoscopy code families. We finalized the replacement of both of these scope equipment items in the CY 2020 final rule (84 FR 62588 through 62590), replacing the colonoscopy videoscope (ES033) with the multi-channeled flexible digital scope, colonoscopy (ES086) equipment item and the gastroscopy videoscopy (ES034) with the multi-channeled flexible digital scope, esophagoscopy gastroscopy duodenoscopy (EGD) (ES087) equipment item. In both cases, the submitted invoices were nearly identical to the finalized prices for the ES086 ($38,058.81) and ES087 ($34,585.35) equipment. We believe that these invoices reinforce the prices finalized through rulemaking last year, and therefore, we are not proposing to further update the prices of these scopes.</P>
                    <P>We remain open to further comments regarding the pricing of the remaining seven scope equipment codes that still lack invoices, as well as additional data regarding the pricing of the scope equipment codes that currently share the same price.</P>
                    <HD SOURCE="HD3">c. Technical Corrections to Direct PE Input Database and Supporting Files</HD>
                    <P>For CY 2021, we are proposing to address the following inconsistencies:</P>
                    <P>• Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and clarified that CPT code 0466T (Insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator) is always performed on an add-on basis and would never be used as a standalone code. Therefore, we are proposing to update the global period for CPT code 0466T to add-on status (ZZZ) to more accurately reflect the way in which this service is performed.</P>
                    <HD SOURCE="HD3">d. Updates to Prices for Existing Direct PE Inputs</HD>
                    <P>In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2021, we are proposing to update the price of one supply and four equipment items in response to the public submission of invoices. As these pricing updates were each part of the formal review for a code family, we are proposing that the new pricing take effect for CY 2021 for these items instead of being phased in over 4 years. These supply and equipment items with updated prices associated with the formal review of a code family are listed in the valuation of specific codes section of the preamble under Table 27: CY 2021 Invoices Received for Existing Direct PE Inputs.</P>
                    <HD SOURCE="HD3">(1) Market-Based Supply and Equipment Pricing Update</HD>
                    <P>Section 220(a) of the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93, enacted April 1, 2014) provides that the Secretary may collect or obtain information from any eligible professional or any other source on the resources directly or indirectly related to furnishing services for which payment is made under the PFS, and that such information may be used in the determination of relative values for services under the PFS. Such information may include the time involved in furnishing services; the amounts, types and prices of PE inputs; overhead and accounting information for practices of physicians and other suppliers, and any other elements that would improve the valuation of services under the PFS.</P>
                    <P>
                        As part of our authority under section 1848(c)(2)(M) of the Act, we initiated a market research contract with StrategyGen to conduct an in-depth and robust market research study to update the PFS direct PE inputs (DPEI) for supply and equipment pricing for CY 2019. These supply and equipment prices were last systematically developed in 2004-2005. StrategyGen submitted a report with updated pricing recommendations for approximately 1300 supplies and 750 equipment items currently used as direct PE inputs. This report is available as a public use file displayed on the CMS website under downloads for the CY 2019 PFS final rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                    </P>
                    <P>The StrategyGen team of researchers, attorneys, physicians, and health policy experts conducted a market research study of the supply and equipment items currently used in the PFS direct PE input database. Resources and methodologies included field surveys, aggregate databases, vendor resources, market scans, market analysis, physician substantiation, and statistical analysis to estimate and validate current prices for medical equipment and medical supplies. StrategyGen conducted secondary market research on each of the 2,072 DPEI medical equipment and supply items that CMS identified from the current DPEI. The primary and secondary resources StrategyGen used to gather price data and other information were:</P>
                    <P>• Telephone surveys with vendors for top priority items (Vendor Survey).</P>
                    <P>• Physician panel validation of market research results, prioritized by total spending (Physician Panel).</P>
                    <P>• The General Services Administration system (GSA).</P>
                    <P>• An aggregate health system buyers database with discounted prices (Buyers).</P>
                    <P>• Publicly available vendor resources, that is, Amazon Business, Cardinal Health (Vendors).</P>
                    <P>
                        • The 
                        <E T="04">Federal Register</E>
                        , current DPEI data, historical proposed and final rules prior to CY 2018, and other resources; that is, AMA RUC reports (References).
                    </P>
                    <P>StrategyGen prioritized the equipment and supply research based on current share of PE RVUs attributable by item provided by CMS. StrategyGen developed the preliminary Recommended Price (RP) methodology based on the following rules in hierarchical order considering both data representativeness and reliability.</P>
                    <P>(1) If the market share, as well as the sample size, for the top three commercial products were available, the weighted average price (weighted by percent market share) was the reported RP. Commercial price, as a weighted average of market share, represents a more robust estimate for each piece of equipment and a more precise reference for the RP.</P>
                    <P>(2) If no data were available for commercial products, the current CMS prices were used as the RP.</P>
                    <P>GSA prices were not used to calculate the StrategyGen recommended prices, due to our concern that the GSA system curtails the number and type of suppliers whose products may be accessed on the GSA Advantage website, and that the GSA prices may often be lower than prices that are available to non-governmental purchasers. After reviewing the StrategyGen report, we proposed to adopt the updated direct PE input prices for supplies and equipment as recommended by StrategyGen.</P>
                    <P>
                        StrategyGen found that despite technological advancements, the average commercial price for medical equipment and supplies has remained relatively consistent with the current 
                        <PRTPAGE P="50089"/>
                        CMS price. Specifically, preliminary data indicated that there was no statistically significant difference between the estimated commercial prices and the current CMS prices for both equipment and supplies. This cumulative stable pricing for medical equipment and supplies appears similar to the pricing impacts of non-medical technology advancements where some historically high-priced equipment (that is, desktop PCs) has been increasingly substituted with current technology (that is, laptops and tablets) at similar or lower price points. However, while there were no statistically significant differences in pricing at the aggregate level, medical specialties would experience increases or decreases in their Medicare payments if we were to adopt the pricing updates recommended by StrategyGen. At the service level, there may be large shifts in PE RVUs for individual codes that happened to contain supplies and/or equipment with major changes in pricing, although we note that codes with a sizable PE RVU decrease would be limited by the requirement to phase in significant reductions in RVUs, as required by section 1848(c)(7) of the Act. The phase-in requirement limits the maximum RVU reduction for codes that are not new or revised to 19 percent in any individual calendar year.
                    </P>
                    <P>We believe that it is important to make use of the most current information available for supply and equipment pricing instead of continuing to rely on pricing information that is more than a decade old. Given the potentially significant changes in payment that would occur, both for specific services and more broadly at the specialty level, in the CY 2019 PFS proposed rule we proposed to phase in our use of the new direct PE input pricing over a 4-year period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 percent (CY 2021), and 100/0 percent (CY 2022) split between new and old pricing. This approach is consistent with how we have previously incorporated significant new data into the calculation of PE RVUs, such as the 4-year transition period finalized in CY 2007 PFS final rule with comment period when changing to the “bottom-up” PE methodology (71 FR 69641). This transition period will not only ease the shift to the updated supply and equipment pricing, but will also allow interested parties an opportunity to review and respond to the new pricing information associated with their services.</P>
                    <P>We proposed to implement this phase-in over 4 years so that supply and equipment values transition smoothly from the prices we currently include to the final updated prices in CY 2022. We proposed to implement this pricing transition such that one quarter of the difference between the current price and the fully phased-in price is implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 6.</P>
                    <GPH SPAN="3" DEEP="90">
                        <GID>EP17AU20.006</GID>
                    </GPH>
                    <P>For new supply and equipment codes for which we establish prices during the transition years (CYs 2019, 2020 and 2021) based on the public submission of invoices, we proposed to fully implement those prices with no transition since there are no current prices for these supply and equipment items. These new supply and equipment codes would immediately be priced at their newly established values. We also proposed that, for existing supply and equipment codes, when we establish prices based on invoices that are submitted as part of a revaluation or comprehensive review of a code or code family, they will be fully implemented for the year they are adopted without being phased in over the 4-year pricing transition. The formal review process for a HCPCS code includes a review of pricing of the supplies and equipment included in the code. When we find that the price on the submitted invoice is typical for the item in question, we believe it would be appropriate to finalize the new pricing immediately along with any other revisions we adopt for the code valuation.</P>
                    <P>For existing supply and equipment codes that are not part of a comprehensive review and valuation of a code family and for which we establish prices based on invoices submitted by the public, we proposed to implement the established invoice price as the updated price and to phase in the new price over the remaining years of the proposed 4-year pricing transition. During the proposed transition period, where price changes for supplies and equipment are adopted without a formal review of the HCPCS codes that include them (as is the case for the many updated prices we proposed to phase in over the 4-year transition period), we believe it is important to include them in the remaining transition toward the updated price. We also proposed to phase in any updated pricing we establish during the 4-year transition period for very commonly used supplies and equipment that are included in 100 or more codes, such as sterile gloves (SB024) or exam tables (EF023), even if invoices are provided as part of the formal review of a code family. We would implement the new prices for any such supplies and equipment over the remaining years of the proposed 4-year transition period. Our proposal was intended to minimize any potential disruptive effects during the proposed transition period that could be caused by other sudden shifts in RVUs due to the high number of services that make use of these very common supply and equipment items (meaning that these items are included in 100 or more codes).</P>
                    <P>
                        We believed that implementing the proposed updated prices with a 4-year phase-in would improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. Updating the pricing of direct PE inputs for supplies and equipment over a longer timeframe will allow more opportunities for public 
                        <PRTPAGE P="50090"/>
                        comment and submission of additional, applicable data. We welcomed feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.
                    </P>
                    <P>We received many comments regarding the market-based supply and equipment pricing proposal following the publication of the CY 2019 PFS proposed rule. For a full discussion of these comments, we direct readers to the CY 2019 PFS final rule (83 FR 59475 through 59480). In each instance in which a commenter raised questions about the accuracy of a supply or equipment code's recommended price, the StrategyGen contractor conducted further research on the item and its price with special attention to ensuring that the recommended price was based on the correct item in question and the clarified unit of measure. Based on the commenters' requests, the StrategyGen contractor conducted an extensive examination of the pricing of any supply or equipment items that any commenter identified as requiring additional review. Invoices submitted by multiple commenters were greatly appreciated and ensured that medical equipment and supplies were re-examined and clarified. Multiple researchers reviewed these specified supply and equipment codes for accuracy and proper pricing. In most cases, the contractor also reached out to a team of nurses and their physician panel to further validate the accuracy of the data and pricing information. In some cases, the pricing for individual items needed further clarification due to a lack of information or due to significant variation in packaged items. After consideration of the comments and this additional price research, we updated the recommended prices for approximately 70 supply and equipment codes identified by the commenters. Table 9 in the CY 2019 PFS final rule lists the supply and equipment codes with price changes based on feedback from the commenters and the resulting additional research into pricing (83 FR 59479 through 59480).</P>
                    <P>After consideration of the public comments, we finalized our proposals associated with the market research study to update the PFS direct PE inputs for supply and equipment pricing. We continue to believe that implementing the proposed updated prices with a 4-year phase-in will improve payment accuracy, while maintaining stability and allowing stakeholders the opportunity to address potential concerns about changes in payment for particular items. We continue to welcome feedback from stakeholders on the proposed updated supply and equipment pricing, including the submission of additional invoices for consideration.</P>
                    <P>For CY 2021, we received invoice submissions for approximately a dozen supply and equipment codes from stakeholders as part of the third year of the market-based supply and equipment pricing update. The submitted invoices were used in many cases to supplement the pricing originally proposed for the CY 2019 PFS rule cycle. We reviewed the invoices as well as prior data for the relevant supply/equipment codes to make sure the item in the invoice was representative of the supply/equipment item in question and aligned with past research. Based on this research, we are proposing to update the prices of the supply and equipment items listed in Table 7 of the CY 2021 PFS proposed rule.</P>
                    <P>We finalized a policy in CY 2019 to phase in the new supply and equipment pricing over 4 years so that supply and equipment values transition smoothly from their current prices to the final updated prices in CY 2022. We finalized our proposal to implement this pricing transition such that one quarter of the difference between the current price and the fully phased in price was implemented for CY 2019, one third of the difference between the CY 2019 price and the final price is implemented for CY 2020, and one half of the difference between the CY 2020 price and the final price is implemented for CY 2021, with the new direct PE prices fully implemented for CY 2022. An example of the transition from the current to the fully-implemented new pricing is provided in Table 6. For CY 2021, one half of the difference between the CY 2020 price and the final price will be implemented as per the previously finalized policy. Table 7 contains the list of proposed CY 2021 market-based supply and equipment pricing updates:</P>
                    <GPH SPAN="3" DEEP="190">
                        <GID>EP17AU20.007</GID>
                    </GPH>
                    <P>The proposed prices for the supply and equipment items listed in Table 7 were calculated based on averaging together the prices on the submitted invoices. In the case of the vascular sheath (SD136) and RF endovenous occlusion catheter (SD155) supplies, the proposed price was determined by removing the sheath or catheter from the eight submitted kit invoices and then averaging the resulting price together with the single standalone sheath/catheter invoice.</P>
                    <P>
                        In addition to submitting invoices with information updating the price of 
                        <PRTPAGE P="50091"/>
                        the “Vmax 22d and 62j (PFT equip, autobox, computer system)” (EQ041) equipment, stakeholders also clarified that the “Vmax 229 (spirometry testing equip, computer system)” (EQ040) and “Vmax 29s (spirometry testing equip, computer system)” (EQ043) equipment items have become obsolete and are no longer typically used in any HCPCS codes. Based on the information supplied by the stakeholders, we are proposing to remove the EQ040 and EQ043 equipment items, replacing them with the EQ041 equipment at the same number of minutes in the six HCPCS codes where they are utilized.
                    </P>
                    <P>We are not proposing to update the price of additional supply and equipment items for which invoices were submitted following the publication of the CY 2020 PFS final rule. We are not proposing to update the price for the “pipette, transfer 23ml” (SL109), “slide specimen mailer (1-5 microscope slides)” (SL121), “stain, hematoxylin” (SL135), “stain, eosin” (SL201), and “stain, PAP OG-6” (SL491) supplies. In each case we received a single invoice for these five supplies detailing price increases ranging from 82 percent to 160 percent above the current pricing. These supplies are commonly used in cytopathology procedures and we disagree that the typical price for these supplies has more than doubled since being reviewed by the StrategyGen contractor two years ago for CY 2019.</P>
                    <P>We are also not proposing to update the price for the “embedding mold” (SL060) supply or the “microscope, compound” (EP060) equipment based on the same rationale. The submitted invoices represent pricing increases of 339 percent for the compound microscope and 7800 percent for the embedding mold and, based on the recent review of the pricing of these items by our contractor, we do not believe that the submitted invoices reflect typical market-based pricing. The same stakeholder also submitted an invoice to update the price of the surgical mask (SB033) supply by 617 percent over the current price. However, the invoice in question contains the price for a surgical mask with face shield, which is described by the SB034 supply code, not the SB033 supply code. Therefore, we are not proposing to update the price of the surgical mask (SB033) supply based on this invoice. Finally, we received an invoice for a ClosureFast Procedure Pack (CFP) but it was unclear what supply or equipment item this invoice was intended to update. As a result, we were unable to use this invoice to make a pricing proposal.</P>
                    <HD SOURCE="HD3">(2) Invoice Submission</HD>
                    <P>
                        The full list of updated supply and equipment pricing as it will be implemented over the 4-year transition period will be made available as a public use file displayed on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                    </P>
                    <P>
                        We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline we noted for consideration of RUC recommendations. However, we will consider invoices submitted as public comments during the comment period following the publication of the PFS proposed rule, and would consider any invoices received after February 10th or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices. Stakeholders are encouraged to submit invoices as part of their public comments or, if outside the public comment process, via email at 
                        <E T="03">PE_Price_Input_Update@cms.hhs.gov.</E>
                    </P>
                    <HD SOURCE="HD3">(3) Updated Supply Pricing for Venous and Arterial Stenting Services</HD>
                    <P>Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding supply pricing for certain venous and arterial stenting services. These stakeholders stated that the use of the “stent, vascular, deployment system, Cordis SMART” (SA103) supply was no longer typical in CPT codes 37238 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; initial vein) and 37239 (Transcatheter placement of an intravascular stent(s), open or percutaneous, including radiological supervision and interpretation and including angioplasty within the same vessel, when performed; each additional vein). The stakeholders stated that a new venous stent system had become the typical standard of care for these services, and they supplied ten invoices for use in pricing this supply.</P>
                    <P>The stakeholders also requested additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply included in CPT codes 37236 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; initial artery) and 37237 (Transcatheter placement of an intravascular stent(s) (except lower extremity artery(s) for occlusive disease, cervical carotid, extracranial vertebral or intrathoracic carotid, intracranial, or coronary), open or percutaneous, including radiological supervision and interpretation and including all angioplasty within the same vessel, when performed; each additional artery). The stakeholders specifically were unclear what the implantable stent balloon represented and sought guidance on whether pricing involved a stent, a balloon, or a combination of both.</P>
                    <P>In response to the additional information provided by the stakeholders, we are proposing to remove the SA103 supply item from CPT codes 37238 and 37239. We are proposing to replace it with a newly created “venous stent system” (SD340) supply at the same supply quantity. We are proposing a price of $1,750.00 for the venous stent system based on the median price of the ten invoices supplied by the stakeholders. We are proposing the use of the median price due to the presence of several invoices that appear to be outliers which are not reflective of market pricing for the venous stent system. With regards to the request for additional information regarding the nature of the “stent, balloon, implantable” (SD299) supply, the original invoice used to price this supply during the CY 2015 rule cycle listed an item named “Renal and Biliary Stent System 7.0 mm x 15 mm x 135 cm”. We welcome additional information from stakeholders regarding the nature and pricing of this supply item.</P>
                    <HD SOURCE="HD3">(4) Myocardial PET Equipment Inputs</HD>
                    <P>
                        Following the publication of the CY 2020 PFS final rule, stakeholders contacted CMS and presented additional information regarding the direct PE inputs for several codes associated with Myocardial PET services. The stakeholders stated that the nuclide rod source set (ER044) equipment was inadvertently excluded 
                        <PRTPAGE P="50092"/>
                        from the direct PE recommendations for CPT codes 78432 (Myocardial imaging, positron emission tomography (PET), combined perfusion with metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), dual radiotracer (
                        <E T="03">e.g.,</E>
                         myocardial viability);), 78459 (Myocardial imaging, positron emission tomography (PET), metabolic evaluation study (including ventricular wall motion[s] and/or ejection fraction[s], when performed), single study;), 78491 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); single study, at rest or stress (exercise or pharmacologic)), and 78492 (Myocardial imaging, positron emission tomography (PET), perfusion study (including ventricular wall motion[s] and/or ejection fraction[s], when performed); multiple studies at rest and stress (exercise or pharmacologic)), and requested that CMS add this equipment to the direct inputs for this group of CPT codes. The stakeholders also stated that the current useful life of 5 years for the ER044 equipment was incorrect as these sources are replaced every 9 months to 1 year. The stakeholders requested that CMS update the useful life of ER044 to 0.75 years. Finally, the stakeholders stated that the costs for the purchase of the Rubidium PET Generator (ER114) equipment are captured elsewhere through the billing of HCPCS supply code A9555, and the stakeholders recommended that we remove equipment item ER114 to avoid incorrect billing duplication.
                    </P>
                    <P>We appreciate the additional information submitted by the stakeholders regarding the direct PE inputs for these Myocardial PET services. In response to this new information, we are proposing to update the price for the nuclide rod source set (ER044) equipment to $2,081.17 based on averaging together the price of the three submitted invoices after removing the shipping and delivery costs according to our standard pricing methodology. We are also proposing to add the ER044 equipment to CPT codes 78432, 78459, 78491, and 78492 as requested, assigning the same equipment time utilized by the “PET Refurbished Imaging Cardiac Configuration” (ER110) equipment in each service. We are proposing to update the useful life of the ER044 equipment to one year in accordance with our proposed policy to treat equipment useful life durations of less than 1 year as having a duration of one year. As we stated previously in section II.B we have concerns that assigning very low useful life durations of less than 1 year would fail to maintain relativity with other equipment on the PFS, and the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. We direct readers to the previous discussion regarding equipment cost per minute methodology earlier in section II.B. of this proposed rule. Finally, we are removing the “PET Generator (Rubidium)” (ER114) equipment from our database as requested by the stakeholders. We note that since the technical components for CPT codes 78432, 78459, 78491, and 78492 are all contractor-priced, there will be no change to the national pricing of these codes.</P>
                    <HD SOURCE="HD3">(5) Adjustment to Allocation of Indirect PE for Some Office-Based Services</HD>
                    <P>In the CY 2018 PFS final rule (82 FR 52999 through 53000), we established criteria for identifying the services most affected by the indirect PE allocation anomaly that does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. We also finalized a modification in the PE methodology for allocating indirect PE RVUs to better reflect the relative indirect PE resources involved in furnishing these services. The methodology, as described, is based on the difference between the ratio of indirect PE to work RVUs for each of the codes meeting eligibility criteria and the ratio of indirect PE to work RVU for the most commonly reported visit code. We refer readers to the CY 2018 PFS final rule (82 FR 52999 through 53000) for a discussion of our process for selecting services subject to the revised methodology, as well as a description of the methodology, which we began implementing for CY 2018 as the first year of a 4-year transition.</P>
                    <P>For CY 2021, we are proposing to continue with the fourth and final year of the transition of this adjustment to the standard process for allocating indirect PE.</P>
                    <HD SOURCE="HD3">e. Update on Technical Expert Panel Related to Practice Expense</HD>
                    <P>The RAND Corporation is currently studying potential improvements to CMS' PE allocation methodology and the data that underlie it. As we noted earlier in this section, our current system for setting PE RVUs relies in part on data collected in the Physician Practice Information Survey (PPIS), which was administered by the AMA in CY 2007 and 2008.</P>
                    <P>
                        RAND, in its first phase of research, available at 
                        <E T="03">https://www.rand.org/pubs/research_reports/RR2166.html,</E>
                         found that the PPIS data are outdated and may no longer reflect the resource allocation, staffing arrangements, and cost structures that describe practitioners' resource requirements in furnishing services to Medicare beneficiaries, and consequently may not accurately capture the indirect PE resources required to furnish services to Medicare FFS beneficiaries. For example, the PPIS preceded the widespread adoption of electronic health records, quality reporting programs, billing codes that promote team-based care, and hospital acquisition of physician practices. Notably, RAND found that practice ownership was strongly associated with indirect PE, with physician-owned practices requiring 190% higher indirect PE compared to facility-owned practices, suggesting a need to potentially update demographic information. Additionally, RAND found that aggregating Medicare provider specialties into broader categories resulted in small specialty-level impacts relative to the current system, suggesting that specialty-specific inputs may not be required to accurately reflect resource costs.
                    </P>
                    <P>
                        To follow up on these and other issues raised in the first phase of RAND's research, in the CY 2020 PFS, we announced that RAND was convening a technical expert panel (TEP) to obtain input from stakeholders including physicians, practice and health system managers, health care accountants, and health policy experts. The TEP occurred on January 10, 2020 and its report is available at 
                        <E T="03">https://www.rand.org/pubs/working_papers/WR1334.html.</E>
                         Topics discussed included identifying issues with the current system; changes in medicine that have affected PE; how PE inputs could be updated, including through a potential new survey instrument; how best to aggregate PE categories if there were to be new survey instrument; ways to maximize response rates in a potential new survey; and using existing data to inform PFS PE rates. In addition, RAND has issued the results of its subsequent phase of research, available at 
                        <E T="03">www.rand.org/t/RR3248.</E>
                         This report is also available as a public use file displayed on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                        <PRTPAGE P="50093"/>
                    </P>
                    <P>
                        Based on the results of the TEP and RAND's other ongoing research, we are interested in potentially refining the PE methodology and updating the data used to make payments under the PFS. We believe that potential refinements could improve payment accuracy and strengthen Medicare. Our goals are to balance obtaining the data as soon as practicable and in a way that would allow stakeholders and CMS to collectively examine many of the issues the TEP and RAND's research identified. We are thinking through several questions, including how to best incorporate market-based information, which could be similar to the market research that we recently conducted to update supply and equipment pricing used to determine direct PE inputs under the PFS payment methodology. For example, stakeholders have expressed an interest in updating the clinical labor data that we use for direct PE inputs based on current salaries and compensation for the health care workforce. We are soliciting comment regarding how we might update the clinical labor data. Historically, we have used data from the Bureau of Labor Statistics and are seeking comment to determine if this is the best data source or if there is an alternative. We are also interested in hosting a Town Hall meeting at a date to be determined to provide an open forum for discussion with stakeholders on our ongoing research to potentially update the PE methodology and the underlying inputs. Finally, we welcome feedback from all interested parties regarding RAND's report and we are not making any proposals based on this report at this time. Stakeholders are encouraged to submit feedback as part of their public comments or, if outside the public comment process, via email at 
                        <E T="03">PE_Price_Input_Update@cms.hhs.gov.</E>
                    </P>
                    <HD SOURCE="HD2">C. Potentially Misvalued Services Under the PFS</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Section 1848(c)(2)(K) of the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.</P>
                    <P>As discussed in section II.H. of this proposed rule, Valuation of Specific Codes, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association Resource-Based Relative Value Scale (RVS) Update Committee (RUC), Medicare Payment Advisory Commission (MedPAC), and other stakeholders. For many years, the RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA), National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based Incentive Payment System (MIPS) data. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.</P>
                    <P>
                        In its March 2006 Report to the Congress (
                        <E T="03">http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0</E>
                        ), MedPAC discussed the importance of appropriately valuing physicians' services, noting that misvalued services can distort the market for physicians' services, as well as for other health care services that physicians order, such as hospital services. In that same report, MedPAC postulated that physicians' services under the PFS can become misvalued over time. MedPAC stated, “When a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” We believe services can also become overvalued when PE costs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PE costs rises.
                    </P>
                    <P>
                        As MedPAC noted in its March 2009 Report to Congress (
                        <E T="03">http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf</E>
                        ), in the intervening years since MedPAC made the initial recommendations, CMS and the RUC have taken several steps to improve the review process. Also, section 1848(c)(2)(K)(ii) of the Act augments our efforts by directing the Secretary to specifically examine, as determined appropriate, potentially misvalued services in the following categories:
                    </P>
                    <P>• Codes that have experienced the fastest growth.</P>
                    <P>• Codes that have experienced substantial changes in PE.</P>
                    <P>• Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.</P>
                    <P>• Codes which are multiple codes that are frequently billed in conjunction with furnishing a single service.</P>
                    <P>• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.</P>
                    <P>• Codes that have not been subject to review since implementation of the fee schedule.</P>
                    <P>• Codes that account for the majority of spending under the PFS.</P>
                    <P>• Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.</P>
                    <P>• Codes for which there may be a change in the typical site of service since the code was last valued.</P>
                    <P>• Codes for which there is a significant difference in payment for the same service between different sites of service.</P>
                    <P>• Codes for which there may be anomalies in relative values within a family of codes.</P>
                    <P>
                        • Codes for services where there may be efficiencies when a service is 
                        <PRTPAGE P="50094"/>
                        furnished at the same time as other services.
                    </P>
                    <P>• Codes with high intraservice work per unit of time.</P>
                    <P>• Codes with high PE RVUs.</P>
                    <P>• Codes with high cost supplies.</P>
                    <P>• Codes as determined appropriate by the Secretary.</P>
                    <P>Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) that may include consolidation of individual services into bundled codes for payment under the PFS.</P>
                    <HD SOURCE="HD3">2. Progress in Identifying and Reviewing Potentially Misvalued Codes</HD>
                    <P>
                        To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as specified in section 1848(c)(2)(K)(ii) of the Act, and we intend to continue our work examining potentially misvalued codes in these areas over the upcoming years. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well. Individuals and stakeholder groups may submit codes for review under the potentially misvalued codes initiative to CMS in one of two ways. Nominations may be submitted to CMS via email or through postal mail. Email submissions should be sent to the CMS emailbox 
                        <E T="03">MedicarePhysicianFeeSchedule@cms.hhs.gov,</E>
                         with the phrase “Potentially Misvalued Codes” and the referencing CPT code number(s) and/or the CPT descriptor(s) in the subject line. Physical letters for nominations should be sent via the U.S. Postal Service to the Centers for Medicare &amp; Medicaid Services, Mail Stop: C4-01-26, 7500 Security Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination letters must be labeled “Attention: Division of Practitioner Services, Potentially Misvalued Codes”. Nominations for consideration in our next annual rule cycle should be received by our February 10th deadline. Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review process, we have reviewed over 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the Medicare Program; Payment Policies Under the Physician Fee Schedule, Five-Year Review of Work Relative Value Units, Clinical Laboratory Fee Schedule: Signature on Requisition, and Other Revisions to Part B for CY 2012; final rule (76 FR 73052 through 73055) (hereinafter referred to as the “CY 2012 PFS final rule with comment period”). In the CY 2012 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.
                    </P>
                    <P>In the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013 (77 FR 68892) (hereinafter referred to as the “CY 2013 PFS final rule with comment period”), we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In the Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2009; and Revisions to the Amendment of the E-Prescribing Exemption for Computer Generated Facsimile Transmissions; Proposed Rule (73 FR 38589) (hereinafter referred to as the “CY 2009 PFS proposed rule”), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time). We have continued each year to consider and finalize a list of potentially misvalued codes that have or will be reviewed and revised as appropriate in future rulemaking.</P>
                    <HD SOURCE="HD3">3. CY 2021 Identification and Review of Potentially Misvalued Services</HD>
                    <P>In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. In the CY 2015 PFS final rule with comment period (79 FR 67606 through 67608), we modified this process whereby the public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10th of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:</P>
                    <P>• Documentation in peer reviewed medical literature or other reliable data that demonstrate changes in physician work due to one or more of the following: Technique, knowledge and technology, patient population, site-of-service, length of hospital stay, and work time.</P>
                    <P>• An anomalous relationship between the code being proposed for review and other codes.</P>
                    <P>• Evidence that technology has changed physician work.</P>
                    <P>
                        • Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
                        <PRTPAGE P="50095"/>
                    </P>
                    <P>• Evidence that incorrect assumptions were made in the previous valuation of the service, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.</P>
                    <P>• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.</P>
                    <P>• Analyses of work time, work RVU, or direct PE inputs using other data sources (for example, VA, NSQIP, the STS National Database, and the MIPS data).</P>
                    <P>• National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.</P>
                    <P>We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes and indicate for each nominated code whether we agree with its inclusion as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.</P>
                    <HD SOURCE="HD3">a. Public Nominations</HD>
                    <P>We received submissions nominating codes for review under the potentially misvalued code initiative, and several requests for review of practice expense related inputs prior to our February 10, 2020 deadline. We refer readers to section II.B. of this proposed rule, Determination of Practice Expense RVUs, for further discussion on the PE-related submissions. Our summary of the submissions reviewed under the potentially misvalued code initiative is discussed below.</P>
                    <P>
                        We received multiple submissions requesting that CMS consider CPT code 22867 (
                        <E T="03">Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level</E>
                        ) for nomination as potentially misvalued. In their request, the submitters suggested that the physician work assigned to this code significantly undervalues the procedure relative to the value of CPT code 63047 (
                        <E T="03">Laminectomy, facetectomy and foraminotomy (unilateral or bilateral with decompression of spinal cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess stenosis]), single vertebral segment; lumbar</E>
                        ). The submitters stated that the work performed during the surgical steps to perform a laminectomy for both procedures is generally similar except for the additional intensity and complexity involved in CPT code 22867 to implant the interspinous stabilization device. The submitters also requested that the malpractice RVUs assigned to this code be increased to better align with similar spine procedures, in terms of specialty level and service level risk factors, in addition to the intensity and complexity of the procedure. After considering the information provided by the submitter, which suggests that the current valuation for the service may not reflect the level of intensity inherent in furnishing the service relative to other similar services with inputs that exceed those for the nominated service we are proposing to nominate CPT code 22867 as potentially misvalued and welcome public comment on this code.
                    </P>
                    <HD SOURCE="HD2">D. Telehealth and Other Services Involving Communications Technology</HD>
                    <HD SOURCE="HD3">1. Payment for Medicare Telehealth Services Under Section 1834(m) of the Act</HD>
                    <P>As discussed in this proposed rule and in prior rulemaking, several conditions must be met for Medicare to make payment for telehealth services under the PFS. For further details, see the full discussion of the scope of Medicare telehealth services in the CY 2018 PFS final rule (82 FR 53006) and in 42 CFR 410.78 and 414.65.</P>
                    <HD SOURCE="HD3">a. Adding Services to the Medicare Telehealth Services List</HD>
                    <P>In the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the Medicare telehealth services list in accordance with section 1834(m)(4)(F)(ii) of the Act. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us. Under this process, we assign any submitted request to add to the Medicare telehealth services list to one of the following two categories:</P>
                    <P>
                        • 
                        <E T="03">Category 1:</E>
                         Services that are similar to professional consultations, office visits, and office psychiatry services that are currently on Medicare telehealth services list. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter, a practitioner who is present with the beneficiary in the originating site. We also look for similarities in the telecommunications system used to deliver the 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 those on the current Medicare telehealth services list. Our review of these requests includes an assessment of whether the service is accurately described by the corresponding code when furnished via telehealth and whether the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient. Submitted evidence should include both a description of relevant clinical studies that demonstrate the service furnished by telehealth to a Medicare beneficiary improves the diagnosis or treatment of an illness or injury or improves the functioning of a malformed body part, including dates and findings, and a list and copies of published peer reviewed articles relevant to the service when furnished via telehealth. Our evidentiary standard of clinical benefit does not include minor or incidental benefits.
                    </P>
                    <P>Some examples of clinical benefit include the following:</P>
                    <P>• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in-person diagnostic services.</P>
                    <P>• Treatment option for a patient population without access to clinically appropriate in-person treatment options.</P>
                    <P>• Reduced rate of complications.</P>
                    <P>• Decreased rate of subsequent diagnostic or therapeutic interventions (for example, due to reduced rate of recurrence of the disease process).</P>
                    <P>• Decreased number of future hospitalizations or physician visits.</P>
                    <P>• More rapid beneficial resolution of the disease process treatment.</P>
                    <P>• Decreased pain, bleeding, or other quantifiable symptom.</P>
                    <P>• Reduced recovery time.</P>
                    <P>
                        The Medicare telehealth services list, including the additions described later in this section, is available on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.</E>
                    </P>
                    <P>
                        For CY 2021, requests to add services to the Medicare telehealth services list must have been submitted and received by February 10, 2020. Each request to add a service to the Medicare telehealth services list must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as the vehicle to 
                        <PRTPAGE P="50096"/>
                        make changes to the Medicare telehealth services list, requesters should be advised that any information submitted as part of a request is subject to public disclosure for this purpose. For more information on submitting a request to add services to the Medicare telehealth services list, including where to mail these requests, see our website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.</E>
                    </P>
                    <HD SOURCE="HD3">b. Requests To Add Services to the Medicare Telehealth Services List for CY 2021</HD>
                    <P>Under our current policy, we add services to the Medicare telehealth services list on a Category 1 basis when we determine that they are similar to services on the existing Medicare telehealth services list for the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73098), we believe that the Category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the Medicare telehealth services list that resemble those services already on the Medicare telehealth services list. We received several requests to add various services as Medicare telehealth services effective for CY 2021. We also conducted an internal review of potential services to add to the Medicare telehealth services list.</P>
                    <P>In response to the PHE for the COVID-19 pandemic, CMS undertook emergency rulemaking to add a number of services to the Medicare telehealth services list on an interim final basis. In the “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final rule with comment period (IFC), (85 FR 19230, 19234 through 19241, March 31, 2020) (hereinafter referred to as the “March 31st COVID-19 IFC”), on an interim final basis for the duration of the PHE for the COVID-19 pandemic, we also finalized the addition of a number of services to the Medicare telehealth services list on a Category 2 basis. The following is a list of those services:</P>
                    <P>• Emergency Department (ED) Visits, Levels 1-5 (CPT codes 99281-99285).</P>
                    <P>• Initial and Subsequent Observation and Observation Discharge Day Management (CPT codes 99217-99220; CPT codes 99224-99226; CPT codes 99234-99236).</P>
                    <P>• Initial hospital care and hospital discharge day management (CPT codes 99221-99223; CPT codes 99238-99239).</P>
                    <P>• Initial nursing facility visits, All levels (Low, Moderate, and High Complexity) and nursing facility discharge day management (CPT codes 99304-99306; CPT codes 99315-99316).</P>
                    <P>• Critical Care Services (CPT codes 99291-99292).</P>
                    <P>• Domiciliary, Rest Home, or Custodial Care services, New and Established patients (CPT codes 99327-99328; CPT codes 99334-99337).</P>
                    <P>• Home Visits, New and Established Patient, All levels (CPT codes 99341-99345; CPT codes 99347-99350).</P>
                    <P>• Inpatient Neonatal and Pediatric Critical Care, Initial and Subsequent (CPT codes 99468-99473; CPT codes 99475-99476).</P>
                    <P>• Initial and Continuing Intensive Care Services (CPT code 99477-994780).</P>
                    <P>• Assessment and Care Planning for Patients with Cognitive Impairment (CPT code 99483).</P>
                    <P>• Group Psychotherapy (CPT code 90853).</P>
                    <P>• End-Stage Renal Disease (ESRD) Services (CPT codes 90952, 90953, 90959, and 90962).</P>
                    <P>• Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes 96136-96139).</P>
                    <P>• Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521-92524, 92507).</P>
                    <P>• Radiation Treatment Management Services (CPT codes 77427).</P>
                    <P>When we previously considered adding these services to the Medicare telehealth services list, either through a public request or through our own internal review, we considered whether these services met the Category 1 or Category 2 criteria. In many cases, we reviewed requests to add these services on a Category 1 basis, but did not receive or identify information that allowed us to review the services on a Category 2 basis. While we stated in the March 31st COVID-19 IFC that we did not believe the context of the PHE for the COVID-19 pandemic changes the assessment of these services as Category 1, we did reassess all of these services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community. Given the exposure risks for beneficiaries, the health care work force, and the community at large, we stated that in-person interaction between professionals and patients poses an immediate potential risk that would not have been present when we previously reviewed these services. We were concerned that this new risk created a unique circumstance where health care professionals might have to choose between the best means to mitigate exposure risk for themselves and for their patients or seeking Medicare payment for the service. For example, certain persons, especially older adults who are particularly vulnerable to complications from this specific viral infection; those considered at risk because of underlying health conditions; and those known to be recently exposed or diagnosed, and therefore, likely to spread the virus to others, were often being directed by local public health officials to self-isolate as much as possible. At the same time, we noted that the risk to medical professionals treating patients is high and we considered it likely that medical professionals would try to treat patients as effectively as possible without exposing themselves or their patients unnecessarily. We explained that, in some cases, the use of telecommunication technology could mitigate the exposure risk; and in such cases, there is a clear clinical benefit of using such technology in furnishing the service. In other words, patients who should not be seen by a professional in-person due to the exposure risk were highly likely to be without access to clinically appropriate treatment or diagnostic options unless they have access to services furnished through interactive communication technology. Therefore, in the context of the PHE for the COVID-19 pandemic, we believed that all of the services we added met the Category 2 criteria to be added to the Medicare telehealth services list on the basis that there was a patient population that would otherwise not have access to clinically appropriate treatment. We noted that, as with other services on the Medicare telehealth services list, it may not be clinically appropriate or possible to use telecommunications technology to furnish these particular services to every person or in every circumstance. However, in the context of the PHE for the COVID-19 pandemic with specific regard to the exposure risks noted above, we recognized the clinical benefit of access to medically reasonable and necessary services furnished using telecommunications technology as opposed to the potential lack of access that could occur to mitigate the risk of disease exposure.</P>
                    <P>
                        In addition to considering public requests and services identified through internal review for additions to the Medicare telehealth services list, we have also considered which of the services added to the Medicare 
                        <PRTPAGE P="50097"/>
                        telehealth services list on an interim basis should remain on the Medicare telehealth services list permanently or on an interim basis after the end of the PHE. The following presents a discussion of these services and related proposals.
                    </P>
                    <P>After reviewing the requests we received, the services we identified, and the services we added to the Medicare telehealth services list on an interim basis for the duration of the PHE, we identified the services we have listed in Table 8 as being sufficiently similar to services currently on the Medicare telehealth services list to be added on a Category 1 basis. Therefore, we are proposing to add the services in Table 8 to the Medicare telehealth services list on a Category 1 basis for CY 2021.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="556">
                        <GID>EP17AU20.008</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="50098"/>
                    <P>We believe the services described by the HCPCS codes in Table 8 are similar to services currently on the Medicare telehealth services list. The add-on codes to the office/outpatient E/M services are, by definition, part of the office/outpatient E/M services since they cannot be billed with any other codes. The Assessment of and Care Planning for Patients with Cognitive Impairment was defined as a service meant to be billed in specific clinical scenarios in lieu of a level 5 office/outpatient E/M visit. As such, these services fall within the Category 1 criteria because they are similar to the office visits that are already on the Medicare telehealth services list. As it describes group therapy, CPT code 90853 is similar to the other group therapy services currently on the Medicare telehealth services list.</P>
                    <P>While the patient's home cannot serve as an originating site (where the patient is located) for purposes of most Medicare telehealth services, the SUPPORT for Patients and Communities Act amended section 1834(m)(4)(C) of the Act and added a new paragraph at section 1834(m)(7) of the Act to remove geographic limitations and authorize the patient's home to serve as a telehealth originating site for purposes of treatment of a substance use disorder or a co-occurring mental health disorder, furnished on or after July 1, 2019, to an individual with a substance use disorder diagnosis. These domiciliary/home visits contain the same elements and similar descriptors to the office/outpatient E/M visits, and therefore, we believe there is sufficient justification to add them to the Medicare telehealth services list on a Category 1 basis. Additionally, we believe that, due to the vulnerability of this particular patient population, who are receiving treatment for a diagnosed substance use disorder or co-occurring mental health disorder, we should maximize the availability of telehealth services for the treatment of substance use disorders and co-occurring mental health disorders. We note that, because the home is not generally a permissible telehealth originating site, these services could be billed when furnished as telehealth services only for treatment of a substance use disorder or co-occurring mental health disorder.</P>
                    <P>
                        Finally, we received a request to add CPT code 96121 (
                        <E T="03">Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment,</E>
                         [
                        <E T="03">e.g.,</E>
                         acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; each additional hour (List separately in addition to code for primary procedure)) on the basis that this is an add-on code to CPT code 96116 (
                        <E T="03">Neurobehavioral status exam (clinical assessment of thinking, reasoning and judgment, </E>
                        [
                        <E T="03">e.g.,</E>
                         acquired knowledge, attention, language, memory, planning and problem solving, and visual spatial abilities]), by physician or other qualified health care professional, both face-to-face time with the patient and time interpreting test results and preparing the report; first hour) which is currently on the Medicare telehealth services list. In the past we have added services to the Medicare telehealth services list that are add-on codes that describe a continuation or additional elements of services currently on the Medicare telehealth services list since the services would only be considered telehealth services when billed as an add-on to codes already on the Medicare telehealth services list (82 FR 53008). Therefore, we are proposing to add CPT code 96121 to the Medicare telehealth services list.
                    </P>
                    <P>We also received a request to add services to the Medicare telehealth services list that do not meet our criteria for addition to the Medicare telehealth services list, as explained below. We are not proposing to add the services listed in Table 9 to the Medicare telehealth services list.</P>
                    <GPH SPAN="3" DEEP="92">
                        <GID>EP17AU20.009</GID>
                    </GPH>
                    <P>We received a request to add Medical Genetics services to the Medicare telehealth services list. We note that CPT code 96040 is considered bundled into office/outpatient E/M visits, which are already on the Medicare telehealth services list. Therefore, we do not believe it is necessary to add CPT code 96040. As we stated in the CY 2012 PFS final rule with comment period (76 FR 73096 through 73097), physicians and nonphysician practitioners who may independently bill Medicare for their services and who are counseling individuals would generally report office or other outpatient evaluation and management (E/M) CPT codes for office visits that involve significant counseling, including genetic counseling, and these office visit CPT codes are already on the Medicare telehealth services list. CPT code 96040 would only be reported by genetic counselors for genetic counseling services. Genetic counselors are not among the practitioners who can bill Medicare directly for their professional services, and they are also not practitioners who can furnish telehealth services as specified in section 1834(m)(4)(E) of the Act. As such, we do not believe that it would be necessary or appropriate to add CPT code 96040 to the Medicare telehealth services list.</P>
                    <P>HCPCS code S0265 is a Medication, Supplies, and Services code; and there is no separate payment under the PFS for this category of codes. Therefore, we are not proposing to add this service to the Medicare telehealth services list.</P>
                    <HD SOURCE="HD3">c. Proposed Temporary Addition of a Category 3 Basis for Adding to or Deleting Services From the Medicare Telehealth Services List</HD>
                    <P>
                        Recently enacted legislation to address the COVID-19 pandemic provided the Secretary with new authorities under section 1135(b)(8) of the Act, as added by section 102 of the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (Pub. L. 116-123, March 6, 2020) and subsequently amended by section 6010 of the Families First Coronavirus Response Act (Pub. L. 116-127, March 18, 2020) and section 3703 of the 
                        <PRTPAGE P="50099"/>
                        Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136, March 27, 2020)), to waive or modify Medicare telehealth payment requirements during the PHE for the COVID-19 pandemic. Due to the circumstances of the COVID-19 pandemic, particularly the need to maintain physical distance to avoid exposure to the virus, we anticipate that health care practitioners are developing new approaches to providing care using various forms of technology when they are not physically present with the patient. We have established several flexibilities to accommodate these changes in the delivery of care. Through waiver authority under section 1135(b)(8) of the Act, in response to the PHE for the COVID-19 pandemic, we have removed the geographic and site of service originating site restrictions in section 1834(m)(4)(C) of the Act, as well as the restrictions in section 1834(m)(4)(E) of the Act on the types of practitioners who may furnish telehealth services, for the duration of the PHE for the COVID-19 pandemic. We also used waiver authority to allow certain telehealth services to be furnished via audio-only communication technology. In the March 31st COVID-19 IFC, we added to the Medicare telehealth services list on an interim basis the services identified at the beginning of this section. Through the May 1st COVID-19 IFC, on an interim basis, we removed the requirement that we undertake rulemaking to add or delete services on the Medicare telehealth services list so that we could consider the addition of services on a subregulatory basis as they were recommended by the public or identified internally. On a subregulatory basis, we simultaneously added several more additional services to the Medicare telehealth services list when we issued the May 1st COVID-19 IFC. At the conclusion of the PHE, these waivers and interim policies will expire, payment for Medicare telehealth services will once again be limited by the requirements of section 1834(m) of the Act, and we will return to the policies established through the regular notice and comment rulemaking process, including the previously established Medicare telehealth services list. We believe that the experiences of clinicians who are furnishing telehealth services during the PHE will be useful to inform decisions about which of the services we added temporarily to the Medicare telehealth services list might be appropriate to add on a permanent basis. However, we also recognize that the annual PFS rulemaking schedule may not align perfectly with the expiration of the PHE, and that the clinicians providing services via telehealth during the PHE may not have the opportunity to conduct the kinds of review or develop the kind of evidence we usually consider when adding services to the Medicare telehealth services list on a permanent basis. In the event that the PHE ends prior to the end of calendar year 2021, stakeholders might not have the opportunity to use our current consideration process for telehealth services to request permanent additions to the Medicare telehealth services list prior to those services being removed from the Medicare telehealth services list. This is especially true for those services that might need to be considered on a Category 2 basis, which involves providing supporting documentation to illustrate the clinical benefit of such services. Recognizing the extent to which practice patterns are shifting as a result of the PHE from a model of care based on in-person services to one that relies on a combination of in-person services and virtual care, we believe that it would be disruptive to both clinical practice and beneficiary access to abruptly eliminate Medicare payment for these services when furnished via telehealth as soon as the PHE ends without first providing an opportunity to use information developed during the PHE to support requests for permanent changes to the Medicare telehealth services list.
                    </P>
                    <P>As previously noted, in response to the PHE for the COVID-19 pandemic, we have added a broad range of services to the Medicare telehealth services list. Before eliminating the full range of these services from the Medicare telehealth services list and potentially jeopardizing beneficiary access to those services that have been clinically beneficial, based primarily on the timing of annual rulemaking, we believe it would be prudent to collect information from the public regarding which, where and how various telehealth services have been in use in various communities during the COVID-19 response. Feedback from patients and clinicians is essential to help CMS understand how the use of telehealth services may have contributed positively to, or negatively affected, the quality of care provided to beneficiaries during the PHE for the COVID-19 pandemic so that we can understand which services should be retained on the Medicare telehealth services list until we can give them full consideration under our established rulemaking process.</P>
                    <P>Therefore, we are proposing to create a third category of criteria for adding services to the Medicare telehealth services list on a temporary basis. This new category would describe services that would be included on the Medicare telehealth services list on a temporary basis. We would include in this category the services that were added during the PHE for which there is likely to be clinical benefit when furnished via telehealth, but for which there is not yet sufficient evidence available to consider the services as permanent additions under Category 1 or Category 2 criteria. Recognizing that the services we would add on a temporary basis under Category 3 would ultimately need to meet the criteria under categories 1 or 2 in order to be permanently added to the Medicare telehealth services list, and the potential for evidence development that could continue through the Category 3 temporary addition period, we considered each of the services we added on an interim final basis during the PHE. In developing the proposal to add specific services on a Category 3 basis, we conducted a clinical assessment to identify those services for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth outside the circumstances of the PHE and that we anticipate would be able to demonstrate that clinical benefit in such a way as to meet our Category 2 criteria in full. Any service added under the proposed Category 3 would remain on the Medicare telehealth services list through the calendar year in which the PHE ends. When assessing whether there was a potential likelihood of clinical benefit for a service such that it should be added to the Medicare telehealth services list on a Category 3 basis, we considered the following factors:</P>
                    <P>• Whether, outside of the circumstances of the PHE, there are increased concerns for patient safety if the service is furnished as a telehealth service.</P>
                    <P>• Whether, outside of the circumstances of the PHE, there are concerns about whether the provision of the service via telehealth is likely to jeopardize quality of care.</P>
                    <P>• Whether all elements of the service could fully and effectively be performed by a remotely located clinician using two-way, audio/video telecommunications technology.</P>
                    <P>
                        We recognize that the circumstances of the PHE have provided clinicians with the opportunity to use telecommunications technology in health care delivery in a scope and manner far surpassing the telehealth services described under section 1834(m) of the Act, particularly as a 
                        <PRTPAGE P="50100"/>
                        result of the removal of geographic and site of service restrictions, and the addition of many services to the Medicare telehealth services list. When adding services to the Medicare telehealth services list on an interim basis during the PHE, we reassessed services on a Category 2 basis in the context of the widespread presence of COVID-19 in the community. We recognized that healthcare access issues could arise due to the immediate potential exposure risks to patients and healthcare workers, and that the use of telecommunication technology could mitigate risk and facilitate clinically appropriate treatment. In the context of the PHE for the COVID-19 pandemic, we found that the added services met the Category 2 criteria on the basis that there is a patient population that would otherwise not have access to clinically appropriate care (85 FR 19234). While the interim addition of a broad swath of services to the Medicare telehealth services list is responsive to critical needs during the COVID-19 PHE, the impact of adding these services to the Medicare telehealth services list on a permanent basis is currently unknown. Specifically, although it is possible to assess the uptake among health care practitioners of the added telehealth services, the extent to which service delivery via telehealth demonstrates clinical benefit outside the conditions of the PHE is not known at this time. Adding services to the Medicare telehealth services list on a Category 3 basis will give the public the opportunity to gather data and generate requests to add certain services to the Medicare telehealth services list permanently, which would be adjudicated on a Category 1 or Category 2 basis during future PFS annual rulemaking, while maintaining access to telehealth services with potential likelihood of clinical benefit. We are also proposing that the Category 3 criteria and basis for considering additions to the Medicare telehealth services list would be temporary, to expire at the end of the calendar year in which the PHE expires.
                    </P>
                    <P>We have identified a number of services that we believe, based on our clinical assessment, fit the Category 3 criteria enumerated above in that we did not identify significant concerns over patient safety, quality of care, or the ability of clinicians to provide all elements of the service remotely if these services were to remain on the Medicare telehealth services list for an additional period beyond the PHE. Therefore we are proposing to continue including these services on the Medicare telehealth services list through the calendar year in which the PHE ends. These services are listed in Table 10. We invite public comment on the services we identified for temporary addition to the Medicare telehealth services list through the Category 3 criteria—including whether some should not be considered as Category 3 temporary additions to the Medicare telehealth services list, or whether services currently not proposed as Category 3 additions to the Medicare telehealth services list should be considered as such. While our clinical assessment indicated that the services in Table 10 demonstrate potential likelihood of clinical benefit when furnished as telehealth services and, as such, the potential to meet the Category 1 or Category 2 criteria for permanent addition to the Medicare telehealth services list with the development of additional evidence, we are seeking information from the public that would supplement our clinical assessment and assist us in consideration of our proposals regarding the Category 3 addition of services, even though we recognize that formal analyses may not yet be available. The following are examples of the kinds of information we are seeking from the public to help inform our decisions about proposed additions under Category 3:</P>
                    <P>• By whom and for whom are the services being delivered via telehealth during the PHE;</P>
                    <P>• What practical safeguards are being employed to maintain safety and clinical effectiveness of services delivered via telehealth; and how are practices quickly and efficiently transitioning patients from telehealth to in-person care as needed;</P>
                    <P>• What specific health outcomes data are being or are capable of being gathered to demonstrate clinical benefit;</P>
                    <P>• How is technology being used to facilitate the acquisition of clinical information that would otherwise be obtained by a hands-on physical examination if the service was furnished in person. Certain services on the Medicare telehealth services list prior to the PHE, specifically the office/outpatient E/M code set, involve a physical exam. With the telehealth expansions during the PHE, clinicians may have had valuable experience providing other telehealth services to patients in higher acuity settings of care, such as an emergency department, that involve a hands-on physical examination when furnished in person.</P>
                    <P>• Whether patient outcomes are improved by the addition of one or more services to the Medicare telehealth services list, including whether inclusion on the Medicare telehealth services list increases access, safety, patient satisfaction, and overall quality of care;</P>
                    <P>• Whether furnishing this service or services via telecommunication technology promotes prudent use of resources;</P>
                    <P>• Whether the permanent addition of specific, individual services or categories of services to the Medicare telehealth services list supports quick responses to the spread of infectious disease or other emergent circumstances that may require widespread use of telehealth; and</P>
                    <P>• What is the impact on the health care workforce of the inclusion of one or more services or categories of services on the Medicare telehealth services list (for example, whether the health care workforce and its capabilities to provide care are expanded).</P>
                    <P>In addition, we note that CMS is committed to the following broad goals, and these weigh heavily in our decision-making around the addition, whether temporary or permanent, of a service or services to the Medicare telehealth services list. We request that commenters consider these goals in conjunction with their comments on our proposals for the treatment of the telehealth services we added on an interim basis during the PHE for the COVID-19 pandemic:</P>
                    <P>• Maintaining the capacity to enable rapid assessment of patterns of care, safety, and outcomes in the Medicare, Medicaid, CHIP and Marketplace populations;</P>
                    <P>• Establishing system safeguards to detect and avert unintended patient harms that result from policy adjustments;</P>
                    <P>• Ensuring high quality care is maintained;</P>
                    <P>• Demonstrating ongoing quality improvement efforts by Medicare participating providers, while maintaining access to necessary care;</P>
                    <P>• Establishing protections for vulnerable beneficiary populations (those with multiple chronic conditions, functional limitations, heart failure, COPD, diabetes, dementia), and sites of heightened vulnerability (such as nursing homes, rural communities) with high risk of adverse outcomes;</P>
                    <P>• Ensuring appropriate resource utilization and supporting cost efficiency;</P>
                    <P>• Supporting emergency preparedness and maintaining capacity to surge for potential coronavirus resurgence or other healthcare issues; and</P>
                    <P>
                        • Considering timing and pace of policy corrections in light of local and 
                        <PRTPAGE P="50101"/>
                        regional variations in systems of care and the impact of the COVID-19 pandemic.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="620">
                        <GID>EP17AU20.010</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="294">
                        <PRTPAGE P="50102"/>
                        <GID>EP17AU20.011</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">d. Comment Solicitation on Medicare Telehealth Services Added on an Interim Basis During the PHE for the COVID-19 Pandemic That CMS Is Not Proposing To Retain After the PHE Ends</HD>
                    <P>In the March 31st COVID-19 IFC and the May 1st COVID-19 IFC, we finalized on an interim basis during the PHE for the COVID-19 pandemic the addition of a number of services to the Medicare telehealth services list. While a number of these services were previously requested and reviewed for addition by external stakeholders as part of our standard process for updating the Medicare telehealth services list, a few were identified through internal review. As discussed above, we conducted a clinical assessment of each of the services added to the Medicare telehealth services list to identify those for which we could foresee a reasonable potential likelihood of clinical benefit when furnished via telehealth outside the circumstances of the PHE. In our clinical review of these services, we did not identify sufficient information to suggest there is a potential likelihood of clinical benefit for these services such that they could meet the Category 1 or Category 2 criteria outside the circumstances of the PHE. We specifically considered the potential for these services to be furnished, outside the circumstances of the PHE, without increased concerns for patient safety or jeopardizing quality of care; and furnished fully and effectively, including all elements of the service, by a remotely located clinician via two-way, audio/video telecommunications technology. Due to these concerns, we did not find a potential likelihood that the services could meet Category 2 criteria even with development of additional evidence. However, we are inviting public comment on whether any service added to the Medicare telehealth services list for the duration of the PHE for the COVID-19 pandemic should be added to the Medicare telehealth services list on a temporary, Category 3 basis, based on the criteria outlined above. We welcome additional information from commenters about these services, as outlined in our request for comment for services we are proposing to add to the Medicare telehealth services list on a Category 3 basis.</P>
                    <P>We are also seeking specific comment on the following considerations associated with particular services. Comments on these specific concerns will also inform our final decisions on whether these services should be added to the Medicare telehealth services list on a temporary, Category 3 basis:</P>
                    <P>
                        • 
                        <E T="03">Initial and final/discharge interactions (CPT codes 99234-99236 and 99238-99239):</E>
                         We believe that the potential acuity of the patient described by these codes would require an in-person physical exam in order to fulfill the requirements of the service. We have concerns that without an in-person physical examination the need for the physician or health care provider to fully understand the health status of the person with whom they are establishing a clinical and therapeutic relationship would be compromised. We believe that the need for an in-person interaction would rise beyond any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We are concerned that, without an in-person interaction, care planning that includes risk-benefit considerations and clinical decision-making will be less well-informed and create risk of patient harm.
                    </P>
                    <P>
                        • 
                        <E T="03">Higher level emergency department visits (CPT codes 99284-99285):</E>
                         We are concerned that the full scope of service elements of these codes cannot be met via two-way, audio/video telecommunications technology as higher levels are indicated by patient characteristics, clinical complexity, urgency for care, and require complex decision-making. We also believe, due to the acuity of the patient described by these codes, that an in-person physical examination is necessary to fulfill the service requirements.
                    </P>
                    <P>
                        • 
                        <E T="03">
                            Hospital, Intensive Care Unit, Emergency care, Observation stays (CPT 
                            <PRTPAGE P="50103"/>
                            codes CPT 99217-99220; 99221-99226; 99484-99485, 99468-99472, 99475-99476, and 99477-99480):
                        </E>
                         These codes describe visits that are furnished to patients who are ill enough to require hospital evaluation and care. We believe that the codes describe an evaluation for these potentially high acuity patients that is comprehensive and includes an in-person physical examination. Our view that in-person care is necessary to fulfill the requirements of the code is driven by the need for the physician or health provider to fully understand the health status of the person with whom they are establishing a clinical and therapeutic relationship. We believe that the need for an in-person interaction would rise above any specific diagnosis, and serves as the foundation upon which any and all clinical decisions are based for these services. We are concerned that, without an in-person interaction, care planning that includes risk-benefit considerations and clinical decision-making will be less well-informed and create risk of patient harm.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="632">
                        <PRTPAGE P="50104"/>
                        <GID>EP17AU20.012</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="630">
                        <PRTPAGE P="50105"/>
                        <GID>EP17AU20.013</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="637">
                        <PRTPAGE P="50106"/>
                        <GID>EP17AU20.014</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="631">
                        <PRTPAGE P="50107"/>
                        <GID>EP17AU20.015</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="629">
                        <PRTPAGE P="50108"/>
                        <GID>EP17AU20.016</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="189">
                        <PRTPAGE P="50109"/>
                        <GID>EP17AU20.017</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>With regard to the physical therapy, occupational therapy, and speech-language pathology services in Table C received a number of requests that we add therapy services to the Medicare telehealth services list. In the CY 2018 PFS final rule, we noted that section 1834(m)(4)(E) of the Act specifies the types of practitioners who may furnish and bill for Medicare telehealth services as those practitioners under section 1842(b)(18)(C) of the Act. Physical therapists (PTs), occupational therapists (OTs) and speech-language pathologists (SLPs) are not among the practitioners identified in section 1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 FR 80198) that because these services are predominantly furnished by PTs, OTs, and SLPs, we did not believe it would be appropriate to add them to the Medicare telehealth services list at this time. In a subsequent request to consider adding these services for 2018, the original requester suggested that we might propose these services to be added to the Medicare telehealth services list so that payment can be made for them when furnished via telehealth by physicians or practitioners who can serve as distant site practitioners. We stated that since the majority of the codes are furnished over 90 percent of the time by therapy professionals who are not included on the statutory list of eligible distant site practitioners, we believed that adding therapy services to the Medicare telehealth services list could result in confusion about who is authorized to furnish and bill for these services when furnished via telehealth. While we continue to believe this is generally the case, and we are not proposing to add these services permanently to the Medicare telehealth services list, we are seeking comment on whether these services should be added to the Medicare telehealth services list so that, in instances when a practitioner who is eligible to bill for telehealth services furnishes these services via telehealth, they could bill and receive payment for them. We are also seeking comment on whether all aspects of these services can be fully and effectively furnished via two-way, audio/video telecommunications technology. We also note that given our clarification regarding telehealth services furnished incident to the professional services of a physician or practitioner (85 FR 27562), if these services were added to the Medicare telehealth services list, they could be furnished by a therapist and billed by a physician or practitioner who can furnish and bill for telehealth services provided that all of the “incident to” requirements are met.</P>
                    <P>
                        With regard to the critical care services listed in Table 11, we have received a number of requests in prior years to add these services to the Medicare telehealth services list. In response to one such request, we finalized creation of two HCPCS G codes, G0508 (
                        <E T="03">Telehealth consultation, critical care, initial, physicians typically spend 60 minutes communicating with the patient and providers via telehealth</E>
                        ) and G0509 (
                        <E T="03">Telehealth consultation, critical care, subsequent, physicians typically spend 50 minutes communicating with the patient and providers via telehealth</E>
                        ), to describe the work associated with furnishing consultation services via Medicare telehealth to critically ill patients in the CY 2017 PFS final rule. We stated that CPT guidance makes clear that a variety of other services are bundled into the payment rates for critical care, including gastric intubations and vascular access procedures, among others. While we continue to believe that the full range of care for critically ill patients cannot be performed via two-way, audio/video telecommunications technology for the reasons articulated above, we are seeking comment on whether current coding (either through the CPT codes describing in-person critical care or the HCPCS G codes describing critical care consults furnished via telehealth) does not reflect additional models of critical care delivery, specifically, models of care delivery that utilize a combination of remote monitoring and clinical staff at the location of the beneficiary to allow, when an onsite practitioner is not available, for a practitioner at a distant site to monitor vital signs and direct in-person care as needed.
                    </P>
                    <P>We are seeking comment on the definition, potential coding and valuation for this kind of remote service. We are also seeking comment on the following concerns:</P>
                    <P>• How to distinguish the technical component of the remote monitoring portion of the service from the diagnosis-related group (DRG) payment already being provided to the hospital.</P>
                    <P>• How to provide payment only for monitoring and interventions furnished to Medicare beneficiaries when the remote intensivist is monitoring multiple patients, some of which may not be Medicare beneficiaries.</P>
                    <P>• How this service intersects with both the critical care consult G codes and the in-person critical care services.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="500">
                        <PRTPAGE P="50110"/>
                        <GID>EP17AU20.018</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">2. Technical Refinement to the Medicare Telehealth Services List To Reflect Current Coding</HD>
                    <P>
                        For CY 2020, the CPT Editorial Panel deleted the six existing Health and Behavior Assessment and Intervention procedure CPT codes and replaced them with nine new CPT codes. The six deleted CPT codes include CPT code 96150 (
                        <E T="03">Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment</E>
                        ), CPT code 96151 (
                        <E T="03">Health and behavior assessment (e.g., health-focused clinical interview, behavioral observations, psychophysiological monitoring, health oriented questionnaires), each 15 minutes face-to-face with the patient; reassessment</E>
                        ), CPT code 96152 (
                        <E T="03">Health and behavior intervention, each 15 minutes, face-to-face; individual</E>
                        ), CPT code 96153 (
                        <E T="03">Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients)),</E>
                         CPT code 96154 (
                        <E T="03">Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)),</E>
                         and CPT code 96155 (
                        <E T="03">Health and behavior intervention, each 15 minutes, face-to-face; family (without the patient present</E>
                        )). However, we inadvertently neglected to make the corresponding update to reflect these coding changes on the Medicare telehealth services list in CY 2020 PFS rulemaking. Therefore, we are proposing to delete CPT codes 96150-96155 from the Medicare telehealth services list and replace them with the following successor codes: CPT code 96156 (
                        <E T="03">
                            Health behavior assessment, including reassessment (i.e., health-focused clinical interview, 
                            <PRTPAGE P="50111"/>
                            behavioral observations, clinical decision making
                        </E>
                        )); CPT code 96158 (
                        <E T="03">Health behavior intervention, individual, face-to-face; initial 30 minutes</E>
                        ); CPT code 96159 (
                        <E T="03">Health behavior intervention, individual, face-to-face; each additional 15 minutes (list separately in addition to code for primary service)</E>
                        ); CPT code 96164 (
                        <E T="03">Health behavior intervention, group (2 or more patients), face-to-face; initial 30 minutes</E>
                        ); CPT code 96165 (
                        <E T="03">Health behavior intervention, group (2 or more patients), face-to-face; each additional 15 minutes (list separately in addition to code for primary service)</E>
                        ); CPT code 96167 (
                        <E T="03">Health behavior intervention, family (with the patient present), face-to-face; initial 30 minutes</E>
                        ); CPT code 96168 (
                        <E T="03">Health behavior intervention, family (with the patient present), face-to-face each additional 15 minutes (list separately in addition to code for primary service)</E>
                        ); CPT code 96170 (
                        <E T="03">Health behavior intervention, family (without the patient present), face-to-face; initial 30 minutes</E>
                        ); and CPT code 96171 (
                        <E T="03">Health behavior intervention, family (without the patient present), face-to-face; each additional 15 minutes (list separately in addition to code for primary service</E>
                        ).
                    </P>
                    <P>We are also proposing to amend our regulations to stipulate that when new codes are issued to replace codes that describe the same clinical services that are currently on the Medicare telehealth services list, we will consider those new codes to be successor codes to those that are on the Medicare telehealth services list, and will update the Medicare telehealth services list accordingly. At § 410.78(f), we are proposing to revise the final sentence of the paragraph to read: CMS maintains on the CMS website the Medicare telehealth services list under this section, including the current HCPCS codes that describe the services.</P>
                    <HD SOURCE="HD3">3. Furnishing Telehealth Visits in Inpatient and Nursing Facility Settings, and Critical Care Consultations</HD>
                    <P>The long term care facility regulations at § 483.30(c) require that residents of SNFs receive an initial visit from a physician, and periodic personal visits subsequently by either a physician or other nonphysician practitioner (NPP). In the CY 2010 PFS final rule with comment period (74 FR 61762) we stated that these regulations ensure that at least a minimal degree of personal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. In that rule we stated that we believe that these federally-mandated visits should be conducted in-person, and not as Medicare telehealth services. We therefore revised § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.30(c).</P>
                    <P>
                        During the PHE for the COVID-19 pandemic, we waived the requirement in 42 CFR 483.30 for physicians and nonphysician practitioners to personally perform required visits for nursing home residents, and allowed visits to be conducted via telehealth (
                        <E T="03">https://www.cms.gov/files/document/summary-covid-19-emergency-declaration-waivers.pdf</E>
                        ).
                    </P>
                    <P>We are seeking public comment on whether it would be appropriate to maintain this flexibility on a permanent basis outside of the PHE for the COVID-19 pandemic. We invite public comment on whether the in-person visit requirement is necessary, or whether two-way, audio/video telecommunications technology would be sufficient in instances when, due to continued exposure risk, workforce capacity, or other factors, the clinician determines an in-person visit is not necessary.</P>
                    <P>We have also received requests to revise our frequency limitations for telehealth subsequent inpatient and nursing facility visits. Currently, we limit the provision of subsequent inpatient visits via Medicare telehealth to once every 3 days and subsequent nursing facility visits to once every 30 days. We received a request to remove the frequency limitation on the subsequent inpatient services and a separate request to revise the subsequent nursing facility visits to once every 3 days, rather than 30 days.</P>
                    <P>As we stated in the CY 2019 PFS final rule, we believed the potential acuity of illness of hospital inpatients is greater than that of patients who are likely to receive services that were on the Medicare telehealth services list at that time. We also stated that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth to ensure that hospitalized patients have frequent encounters with their admitting practitioner. In addition, we expressed our belief that the majority of these visits should be furnished in person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis. Because of our concerns regarding the potential acuity of illness of hospital inpatients, we finalized the addition of CPT codes 99231-99233 to the Medicare telehealth services list, but limited the provision of these subsequent hospital care services through telehealth to once every 3 days. We continue to believe that admitting practitioners should continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Our concerns with, and position on, the provision of subsequent hospital care services via telehealth have not changed (83 FR 59493). Therefore, we are not proposing to modify our current policy.</P>
                    <P>
                        In the CY 2018 PFS final rule, we reiterated that we believed it would be appropriate to permit some subsequent nursing facility (NF) care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, but because of our concerns regarding the potential acuity and complexity of NF inpatients, we limited the provision of subsequent NF care services furnished through telehealth to once every 30 days. We also stated that we continued to have concerns regarding more routine use of telehealth given the potential acuity and complexity of NF inpatients, and therefore, we were not proposing to remove the frequency limitation for subsequent NF care services (83 FR 59494). We have received comments from stakeholders who stated that the once every 30-day frequency limitation for subsequent NF visits furnished via Medicare telehealth limits access to care for Medicare beneficiaries in the NF setting. Stakeholders stated that the use of Medicare telehealth is crucial to maintaining a continuum of care in this setting and that CMS should leave it up to clinicians to decide how frequently a visit may be furnished as a Medicare telehealth service rather than in person depending on the needs of specific patients. We are persuaded by the comments from these stakeholders, and therefore, are proposing to revise the frequency limitation from one visit every 30 days to one visit every 3 days. We believe this interval strikes the right balance between requiring in-person visits and allowing flexibility to furnish services via telehealth when clinically appropriate to do so. We are also seeking comment on whether frequency limitations broadly are burdensome and limit access to necessary care when services are available only through telehealth, and how best to ensure that patients are receiving necessary in-person care.
                        <PRTPAGE P="50112"/>
                    </P>
                    <HD SOURCE="HD3">4. Proposed Technical Amendment To Remove References to Specific Technology</HD>
                    <P>The final sentence of our regulation at § 410.78(a)(3) prohibits the use of telephones, facsimile machines, and electronic mail systems for purposes of furnishing Medicare telehealth services. In the March 31st COVID-19 IFC, we added a new § 410.78(a)(3)(i) (and reserved § 410.78(a)(3)(ii) for later use) to provide for an exception that removes application of that sentence during the PHE for the COVID-19 pandemic. We added the new section on an interim final basis because we believe that the first sentence of § 410.78(a)(3) adequately describes the technology requirements for an interactive telecommunication system that may be used to furnish a Medicare telehealth service. That sentence defines interactive telecommunication system as “multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication.” We were also concerned that the reference to “telephones” in the second sentence of the regulation as impermissible technology could cause confusion in instances where an otherwise eligible device, such as a smart phone, may also be used as a telephone. Because these concerns are not situation- or time-limited to the PHE for COVID-19, we are proposing to remove the second sentence of the regulation at § 410.78(a)(3) which specifies that “[t]elephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system.” As we are proposing to adopt this change on a permanent basis, we are also proposing to delete the subparagraphs at § 410.78(a)(3)(i) and 410.78(a)(3)(ii). We believe these amendments to our regulations would remove outdated references to specific types of technology and provide a clearer statement of our policy.</P>
                    <HD SOURCE="HD3">5. Communication Technology-Based Services (CTBS)</HD>
                    <P>
                        In the CY 2019 PFS final rule, we finalized separate payment for a number of services that could be furnished via telecommunications technology, but that are not considered Medicare telehealth services. Specifically, we finalized HCPCS code G2010 (
                        <E T="03">Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment</E>
                        ), and HCPCS code G2012 (
                        <E T="03">Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion</E>
                        ). We finalized maintenance of these codes as part of the set of codes that is only reportable by those practitioners that can furnish E/M services. We stated that we believed this was appropriate since the service describes a check-in directly with the billing practitioner to assess whether an office visit is needed. However, we did note that similar check-ins provided by nurses and other clinical staff can be important aspects of coordinated patient care (83 FR 59486).
                    </P>
                    <P>
                        In the CY 2020 PFS final rule, we finalized separate payment for HCPCS codes G2061 (
                        <E T="03">Qualified nonphysician healthcare professional online assessment and management, for an established patient, for up to seven days, cumulative time during the 7 days; 5-10 minutes</E>
                        ), G2062 (
                        <E T="03">Qualified nonphysician healthcare professional online assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 11-20 minutes</E>
                        ), and G2063 (
                        <E T="03">Qualified nonphysician qualified healthcare professional assessment and management service, for an established patient, for up to seven days, cumulative time during the 7 days; 21 or more minutes</E>
                        ). In that rule, we stated that these codes may be billed by nonphysician practitioners (NPPs) consistent with the definition of their respective benefit category, although we did not provide specific examples (84 FR 62796).
                    </P>
                    <P>We have received a number of questions regarding which benefit categories HCPCS codes G2061 through G2063 fall under. In the March 31st COVID-19 IFC (85 FR 19244-19245) we established on an interim basis for the duration of the PHE for the COVID-19 pandemic that these services could be billed for example, by licensed clinical social workers and clinical psychologists, as well as PTs, OTs, and SLPs who bill Medicare directly for their services when the service furnished falls within the scope of these practitioner's benefit categories. We are proposing to adopt that policy on a permanent basis. We note that this is not an exhaustive list and we are seeking comment on other benefit categories into which these services fall.</P>
                    <P>We are also proposing to allow billing of other CTBS by certain nonphysician practitioners, consistent with the scope of these practitioners' benefit categories through the creation of two additional HCPCS G codes that can be billed by practitioners who cannot independently bill for E/M services:</P>
                    <P>
                        • G20X0 (
                        <E T="03">Remote assessment of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment.</E>
                        )
                    </P>
                    <P>
                        • G20X2 (
                        <E T="03">Brief communication technology-based service, e.g. virtual check-in, by a qualified health care professional who cannot report evaluation and management services, provided to an established patient, not originating from a related e/m</E>
                          
                        <E T="03">service provided within the previous 7 days nor leading to a service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion</E>
                        ).
                    </P>
                    <P>We are proposing to value these services identically to HCPCS codes G2010 and G2012, respectively. We acknowledge that it has been agency policy, in general, to differentially value similar services that are performed by practitioners who can and cannot, respectively, bill independently for E/M services, with higher values for the service performed by practitioners who can independently bill E/M services. However, given the relatively low values for HCPCS codes G2010 and G2012, we do not think that there is a significant differential in resource costs to warrant different values, but are seeking comment on whether we should value these services differentially, including potentially increasing the valuation of HCPCS codes G2010 and G2012.</P>
                    <P>
                        Further, to facilitate billing of the CTBS by therapists, we are proposing to designate HCPCS codes G20X0, G20X2, G2061, G2062, and G2063 as “sometimes therapy” services. When billed by a private practice PT, OT, or SLP, the codes would need to include the corresponding GO, GP, or GN therapy modifier to signify that the CTB are furnished as therapy services furnished under an OT, PT, or SLP plan of care.
                        <PRTPAGE P="50113"/>
                    </P>
                    <P>We also note that in section II.K. of this proposed rule we are proposing for CY 2021 to replace the eVisit G codes with corresponding CPT codes, and that this policy would also apply to those codes.</P>
                    <P>For all of these CTBS, we are also making clear that the consent from the patient to receive these services can be documented by auxiliary staff under general supervision, as well as by the billing practitioner. While we continue to believe that beneficiary consent is necessary so that the beneficiary is notified of cost sharing when receiving these services, we do not believe that the timing or manner in which beneficiary consent is acquired should interfere with the provision of one of these services. We are retaining the requirement that, in instances when the brief communication technology-based service originates from a related E/M service (including one furnished as a telehealth service) provided within the previous 7 days by the same physician or other qualified health care professional, this service would be considered bundled into that previous E/M service and would not be separately billable.</P>
                    <HD SOURCE="HD3">6. Comment Solicitation on Continuation of Payment for Audio-Only Visits</HD>
                    <P>
                        In the March 31st COVID-19 IFC, we established separate payment for audio-only telephone evaluation and management (E/M) services (85 FR 19264 through 19266). The telephone E/M services are CPT codes 99441 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion</E>
                        ); 99442 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion</E>
                        ); and 99443 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion</E>
                        ). We noted that, although these services were previously considered non-covered under the PFS, in the context of the PHE and with the goal of reducing exposure risks associated with the COVID-19 pandemic, especially in the case that two-way, audio and video technology is not available to furnish a Medicare telehealth service, we believed there are circumstances where prolonged, audio-only communication between the practitioner and the patient could be clinically appropriate, yet not fully replace a face-to-face visit. For example, an established patient who was experiencing an exacerbation of their condition could have a 25-minute phone conversation with their physician during which the physician determines that an adjustment to the patient's medication would alleviate their symptoms. The use of CPT code 99443 in this situation prevents a similar in-person service as the evaluation of the patient's symptoms and determination to adjust medication could be conducted without patient and the practitioner being in the same location. We stated our belief that these telephone E/M codes, with their established description and valuation, were the best way to recognize the relative resource costs of these kinds of services and make payment for them under the PFS. For these codes, we initially finalized on an interim basis during the PHE for the COVID-19 pandemic, work relative value units (RVUs) as recommended by the American Medical Association (AMA) Relative Value Scale Update Committee (RUC), as discussed in the CY 2008 PFS final rule with comment period (72 FR 66371), of 0.25 for CPT code 99441, 0.50 for CPT code 99442, and 0.75 for CPT code 99443. We also finalized the RUC-recommended direct practice expense (PE) inputs which consist of 3 minutes of post-service Registered Nurse/Licensed Practical Nurse/Medical Technical Assistant clinical labor time for each code.
                    </P>
                    <P>
                        In the May 1st COVID-19 IFC, we noted that in the time since we established these payment amounts, stakeholders had informed us that use of audio-only services was more prevalent than we had previously considered, especially because many beneficiaries were not utilizing video-enabled communication technology from their homes. In other words, there were many cases where practitioners would under ordinary circumstances utilize telehealth or in-person visits to evaluate and manage patients' medical concerns, but were instead using audio-only interactions to manage more complex care (85 FR 27589 through 27590). While we had previously acknowledged the likelihood that, under the circumstances of the PHE, more time would be spent interacting with the patient via audio-only technology, we stated that the intensity of furnishing an audio-only visit to a beneficiary during the unique circumstances of the COVID-19 pandemic was not accurately captured by the valuation of these services we established in the March 31st COVID-19 IFC. This would be particularly true to the extent that these audio-only services are actually serving as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enabled telecommunications technology contrary to the situation we anticipated when establishing payment for them in the March 31st COVID-19 IFC. We stated that, given our understanding that these audio-only services were being furnished primarily as a replacement for care that would otherwise be reported as an in-person or telehealth visit using the office/outpatient E/M codes, we established new RVUs for the telephone E/M services based on crosswalks to the most analogous office/outpatient E/M codes, based on the time requirements for the telephone codes and the times assumed for valuation for purposes of the office/outpatient E/M codes. Specifically, we crosswalked CPT codes 99212, 99213, and 99214 to CPT codes 99441, 99442, and 99443, respectively. We therefore finalized, on an interim basis and for the duration of the COVID-19 PHE, the following work RVUs: 0.48 for CPT code 99441; 0.97 for CPT code 99442; and 1.50 for CPT code 99443. We also finalized the direct PE inputs associated with CPT code 99212 for CPT code 99441, the direct PE inputs associated with CPT code 99213 for CPT code 99442, and the direct PE inputs associated with CPT code 99214 for CPT code 99443. We did not finalize increased payment rates for CPT codes 98966-98968 as these codes describe services furnished by practitioners who cannot independently bill for E/M services and so these telephone assessment and management services, by definition, are not being furnished in lieu of an office/outpatient E/M service. We noted that to the extent that these extended phone services are taking 
                        <PRTPAGE P="50114"/>
                        place instead of office/outpatient E/M visits (either in-person or via telehealth), the direct crosswalk of RVUs also better maintains overall budget neutrality and relativity under the PFS. We stated that we believed that the resources required to furnish these services during the PHE for the COVID-19 pandemic are better captured by the RVUs associated with the level 2-4 established patient office/outpatient E/M visits. Additionally, we stated that, given our understanding that these audio-only services were being furnished as substitutes for office/outpatient E/M services, we recognized that they should be considered as telehealth services, and added them to the Medicare telehealth services list for the duration of the PHE. For these audio-only E/M services, we separately issued a waiver under section 1135(b)(8) of the Act, as amended by section 3703 of the CARES Act, of the requirements under section 1834(m) of the Act and our regulation at § 410.78 that Medicare telehealth services must be furnished using video technology.
                    </P>
                    <P>We are not proposing to continue to recognize these codes for payment under the PFS after conclusion of the PHE for the COVID-19 pandemic because, outside of the circumstances of the PHE, we are not able to waive the requirement that telehealth services be furnished using an interactive telecommunications system that includes two-way, audio/video communication technology. However, we recognize that the need for audio-only interaction could remain as beneficiaries continue to try to avoid sources of potential infection, such as a doctor's office; and in that circumstance, a longer phone conversation may be needed to determine if an in-person visit is necessary than what is described by the virtual check-in. We are seeking comment on whether CMS should develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and with an accordingly higher value. We are seeking input from the public on the appropriate duration interval for such services and the resources in both work and PE that would be associated with furnishing them. We are also seeking comment on whether separate payment for such telephone-only services should be a provisional policy to remain in effect until a year or some other period after the end of the PHE or if it should be PFS payment policy permanently.</P>
                    <HD SOURCE="HD3">7. Comment Solicitation on Coding and Payment for Virtual Services</HD>
                    <P>The health care community uses the term “telehealth” broadly to refer to medical services furnished via communications technology. Under current PFS payment rules, Medicare routinely pays for many of these kinds of services. This includes some kinds of remote patient monitoring (either as separate services or as parts of bundled services), interpretations of diagnostic tests when furnished remotely and, under conditions specified in section 1834(m) of the Act, services that would otherwise be furnished in person but are instead furnished via real-time, interactive communication technology. Over the past several years, we have also established several PFS policies to make separate payment for non-face-to-face services included as part of ongoing care management. Although all of the kinds of services stated above might be called “telehealth” by patients, other payers and health care providers, we have generally used the term “Medicare telehealth services” to refer to the subset of services defined in section 1834(m) of the Act. Section 1834(m) of the Act defines Medicare telehealth services and specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real time telecommunication technology.</P>
                    <P>We believe that the provisions in section 1834(m) of the Act apply particularly to the kinds of professional services explicitly enumerated in the statutory provisions, like professional consultations, office visits, and office psychiatry services. Generally, the services we have added to the Medicare telehealth services list are similar to these kinds of services. As has long been the case, certain other kinds of services that are furnished remotely using communications technology are not considered “Medicare telehealth services” and are not subject to the restrictions articulated in section 1834(m) of the Act. This is true for services that were routinely paid separately prior to the enactment of the provisions in section 1834(m) of the Act and do not usually include patient interaction (such as remote interpretation of diagnostic imaging tests), and for services that were not discretely defined or separately paid for at the time of enactment and that do include patient interaction (such as chronic care management services).</P>
                    <P>In recent years, we have begun making separate payment for a number of services that use telecommunications technology but are not considered Medicare telehealth services. These CTB services include, for example, certain kinds of remote patient monitoring (either as separate services or as parts of bundled services), a virtual check-in, and a remote asynchronous service. These services are different than the kinds of services specified in section 1834(m) of the Act, in that they are not the kind of services that are ordinarily furnished in person but are routinely furnished using a telecommunications system.</P>
                    <P>In the past, we have received requests to add certain services, such as chronic care management or remote physiologic monitoring to the Medicare telehealth services list. However, as these services fall outside the scope of services addressed, and the enumerated list of services included in section 1834(m) of the Act, they are not considered telehealth services and, therefore, are not subject to the same restrictions. We are seeking comment on whether there are additional services that fall outside the scope of telehealth services under section 1834(m) of the Act where it would be helpful for us to clarify that the services are inherently non-face-to-face, so do not need to be on the Medicare telehealth services list in order to be billed and paid when furnished using telecommunications technology rather than in person with the patient present. We are also seeking comment on physicians' services that use evolving technologies to improve patient care that may not be fully recognized by current PFS coding and payment, including, for example, additional or more specific coding for care management services. Finally, we are broadly seeking comment on any impediments that contribute to healthcare provider burden and that may result in practitioners being reluctant to bill for CTBS. We appreciate the ongoing engagement and additional information from stakeholders as we work to improve coding and payment for these services that utilize telecommunications technology.</P>
                    <HD SOURCE="HD3">8. Proposed Clarification of Existing PFS Policies for Telehealth Services</HD>
                    <P>
                        In response to the waiver of statutory requirements and the relaxation of regulatory requirements for telehealth during the PHE for the COVID-19 pandemic, we received a number of requests to clarify existing PFS policy for telehealth. For example, we received questions as to whether Medicare allows incident-to billing for telehealth services, particularly for practitioners such as counselors who are supervised 
                        <PRTPAGE P="50115"/>
                        by a physician in private practice. We note that there are no Medicare regulations that explicitly prohibit eligible distant site practitioners from billing for telehealth services provided incident to their services. However, we also note that our existing definition of direct supervision requires on-site presence of the billing clinician when the service is provided. That requirement could make it difficult for a billing clinician to provide the direct supervision of services provided via telehealth incident to their professional services by auxiliary personnel. Under our proposed amendment to the definition of direct supervision to permit virtual presence, we acknowledge that billing practitioners could more easily meet the direct supervision requirements for telehealth services provided incident to their services. Consequently, we believe that services provided incident to the professional services of an eligible distant site physician or practitioner could be reported when they meet direct supervision requirements at both the originating and distant site through the virtual presence of the billing physician or practitioner. Therefore, we are proposing to clarify that services that may be billed incident-to may be provided via telehealth incident to a physicians' service and under the direct supervision of the billing professional. This is consistent with a policy clarification that we made through the May 1st COVID-19 IFC (85 FR 27562).
                    </P>
                    <P>We have also received questions as to whether services should be reported as telehealth services when the individual physician or practitioner furnishing the service is in the same location as the beneficiary; for example, if the physician or practitioner furnishing the service is in the same institutional setting but is utilizing telecommunications technology to furnish the service due to exposure risks. We are clarifying, as we did in the May 1st COVID-19 IFC (85 FR 27562) that if audio/video technology is used in furnishing a service when the beneficiary and the practitioner are in the same institutional or office setting, then the practitioner should bill for the service furnished as if it was furnished in person, and the service would not be subject to any of the telehealth requirements under section 1834(m) of the Act or § 410.78 of our regulations.</P>
                    <HD SOURCE="HD3">9. Direct Supervision by Interactive Telecommunications Technology</HD>
                    <P>Many services for which payment is made under the PFS can be furnished under a level of physician or NPP supervision rather than being performed directly by the billing practitioner. In many cases, the supervision requirements necessitate the presence of the physician or NPP in a particular location, usually in the same location as the beneficiary when the service is provided. For example, as described at § 410.26, services furnished by auxiliary personnel incident to a physician's or NPP's professional service usually require the direct supervision of the physician or NPP. In addition to these “incident to” services, there are a number of diagnostic services under the PFS that also must be furnished under direct supervision. As currently defined in §§ 410.26 and 410.32(b)(3)(ii), direct supervision means that the physician or NPP must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed.</P>
                    <P>For the duration of the PHE for the COVID-19 pandemic, for purposes of limiting exposure to COVID-19, we adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology (85 FR 19245). We recognized that in some cases, the physical proximity of the physician or practitioner might present additional infection exposure risk to the patient and/or practitioner. In the context of the PHE for the COVID-19 pandemic, given the risks of exposure, the immediate risk of foregone medical care, the increased demand for healthcare professionals, and the widespread use of telecommunications technology, we believed that individual practitioners were in the best position to make decisions about how to meet the requirement to provide appropriate direct supervision based on their clinical judgment in particular circumstances.</P>
                    <P>We are proposing to extend this policy until the later of the end of the calendar year in which the PHE ends or December 31, 2021, to recognize the different and unique circumstances faced by individual communities that may continue after the PHE ends, and provide time to solicit public input on circumstances where the flexibility to use interactive audio/video real-time communications technology to provide virtual direct supervision could still be needed and appropriate. The extension of this flexibility would allow time for clinicians to make adjustments and for us to obtain public input on services and circumstances for which this policy might be appropriate on a permanent basis. We note that if we finalize this proposal and the PHE ends before the CY 2021 PFS final rule takes effect, the interim policy adopted during the PHE to allow direct supervision using real-time, interactive audio and video technology would no longer be in effect during the period between expiration of the PHE and the date the final policy takes effect.</P>
                    <P>Given our continued interaction with practitioners during the PHE and our growing understanding of how services may be furnished remotely and safely, we now have a better understanding of how, in some cases, depending upon the unique circumstances of individual patients and billing practitioners or physicians, telecommunications technology could safely allow the practitioner or physician's immediate availability to furnish assistance and direction without necessarily requiring the supervising practitioner's or physician's physical presence in the location where the service is being furnished. In such cases, the use of real-time, audio and video telecommunications technology may allow the supervising practitioner or physician to observe the beneficiary and the auxiliary staff performing the service or be engaged (Direct supervision does not require the physician or NPP to be present in the room when the service or procedure is performed) to provide assistance and direction of the service through virtual means, and without the supervising practitioner or physician being physically present.</P>
                    <P>
                        Consequently, we are proposing to revise § 410.32(b)(3)(ii) to allow direct supervision to be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021. Specifically, we propose to continue our current rule that “Direct supervision” in the office setting means the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician (or other supervising practitioner) must be present in the room when the procedure is performed. We propose to add that, until the later of the end of the calendar year in which the PHE ends or December 31, 2021, the presence of the physician (or other practitioner) may include virtual presence through audio/video real-time communications technology (excluding audio-only) subject to the clinical judgement of the 
                        <PRTPAGE P="50116"/>
                        supervising physician or (other supervising practitioner). In response to questions received since we issued our interim policy for the PHE, we are clarifying that, to the extent our policy allows direct supervision through virtual presence using audio/video real-time communications technology, the requirement could be met by the supervising physician (or other practitioner) being immediately available to engage via audio/video technology (excluding audio-only), and would not require real-time presence or observation of the service via interactive audio and video technology throughout the performance of the procedure.
                    </P>
                    <P>While flexibility to provide direct supervision through audio/video real-time communications technology was adopted to be responsive to critical needs during the PHE to ensure beneficiary access to care, reduce exposure risk and to increase the capacity of practitioners and physicians to respond to COVID-19, we are concerned that direct supervision through virtual presence may not be sufficient to support PFS payment on a permanent basis, beyond the PHE, due to issues of patient safety. For instance, in complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change and we believe it is necessary for such services to be furnished or supervised in person to allow for rapid on-site decision-making in the event of an adverse clinical situation. For example, there could be a case in which a practitioner or physician uses audio/video interactive communications to virtually supervise a nurse performing a post-op evaluation following surgery for hip fracture, and the nurse might note that the patient is uncooperative. In this scenario, had a full exam been performed directly by the practitioner or physician, or under the in-person supervision of a practitioner or physician who was physically or immediately available in the clinic to provide the necessary direction, the physician or practitioner would have recognized that the patient exhibited signs of crystal-mediated acute arthritis, and that the patient's lack of cooperation was likely due to hypoactive delirium. Instead, the supervising practitioner or physician may not have been able to identify this clinical issue as a result of being available only via audio/video interactive communications technology. In this case, the presence of the supervising practitioner or physician through audio/video interactive communications technology would have been insufficient. There also may be certain patient populations that require greater clinical attentiveness and skill than the supervising practitioner or physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia, or patients with communication disabilities, may require the experience and skill of a physically present supervising practitioner or physician to recognize needs such as the need for specialized testing. It may not be possible for a supervising practitioner or physician to recognize or meet these clinical needs while being present for the service only through audio/video interactive communications technology. Moreover, the virtual connection between the individual performing the service and the supervising practitioner or physician could be disrupted, making it challenging for the supervising practitioner or physician to remain immediately available to provide assistance and direction to the physically present clinical staff or auxiliary personnel to furnish appropriate care to the patient.</P>
                    <P>We are seeking information from commenters as to whether there should be any additional “guardrails” or limitations to ensure patient safety/clinical appropriateness, beyond typical clinical standards, as well as restrictions to prevent fraud or inappropriate use if we were to finalize a policy to permit direct supervision through audio/video interactive communications technology, with consideration of relevant patient safety, clinical appropriateness criteria or other restrictions, on a temporary basis through the later of the end of the calendar year in which the PHE ends or December 31, 2021, or consider it beyond the time specified. We are also seeking information on what risks this policy might introduce to beneficiaries as they receive care from practitioners that would supervise care virtually in this way. Further we are seeking comment on potential concerns around induced utilization and fraud, waste, and abuse and how those concerns might be addressed. We also invite commenters to provide data and information about their implementation experience with direct supervision using virtual presence during the PHE, and are interested in comments on the degree of aging and disability competency training that is required for effective use of audio/video real-time communications technology.</P>
                    <HD SOURCE="HD3">10. Comment Solicitation on PFS Payment for Specimen Collection for COVID-19 Tests</HD>
                    <P>When physicians and other practitioners collect specimens for clinical diagnostic laboratory tests as part of their professional services, Medicare generally makes payment for the services under the PFS, though often that payment is bundled into the payment rate for other services, including office and outpatient visits. Typically, collection of a specimen via nasal swab or other method during the provision of a service might be reported as part of (bundled with) an office/outpatient E/M visit (CPT codes 99201 through 99205, 99211 through 99215). In visits where a patient has a face-to-face interaction with a billing professional with whom they have an established relationship, these services are generally reported with a level 2 through a level 5 visit (CPT codes 99212 through 99215). In cases where the specimen is collected during a visit where the face-to-face interaction only involves clinical staff of the billing professional with whom the patient has an established relationship, these services are generally reported using CPT code 99211.</P>
                    <P>In the May 1st COVID-19 IFC (85 FR 27604-27605), we finalized on an interim basis that physicians and NPPs may use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, if the billing practitioner does not also furnish a higher level E/M service to the patient on the same day. We are considering whether to extend or make permanent the policy to allow physicians and NPPs to use CPT code 99211 to bill for services furnished incident to their professional services, for both new and established patients, when clinical staff assess symptoms and collect specimens for purposes of COVID-19 testing, and are soliciting public comments on whether we should continue this policy for a period of time, or permanently, after the COVID-19 PHE ends.</P>
                    <HD SOURCE="HD2">E. Care Management Services and Remote Physiologic Monitoring Services</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        In recent years, we have updated PFS policies to improve payment for care management and coordination. Working with the CPT Editorial Panel and other clinicians, we have expanded the suite of codes describing these services. New CPT codes were created that describe services that involve direct patient 
                        <PRTPAGE P="50117"/>
                        contact (for some services, in-person) or do not involve direct patient contact; represent a single encounter, monthly service, or both; are timed services; address specific conditions; and represent the work of the billing practitioner, auxiliary personnel (specifically, clinical staff), or both (
                        <E T="03">see</E>
                         Table 13). In this proposed rule for CY 2021, we continue our work to improve payment for care management services through proposed code refinements related to remote physiologic monitoring (RPM), transitional care management (TCM), and psychiatric collaborative care model (CoCM) services.
                    </P>
                    <GPH SPAN="3" DEEP="411">
                        <GID>EP17AU20.019</GID>
                    </GPH>
                    <HD SOURCE="HD3">2. Digitally Stored Data Services/Remote Physiologic Monitoring/Treatment Management Services (RPM)</HD>
                    <P>RPM involves the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to a chronic and/or acute health illness or condition. In recent years, we have finalized payment for seven CPT codes in the RPM code family. Five of the seven codes have been the focus of frequent questions from stakeholders.</P>
                    <P>In response to proposals in the CY 2019 PFS proposed rule (83 FR 35771) and the CY 2020 PFS proposed rule (84 FR 40555 through 40556), stakeholders requested that we clarify how we interpret aspects of the RPM code descriptors for CPT codes 99453, 99454, 99091, and 99457. Commenters asked us, for example, to identify who can furnish RPM services, what kinds of medical devices can be used to collect data, how data should be collected, and how “interactive communication” is defined. We stated in the CY 2020 PFS final rule (84 FR 62697) that we would provide guidance in the future about the codes. For CY 2021, we are clarifying how we read CPT code descriptors and instructions associated with CPT codes 99453, 99454, 99091, and 99457 (and the add-on code, CPT code 99458) and their use to describe remote monitoring of physiologic parameters of a patient's health.</P>
                    <P>
                        The RPM process begins with two practice expense (PE) only codes, CPT codes 99453 and 99454, finalized in the CY 2019 PFS final rule (83 FR 39574 through 39576). As PE only codes they are valued to include clinical staff time, supplies, and equipment, including the medical device for the typical case of remote monitoring. CPT code 99453 (
                        <E T="03">Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; set-up and patient education on use of equipment</E>
                        ) is 
                        <PRTPAGE P="50118"/>
                        valued to reflect clinical staff time that includes instructing a patient and/or caregiver about using one or more medical devices. CPT code 99454 (
                        <E T="03">Remote monitoring of physiologic parameter(s) (e.g., weight, blood pressure, pulse oximetry, respiratory flow rate), initial; device(s) supply with daily recording(s) or programmed alert(s) transmission, each 30 days</E>
                        ) is valued to include the medical device or devices supplied to the patient and the programming of the medical device for repeated monitoring. We reviewed the PE inputs for CPT code 99454 for purposes of this proposal, and are clarifying that the medical device or devices that are supplied to the patient and used to collect physiologic data are considered equipment and as such are direct PE inputs for the code.
                    </P>
                    <P>Review of CPT prefatory language (CPT® 2020 Professional Codebook (hereafter, CPT Codebook), p. 42) provides additional information about the two PE only codes. For example, the CPT prefatory language indicates that monitoring must occur over at least 16 days of a 30-day period in order for CPT codes 99453 and 99454 to be billed. Additionally, these two codes are not to be reported for a patient more than once during a 30-day period. This language suggests that even when multiple medical devices are provided to a patient, the services associated with all the medical devices can be billed only once per patient per 30-day period and only when at least 16 days of data have been collected. We also note that CPT 99453 can be billed only once per episode of care where an episode of care is defined as “beginning when the remote physiologic monitoring service is initiated and ends with attainment of targeted treatment goals” (CPT Codebook, p. 42).</P>
                    <P>Other stakeholder inquiries about CPT codes 99453 and 99454 focus upon the kinds of medical devices that can be used to collect the patient's physiologic data. Prefatory language in the CPT Codebook states that “the device must be a medical device as defined by the FDA.” CPT simply specifies that the device must meet the FDA's definition of a medical device as described in section 201(h) of the Federal, Food, Drug and Cosmetic Act (FFDCA). We have found no language in the CPT Codebook indicating that a medical device must be FDA cleared as some stakeholders have suggested although such clearance may be appropriate. Nor have we found information that suggests a medical device must be prescribed by a physician, although this could be possible depending upon the medical device. Beyond acknowledging the CPT specification that the medical device supplied for CPT code 99454 must meet the FDA definition of a medical device, we are clarifying that the medical device should digitally (that is, automatically) upload patient physiologic data (that is, data are not patient self-recorded and/or self-reported). We note also that use of the medical device or devices that digitally collect and transmit a patient's physiologic data must, as usual for most Medicare covered services, be reasonable and necessary for the diagnosis or treatment of the patient's illness or injury or to improve the functioning of a malformed body member. Further, the device must be used to collect and transmit reliable and valid physiologic data that allow understanding of a patient's health status to develop and manage a plan of treatment.</P>
                    <P>The CPT Codebook lists the RPM codes under the main heading Evaluation and Management (E/M). We are clarifying that as E/M codes, CPT codes 99453, 99454, 99091, 99457, and 99458, can be ordered and billed only by physicians or nonphysician practitioners (NPPs) who are eligible to bill Medicare for E/M services.</P>
                    <P>Although we initially described RPM services in the CY 2019 PFS final rule (83 FR 35771) as services furnished to patients with chronic conditions, we are also clarifying that practitioners may furnish these services to remotely collect and analyze physiologic data from patients with acute conditions, as well as from patients with chronic conditions.</P>
                    <P>
                        After the 30-day data collection period for CPT codes 99453 and 99454, the physiologic data that are collected and transmitted are analyzed and interpreted by the physician or practitioner as described by CPT code 99091, a code that includes only professional work, that is, there are no direct PE inputs. We finalized payment for CPT code 99091 (
                        <E T="03">Collection and interpretation of physiologic data digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified health care professional, qualified by education, training, licensure/regulation requiring a minimum of 30 minutes of time, each 30 days</E>
                        ) in the CY 2018 PFS final rule (82 FR 59473). The valuation for CPT code 99091 includes a total time of 40 minutes of physician or nonphysician practitioner work broken down as follows: 5 minutes of preservice work (for example, chart review); 30 minutes of intra-service work (for example, data analysis and interpretation, report based upon the physiologic data, as well as a possible phone call to the patient); and 5 minutes of post-service work (that is, chart documentation). We note that stakeholders have expressed confusion about the specification in the code descriptor for CPT code 99091 that the service is furnished by a “physician or other qualified health care professional, qualified by education, training, licensure/regulation.” The phrase “physician or other qualified healthcare professional” is defined by CPT as, “an individual who is qualified by education, training, licensure/regulation (when applicable) and facility privileging (when applicable) who performs a professional service within his/her scope of practice and independently reports that professional service. These professionals are distinct from “clinical staff . . . [which refers to] a person who works under the supervision of a physician or other qualified healthcare professional and who is allowed by law, regulation, and facility policy to perform or assist in the performance of a specified professional service but does not individually report that professional service.” 
                        <SU>1</SU>
                        <FTREF/>
                         Accordingly, when referring to a particular service described by a CPT code for Medicare purposes, a physician or other qualified healthcare professional is an individual whose scope of practice and Medicare benefit category includes the service and who is authorized to independently bill Medicare for the service. See our previous discussion of this in the CY 2016 PFS final rule at 80 FR 70957. Medicare also covers and makes payment for certain services performed by auxiliary personnel (which includes clinical staff) “incident to” the professional services of the billing practitioner. Our regulation at § 410.26(a) defines auxiliary personnel (a term that includes clinical staff) and delineates the conditions for payment for “incident to” services.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             CPT Codebook, p.xiii.
                        </P>
                    </FTNT>
                    <P>
                        After analyzing and interpreting a patient's remotely collected physiologic data, the next step in the process of RPM is the development of a treatment plan that is informed by the analysis and interpretation of the patient's data. It is at this point that the physician or nonphysician practitioner develops a treatment plan with the patient and/or caregiver (that is, patient-centered care) and then manages the plan until the targeted goals of the treatment plan are attained, which signals the end of the episode of care. CPT code 99457 (
                        <E T="03">
                            Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar 
                            <PRTPAGE P="50119"/>
                            month requiring interactive communication with the patient/caregiver during the month; first 20 minutes
                        </E>
                        ) and its add-on code, CPT code 99458 (
                        <E T="03">Remote physiologic monitoring treatment management services, clinical staff/physician/other qualified health care professional time in a calendar month requiring interactive communication with the patient/caregiver during the month; each additional 20 minutes</E>
                        ) describe the treatment and management services associated with RPM. Medicare stakeholders have requested that we clarify aspects of these two codes. The two most frequently asked questions include, “Who can furnish the services described by CPT codes 99457 and 99458? ” and “What does it mean to have an `interactive communication' with a patient? ”
                    </P>
                    <P>We addressed who can furnish CPT codes 99457 and 99458 in the CY 2020 PFS final rule (84 FR 62697 through 62698) when we designated both codes as care management services. We explained that, like other care management services, CPT codes 99457 and 99458 can be furnished by clinical staff under the general supervision of the physician or NPP. We note that RPM services are not considered to be diagnostic tests; that is, they cannot be furnished and billed by an Independent Diagnostic Testing Facility on the order of a physician or NPP.</P>
                    <P>
                        The services described by CPT codes 99457 and 99458 are services that are typically furnished remotely using communications technologies that allow “interactive communication,” which we read as real-time interaction, between a patient and the physician, nonphysician practitioner, or clinical staff who provide the services. Stakeholders have requested that we define “interactive communication” as used in the code descriptors for CPT codes 99457 and 99458. We see this remote, non-face-to-face exchange as being similar to the exchange that occurs in providing services described by HCPCS code G2012, 
                        <E T="03">Brief Communication Technology Based Service,</E>
                         which we finalized in the CY 2019 final rule (83 FR 59483 through 59486). Thus, we are clarifying that “interactive communication” for purposes of CPT codes 99457 and 99458 involves, at a minimum, a real-time synchronous, two-way audio interaction that is capable of being enhanced with video or other kinds of data transmission. As indicated in the code descriptor for CPT code 99457, the interactive communication must total at least 20 minutes of interactive time with the patient over the course of a calendar month for CPT code 99457 to be reported. Each additional 20 minutes of interactive communication between the patient and the physician/nonphysician practitioner/clinical staff is reported using CPT code 99458. The CPT Codebook states that unless there are code- or code-range specific instructions, parenthetical instructions, or code descriptors to the contrary, time is considered to be the “face-to-face” time with the patient or patient's caregiver/medical decision-maker. See the CPT Codebook, page xvii, as well as pages 10, 13, and 16 for more information about measuring time. Where, as here, the services are not typically furnished in person with the patient, we interpret time in the code descriptor to mean the time spent in direct, real-time interactive communication with the patient.
                    </P>
                    <P>Lastly, we are proposing to establish as permanent policy two of the changes we made on an interim basis to the requirements for furnishing RPM services in response to the PHE for the COVID-19 pandemic. (See 85 FR 19264 and 85 FR 27605 through 27606 for the interim modifications and clarifications to RPM services in response to the PHE for the COVID-19 pandemic).</P>
                    <P>Our goals during the PHE for the COVID-19 pandemic have been to reduce exposure risks to the Novel Coronavirus for practitioners and patients while also increasing access to health care services. We eliminated as many obstacles as possible to allow timely delivery of reasonable and necessary health care. We wanted patients to be able to access services quickly and without barriers. With the goals of reducing exposure and increasing access to services, we finalized that RPM services could be furnished to new patients, as well as established patients. We also finalized on an interim basis for the duration of the PHE for the COVID-19 pandemic policies to allow consent to be obtained at the time services are furnished, and by individuals providing RPM services under contract with the billing physician or practitioner; and to allow RPM codes to be billed for a minimum of 2 days of data collection over a 30-day period, rather than the required 16 days of data collection over a 30-day period as provided in the CPT code descriptors.</P>
                    <P>For CY 2021, we are proposing on a permanent basis to allow consent to be obtained at the time that RPM services are furnished. Because the CPT code descriptors do not specify that clinical staff must perform RPM services, we are also proposing to allow auxiliary personnel (which includes other individuals who are not clinical staff but are employees, or leased or contracted employees) to furnish services described by CPT codes 99453 and 99454 under the general supervision of the billing physician or practitioner.</P>
                    <P>When the PHE for the COVID-19 pandemic ends, we again will require that RPM services must be furnished only to an established patient. We believe that a physician or practitioner who has an established relationship with a patient would likely have had an opportunity to provide a new patient E/M service. During the new patient E/M service, the physician or practitioner would have collected relevant patient history and conducted a physical exam, as appropriate. As a result, the physician or practitioner would possess information needed to understand the current medical status and needs of the patient prior to ordering RPM services to collect and analyze the patient's physiologic data and to develop a treatment plan. Additionally, and in keeping with the CPT prefatory language for CPT codes 99453 and 99454, when the PHE for the COVID-19 pandemic ends, we will once again require that 16 days of data be collected within 30 days to meet the requirements to bill CPT codes 99453 and 99454.</P>
                    <P>
                        Finally, in response to the May 19, 2020 Executive Order 13924, “Regulatory Relief To Support Economic Recovery,” (85 FR 31353 through 31356), we are seeking comment from the medical community and other members of the public on whether the current RPM coding accurately and adequately describes the full range of clinical scenarios where RPM services may be of benefit to patients. For example, CPT codes 99453 and 99454 currently require use of a medical device (as defined by the FDA) that digitally collects and transmits 16 or more days of data every 30 days in order for the codes to be billed. However, some patients may not require remote monitoring for 16 or more days in a 30-day period. For some patients, continuous short-term monitoring might be more appropriate. For example, a post-surgical patient who is recovering at home might benefit from remote monitoring of his or her body temperature as a means of assessing infection and managing medications or dosage. In some situations, monitoring several times throughout a day, over a period of 10 days, may be reasonable and necessary. Sixteen or more days might be unnecessary. We are asking for information that would help us to understand whether it would be beneficial to consider establishing 
                        <PRTPAGE P="50120"/>
                        coding and payment rules that would allow practitioners to bill and be paid for RPM services with shorter monitoring periods. Specifically, we are interested in understanding whether one or more codes that describe a shorter duration, for example, 8 or more days of remote monitoring within 30 days, might be useful. We welcome comments including any additional information that the medical community and other members of the public believe may provide further clarification on how RPM services are used in clinical practice, and how they might be coded, billed and valued under the Medicare PFS.
                    </P>
                    <HD SOURCE="HD3">3. Transitional Care Management (TCM)</HD>
                    <P>
                        Payment for TCM CPT codes 99495 (
                        <E T="03">Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge</E>
                        ) and 99496 (
                        <E T="03">Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge</E>
                        ) was finalized in the CY 2013 PFS final rule (77 FR 68979 through 68993). At that time, we identified a list of 57 HCPCS codes (see 77 FR 68990 for the original guidance) that we stated could not be billed concurrently with TCM services because of potential duplication of services.
                    </P>
                    <P>For CY 2020, recognizing that use of TCM services was low when compared to the number of Medicare beneficiaries with eligible discharges and that increased utilization of medically necessary TCM services could improve patient outcomes, one of our proposals included modifying our prior rule that prohibited the billing of TCM services with many other services that we had viewed as duplicative (77 FR 68990). In the CY 2020 PFS final rule (84 FR 40549 through 40550), we finalized a policy to allow concurrent billing of TCM services, when reasonable and necessary, with 16 actively priced (that is, not bundled or non-covered) codes during the 30-day period covered by TCM services. We stated at the time that we would continue to refine our billing policies for TCM through future notice and comment rulemaking.</P>
                    <P>We are proposing now for CY 2021 to remove 14 additional actively priced (not bundled or non-covered) HCPCS codes from the list of remaining HCPCS codes that cannot be billed concurrently with TCM. We believe that no overlap exists that would warrant preventing concurrent reporting between TCM and the services of these 14 codes. We are also proposing to allow the new Chronic Care Management code HCPCS code G2058 to be billed concurrently with TCM when reasonable and necessary. We note that the minutes counted for TCM services cannot also be counted towards other services. See Table 14 for the list of 15 codes that we are proposing could be billed concurrently with TCM services when reasonable and necessary. We welcome comment on our proposal to allow these additional services to billed concurrently with the TCM service.</P>
                    <GPH SPAN="3" DEEP="348">
                        <GID>EP17AU20.020</GID>
                    </GPH>
                    <PRTPAGE P="50121"/>
                    <HD SOURCE="HD3">4. Psychiatric Collaborative Care Model (CoCM) Services (HCPCS Code GCOL1)</HD>
                    <P>In the CY 2017 PFS final rule (81 FR 80230), we established G-codes used to bill for monthly services furnished using the Psychiatric Collaborative Care Model (CoCM), an evidence-based approach to behavioral health integration that enhances “usual” primary care by adding care management support and regular psychiatric inter-specialty consultation. These G-codes were replaced by CPT codes 99492-99494, which we established for payment under the PFS in the CY 2018 PFS final rule (82 FR 53077).</P>
                    <P>Stakeholders have requested additional coding to capture shorter increments of time spent, for example, when a patient is seen for services, but is then hospitalized or referred for specialized care, and the number of minutes required to bill for services using the current coding is not met. To accurately account for these resources costs, we are proposing to establish a G-code to describe 30 minutes of behavioral health care manager time. Since this code would describe one half of the time described by the existing code that describes subsequent months of CoCM services, we are proposing to price this code based on one half the work and direct PE inputs for CPT code 99493 (Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:</P>
                    <P>• Tracking patient follow-up and progress using the registry, with appropriate documentation; participation in weekly caseload consultation with the psychiatric consultant;</P>
                    <P>• Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health practitioners;</P>
                    <P>• Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;</P>
                    <P>• Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;</P>
                    <P>• Monitoring of patient outcomes using validated rating scales; and</P>
                    <P>• Relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals and are prepared for discharge from active treatment.), which is assigned a work RVU of 1.53.</P>
                    <P>Therefore, the proposed work RVU for the new proposed code is 0.77. We are proposing that this code could be used for either the initial month or subsequent months. We note that the existing CPT time rules for the CoCM services would apply. The proposed code is:</P>
                    <P>• GCOL1: Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional.</P>
                    <P>We are proposing that the required elements listed for CPT code 99493 would also be required elements for billing HCPCS cod GCOL1. Additionally, we propose that CPT time rules would apply, consistent with the guidance in the CPT codebook for CPT codes 99492-99494.</P>
                    <P>In the CY 2017 PFS final rule (81 FR 80235), we finalized that CCM and BHI services could be billed during the same month for the same beneficiary if all the requirements to bill each service are separately met. We are also proposing that HCPCS code GCOL1 could be billed during the same month as CCM and TCM services, provided that all requirements to report each service are met and time and effort are not counted more than once. We note that the patient consent requirement would apply to each service independently.</P>
                    <P>In the CY 2017 PFS final rule (81 FR 80235), we finalized that the psychiatric CoCM services may be furnished under general supervision because we do not believe it is clinically necessary that the professionals on the team who provide services other than the treating practitioner (namely, the behavioral health care manager and the psychiatric consultant) must have the billing practitioner immediately available to them at all times, as would be required under a higher level of supervision. Therefore, consistent with the other codes in this code family (CPT codes 99492-99494), we propose to add HCPCS code GCOL1 to the list of designated care management services for which we allow general supervision.</P>
                    <P>We welcome comments on the proposal to create this new code, as well as the proposed valuation.</P>
                    <HD SOURCE="HD2">F. Refinements to Values for Certain Services To Reflect Revisions to Payment for Office/Outpatient Evaluation and Management (E/M) Visits and Promote Payment Stability During the COVID-19 Pandemic</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <HD SOURCE="HD3">a. Evaluation and Management (E/M) Visits Overview</HD>
                    <P>
                        Physicians and other practitioners who are paid under the PFS bill for common office visits for evaluation and management (E/M) visits using a relatively generic set of CPT codes (Level I HCPCS codes) that distinguish visits based on the level of complexity, site of service, and whether the patient is new or established. These CPT codes are broadly referred to as E/M visit codes and historically have included three key components within their code descriptors: History of present illness (history), physical examination (exam), and medical decision-making (MDM).
                        <SU>2</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             2019 CPT Codebook, Evaluation and Management, pages 6 through 13.
                        </P>
                    </FTNT>
                    <P>Currently, there are five levels of office/outpatient E/M visits. There are five codes representing each level for new patients (CPT codes 99201 through 99205), and five codes representing each level for established patients (CPT codes 99211 through 99215). CPT code 99211 (Level 1 established patient) is the only code in the office/outpatient E/M visit code set that describes a visit that may be performed by the billing practitioner or by clinical staff under supervision, and that has no specified history, exam or MDM (see Table 15).</P>
                    <P>
                        In total, E/M visits billed using these CPT codes comprise approximately 40 percent of allowed charges for PFS services; and office/outpatient E/M visits, in particular, comprise approximately 20 percent of allowed charges for PFS services. Within the E/M visits represented in these percentages, there is wide variation in the volume and level of E/M visits billed by different specialties. According to Medicare claims data, E/M visits are furnished by nearly all specialties, but represent a greater share of total allowed charges for physicians and other practitioners who do not routinely furnish procedural interventions or diagnostic tests. Generally, these practitioners include primary care practitioners and certain other specialists such as neurologists, endocrinologists and rheumatologists. Certain specialties, such as podiatry, tend to furnish lower level E/M visits more often than higher level E/M visits. Some specialties, such as dermatology, 
                        <PRTPAGE P="50122"/>
                        tend to bill more E/M visits on the same day as they bill minor procedures.
                    </P>
                    <HD SOURCE="HD3">b. Overview of Policies Finalized in CY 2020 for CY 2021</HD>
                    <P>
                        In the CY 2020 PFS final rule (84 FR 62844 through 62860), for the office/outpatient E/M visit code set (CPT codes 99201 through 99215), we finalized a policy to generally adopt the new coding, prefatory language, and interpretive guidance framework that has been issued by the AMA's CPT Editorial Panel (see 
                        <E T="03">https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management</E>
                        ) and will be effective January 1, 2021. Under this new CPT coding framework, history and exam will no longer be used to select the level of code for office/outpatient E/M visits. Instead, an office/outpatient E/M visit will include a medically appropriate history and exam, when performed. The clinically outdated system for number of body systems/areas reviewed and examined under history and exam will no longer apply, and the history and exam components will only be performed when, and to the extent, reasonable and necessary, and clinically appropriate.
                    </P>
                    <P>
                        As indicated in Table 15, the changes will include deletion of CPT code 99201 (
                        <E T="03">Level 1 office/outpatient visit, new patient</E>
                        ), which the CPT Editorial Panel decided to eliminate because CPT codes 99201 and 99202 are both straightforward MDM and currently largely differentiated by history and exam elements. Table 15 provides an overview of how the level 1 and level 2 office/outpatient E/M visits are currently structured, demonstrating this current overlap.
                    </P>
                    <GPH SPAN="3" DEEP="231">
                        <GID>EP17AU20.021</GID>
                    </GPH>
                    <P>
                        For levels 2 through 5 office/outpatient E/M visits, selection of the code level to report will be based on either the level of MDM (as redefined in the new AMA/CPT guidance framework, also available on the AMA website at 
                        <E T="03">https://www.ama-assn.org/practice-management/cpt/cpt-evaluation-and-management</E>
                         or the total time personally spent by the reporting practitioner on the day of the visit (including face-to-face and non-face-to-face time). We continue to believe these policies will further our ongoing effort to reduce administrative burden, improve payment accuracy, and update the office/outpatient E/M visit code set to better reflect the current practice of medicine.
                    </P>
                    <P>
                        Regarding prolonged visits, we finalized separate payment for a new prolonged visit add-on CPT code (CPT code 99XXX), and discontinued the use of CPT codes 99358 and 99359 (
                        <E T="03">prolonged E/M visit without direct patient contact</E>
                        ) to report prolonged time associated with office/outpatient E/M visits. We refer readers to the CY 2020 PFS final rule for a detailed discussion of this policy (84 FR 62849 through 62850).
                    </P>
                    <P>Also we finalized separate payment for HCPCS code GPC1X, to provide payment for visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious, or complex chronic condition.</P>
                    <P>The AMA RUC resurveyed and revalued the revised office/outpatient E/M visit code set, concurrent with the CPT Editorial Panel redefining the services and associated interpretive guidance, and provided us with its recommendations. In the CY 2020 PFS final rule, we also addressed and responded to the AMA RUC recommendations. We finalized new values for CPT codes 99202 through 99215, and assigned RVUs to the new office/outpatient E/M prolonged visit CPT code 99XXX, as well as the new HCPCS code GPC1X. These valuations were finalized with an effective date of January 1, 2021. In Table 16, we provide a summary of the codes and work RVUs finalized in the CY 2020 PFS final rule for CY 2021.</P>
                    <GPH SPAN="3" DEEP="193">
                        <PRTPAGE P="50123"/>
                        <GID>EP17AU20.022</GID>
                    </GPH>
                    <HD SOURCE="HD3">c. Continuing Stakeholder Feedback</HD>
                    <P>Since issuing the CY 2020 PFS final rule, we have continued to engage with the stakeholder community on the issues addressed in this section of our proposed rule. In the CY 2020 PFS final rule (84 FR 62859 through 62860), we discussed public comments we received in response to our request for comment about whether it would be appropriate to revalue certain services, other than the global surgical codes which we addressed separately, for which the values are closely tied to the values of the office/outpatient E/M visit codes in order to improve payment accuracy and maintain relativity within the PFS. We responded that we would consider the commenters' recommendations for future rulemaking. Since publication of the CY 2020 PFS final rule, we have received additional feedback from stakeholders, in the form of written requests and in-person meetings, indicating that certain other services on which we did not seek comment in the CY 2020 PFS proposed rule, but which are similar to the office/outpatient E/M visits, have values that were established relative to values for the office/outpatient E/M visits or contain office/outpatient E/M visits as constituent parts of the bundled services included in the code for the service. We address many of these requests in the following section, and are seeking comment on whether there are additional, similarly situated services for which we should consider similar adjustment or revaluation through future rulemaking. We have also received questions about the definition and utilization assumptions for the HCPCS add on code GPC1X.</P>
                    <HD SOURCE="HD3">2. Proposals for CY 2021</HD>
                    <HD SOURCE="HD3">a. Time Values for Levels 2-5 Office/Outpatient E/M Visit Codes</HD>
                    <P>In the CY 2020 PFS proposed rule (84 FR 62568), we sought comment on the times associated with the office/outpatient E/M visits as recommended by the AMA RUC. When surveying these services for purposes of valuation, the AMA RUC requested that survey respondents consider the total time spent on the day of the visit, as well as any pre- and post-service time occurring within a timeframe of 3 days prior to the visit and 7 days after, respectively. In developing its recommendations to us, the AMA RUC then separately averaged the survey results for pre-service, day of service, and post-service times, and the survey results for total time, with the result that, for some of the codes, the sum of the times associated with the three service periods does not match the RUC-recommended total time. The approach used by the AMA RUC to develop recommendations sometimes resulted in two conflicting sets of times: The component times as surveyed and the total time as surveyed. In the CY 2020 PFS final rule, we finalized adoption of the RUC-recommended times as explained below, but stated that we would continue to consider whether this issue has implications for the PFS broadly. When we establish pre-, intra-, and post-service times for a service under the PFS, these times always sum to the total time. We believe it would be illogical for component times not to sum to the total, and this idea is reflected in our ratesetting system which requires component times to sum to the total time. Commenters on the CY 2020 PFS proposed rule (84 FR 62849) stated that we should adopt the times as recommended by the RUC, and did not provide any additional details on the times they believed we should use when the total time is not the sum of the component times. Table 17 illustrates the AMA RUC surveyed times for each service period and the surveyed total time. It also shows the actual total time calculated as the sum of the component times.</P>
                    <GPH SPAN="3" DEEP="157">
                        <PRTPAGE P="50124"/>
                        <GID>EP17AU20.023</GID>
                    </GPH>
                    <P>Given the lack of clarity provided by commenters on the CY 2020 PFS proposed rule about why the sum of minutes in the components would differ from the total minutes, and our view and systems requirement that total time must equal the mathematical total of component times, we are proposing beginning for CY 2021 to adopt the actual total times (defined as the sum of the component times) rather than the total times recommended by the RUC for CPT codes 99202 through 99215.</P>
                    <HD SOURCE="HD3">b. Revaluing Services That Are Analogous to Office/Outpatient E/M Visits</HD>
                    <P>In the CY 2020 PFS proposed rule, we recognized that there are services other than the global surgical codes for which the values are closely tied to the values of the office/outpatient E/M visit codes. We specifically identified transitional care management (TCM) services (CPT codes 99495, 99496); cognitive impairment assessment and care planning (CPT code 99483); certain end-stage renal disease (ESRD) services (CPT codes 90951 through 90970); and the annual wellness visit (AWV) and initial preventive physical exam (IPPE) (HCPCS codes G0402, G0438, G0439). Many of these services were valued via a building block methodology and have office/outpatient E/M visits explicitly built into their definition or valuation. We stated that we may consider adjusting the RVUs for these services in future rulemaking, and we sought public input on such a policy. We noted that, unlike the global surgical codes, some of these services always include an office/outpatient E/M visit(s) furnished by the reporting practitioner as part of the service, and therefore, it may be appropriate to adjust their valuations commensurate with any changes made to the values for office/outpatient E/M visits. Some of these services do not actually include an E/M visit, but we valued them using a direct crosswalk to the RVUs assigned to an office/outpatient E/M visit(s), and for this reason they are closely tied to values for office/outpatient E/M visits. Overall, we believe that the magnitude of the changes to the values of the office/outpatient E/M visit codes and the associated redefinitions of the codes themselves are significant enough to warrant an assessment of the accuracy of the values of services containing, or closely analogous to, office/outpatient E/M visits. These proposals take into account input from the public and our own internal review.</P>
                    <P>We received public comments in support of revaluing certain services relative to the new office/outpatient E/M visit values. There was particular support for revaluing the ESRD monthly capitation payment (MCP) services, TCM services, cognitive impairment assessment and care planning services, and the emergency department (ED) visits. Based on input provided since publication of the CY 2020 PFS final rule by the American College of Obstetricians and Gynecologists (ACOG), we have also considered the maternity surgical packages which, unlike other global surgery services, were valued using a methodology, described in more detail below, that allowed the valuation of the composite parts of the package to sum to the total value. Additionally, unlike the 10- and 90-day global surgical services codes (referred to in this section as 10- and 90-day globals), we have never expressed concerns as to the accuracy of the values of the maternity packages, and these services were not part of the policy we adopted to transition all 10- and 90-day globals to 0-day globals (79 FR 67591), though that policy was overridden by statutory amendments before it took effect.</P>
                    <HD SOURCE="HD3">(1) End-Stage Renal Disease Monthly Capitation Payment Services</HD>
                    <P>In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G codes for ESRD services and established MCP rates for them as specified under section 1881(b)(3)(A)(ii) of the Act. For ESRD center-based patients, payment for the G codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2-3 visits and 4 or more visits). We believed that many physicians would provide 4 or more visits to center-based ESRD patients, and a small proportion would provide 2-3 visits or only one visit per month. Under the MCP methodology, to receive the highest payment, a physician would have to furnish at least 4 ESRD-related visits per month. In contrast, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required visits for home dialysis MCP services, we stated that we expect physicians to provide clinically appropriate care to manage the home dialysis patient.</P>
                    <P>The CPT Editorial Panel created new CPT codes to replace the G codes for monthly ESRD-related services, and we finalized the new codes for use under the PFS in CY 2009 (73 FR 69898). The codes created were CPT codes 90951 through 90962 for monthly ESRD-related services with a specified number of visits; CPT codes 90963 through 90966 for monthly ESRD-related services for home dialysis patients; and CPT codes 90967 through 90970 for home dialysis patients with less than a full month of services. The latter set of codes are billed per encounter and valued to be 1/30 of the value of CPT codes 90965 and 90966.</P>
                    <P>
                        In response to our comment solicitation in the CY 2020 PFS final rule and interim final rule regarding 
                        <PRTPAGE P="50125"/>
                        whether to adjust the values of the ESRD MCP codes to reflect the increased values of the office/outpatient E/M visit codes, we received a number of supportive comments, particularly from specialty societies representing nephrologists. These commenters pointed out that the MCP bundled payments for all ESRD-related care for a month were constructed using a building block methodology and a number of office/outpatient E/M visits were component parts of those bundles; and that the specified number of visits in the code descriptor must be furnished in order to bill for the service. Commenters also noted that although the values of office/outpatient E/M visit codes have been increased once since the creation of the MCP G codes and once after adoption of the MCP CPT codes, the valuation of the ESRD MCP codes was never adjusted to account for increases to the office/outpatient E/M visit codes. In Table 18, we provide a summary of the visits bundled into each ESRD MCP service.
                    </P>
                    <GPH SPAN="3" DEEP="342">
                        <GID>EP17AU20.024</GID>
                    </GPH>
                    <P>In the past, we have not updated the valuation of this code set to reflect updates to the valuation of the office/outpatient E/M visit code set and so over time, the values of the ESRD MCP codes have become out of step with valuation of their constituent visits. We believe there is sufficient reason to revalue these services to take into account the changes in valuation for the office/outpatient E/M visits. These services were initially valued using a building block methodology which summed the value of the individual service from its components, and for some of the codes in this code set, a specified number of visits must be furnished in order to bill for the respective ESRD MCP code because they are included in the code descriptor.</P>
                    <P>
                        Therefore, we believe that the ESRD MCP codes should be updated to more accurately account for the associated office/outpatient E/M visits. We are proposing to increase the work, physician time, and PE inputs in the form of clinical staff time of the ESRD MCP codes based on the marginal difference between the 2020 and 2021 office/outpatient E/M visit work, physician time, and PE inputs built into each code, as summarized in Tables 19 and 20. By improving payment accuracy for the ESRD MCP codes, we would also be supporting broader efforts at advancing kidney health.
                        <SU>3</SU>
                        <FTREF/>
                         We believe the majority of the visits included in the ESRD MCP bundles are being furnished, but are seeking comment on whether there are instances where the number and level of visits being furnished are not consistent with the number and level of visits built into the valuation of the code.
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             HHS Launches President Trump's `Advancing American Kidney Health' Initiative: 
                            <E T="03">https://www.hhs.gov/about/news/2019/07/10/hhs-launches-president-trump-advancing-american-kidney-health-initiative.html.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. TCM Services (CPT Codes 99495 and 99496)</HD>
                    <P>
                        The goal of TCM services is to improve the health outcomes of patients recently discharged from inpatient and certain outpatient facility stays. We began making separate payment for TCM services in CY 2013. At that time, CPT code 99495 (
                        <E T="03">
                            Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) 
                            <PRTPAGE P="50126"/>
                            with the patient and/or caregiver with 2 business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge
                        </E>
                        ) was valued to include one, level 4 established patient office/outpatient visit, while CPT code 99496 (
                        <E T="03">Transitional Care Management Services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver with 2 business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge</E>
                        ) was valued to include one, level 5 established patient office/outpatient visit (77 FR 68991). In the CY 2020 PFS final rule (84 FR 62687), we finalized the RUC-recommended work and direct PE inputs for the TCM codes which resulted in small RVU increases for both codes.
                    </P>
                    <P>Because both TCM codes include a required face-to-face E/M visit (either a level 4 or 5 office/outpatient E/M visit), we are proposing to increase the work RVUs associated with the TCM codes commensurate with the new valuations for the level 4 (CPT code 99214) and level 5 (CPT code 99215) office/outpatient E/M visits for established patients. Please see Tables 19 and 20 for long descriptors, as well as current and proposed work RVUs, physician time, and clinical staff time, for the TCM codes.</P>
                    <HD SOURCE="HD3">4. Maternity Services</HD>
                    <P>In the CY 2002 PFS final rule with comment period (66 FR 55393), we finalized separate payment for maternity care services. The maternity packages are unlike other services for which payment is made under the PFS in that they are the only global codes that provide a single payment for almost 12 months of services, including visits, surgical services, and imaging (among other services); and were valued using a building-block methodology as opposed to the magnitude estimation method that is commonly used to value the 10- and 90-day global services. There are 17 CPT codes that are used for billing delivery, antepartum, and postpartum maternity care services, and these codes are all designated with a unique global period indicator “MMM.”</P>
                    <P>For CY 2021, the AMA RUC made a recommendation to revalue these services, along with their recommendations to revalue the 10- and 90-day global surgical packages, to account for increases in the values of office/outpatient E/M visits. In the CY 2020 PFS final rule, we decided not to make changes to the valuation of 10- and 90-day global surgical packages to reflect changes made to values for the office/outpatient E/M visit codes while we continue to collect and analyze the data on the number and level of office/outpatient E/M visits that are actually being performed as part of these services.</P>
                    <P>The 10- and 90-day global surgical packages are commonly valued using a methodology known as magnitude estimation. Magnitude estimation refers to a methodology for valuing work that identifies the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS, without explicitly valuing the components of that work. Since its inception, the AMA RUC has worked under the prevailing assumption that magnitude estimation is the standard for valuation of all physicians' services, including those with global surgical packages. Consequently, the work values associated with expected typical E/M visits within a code's global period are not necessarily added to the physician work value for the code to determine the final work RVU. The postoperative visits in the 10- or 90-day global surgical code periods are often valued with reference to RVUs for separately-billed E/M visits, but the bundled post-operative visit RVUs do not directly contribute a certain number of RVUs to the valuation of the procedures. However, the MMM codes are unique in both the length of the global period and the methodology under which they were valued. When CMS established values for the maternity packages, we based them on RUC recommendations developed by the relevant specialty societies using the building block methodology. When it is used for a CPT code representing a bundle of services, the building block methodology components are the CPT codes that make up the bundled code and the inputs associated with those codes. Therefore, when the maternity packages were valued, the work (and other inputs) associated with the office/outpatient E/M visits in each package were explicitly accounted for.</P>
                    <P>
                        In addition, unlike the global surgical codes, we have reason to believe the visits included in the maternity codes are actually furnished given the evidence-based standards and professional guidelines for obstetrical care. For example, The 
                        <E T="03">Guidelines for Perinatal Care</E>
                         state that “a woman with an uncomplicated first pregnancy is examined every 4 weeks for the first 28 weeks of gestation, every 2 weeks until 36 weeks of gestation, and weekly thereafter.” 
                        <SU>4</SU>
                        <FTREF/>
                         For this reason, we excluded the maternity codes from our recent global surgery data collection.
                    </P>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             Kilpatrick SJ, Papile L, and Macones GA, eds. AAP Committee on Fetus and Newborn and ACOG Committee on Obstetric Practice. Guidelines for Perinatal Care. Eighth Edition. 2017. Page 150.
                        </P>
                    </FTNT>
                    <P>Given the valuation methodology and expectations for office/outpatient E/M visits in the maternity package codes, and the revaluation recommendation developed by the AMA RUC, we believe that the maternity packages should be updated to more accurately reflect the values of the office/outpatient E/M visits included in the packages. We believe that, due to the use of the building block valuation methodology rather than magnitude estimation, and the likelihood that the bundled visits are actually being furnished, the valuations recommended to us by the AMA RUC more accurately reflect the resource costs associated with furnishing these services. In the past, the work, physician time, and PE for these services have not been revalued to reflect changes to the office/outpatient E/M visits that are included as part of the package and therefore, the valuation of the MMM surgical packages have become misaligned with the valuation of their constituent office visits.</P>
                    <P>When revaluing the maternity packages, the AMA RUC used a methodology similar to what we used when revaluing the ESRD MCP codes and TCM by adding in the marginal differences in work, physician time, and practice expense (PE) in the form of clinical staff time between the current and 2021 E/M values. We believe that this method accurately accounts for the increase in valuation relative to the office/outpatient E/M visits, and therefore, we are proposing to increase the work RVUs, physician time, and PE inputs in the form of clinical staff time associated with the maternity packages by accepting the revaluation recommendation from the AMA RUC as detailed in Tables 19 and 20.</P>
                    <P>
                        We would also note that, in addition to appropriately reflecting changes to values of the office and outpatient E/M visits, increases made to the valuation of the maternity package codes would be consistent with our broader focus on improving maternal health and birth outcomes. The proposed changes would account for additional resources involved with additional work that is needed on the part of practitioners to improve care for this patient population, such as risk identification and ensuring appropriate interventions and referrals.
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             
                            <E T="03">
                                https://www.hhs.gov/blog/2020/01/29/achieving-better-health-mothers-and-babies.html; https://www.cms.gov/About-CMS/Agency-
                                <PRTPAGE/>
                                Information/OMH/equity-initiatives/rural-health/21-Maternal-Health-Forum-Improving-Maternal-Health-for-Our-Communities.pdf;
                            </E>
                              
                            <E T="03">https://innovation.cms.gov/innovation-models/maternal-opioid-misuse-model.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="50127"/>
                    <HD SOURCE="HD3">5. Assessment and Care Planning for Patients With Cognitive Impairment (CPT Code 99483)</HD>
                    <P>
                        In CY 2017, we established payment for HCPCS code G0505 (
                        <E T="03">Assessment and care planning for patients with cognitive impairment</E>
                        ) to provide payment for cognitive impairment assessment and care planning, believing that the CPT Editorial Panel was developing new coding for that service. In response to the CY 2017 PFS proposed rule, the AMA RUC submitted recommended values for this code, which we adopted in the CY 2017 PFS final rule. In CY 2018, the CPT Editorial Panel created CPT code 99483 for reporting of this service and in CY 2018, CMS adopted CPT code 99483 (deleting HCPCS code G0505) without changing the service valuation. Based on input from commenters and the AMA RUC, the valuation of this service reflected the complexity involved in assessment and care planning for patients with cognitive impairment by including resource costs that are greater than the highest valued office/outpatient E/M visit (CPT code 99205, new patient level 5 visit) (81 FR 80352). Specifically, the service includes a cognition-focused evaluation including a pertinent history and examination, and medical decision making of moderate or high complexity, in addition to many functional and other assessments specific to cognitive status. With the revaluation we finalized in the CY 2020 PFS final rule for CPT code 99205 effective beginning in CY 2021, the current work RVU for CPT code 99483 would have a lower work RVU than a new patient level 5 office/outpatient E/M visit, which would create a rank order anomaly between the two codes that, given the way the code was valued, we do not believe would be appropriate. Rather, because CPT code 99483 was valued in relation to a level 5 office/outpatient E/M visit, we believe that an adjustment to the work, physician time, and PE for this service to reflect the marginal difference between the value of the level 5 new patient office/outpatient E/M visit in CY 2020 and CY 2021 would be appropriate to maintain payment accuracy. Therefore, we are proposing to adjust the work, time, and PE in the form of clinical staff time for CPT code 99483 as shown in Tables 19 and 20.
                    </P>
                    <HD SOURCE="HD3">6. Initial Preventive Physical Examination (IPPE) and Initial and Subsequent Annual Wellness (AWV) Visits</HD>
                    <P>
                        In the CY 2011 PFS final rule with comment period, we finalized separate payment for HCPCS codes G0438 (
                        <E T="03">Annual wellness visit; includes a personalized prevention plan of service (pps), initial visit</E>
                        ) and G0439 (
                        <E T="03">Annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit</E>
                        ). These services were valued via a direct crosswalk to the work, time, and direct PE inputs associated with CPT codes 99204 and 99214, respectively. In that same rule, we stated that the HCPCS code G0402 (
                        <E T="03">Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment)</E>
                         was also valued based on a direct crosswalk to the work, time, and direct PE inputs for CPT code 99204 (75 FR 73408-73411).
                    </P>
                    <P>Because these codes are valued using direct crosswalks to office/outpatient E/M visits, and based on the principles articulated above, we believe that to maintain payment accuracy for the IPPE and the AWV, their values should be adjusted to reflect the changes in value for CPT codes 99204 and 99214. Therefore, we are proposing to revise the work, physician time, and direct PE inputs for these codes as shown in Tables 19 and 20.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="637">
                        <PRTPAGE P="50128"/>
                        <GID>EP17AU20.025</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50129"/>
                        <GID>EP17AU20.026</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50130"/>
                        <GID>EP17AU20.027</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="129">
                        <PRTPAGE P="50131"/>
                        <GID>EP17AU20.028</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="637">
                        <PRTPAGE P="50132"/>
                        <GID>EP17AU20.029</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="311">
                        <PRTPAGE P="50133"/>
                        <GID>EP17AU20.030</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">7. Emergency Department Visits</HD>
                    <P>The ED visit codes have been revalued under the PFS three times- in 1997, 2007, and most recently in 2018 as part of the misvalued code initiative for CY 2020 rulemaking. Each subsequent revaluation was done in part to maintain relativity with the office/outpatient E/M visit codes. Specifically, when these services were revalued in prior rulemaking, the principle was that levels 1 through 3 of the ED visits should have the same value as the level 1 through 3 new patient office/outpatient E/M visits and that the levels 4 and 5 ED visits should be valued higher than the levels 4 and 5 new patient office/outpatient E/M visits to reflect higher typical intensity in the ED setting. In the CY 2018 PFS final rule, we finalized a proposal to nominate the level 1 through level 5 ED visit codes (CPT codes 99281-99285, see Table 21 for long descriptors) as potentially misvalued based on information suggesting that the work RVUs for ED visits may not appropriately reflect the full resources involved in furnishing these services. Specifically, stakeholders expressed concerns that the work RVUs for these services have been undervalued given the increased acuity of the patient population and the heterogeneity of the sites, such as freestanding and off-campus EDs, where ED visits are furnished (82 FR 53018). The AMA RUC surveyed and reviewed five of these codes for the April 2018 RUC meeting and provided a recommendation to CMS for consideration in CY 2020 rulemaking. In the CY 2020 PFS final rule, we finalized the RUC-recommended work RVUs of 0.48 for CPT code 99281, a work RVU of 0.93 for CPT code 99282, a work RVU of 1.42 for 99283, a work RVU of 2.60 for 99284, and a work RVU of 3.80 for CPT code 99285. The RUC did not recommend, and we did not finalize, any direct PE inputs for the codes in this family. The AMA RUC submitted these recommended values to CMS prior to the submission of the RUC-recommended revaluation of the office/outpatient E/M visit code family.</P>
                    <P>In response to our comment solicitation in CY 2020 PFS rulemaking regarding whether certain services should be revalued to maintain relativity with office/outpatient E/M visits, the American College of Emergency Physicians submitted a public comment stating that relativity between the ED visits and office/outpatient E/M visits should be maintained, and provided CMS with a specific recommendation for CPT codes 99283-99285. The association believed we should continue to preserve the same relationship between the ED and office/outpatient E/M visit code sets that was established in prior years and would have likely been maintained had the office/outpatient E/M visits been revalued prior to the ED visits. They have also submitted a subsequent letter to this effect. We agree with the society, particularly since the justification provided by the AMA RUC recommendations we accepted for the CY 2020 revaluation was, in part, to maintain relativity with the office/outpatient E/M visits, and that relativity would be disrupted if they were to remain unadjusted. The proposed values are consistent with the principle that the levels 1-3 ED visits should remain the same as the levels 1-3 new patient office visits but the levels 4-5 ED visits should have a higher value than the corresponding office visits, due to the complexity of the patients requiring that level of emergency care. Therefore, we are proposing the values recommended by ACEP as shown in Table 21.</P>
                    <HD SOURCE="HD3">8. Therapy Evaluations</HD>
                    <P>
                        There are a number of services paid under the PFS that are similar in many respects to the office/outpatient E/M visit code set, but do not specifically include, were not valued to include, and were not necessarily valued relative to, 
                        <PRTPAGE P="50134"/>
                        office/outpatient E/M visits. These codes inherently include work associated with assessment and work associated with management, similar to the work included in the office/outpatient E/M visits, which involve time spent face-to-face assessing and treating the patient. These services include therapy evaluation services and psychiatric diagnostic evaluation services. The practitioners who furnish these services are prohibited by CMS from billing E/M services due to the limitations of their Medicare benefit categories. As such, the CPT Editorial Panel has created specific coding to describe the services furnished by these practitioners. Although these services are billed using specific, distinct codes relating to therapy evaluations and psychiatric diagnostic evaluations, we believe that a significant portion of the overall work in the codes is for assessment and management of patients, as it is for the office/outpatient E/M visit codes.
                    </P>
                    <P>
                        Therefore, we are proposing to adjust the work RVUs for these services based on a broad-based estimate of the overall change in the work associated with assessment and management to mirror the overall increase in the work of the office/outpatient E/M visits. We calculated this adjustment based on a volume-weighted average of the increases to the office/outpatient E/M visit work RVUs from CY 2020 to CY 2021. Details on this calculation are available as a public use file on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.</E>
                         We are proposing to apply that percentage increase, which we estimate to be approximately 28 percent, to the work RVUs for the therapy evaluation and psychiatric diagnostic evaluation services codes. We believe that it is important to the relativity of the PFS to revalue these services to reflect the overall increase in value associated with spending time assessing and managing patients, as reflected in the changes to work values for the office/outpatient E/M visits, particularly in recognition of the value of the clinicians' time which is spent treating a growing number of patients with greater needs and multiple medical conditions. We recognize that this is not the methodology typically used to value services under the PFS and are seeking comment on potential alternative methodologies or specific values for these services, particularly about whether commenters believe it would be better to develop values using comparator codes from the office/outpatient E/M visit code set, and if so, why.
                    </P>
                    <HD SOURCE="HD3">9. Behavioral Healthcare Services</HD>
                    <P>
                        The psychotherapy code set is divided into psychotherapy that can be furnished as a standalone service and psychotherapy furnished in conjunction with an office/outpatient E/M visit. The standalone psychotherapy services are CPT codes 90832, 90834, and 90837 (See Table 21 for long descriptors). The CPT codes describing psychotherapy furnished in conjunction with an office/outpatient E/M visit are CPT codes 90833 (
                        <E T="03">Psychotherapy, 30 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)</E>
                        ), 90836 (
                        <E T="03">Psychotherapy, 45 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)</E>
                        ) and 90838 (
                        <E T="03">Psychotherapy, 60 minutes with patient when performed with an evaluation and management service (List separately in addition to the code for primary procedure)</E>
                        ). As the values for the office/outpatient E/M visits are increasing, there will necessarily be an increase in the overall value for psychotherapy furnished in conjunction with office/outpatient E/M visits. We believe that it is important, both in terms of supporting access to behavioral health services through appropriate payment and maintaining relativity within this code family, to increase the values for the standalone psychotherapy services to reflect changes to the value of the office/outpatient E/M visits which are most commonly furnished with the add-on psychotherapy services with equivalent times. For example, under the finalized revaluation of the office/outpatient E/M visits, the proportional work value of the standalone psychotherapy CPT code 90834 (
                        <E T="03">Psytx w pt 45 minutes</E>
                        ) would decrease relative to the combined work RVUs for CPT code 99214 (
                        <E T="03">Level 4 Office/outpatient visit est</E>
                        ) when billed with CPT code 90836 (
                        <E T="03">Psytx w pt w e/m 45 min</E>
                        ). The current combined work RVU for CPT code 99214 when reported with CPT code 90836 is 3.40 (1.90 + 1.50) and the current work RVU for CPT code 90834 is 2.0. With the revaluation of the office/outpatient E/M visits beginning for CY 2021, the combined work RVU for CPT codes 99214 and 90836 would be 3.82 (1.90 + 1.92), while the current work RVU for 90834 would remain at 2.0, resulting in a change to relativity between these services.
                    </P>
                    <P>To maintain the current relativity, which we believe to be appropriate based on the proportionate difference between these services, we are proposing to increase the work RVU for CPT code 90834 from 2.00 to 2.25 based on the marginal increase in work value for CPT code 99214 from CY 2020 to CY 2021. Similarly, for CPT code 90832, which describes 30 minutes of psychotherapy, we are proposing to increase its work RVU based on the increase to CPT code 99213, which is most commonly billed with the 30 minutes of psychotherapy add-on, CPT code 90833. For CPT code 90837, which describes 60 minutes of psychotherapy, we propose to increase the work RVU based on the proportional increase to CPT codes 99214 and 90838, which is the office/outpatient E/M visit code most frequently billed with the 60 minutes of psychotherapy add-on. Table 21 provides a summary of the current and proposed RVUs for these services.</P>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50135"/>
                        <GID>EP17AU20.031</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50136"/>
                        <GID>EP17AU20.032</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="246">
                        <PRTPAGE P="50137"/>
                        <GID>EP17AU20.033</GID>
                    </GPH>
                    <HD SOURCE="HD3">10. Ophthalmological Services</HD>
                    <P>We received a request to revalue the following ophthalmological services which we are not proposing to revalue:</P>
                    <P>
                        • CPT code 92002: 
                        <E T="03">Ophthalmological services: medical examination and evaluation with initiation of diagnostic and treatment program; intermediate, new patient.</E>
                    </P>
                    <P>
                        <E T="03">•</E>
                         CPT code 92004: 
                        <E T="03">Ophthalmological services: medical examination and evaluation with initiation of diagnostic and treatment program; comprehensive, new patient, 1 or more visits.</E>
                    </P>
                    <P>
                        <E T="03">•</E>
                         CPT code 92012: 
                        <E T="03">Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; intermediate, established patient.</E>
                    </P>
                    <P>
                        <E T="03">•</E>
                         CPT code 92014: 
                        <E T="03">Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, 1 or more visits.</E>
                    </P>
                    <P>
                        We are not proposing to revalue these services because they are not sufficiently analogous or connected to the office/outpatient E/M visit codes. While these ophthalmological services have historically been valued relative to office/outpatient E/M visits, they have not been reviewed by the RUC since 2007. Two of these ophthalmological services can include more than one visit, and the number of visits included in the package is uncertain and therefore are not so closely tied to office and outpatient E/M services which describe a single visit. In addition, starting in 2021, the office/outpatient E/M visit codes will be substantially redefined to allow time or medical decision-making for code level selection, concepts that do not apply in these ophthalmological visits which rely on criteria specific to evaluation, examination, specified technical procedures, and treatment of ocular conditions for purposes of level selection.
                        <SU>6</SU>
                        <FTREF/>
                         The number of levels within the two code sets differs, and the number of levels has changed for office/outpatient E/M visits. Given the revised code set and framework for level selection for office/outpatient E/M visits, the level of office/outpatient E/M visits to which the ophthalmological visits might be analogous is no longer clear. We are also aware that ophthalmologists report office/outpatient E/M visits as well these ophthalmologic-specific evaluation codes. The relationship between the two separate code sets and the reason for relying on both of them is unclear.
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             CPT Codebook pp. 656-7.
                        </P>
                    </FTNT>
                    <P>
                        In addition, the four ophthalmological evaluation codes are reported with modifier -25 (significant, separately identifiable E/M service by the same physician on the same day of the procedure or other service) approximately 4 to 14 percent of the time (depending on the code in question). Similarly, ED visits are reported with modifier -25 approximately 4 to 12 percent of the time (depending on the code in question). In contrast, the office/outpatient E/M visit codes are reported with modifier -25 approximately 18 to 35 percent of the time (depending on the code in question). We are in the process of analyzing these data further to assess how often the accompanying service is a minor procedure rather than a visit. We believe that visit/evaluation codes furnished the same day as a minor procedure are not closely analogous to stand-alone office/outpatient E/M visits, and therefore should not be revalued commensurate with the increase to stand-alone office/outpatient E/M visits for 2021. As we discussed in prior PFS rules, we continue to believe that separately identifiable visits occurring on the same day as minor procedures (such as zero-day global procedures) have resources that are sufficiently distinct from the costs associated with furnishing office/outpatient E/M visits to warrant different payment (see, for example, the CY 2019 PFS final rule, 83 FR 59639)). As we continue our analysis, we are seeking public comment on whether visits/evaluations that are furnished frequently with same-day procedures should be revalued commensurate with increases to the office/outpatient E/M visits, or whether they are substantially different enough to warrant independent valuation. We note that the stand-alone psychotherapy services would be revalued to maintain relativity with the psychotherapy services that can be performed in conjunction with an E/M visit. Standalone psychotherapy services cannot be billed with office/outpatient E/M visits while ophthalmological visits can, as well as with a separate procedure.
                        <PRTPAGE P="50138"/>
                    </P>
                    <HD SOURCE="HD3">c. Comment Solicitation on the Definition of HCPCS Code GPC1X</HD>
                    <P>Although we believe that the RUC-recommended values for the revised office/outpatient E/M visit codes will more accurately reflect the resources involved in furnishing a typical office/outpatient E/M visit, we continue to believe that the typical visit described by the revised and revalued office/outpatient E/M visit code set still does not adequately describe or reflect the resources associated with primary care and certain types of specialty visits. Therefore, in the CY 2020 PFS final rule (84 FR 62856), we finalized the HCPCS add-on code GPC1X which describes the “visit complexity inherent to evaluation and management associated with medical care services that serve as the continuing focal point for all needed health care services and/or with medical care services that are part of ongoing care related to a patient's single, serious, or complex condition.” We stated that we were not restricting billing based on specialty, but that we did assume that certain specialties furnished these types of visits more than others.</P>
                    <P>Since the publication of the CY 2020 PFS final rule, some specialty societies have stated that our definition of this service, as articulated in the code descriptor and the associated preamble discussion, is unclear. For example, some stakeholders have suggested that HCPCS add-on code GPC1X, as currently described, could be applicable for every office/outpatient E/M visit. They have also expressed concerns regarding our utilization assumptions, since we assumed that specialties that predominantly furnish the kind of care described by the code would bill it with every visit. Therefore, we are soliciting from the public comments providing additional, more specific information regarding what aspects of the definition of HCPCS add-on code GPC1X are unclear, how we might address those concerns, and how we might refine our utilization assumptions for the code.</P>
                    <P>We continue to believe that the time, intensity, and PE involved in furnishing services to patients on an ongoing basis that result in a comprehensive, longitudinal, and continuous relationship with the patient and involves delivery of team-based care that is accessible, coordinated with other practitioners and providers, and integrated with the broader health care landscape, are not adequately described by the revised office/outpatient E/M visit code set. We believe the inclusion of HCPCS add-on code GPC1X appropriately recognizes the resources involved when practitioners furnish services that are best-suited to patients' ongoing care needs and potentially evolving illness. We also believe the work reflected in HCPCS add-on code GPC1X is inherently distinct from existing coding that describes preventive and care management services. For example, the AWV describes and pays for a static annual health assessment rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Similarly, TCM service codes are focused on care management for 30 days following a discharge rather than the time, intensity, and PE involved in furnishing services to patients on an ongoing basis. Chronic care management and principal care management service codes are limited to patients with chronic condition(s). Under chronic care management codes, patients have two or more chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, whereas principal care management services are for patients who have a single high-risk disease of sufficient severity to place the patient at risk of hospitalization or have been the cause of recent hospitalization. In contrast, we believe HCPCS add-on code GPC1X reflects the time, intensity, and PE when practitioners furnish services that enable them to build longitudinal relationships with all patients (that is, not only those patients who have a chronic condition or single-high risk disease) and to address the majority of patients' health care needs with consistency and continuity over longer periods of time. For example, in the context of primary care, HCPCS add-on code GPC1X could recognize the resources inherent in holistic, patient-centered care that integrates the treatment of illness or injury, management of acute and chronic health conditions, and coordination of specialty care in a collaborative relationship with the clinical care team. In the context of specialty care, HCPCS add-on code GPC1X could recognize the resources inherent in engaging the patient in a continuous and active collaborative plan of care related to an identified health condition the management of which requires the direction of a clinician with specialized clinical knowledge, skill and experience. Such collaborative care includes patient education, expectations and responsibilities, shared decision-making around therapeutic goals, and shared commitments to achieve those goals. In both examples, HCPCS add-on code GPC1X reflects the time, intensity, and PE associated with providing services that result in care that is personalized to the patient. Finally, we believe that the HCPCS add-on code GPC1X could bolster the efforts of practitioners in rural communities, including NPPs, to deliver the comprehensive and longitudinal care that HCPCS add-on code GPC1X describes.</P>
                    <HD SOURCE="HD3">d. Prolonged Office/Outpatient E/M Visits (CPT Code 99XXX)</HD>
                    <P>
                        We reviewed our final policy for 2021 regarding the reporting of prolonged office/outpatient E/M visits finalized in the CY 2020 PFS final rule (84 FR 62848 through 62850). To report these visits beginning in 2021, we finalized CPT code 99XXX 
                        <E T="03">(Prolonged office or other outpatient evaluation and management service(s) (beyond the total time of the primary procedure which has been selected using total time), requiring total time with or without direct patient contact beyond the usual service, on the date of the primary service; each additional 15 minutes (List separately in addition to CPT codes 99205, 99215 for office or other outpatient evaluation and management services)).</E>
                         CPT code 99XXX is only reported when time is used to select the visit level, and only time of the physician or qualified healthcare professional is counted. In the CY 2020 PFS final rule, we stated that our interpretation of revised CPT prefatory language and reporting instructions would mean that CPT code 99XXX could be reported when the physician's (or NPP's) time is used for code level selection and the time for a level 5 office/outpatient E/M visit (the floor of the level 5 time range) is exceeded by 15 minutes or more on the date of service (84 FR 62848 through 62849). The intent of the CPT Editorial Panel was unclear because of the use of the terms “total time” and “usual service” in the CPT code descriptor (“
                        <E T="03">requiring total time with or without direct patient contact beyond the usual service.</E>
                        ”) The term “total time” is unclear because office/outpatient E/M visits now represent a range of time, and “total” time could be interpreted as including prolonged time. Further, the term, “usual service” is undefined. There is no longer a typical time in the code descriptor that could be used as point of reference for when the “usual time” is exceeded for all practitioners, and there would be variation (as well as potential double counting of time) if applied at the individual practitioner level.
                    </P>
                    <P>
                        Having reviewed the policy we finalized last year, we believe that allowing reporting of CPT code 99XXX 
                        <PRTPAGE P="50139"/>
                        after the minimum time for the level 5 visit is exceeded by at least 15 minutes would result in double counting time. As a specific example, the time range for CPT code 99215 is 40-54 minutes. If the reporting practitioner spent 55 minutes of time, 14 of those minutes are included in the services described by CPT code 99215. Therefore, only 1 minute should be counted towards the additional 15 minutes needed to report CPT code 99XXX and prolonged services should not be reportable as we finalized last year (see Table 33 of the CY 2020 PFS final rule (84 FR 62849)). Therefore, we are proposing that when the time of the reporting physician or NPP is used to select office/outpatient E/M visit level, CPT code 99XXX could be reported when the maximum time for the level 5 office/outpatient E/M visit is exceeded by at least 15 minutes on the date of service. In Tables 22 and 23, we provide examples.
                    </P>
                    <GPH SPAN="3" DEEP="117">
                        <GID>EP17AU20.034</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="118">
                        <GID>EP17AU20.035</GID>
                    </GPH>
                    <HD SOURCE="HD2">G. Scope of Practice and Related Issues</HD>
                    <P>
                        We are proposing several policies consistent with the President's Executive Order 13890 on “Protecting and Improving Medicare for Our Nation's Seniors” to modify supervision and other requirements of the Medicare program that limit healthcare professionals from practicing at the top of their license (84 FR 53573, October 8, 2019, Executive Order #13890). In December 2019, we requested feedback in response to part of this Executive Order seeking the public's help in identifying additional Medicare regulations which contain more restrictive supervision requirements than existing state scope of practice laws, or which limit health professionals from practicing at the top of their license (the request for feedback is available at 
                        <E T="03">https://www.cms.gov/files/document/request-information-reducing-scope-practice-burden.pdf</E>
                        ). Through review of the feedback we received, we identified the policies in this section to address in the PFS proposed rule. We believe that physicians, NPPs, and other professionals should be able to furnish services to Medicare beneficiaries in accordance with their scope of practice and state licensure, including education and training, to the extent permitted under the Medicare statute, as long as it is not likely to result in fraud, waste or abuse. These proposed policies may also help ensure an adequate number of clinicians, in addition to physicians are able to furnish critical services including primary care services in areas where there is a shortage of physicians.
                        <SU>7</SU>
                        <FTREF/>
                         Some of the proposals may also help alleviate the opioid crisis.
                    </P>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             Zhang et al. Physician workforce in the United States of America: forecasting nationwide shortages. 
                            <E T="03">Human Resources for Health</E>
                             (2020); 18:8. Published online February 6, 2020 and available online at 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7006215/.</E>
                        </P>
                    </FTNT>
                    <P>
                        We note that the responses to our request for feedback on the topics in this section did not indicate the number of states that have more flexible scope of practice rules than our federal regulations, or whether facilities (such as hospitals or nursing facilities) have relevant policies that limit the ability of the impacted professionals to perform certain services. For example, if Medicare payment policy provided for payment of diagnostic tests supervised by NPPs, there may still be facility- or state-specific policies in place that limit NPPs' ability to supervise some or all diagnostic tests, and those limitations would inform the potential impact of changing our policy. While our proposed flexibility may increase the capacity and availability of practitioners who can supervise diagnostic tests, which would alleviate some of the demand on physicians as the only source to perform this particular function, we have not located information indicating the degree to which NPP scope of practice includes supervision of auxiliary staff, especially for the subset of services that are diagnostic tests. There is a wide range of diagnostic tests, from a simple strep throat swab to more sophisticated and/or invasive tests such as x-rays and cardiology procedures. We would need to understand the scope of practice for many types of auxiliary staff (some of whom are not licensed) who could potentially provide these tests under the supervision of an NPP, including RNs, LPNs, medical assistants, radiologic technicians, and many others. To the extent practice patterns change, there 
                        <PRTPAGE P="50140"/>
                        could be induced utilization that would increase costs, but this might be offset by reduced payment rates because direct payment to NPPs is at a lower rate than payment to physicians. Therefore, in this proposed rule, we are also seeking information about the number and names of states that have licensure or scope of practice laws in place, as well as any facility-specific policies, that would impact the ability of clinicians to exercise the flexibilities we are proposing, to help us assess the potential impact of, or challenges for, our proposed changes. Information about specific services (service-level information) would be especially helpful. We are seeking public comment on whether applicable state laws, scope of practice, and facility policies would permit practitioners to exercise the proposed flexibilities if CMS were to adopt the policies proposed in this section, and to what extent practitioners would be permitted to exercise these proposed flexibilities, such as for all diagnostic tests or only a subset.
                    </P>
                    <HD SOURCE="HD3">1. Teaching Physician and Resident Moonlighting Policies</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>In the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 1st COVID-19 IFC (85 FR 27550 through 27629), we implemented several policies on an interim final basis related to PFS payment for the services of teaching physicians involving residents and resident moonlighting regulations. The comment periods for both the March 31st COVID-19 IFC (85 FR 19230) and the May 1st COVID-19 IFC (85 FR 27550) have closed. Therefore, we plan to address the IFC comments for issues in which we have proposals in this proposed rule when we publish the PFS final rule. We are considering whether these policies should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule.</P>
                    <P>For teaching physicians, section 1842(b)(7)(A)(i)(I) of the Act specifies that in the case of physicians' services furnished to a patient in a hospital with a teaching program, the Secretary shall not provide payment for such services unless the physician renders sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the management of the portion of the case for which payment is sought.</P>
                    <P>Regulations regarding PFS payment for teaching physician services and services of moonlighting residents are codified in 42 CFR part 415. In general, under § 415.170, payment is made under the PFS for services furnished in a teaching hospital setting if the services are personally furnished by a physician who is not a resident, or the services are furnished by a resident in the presence of a teaching physician, with exceptions as specified in subsequent regulatory provisions in part 415. Under § 415.172, if a resident participates in a service furnished in a teaching setting, PFS payment is made only if the teaching physician is present during the key portion of any service or procedure for which payment is sought. The regulation at § 415.180 states that, for the interpretation of diagnostic radiology and other diagnostic tests, PFS payment is made if the interpretation is performed or reviewed by a physician other than a resident. Under § 415.184, PFS payment is made for psychiatric services furnished under an approved graduate medical education (GME) program if the requirements of §§ 415.170 and 415.172 are met, except that the requirement for the presence of the teaching physician during psychiatric services in which a resident is involved may be met by observation of the service by use of a one-way mirror, video equipment, or similar device.</P>
                    <HD SOURCE="HD3">b. Supervision of Residents in Teaching Settings Through Audio/Video Real-Time Communications Technology</HD>
                    <P>In both the March 31st COVID-19 IFC (85 FR 19258 through 19261) and the May 1st COVID-19 IFC (85 FR 27550 through 27629), we adopted a policy on an interim basis during the COVID-19 PHE that, under § 415.172, the requirement for the presence of a teaching physician during the key portion of the service furnished with the involvement of a resident can be met using audio/video real-time communications technology. In other words, the teaching physician must be present, either in person or virtually through audio/video real-time communications technology, during the key portion of the service. This policy generally requires real-time observation (not mere availability) by the teaching physician through audio and video technology, and does not include audio-only technology (for example, telephone without video). For the primary care exception under § 415.174(c), we adopted a policy on an interim final basis for the duration of the COVID-19 PHE to allow the teaching physician to direct the care furnished by the resident, and to review the services furnished by the resident during or immediately after the visit, remotely using audio/video real-time communications technology.</P>
                    <P>Under § 415.180, we adopted a policy on an interim basis for the duration of the COVID-19 PHE to allow PFS payment to be made for the interpretation of diagnostic radiology and other diagnostic tests if the interpretation is performed by a resident when the teaching physician is present through audio/video real-time communications technology. A physician other than the resident must still review the resident's interpretation. Under § 415.184, we adopted a policy on an interim basis during the COVID-19 PHE that the requirement for the presence of the teaching physician during the psychiatric service in which a resident is involved may be met by the teaching physician's direct supervision using audio/video real-time communications technology.</P>
                    <P>We are considering whether the flexibilities described above that we implemented on an interim basis during PHE under §§ 415.172, 415.174, 415.180, and 415.184 should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. In addition, we are proposing to make a technical edit to the regulation text at § 415.184 to eliminate the term “direct supervision” to conform with the language in sections §§ 415.172, 415.174, and 415.180 regarding the presence of the teaching physician via audio/video real-time communications technology.</P>
                    <P>
                        While we believe it was appropriate to permit teaching physicians to be involved in services furnished with residents through audio/video real-time communications technology to respond to critical needs during the PHE to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we are concerned that continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching 
                        <PRTPAGE P="50141"/>
                        physician on a temporary or permanent basis. Absent the circumstances of the PHE, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case.
                    </P>
                    <P>We also have some concerns about patient safety when the teaching physician is only virtually present. For example, in the March 31st COVID-19 IFC, we excluded the surgical, high risk, interventional, endoscopic, or other complex procedures identified under § 415.172(a)(1), and anesthesia services under § 415.178 from the policy to allow the teaching physician to be present using audio-video real-time communications technology because we believe the requirement for the physical, in-person presence of the teaching physician for either the entire procedure or the key portion of the service with immediate availability throughout the procedure, as applicable, is necessary for patient safety given the risks associated with these services. In complex, high-risk, surgical, interventional, or endoscopic procedures, or anesthesia procedures, a patient's clinical status can quickly change. To permit payment under the PFS for these teaching physician services, we believe the services must be furnished with a certain level of personal oversight and involvement of the teaching physician who has the experience and judgment that is necessary for rapid on-site decision-making during these procedures.</P>
                    <P>There may be circumstances in which virtual presence of the teaching physician, considered in light of the potential risks to patient safety and absent exposure risk concerns due to COVID-19, does not demonstrate sufficient personal involvement in the service to the patient to warrant payment to the teaching physician under the PFS. For example, a resident could evaluate a patient for change in mental status following surgery for hip fracture, perform a physical exam and report it as unrevealing, and note that the patient is uncooperative with a full exam. If a full exam had been performed by the teaching physician or with the physical presence of the teaching physician (or with the teaching physician immediately available in the clinic to provide the necessary direction, under the primary care exception) to render personal and identifiable physicians' services to the patient, the exam would likely have revealed crystal-mediated acute arthritis, and that the patient's lack of cooperation was due to hypoactive delirium. However, the teaching physician may not have been able to identify this concern through the use of audio/video interactive communications technology. In this case, the presence of the teaching physician through audio/video interactive communications technology might have been insufficient to allow the teaching physician to render personal and identifiable physicians' services to exercise full, personal control over the key portion of the encounter.</P>
                    <P>There also may be certain patient populations that require greater clinical attentiveness and skill than the teaching physician could provide via audio/video interactive communications technology. For example, patients with cognitive impairment or dementia may require the experience and skill to recognize a need for specialized testing, and patients with communication disabilities may require more experience and skill to recognize specialized needs. It may not be possible for the teaching physician to meet these clinical needs and exercise full, personal control while being present for the key portion of the service through audio/video interactive communications technology. Moreover, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the services, and potentially putting the patient's safety at risk.</P>
                    <P>While we have significant concerns about extending our interim policy to permit virtual presence of the teaching physician, whether on a temporary or permanent basis, we believe public comment would be helpful as we further consider the status of this policy. For example, because COVID-19 may continue to persist in some communities after the expiration of the PHE, we are considering extending our policy to permit the teaching physician to be present through audio/video interactive communications technology on a temporary basis until the end of the calendar year in which the PHE ends. The presence of COVID-19 may result in a need for some teaching settings to continue to limit exposure risks, especially for high risk patients isolated for their own protection or in cases where the teaching physician has been exposed to the virus and must be under quarantine. If the teaching physician is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access to services for Medicare patients. Some communities may experience a resurgence of COVID-19, and extending our policy until the end of the calendar year in which the PHE ends to permit PFS payment when the teaching physician is present through audio/video real-time communications technology could temporarily help teaching settings remain prepared with surge capacity.</P>
                    <P>
                        Based on the clinical experience gained during the PHE, we might identify circumstances or procedures for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case when the services are furnished by a resident with the teaching physician present through audio/video real-time communications technology. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient evaluation and management (E/M) visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes are discussed in section II.F. of this proposed rule). Additionally, the teaching physician may be able to provide sufficient involvement for simple procedures such as CPT code 36410 (
                        <E T="03">Venipuncture, age 3 years or older, necessitating the skill of a physician or other qualified health care professional (separate procedure), for diagnostic or therapeutic purposes (not to be used for routine venipuncture)</E>
                         or CPT code 51701 (
                        <E T="03">Insertion of non-indwelling bladder catheter (e.g., straight catheterization for residual urine).</E>
                         For such circumstances and procedures, it may be appropriate to continue the virtual presence policy on a temporary or permanent basis.
                    </P>
                    <P>
                        We note that having the virtual presence policy in place temporarily or permanently would not preclude teaching physicians from providing a greater degree of involvement in services furnished with residents, and teaching physicians would still have discretion to determine whether, and if 
                        <PRTPAGE P="50142"/>
                        so, when it is appropriate to be present virtually rather than in person depending on the services being furnished and the experience of the particular residents involved. We seek comment to help us understand how the option to provide for teaching physician presence using audio/video real-time communications technology would support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability); ensure burden reduction without creating risks to patient care or increasing fraud; avoid duplicative payment between the PFS and the IPPS for GME programs; and support emergency preparedness. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.
                    </P>
                    <HD SOURCE="HD3">c. Virtual Teaching Physician Presence During Medicare Telehealth Services</HD>
                    <P>In the March 31st COVID-19 IFC (85 FR 19260), we adopted a policy on an interim basis to allow Medicare to make payment under the PFS for teaching physician services when a resident furnishes Medicare telehealth services to beneficiaries while a teaching physician is present using audio/video real-time communications technology. We are considering whether this policy should be extended on a temporary basis (that is, if the PHE ends in 2021, this policy could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. Outside the circumstances of the PHE, under the requirements at section 1834(m) of the Act that discuss payment for telehealth services, the patient would be located at a telehealth originating site, and the teaching physician would be furnishing the service as the distant site practitioner with the involvement of the resident.</P>
                    <P>While teaching physician presence through audio/video real-time communications technology when a resident furnishes Medicare telehealth services was responsive to critical needs during the PHE to reduce exposure risk and to increase the capacity of teaching settings to respond to COVID-19, we are concerned that the policy to permit virtual presence of the teaching physician may not allow for sufficient personal and identifiable physicians' services to exercise full, personal control over the services such that PFS payment to the teaching physician would be appropriate outside the circumstances of the PHE on a temporary or permanent basis. We are concerned that if the resident was furnishing the service at the distant site and the teaching physician was at a third site and present with the resident through audio/video real-time communications technology, the teaching physician may not be able to render sufficient personal and identifiable physicians' services to the patient to exercise full, personal control over the service to warrant separate payment on the PFS.</P>
                    <P>Absent the need to reduce exposure risk to COVID-19 during the PHE, we also have some concerns about patient safety when the teaching physician is present only virtually during a telehealth service furnished by a resident. For example, the virtual connection between the teaching physician and the resident who is with the patient could be disrupted (as with any virtual supervision scenario), rendering it impossible for the teaching physician to provide necessary direction for the resident to furnish appropriate care to the patient, thus foreclosing the ability of the teaching physician to exercise full, personal control over the key portion of the service, and potentially putting the patient's safety at risk.</P>
                    <P>However, because COVID-19 may continue to persist in some communities and some communities may experience a resurgence of COVID-19 after the expiration of the PHE, we are seeking comment about whether it would be appropriate to extend this policy on a temporary basis until the end of the calendar year in which the PHE ends. The presence of COVID-19 may result in a need to continue to limit exposure risks. In cases where the teaching physician has been exposed to the virus and is under quarantine, termination of the policy to permit virtual presence of the teaching physician could unintentionally limit the number of licensed practitioners available to furnish services to Medicare patients in some communities, and could have the unintended consequence of limiting access for Medicare patients. Finally, based on experience gained during the PHE, we might identify circumstances for which the teaching physician can routinely render sufficient personal and identifiable services to the patient to exercise full, personal control over the management of the key portion of the case while providing virtual presence during Medicare telehealth services furnished by a resident on a permanent basis. For example, under ordinary circumstances for the primary care exception at § 415.174, we permit PFS payment to the teaching physician when a resident furnishes office/outpatient E/M visit codes of lower and mid-level complexity and annual wellness visits without the presence of a teaching physician (these codes are discussed in section II.F. of this proposed rule). For such services, it may be appropriate to continue the virtual presence policy on a temporary or permanent basis. We seek comment to help us understand how the option to allow teaching physician presence using audio/video real-time communications technology could support patient safety for all patients and particularly for at-risk patients (for example, patients who are aged and/or who have a disability), ensure burden reduction without creating risks to patient care or increasing fraud, avoid duplicative payment between the PFS and the IPPS for GME programs, and support emergency preparedness. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.</P>
                    <HD SOURCE="HD3">d. Resident Moonlighting in the Inpatient Setting</HD>
                    <P>
                        Under certain conditions, the services of a licensed resident physician who is “moonlighting” are considered to be furnished by the individual in their capacity as a physician, rather than as a resident in an approved GME program. As specified in the regulation at § 415.208, except during the PHE, as defined in the regulation at § 400.200, the services of residents to inpatients of hospitals in which the residents have their approved GME program are not considered separately billable as physicians' services and instead are payable under §§ 413.75 through 413.83 regarding direct GME payments, whether or not the services are related to the approved GME training program. When a resident furnishes services that are not related to their approved GME programs in an outpatient department or emergency department of a hospital in which they have their training program, those services can be billed separately as physicians' services and payable under the PFS if they meet the criteria described in our regulation at § 415.208(b)(2) (i) through (iii). In addition, under § 415.208(c), services of a licensed resident furnished outside the scope of an approved GME program when moonlighting in a hospital or other setting that does not participate in 
                        <PRTPAGE P="50143"/>
                        the approved GME program are payable under the PFS when the resident is fully licensed to practice in the state where the services are furnished, and the resident's time spent in patient care activities in that setting is not counted for the purpose of Medicare direct GME payments.
                    </P>
                    <P>In the March 31st COVID-19 IFC, we amended our regulation at § 415.208 to state that, during the PHE for COVID-19, the services of residents that are not related to their approved GME programs and are furnished to inpatients of a hospital in which they have their training program are separately billable physicians' services for which payment can be made under the PFS provided that the services are identifiable physicians' services and meet the conditions for payment of physicians' services to beneficiaries in providers in § 415.102(a), the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the state in which the services are performed, and the services can be separately identified from those services that are required as part of the approved GME program.</P>
                    <P>We are considering whether this flexibility that we implemented on an interim basis should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. We are concerned that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. However, because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 after the expiration of the PHE, it may be appropriate for us to extend this policy on a temporary basis to meet the needs of teaching hospitals to ensure that there are as many qualified practitioners available as possible. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.</P>
                    <HD SOURCE="HD3">e. Primary Care Exception Policies</HD>
                    <P>The regulation at § 415.174 sets forth an exception to the conditions for PFS payment for services furnished in teaching settings in the case of certain E/M services furnished in certain centers. Under the so-called “primary care exception,” Medicare makes PFS payment in certain teaching hospital primary care centers for certain services of lower and mid-level complexity furnished by a resident without the physical presence of a teaching physician. Section 415.174(a)(3) requires that the teaching physician must not direct the care of more than four residents at a time, and must direct the care from such proximity as to constitute immediate availability (that is, provide direct supervision) and must review with each resident during or immediately after each visit, the beneficiary's medical history, physical examination, diagnosis, and record of tests and therapies. Section 415.174(a)(3) also requires that the teaching physician must have no other responsibilities at the time, assume management responsibility for the beneficiaries seen by the residents, and ensure that the services furnished are appropriate.</P>
                    <P>
                        As provided in the regulation at § 415.174(a), the codes of lower and mid-level complexity that can be furnished under the primary care exception are specified in section 100 of chapter 12 of the Medicare Claims Processing Manual (
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c12.pdf</E>
                        ). They are the following:
                    </P>
                    <P>
                        • CPT code 99201 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family</E>
                        );
                    </P>
                    <P>
                        • CPT code 99202 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: An expanded problem focused history; An expanded problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 20 minutes are spent face-to-face with the patient and/or family</E>
                        );
                    </P>
                    <P>
                        • CPT code 99203 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A detailed history; A detailed examination; Medical decision making of low complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate severity. Typically, 30 minutes are spent face-to-face with the patient and/or family</E>
                        );
                    </P>
                    <P>
                        • CPT code 99211 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services</E>
                        );
                    </P>
                    <P>
                        • CPT code 99212 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self-limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family</E>
                        );
                    </P>
                    <P>
                        • CPT code 99213 (
                        <E T="03">
                            Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: An expanded problem focused history; An expanded problem focused examination; Medical decision making of low complexity. Counseling and coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or 
                            <PRTPAGE P="50144"/>
                            family's needs. Usually, the presenting problem(s) are of low to moderate severity. Typically, 15 minutes are spent face-to-face with the patient and/or family
                        </E>
                        );
                    </P>
                    <P>
                        • HCPCS code G0402 (
                        <E T="03">Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment</E>
                        );
                    </P>
                    <P>
                        • HCPCS code G0438 (
                        <E T="03">Annual wellness visit; includes a personalized prevention plan of service (PPS), initial visit</E>
                        ); and
                    </P>
                    <P>
                        • HCPCS code G0439 (
                        <E T="03">Annual wellness visit, includes a personalized prevention plan of service (PPS), subsequent visit</E>
                        ).
                    </P>
                    <P>In the March 31st COVID-19 IFC, we amended § 415.174 of our regulations to allow, during the PHE for COVID-19, all levels of office/outpatient E/M visits to be furnished by the resident and billed by the teaching physician under the primary care exception. In the May 1st COVID-19 IFC (85 FR 27550 through 27629), we further expanded the list of services included in the primary care exception during the PHE for COVID-19. We also allowed PFS payment to the teaching physician for services furnished by residents via telehealth under the primary care exception if the services were also on the list of Medicare telehealth services.</P>
                    <P>We are considering whether these policies should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent, and are soliciting public comments on whether these policies should continue once the PHE ends. We believe public comment will assist us in identifying appropriate policy continuation decisions that we would consider finalizing in the CY 2021 PFS final rule. We are also considering whether specific services added under the primary care exception should be extended temporarily or made permanent and are soliciting public comment on whether these services should continue as part of the primary care exception once the PHE ends. These services are the following:</P>
                    <P>
                        • CPT code 99204 
                        <E T="03">(Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 45 minutes are spent face-to-face with the patient and/or family);</E>
                    </P>
                    <P>
                        • CPT code 99205 
                        <E T="03">(Office or other outpatient visit for the evaluation and management of a new patient, which requires these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 60 minutes are spent face-to-face with the patient and/or family);</E>
                    </P>
                    <P>
                        • CPT code 99214 
                        <E T="03">(Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A detailed history; A detailed examination; Medical decision making of moderate complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 25 minutes are spent face-to-face with the patient and/or family);</E>
                    </P>
                    <P>
                        • CPT code 99215 
                        <E T="03">(Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A comprehensive history; A comprehensive examination; Medical decision making of high complexity. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are of moderate to high severity. Typically, 40 minutes are spent face-to-face with the patient and/or family);</E>
                    </P>
                    <P>
                        • CPT code 99495 (
                        <E T="03">Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least moderate complexity during the service period; face-to-face visit within 14 calendar days of discharge</E>
                        );
                    </P>
                    <P>
                        • CPT code 99496 (
                        <E T="03">Transitional Care Management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within two business days of discharge; medical decision making of at least high complexity during the service period; face-to-face visit within 7 calendar days of discharge</E>
                        );
                    </P>
                    <P>
                        • CPT code 99421 (
                        <E T="03">Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes</E>
                        );
                    </P>
                    <P>
                        • CPT code 99422 (
                        <E T="03">Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 11-20 minutes</E>
                        );
                    </P>
                    <P>
                        • CPT code 99423 (
                        <E T="03">Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes</E>
                        );
                    </P>
                    <P>
                        • CPT code 99452 (
                        <E T="03">Interprofessional telephone/internet/electronic health record referral service(s) provided by a treating/requesting physician or qualified health care professional, 30 minutes</E>
                        );
                    </P>
                    <P>
                        • CPT code G2012 (
                        <E T="03">Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion</E>
                        ); and
                    </P>
                    <P>
                        • HCPCS code G2010 (
                        <E T="03">Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment</E>
                        ).
                    </P>
                    <P>
                        Expanding the array of services for which Medicare may make PFS payment to the teaching physician when furnished by a resident under the primary care exception was responsive to critical needs during the PHE for patients who may be quarantined at home or who may need to be isolated for purposes of minimizing exposure risk based on presumed or confirmed COVID-19 infection. Because COVID-19 may continue to persist in some communities or some communities may experience a resurgence of COVID-19 
                        <PRTPAGE P="50145"/>
                        after the expiration of the PHE, it may be appropriate for us to extend all of these services on a temporary basis (that is, until the end of the calendar year in which the PHE ends).
                    </P>
                    <P>However, we are concerned that it may be inappropriate to extend all of these services on a temporary basis or add them to the primary care exception permanently. The intent of the primary care exception as described in § 415.174 is that E/M visits of lower and mid-level complexity furnished by residents are simple enough for a teaching physician to be able to direct and manage the care of up to four residents at any given time and direct the care from such proximity as to constitute immediate availability. While CPT code 99421 and HCPCS code G2012 may be simple services, others such as levels 4 and 5 office/outpatient E/M visits (CPT codes 99204 through 99205 and CPT codes 99214 through 99215) and transitional care management codes (CPT codes 99495 through 99496) require medical decision making that is of at least moderate complexity. We are concerned that the teaching physician may not be able to maintain sufficient personal involvement in all of the care to warrant PFS payment for the services being furnished by up to four residents when some or all of the residents might be furnishing services that are more than lower and mid-level complexity. We are also concerned that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision making, the ability to be immediately available to other residents could be compromised, potentially putting patients at risk. Thus, we are considering whether, upon expiration of the PHE, we should extend on a temporary basis some or all of the services we added to the primary care exception list during the PHE and are soliciting public comments on whether these services should continue as part of the primary care exception after the PHE ends. We also invite commenters to provide data and other information on their experiences implementing this policy during the PHE.</P>
                    <P>We are also considering whether our interim final policy that PFS payment could be made to the teaching physician when residents furnish telehealth services under the primary care exception should be extended on a temporary basis or be made permanent, and are soliciting public comments on whether this policy should continue once the PHE ends. In these cases, outside the circumstances of the PHE, the patient would be at the originating site and the resident furnishing the care, along with the teaching physician billing for it, would be located at the primary care center as the distant site practitioner. If we were to temporarily extend or add permanently to the primary care exception services such as e-visits or communication technology-based services, it may also make sense to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth, on the basis that the patient is not physically in the clinic and that these services all involve the use of virtual technology (for example, patient portals for e-visits, telecommunications technology for the office/outpatient E/M visit) to facilitate care delivery. If we were to remove the services that we added to the primary care exception on an interim basis, we could separately consider continuing to permit PFS payment to the teaching physician when the resident furnishes an office/outpatient E/M visit via telehealth because the teaching physician would be immediately available in the distant site clinic with the resident to direct and manage the care.</P>
                    <HD SOURCE="HD3">f. Conclusion</HD>
                    <P>In summary, we remind stakeholders that during the PHE we implemented these policies on an interim basis to support our goals of ensuring beneficiary access to necessary services and maintenance of sufficient workforce capacity through flexibilities afforded to providers to safely furnish services to patients. While we anticipate reverting to our previous teaching physician policy that was in place prior to the PHE for the reasons discussed above, we are considering whether the teaching physician and resident moonlighting policies that we implemented on an interim basis should be extended on a temporary basis (that is, if the PHE ends in 2021, these policies could be extended to December 31, 2021 to allow for a transition period before reverting to status quo policy) or be made permanent policy for CY 2021. We are soliciting public comments on whether these policies should be continued, and if so, whether they should be made permanent, or temporarily extended and the appropriate scope of the extension. As discussed above, we are concerned that the teaching physician may not be able to maintain sufficient personal involvement in all of the care to warrant PFS payment for the services being furnished by up to four residents when some or all of the residents might be furnishing services that are more than lower and mid-level complexity. We are also concerned that when the teaching physician is directing the care of a patient that requires moderate or higher medical decision making, the ability to be immediately available to other residents could be compromised, potentially putting patients at risk. We will also consider under which scenarios our policies for moonlighting or virtual presence as discussed above, should apply, if any. As discussed for our moonlighting policy, we are concerned that there may be risks to program integrity in allowing residents to furnish separately billable physicians' services to inpatients in the teaching hospitals where they are training when the services are outside the scope of their approved GME program. For example, there could be a risk of duplicate Medicare payment for the resident's services under the IPPS for GME and the PFS if the physicians' services furnished by residents were not adequately separately identified from those services that are required as part of the GME program. Under our discussion of virtual presence, we highlighted concerns about how continuing to permit teaching physicians to be involved through their virtual presence may not be sufficient to warrant PFS payment to the teaching physician on a temporary or permanent basis. Absent the circumstances of the PHE, the physical, in-person presence of the teaching physician may be necessary to provide oversight to ensure that care furnished to Medicare beneficiaries is medically reasonable and necessary, and to ensure that the teaching physician renders sufficient personal services to exercise full, personal control of the key portion of the case. We also discussed concerns about patient safety when the teaching physician is only virtually present.</P>
                    <P>
                        We believe public comment, especially those that focus on the variables we identify above regarding the specific services included on the primary exception list, clinical scenarios under which residents could moonlight or furnish certain types of services under the supervision of a teaching physician via virtual presence, will assist us in identifying the appropriate policy continuation decisions after the end of the PHE, which we will consider finalizing in the CY 2021 PFS final rule. As part of our review of public comments, we will weigh and make decisions based on the potential benefits and risks associated with the potential temporary or permanent continuation, in whole or in part, of these policies. The benefits of continuation may include limiting COVID-19 exposure risk for practitioners and patients, increasing workforce capacity of teaching settings 
                        <PRTPAGE P="50146"/>
                        to respond to continuing effects following the PHE as practitioners may be asked to assist with the response, and increasing access so that we do not unintentionally limit the number of licensed practitioners available to furnish services to Medicare beneficiaries, which could have the unintended consequence of limiting access to services paid under the PFS. The risks may include the potential for duplicative payment with Medicare Part A reimbursement for graduate medical education training programs, the potential for increases to cost-sharing for Medicare beneficiaries that could result from additional Part B claims for services furnished by the teaching physician with the involvement of residents, and potential risks to patient safety.
                    </P>
                    <HD SOURCE="HD3">2. Supervision of Diagnostic Tests by Certain NPPs</HD>
                    <P>In response to Executive Order #13890 discussed above, we sought assistance from stakeholders in identifying Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license. In response to our request for feedback discussed above, physician assistants (PAs) and nurse practitioners (NPs) recommended regulatory changes that would allow them to supervise the performance of diagnostic tests because they are currently authorized to do so under their state scope of practice rules in many states. In the May 1st COVID-19 IFC (85 FR 27550 through 27629), we established on an interim basis during the COVID-19 PHE, a policy to permit these and certain other NPPs to supervise diagnostic tests. We now propose to make those changes permanent by making modifications to the regulations at § 410.32. We are planning to address comments we receive on our proposals included in this proposed rule and comments received on the May 1st COVID-19 IFC (85 FR 27550 through 27629) simultaneously in the final rule since the comment period for the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629) recently closed on July 7, 2020.</P>
                    <P>Prior to the COVID-19 PHE, under § 410.32(a)(2), physicians, NPs, CNSs, PAs, certified nurse-midwives (CNMs), clinical psychologists (CPs), and clinical social workers (CSWs) who are treating a beneficiary for a specific medical problem may order diagnostic tests when they use the results of the tests in the management of the beneficiary's specific medical problem. However, generally only physicians were permitted to supervise diagnostic tests. The regulation at § 410.32(b)(1) provided as a basic general rule that all diagnostic tests paid under the PFS must be furnished under an appropriate level of supervision by a physician as defined in section 1861(r) of the Act. Section 410.32(b)(2) then provided for certain exceptions to which this basic rule did not apply. For instance, under § 410.32(b)(2)(v), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by an NP or CNS authorized under applicable state law to furnish the test. (We note that, as for all services furnished by a NP or CNS, they would have to be furnished working in collaboration with a physician as provided in regulations at §§ 410.75 and 410.76, respectively). Similarly, under the regulation at § 410.32(b)(2)(vii), the requirement that diagnostic tests must be furnished under the appropriate level of supervision by a physician did not apply for tests performed by a CNM authorized under applicable state law to furnish the test. This exception is in place because the Medicare statute does not include any physician supervision requirement for CNM services. Thus, while NPs, CNSs, PAs, and CNMs were permitted to furnish diagnostic tests to the extent they were authorized under state law and their scope of practice to do so, the regulations at § 410.32 did not address whether these practitioners could supervise others who furnished diagnostic tests.</P>
                    <P>In light of stakeholder feedback to CMS on identifying additional Medicare regulations that contain more restrictive supervision requirements than existing state scope of practice laws, or that limit health professionals from practicing at the top of their license, effective January 1, 2021, we are proposing to amend the basic rule under the regulation at § 410.32(b)(1) to allow NPs, CNSs, PAs or CNMs to supervise diagnostic tests on a permanent basis as allowed by state law and scope of practice. These NPPs have separately enumerated benefit categories under Medicare law that permit them to furnish services that would be physician's services if furnished by a physician, and are authorized to receive payment under Medicare Part B for the professional services they furnish either directly or “incident to” their own professional services, to the extent authorized under state law and scope of practice.</P>
                    <P>We are proposing to amend the regulation at § 410.32(b)(2)(iii)(B) on a permanent basis to specify that supervision of diagnostic psychological and neuropsychological testing services can be done by NPs, CNS's, PAs or CNMs to the extent that they are authorized to perform the tests under applicable State law and scope of practice, in addition to physicians and CPs who are currently authorized to supervise these tests. We are also proposing to amend on a permanent basis, the regulation at § 410.32 to add paragraph (b)(2)(ix) to specify that diagnostic tests performed by a PA in accordance with their scope of practice and State law do not require the specified level of supervision assigned to individual tests, because the relationship of PAs with physicians under § 410.74 would continue to apply. We are also proposing to make permanent the removal of the parenthetical, previously made as part of the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629), at § 410.32(b)(3) that required a general level of physician supervision for diagnostic tests performed by a PA.</P>
                    <HD SOURCE="HD3">3. Pharmacists Providing Services Incident to Physicians' Services</HD>
                    <P>Stakeholders have asked us to clarify that pharmacists can provide services incident to the professional services of a physician or other NPP just as other clinical staff may do. These stakeholders have asked us, in particular, about pharmacists who provide medication management services. Medication management is covered under both Medicare Part B and Part D. We are reiterating the clarification we provided in the May 1st COVID-19 IFC (85 FR 27550 through 27629), that pharmacists fall within the regulatory definition of auxiliary personnel under our regulations at § 410.26. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist's state scope of practice and applicable state law.</P>
                    <P>
                        We note that when a pharmacist provides services that are paid under the Part D benefit, the services are not also reportable or paid for under Part B. In addition to circumstances where medication management is offered as part of the Part D benefit, Part B payment is also not available for services included in the Medicare Part D dispensing fees, such as a pharmacist's time in checking the computer for information about an individual's coverage, measurement or 
                        <PRTPAGE P="50147"/>
                        mixing of the covered Part D drug, filling the container, physically providing or delivering the completed prescription to the Part D enrollee. Similarly, performing required quality assurance activities consistent with § 423.153(c)(2), such as screening for potential drug therapy problems due to therapeutic duplication, age/gender-related contraindications, potential over-utilization and under-utilization, drug-drug interactions, incorrect drug dosage or duration of drug therapy, drug-allergy contraindications, and clinical abuse/misuse are considered part of dispensing fees under Part D and are not separately reportable services under Part B. Additionally, services and supplies paid under the incident to benefit must be an integral, though incidental, part of the service of a physician (or other practitioner) in the course of diagnosis or treatment of an injury or illness (§ 410.26). We also note that our manual provisions specify that “incident to” services must be of a type that are medically appropriate to provide in the office setting; and that where a physician supervises auxiliary personnel to assist him or her in rendering services to patients and includes the charges for their services in his or her own bills, the services of such personnel are considered incident to the physicians' service if there is a physicians' service rendered to which the services of such personnel are an incidental part and there is direct supervision by the physician (section 60.1 of chapter 15 of the Medicare Benefit Policy Manual (Pub. 100-02) available on the CMS website at 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf</E>
                        ).
                    </P>
                    <P>Although it is fully consistent with current CMS policy for pharmacists to provide services incident to the services of the billing physician or NPP, we believe this clarification may encourage pharmacists to work with physicians and NPPs in new ways where pharmacists are working at the top of their training, licensure and scope of practice. It may free up the time of physicians and NPPs for other work and increase access to medication management services, for individuals with chronic conditions and other conditions. As an example, we found that this clarification was helpful in recently addressing in the May 1st COVID-19 IFC (85 FR 27550 through 27629), the ability of pharmacies to enroll as laboratories and work with physicians in the assessment of clinical information, specimen collection and reporting results of COVID-19 clinical diagnostic laboratory tests.</P>
                    <HD SOURCE="HD3">4. Provision of Maintenance Therapy by Therapy Assistants</HD>
                    <P>In response to our request for feedback on scope of practice (noted above), consistent with Executive Order #13890, respondents requested that we allow physical therapist assistants (PTAs) and occupational therapy assistants (OTAs) to furnish maintenance therapy services associated with a maintenance program. The respondents said that our Part B therapy policy is not consistent with policies for these services when provided to patients in the skilled nursing facility (SNF) and home health (HH) settings paid under Part A. Other respondents told us that because the therapist is responsible for a patient's care over an episode, that this should include assigning responsibilities for maintenance therapy to an assistant when it is clinically appropriate. Some respondents stated that permitting PTAs and OTAs to furnish maintenance therapy services would give Medicare patients greater access to care and permit therapists and therapy providers more flexibility for resource utilization.</P>
                    <P>After considering respondents' concerns about the incongruity between our Part B and Part A maintenance therapy policy, and to provide flexibility to increase the availability of needed health care services during the COVID-19 PHE, we amended our policy on an interim final basis in the May 1st COVID-19 IFC (85 FR 27550 through 27629) to allow the physical therapist (PT) or occupational therapist (OT) who established the maintenance program to assign the duties to a PTA or OTA, as clinically appropriate, to perform maintenance therapy services.</P>
                    <P>We explained that making this change could free-up the PT or OT to furnish other services, particularly those related to the COVID-19 PHE that require a therapist's assessment and evaluation skills, and including the CTBS, that is, e-visits, virtual visits, remote evaluations, and phone evaluations—that were added as “sometimes therapy” services in the March 31st COVID-19 IFC for PTs, OTs and speech-language pathologists (SLPs). We stated explicitly that the maintenance therapy services furnished by therapist-supervised OTAs and PTAs will be paid in the same manner as those we already pay for as rehabilitative therapy services, and referred the reader to regulatory payment conditions for Part B outpatient occupational and physical therapy services (§§ 410.59 and 410.60, respectively) that require, as a basic rule, that the services be provided by an individual meeting qualifications in 42 CFR part 484 for an OT or PT, or an appropriately supervised OTA or PTA.</P>
                    <P>In this proposed rule, we are proposing to make permanent our Part B policy for maintenance therapy services effective January 1, 2021 in order to create greater conformity in payment policy for maintenance therapy services that are furnished and paid under Part B with those in SNF and HH settings under Part A. If adopted, our policy would dovetail with our amended policy set forth in the May 1st COVID-19 IFC (85 FR 27550 through 27629) that grants PTs and OTs the discretion to delegate maintenance therapy services to the PTAs and OTAs, as clinically appropriate, for the duration of the PHE. If the PHE is ended prior to January 1, 2021, the therapist would need to personally furnish the maintenance therapy services until the proposed policy change takes effect. We plan to address comments from the May 1st COVID-19 IFC in conjunction with the comments from this proposed rule in the final rule, given the comment period has only just closed on that IFC.</P>
                    <P>
                        Our policy for maintenance therapy services is explained in section 220.2 of chapter 15 of the Medicare Benefit Policy Manual (see 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf</E>
                        ) in cases where rehabilitative services, requiring the improvement in the patient's functional status, are no longer or were not previously covered. This manual section explains that skilled therapy services related to a reasonable and necessary maintenance program are available for the establishment or design of the maintenance program and the delivery of the maintenance program, that is, maintenance therapy, when it needs to be carried out as maintenance therapy services. Maintenance programs that can be carried out by the patient alone or with the assistance of caregivers, are not covered. Sections 230.1 and 230.2 of chapter 15 of the Medicare Benefit Policy Manual specify that a PTA or OTA may not provide skilled maintenance program services.
                    </P>
                    <P>
                        In considering our proposal, we reviewed regulatory requirements for conditions of payment for outpatient occupational therapy, physical therapy, and speech-language pathology services at §§ 410.59, 410.60 and 410.62; the regulation for therapy treatment plans at § 410.61, and the regulations specifying treatment plan certification and recertification requirements at § 424.24 for Part B occupational therapy, physical therapy, and speech-language 
                        <PRTPAGE P="50148"/>
                        pathology services, in addition to the above mentioned manual provisions.
                    </P>
                    <P>Given that we already make payment for rehabilitative services requiring improvement in the patient's functional status when they are furnished by PTAs and OTAs at the discretion of the supervising therapist treating the patient in accordance with the therapist-established plan of care, we believe that it would be appropriate for the therapist to use that same judgement in deciding whether to delegate to the PTA or OTA the performance of maintenance therapy services under the associated plan of care. We believe that there is little difference between the rehabilitative therapy services furnished to improve a patient's functional status and those for maintenance therapy services other than the goals set by the therapist in the therapy plan that are aimed to maintain, slow or prevent further decline of a patient's condition. We do not believe that the therapist-only maintenance therapy requirement is needed in the case of outpatient physical or occupational therapy services, and instead believe that it would be appropriate for an OT or PT to be permitted to use their professional judgement to assign the performance of maintenance therapy services to an OTA or PTA when it is clinically appropriate to do so.</P>
                    <P>As such, we propose to allow, on a permanent basis, therapists to delegate performance of maintenance therapy services to an OTA or PTA for outpatient occupational and physical therapy services in Part B settings beginning January 1, 2021. This proposal would better align our Part B policy with that in SNFs and HH paid under Part A where maintenance therapy services may be performed by a therapist or a therapy assistant. Since our regulations at §§ 410.59, 410.60, 410.61, 410.62 and 424.24, do not now distinguish between rehabilitative and maintenance therapy services, we are not proposing to amend them. Instead, we propose to revise sections 220.2, 230.1 and 230.2 of chapter 15 of the Medicare Benefit Policy Manual to clarify that PTs and OTs no longer need to personally perform maintenance therapy services and to specifically remove the prohibitions on PTAs and OTAs from furnishing such services. Therefore, we believe our proposal to allow PTs and OTs to delegate maintenance therapy services to their supervised assistants is in keeping with Executive Order #13890 and appeals by respondents to our request for feedback on scope of practice that followed, rather than the alternative option of maintaining the pre-COVID-19 policy of requiring PTs and OTs to personally furnish them, after the COVID-19 PHE is ended.</P>
                    <P>We note that therapists and therapy providers should consult the CQ and CO modifier policies to consider whether these modifiers should be applied to claims for services furnished in whole or in part by PTAs and OTAs which will, beginning January 1, 2022, be paid at 85 percent of the amount that would otherwise apply for the service, as required by section 1834(v) of the Act which was added by section 53107 of the Bipartisan Budget Act of 2018. See the CY 2020 PFS rulemaking for policies related to the application of CQ and CO modifiers and the associated regulatory requirements (84 FR 40558 through 40564 (proposed rule) and 84 FR 62702 through 60708 (final rule)).</P>
                    <HD SOURCE="HD3">5. Medical Record Documentation</HD>
                    <P>As we established in the CY 2020 PFS final rule (84 FR 62681 through 62684), and similarly expressed in the May 1st COVID-19 IFC (85 FR 27556 through 27557), any individual who is authorized under Medicare law to furnish and bill for their professional services, whether or not they are acting in a teaching role, may review and verify (sign and date) the medical record for the services they bill, rather than re-document, notes in the medical record made by physicians, residents, nurses, and students (including students in therapy or other clinical disciplines), or other members of the medical team. We note that although there are currently no documentation requirements that would impact payment for PTs, OTs, or SLPs when documentation is added to the medical record by persons other than the therapist, we are responding in this proposed rule to stakeholder requests for clarification. Specifically, we are clarifying that the broad policy principle that allows billing clinicians to review and verify documentation added to the medical record for their services by other members of the medical team also applies to therapists. This will help ensure that therapists are able to spend more time furnishing therapy services, including pain management therapies to patients that may minimize the use of opioids and other medications, rather than spending time documenting in the medical record. We emphasize that, while any member of the medical team may enter information into the medical record, only the reporting clinician may review and verify notes made in the record by others for the services the reporting clinician furnishes and bills. We also emphasize that information entered into the medical record should document that the furnished services are reasonable and necessary.</P>
                    <HD SOURCE="HD2">H. Valuation of Specific Codes</HD>
                    <HD SOURCE="HD3">1. Background: Process for Valuing New, Revised, and Potentially Misvalued Codes</HD>
                    <P>Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011, and revised MP RVUs in CY 2010 and CY 2015. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.C. of this proposed rule, Potentially Misvalued Services under the PFS. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule with comment period for a year. Then, during the 60-day period following the publication of the final rule with comment period, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.</P>
                    <P>
                        In the CY 2015 PFS final rule with comment period (79 FR 67547), we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the new process was applicable to all codes, except for new codes that describe truly 
                        <PRTPAGE P="50149"/>
                        new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period (81 FR 80170), we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period (80 FR 70886), and re-proposed values for those codes in the CY 2017 PFS proposed rule.
                    </P>
                    <P>We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values.</P>
                    <P>As part of our obligation to establish RVUs for the PFS, we thoroughly review and consider available information including recommendations and supporting information from the RUC, the Health Care Professionals Advisory Committee (HCPAC), public commenters, medical literature, Medicare claims data, comparative databases, comparison with other codes within the PFS, as well as consultation with other physicians and healthcare professionals within CMS and the federal government as part of our process for establishing valuations. Where we concur that the RUC's recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we proposed those values as recommended. Additionally, we continually engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes, and as we prioritize our obligation to value new, revised, and potentially misvalued codes. We continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process.</P>
                    <HD SOURCE="HD3">2. Methodology for Establishing Work RVUs</HD>
                    <P>For each code identified in this section, we conduct a review that includes the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs generally include, but have not been limited to, a review of information provided by the RUC, the HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalks to key reference or similar codes, and magnitude estimation (see the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329) for more information). When referring to a survey, unless otherwise noted, we mean the surveys conducted by specialty societies as part of the formal RUC process.</P>
                    <P>Components that we use in the building block approach may include preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. We use the building block methodology to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we frequently utilize an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we refine the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.</P>
                    <P>Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently, there are preservice time packages for services typically furnished in the facility setting (for example, preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.</P>
                    <P>We developed several standard building block methodologies to value services appropriately when they have common billing patterns. In cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.</P>
                    <P>Accordingly, in cases where we believe that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.</P>
                    <P>
                        Therefore, in many cases when we remove 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we do not believe the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.
                        <PRTPAGE P="50150"/>
                    </P>
                    <P>The following paragraphs contain a general discussion of our approach to reviewing RUC recommendations and developing proposed values for specific codes. When they exist we also include a summary of stakeholder reactions to our approach. We note that many commenters and stakeholders have expressed concerns over the years with our ongoing adjustment of work RVUs based on changes in the best information we had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we used to make the adjustments is derived from their survey process. We are obligated under the statute to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.</P>
                    <P>We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have started by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs do not appear to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we sometimes use the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.</P>
                    <P>In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe were not otherwise reflected in the RUC-recommended value. If we believe that such changes in time are already accounted for in the RUC's recommendation, then we do not make such adjustments. Likewise, we do not arbitrarily apply time ratios to current work RVUs to calculate proposed work RVUs. We use the ratios to identify potential work RVUs and consider these work RVUs as potential options relative to the values developed through other options.</P>
                    <P>We do not imply that the decrease in time as reflected in survey values should always equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we believe that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC's recommendation has appeared to disregard or dismiss the changes in time, without a persuasive explanation of why such a change should not be accounted for in the overall work of the service, then we have generally used one of the aforementioned methodologies to identify potential work RVUs, including the methodologies intended to account for the changes in the resources involved in furnishing the procedure.</P>
                    <P>Several stakeholders, including the RUC, have expressed general objections to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed general concerns with CMS refinements to RUC-recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277), we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule (81 FR 46162), we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives. As described earlier in this section, crosswalks to key reference or similar codes are one of the many methodological approaches we have employed to identify potential values that reconcile the RUC-recommend work RVUs with the recommended time values when the RUC-recommended work RVUs did not appear to account for significant changes in time.</P>
                    <P>
                        We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes; and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to the detailed discussion in this section of the valuation considered for specific codes. Table 24 contains a list of codes and descriptors for which we are proposing work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2020. The proposed work RVUs, work time and other payment information for all CY 2021 payable codes are available on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html</E>
                        ).
                    </P>
                    <HD SOURCE="HD3">3. Methodology for the Direct PE Inputs To Develop PE RVUs</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>
                        On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct 
                        <PRTPAGE P="50151"/>
                        PE inputs and refine the inputs accordingly.
                    </P>
                    <P>Our review and refinement of the RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 25 details our refinements of the RUC's direct PE recommendations at the code-specific level. In section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), we address certain refinements that would be common across codes. Refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.35 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. We also note that approximately half of the refinements listed in Table 25 result in changes under the $0.35 threshold and are unlikely to result in a change to the RVUs.</P>
                    <P>
                        We also note that the direct PE inputs for CY 2021 are displayed in the CY 2021 direct PE input files, available on the CMS website under the downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                         The inputs displayed there have been used in developing the CY 2021 PE RVUs as displayed in Addendum B.
                    </P>
                    <HD SOURCE="HD3">b. Common Refinements</HD>
                    <HD SOURCE="HD3">(1) Changes in Work Time</HD>
                    <P>Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.</P>
                    <HD SOURCE="HD3">(2) Equipment Time</HD>
                    <P>Prior to CY 2010, the RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general guidelines regarding appropriate equipment time inputs. We appreciate the RUC's willingness to provide us with these additional inputs as part of its PE recommendations.</P>
                    <P>In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up postoperative visits included in the global period for a service, the equipment time would also reflect that use.</P>
                    <P>We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).</P>
                    <HD SOURCE="HD3">(3) Standard Tasks and Minutes for Clinical Labor Tasks</HD>
                    <P>In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there is a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.</P>
                    <P>We refer readers to section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units (PE RVUs), for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.</P>
                    <HD SOURCE="HD3">(4) Recommended Items That Are Not Direct PE Inputs</HD>
                    <P>In some cases, the PE worksheets included with the RUC's recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.</P>
                    <HD SOURCE="HD3">(5) New Supply and Equipment Items</HD>
                    <P>
                        The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. However, some recommendations include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the 
                        <PRTPAGE P="50152"/>
                        specialty societies to provide us copies of sales invoices. For CY 2021 we received invoices for several new supply and equipment items. Tables 27 and 28 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this proposed rule, Determination of Practice Expense Relative Value Units, we encouraged stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encouraged stakeholders to submit invoices or other information to improve the accuracy of pricing for these items in the direct PE database by February 10th of the following year for consideration in future rulemaking, similar to our process for consideration of RUC recommendations.
                    </P>
                    <P>We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 27 and 28 also include the number of invoices received and the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.</P>
                    <P>In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the final PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.</P>
                    <HD SOURCE="HD3">(6) Service Period Clinical Labor Time in the Facility Setting</HD>
                    <P>Generally speaking, our direct PE inputs do not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address code-specific refinements to clinical labor in the individual code sections.</P>
                    <HD SOURCE="HD3">(7) Procedures Subject to the Multiple Procedure Payment Reduction (MPPR) and the OPPS Cap</HD>
                    <P>
                        We note that the public use files for the PFS proposed and final rules for each year display the services subject to the MPPR for diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services, and therapy services. We also include a list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2021 are available on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                         For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule with comment period (78 FR 74261 through 74263). For more information regarding the history of the OPPS cap, we refer readers to the CY 2007 PFS final rule with comment period (71 FR 69659 through 69662).
                    </P>
                    <HD SOURCE="HD3">4. Proposed Valuation of Specific Codes for CY 2021</HD>
                    <HD SOURCE="HD3">(1) Fine Needle Aspiration (CPT Codes 10021, 10004, 10005, 10006, 10007, 10008, 10009, 10010, 10011, and 10012)</HD>
                    <P>
                        In June 2017, the CPT Editorial Panel deleted CPT code 10022, revised CPT code 10021, and created nine new codes to describe fine needle aspiration procedures with and without imaging guidance. These ten codes were surveyed and reviewed for the October 2017 and January 2018 RUC meetings. In the CY 2019 final rule, we finalized the RUC-recommended work RVU for seven of the ten codes in the family, while finalizing a lower work RVU for CPT codes 10005 (
                        <E T="03">Fine needle aspiration biopsy, including ultrasound guidance; first lesion</E>
                        ), 10009 (
                        <E T="03">Fine needle aspiration biopsy, including CT guidance; first lesion</E>
                        ), and 10021 (
                        <E T="03">Fine needle aspiration biopsy, without imaging guidance; first lesion</E>
                        ). For a full discussion of this review, we refer readers to the CY 2019 PFS final rule (83 FR 59517 through 59521).
                    </P>
                    <P>Following the publication of the CY 2019 final rule, RUC staff stated that CMS erroneously double-counted the utilization for new codes that had image guidance bundled. We disagreed that this constituted a technical error and communicated to the RUC in conversations following the publication of the rule that the surveying specialties could instead nominate the affected codes from these families as being potentially misvalued. At the January 2020 RUC meeting, the RUC reaffirmed its CY 2019 recommendations for physician work and direct practice expense (PE) for the ten codes in the Fine Needle Aspiration code family.</P>
                    <P>
                        In discussing this group of codes, we would like to clarify again that we disagree with the RUC and do not believe that utilization was erroneously double-counted for this code family. We publish our proposed utilization crosswalk each year as a public use file available on the CMS website; the current such file is available under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.</E>
                         During the CY 2019 rule cycle, we proposed the utilization crosswalk for the Fine Needle Aspiration family as it was recommended to CMS by the RUC, and we did not receive any comments on this subject until after the valuation of these codes had been finalized. We proposed and finalized the utilization crosswalk for this code family as recommended by the RUC without receiving any comments from the RUC or other stakeholders. If the RUC or other stakeholders believed that what CMS had proposed was incorrect or misunderstood what the RUC had recommended, there was an opportunity to comment during the 60 days following the publication of the proposed rule. We disagree that the utilization crosswalk was erroneous, and we did not make a technical correction following the publication of the CY 2019 final rule for this reason.
                    </P>
                    <P>
                        We also disagree with the RUC that the utilization crosswalk was “the 
                        <PRTPAGE P="50153"/>
                        principle reason CMS rejected the RUC recommendations” for the codes in the Fine Needle Aspiration family, as stated in the RUC's CY 2021 recommendations for this code family. As we stated in the CY 2019 proposed rule and restated in the CY 2019 final rule, our refinements to the work RVUs of CPT codes 10021, 10005, and 10009 were primarily based on changes in surveyed work time and the relationship between the codes in the family. For example, this was our rationale for refining the work RVU of CPT code 10021 from the RUC-recommended value of 1.20 to the finalized value of 1.03: In reviewing CPT code 10021, we noted that the recommended intraservice time is decreasing from 17 minutes to 15 minutes (12 percent reduction), and the recommended total time is decreasing from 48 minutes to 33 minutes (32 percent reduction); however, the RUC-recommended work RVU is only decreasing from 1.27 to 1.20, which is a reduction of just over 5 percent. In the case of CPT code 10021, we believed that it was more accurate to propose a work RVU of 1.03 based on a crosswalk to CPT code 36440 to account for these decreases in the surveyed work time (83 FR 59518). We note that this primary rationale for refining the work RVU did not mention the utilization crosswalk at all.
                    </P>
                    <P>When we communicated to the RUC following the publication of the CY 2019 final rule that the codes in the Fine Needle Aspiration family could be nominated as potentially misvalued, we indicated that we were open to receiving new information about the valuation of these codes. In reaffirming its recommendations from CY 2019, however, the RUC has not provided any new information that was not already presented for the previous CMS review of these codes. Therefore, we are not proposing any changes to the codes in the Fine Needle Aspiration family, as the reaffirmed CY 2021 RUC recommendations are identical to the CY 2019 RUC recommendations that already went through notice and comment rulemaking. We welcome the submission of new information regarding these services that was not part of the previous CY 2019 review of the code family.</P>
                    <HD SOURCE="HD3">(2) Tissue Expander Other Than Breast (CPT Code 11960)</HD>
                    <P>This service was included in a larger group of similarly related codes that were recommended for review for the October 2019 RUC meeting. The RUC recommended to re-review this code at a more granular level for the January 2020 RUC meeting.</P>
                    <P>We disagree with the RUC-recommended work RVU of 12.40 for CPT code 11960 (tissue expander other than breast). We are proposing to maintain the current work RVU of 11.49 supported by a reference code, CPT code 45560 (repair of rectocele (separate procedure)), which has a work RVU of 11.50. CPT code 45560 shares the same intraservice time of 90 minutes with CPT code 11960 and has a slightly higher total time of 367 minutes. The recommended total time for CPT code 11960 decreased from 444 minutes to 357 minutes, with a slight increase in intraservice time of 78 minutes to 90 minutes. We believe the similar work RVU of the reference CPT code 45560, as well as the reduction in total time, supports maintaining the current work RVU of 11.49 for CPT code 11960. We are proposing the RUC-recommended direct PE inputs for CPT code 11960 without refinements.</P>
                    <HD SOURCE="HD3">(3) Breast Implant-Expander Placement (CPT Codes 11970, 19325, 19340, 19342, and 19357)</HD>
                    <P>These services were included in a larger group of 22 breast reconstruction and similarly related codes that were recommend for survey for the October 2019 RUC meeting. At the October 2019 RUC meeting, these codes were recommended for a more granular review for the January 2020 RUC meeting.</P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 8.01 for CPT code 11970 (
                        <E T="03">replacement of tissue expander with permanent implant</E>
                        ). We are proposing a work RVU of 7.49 supported by a reference code CPT code 35701 (
                        <E T="03">exploration not followed by surgical repair, artery; neck (e.g., carotid, subclavian)</E>
                        ), which has a work RVU of 7.50. CPT code 35701 shares the same intraservice time of 60 minutes with CPT code 11970 and has a slightly higher total time of 229 minutes as compared to 216 minutes. In addition, during our review of CPT code 11970, we noted that the recommended intraservice time is decreasing from 78 minutes to 60 minutes and the recommended total time of 231 minutes is decreasing to 216 minutes. We also note that our proposed work RVU of 7.49 for CPT code 11970 is equal to the total time ratio amount, which is the current total time compared to the RUC-recommended total time. We are proposing the RUC-recommended direct PE inputs for CPT code 11970.
                    </P>
                    <P>We disagree with the RUC-recommended work RVU of 8.64 for CPT code 19325 (breast augmentation with implant). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 19325 is equivalent to the RUC-recommended interval of 0.63 RVUs. Therefore, we are proposing a work RVU of 8.12 for CPT code 19325, based on the recommended interval of 0.63 additional RVUs above our proposed work RVU of 7.49 for CPT code 11970. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We are also supporting our proposed work RVU of 8.12 based on a reference code, CPT code 25652 (open treatment of ulnar styloid fracture). CPT code 25652 shares the same intraservice time of 60 minutes and the same total time of 225 minutes with a lower work RVU of 8.06. In addition, during our review of CPT code 19325, we noted that the total time has decreased from 244 minutes to 225 minutes and the intraservice time has decreased from 90 minutes to 60 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19325.</P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 11.00 for CPT code 19340 (
                        <E T="03">insertion of breast implant on same day of mastectomy (i.e. immediate)</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19325 and 19340 is equivalent to the RUC-recommended interval of 2.36 RVUs. Therefore, we are proposing a work RVU of 10.48 for CPT code 19340, based on the recommended interval of 2.36 additional RVUs above our proposed work RVU of 8.12 for CPT code 19325. We are also supporting our proposed work RVU of 10.48 based on a reference code, CPT code 47562 (
                        <E T="03">laparoscopy, surgical; cholecystectomy</E>
                        ). CPT code 47562 shares the same intraservice time of 80 minutes and only a slightly lower total time of 251 minutes with a similar work RVU of 10.47. In addition, during our review of CPT code 19340, we noted that the total time has decreased from 366 minutes to 261 minutes and the intraservice time has decreased from 120 minutes to 80 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19340.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 11.00 for CPT code 19342 (
                        <E T="03">insertion or replacement of breast implant on different day from mastectomy</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work 
                        <PRTPAGE P="50154"/>
                        between CPT codes 19325 and 19342 is equivalent to the RUC-recommended interval of 2.36 RVUs. Therefore, we are proposing a work RVU of 10.48 for CPT code 19342, based on the recommended interval of 2.36 additional RVUs above our proposed work RVU of 8.12 for CPT code 19325. We also note that the RUC-recommended work RVU of 11.00 is equal to the RUC-recommended work RVU for CPT code 19340 because they have stated that both services involve an identical amount of physician work and similar times. We are also supporting our proposed work RVU of 10.48 based on a reference code, CPT code 47562 
                        <E T="03">(laparoscopy, surgical; cholecystectomy</E>
                        ). CPT code 47562 shares the same intraservice time of 80 minutes and only a slightly lower total time of 251 minutes with a similar work RVU of 10.47. The total time for CPT code 19342 has decreased from 320 minutes to 252 minutes and the intraservice time has decreased from 115 minutes to 80 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19342.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 15.36 for CPT code 19357 (
                        <E T="03">tissue expander placement in breast reconstruction, including subsequent expansion</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 19357 is equivalent to the RUC-recommended interval of 7.35 RVUs. Therefore, we are proposing a work RVU of 14.84 for CPT code 19357, based on the recommended interval of 7.35 additional RVUs above our proposed work RVU of 7.49 for CPT code 11970. We are also supporting our proposed work RVU of 14.84 based on a reference code, CPT code 37605 (
                        <E T="03">ligation; internal or common carotid artery</E>
                        ). CPT code 37605 shares the same intraservice time of 90 minutes and only a slightly lower total time of 342 minutes with a lower work RVU of 14.28. In addition, during our review of CPT code 19357, we noted that the total time has decreased from 468 minutes to 344 minutes and the intraservice time has decreased from 110 minutes to 90 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19357.
                    </P>
                    <HD SOURCE="HD3">(4) Breast Implant-Expander Removal (CPT Codes 11971, 19328, and 19330)</HD>
                    <P>These services were included in a group of codes that were recommended for survey for the October 2019 RUC meeting as part of a large group of 22 breast reconstruction and similarly related services. At the October 2019 RUC meeting, they agreed that a 22 code family was too expansive. They recommended these codes be re-reviewed as part of a smaller and more granular code family for the January 2020 RUC meeting.</P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 7.02 for CPT code 11971 (
                        <E T="03">removal of tissue expander w/out insertion of implant</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 11970 and 11971 is equivalent to the RUC recommended interval of 0.99 RVUs. Therefore, we are proposing a work RVU of 6.50 for CPT code 11971, based on the recommended interval of 0.99 RVUs below our proposed work RVU of 7.49 for CPT code 11970. We note that as stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within families of similarly revised codes. We are also supporting our proposed work RVU of 6.50 based on a reference code, CPT code 25671 (
                        <E T="03">percutaneous skeletal fixation of distal radioulnar dislocation</E>
                        ). CPT code 25671 shares the same intraservice time of 45 minutes and a slightly less total time of 210 minutes with a very similar work RVU of 6.46. In addition, during our review of CPT code 11971, we noted that the total time has decreased from 303 minutes to 215 minutes and the intraservice time has decreased from 90 to 45 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 11971.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 7.44 for CPT code 19328 (
                        <E T="03">removal of intact breast implant</E>
                        ). Although we disagree with the RUC-recommended work RVU, we propose increasing the current work RVU from 6.48 to 6.92 to account for the increases in total and intraservice time. We also concur that the relative difference in work between CPT codes 11971 and 19328 is equivalent to the RUC recommended interval of 0.42 RVUs. Therefore, we are proposing a work RVU of 6.92 for CPT code 19328, based on the recommended interval of 0.42 additional RVUs above our proposed work RVU of 6.50 for CPT code 11970. We are also supporting our proposed work RVU of 6.92 based on a reference code, CPT code 28289 (
                        <E T="03">Hallux rigidus correction with cheilectomy, debridement and capsular release of the first metatarsophalangeal joint; without implant</E>
                        ). CPT code 28289 shares the same intraservice time of 45 minutes and a slightly higher total time of 210 minutes with a very similar work RVU of 6.90. The total time for CPT code 19328 has increased from 173 minutes to 199 minutes and the intraservice time has increased from 38 to 45 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19328.
                    </P>
                    <P>
                        We are proposing the RUC-recommended work RVU of 9.00 for CPT code 19330 (
                        <E T="03">removal of ruptured breast implant, including implant contents</E>
                        ). The survey total time for CPT code 19330 has increased from 218 minutes to 229 minutes and the intraservice time has increased from 62 minutes to 75 minutes. We are also proposing the RUC-recommended direct PE inputs for this code without refinements.
                    </P>
                    <HD SOURCE="HD3">(5) Modified Radical Mastectomy (CPT Code 19307)</HD>
                    <P>
                        The RUC recommended that CPT code 19307 (
                        <E T="03">Mastectomy, modified radical, including axillary lymph nodes, with or without pectoralis minor muscle, but excluding pectoralis major muscle</E>
                        ) be surveyed for the January 2020 RUC meeting for site of service anomaly. The Relativity Assessment Workgroup identified services performed less than 50 percent of the time in the inpatient setting yet included inpatient hospital E/M services within the global period and with 2018 Medicare utilization over 5,000. The RUC recommended lowering the work RVU to 17.99 which is the survey 25th percentile.
                    </P>
                    <P>We are proposing the RUC-recommended work RVUs of 17.99 for CPT code 19307. We are also proposing the RUC-recommended direct PE inputs for this code.</P>
                    <HD SOURCE="HD3">(6) Breast Lift-Reduction (CPT Codes 19316 and 19318)</HD>
                    <P>
                        These services were included in a larger code group of similarly related services that were recommended for review for the October 2019 RUC meeting. CPT code 19316 (
                        <E T="03">mastopexy</E>
                        ) and CPT code 19318 (
                        <E T="03">Breast reduction</E>
                        ) were then recommended for a more granular review for the January 2020 RUC meeting.
                    </P>
                    <P>
                        We are proposing the RUC-recommended work RVU of 11.09 for CPT code 19316 (
                        <E T="03">mastopexy</E>
                        ) and 16.03 for CPT code 19318 (
                        <E T="03">Breast reduction</E>
                        ). We are proposing the RUC-recommended direct PE inputs for this code family without refinements.
                    </P>
                    <HD SOURCE="HD3">(7) Secondary Breast Mound Procedure (CPT Codes 19370, 19371, and 19380)</HD>
                    <P>
                        These services were included in a large group of breast reconstruction codes that were recommended to be surveyed for the October 2019 RUC meeting. At the October 2019 RUC meeting, the RUC concurred with the 
                        <PRTPAGE P="50155"/>
                        more granular code families but recommended these codes be re-surveyed for the January 2020 RUC meeting.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 10.0 for CPT code 19370 (
                        <E T="03">Revision of peri-implant capsule, breast, including capsulorrhaphy, and/or partial capsulectomy</E>
                        ). We are proposing to maintain the current work RVU of 9.17 based on a supporting reference code, CPT code 28299 (
                        <E T="03">Correction, hallux valgus (bunionectomy</E>
                        ), with sesamoidectomy, when performed; with double osteotomy, any method), which has a work RVU of 9.29. CPT code 28299 shares a similar intraservice time of 75 minutes with CPT code 19370 and has a slightly higher total time of 256 minutes. In addition, we noted during our review of CPT code 19370 that the recommended total time has increased minimally from 253 minutes to 255 minutes, with a slight decrease in intraservice time of 82 minutes to 78 minutes. We believe the similar work RVU of the supporting CPT code 28299, as well as the minimal changes in physician work time for CPT code 19370, supports maintaining the current work RVU of 9.17. We are proposing the RUC-recommended direct PE inputs for CPT code 19370 without refinements.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 10.81 for CPT code 19371 (
                        <E T="03">Peri-implant capsulectomy, breast, complete, including removal of all intra-capsular contents</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19370 and 19371 is equivalent to the RUC recommended interval of 0.81 RVUs. Therefore, we are proposing a work RVU of 9.98 for CPT code 19371, based on the recommended interval of 0.81 additional RVUs above our proposed work RVU of 9.17 for CPT code 19370. We note that as stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We are also supporting our proposed work RVU of 9.98 based on a reference code, CPT code 25628 (
                        <E T="03">Open treatment of carpal scaphoid (navicular) fracture, includes internal fixation, when performed</E>
                        ). CPT code 25628 shares the same intraservice time of 90 minutes and a slightly higher total time of 277 minutes with a work RVU of 9.67. In addition, during our review of CPT code 19371, we noted that the total time for CPT code 19371 has decreased from 306 minutes to 261 minutes and the intraservice time has decreased from 117 to 90 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19371.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 12.00 for CPT code 19380 (Revision of reconstructed breast (
                        <E T="03">eg, significant removal of tissue, re-advancement and/or re-inset of flaps in autologous reconstruction or significant capsular revision combined with soft tissue excision in implant-based reconstruction)</E>
                        ). Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 19371 and 19380 is equivalent to the RUC recommended interval of 1.19 RVUs. Therefore, we are proposing a work RVU of 11.17 for CPT code 19380, based on the recommended interval of 1.19 additional RVUs above our proposed work RVU of 9.98 for CPT code 19371. We are also supporting our proposed work RVU of 11.17 based on a reference code, CPT code 64569 (
                        <E T="03">Revision or replacement of cranial nerve (eg, vagus nerve) neurostimulator electrode array, including connection to existing pulse generato</E>
                        ). CPT code 64569 shares the same intraservice time of 120 minutes and only a slightly higher total time of 312 minutes with a work RVU of 11.0. The total time increased from 277 minutes to 307 minutes and the intraservice time has increased from 89 minutes to 120 minutes. We are proposing the RUC-recommended direct PE inputs for CPT code 19380.
                    </P>
                    <HD SOURCE="HD3">(8) Hip-Knee Arthroplasty (CPT Codes 27130 and 27447)</HD>
                    <P>
                        CPT codes 27130 (
                        <E T="03">Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft</E>
                        ) and 27447 (
                        <E T="03">Arthroplasty, knee, condyle and plateau; medial AND lateral compartments with or without patella resurfacing (total knee arthroplasty)</E>
                        ) were identified as potentially misvalued codes under the CMS high expenditure procedural code screen in the CY 2014 final rule with comment period (78 FR 74334). These codes were reviewed by the AMA RUC who provided recommendations for work RVUs and physician time for these services for CY 2014. We agreed with the RUC recommendation to value CPT code 27130 and CPT code 27447 equally and thus established the same CY 2014 interim final work RVUs for these two procedures (78 FR 74334). This change resulted in a 1.12 work RVU increase for the visits in the global period. We added the additional work to the AMA RUC-recommended work RVU of 19.60 for CPT codes 27130 and 27447, resulting in an interim final work RVU of 20.72 for both services.
                    </P>
                    <P>In the CY 2015 final rule with comment period (79 FR 67632), we discussed how in the CY 2014 final rule with comment period, we sought public comment regarding the appropriate work RVUs for these services and the most appropriate reconciliation for the conflicting information regarding time values for these services as presented to us by the physician community. We did not find the rationales provided for modifying the interim final work values established in CY 2014 compelling, and thus we finalized the CY 2014 interim final values for these procedures based upon the best data we had available and to preserve appropriate relativity with other codes.</P>
                    <P>In the CY 2019 final rule (83 FR 59500 through 595303), CPT code 27130 and CPT code 27447 were added to the list of potentially misvalued codes. A stakeholder submitted information requesting that CMS nominate these codes as potentially misvalued. The stakeholder stated that there were substantial overestimates in pre-service and post-service time including follow-up inpatient and outpatient visits that do not take place included in the valuation of the service. As a result the codes were resurveyed for the October 2019 RUC meeting.</P>
                    <P>
                        We are proposing the RUC-recommended work RVU of 19.60 for CPT code 27130 and the RUC-recommended work RVU of 19.60 for CPT code 27447. We are also proposing the RUC-recommended direct PE inputs for both codes. Additionally, we are seeking comment from the medical community on how to consider and/or include pre-optimization time (pre-service work and/or activities to improve surgical outcomes) going forward. We are also interested in stakeholders' thoughts on what codes could be used to capture these pre-optimization activities that could be billed in conjunction with the services discussed previously. Overall, we are interested in continuing our ongoing dialog with stakeholders about how CMS might pay more accurately for improved clinical outcomes that may result from increased efficiency in furnishing care through activities, such as pre-optimization and are appreciative of information provided by the medical community. We invite the medical community to continue to engage with CMS on this and other topics.
                        <PRTPAGE P="50156"/>
                    </P>
                    <HD SOURCE="HD3">(9) Toe Amputation (CPT Codes 28820 and 28825)</HD>
                    <P>These services were identified by the RUC Relativity Assessment Workgroup through a site of service anomaly screen based on the review of 3 years of data (2015, 2016 and 2017) for services with utilization over 10,000 in which a service is typically performed in the inpatient hospital setting, yet only a half discharge day management identified by CPT code 99238 is included. Prior to conducting the RUC survey, the specialty societies recommended that it would be appropriate for these services to have their global period changed from 090-day to 000-day so the site of service is less of a contributing factor to the codes' valuation. These codes were surveyed as a 000-day global service, and we are proposing them as 000-day global services.</P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 4.10 for CPT code 28820 (
                        <E T="03">Amputation, toe; metatarsophalangeal joint</E>
                        ). We believe that it would be more accurate to propose a work RVU of 3.51, and we are supporting this value with a crosswalk to CPT code 33958 (
                        <E T="03">Extracorporeal membrane oxygenation (ECMO)/extracorporeal life support (ECLS) provided by physician; reposition peripheral (arterial and/or venous) cannula(e), percutaneous, 6 years and older (includes fluoroscopic guidance, when performed</E>
                        )), which has a work RVU of 3.51, to account for the decrease in the surveyed work time. We do not believe the RUC-recommended reduction in work RVU from the current value of 5.82 is commensurate with the RUC-recommended 102-minute reduction in total time. We believe that a further reduction in work RVUs is warranted given the significant reduction in RUC-recommended physician time.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 4.00 for CPT code 28825 (
                        <E T="03">Amputation, toe; interphalangeal joint</E>
                        ). We are proposing a work RVU of 3.41 based on the RUC-recommended increment relationship between this code and CPT 28820 (a difference of -0.10), which we apply to our proposed value for the latter code. We do not believe the RUC-recommended reduction in work RVU from the current value of 5.37 is commensurate with the RUC-recommended 97-minute reduction in total time. We believe that a further reduction in work RVUs is warranted given the significance of RUC-recommended reduction in physician time.
                    </P>
                    <P>For the direct PE inputs, we are proposing to refine the pre-service clinical labor times to conform to the 000-day global period standards for both codes in the family for CPT codes 28820 and 28825. We are also proposing to refine the clinical labor times for the “Provide education/obtain consent” (CA011) and the “Prepare room, equipment and supplies” (CA013) activities to conform to our established standard time of 2 minutes each in the non-facility setting for CPT codes 28820 and 28825. We are also proposing to refine the equipment time to conform to these changes in the clinical labor time for both codes.</P>
                    <HD SOURCE="HD3">(10) Shoulder Debridement (CPT Codes 29822 and 29823)</HD>
                    <P>
                        In September 2019, the CPT Editorial Panel approved revision of CPT code 29822 (
                        <E T="03">Arthroscopy, shoulder, surgical; debridement, limited, 1 or 2 discrete structures (eg, humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies])</E>
                        ) and CPT code 29823 (
                        <E T="03">Arthroscopy, shoulder, surgical; debridement, extensive, 3 or more discrete structures (eg, humeral bone, humeral articular cartilage, glenoid bone, glenoid articular cartilage, biceps tendon, biceps anchor complex, labrum, articular capsule, articular side of the rotator cuff, bursal side of the rotator cuff, subacromial bursa, foreign body[ies])</E>
                        ) to clarify limited and extensive debridement by specifying the number of discrete structures debrided and providing examples of the structures.
                    </P>
                    <P>We are proposing the RUC-recommended work RVU of 7.03 for CPT code 29822 and 7.98 for CPT code 29823 without refinement.</P>
                    <P>For the direct PE inputs, we are proposing the RUC recommendations CPT codes 29822 and 29823 without refinement.</P>
                    <HD SOURCE="HD3">(11) Absorbable Nasal Implant Repair (CPT Codes 30XX0)</HD>
                    <P>
                        In September 2019, the CPT Editorial Panel approved the addition of CPT code 30XX0 (
                        <E T="03">Repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s)) to report repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s)</E>
                        ).
                    </P>
                    <P>We are proposing the RUC-recommended value of 2.80 work RVUs without refinement for CPT code 30XX0.</P>
                    <P>For the direct PE inputs, were also proposing the RUC-recommended values without refinement.</P>
                    <HD SOURCE="HD3">(12) Lung Biopsy-CT Guidance Bundle (CPT Code 324X0)</HD>
                    <P>
                        CPT codes 32405 (
                        <E T="03">Biopsy, lung or mediastinum, percutaneous needle</E>
                        ) and 77012 (
                        <E T="03">Computed tomography guidance for needle placement (eg, biopsy, aspiration, injection, localization device), radiological supervision and interpretation</E>
                        ) were identified by the AMA through a screen of code pairs that are reported on the same day, same patient and same NPI number at or more than 75 percent of the time. The CPT Editorial Panel deleted CPT code 32405 and replaced it with 324X0 (
                        <E T="03">Core needle biopsy, lung or mediastinum, percutaneous, including imaging guidance, when performed</E>
                        ).
                    </P>
                    <P>We are not proposing the RUC-recommended work RVU of 4.00, which is the survey median, because we believe this value somewhat overstates the increase in intensity. Although we do not imply that the decrease in time, when considering the aggregate time values for CPT codes 32405 and 77012, as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in the work RVU. Intraservice and total time ratios using the aggregate time values of current CPT codes 32405 and 77012 suggest a significantly lower work RVU; however, we do not believe a decrease from the current aggregate value of 32405 and 77012 is warranted. We believe there is some overlap in physician work and time for the two current services, and that the recommended increase to 4.00 does not appropriately recognize this overlap. Therefore, we are proposing a work RVU of 3.18, which is the sum of the work RVUs of the two base codes.</P>
                    <P>We are proposing the RUC-recommended direct PE inputs without refinement.</P>
                    <HD SOURCE="HD3">(13) Atrial Septostomy (CPT Codes 33XX0, 33XX1, 33XX2)</HD>
                    <P>
                        Septostomy procedures are performed on extremely small newborns and neonates with severe forms of congenital heart disease and are lifesaving/temporizing procedures that do not provide definitive therapy to these critically ill patients. These procedures are not typical of the Medicare population and are of low volume. CPT code 92992 (
                        <E T="03">
                            Atrial septectomy or septostomy; transvenous 
                            <PRTPAGE P="50157"/>
                            method, balloon (eg, Rashkind type) (includes cardiac catheterization)
                        </E>
                        ) and CPT code 92993 (
                        <E T="03">Atrial septectomy or septostomy; blade method (Park septostomy) (includes cardiac catheterization)</E>
                        ), are carrier-priced codes. These services were not formally designated as potentially misvalued in the CY 2019 PFS final rule (83 FR 59500), but we did make mention that the RUC had signaled their intention to review these two codes. Both services were referred to the CPT Editorial Panel by the specialty societies who indicated that CPT code 92992 may not have included related imaging guidance, and also commented that CPT code 92993 was antiquated and rarely performed, so both CPT codes were deleted and are now being replaced with the following proposed CPT codes.
                    </P>
                    <P>
                        CPT code 33XX0 (
                        <E T="03">Transcatheter atrial septostomy (TAS) for congenital cardiac anomalies to create effective atrial flow, including all imaging guidance by the proceduralist, when performed, any method (eg, Rashkind, Sang-Park, balloon, cutting balloon, blade)</E>
                        ), is one of three codes intending to replace the two deleted Septostomy codes. For CPT code 33XX0, the RUC recommends an RVU only crosswalk to CPT code 33340 (
                        <E T="03">Percutaneous transcatheter closure of the left atrial appendage with endocardial implant, including fluoroscopy, transseptal puncture, catheter placement(s), left atrial angiography, left atrial appendage angiography, when performed, and radiological supervision and interpretation</E>
                        ), which has a work RVU of 14.00. The RUC recommends 20 minutes of preservice evaluation time, 15 minutes of preservice positioning time, 15 minutes preservice scrub/dress/wait time, 55 minutes intraservice time and 45 minutes immediate postservice time, for 150 minutes total time. We are proposing the RUC recommended work RVU of 14.00 and physician times without refinement.
                    </P>
                    <P>
                        CPT code 33XX1 (
                        <E T="03">Transcatheter intracardiac shunt (TIS) creation by stent placement for congenital cardiac anomalies to establish effective intracardiac flow, all imaging guidance by the proceduralist when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); initial intracardiac shunt</E>
                        ) is another proposed new procedure currently performed on neonate infants to children with severe forms of congenital heart disease, by having a stent implanted inside of an infant's beating heart (and not within a blood vessel). This stent replaces the methods in the old atrial septostomy codes utilizing the balloon and blade method. The RUC recommends 25 minutes preservice evaluation time, 15 minutes preservice positioning time, 15 minutes preservice scrub/dress/wait time, 92 minutes intraservice time and 60 minutes immediate postservice time, for 207 minutes total time. The RUC recommends 20.00 work RVUs for CPT code 33XX1. We are proposing the RUC recommended work RVUs and their recommended physician times.
                    </P>
                    <P>
                        CPT code 33XX2, (
                        <E T="03">Transcatheter intracardiac shunt (TIS) creation by stent placement for congenital cardiac anomalies to establish effective intracardiac flow, all imaging guidance by the proceduralist when performed, left and right heart diagnostic cardiac catherization for congenital cardiac anomalies, and target zone angioplasty, when performed (eg, atrial septum, Fontan fenestration, right ventricular outflow tract, Mustard/Senning/Warden baffles); each additional intracardiac shunt location (List separately in addition to code for primary procedure)</E>
                        ), is the add-on code to the proposed new procedure CPT code 33XX1, for 60 minutes of physician intraservice time. The RUC recommends a work RVU of 10.50 for CPT code 33XX2. This value for the add-on code, in comparison to the recommended work value of 20.00 RVUs with 92 minutes/intraservice time and 207 minutes of total time for CPT code 33XX1 appears to be unsupportable given the 60 minutes of additional physician intraservice time. We are instead proposing a work RVU of 8.00 for add-on CPT code 33XX2, which is the 25th percentile value from the survey and of similar valuation from reference CPT code 93592 (
                        <E T="03">Percutaneous transcatheter closure of paravalvular leak; each additional occlusion device (List separately in addition to code for primary procedure)</E>
                        ).
                    </P>
                    <P>This family of CPT codes are facility-only services and have no direct PE inputs.</P>
                    <HD SOURCE="HD3">(14) Percutaneous Ventricular Assist Device Insertion (CPT Codes 339X1, 33990, 33991, 33992, 339X2, and 33993)</HD>
                    <P>In May 2019, the CPT Editorial Panel approved the revision of four codes to clarify the insertion and removal of right and left heart percutaneous ventricular assist devices (PVAD), and the addition of two codes to report insertion of PVAD venous access and removal of right heart PVAD. These codes were surveyed with 000-day global periods and reviewed at the October 2019 RUC meeting.</P>
                    <P>
                        We are proposing the RUC-recommended work RVUs for all six codes in the family. We are proposing a work RVU of 6.75 for CPT code 33990 (
                        <E T="03">Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, arterial access only</E>
                        ), a work RVU of 6.75 for CPT code 339X1 (
                        <E T="03">Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; right heart, venous access only</E>
                        ), a work RVU of 8.84 for CPT code 33991 (
                        <E T="03">Insertion of ventricular assist device, percutaneous, including radiological supervision and interpretation; left heart, both arterial and venous access, with transseptal puncture</E>
                        ), a work RVU of 3.55 for CPT code 33992 (
                        <E T="03">Removal of percutaneous left heart ventricular assist device, arterial or arterial and venous cannula(s), separate and distinct session from insertion</E>
                        ), a work RVU of 3.00 for CPT code 339X2 (
                        <E T="03">Removal of percutaneous right heart ventricular assist device, venous cannula, separate and distinct session from insertion</E>
                        ), and a work RVU of 3.10 for CPT code 33993 (
                        <E T="03">Repositioning of percutaneous right or left heart ventricular assist device, with imaging guidance, at separate and distinct session from insertion</E>
                        ).
                    </P>
                    <P>Stakeholders contacted CMS regarding the valuation of the codes in this family following the arrival of the RUC recommendations. They stated that the RUC recommendations did not accurately reflect the work time of these procedures, which they stated to be increasing due to the adoption of new technology. The stakeholders requested that CMS propose to maintain the current work RVUs for the codes in this family and to crosswalk the work RVU of the new codes to existing codes.</P>
                    <P>
                        We disagree with the stakeholders and are proposing the RUC-recommended work RVUs for each code in this family as noted previously. We note that in this case where the surveyed work times for the existing codes are decreasing and the utilization of CPT code 33990 is increasing significantly (quadrupling in the last 5 years), we have reason to believe that practitioners are becoming more efficient at performing the procedure, which, under the resource-based nature of the RVU system, lends support for proposing the RUC's recommended work RVUs. Although the incorporation of new technology can sometimes make services more complex and difficult to perform, it can also have the opposite effect by making services less reliant on manual skill and technique. We disagree 
                        <PRTPAGE P="50158"/>
                        with the stakeholders that the incorporation of this new technology would necessarily be grounds for maintaining the current work RVU, as improvements in technology are commonplace across many different services and are not specific to this procedure. As detailed earlier, we also have reason to believe that the improved technology has led to greater efficiencies in the procedure which, under the resource-based nature of the RVU system, lends further support for proposing a lower work RVU for the existing CPT codes.
                    </P>
                    <P>The RUC did not recommend and we are not proposing any direct PE inputs for this facility only code family. We are proposing a 000-day global period for all six codes as surveyed by the RUC.</P>
                    <HD SOURCE="HD3">(15) Esophagogastroduodenoscopy (EGD) With Biopsy (CPT Code 43239)</HD>
                    <P>
                        In the CY 2019 PFS final rule (83 FR 59500), CPT code 43239 (
                        <E T="03">Esophagogastroduodenoscopy, flexible, transoral; with biopsy, single or multiple</E>
                        ) was publicly nominated for review under the potentially misvalued code initiative. As requested, the specialty societies conducted a survey for the April 2019 RUC meeting. The RUC survey results showed that the current work RVU of 2.39, which is below the survey 25th percentile work RVU of 2.50, accurately reflects the physician work for CPT code 43239.
                    </P>
                    <P>We are proposing to maintain the current work RVU of 2.39 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 43239 without refinement.</P>
                    <HD SOURCE="HD3">(16) Colonoscopy (CPT Code 45385)</HD>
                    <P>
                        In the CY 2019 final rule (83 FR 59500), CPT code 45385 (
                        <E T="03">Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique</E>
                        ) was publicly nominated for review under the potentially misvalued code initiative. As requested, the specialty societies conducted a survey for the April 2019 RUC meeting. The RUC survey results showed that the current work RVU of 4.57, which is slightly above the survey 25th percentile work RVU of 4.50, accurately reflects the physician work for CPT code 45385.
                    </P>
                    <P>We are proposing to maintain the current work RVU of 4.57 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 45385 without refinement.</P>
                    <HD SOURCE="HD3">(17) Transrectal High Intensity Focused US Prostate Ablation (CPT Codes 558XX)</HD>
                    <P>
                        In May 2019, the CPT Editorial Panel established a new code to report ablation of malignant prostate tissue with high intensity focused ultrasound (HIFU), including ultrasound guidance. For CPT code 558XX, we are not proposing the RUC recommendation to use the survey median work RVU of 20.00 to value this service because we believe total time ratios to the two key reference codes, CPT codes 55840 (
                        <E T="03">Prostatectomy, retropubic radical, with or without nerve sparing</E>
                        ) and 55873 (
                        <E T="03">Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring)</E>
                        ) indicate that this value is somewhat overstated and does not accurately reflect the physician time, and because an analysis of all 090-global period codes with similar time values indicates that this service is overvalued. We are proposing a work RVU of 17.73 based on a crosswalk to CPT code 69930 (
                        <E T="03">Cochlear device implantation, with or without mastoidectomy</E>
                        ) which has similar total time and identical intraservice time values and is more consistent with other codes of similar time. We are proposing the RUC-recommended PE inputs without refinement.
                    </P>
                    <HD SOURCE="HD3">(18) Computer-Aided Mapping of Cervix Uteri (CPT Code 57XX0)</HD>
                    <P>
                        In September 2019, the addition of CPT code 57XX0 (
                        <E T="03">Computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect (List separately in addition to code for primary procedure)</E>
                        ) was approved by the CPT Editorial Panel to report computer-aided mapping of cervix uteri during colposcopy. The RUC recommended the survey median work RVU of 0.81 for this service. We are proposing the RUC-recommended value of 0.81 for CPT code 57XX0. We are also proposing the RUC-recommended direct PE inputs for this code.
                    </P>
                    <P>We are seeking comment on a new medical supply indicated on the PE spreadsheet submitted by the RUC. A “computer aided spectral imaging system (colposcopy) disposal speculum” was noted in the RUC PE meeting materials. This name suggests it is digital. However, on the actual invoice submitted, the supply item in question was listed as a “disposable medium speculum” with no mention of a spectral imaging system or a digital component. We researched this speculum and could not find any evidence that it has a digital component. Therefore, we are proposing to change the name of this new supply item to “disposable speculum, medium” (SD337) to reflect the actual product on the invoice submitted. We are seeking clarification as to what aspect of the speculum is digital or if a cheaper, non-digital speculum would suffice. We note for example that the vaginal specula (SD118) supply has a CY 2021 price of $1.12 and we were able to find disposable medium specula readily available online for a price of roughly $1.00. We are proposing the new SD337 supply at the $5.80 price as listed on the invoice submitted in the RUC materials and are seeking comment as to why other disposable speculums at a lower price would not be typical for this procedure.</P>
                    <HD SOURCE="HD3">(19) Colpopexy (CPT Codes 57282 and 57283)</HD>
                    <P>
                        The CPT codes 57282 (
                        <E T="03">Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus)</E>
                        ) and 57283 (
                        <E T="03">Colpopexy, vaginal; intra-peritoneal approach (uterosacral, levator myorrhaphy)</E>
                        ) were identified by the RUC Relativity Assessment Workgroup as services performed less than 50 percent of the time in the inpatient setting yet include inpatient hospital E/M services within the global period and the 2018 Medicare utilization is over 5,000. This code family was surveyed and reviewed for the January 2020 RUC meeting. For CY 2021, the RUC recommended a work RVU of 13.48 for CPT code 57282, and a work RVU of 13.51 for CPT code 57283.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVUs for the CPT code family of 57282 and 57283. We are proposing a work RVU of 11.63 for CPT code 57282, and are also proposing to maintain the current work RVU of 11.66 for CPT code 57283. For CPT code 57283, we based our disagreement on the total time ratio between the current time of 349 minutes and the recommended time established by the survey of 231 minutes. This ratio equals 66 percent, and 66 percent of the current work RVU of 11.66 for CPT code 57283 equals a work RVU of 7.70. When we reviewed CPT code 57283, we found that the recommended work RVU was higher than other codes with similar time values. This is supported by the reference CPT codes we compared to CPT code 57283 with 90 minutes of intraservice time; reference CPT code 19350 (
                        <E T="03">Nipple/areola reconstruction</E>
                        ) has a work RVU of 9.11 with 229 minutes of total time, and reference CPT 
                        <PRTPAGE P="50159"/>
                        code 47563 (
                        <E T="03">Laparoscopy, surgical; cholecystectomy with cholangiography</E>
                        ) which has a work RVU of 11.47 with 238 minutes of total time. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be reflected in decreases to work RVUs. The recommendation from the RUC acknowledged that the time had decreased for CPT code 57283, and also noted that there has been an increase in intensity due to a change in technique and knowledge necessary to perform the service. In the case of CPT code 57283, we believe it would be more accurate to propose maintaining the current work RVU of 11.66 instead of the RUC-recommended work RVU of 13.51 to account for these decreases in the surveyed work time while still accounting for the increase in intensity. We also note that the intensity of CPT code 57283 would nearly double by maintaining the proposed work RVU of 11.66, due to the significant decreases in surveyed work time, which we believe supports the RUC's contention that the intensity of this code has increased over time.
                    </P>
                    <P>For CPT code 57282, we disagree with the RUC-recommended RVU of 13.48. We note that the significant decrease in total time for code 57282 suggests an RVU lower than 13.48. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference in work between CPT codes 57282 and 57283 is equivalent to the RUC-recommended interval of 0.03 RVUs. We believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. Therefore, we are proposing a work RVU of 11.63 for CPT code 57282, based on the RUC recommended interval of 0.03 RVUs below our proposed work RVU of 11.66 for CPT code 57283.</P>
                    <P>We are proposing the RUC-recommended direct PE inputs for the CPT code family of 57282 and 57283 without refinement.</P>
                    <HD SOURCE="HD3">(20) Laparoscopic Colpopexy (CPT Code 57425)</HD>
                    <P>
                        The CPT code 57425 (
                        <E T="03">Laparoscopy, surgical, colpopexy (suspension of vaginal apex)</E>
                        ) was identified by the RUC Relativity Assessment Workgroup as a service performed less than 50 percent of the time in the inpatient setting yet includes inpatient hospital E/M services within the global period and the 2018 Medicare utilization is over 5,000. This service was surveyed and reviewed for the January 2020 RUC meeting.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 18.02 for CPT code 57425 and propose to maintain the current RVU of 17.03 based on the total time ratio between the current time of 404 minutes and the recommended time established by the survey of 351 minutes. This is supported by the reference CPT codes we compared to CPT code 57425 with the same intraservice time; reference CPT code 26587 (
                        <E T="03">Reconstruction of polydactylous digit, soft tissue and bone</E>
                        ) which has a work RVU of 14.50, and reference CPT code 20696 (
                        <E T="03">Application of multiplane (pins or wires in more than 1 plane), unilateral, external fixation with stereotactic computer-assisted adjustment (e.g., spatial frame), including imaging; initial and subsequent alignment(s), assessment(s), and computation(s) of adjustment schedule(s)</E>
                        ) which has a work RVU of 17.56. Both CPT codes 26587 and 20696 have 180 minutes of intraservice time, which is equal to the 180 minutes of intraservice time in the RUC recommendation for CPT code 57425, and over 400 minutes of total time. The total time for CPT code 57425 decreased from 404 to 351 minutes and the RUC did not appear to take this into account. Therefore, we are proposing to maintain the current work RVU of 17.03.
                    </P>
                    <P>We are proposing the RUC-recommended direct PE inputs for CPT code 57425 without refinement.</P>
                    <HD SOURCE="HD3">(21) Intravitreal Injection (CPT Code 67028)</HD>
                    <P>
                        CPT code 67028 (
                        <E T="03">Intravitreal injection of a pharmacologic agent</E>
                        ) was identified via the RUC's Relativity Assessment Workgroup as a code where the original valuation was based on a crosswalk code that had since been revalued. The RUC recommended that CPT code 67028 should be surveyed for the April 2019 RUC meeting. We are proposing the RUC-recommended work RVU of 1.44 for CPT code 67028.
                    </P>
                    <P>
                        For the direct PE inputs, we are proposing to refine the clinical labor time for the “Clean room/equipment by clinical staff” (CA024) activity from the RUC-recommended 5 minutes to 3 minutes for CPT code 67028, because 3 minutes is the standard time for this clinical labor activity code, and we disagree that there would typically be a need for 2 additional minutes for cleaning, sterilizing, and re-packaging a reusable eyelid speculum in a sterile package to prepare for its next case. Additionally, 3 minutes is the standard time for cleaning the room 
                        <E T="03">and</E>
                         cleaning the equipment; although we agree that these cleaning tasks would take place, we do not believe that the removal of the same day E/M visit would result in the need for 2 additional minutes of cleaning time. We note that we are proposing to maintain the current time for this clinical labor activity, which was previously finalized in the CY 2011 PFS final rule at the standard value of 3 minutes (75 FR 73353). We are also proposing to refine the equipment times to match the change in clinical labor time.
                    </P>
                    <HD SOURCE="HD3">(22) Dilation of Eustachian Tube (CPT Codes 697XX and 697X1)</HD>
                    <P>
                        In September 2019, the CPT Editorial Panel created two new codes CPT code 697XX (
                        <E T="03">Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral</E>
                        ) and CPT code 697X1(
                        <E T="03">Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); bilateral)</E>
                        ) to describe the dilation of the eustachian tube via surgical nasopharyngoscopy, unilateral and bilateral. We are proposing the RUC-recommended work RVUs of 3.00 and 4.27 for CPT codes 697XX and 697X1, respectively. For the direct PE inputs, we are proposing the RUC-recommended values without refinement.
                    </P>
                    <HD SOURCE="HD3">(23) X-Ray of Eye (CPT Code 70030)</HD>
                    <P>
                        CPT code 70030 (
                        <E T="03">Radiologic examination, eye, for detection of foreign body</E>
                        ) was identified through an updated screen of CMS/Other source codes with Medicare utilization over 20,000. We are proposing the RUC-recommended work RVU of 0.18 for this service. We are proposing the RUC-recommended direct PE inputs without refinement.
                    </P>
                    <HD SOURCE="HD3">(24) CT Head-Brain (CPT Codes 70450, 70460, and 70470)</HD>
                    <P>
                        In the CY 2019 PFS final rule (83 FR 59500 through 59503), a stakeholder nominated CPT code 70450 (
                        <E T="03">Computed tomography, head or brain; without contrast material</E>
                        ) as potentially misvalued, citing GAO and MedPAC reports that suggest that work RVUs are overstated for procedures such as these, and the specialty society surveyed family codes 70460 (Computed tomography, head or brain; with contrast material(s)) and 70470 (Computed tomography, head or brain; without contrast material, followed by contrast material(s) and further sections). We are proposing the RUC 
                        <PRTPAGE P="50160"/>
                        recommendation to maintain the current work RVUs of 0.85, 1.13, and 1.27 for CPT codes 70450, 70460, and 70470, respectively. For CPT code 70450, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70486 (
                        <E T="03">Computed tomography, maxillofacial area; without contrast material</E>
                        ), which has similar physician time and the same work RVU, is appropriate. For CPT code 70460, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70487 (
                        <E T="03">Computed tomography, maxillofacial area; with contrast material(s)</E>
                        ), which has similar physician time and the same work RVU is appropriate. Similarly, for CPT code 70470, we note that the surveyed times are nearly identical to the current times for these services, and we believe that the RUC's reference to CPT code 70488 (
                        <E T="03">Computed tomography, maxillofacial area; without contrast material, followed by contrast material(s) and further sections</E>
                        )), which has similar physician time and the same work RVU, is appropriate. We also note that these codes are relatively consistently valued compared to other codes with similar time values and a global period of XXX. We are proposing the RUC-recommended direct PE inputs without refinement.
                    </P>
                    <HD SOURCE="HD3">(25) Screening CT of Thorax (CPT Codes 71250, 71260, 71270, and 712X0)</HD>
                    <P>
                        In October 2018, AMA staff identified the CMS/Other Source codes with 2017 Medicare utilization over 30,000. HCPCS code G0297 (
                        <E T="03">Low dose ct scan (ldct) for lung cancer screening</E>
                        ) was identified. In January 2019, the RUC recommended to refer to CPT Editorial Panel to establish a permanent code for this procedure. In May 2019, the CPT Editorial Panel revised three codes and added one code to distinguish diagnostic computed tomography, thorax from computed tomography, thorax, low dose for lung cancer screening.
                    </P>
                    <P>
                        For CPT code 71250 (
                        <E T="03">Computed tomography, thorax; without contrast material</E>
                        ), we are not proposing the RUC recommendation to maintain the current work RVU of 1.16 as we believe this does not accurately reflect the reduction in physician work time, and because an analysis of all XXX-global period codes with similar time values indicates that this service is overvalued. We are instead recommending to propose a work RVU of 1.08 based on the ratio of current to RUC-recommended intraservice time. As support for this value, we note that it falls slightly below CPT code 76391 (
                        <E T="03">Magnetic resonance (eg, vibration) elastography</E>
                        ), which has a work RVU of 1.10 and also has higher physician time values.
                    </P>
                    <P>
                        Similarly, for CPT code 71260 (
                        <E T="03">Computed tomography, thorax; with contrast material(s)</E>
                        ), we are not proposing the RUC recommendation to maintain the current work RVU of 1.24 as we believe this does not accurately reflect the reduction in physician time, and we are instead proposing a work RVU of 1.16 based the ratio of current to RUC-recommended intraservice time. Although we disagree with the RUC-recommended work RVU, we concur that the relative difference between CPT codes 71250 and 71260 is equivalent to the RUC-recommended interval of 0.08 RVUs. As stated previously, we believe the use of an incremental difference between these CPT codes is a valid methodology for setting values, especially in valuing services within a family of revised codes where it is important to maintain appropriate intra-family relativity. We note that that the proposed work RVU of 1.16 maintains the RUC-recommended interval of 0.08 additional RVUs above our proposed work RVU of 1.08 for CPT code 71250.
                    </P>
                    <P>
                        For CPT code 71270 (
                        <E T="03">Computed tomography, thorax; without contrast material, followed by contrast material(s) and further sections)</E>
                        ), we are not proposing the RUC recommendation to maintain the current work RVU of 1.38 as we believe this does not accurately reflect the reduction in physician time, and we are instead proposing a work RVU of 1.25 with a crosswalk to CPT code 93284 (
                        <E T="03">Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with analysis, review and report by a physician or other qualified health care professional; multiple lead transvenous implantable defibrillator system</E>
                        ) and we support this value by noting that it is slightly higher than values suggested by the ratio of current to RUC-recommended intraservice time For CPT code 712X0 (
                        <E T="03">Computed tomography, thorax, low dose for lung cancer screening, without contrast material(s)</E>
                        ), we are not proposing the RUC-recommended work RVU of 1.16, and we are instead proposing a work RVU of 1.08 so that the value of this code is consistent with that of CPT code 71250 as current code G0297 is valued based on the value of CPT code 71250, and to maintain the relative relationship among these codes. In the CY 2016 PFS final rule (80 FR 70974) we finalized that CPT code G0297 should be identically valued to CPT code 71250.
                    </P>
                    <P>We are proposing the RUC-recommended direct PE inputs without refinement for CPT codes 71250, 71260, and 71270. For the direct PE inputs for CPT code 712X0, we are proposing 2 minutes for the clinical labor activity CA011: “Provide education/obtain consent” rather than the RUC-recommended 3 minutes to be consistent with other non-contrast screening codes, and we are proposing 4 minutes for the clinical labor activity CA038 “Coordinate post-procedure services” rather than the RUC-recommended 6 minutes to be consistent with other screening services, and because we do not see any compelling evidence that this service has changed significantly since G0297 was implemented for CY 2015 to warrant the recommended 2 additional minutes.</P>
                    <HD SOURCE="HD3">(26) X-Ray Bile Ducts (CPT Codes 74300, 74328, 74329, and 74330)</HD>
                    <P>
                        CPT codes 74300 (
                        <E T="03">Cholangiography and/or pancreatography; intraoperative, radiological supervision and interpretation</E>
                        ) and 74328 (
                        <E T="03">Endoscopic catheterization of the biliary ductal system, radiological supervision and interpretation</E>
                        ) were identified through a screen of CMS/Other Source codes with 2017 Medicare utilization over 30,000. CPT codes 74329 (
                        <E T="03">Endoscopic catheterization of the pancreatic ductal system, radiological supervision and interpretation</E>
                        ) and 74330 (
                        <E T="03">Combined endoscopic catheterization of the biliary and pancreatic ductal systems, radiological supervision and interpretation</E>
                        ) were included as part of the same code family and the family was surveyed. The codes describe x-rays of the liver, pancreas, and bile ducts. They are performed in facilities and have no direct PE inputs.
                    </P>
                    <P>
                        We disagree with the RUC-recommended work RVU of 0.32 for CPT code 74300. We are proposing a work RVU of 0.27 based on a crosswalk to CPT code 74021 (
                        <E T="03">Radiologic examination, abdomen; 3 or more views</E>
                        ), one of the reference services from the RUC survey and that has an intraservice time of 4 minutes, nearly identical to the RUC's recommendation of 5 minutes of intraservice time for CPT code 74300. Our proposal is supported by CPT code 93922 (
                        <E T="03">Limited bilateral noninvasive physiologic studies of upper or lower extremity arteries</E>
                        ) with a work RVU of 0.25 and an intraservice time of 5 minutes and a total time of 10 minutes. These times are nearly identical to the RUC's recommended 
                        <PRTPAGE P="50161"/>
                        intraservice of 5 minutes and total time of 10 minutes for CPT code 74300.
                    </P>
                    <P>
                        We are proposing the RUC-recommended work RVU of 0.47 for CPT code 74328 (
                        <E T="03">Endoscopic catheterization of the biliary ductal system, radiological supervision and interpretation</E>
                        ), with an intraservice time of 10 minutes and a total time of 20 minutes.
                    </P>
                    <P>
                        We disagree with the RUC's recommended work RVU of 0.50 for CPT code 74329 (
                        <E T="03">Endoscopic catheterization of the pancreatic ductal system, radiological supervision and interpretation</E>
                        ). We are proposing a crosswalk to CPT code 74328 at a work RVU of 0.47 because the intraservice and total times for both codes are identical and we believe the work involved in the biliary ductal and pancreatic ductal systems is similar.
                    </P>
                    <P>
                        We disagree with the RUC's recommended work RVU of 0.70 for CPT code 74330 (
                        <E T="03">Combined endoscopic catheterization of the biliary and pancreatic ductal systems, radiological supervision and interpretation</E>
                        ) and we are proposing a work RVU of 0.56 based on our proposal of the RUC's recommendation for CPT code 74328 to create internal consistency within the code family, based on our time ratio methodology and further supported by a reference to CPT code 93228 (
                        <E T="03">External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional</E>
                        ) with nearly identical and total time values to CPT code 74330.
                    </P>
                    <P>The RUC did not recommend and we are not proposing any direct PE inputs for these codes.</P>
                    <HD SOURCE="HD3">(27) Venography (CPT Codes 75820 and 75822)</HD>
                    <P>
                        The review of CPT code 75820 (
                        <E T="03">Venography, extremity, unilateral, radiological supervision and interpretation</E>
                        ) was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 20,000 claims in a year. CPT code 75820 currently has a work RVU of 0.70 with 14 minutes of total time. This service involves the supervision and interpretation of a contrast injection and imaging of either the upper or lower extremity. For CPT code 75820, the RUC recommends 12 minutes preservice time, 20 minutes intraservice time, 10 minutes postservice time and 42 minutes of total time. The specialty societies' survey at the 25th percentile yielded a 1.05 work RVU, and it is the RUC's recommended work value. We are proposing the RUC recommended value for CPT code 75820.
                    </P>
                    <P>
                        CPT code 75822 (
                        <E T="03">Venography, extremity, bilateral, radiological supervision and interpretation</E>
                        ) is reviewed as part of the family of codes included with CPT code 75820. CPT code 75822 has a current 1.06 work RVU and 21 minutes of total time. The RUC recommends 15 minutes preservice time, 30 minutes intraservice time, 12 minutes postservice time and 57 minutes of total time, and the survey's 25th percentile work RVU of 1.48. The service is similar to CPT 75820, except that this CPT code is bilateral, involving the supervision and interpretation of a contrast injection and imaging of both of either the upper or lower extremities. The RUC recommends 1.48 work RVU and 57 minutes of total time for CPT code 75822. We are proposing these RUC recommended values for CPT code 75822.
                    </P>
                    <HD SOURCE="HD3">(28) Introduction of Catheter or Stent (CPT Code 75984)</HD>
                    <P>
                        The RUC recommended reviewing CPT code 75984 (
                        <E T="03">Change of percutaneous tube or drainage catheter with contrast monitoring (e.g., genitourinary system, abscess) radiological supervision and interpretation</E>
                        ) after more utilization data was available, which resulted in this service being surveyed and reviewed for the April 2019 RUC meeting. We are proposing the work RVU of 0.83 as recommended by the RUC. We are proposing the RUC-recommended direct PE inputs for CPT code 75984 without refinement.
                    </P>
                    <HD SOURCE="HD3">(29) Medical Physics Dose Evaluation (CPT Code 7615X)</HD>
                    <P>
                        The CPT Editorial Panel created CPT code 7615X (
                        <E T="03">Medical physics dose evaluation for radiation exposure that exceeds institutional review threshold, including report</E>
                        ), which is a new PE-only code. Because of the high amount of clinical staff time and the fact that there are not analogous services, the PE Subcommittee requested that the specialty societies conduct a PE survey. In addition, they stated that the service is stand-alone, meaning that the medical physicist works independently from a physician and there are no elements of the PE that are informed by time from a physician work survey. Following the meeting, the specialty societies developed a PE survey which was reviewed and approved by the Research Subcommittee. We are proposing the RUC-recommended direct PE inputs for CPT code 7615X without refinement.
                    </P>
                    <HD SOURCE="HD3">(30) Ophthalmic Ultrasound Anterior Segment (CPT Code 76513)</HD>
                    <P>
                        CPT code 76513 (
                        <E T="03">Ophthalmic ultrasound, diagnostic; anterior segment ultrasound, immersion (water bath) B-scan or high resolution biomicroscopy</E>
                        ) was identified by the RUC due to volume growth, attributed to improved equipment. The CPT Editorial Panel has since revised this code to clarify that it is either unilateral or bilateral (it was previously unilateral). It was then surveyed. The code describes a test for glaucoma and is performed on the same day as an office/outpatient evaluation and management (O/O E/M) visit. The CPT and RUC removed CPT code 76513 from its former code family, creating a family of 1 service.
                    </P>
                    <P>
                        In reviewing this code, we noted that the recommended total time is decreasing from 19 minutes to 15 minutes (21 percent) while the RUC-recommended work RVU is decreasing from 0.66 to 0.60 (9 percent). We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 76513, we believe that it would be more accurate to propose a work RVU of 0.53 based on a crosswalk to CPT code 74230 (
                        <E T="03">Radiologic examination, swallowing function, with cineradiography/videoradiography, including scout neck radiograph(s) and delayed image(s), when performed, contrast (eg, barium) study</E>
                        ) with identical intraservice and total times.
                    </P>
                    <P>
                        For the direct PE inputs, we are proposing to make two refinements to the clinical labor times of CPT code 76513. We are proposing a reduction of 1 minute for the clinical labor task CA009: “Greet patient, provide gowning, ensure appropriate medical records are available” because the EHR information should already be linked from the preceding O/O E/M visit and the entry of information would be redundant and paid under indirect PE. We are also proposing a reduction of 1 minute for the clinical labor task CA011: “Provide education/obtain consent” to be consistent with the time for this 
                        <PRTPAGE P="50162"/>
                        clinical labor task for the services in CPT code 76513's former code family.
                    </P>
                    <HD SOURCE="HD3">(31) Radiation Treatment Delivery (CPT Code 77401)</HD>
                    <P>
                        CPT code 77401 (
                        <E T="03">Radiation treatment delivery, superficial and/or ortho voltage, per day</E>
                        ) was identified by the RUC Relativity Assessment Workgroup through a screen of high-volume growth, for services with 2017 Medicare utilization of 10,000 or more that has increased by at least 100 percent from 2012 through 2017. In January 2019, the RUC recommended to refer to this service to the CPT Editorial Panel to better define the set of services associated with delivery of superficial radiation therapy (SRT).
                    </P>
                    <P>We are proposing the following direct PE refinements: A reduction of 2 minutes for the clinical labor task CA024: “Clean room/equipment by clinical staff,” to the standard 3 minutes, and we are not proposing to include the new equipment item ER119 “Lead Room,” as we do not have enough information on what this equipment item contains, and we are requesting more information to allow us to determine if it is more accurately priced as direct or indirect PE. CPT code 77401 is a PE only code and we are proposing to maintain the current work RVU of 0.00.</P>
                    <HD SOURCE="HD3">(32) Proton Beam Treatment Delivery (CPT Codes 77520, 77522, 77523, and 77525)</HD>
                    <P>
                        In April 2018, the RUC's Relativity Assessment Workgroup (RAW) identified CPT code 77522 (
                        <E T="03">Proton treatment delivery; simple, with compensation) and CPT code 77523 (Proton treatment delivery; intermediate</E>
                        ) as contractor-priced Category I CPT codes with 2017 estimated Medicare utilization over 10,000 services. Although the RAW agreed with the specialty society that this family of codes should remain contractor priced, the RUC determined that these services should be surveyed for PE. CPT codes 77520 (
                        <E T="03">Proton treatment delivery; simple, without compensation</E>
                        ) and 77525 (
                        <E T="03">Proton treatment delivery; complex</E>
                        ) were added to the family and the group was surveyed for PE for the April 2019 RUC meeting.
                    </P>
                    <P>We encountered significant difficulties in reviewing the recommended direct PE inputs for the codes in the Proton Beam Treatment Delivery family. These difficulties were largely associated with determining a price for the two new equipment items in the code family, the Proton Treatment Vault (ER115) and the Proton Treatment Delivery System (ER116). These equipment items had extraordinarily high prices of $19,001,914 and $30,400,000 respectively on the invoices submitted with the code family. By way of comparison, the highest equipment price currently existing in our database for CY 2021 is the “SRS system, Linac” (ER082) equipment item at $4,233,825. We have concerns that establishing equipment pricing for the proton treatment vault and delivery system at a rate that is so much higher than anything else in our equipment database could distort relativity.</P>
                    <P>We also have concerns about the information provided on the submitted invoices used for the pricing of these two new equipment items. The invoices for both the Proton Treatment Vault and the Proton Treatment Delivery System contained building construction costs such as asphalt paving, masonry and carpentry expenses, drywall packaging, and the installation of electrical systems. We understand that these proton treatment equipment items are extremely capital-intensive and require the construction of custom-built offices to house the equipment. However, the expenses associated with constructing new office facilities fall outside of our direct PE methodology, and would be more accurately classified as a form of building maintenance or office rent under indirect PE. We do not agree that construction costs should be included as a form of direct PE because they are not individually allocable to a particular patient for a particular service. Although we agree that the provider does need to bear the costs associated with the storage of this equipment, this is a form of indirect PE under our methodology. We do not believe that it would serve the interests of relativity to include these building construction costs for the proton treatment equipment as a type of direct PE expense.</P>
                    <P>As a result, we are proposing to maintain contractor pricing for CPT codes 77520, 77522, 77523, and 77525 instead of proposing active pricing for these services. We believe that maintaining contractor pricing will allow the limited providers of these very expensive services to adapt more quickly to shifts in the market-based costs associated with the proton treatment equipment. The RUC similarly expressed concern in its recommendations about the extremely high cost of this equipment, agreed that these services were extremely hard to value, and noted the difficulties that had taken place in surveying the family of codes. The recommendations from the RUC also noted that proton treatment is a rapidly changing technology and the change in the treatment equipment often requires extensive modification to the vault. We believe that these frequent changes can be more accurately captured through contractor pricing as opposed to the need to update the pricing of the proton treatment equipment on an annual basis.</P>
                    <P>If we were to propose active pricing for the codes in this family, we believe that we would need to remove the building construction costs from the Proton Treatment Vault and the Proton Treatment Delivery System as forms of indirect PE, which would substantially lower their overall equipment prices. We would also refine the equipment times to the standard formula for highly technical equipment, which would result in 3 minutes less time for each equipment item (such as 14 minutes for all three equipment items in CPT code 77522).</P>
                    <HD SOURCE="HD3">(33) Immunization Administration (CPT Codes 90460, 90461, 90471, 90472, 90473, and 90474 and HCPCS codes G0008, G0009, and G0010)</HD>
                    <P>Especially in the context of the current Public Health Emergency (PHE) related to the COVID-19 pandemic, it is evident that consistent beneficiary access to vaccinations is vital to public health. Many stakeholders have raised concerns regarding the reductions in payment rates for vaccine administration services over the past several years. The codes that describe these services have generally been valued based on a direct crosswalk to CPT code 96372 (Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular). Because we proposed and finalized reductions in valuation for that code for CY 2018 and because the reductions in overall valuation have been subject to the multi-year phase-in of significant reductions in RVUs, the payment rate for the vaccine administration codes has been concurrently reduced.</P>
                    <P>
                        In the CY 2020 PFS final rule, we acknowledged that it is in the public interest to ensure appropriate resource cost are reflected in the valuation of the immunization administration services that are used to deliver vaccines and noted that we planned to review the valuations for these services in future rulemaking. For CY 2020, we maintained the CY 2019 national payment amount for immunization administration services described by HCPCS codes G0008 (
                        <E T="03">Administration of influenza virus vaccine</E>
                        ), G0009 (
                        <E T="03">
                            Administration of pneumococcal 
                            <PRTPAGE P="50163"/>
                            vaccine
                        </E>
                        ), and G0010 (
                        <E T="03">Administration of hepatitis b vaccine</E>
                        ) in the interim.
                    </P>
                    <P>
                        The RUC has recently re-submitted recommendations from 2009 regarding the appropriate valuation for the broader range of vaccine administration services, including CPT codes 90460 (
                        <E T="03">Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; first or only component of each vaccine or toxoid administered</E>
                        ), 90471 (
                        <E T="03">Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); 1 vaccine (single or combination vaccine/toxoid))</E>
                        , and 90473 (
                        <E T="03">Immunization administration by intranasal or oral route; 1 vaccine (single or combination vaccine/toxoid))</E>
                        . In its recommendation, the RUC noted that the current RVUs assigned are directly crosswalked from CPT code 96372 (like the vaccine administration G-codes had been) and the resulting payment rates are substantially lower than current Centers for Disease Control and Prevention (CDC) regional maximum charges. The RUC also pointed out that that appropriate payment for immunization administration that reflects resource cost is critical in maintaining high immunization rates in the United States, as well as having the capacity to respond quickly to vaccinate against preventable disease outbreaks.
                    </P>
                    <P>We agree with the RUC's assertions regarding the importance of appropriate resource based valuations for vaccine administration services. We also recognize that the importance of these services is increased in the context of the current PHE related to the COVID-19 pandemic, especially should there be a vaccine for this particular disease.</P>
                    <P>We reviewed and considered the 2009 RUC-recommended direct PE inputs for CPT codes 90460-90474 (as well as the related G-codes) in place of the existing policy based on a crosswalk to CPT code 96372. However, the RUC-recommended direct PE inputs from 2009 would result in significant decreases in valuation for these 6 CPT codes even compared to the current crosswalk. At this time, we do not believe that either the existing crosswalk or the RUC recommendations from over a decade ago reflect the relative resource costs associated with these services. Without updated information to use in developing rates specific to these codes based on direct PE inputs, and in consideration of the import of these services for Medicare beneficiaries, as well as the public health concerns raised by commenters, we believe that it would be most appropriate to value these services using a crosswalk methodology that better reflects the relative resources involved in furnishing all of these services.</P>
                    <P>
                        Therefore, we are proposing to crosswalk the valuation of CPT codes 90460, 90471, and 90473 and HCPCS codes G0008, G0009, and G0010 to CPT code 36000 (
                        <E T="03">Introduction of needle or intracatheter, vein</E>
                        ). CPT code 36000 is a service with a nearly identical work RVU (0.18 as compared to 0.17 for CPT codes 90460, 90471, and 90473) and a similar clinical vignette. We believe that the additional clinical labor, supply, and equipment resources associated with the furnishing of CPT code 36000 more accurately capture the costs associated with these immunization codes. We also note that this crosswalk will result in payment rates for vaccine administration services at approximately the same CY 2017 rates that were paid prior to the revaluation of CPT code 96372, which had previously served as the basis of the crosswalk. We believe that the proposed crosswalk is the most accurate valuation of these services and will also serve to ensure the appropriate relative resources involved in furnishing all of these services is reflected in the payment for these critical immunization and vaccination services in the context of the health needs of Medicare beneficiaries.
                    </P>
                    <P>
                        Regarding the add-on codes associated with these services, CPT codes 90461 (
                        <E T="03">Immunization administration through 18 years of age via any route of administration, with counseling by physician or other qualified health care professional; each additional vaccine or toxoid component administered</E>
                        ), 90472 (
                        <E T="03">Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid)</E>
                        ), and 90474 (
                        <E T="03">Immunization administration by intranasal or oral route; each additional vaccine (single or combination vaccine/toxoid)</E>
                        ), we note that the previous valuation methodology set their RVUs at approximately half of the valuation for the associated base codes, described above. Absent additional information, we are proposing to maintain that approach by valuing the three add-on codes at half of the RVUs of the aforementioned crosswalk to CPT code 36000.
                    </P>
                    <P>Finally, we are proposing this valuation to apply to all of these existing vaccine administration codes, using the valuation of CPT code 90471 for base codes and CPT code 90472 for add-on codes. Should a vaccine for COVID-19 or other infectious disease become available during CY 2021, we would anticipate applying the same approach to valuing the administration of such vaccines, regardless of whether separate coding for such services would need to be introduced.</P>
                    <HD SOURCE="HD3">(34) Liver Elastography (CPT Code 91200)</HD>
                    <P>
                        CPT code 91200 (
                        <E T="03">Liver elastography, mechanically induced shear wave (eg, vibration), without imaging, with interpretation and report</E>
                        ) was targeted for review through the RUC's new technology/new services screen. The RUC reviewed 3 years of available Medicare claims data (2016, 2017 and 2018) and surveyed the code for the January 2020 meeting.
                    </P>
                    <P>We are proposing the RUC-recommended work RVU of 0.21. We are also proposing the RUC-recommended direct PE inputs for CPT code 91200 without refinement.</P>
                    <HD SOURCE="HD3">(35) Remote Retinal Imaging (CPT Codes 92227, 92228, and 9225X)</HD>
                    <P>
                        The AMA CPT Editorial Panel revised CPT code 92227 (
                        <E T="03">Imaging of retina for detection or monitoring of disease; with remote clinical staff review and report, unilateral or bilateral</E>
                        ) and CPT code 92228 (
                        <E T="03">Imaging of retina for detection or monitoring of disease; with remote physician or qualified health professional review and report, unilateral or bilateral</E>
                        ) that are reported for the treatment of diabetic retinopathy. Two practice sites are involved in these services: The acquiring site (for example, a primary care practice) and the reading site (for example, the ophthalmology practice). Both codes can be used to report diagnostic and monitoring services and the distinction is in whom provides the service: Physician (CPT code 92228) or clinical staff only (CPT code 92227). Thus, only CPT code 92228 includes work, accounting for the physician at the reading site. For both CPT codes 92227 and 92228, direct PE pays for the clinical staff at both sites.
                    </P>
                    <P>
                        The AMA CPT Editorial Panel also created CPT code 9225X (
                        <E T="03">Imaging of retina for detection or monitoring of disease; with point-of-care automated analysis with diagnostic report; unilateral or bilateral</E>
                        ) for point-of-care automated analysis that uses innovative artificial intelligence technology to perform the interpretation of the eye exam, without requiring that an ophthalmologist interpret the results. CPT code 9225X can be used at a primary care practice site and the artificial intelligence technology 
                        <PRTPAGE P="50164"/>
                        interprets the test instead of a remotely located ophthalmologist. Because no physician is involved, this service is PE only. We are considering CPT code 9225X to be a diagnostic service under the PFS and are creating separate payment for it.
                    </P>
                    <P>For CPT code 92228, we are proposing the RUC's recommended work RVU of 0.32. CPT codes 92227 and 9225X are PE only codes, and we are proposing a work RVU of 0.00 for both codes.</P>
                    <P>For both CPT codes 92227 and 92228, we are proposing the AMA RUC's recommended direct PE inputs. We are proposing two refinements to the direct PE inputs for CPT code 9225X. We are proposing a reduction of 1 minute for the clinical labor task CA009, “Greet patient, provide gowning, ensure appropriate medical records are available,” to be consistent with the amount of clinical labor for this task in CPT codes 92228 and 92227. We are also not proposing the RUC's recommendation of a $25 analysis fee for remote imaging because we consider this a service fee that constitutes a form of indirect PE and that this cost is appropriately captured via the indirect PE methodology as opposed to being included as a separate direct PE input. We do not believe that the analysis fee would be allocated to the use of an individual patient for an individual service, and can be better understood as an indirect cost similar to other administrative expenses.</P>
                    <HD SOURCE="HD3">(36) Auditory Evoked Potentials (CPT Codes 92584, 92X51, 92X52, 92X53, and 92X54)</HD>
                    <P>
                        CPT codes 92585 (
                        <E T="03">Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; comprehensive</E>
                        ) and 92586 (
                        <E T="03">Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; limited</E>
                        ) were identified through a RAW requested screen of CMS/Other Source codes with 2017 Medicare utilization over 30,000. Since these codes were last valued, audiologists, the primary reporter of these services, can now report Medicare services independently. As a result, the audiologist work for these services is moving from PE to work.
                    </P>
                    <P>
                        To better describe tests of auditory function, the CPT created CPT code 92584 (
                        <E T="03">Electrocochleography</E>
                        ) and replaced CPT codes 92585 and 92586 with four new services. We are proposing the RUC-recommended work RVUs of 1.00 for CPT code 92584, 1.00 for CPT code 92X52 (
                        <E T="03">Auditory evoked potentials; for hearing status determination, broadband stimuli, with interpretation and report</E>
                        ), 1.50 for CPT code 92X53 (
                        <E T="03">Auditory evoked potentials; for threshold estimation at multiple frequencies, with interpretation and report</E>
                        ), and 1.05 for CPT code 92X54 (
                        <E T="03">Auditory evoked potentials; neurodiagnostic, with interpretation and report</E>
                        ). CPT code 92X51 (
                        <E T="03">Auditory evoked potentials; screening of auditory potential with broadband stimuli, automated analysis</E>
                        ) is a screening service and is not payable by Medicare. Therefore, we are not proposing a valuation for this code; however, we will display the RUC-recommended work RVU of 0.25.
                    </P>
                    <P>We are proposing the RUC-recommended direct PE inputs for this code family without refinement.</P>
                    <HD SOURCE="HD3">(37) Vestibular Evoked Myogenic Potential Testing (CPT Codes 925X1, 925X2, and 925X3)</HD>
                    <P>
                        In response to a 2017 RAW request, AMA staff compiled a list of CMS/Other codes with Medicare Utilization of 30,000 or more. CPT code 92585 (
                        <E T="03">Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; comprehensive</E>
                        ) was identified as one of the codes. In 2018, the AMA/RUC referred CPT code 92585 and its family member CPT code 92586 (
                        <E T="03">Auditory evoked potentials for evoked response audiometry and/or testing of the central nervous system; limited</E>
                        ) to the February 2019 CPT Editorial Panel meeting to clarify code descriptors and define the terms “limited” and “comprehensive” auditory evoked potentials.
                    </P>
                    <P>
                        During the discussion of CPT codes 92585 and 92586 at the February 2019 CPT Editorial Panel meeting, specialty societies introduced a new procedure, Vestibular Evoked Myogenic Potential (VEMP), and suggested new coding. As a result, the CPT Editorial Panel created 3 new codes: CPT code 925X1 (
                        <E T="03">Vestibular evoked myogenic potential testing, with interpretation and report; cervical (cVEMP)</E>
                        ); CPT code 925X2 (
                        <E T="03">Vestibular evoked myogenic potential testing, with interpretation and report; ocular (oVEMP)</E>
                        ); and CPT code 925X3 (
                        <E T="03">Vestibular evoked myogenic potential testing, with interpretation and report; cervical and ocular</E>
                        ). The RUC reviewed the three codes at its April 2019 meeting.
                    </P>
                    <P>We are proposing the RUC-recommended work RVU of 0.80 for CPT codes 925X1 and 925X2. For CPT code 925X3, we are proposing the RUC-recommended work RVU of 1.20. We also are proposing the RUC-recommended direct PE inputs without refinement for these three VEMP codes.</P>
                    <HD SOURCE="HD3">(38) Complete Electrocardiogram (CPT Codes 93000, 93005, and 93010)</HD>
                    <P>
                        In the CY 2019 PFS final rule (83 FR 59452), CPT code 93000 was nominated for review under the potentially misvalued code initiative. The RUC reviewed these services at the April 2019 meeting where the specialty societies explained that the family of electrocardiogram (ECG) codes were relatively unique in that CPT code 93000 (
                        <E T="03">Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report</E>
                        ) is the global service which is billed in the hospital setting, CPT 93005 (
                        <E T="03">Electrocardiogram, routine ECG with at least 12 leads; tracing only, without interpretation and report</E>
                        ) is the technical component and CPT 93010 is the professional component.
                    </P>
                    <P>We are proposing the RUC-recommended work RVU of 0.17, which is the current value for both codes, for CPT codes 93000 and 93010. CPT code 93005 is a PE only technical component code, and we are proposing to maintain the current work RVU of 0.00.</P>
                    <P>For the direct PE inputs, we are also proposing the RUC-recommended values without refinement.</P>
                    <HD SOURCE="HD3">(39) External Extended ECG Monitoring (CPT Codes 93224, 93225, 93226, 93227, 93XX0, 93XX1, 93XX2, 93XX3, 93XX4, 93XX5, 93XX6, and 93XX7)</HD>
                    <P>In September 2019, the CPT Editorial Panel replaced four Category III codes with 8 new Category I codes to report external electrocardiographic (ECG) recording by continuous rhythm recording and storage for periods longer than 48 hours. The existing Holter monitor codes (CPT codes 93224 through 93227) that include up to 48 hours of continuous recording were also reviewed as part of this family of services at the January 2020 RUC meeting.</P>
                    <P>
                        We are proposing the RUC-recommended work RVU for all 12 codes in the family. We are proposing a work RVU of 0.39 for CPT codes 93224 (
                        <E T="03">External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation by a physician or other qualified health care professional</E>
                        ) and 93227 (
                        <E T="03">External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; review and interpretation by a physician or other qualified health care professional</E>
                        ); a work RVU of 0.50 for CPT codes 93XX0 (
                        <E T="03">
                            External electrocardiographic recording for more than 48 hours up to 7 days by 
                            <PRTPAGE P="50165"/>
                            continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation
                        </E>
                        ) and 93XX3 (
                        <E T="03">External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; review and interpretation</E>
                        ); and a work RVU of 0.55 for CPT codes 93XX4 (
                        <E T="03">External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; includes recording, scanning analysis with report, review and interpretation</E>
                        ) and 93XX7 (
                        <E T="03">External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; review and interpretation</E>
                        ).
                    </P>
                    <P>
                        The other six codes in the family are technical component codes that do not have a work RVU; we are proposing a work RVU of 0.00 for CPT codes 93225 (
                        <E T="03">External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; recording (includes connection, recording, and disconnection)</E>
                        ), 93226 (
                        <E T="03">External electrocardiographic recording up to 48 hours by continuous rhythm recording and storage; scanning analysis with report</E>
                        ), 93XX1 (
                        <E T="03">External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; recording (includes connection and initial recording)</E>
                        ), 93XX2 (
                        <E T="03">External electrocardiographic recording for more than 48 hours up to 7 days by continuous rhythm recording and storage; scanning analysis with report</E>
                        ), 93XX5 (
                        <E T="03">External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; recording (includes connection and initial recording)</E>
                        ), and 93XX6 (
                        <E T="03">External electrocardiographic recording for more than 7 days up to 15 days by continuous rhythm recording and storage; scanning analysis with report</E>
                        ).
                    </P>
                    <P>For the direct PE inputs, we are proposing to refine the clinical labor time for the “Perform procedure/service—NOT directly related to physician work time” (CA021) activity for CPT codes 93XX0, 93XX2, 93XX4, and 93XX6. We are proposing to reduce the clinical labor time by 5 minutes for each code as the description of the tasks taking place in the recommended materials includes activities that are considered to be indirect PE under our methodology. The recommended materials stated that “incoming patch deliveries are sorted and distributed to work queues. The return box is opened, diary book removed, top housing is removed using a custom tool to expose USB connection, and device is plugged in to extract serial number and diagnostic logs.” These unboxing and filing activities are classified as administrative expenses under our PE methodology, and therefore, do not constitute clinical labor as a direct expense. We are proposing to remove 5 minutes from the clinical labor to reflect these activities which are indirect as opposed to direct costs. We are also proposing to refine the equipment time for the desktop computer (ED021) to reflect these changes in the clinical labor time.</P>
                    <P>We noted an inconsistency in the RUC-recommended direct PE inputs for CPT codes 93XX0 and 93XX4. Both of these codes are the “global component” for their respective group of codes, such that the direct costs for CPT codes 93XX1-93XX3 must sum up to the direct cost of CPT code 93XX0 and the direct costs for CPT codes 93XX5 through 93XX7 must sum up to the direct cost of CPT code 93XX4. However, CPT codes 93XX0 and 93XX4 each contained 2 pairs of non-sterile gloves (SB022) whereas their constituent technical component codes (93XX1 and 93XX5 respectively) only contained a single pair of non-sterile gloves. Therefore, we are proposing to refine the quantity of the non-sterile gloves down to 1 pair for CPT codes 93XX0 and 93XX4 to correct this inconsistency. We also considered increasing the quantity of the gloves to 2 as in CPT codes 93224 through 93227. However, we believe that only 1 pair of gloves would typically be needed to attach the ECGs, as the patient does not return to have the ECGs removed in CPT codes 93XX0 through 93XX7 as opposed to CPT codes 93224 through 93227 where the patient does return for ECG removal.</P>
                    <P>We are proposing the RUC-recommended equipment time of 1474 minutes for the Holter monitor (EQ127) equipment included in CPT codes 93224 and 93226, based on an equipment time of 34 minutes during the procedure along with 1440 minutes (24 hours) of equipment time thereafter. We note that an external stakeholder wrote to request that the number of minutes of equipment time for the Holter monitor be increased from 1440 minutes (24 hours) to 2160 minutes (36 hours) to reflect the average length of equipment time. The stakeholder wrote that the 24-hour and 48-hour test were each performed approximately 50 percent of the time and stated that the most accurate number of equipment minutes would be the average time. The RUC disagreed with the stakeholder's request in its review because it concluded that there was insufficient evidence to warrant a change from the current 24 hours of equipment time; the RUC-recommended equipment time for the Holter monitor was based on the typical rather than the average service. We are proposing the RUC-recommended equipment time of 1474 minutes because our PE methodology is indeed based on the typical case, specifically what would be typical and reasonable and necessary for the procedure in question. Although we appreciate the feedback from the stakeholder, our previously finalized PE methodology establishes pricing based on the typical case. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5-year review of work RVUs under the PFS and proposed changes to the PE methodology CY 2007 PFS proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).</P>
                    <P>The recommendations for this family of codes contain one new supply item, the “extended external ECG patch, medical magnetic tape recorder” (SD339). We did not receive a traditional invoice to establish a price for this supply item, instead receiving pricing information from two sources: A weighted median of claims data with the cost of the other direct PE inputs removed, and a top-down approach calculating the cost of the supply per service based on summing the total costs of the provider and dividing by the total number of tests furnished. The former methodology yielded a supply price of approximately $440 while the latter methodology produced an estimated supply price of $416.85. Stakeholders also submitted a series of invoices from the clinical study marketplace with a price of $595. Although we are appreciative of the data provided by the stakeholder, we require an invoice representative of commercial market pricing to establish a national price for a new supply or equipment item. Although we are aware of the unusual circumstances surrounding the “extended external ECG patch, medical magnetic tape recorder” in terms of how it uploads data to the provider, we cannot establish supply pricing based on an analysis of claims data and in absence of a representative invoice.</P>
                    <P>
                        Therefore, we are proposing to employ a crosswalk to an existing supply for use as a proxy price until we have an invoice to use for the “extended external ECG patch, medical magnetic tape recorder” item. We are proposing to use the “kit, percutaneous neuro test stimulation” (SA022) supply as our proxy item at a price of $413.24. 
                        <PRTPAGE P="50166"/>
                        Although this kit is not clinically similar to the extended external ECG patch, we believe that it is the closest match from a pricing perspective to employ as a proxy until we are able to arrive at an invoice that is representative of commercial market pricing. We welcome the submission of invoices or other additional information for use in pricing the “extended external ECG patch, medical magnetic tape recorder” supply.
                    </P>
                    <HD SOURCE="HD3">(40) Complete Transthoracic Echocardiography (TTE) With Doppler (CPT Code 93306)</HD>
                    <P>
                        In the CY 2019 PFS final rule (83 FR 59500), a submitter nominated CPT code 93306 (
                        <E T="03">Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography</E>
                        ) as potentially misvalued, citing GAO, MedPAC, and Urban Institute reports that suggest the work RVUs are overstated. Although the code was most recently surveyed in 2016, the specialty societies and the RUC stated that there has been a change in the technique and technology used to perform the procedure, so they resurveyed the code. The RUC recommended decreasing the work RVU from 1.50 to 1.46 and we are proposing this value.
                    </P>
                    <P>Although we are proposing the RUC's recommended direct PE inputs without refinement we note that the RUC's recommendation included both 25 mL and 50 mL of ultrasound transmission gel. We are proposing a supply quantity of 25 mL and seeking clarification on the correct amount.</P>
                    <HD SOURCE="HD3">(41) Pacing Heart Stimulation (CPT Code 93623)</HD>
                    <P>
                        Review of CPT code 93623 (
                        <E T="03">Programmed stimulation and pacing after intravenous drug infusion (List separately in addition to code for primary procedure)</E>
                        ), was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 30,000 claims in a year. This service is to create an arrhythmia by an intravenous drug infusion and it is an add-on code with 60 minutes of total time and a current work RVU of 2.85.
                    </P>
                    <P>The RUC recommends the 25th percentile survey value of 2.04 work RVUs and 20 minutes of intraservice time.</P>
                    <P>
                        The revision of CPT code 93623 physician's time adjusting from the current 60 minutes to 20 minutes is a significant change. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. In the case of CPT code 93623, we believe that it would be more accurate to propose a work RVU of 0.98 based on CPT code 76810 (
                        <E T="03">Ultrasound, pregnant uterus, real time with image documentation, fetal and maternal evaluation, after first trimester (&gt; or = 14 weeks 0 days), transabdominal approach; each additional gestation (list separately in addition to code for primary procedure)</E>
                        ) with 20 minutes of intraservice time. We are proposing a work RVU of 0.98 with 20 minutes of intraservice time for CPT code 93623.
                    </P>
                    <P>This CPT code is a facility-only service and has no direct PE inputs.</P>
                    <HD SOURCE="HD3">(42) Intracardiac Echocardiography (ECG) (CPT Code 93662)</HD>
                    <P>
                        The review of CPT code 93662 (
                        <E T="03">Intracardiac echocardiography during therapeutic/diagnostic intervention, including imaging supervision and interpretation (List separately in addition to code for primary procedure</E>
                        ), was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 10,000 claims in a year that had an increase in volume by 100 percent between the 2012 to 2017. This procedure has since changed from its last review, in its reduced use of fluoroscopy, now replaced with ultrasound that create arrhythmia mapping systems with intracardiac echo images processed to produce 3-dimensional electroanatomical maps. The physician can now visualize better and have more accurate details for more effective catheter ablation for a wide range of arrhythmias. CPT code 93662 currently has a work RVU of 2.80 with 5 minutes of preservice evaluation time, 55 minutes of intraservice time, 10 minutes of immediate postservice time, and 70 minutes of total time.
                    </P>
                    <P>
                        The survey resulted in a median intraservice time of 25 minutes, a significant shift from the current intraservice time of 55 minutes. The RUC recommends a work RVU of 2.53 and 25 minutes of intraservice time for add-on CPT code 93662. We do not believe the RUC-recommended work RVU appropriately accounts for the substantial reductions in the surveyed work times for the procedure. Although we do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in the valuation of work RVUs, we believe that since the two components of work are time and intensity, significant decreases in time should be appropriately reflected in decreases to work RVUs. CPT code 92979 (
                        <E T="03">Endoluminal imaging of coronary vessel or graft using intravascular ultrasound (ivus) or optical coherence tomography (oct) during diagnostic evaluation and/or therapeutic intervention including imaging supervision, interpretation and report; each additional vessel (list separately in addition to code for primary procedure)</E>
                        ), with 1.44 work RVUs and 25 minutes of intraservice time, is a good equivalent comparator code in light of the significant physician time reduction from 55 minutes. A similarly proportioned reduction of physician intraservice time from the current 55 minutes to the surveyed 25 minutes, if applied to the current work RVU would result in a value much lower than our reference CPT code 92979's work RVU, so we are proposing a work RVU of 1.44 and 25 minutes of intraservice time for add-on CPT code 93662.
                    </P>
                    <P>This CPT code is a facility only service and has no direct PE inputs.</P>
                    <HD SOURCE="HD3">(43) Ventricular Assist Device (VAD) Interrogation (CPT Code 93750)</HD>
                    <P>
                        The review of CPT code 93750, (
                        <E T="03">Interrogation of ventricular assist device (VAD), in person, with physician or other qualified health care professional analysis of device parameters (eg, drivelines, alarms, power surges), review of device function (eg, flow and volume status, septum status, recovery), with programming, if performed, and report</E>
                        ) was prompted by the Relativity Assessment Workgroup Medicare utilization screen of over 10,000 claims in a year and had had an increased in volume by 100 percent between the 2012 to 2017. CPT code 93750 currently has a work RVU of 0.92 with 30 minutes of intraservice time.
                    </P>
                    <P>
                        For physician times, the societies' survey for CPT code 93750 yielded 6 minutes preservice time, 10 minutes intraservice time, 7 minutes immediate post-service time, and 23 minutes of total time. The 25th percentile surveyed work RVU was 0.96. The RUC compared the survey code to CPT code 78598 (
                        <E T="03">Quantitative differential pulmonary perfusion and ventilation (eg, aerosol or gas), including imaging when performed</E>
                        ) (0.85 work RVU and 5 minutes of preservice time, 10 minutes of intraservice time, 9 minutes of immediate postservice time, and total time of 24 minutes). The RUC 
                        <PRTPAGE P="50167"/>
                        recommends crosswalking the work RVU of 0.85 from CPT code 78598 to 93750.
                    </P>
                    <P>
                        CPT code 93289 (
                        <E T="03">Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including analysis of heart rhythm derived data elements</E>
                        ), with 0.75 work RVUs and 5 minutes of preservice time, 10 minutes of intraservice time, 8.5 minutes of immediate postservice time, and total time of 23.5 minutes, we believe is a more precise comparator code. CPT code 93289's intraservice times, pre and post times, and total times are almost identical to CPT code 93750's survey times, so we are proposing a work RVU of 0.75 and 23 minutes of total time for CPT code 93750.
                    </P>
                    <P>The PE Subcommittee corrected the equipment times based on the formulas as provided by CMS. In addition, the PE Subcommittee changed the clinical staff type for direct labor item ID CA013 Prepare Room, Equipment and Supplies, from an RN to the RN/LPN/MTA blend and the direct equipment item ID EQ168 light, exam was removed from CPT code 93750. We are proposing to accept the RUC-recommended direct PE inputs.</P>
                    <HD SOURCE="HD3">(44) Spirometry (CPT Codes 94010 and 94060)</HD>
                    <P>
                        CPT code 94010 (
                        <E T="03">spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation</E>
                        ) and CPT code 94060 (
                        <E T="03">Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator administration</E>
                        ) were identified as part of a Relativity Assessment Workgroup (RAW) review of action plans on the status of services that were RUC referrals to develop CPT Assistant articles. These codes were recommended to be surveyed.
                    </P>
                    <P>
                        We are proposing the RUC-recommended work RVU of 0.17 for CPT code 94010 (
                        <E T="03">spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation</E>
                        ) and the RUC-recommended work RVU of 0.22 for CPT code 94060 (
                        <E T="03">Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator administration</E>
                        ). We are proposing the RUC-recommended direct PE inputs for this code family without refinements.
                    </P>
                    <HD SOURCE="HD3">(45) Exercise Test for Bronchospasm (CPT Codes 946X0, 94617, 94618, and 94621)</HD>
                    <P>
                        In 2018, the CPT Editorial Panel created CPT code 94617 (
                        <E T="03">Exercise test for bronchospasm, including pre- and post-spirometry, electrocardiographic recording(s), and pulse oximetry</E>
                        ), and CPT code 94618 (
                        <E T="03">Pulmonary stress testing (eg, 6-minute walk test), including measurement of heart rate, oximetry, and oxygen titration, when performed</E>
                        ) from the now deleted CPT code 94620 (
                        <E T="03">Pulmonary stress testing; simple (eg, 6-minute walk test, prolonged exercise test for bronchospasm with pre- and post-spirometry and oximetry)</E>
                        ), and revised CPT code 94621 (
                        <E T="03">Cardiopulmonary exercise testing, including measurements of minute ventilation, co2 production, o2 uptake, and electrocardiographic recordings</E>
                        ) to better describe the specialty's pulmonary exercise test. Shortly after the creation and revision of these codes, the specialty society became aware of some providers performing CPT code 94617 without ECG monitoring, so to more accurately account for this work without the ECG monitoring, The CPT Editorial Panel proposed to establish CPT code 946X0 with the descriptor, (
                        <E T="03">Exercise test for bronchospasm, including pre- and post-spirometry and pulse oximetry; without electrocardiographic recording(s)</E>
                        ). For the October 2019 RUC meeting, the specialty societies surveyed CPT code 946X0, and included a request to reaffirm the values of the rest of the codes in the code family.
                    </P>
                    <P>For CPT code 946X0, the surveyed physician time yielded 5 minutes of preservice time, 9 minutes of intraservice time, followed by 10 minutes of immediate post-service time, for a total time of 24 minutes. This distribution of physician times is of course very similar to the times for CPT code 94617, total time of 26 minutes, except without the task of including an electrocardiographic recording. The RUC recommends the survey's median work RVU of 0.49 for CPT code 946X0.</P>
                    <P>We are proposing the RUC's recommendation of a work RVU of 0.49 and a total physician time of 24 minutes for CPT code 946X0.</P>
                    <P>This CPT family of codes that includes CPT code 946X0, are CPT codes 94617, 94618, and 94621 and there are no changes to their physician service times, no change to their descriptors, nor their work RVUs, and remain as they currently are. The specialty societies reaffirmed these current valuations and we propose to accept them without change.</P>
                    <P>We are proposing the RUC-recommended PE changes without refinement.</P>
                    <HD SOURCE="HD3">(46) Evaluation of Wheezing (CPT Codes 94640, 94667, 94668, and 94669)</HD>
                    <P>
                        At the April 2019 RUC meeting, four PE only CPT codes from the Evaluation of Wheezing code family were reviewed. The codes included CPT codes 94640 (
                        <E T="03">Pressurized or nonpressurized inhalation treatment for acute airway obstruction for therapeutic purposes and/or for diagnostic purposes such as sputum induction with an aerosol generator, nebulizer, metered dose inhaler or intermittent positive pressure breathing (IPPB) device</E>
                        ), 94667 (
                        <E T="03">Manipulation chest wall, such as cupping, percussing, and vibration to facilitate lung function; initial demonstration and/or evaluation</E>
                        ), 94668 (
                        <E T="03">Manipulation chest wall, such as cupping, percussing, and vibration to facilitate lunch function; subsequent</E>
                        ), and 94669 (
                        <E T="03">Mechanical chest wall oscillation to facilitate lung function, per session</E>
                        ).
                    </P>
                    <P>We are proposing the RUC-recommended direct PE inputs for the four PE only codes. The RUC did not recommend work RVUs and we are proposing to maintain the current work RVU of 0.00 for all four codes.</P>
                    <HD SOURCE="HD3">(47) Exhaled Nitric Oxide Measurement (CPT Code 95012)</HD>
                    <P>
                        In January 2019, the RAW reviewed services with 2017 Medicare utilization of 10,000 or more that had increased by at least 100 percent from 2012 through 2017. The RUC recommended that CPT code 95012 (
                        <E T="03">Nitric oxide expired gas determination</E>
                        ) be surveyed for the April 2019 meeting. We are proposing the direct PE inputs for CPT code 95012 without refinement. CPT code 95012 is a PE-only code with no work RVU, and we are proposing to maintain the current work RVU of 0.00.
                    </P>
                    <HD SOURCE="HD3">(48) Acupuncture Services (CPT Codes 97810, 97811, 97813, and 97814)</HD>
                    <P>
                        The CPT Editorial Panel created two new codes and two new add-on codes in 2004 to describe the appropriate time or additional time and levels of service that can be performed using acupuncture and electroacupuncture, acupuncture therapy with electrical stimulation. These codes were designated as noncovered services since Medicare did not reimburse for acupuncture services at the time. In January 2020, we issued a decision memo stating that Medicare will cover acupuncture for chronic low back pain 
                        <PRTPAGE P="50168"/>
                        under section 1862(a)(1)(A) of the Act (CAG-00452N). This was reflected in the April 2020 PFS Quarterly Update which changed CPT codes 97810 through 97814 to active payment status (CMS Change Request 11661). Because we had never conducted a review of these four acupuncture codes, the CY 2020 payment rate consisted of the work RVUs recommended by the RUC in 2004.
                    </P>
                    <P>
                        For CY 2021, we are proposing to establish work RVUs for these four acupuncture codes based on a pair of crosswalks to two recently reviewed codes in the Dry Needling family. We are proposing a work RVU of 0.48 for CPT codes 97810 (
                        <E T="03">Acupuncture, 1 or more needles; without electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient</E>
                        ) and 97813 (
                        <E T="03">Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient</E>
                        ) based on a crosswalk to CPT code 20561 (
                        <E T="03">Needle insertion(s) without injection(s); 3 or more muscles</E>
                        ). We are proposing a work RVU of 0.32 for CPT codes 97811 (
                        <E T="03">Acupuncture, 1 or more needles; without electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s)</E>
                        ) and 97814 (
                        <E T="03">Acupuncture, 1 or more needles; with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s)</E>
                        ) based on a crosswalk to CPT code 20560 (
                        <E T="03">Needle insertion(s) without injection(s); 1 or 2 muscle(s)</E>
                        ).
                    </P>
                    <P>CPT codes 20560 and 20561 are clinically similar services associated with dry needling that were reviewed last year for CY 2020. We finalized work RVUs of 0.32 and 0.48 respectively for these two codes following our review of their associated RUC recommendations, while noting that dry needling services were non-covered by Medicare unless otherwise specified through a national coverage determination (NCD) (84 FR 62722 through 62724). Like the acupuncture codes, CPT codes 20560 and 20561 were updated to active payment status in the April 2020 PFS Quarterly Update to reflect the Medicare coverage of acupuncture for chronic low back pain. We note that CPT codes 97810 and 97813 share the identical work time values with CPT code 20561, and that CPT codes 97811 and 97814 differ from CPT code 20560 by only 1 minute of work time, 15 minutes as compared to 16 minutes. Although we do not imply that codes with similar work times must equate to a one-to-one or linear relationship in the valuation of work RVUs, we believe that, since the two components of work are time and intensity, clinically related services with similar intensities and work times should, generally speaking, be valued similarly. Due to the similar clinical nature of these services and their nearly identical work times, we believe that it is more accurate to propose crosswalking CPT codes 97810 through 97814 to the work RVUs of the Dry Needling codes, which were finalized last year, as opposed to proposing work RVUs from 2004, which were never reviewed by CMS.</P>
                    <P>The RUC did not make any recommendations and we are not proposing any changes to the direct PE inputs for CPT codes 97810 through 97814.</P>
                    <HD SOURCE="HD3">(49) Chronic Care Management Services (CPT Code 994XX and HCPCS Code G2058)</HD>
                    <P>
                        We established payment for HCPCS code G2058 (
                        <E T="03">Chronic care management services, each additional 20 minutes of clinical staff time directed by a physician or other qualified healthcare professional, per calendar month</E>
                        ) in the CY 2020 PFS final rule (84 FR 62690). At the January 2020 RUC meeting, specialty societies requested a temporary crosswalk through CY 2021 between the value established by CMS for HCPCS code G2058 and the value of new CPT code 994XX (with a descriptor identical to G2058). The Chronic Care Management code family will be resurveyed during CY 2020 and is expected to be presented for review as part of the 2022 RUC review process.
                    </P>
                    <P>For CY 2021, we are proposing the RUC-recommended work RVU of 0.54 and the RUC-recommended direct PE inputs for CPT code 994XX.</P>
                    <HD SOURCE="HD3">(50) External Counterpulsation (HCPCS Code G0166)</HD>
                    <P>In the CY 2020 PFS proposed rule (84 FR 40516), an external stakeholder nominated HCPCS code G0166 as potentially misvalued due to concerns that the PE RVUs for this code did not fully reflect the total resources required to deliver the service and CMS proposed G0166 as potentially misvalued. The RUC reviewed the direct PE inputs for HCPCS code G0166 at the October 2019 RUC meeting.</P>
                    <P>We are proposing the RUC-recommended preservice period, service period and postservice period with refinements. We propose to replace CA010 (obtain vital signs) during the postservice of service period with CA023 (monitor patient following procedure/service, no multitasking).</P>
                    <P>For the equipment items, we are proposing to update the price of the “EECP, external counterpulsation system” (EQ012) equipment to $101,247.50 based on an average of the five invoices submitted along with the recommendations. We note that the EQ012 equipment is the only current equipment item in our direct PE database with an equipment utilization rate of 25 percent and the only equipment item with a utilization rate under 50 percent. Although we are not proposing to change the equipment utilization rate, we are soliciting feedback from commenters regarding the utilization rate for the EQ012 equipment to help us understand why it should differ from all other medical equipment.</P>
                    <P>We also received invoices for a series of additional equipment items: An EECP service contract, an EECP compression equipment package, and an EECP electrical equipment package. We are not proposing to establish a price for the EECP service contract, as service contracts are considered to be an administrative expense and a form of indirect PE under our methodology. As for the two equipment packages, there were a number of unusual factors involving these items that created difficulties for our equipment methodology. Both equipment packages had a suggested utilization rate of 25 percent, half of our typical utilization rate of 50 percent, and both had a suggested useful life duration of only 3 months. As we stated in section II.B. of this proposed rule, Determination of Practice Expense RVUs, we have concerns that assigning very low useful life durations to this type of equipment would fail to maintain relativity with other equipment on the PFS. We also noted that the equipment cost per minute formula was designed under the assumption that each equipment item would remain in use for a period of several years and depreciate over that span of time. Our current equipment formula is not designed to address cases in which equipment is replaced multiple times per year, and we believe that applying a multi-year depreciation in these situations would not be reflective of market pricing. Although we agree that these costs should be reflected in the pricing of HCPCS code G0166, we believe that the very frequent replacement of the items in the two equipment packages makes them a poor fit under our equipment methodology.</P>
                    <P>
                        Therefore, we are proposing to treat the two EECP equipment packages as supplies instead of treating them as equipment. We are proposing to establish the EECP compression 
                        <PRTPAGE P="50169"/>
                        equipment package (SD341) as a supply with a cost of $645 based on an average of the submitted invoices, and proposing to establish the EECP electrical equipment package (SD342) as a supply with a cost of $500 again based on an average of the submitted invoices. Based on information provided by stakeholders, we are proposing a supply quantity of 1/325 for these two items (0.00308) based on the supply being used on average five times per day and replaced every 3 months (5 uses * 5 days * 13 weeks = 325). We believe that assigning these two items as supplies rather than equipment more accurately captures the unusual circumstances associated with providing this service.
                    </P>
                    <HD SOURCE="HD3">(51) Molecular Pathology Interpretation (HCPCS Code G0452)</HD>
                    <P>
                        At the October 2018 RUC meeting, the Relativity Assessment Workgroup (RAW) identified HCPCS code G0452 (
                        <E T="03">Molecular pathology procedure; physician interpretation and report</E>
                        ) as potentially misvalued on a CMS/Other screen. The RUC had never reviewed HCPCS code G0452 and assumptions regarding work and time were based upon a 1995 vignette. In addition, the specialty society noted that the technology available for furnishing the service, as well as the patient population receiving the service, had changed since the code was valued by CMS.
                    </P>
                    <P>The RUC requested a physician work survey be completed for the October 2019 RUC meeting. It was during the October meeting that the work and PE values for HCPCS code G0452 were reviewed and recommended.</P>
                    <P>For CY 2021, we are proposing the RUC-recommended work RVU of 0.93 and the RUC-recommended direct PE inputs for HCPCS code G0452.</P>
                    <HD SOURCE="HD3">(52) Evaluation and Management, Observation and Provision of Self-Administered Esketamine (HCPCS Codes G2082 and G2083)</HD>
                    <P>
                        In the CY 2020 PFS final rule (84 FR 63102 through 63104), we issued an interim final rule with comment period (IFC) to establish coding and payment for E/M, observation, and the provision of self-administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible. We created two new HCPCS G codes, G2082 and G2083, effective January 1, 2020 on an interim final basis. For CY 2020, we established RVUs for these services that reflect the relative resource costs associated with the E/M, observation and provision of the self-administered esketamine product. The HCPCS G-codes are described as follows: HCPCS code G2082 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of up to 56 mg of esketamine nasal self-administration, includes 2 hours post-administration observation</E>
                        ) and HCPCS code G2083 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of an established patient that requires the supervision of a physician or other qualified health care professional and provision of greater than 56 mg esketamine nasal self-administration, includes 2 hours post-administration observation</E>
                        ).
                    </P>
                    <P>
                        In developing the interim final values for these codes, we used a building block methodology that sums the values associated with several codes. For the overall E/M and observation elements of the services, we incorporated the work RVUs, work time and direct PE inputs associated with a level two office/outpatient visit for an established patient, CPT code 99212 (
                        <E T="03">Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: A problem focused history; A problem focused examination; Straightforward medical decision making. Counseling and/or coordination of care with other physicians, other qualified health care professionals, or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor. Typically, 10 minutes are spent face-to-face with the patient and/or family</E>
                        ), which has a work RVU of 0.48 and a total work time of 16 minutes, which is based on a pre-service evaluation time of 2 minutes, an intraservice time of 10 minutes, and a postservice time of 4 minutes.
                    </P>
                    <P>
                        We also incorporated CPT codes 99415 (
                        <E T="03">Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; first hour (List separately in addition to code for outpatient Evaluation and Management service)</E>
                        ) and 99416 (
                        <E T="03">Prolonged clinical staff service (the service beyond the typical service time) during an evaluation and management service in the office or outpatient setting, direct patient contact with physician supervision; each additional 30 minutes (List separately in addition to code for prolonged service)</E>
                        ) in which neither code has a work RVU, but includes direct PE inputs reflecting the prolonged time for clinical staff under the direct supervision of the billing practitioner.
                    </P>
                    <P>Additionally, to account for the cost of the provision of the self-administered esketamine as a direct PE input, we incorporated the wholesale acquisition cost (WAC) data from the most recent available quarter. For HCPCS code G2082, we are using a price of $590.02 for the supply input that describes 56 mg (supply code SH109) and for HCPCS code G2083, we are using a price of $885.02 for the supply input describing 84 mg of esketamine (supply code SH110).</P>
                    <P>We sought comment on the interim final values we established for HCPCS codes G2082 and G2083, including the assigned work RVUs, work times, and direct PE inputs. We received public comments on this policy. The following is a summary of the comments we received and our responses.</P>
                    <P>
                        <E T="03">Comment:</E>
                         Overall, commenters were supportive of CMS establishing coding and payment for E/M, observation and the provision of self-administered esketamine. However, a few commenters were not in support of the proposal, noting that IV ketamine is cheaper and has been proven to be more effective than esketamine.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the support for our interim final rule with comment period. We continue to believe that it is in the public interest to ensure beneficiaries have access to new, potentially life-saving treatment for treatment-resistant depression (TRD) using esketamine. Therefore, we are proposing to maintain HCPCS codes G2082 and G2083 that describe E/M, observation and the provision of self-administered esketamine.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters suggested including psychotherapy, CPT codes 90833 and 90836, in the valuation of HCPCS codes G2083 and G2083.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We disagree that psychotherapy should be included in the valuation of HCPCS codes G2082 and G2083. HCPCS codes G2082 and G2083 were created to establish coding and payment for E/M, observation and the provision of self-administered esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible. However, practitioners who furnish other allowable, billable services, including psychotherapy, on the same day as an E/M, observation and provision of self-administered esketamine service can bill separately for those services using other codes.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters recommended that esketamine should 
                        <PRTPAGE P="50170"/>
                        have its own J code in addition to the G codes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         HCPCS codes G2082 and G2083 are bundled services that include, as discussed previously, the E/M, observation and the provision of self-administered esketamine. The self-administered esketamine is considered a supply item for this bundled service. Therefore, esketamine cannot be billed separately along with HCPCS codes G2082 and G2033 under the PFS.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Several commenters disagreed with the use of 99212 to establish codes G2082 and G2083. Commenters suggested using 99213, 99214, and/or 99215 instead of 99212. Some commenters indicated that the intraservice work time of 10 minutes is insufficient, and one commenter stated a minimum of 20 minutes would be more appropriate. Another commenter suggested unbundling the code and, in part, indicated that face-to-face visits with the psychiatrist are not required at each visit.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         We appreciate the feedback received from the commenters regarding the E/M elements of the service. We have considered the wide range of recommendations that were received from commenters regarding the E/M elements of the service. One commenter indicated that there is variability in performance and level of E/M services associated with the service (in which self-administered esketamine is provided and observed). Another commenter noted that a face-to face visit with the psychiatrist is not required at each visit, while other commenters recommended using E/M CPT codes up to 99215. We continue to believe that the building block methodology we used incorporating CPT code 99212 is appropriate for valuing this service. Therefore, we are not proposing to change the E/M element of the service by incorporating the work RVUs, work time and direct PE input associated with a level two office/outpatient visit for an established patient, CPT code 99212.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Many commenters urged CMS to ensure PFS payment rates are sufficient to capture the complexity and time for the provision of esketamine.
                    </P>
                    <P>A commenter recommended unbundling all the services. The commenter stated that the way the bundled payments are currently constructed fails to recognize the possible variability of E/M services that may be required, the time and effort required of clinical staff to monitor the patient during the lengthy observation period, and the amount of pre- and post-service work required. The commenter also stated that bundling the physician E/M services and the observation services performed by clinical staff is problematic and including the medication in the bundle is problematic because in many instances the psychiatrist may not be incurring the cost of the medication. The commenter stated that clinical staff time and effort comprise a significant and separate service, including not only the time spent observing and actively monitoring the patient's condition for possible adverse side-effects (that is, nausea, vomiting, escalation in blood pressure), but also extensive pre- and post-service preparation that does not appear to have been included as part of the bundled payment and is not described by existing CPT codes.</P>
                    <P>
                        The commenter recommended increasing the proposed valuation of clinical staff time to more appropriately account for the clinical staff time and the effort required for pre-, intra-, and post- service work. This includes acquisition of the drug, delivery of the medication to the patient, and the observation of the self-administration, followed by active monitoring of the patient's condition (vitals, etc.) for a minimum of 2 hours, the commenter suggested that the more appropriate comparison for the clinical staff time related to the 2-hour observation period is 95076, 
                        <E T="03">Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); initial 120 minutes of testing</E>
                         (110 minutes intra service time; PE RVU 1.81). Both services, the G2082 and G2083 codes and the 95076, require a lengthy observation time (minimum of 2 hours) with clinical staff monitoring for adverse side-effects. The total PE RVU of the 95076 is 1.81 RVUs versus 0.51 RVUs (99415 × 1, 99416 × 2 or 0.27 + (0.12 × 2) = 0.51 RVUs) of the combined 99415 and 99416. The associated add-on code for 95076 is 95079, 
                        <E T="03">Ingestion challenge test (sequential and incremental ingestion of test items, e.g., food, drug or other substance); each additional 60 minutes of testing (List separately in addition to code for primary procedure)</E>
                         (40 minutes intra-service time; PE RVU 0.99), which would account for additional time for this service when required. Procedurally these services are similar in staff time, staff type and effort, and both are reported separately from the E/M service. The commenter requested that we use the PE RVUs for the 95076 and the 95079 in lieu of the 99415 and 99416 in calculating the values for the clinical staff component, to more accurately reflect the time and effort of the clinical staff in the observation of the patient.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         After consideration of comments requesting that we reconsider aspects of our current valuation for these services, including at least 2 hours of post-administration observation, we believe some of the refinements discussed by stakeholders may be appropriate to improve payment accuracy and help ensure that beneficiaries who need esketamine for treatment have access to it. Based on our review of the Spravato Prescribing Information, Medication Guide and REMS requirements, the FDA-approved conditions/requirements indicate that the drug is only available as an integral component of a physician's service.
                        <SU>8</SU>
                         
                        <SU>9</SU>
                         
                        <SU>10</SU>
                        <FTREF/>
                         Spravato is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients.
                        <SU>11</SU>
                        <FTREF/>
                         Therefore, we continue to believe this treatment should be paid for as a bundled service. In consideration of the comment urging us to account for clinical staff time spent observing and actively monitoring the patient for possible side-effects, along with pre- and post-service preparation, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and the 95079 in lieu of the clinical labor time of CPT codes 99415 and 99416. We are specifically proposing 150 minutes of observation time for HCPCS codes G2082 and G2083 based on the sum of the clinical labor for CPT code 95076 (110 minutes) and CPT code 95079 (40 minutes). This would replace our previous interim final valuation of 30 minutes of observation time based on the sum of the clinical labor for CPT code 99415 (15 minutes) and two billings of CPT code 99416 (8 minutes). We are seeking comment on this proposal. Additionally, under circumstances where the health care professional supervising the self-administration and observation does not also provide the esketamine product, the physician or practitioner cannot report HCPCS codes G2082 or G2083. Rather, the visit and the extended observation (by either the billing professional or clinical staff) could be reported using the existing E/M codes that describe the visit and the prolonged 
                        <PRTPAGE P="50171"/>
                        service of the professional or the clinical staff.
                    </P>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&amp;REMS=386.</E>
                        </P>
                        <P>
                            <SU>9</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf.</E>
                        </P>
                        <P>
                            <SU>10</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211243s003lbl.pdf#page=38.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&amp;REMS=386.</E>
                        </P>
                    </FTNT>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter urged CMS to align the HCPCS codes G2082 and G2083 for a visit for the provision of esketamine with prescribing recommendations from the drug manufacturer that include at least 2 hours of post-administration observation until a patient is safe to leave the facility. Another commenter questioned whether the codes should be valued using CPT codes 99213, 99214 and even 99215, with 99354 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)) and 99355 (Prolonged evaluation and management or psychotherapy service(s) (beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; each additional 30 minutes (List separately in addition to code for prolonged service)).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As previously stated, we are proposing to continue valuing HCPCS codes G2082 and G2083, in part, on the basis of a level 2 established patient office/outpatient E/M visit. However, as previously stated, after considering comments regarding the esketamine post-administration observation time, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and the 95079, specifically proposing 150 minutes of observation time. We are seeking comment on this proposal.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         Some commenters indicated that the proposed PE inputs do not reflect the costs of, and overall drug cycle management needed to safely administer, esketamine. One commenter indicated that, after conducting an analysis associated with each patient encounter to include: Physician time and technician time, reception time, rent, furniture, monitoring, electronic health record (EHR), supplies, waste management, etc., their direct overhead cost is $1000 per patient per encounter, not including direct cost and management of the drug. Therefore, the commenter recommends we revise payment by adding 20 percent to the direct expense and mandatory overhead costs of $1000 per patient encounter. Some commenters indicated that the proposed PE inputs do not reflect the costs of initial capital requirements for ongoing resources, maintaining the Risk Evaluation and Mitigation Strategy (REMS) standards with the FDA and overall drug cycle management needed to safely administer esketamine. Specifically, one commenter indicated that Spravato will need to be delivered in the community setting. A typical community psychiatry practice does not have a large enough physical plant to accommodate a 2 hour monitoring period, requiring a lease or purchase of additional space. In addition, Spravato requires administrative support for medication procurement, appropriate storage equipment (for example, Pyxis machine or similar) to mitigate abuse and diversion potential, medically appropriate staffing (for the required observation of self-administration, multiple vital signs checks, completion of REMS monitoring forms and other administrative requirements of the REMS, and discharge assessment), and equipment and services including a chair that can recline and controlled substance waste removal compliance. One commenter indicated that the pricing methodology used for esketamine, whether WAC, ASP or compendia pricing, does not take into account the costs associated with full-management of the drug cycle including ordering, storage, inventory tracking, billing, etc. Therefore, the commenter recommends valuing the bundled esketamine by adding 20 percent to ASP.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Under our PE methodology, the costs identified by the commenter for reception time, rent, furniture, electronic health records (EHRs), and waste management are all types of indirect costs. This means that they are not individually allocable to a particular patient for a particular service, and therefore they are not summed up as separate itemized direct costs for codes such as HCPCS codes G2082 and G2083. CMS is still paying practitioners for these costs through our indirect PE methodology; we note that for a typical HCPCS code, indirect costs make up roughly 75 percent of the total PE. If we were to itemize administrative costs such as rent and furniture as direct costs, we would be double counting them in violation of our standard PE methodology. As previously discussed, we are proposing to refine the direct PE inputs of HCPCS codes G2082 and G2083, in part, by using the clinical labor time for CPT codes 95076 and 95079, in lieu of the clinical labor time of CPT codes 99415 and 99416 to account for the clinical staff time, such that the proposed refinements would increase the clinical labor time from 30 minutes to 150 minutes. We believe this refinement would account for the clinical staff time and efforts including the acquisition and delivery of the medication to the patient as required by the REMS.
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter requested clarification on whether payment is fixed for 2020 or whether the payment will be adjusted to reflect 2020 changes in WAC, for example updated data made available from the most recent quarter. The commenter also questioned whether regulatory changes made under the PFS to values of the component services would also be applied to the G codes, for example, whether changes to values of the E/M codes would also be incorporated into the RVU inputs for G codes. For instance the outpatient E/M values are set to increase in 2021, and the commenter asked whether that increase would automatically be included in the valuation of the bundle, and whether the payment currently ascribed to the bundle for the cost of the medication be updated if the input prices for the services change over time.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Historically, supply input prices are updated on a code-by-code basis and periodically through annual notice and comment rulemaking. The prices, including for a variety of pharmaceutical products, are not routinely updated like Part B drugs paid under the ASP methodologies. For the supply inputs for the esketamine product used in developing rates for HCPCS codes G2082 and G2083, we used the most recent available quarter of WAC data for 2020 pricing, but we anticipate using either data reported for purposes of determining payments under section 1847A of the Act (such as ASP) or compendia pricing information (such as WAC) in future years. Since we reviewed and are proposing refinements to HCPCS codes G2082 and G2083 for the CY 2021 rulemaking cycle, we propose to update the payment to reflect the most recent available quarter of WAC data for CY 2021 pricing, and propose to update the payment to reflect the E/M values (CPT code 99212) for CY 2021. Therefore, to account for the cost of the provision of the self-administered esketamine as a direct PE input, we incorporated the wholesale acquisition cost (WAC) data from the most recent available quarter. For HCPCS code G2082, we propose to update the supply input that describes 56 mg (supply code SH109) from a price of $590.02 to $616.93 and for HCPCS code G2083, we propose to update the price from $885.02 to $928.38 for the supply input 
                        <PRTPAGE P="50172"/>
                        describing 84 mg of esketamine (supply code SH110).
                    </P>
                    <P>
                        <E T="03">Comment:</E>
                         One commenter indicated that the CMS approach to the E/M component of the interim G codes includes inputs associated with an established patient for the first visit or any subsequent treatment, and requested clarification that, if reasonable and necessary, the health care provider could complete an E/M service that is distinct from the E/M services necessary for esketamine administration, and in such an event, separate E/M service would be eligible to be paid separately with E/M codes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Given that HCPCS codes G2082 and G2083 already take into account E/M services in their valuations, it would be duplicative to bill for a separate E/M code along with HCPCS codes G2082 and G2083. However, other reasonable and necessary E/M services may be furnished and billed for a patient on dates before and after HCPCS code G2082 or G2083, for example, when the services are furnished in the course of treating and diagnosing treatment-resistant depression.
                    </P>
                    <P>After considering the comments we received, we are proposing to refine the values for HCPCS codes G2082 and G2083 using a building block methodology that sums the values associated with several codes. For the overall E/M and observation elements of the services, we are incorporating the work RVUs, work time and direct PE inputs associated with a level two office/outpatient visit for an established patient, CPT code 99212. We are also proposing to include the clinical labor for CPT 95076 and 95079 (in lieu of CPT codes 99415 and 99416 as detailed earlier); and to account for the cost of the provision of the self-administered esketamine as a direct PE input, we are proposing to incorporate the wholesale acquisition cost (WAC) data from the most recent available quarter. We are seeking comment on this updated payment proposal and valuation of HCPCS code G2082 and G2083.</P>
                    <HD SOURCE="HD3">(53) Bundled Payments Under the PFS for Substance Use Disorders (HCPCS Codes G2086, G2087, and G2088)</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62673), we finalized the creation of new coding and payment describing a bundled episode of care for the treatment of Opioid Use Disorder (OUD). The codes and descriptors we finalized for CY 2020 were:</P>
                    <P>
                        • HCPCS code G2086: 
                        <E T="03">Office-based treatment for opioid use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month.</E>
                    </P>
                    <P>
                        • HCPCS code G2087: 
                        <E T="03">Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.</E>
                    </P>
                    <P>
                        • HCPCS code G2088: 
                        <E T="03">Office-based treatment for opioid use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure).</E>
                    </P>
                    <P>As noted in the CY 2020 PFS final rule (84 FR 62673), if a patient's treatment involves MAT, this bundled payment would not include payment for the medication itself. Billing and payment for medications under Medicare Part B or Part D would remain unchanged.</P>
                    <P>We have received requests to expand these bundled payments to be inclusive of other SUDs, not just OUD. We agree that doing so could expand access to needed care. We are proposing to expand these bundled payments to be inclusive of all SUDs. To accomplish this, we are proposing to revise the code descriptors for HCPCS codes G2086, G2087, and G2088 by replacing “opioid use disorder” with “a substance use disorder.” The payment and billing rules would otherwise remain unchanged. We note that HCPCS codes G2086, G2087, and G2088 were added to the Medicare Telehealth list in the CY 2020 PFS final rule (84 FR 62628). The proposed revised code descriptors are:</P>
                    <P>
                        • HCPCS code G2086: 
                        <E T="03">Office-based treatment for a substance use disorder, including development of the treatment plan, care coordination, individual therapy and group therapy and counseling; at least 70 minutes in the first calendar month.</E>
                    </P>
                    <P>
                        • HCPCS code G2087: 
                        <E T="03">Office-based treatment for a substance use disorder, including care coordination, individual therapy and group therapy and counseling; at least 60 minutes in a subsequent calendar month.</E>
                    </P>
                    <P>
                        • HCPCS code G2088: 
                        <E T="03">Office-based treatment for a substance use disorder, including care coordination, individual therapy and group therapy and counseling; each additional 30 minutes beyond the first 120 minutes (List separately in addition to code for primary procedure).</E>
                    </P>
                    <P>Additionally, in the CY 2020 PFS final rule we stated that we anticipate that the services described by HCPCS codes G2086, G2087, and G2088 would often be billed by addiction specialty practitioners, but note that these codes are not limited to any particular physician or nonphysician practitioner (NPP) specialty. We also noted that consultation was not a required condition of payment for these codes, but that consultation with a specialist could be counted toward the minutes required for billing HCPCS codes G2086, G2087, and G2088 (84 FR 62674). Although it is not a requirement for billing the code, we encourage that practitioners consult with specialists in cases where it is warranted and refer the patient to specialty care as needed.</P>
                    <P>We note that while these codes describe treatment for any SUD, information about which specific SUDs are being treated would provide valuable information that can help assess local, state, and national trends and needs. We believe it is important that the diagnosis codes listed on the claim form reflect all SUDs being treated, however, we also do not wish to add any additional burden on practitioners related to claims submission, therefore, we are seeking information on whether there are sources of data we could explore in order to provide this information. We are also seeking information on whether there are differences in the resource costs associated with furnishing services for the various SUDs, and accordingly whether there is a need for more stratified coding to describe these services. We note that in some instances, the CPT Editorial Panel has created CPT codes to replace G codes created by CMS, and that we would welcome such input on these services. We look forward to receiving public comments on this proposal in order to help evaluate whether more granular coding is needed.</P>
                    <HD SOURCE="HD3">(54) Initiation of Medication Assisted Treatment (MAT) in the Emergency Department (HCPCS Code GMAT1)</HD>
                    <P>
                        In the CY 2020 PFS proposed rule (84 FR 40545), we sought comment on the use of medication assisted treatment (MAT) in the emergency department (ED) setting, including initiation of MAT and the potential for either referral or follow-up care, to better understand typical practice patterns to help inform whether we should consider making separate payment for such services in future rulemaking. We note that the term MAT generally refers to treatment of OUD that includes both an FDA-approved medication for the treatment of OUD and behavioral/psychosocial treatment, but that care provided in the ED typically would include medication for the treatment of OUD and referral or linkage to primary care or a hospital-
                        <PRTPAGE P="50173"/>
                        based bridge clinic for continuation of medication and potentially other services, including counseling and other psychosocial services.
                    </P>
                    <P>
                        The public comments received in response to the comment solicitation were supportive of us making a proposal, several citing research that indicates improved outcomes for patients who initiate medications for the treatment of OUD in the ED. One commenter noted that by implementing this treatment regimen, practitioners can address a patient's immediate withdrawal symptoms, which allows time to coordinate care and provide a referral to substance use disorder specialists and other community resources who can appropriately carry out long-term treatment. Another commenter cited that the national rate of overdose-related visits seen in EDs nearly doubled between 2005 and 2014 and noted that hospital-based care represents a critical opportunity to initiate treatment and connect patients with OUD to care, noting that patients who receive information about drug treatment in the hospital post-overdose are more likely to seek treatment.
                        <SU>12</SU>
                        <FTREF/>
                         The commenter also cited a randomized clinical trial that showed that more patients were engaged in treatment 30 days after buprenorphine was initiated in the ED and coupled with a referral, compared to interventions that did not include buprenorphine.
                        <SU>13</SU>
                        <FTREF/>
                         Another study found that ED induction of buprenorphine was more cost-effective than either brief intervention or referral upon discharge.
                        <SU>14</SU>
                        <FTREF/>
                         One commenter suggested that CMS institute a G-code to address this coding gap in the short term, while a more permanent solution is pursued to address this site-of-service specification.
                    </P>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             Agency for Healthcare Research and Quality, “Statistical Brief #219: Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009-2014,” (2017), 
                            <E T="03">https://www.hcup-us.ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             Gail D'Onofrio et al., “Emergency Department-Initiated Buprenorphine/Naloxone Treatment for Opioid Dependence Randomized Clinical Trial,” 
                            <E T="03">JAMA</E>
                             16, no. 313 (2015): 2002-2010, 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pubmed/25919527.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             Susan Busch et al., “Cost Effectiveness of Emergency Department-Initiated Treatment for Opioid Dependence”, 
                            <E T="03">Journal of Addiction</E>
                             11, no. 112 (2017), 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pubmed/28815789.</E>
                        </P>
                    </FTNT>
                    <P>We are persuaded by the comments received in response to our comment solicitation that this work is not currently accounted for in the existing code set. To account for the resource costs involved with initiation of medication for the treatment of opioid use disorder in the ED and referral for follow-up care, we are proposing to create one add-on G-code to be billed with E/M visit codes used in the ED setting. This code would include payment for assessment, referral to ongoing care, follow-up after treatment begins, and arranging access to supportive services, but we note that the drug itself would be paid separately. The proposed code is:</P>
                    <P>
                        • HCPCS code GMAT1: 
                        <E T="03">Initiation of medication for the treatment of opioid use disorder in the emergency department setting, including assessment, referral to ongoing care, and arranging access to supportive services (List separately in addition to code for primary procedure).</E>
                    </P>
                    <P>
                        To price this service, we are proposing to use a direct crosswalk to the work and direct PE inputs for HCPCS code G0397 (
                        <E T="03">Alcohol/subs interv &gt;30 min</E>
                        ), which is assigned a work RVU of 1.30. We believe that the work and PE described by this crosswalk code is similar in nature and magnitude to the services described in HCPCS code GMAT1. We note that unlike the requirements for reference code, we are not proposing a required number of minutes to bill HCPCS code GMAT1. We welcome comment on this proposal and whether we should consider a different valuation to account for the resource costs involved with these services.
                    </P>
                    <HD SOURCE="HD3">(55) Percutaneous Creation of an Arteriovenous Fistula (AVF) (HCPCS Code G2170 and G2171)</HD>
                    <P>We received a comment in response to the CY 2020 PFS proposed rule (84 FR 40481), as well as inquiries from stakeholders, requesting that we establish new coding for the percutaneous creation of an arteriovenous fistula (AVF) used for dialysis access.</P>
                    <P>
                        For CY 2019, based on two new technology applications for arteriovenous fistula creation, we established two new HCPCS codes to describe the two modalities of this service. Specifically, we established HCPCS code C9754 (
                        <E T="03">Creation of arteriovenous fistula, percutaneous; direct, any site, including all imaging and radiologic supervision and interpretation, when performed and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization, when performed)</E>
                        ) and HCPCS code C9755 (
                        <E T="03">Creation of arteriovenous fistula, percutaneous using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, venography, and/or ultrasound, with radiologic supervision and interpretation, when performed</E>
                        ). The HCPCS codes were created for institutional payment systems, and thus do not allow for payment for the physician's work portion of the service. Stakeholders have stated that the lack of proper coding to report the physician work associated with these procedures is problematic, as physicians are either billing an unlisted procedure code, or are billing other CPT codes that do not appropriately reflect the resource cost associated with the physician work portion of the service. Stakeholders stated that separate coding for physician payment will allow billing when the procedures are furnished in either a physician office or an institutional setting, and be paid under the respective payment systems, as appropriate. We have recognized that the lack of appropriate coding for this critical physician's service has become an even greater burden given the PHE that was declared effective January 27, 2020 for the COVID-19 epidemic. In order to mitigate potential health risks to beneficiaries, physicians and practitioners as a result of having this procedure performed in an institutional setting, we have created two HCPCS G codes for percutaneous creation of an arteriovenous fistula (AVF). The codes are contractor priced and effective July 1, 2020. This will allow for more accurate billing and coding of a crucial physician service that could then be performed in both institutional and office settings, thus mitigating unnecessary risk to beneficiaries, physicians and practitioners caused by disease transmission. The HCPCS G codes are described as follows:
                    </P>
                    <P>
                        • HCPCS G code G2170 (
                        <E T="03">Percutaneous arteriovenous fistula creation (AVF), direct, any site, by tissue approximation using thermal resistance energy, and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil embolization) when performed, and includes all imaging and radiologic guidance, supervision and interpretation, when performed.</E>
                        )
                    </P>
                    <P>
                        • HCPCS G code G2171 (
                        <E T="03">
                            Percutaneous arteriovenous fistula creation (AVF), direct, any site, using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, wen performed) and fistulogram(s), angiography, venography, and/or ultrasound, with 
                            <PRTPAGE P="50174"/>
                            radiologic supervision and interpretation, when performed.
                        </E>
                        )
                    </P>
                    <P>We are proposing to maintain contractor pricing for these HCPCS codes for CY 2021, however, we are also seeking information from stakeholders on the resource costs involved in furnishing the services described by HCPCS codes G2170 and G2171 to ensure proper payment for these physician's services, for consideration in future rulemaking. We note that under the Outpatient Prospective Payment System (OPPS) these services are assigned to APC 5193, which for CY 2020 has an assigned payment rate of $15,938.20.</P>
                    <HD SOURCE="HD3">(56) Insertion, Removal, and Removal and Insertion of Implantable Interstitial Glucose Sensor System (Category III CPT Codes 0446T, 0447T, and 0448T)</HD>
                    <P>Category III CPT codes 0446T, 0447T, and 0448T describe the services related to the insertion, removal, and removal and insertion of an implantable interstitial glucose sensor from subcutaneous pocket, in a subcutaneous pocket via incision. The implantable interstitial glucose sensors are part of systems that can allow real-time glucose monitoring, provides glucose trend information, and signal alerts for detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The codes that describe the implantation, removal, and removal and implantation of implantable interstitial glucose sensors are currently contractor-priced.</P>
                    <P>• Category III CPT code 0446T (Creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training);</P>
                    <P>• Category III CPT code 0447T (Removal of implantable interstitial glucose sensor from subcutaneous pocket via incision); and</P>
                    <P>
                        • Category III CPT code 0448T (
                        <E T="03">Removal of implantable interstitial glucose sensor with creation of subcutaneous pocket at different anatomic site and insertion of new implantable sensor, including system activation</E>
                        ).
                    </P>
                    <P>In the CY 2020 PFS final rule (84 FR 62627), we requested information from stakeholders to ensure proper payment for this important physician's service and welcomed recommendations on appropriate valuation for these services to be considered in future rulemaking.</P>
                    <P>
                        We are proposing to establish national payment amounts for the codes describing the insertion, removal, and removal and insertion of an implantable interstitial glucose sensor, effective January 1, 2021. We are proposing a work RVU of 1.14 for Category III CPT code 0446T, a work RVU of 1.34 for Category III CPT code 0447T, and work RVU of 1.91 for Category III CPT code 0448T based on a crosswalk to the work RVUs, work time, and direct PE inputs of CPT codes 11981 (
                        <E T="03">Insertion, non-biodegradable drug delivery implant</E>
                        ), 11982 (
                        <E T="03">Removal, non-biodegradable drug delivery implant</E>
                        ), and 11983 (
                        <E T="03">Removal with reinsertion, non-biodegradable drug delivery implant</E>
                        ), respectively, due to the similar clinical nature of these procedures.
                    </P>
                    <P>We are also proposing to include one supply and one equipment item to the direct PE inputs crosswalked from CPT codes 11981-11983. We are adding a new “implantable interstitial glucose sensor” (supply code SD334) for Category III CPT codes 0446T and 0448T to include the supply costs of the “implantable interstitial glucose sensor” (supply code SD334) included in these procedures, which we propose to price at $1,500.00, based on information we received from stakeholders. We are also proposing to include the smart transmitter associated with the use of this implantable interstitial glucose sensor. We propose to price the smart transmitter involved in furnishing this service by using a similar equipment item finalized in the CY 2019 PFS final rule (83 FR 59624) as a proxy, the “heart failure patient physiologic monitoring equipment package” (EQ392); the EQ392 has a price of $1,000.00, and is similarly used for long term remote monitoring of patients. We are proposing to use the EQ392 equipment as a proxy for the valuation of the smart transmitter associated with the implantable interstitial glucose sensor, to which we are assigning a time of 25,920 minutes for EQ392 in Category III CPT codes 0446T and 0448T. This time is derived from 60 minutes per hour times 24 hours per day times 90 days per billing quarter, divided by 1 minute of equipment use out of every 5 minutes of time. We are not including either the implantable interstitial glucose sensor or the EQ392 equipment proxy for Category III CPT code 0447T, as it describes only a removal procedure.</P>
                    <P>We are seeking comment on the proposed values for these Category III CPT codes (0446T, 0447T, and 0448T), and we are seeking comment on the appropriateness and accuracy of the proposed work RVUs, work times, and direct PE inputs.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="638">
                        <PRTPAGE P="50175"/>
                        <GID>EP17AU20.036</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50176"/>
                        <GID>EP17AU20.037</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="639">
                        <PRTPAGE P="50177"/>
                        <GID>EP17AU20.038</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50178"/>
                        <GID>EP17AU20.039</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50179"/>
                        <GID>EP17AU20.040</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50180"/>
                        <GID>EP17AU20.041</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50181"/>
                        <GID>EP17AU20.042</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50182"/>
                        <GID>EP17AU20.043</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="637">
                        <PRTPAGE P="50183"/>
                        <GID>EP17AU20.044</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="638">
                        <PRTPAGE P="50184"/>
                        <GID>EP17AU20.045</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="267">
                        <PRTPAGE P="50185"/>
                        <GID>EP17AU20.046</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50186"/>
                        <GID>EP17AU20.047</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50187"/>
                        <GID>EP17AU20.048</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50188"/>
                        <GID>EP17AU20.049</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50189"/>
                        <GID>EP17AU20.050</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50190"/>
                        <GID>EP17AU20.051</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50191"/>
                        <GID>EP17AU20.052</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50192"/>
                        <GID>EP17AU20.053</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50193"/>
                        <GID>EP17AU20.054</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50194"/>
                        <GID>EP17AU20.055</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50195"/>
                        <GID>EP17AU20.056</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50196"/>
                        <GID>EP17AU20.057</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="520">
                        <PRTPAGE P="50197"/>
                        <GID>EP17AU20.058</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="513">
                        <PRTPAGE P="50198"/>
                        <GID>EP17AU20.059</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50199"/>
                        <GID>EP17AU20.060</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="273">
                        <PRTPAGE P="50200"/>
                        <GID>EP17AU20.061</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50201"/>
                        <GID>EP17AU20.062</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="493">
                        <PRTPAGE P="50202"/>
                        <GID>EP17AU20.063</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">I. Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Section 2005 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act established a new Medicare Part B benefit category for OUD treatment services furnished by OTPs during an episode of care beginning on or after January 1, 2020. In the CY 2020 PFS final rule (84 FR 62630 through 62677), we implemented coverage requirements and established new codes describing the bundled payments for episodes of care for the treatment of OUD furnished by OTPs. We established new codes for and finalized bundled payments for weekly episodes of care that include methadone, oral buprenorphine, implantable buprenorphine, injectable buprenorphine or naltrexone, and non-drug episodes of care, as well as add-on codes for intake and periodic assessments, take-home dosages for methadone and oral buprenorphine, and additional counseling. We are monitoring Medicare enrollment by OTPs and utilization of the new benefit to ensure that Medicare beneficiaries have appropriate access to care. For CY 2021, we are proposing several refinements and seek to provide clarification on certain issues that stakeholders have brought to our attention.</P>
                    <HD SOURCE="HD3">2. Definition of OUD Treatment Services</HD>
                    <P>
                        In the CY 2020 PFS final rule (84 FR 62631 through 62635), we finalized a definition of “OUD treatment services” that reflects the statutory definition in section 1861(jjj)(1)(A) of the Act, which defines covered OUD treatment services to include oral, injected, and implanted opioid agonist and antagonist treatment 
                        <PRTPAGE P="50203"/>
                        medications approved by the Food and Drug Administration (FDA) under section 505 of the FFDCA for use in the treatment of OUD. There are three drugs currently approved by FDA for the treatment of opioid dependence: Buprenorphine; methadone; and naltrexone. In the CY 2020 PFS final rule, we noted that we had received comments supporting the proposed definition of OUD treatment services but also requesting that CMS include naloxone to treat opioid overdose in that definition as a medication used in treatment of OUD. Although we did not finalize including naloxone in the definition of OUD treatment services in that final rule, we indicated that as we continue to work on refining this new Medicare benefit, we would consider including additional drugs in the definition of OUD treatment services under our discretionary authority in section 1861(jjj)(1)(F) of the Act to include other items and services the Secretary determines are appropriate. After further consideration, we have determined that it is appropriate to propose to extend the definition of OUD treatment services to include opioid antagonist medications, such as naloxone, that are approved by FDA under section 505 of the FFDCA for emergency treatment of opioid overdose.
                    </P>
                    <P>
                        Naloxone is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
                        <SU>15</SU>
                        <FTREF/>
                         
                        <SU>16</SU>
                        <FTREF/>
                         Naloxone should be given to a person who shows signs of an opioid overdose or when an overdose is suspected. FDA-approved naloxone products for overdose reversal are effective in reversing opioid overdose, including fentanyl-involved opioid overdoses, although overdoses involving potent (for example, fentanyl) or large quantities of opioids may require higher-than-normal doses of naloxone or repeated administration to reverse overdose.
                        <SU>17</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             
                            <E T="03">https://store.samhsa.gov/system/files/sma18-4742.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Naloxone attaches to opioid receptors and reverses and blocks the effects of other opioids.
                        <SU>18</SU>
                        <FTREF/>
                         FDA has approved injectable naloxone, intranasal naloxone, and naloxone auto-injector as emergency treatments for opioid overdose. The nasal spray is a prefilled, needle-free device that requires no assembly and can deliver a single dose into each nostril with two sprays. The auto-injector is injected into the outer thigh to deliver naloxone to the muscle (intramuscular). These forms of naloxone can easily be administered by persons who do not have medical training and they may be prescribed to a patient who is receiving medication-assisted treatment (MAT) for OUD, especially if the patient is considered to be at risk for opioid overdose.
                        <SU>19</SU>
                        <FTREF/>
                         Both the nasal spray and naloxone auto-injector are packaged in a carton containing two doses to allow for repeat dosing if needed.
                        <E T="51">20 21</E>
                    </P>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             
                            <E T="03">https://www.drugabuse.gov/publications/drugfacts/naloxone.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             
                            <E T="03">https://www.samhsa.gov/medication-assisted-treatment/treatment/naloxone.</E>
                        </P>
                        <P>
                            <SU>20</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf.</E>
                        </P>
                        <P>
                            <SU>21</SU>
                             
                            <E T="03">https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209862lbl.pdf.</E>
                        </P>
                        <P>
                            <SU>22</SU>
                             
                            <E T="03">https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.</E>
                        </P>
                        <P>
                            <SU>23</SU>
                             
                            <E T="03">http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        The U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released a public health advisory stating that, “Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic.” 
                        <SU>22</SU>
                    </P>
                    <P>
                        We are proposing to add naloxone to the definition of OUD treatment services in order to increase access to this important emergency treatment and to allow OTPs to be paid under Medicare for dispensing naloxone to Medicare beneficiaries who are receiving other OUD treatment services from the OTP. Under this proposal, beneficiaries receiving OUD treatment services from the OTP would be able to receive naloxone from the OTP under the OUD treatment services benefit, to the extent it is medically reasonable and necessary as part of their OUD treatment. We note that naloxone is already covered under Medicare Part D. In 2017, 72.5 percent of all Medicare beneficiaries were enrolled in Medicare Part D plans.
                        <SU>23</SU>
                         However, we believe allowing beneficiaries to access this important emergency treatment at the OTP may help decrease barriers to access because there currently are no copayments for services furnished by OTPs and beneficiaries would not need to visit a separate provider to access naloxone.
                    </P>
                    <P>Accordingly, to align with efforts to end the opioid epidemic, under the discretionary authority in section 1861(jjj)(1)(F) of the Act, we propose to amend the definition of OUD treatment services at § 410.67(b) by adding § 410.67(b)(8) to include opioid antagonist medications that are approved by FDA under section 505 of the FFDCA for the emergency treatment of known or suspected opioid overdose. We are proposing to amend the definition of OUD treatment services under the discretionary authority in section 1861(jjj)(1)(F) of the Act rather than the authority under section 1861(jjj)(1)(A) of the Act because section 1861(jjj)(1)(A) of the Act pertains to opioid agonist and antagonist treatment medications (including oral, injected, or implanted versions) that are approved by FDA under section 505 of the FFDCA for use in the treatment of opioid use disorder. Naloxone is not one of the three drugs currently approved by FDA for the treatment of opioid dependence (buprenorphine, methadone, and naltrexone); and, as a result, we do not believe naloxone fits the criteria of section 1861(jjj)(1)(A) of the Act. We seek comment on our proposal to expand the definition of OUD treatment services.</P>
                    <P>
                        Additionally, we agree with the public health advisory quoted previously that community education related to overdose prevention is needed to address the opioid crisis. We believe that prevention and community education efforts would increase awareness of treatment options and could play a role in decreasing opioid overdose deaths. We welcome comments on whether the definition of OUD treatment services should be further revised to include overdose education. Additionally, we welcome comments on whether payment for providing overdose education to the beneficiary and/or the beneficiary's family or partner should be considered to be included in the current weekly bundled payments for episodes of care or whether we should consider establishing an add-on payment for education related to overdose prevention when such services are furnished by OTPs. We are specifically seeking information related to what inputs we might consider in developing the payment rate for such a service, such as payment amounts for similar services under the PFS, if we were to include this type of education as part of the proposed new add-on codes for naloxone discussed later in this section (HCPCS codes GOTP1 and GOTP2). For example, in order to establish a payment rate for education related to overdose prevention for the beneficiary and/or 
                        <PRTPAGE P="50204"/>
                        beneficiary's family or partner, we could consider a crosswalk to the Medicare payment rate for CPT code 96161 
                        <E T="03">(Administration of caregiver-focused health risk assessment instrument (e.g, depression inventory) for the benefit of the patient, with scoring and documentation, per standardized instrument).</E>
                         The current non-facility payment rate under the PFS for CPT code 96161 is $2.53.
                    </P>
                    <HD SOURCE="HD3">a. Proposed Adjustment Made to the Bundled Payments for OUD Treatment Services</HD>
                    <P>Consistent with our proposal to expand the definition of OUD treatment services to include opioid antagonist medications indicated for the emergency treatment of known or suspected opioid overdose, we believe it is appropriate to propose changes to the payment rates for the bundled payments to reflect the costs of these medications. Therefore, we propose to adjust the bundled payment rates through the use of add-on codes to account for instances in which OTPs provide Medicare beneficiaries with naloxone. We believe that beneficiaries receiving naloxone will need a supply at the start of treatment and would only require refills later if the supply is used in an emergency. As a result, we would not expect naloxone to be provided weekly to all patients, but only on an as-needed basis. Accordingly, we believe that making payment for naloxone through the use of an add-on code is the most accurate approach to pricing rather than including the costs of these medications as part of the bundled payment rates for all episodes of care.</P>
                    <P>We propose to adopt the following add-on G codes:</P>
                    <P>
                        • 
                        <E T="03">HCPCS code GOTP1:</E>
                         Take-home supply of nasal naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.
                    </P>
                    <P>
                        • 
                        <E T="03">HCPCS code GOTP2:</E>
                         Take-home supply of auto-injector naloxone (provision of the services by a Medicare-enrolled Opioid Treatment Program); List separately in addition to code for primary procedure.
                    </P>
                    <P>We are proposing to adopt an approach similar to the pricing methodology that was used to price the drug component of the bundled payments in the CY 2020 PFS final rule to determine the payment rate for these proposed new add-on codes for naloxone. In the CY 2020 PFS proposed rule (84 FR 40530), we explained that payment structures that are closely tailored to the provider's actual acquisition cost reduce the likelihood that a drug will be chosen primarily for a reason that is unrelated to the clinical care of the patient, such as the drug's profit margin for a provider. Therefore, we believe it is appropriate to use a similar methodology to determine the payment rates for the add-on codes for naloxone as we adopted in the CY 2020 PFS final rule for purposes of determining the payment rate for the drug component of the bundled payments because it provides our best estimate of an OTP's cost in dispensing naloxone.</P>
                    <P>In the CY 2020 PFS final rule, we adopted a policy under which we apply the methodology set forth in section 1847A of the Act to determine the payment amount for the drug component of the bundled payment for an episode of care that includes implantable or injectable medications, except that the payment amount shall be 100 percent of the average sales price (ASP), if ASP is used. For oral medications, the payment for the drug component is based on 100 percent of ASP, if ASP data are available. However, if ASP is not available, the payment amount for methadone will be based on the TRICARE rate and the payment amount for oral buprenorphine is calculated using the national average drug acquisition cost (NADAC).</P>
                    <HD SOURCE="HD3">Drug Pricing for Nasal Naloxone</HD>
                    <P>Consistent with the approach that we adopted for pricing the drug component of the weekly bundled payments, we are proposing to price the add-on code describing the take home supply of nasal naloxone, HCPCS code GOTP1, using the same methodology we previously adopted for pricing the drug component of an episode of care that include implantable or injectable medications. Accordingly, the payment methodology would be based upon the methodology set forth in section 1847A of the Act, except that payment amounts determined based on ASP and wholesale acquisition cost (WAC) would not include any add-on percentages. We recognize that nasal naloxone is not an oral, implantable or injectable medication; however, ASP data are available. As noted in the CY 2020 PFS final rule (84 FR 62653), we believe using ASP provides a transparent and public benchmark for manufacturers' pricing as it reflects the manufacturers' actual sales prices to all purchasers (with limited exceptions as noted in section 1847A(c)(2) of the Act) and is the only pricing methodology that includes off-invoice rebates and discounts as described in section 1847A(c)(3) of the Act. Therefore, we believe ASP to be the most market-based approach to set drug prices. We seek public comment on our proposal to use ASP+0 to price the add-on payment for nasal naloxone and other potential sources of pricing data for nasal naloxone either generally or specifically with respect to acquisition by OTPs.</P>
                    <HD SOURCE="HD3">Drug Pricing for Auto-Injector Naloxone</HD>
                    <P>We are proposing to price the add-on code describing the take-home supply of auto-injector naloxone, HCPCS code GOTP2, using the lowest pricing available (the lower of ASP + 0, WAC + 0, or NADAC). Currently, there is no ASP or NADAC reported or calculated for auto-injector naloxone. Accordingly, we propose to use WAC + 0 to determine the pricing for the add-on payment for auto-injector naloxone. We believe 100 percent of WAC is a closer estimate of the actual acquisition cost for OTPs compared to WAC with an add-on percentage because, as defined in section 1847A(c)(6)(B) of the Act, WAC does not include prompt pay discounts, rebates or reductions in price. Thus, there should be no need to pay an add-on percentage to ensure OTPs are reimbursed for their acquisition costs for auto-injector naloxone. However, in the future, we believe using the lowest pricing available for auto-injector naloxone may be most appropriate, because if ASP and/or NADAC pricing were to become available for auto-injector naloxone, they would be more reflective of actual costs than a list price.</P>
                    <PRTPAGE P="50205"/>
                    <P>
                        We note that auto-injector naloxone is available in both a generic and brand name version. We considered comparing the Medicare Part D utilization for each formulation to determine the frequency with which the generic and brand name versions might dispensed by OTPs. However, because the generic auto-injector naloxone is rather new to the marketplace,
                        <SU>24</SU>
                         there are limited utilization data available for the generic product. Based on historical information reflecting a trend of increased generic utilization uptake,
                        <SU>25</SU>
                         we believe that in most cases where the auto-injector naloxone is prescribed and dispensed by OTPs to beneficiaries, it will be the generic formulation of the product. Therefore, we believe using the price for the generic formulation is a reasonable approach to pricing the proposed add-on code for auto-injector naloxone and will ensure that beneficiaries who need this drug as part of their treatment for OUD have access to it and that OTPs receive a reasonable payment for dispensing the drug. Accordingly, we are proposing to use the price of the generic formulation, determined as WAC + 0, to pay for auto-injector naloxone when the drug is provided by an OTP as part of an episode of care. We seek comment on our proposed pricing methodology to pay for auto-injector naloxone and other potential sources of pricing data for auto-injector naloxone either generally or specifically with respect to acquisition by OTPs.
                    </P>
                    <HD SOURCE="HD3">Frequency Limit</HD>
                    <P>
                        We note that Medicare Part D allows prescription drug plans to place quantity limits (QL) on most drugs, including on naloxone. While most Part D plans do not limit the amount of naloxone a beneficiary is able to receive in a given month, when they do, they most frequently allow a plan enrollee a maximum of 4 units per 30 days (2 boxes of 2 units). In the current contract year (2020) only 22 percent of Medicare Part D formularies apply a QL to naloxone (115/535 formularies), while for the 2021 contract year only 19 percent of Part D formularies plan to apply a QL to this product (106/564 formularies). However, a review of Part D claims data shows that beneficiaries who use naloxone most frequently use only one box (2 units) within a 30-day period even though nearly all plans would have permitted additional doses. Under TRICARE, auto-injector naloxone is covered for a maximum quantity of one carton at retail network pharmacies for up to a 30-day supply.
                        <SU>26</SU>
                        <FTREF/>
                         We believe it would be appropriate to apply a similar limit on the frequency of the add-on payment for naloxone dispensed by OTPs. We believe that applying a frequency limit would assist in enhancing patient safety and discourage misuse, waste and abuse. Furthermore, we believe such a limitation is reasonable because there are other services that OTPs should already be performing, and which are already included in the weekly bundled payments for episodes of care, such as counseling and individual and group therapy, that should limit the need for this emergency treatment. However, we do not want to limit access to naloxone when it is a medically reasonable and necessary part of the treatment for OUD. Therefore, we propose to limit Medicare payment to OTPs for naloxone to one add-on code (HCPCS code GOTP1 or GOTP2) every 30 days to the extent that it is medically reasonable and necessary. We seek comment on whether this proposed limit is reasonable and whether special circumstances may arise under which more frequent payment is medically reasonable and necessary and the types of circumstances that should qualify for more frequent payment. However, we note that we also expect OTPs and their treating practitioners will use their clinical judgment as to whether there may be cases in which a referral to a higher level of care may be needed for some beneficiaries in order to reduce the risk of overdose and the need for more frequent emergency treatment. We propose to add § 410.67(d)(4)(i)(E) to describe payment for a take-home supply of opioid antagonist medications that are approved by FDA under section 505 of the FFDCA for the emergency treatment of known or suspected opioid overdose.
                    </P>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             
                            <E T="03">https://kaleo.com/in-the-news/authorized-generic-for-evzio-naloxone-hcl-injection-to-be-available-at-a-reduced-list-price-of-178/.</E>
                        </P>
                        <P>
                            <SU>25</SU>
                             In 2015, approximately 87 percent of prescriptions filled under Part D were for generic drugs, compared with 61 percent in 2007. 
                            <E T="03">http://www.medpac.gov/docs/default-source/reports/mar18_medpac_ch14_sec.pdf.</E>
                        </P>
                        <P>
                            <SU>26</SU>
                             
                            <E T="03">https://www.express-scripts.com/static/formularySearch/2.9.6/#/formularySearch/drugSearch.</E>
                        </P>
                    </FTNT>
                    <P>We invite public comments on the proposed pricing for nasal naloxone and auto-injector naloxone. We also seek comment on our proposal to limit payment for the proposed add-on codes for take-home supplies of these medications to once every 30 days to the extent that it is medically reasonable and necessary.</P>
                    <P>
                        Additionally, we seek comment on whether we should consider creating a code and establishing an add-on payment for injectable naloxone. We note that all three forms of naloxone (injectable, auto-injector, and nasal spray) are FDA-approved and may be considered as options for community distribution and use by individuals with or without medical training to stop or reverse the effects of an opioid overdose.
                        <SU>27</SU>
                        <FTREF/>
                         If we were to establish an add-on payment for injectable naloxone, we would consider using the same methodology we adopted for pricing the drug component of an episode of care that includes implantable or injectable medications, as described in § 410.67(d)(2)(i)(A).
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             
                            <E T="03">https://www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all-forms-naloxone-help-reduce-opioid-overdose.</E>
                        </P>
                    </FTNT>
                    <P>Table 30 details the proposed coding and summarizes the proposed payment amounts for nasal naloxone and auto-injector naloxone.</P>
                    <GPH SPAN="3" DEEP="176">
                        <PRTPAGE P="50206"/>
                        <GID>EP17AU20.064</GID>
                    </GPH>
                    <HD SOURCE="HD3">Duplicative Payment</HD>
                    <P>Section 1834(w)(1) of the Act, added by section 2005(c) of the SUPPORT Act, requires the Secretary to ensure, as determined appropriate by the Secretary, that no duplicative payments are made under Part B or Part D for items and services furnished by an OTP. We note that under our proposal, OTPs would be able to provide naloxone to Medicare beneficiaries and bill for it as an add-on to the bundled payment. Consistent with § 410.67(e), the beneficiary's copayment amount would remain zero. We also realize that naloxone may also be appropriately available to beneficiaries through other Medicare benefits, including, for example, Medicare Part D, under which the beneficiary would be responsible for the applicable cost sharing. As discussed in the CY 2020 PFS final rule (84 FR 62664) and codified at § 410.67(d)(5), we define duplicative payment to involve only those circumstances where medications that are delivered, administered or dispensed to a beneficiary are paid as part of the OTP bundled payment, and where the delivery, administration or dispensing of the same medication (that is, same drug, dosage and formulation) is also separately paid under Medicare Part B or Part D for the same beneficiary on the same date of service. Because we are proposing to pay for naloxone as an add-on to the weekly bundled payment, any payment to an OTP for naloxone would be duplicative if the same medication is separately paid under Medicare Part B or Part D for the same beneficiary on the same date of service. Consistent with § 410.67(d)(5), CMS would recoup any duplicative payment made to an OTP for naloxone.</P>
                    <P>Additionally, we understand that some OTPs negotiate arrangements whereby community pharmacies supply MAT-related medications to OTPs. However, as we stated in the CY 2020 PFS final rule, if the OTP provides reasonable and necessary MAT-related medications as part of an episode of care, we would expect the OTP to take measures to ensure that there is no claim for payment for these drugs other than as part of the OTP bundled payment. Thus, naloxone billed by an OTP as an add-on to the bundled payment should not be reported to or paid under a Part D plan. We expect that OTPs will take reasonable steps to prevent duplicative payment for naloxone furnished under their care by ensuring it is not reported or billed under a different Medicare benefit. We intend to monitor for duplicative payments, and would take appropriate action as needed when and if such duplicative payments are identified.</P>
                    <HD SOURCE="HD3">3. WAC Pricing</HD>
                    <P>Section 1834(w) of the Act gives the Secretary significant discretion to establish bundled payment rates for OUD treatment services. In the CY 2020 PFS final rule, we finalized a payment methodology for the drug component of the bundled payment rates for OUD treatment services, under which we use the payment methodology set forth in section 1847A of the Act (which bases most payment on ASP) to set the payment rates for implantable and injectable drugs and limited the payment amount for these drugs to 100 percent of the volume-weighted ASP for a drug category or code, if ASP is used. We codified this payment methodology at § 410.67(d)(2)(i)(A).</P>
                    <P>Section 1847A of the Act provides for the use of other payment methodologies when ASP is not available, including WAC and average manufacturer price (AMP). In the CY 2020 PFS final rule, we limited payments to OTPs for injectable and implantable drugs to 100 percent of ASP, but did not otherwise diverge from the payment methodology that would apply under section 1847A of the Act. In this proposed rule, we believe that it is necessary to amend the OTP drug pricing methodology in order to limit WAC-based payments to 100 percent of WAC. As discussed previously, we are proposing to use WAC pricing to determine the payment rate for the add-on code for the auto-injector naloxone. Although none of the drugs that are currently included in the drug component of an episode of care is currently paid based on WAC, we believe it is possible that we may use WAC to determine the payment for the drug component of an episode of care in the future, and want to establish, in advance, the methodology that would apply for purposes of determining the payment rate.</P>
                    <P>
                        As authorized under section 1847A of the Act, some Part B drugs are paid based on WAC. For example, for single source drugs, payment is 106 percent of the lesser of WAC or ASP (section 1847A(b)(4) of the Act), and in cases where ASP is unavailable during the first quarter of sales (section 1847A(c)(4) of the Act), 103 percent of WAC is used. Additionally, there are some instances where drugs lack ASP data for reasons other than being new, for example, in cases where the manufacturer had no sales in a reporting quarter. In those situations, the Medicare payment method varies, but in some cases, the payment may be 106 percent of the WAC.
                        <SU>28</SU>
                        <FTREF/>
                         As we stated in the CY 2020 PFS final rule (84 FR 62651), payment structures that are closely tailored to the provider's actual acquisition cost reduce the likelihood that a drug will be chosen primarily for a reason that is unrelated 
                        <PRTPAGE P="50207"/>
                        to the clinical care of the patient, such as the drug's profit margin for a provider. The WAC is defined in section 1847A(c)(6)(B) as the manufacturer's list price for a drug to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates, or reductions in price. A drug's WAC is ultimately controlled by the manufacturer. Unlike ASP, a drug's WAC does not incorporate prompt-pay or other discounts. If discounts are available on drugs reimbursed by Medicare at 106 percent of WAC, then Medicare is paying more for drugs than it otherwise would under the ASP-based formula.
                        <SU>29</SU>
                        <FTREF/>
                         Therefore, consistent with our existing policy to set the payment amount at 100 percent of the ASP, if ASP is used to determine the payment for the drug component of an episode of care, we are proposing that when WAC-based pricing is used, the payment amount shall be WAC + 0. We are proposing to amend the provision at § 410.67(d)(2)(i)(A) to reflect this limitation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             
                            <E T="03">http://www.medpac.gov/-blog-/requiring-reporting-of-sales-price-data/2019/06/14/payment-for-part-b-drugs.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             
                            <E T="03">http://medpac.gov/docs/default-source/reports/jun17_ch2.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We welcome comments on this proposed alternative pricing methodology when the payment for an implantable or injectable medication included in the drug component of an episode of care is determined using the methodology set forth in section 1847A of the Act, and ASP pricing data are not available.</P>
                    <HD SOURCE="HD3">4. Billing and Payment Policies</HD>
                    <HD SOURCE="HD3">a. Institutional Claim Forms</HD>
                    <P>We have received several requests to allow OTPs to bill on an institutional claim form. We were informed by representatives from the state of New York that all OTPs in New York state bill on institutional claim forms, not just those that are part of a hospital system. Given the public health need related to the opioid epidemic, we are exploring claims processing flexibilities requested by some OTPs that would allow them to bill services on institutional claims. See also section III.B. of this proposed rule, OTP Provider Enrollment Regulation Updates for Institutional Claim Submissions, for a discussion related to OTP enrollment as it relates to institutional claims. There would be no differences in coverage or payment between services billed on the institutional claim form versus the professional claim form. We note that the National Uniform Billing Committee (NUBC) approved a new Type Of Bill (087x) for Freestanding Non-residential Opioid Treatment Program provider billing, as well as a new condition code (89) for Opioid Treatment Program/Indicates claim for opioid treatment program services, to be used on hospital based OTP claims (TOB 013x and 085x). We are seeking information on the reasons this flexibility is necessary for OTPs, and will address any changes to provider billing policies in subsequent claims processing instructions.</P>
                    <HD SOURCE="HD3">b. Periodic Assessments</HD>
                    <P>
                        In the CY 2020 PFS final rule (84 FR 62634), we stated that we understood that intake activities and periodic assessments are integral services for the establishment and maintenance of OUD treatment for a beneficiary at an OTP, and therefore, we believed it was reasonable to include these services in the definition of OUD treatment services. Accordingly, we finalized a definition of OUD treatment services in § 410.67(b) that reflected the required intake activities and periodic assessments. We stated it was our understanding that these services are furnished much less frequently than the other services included in the weekly bundled payments; therefore, we created add-on G codes to describe these services, which would allow us to make more targeted payments for these services. We noted that the add-on code describing intake activities should only be billed for new patients (that is, patients starting treatment at the OTP). We agreed with the commenters that the level 4 office/outpatient E/M visits for new and established patients are a good approximation of the services provided at intake and during periodic assessments at OTPs based on the expected acuity of patients with OUD receiving services at OTPs, who are likely to have multiple co-morbidities and present with problems that are of moderate to high severity and require medical decision making of moderate complexity. The finalized add-on codes are HCPCS code G2076 (
                        <E T="03">Intake activities; including initial medical examination that is a complete, fully documented physical evaluation and initial assessment conducted by a program physician or a primary care physician, or an authorized health care professional under the supervision of a program physician or qualified personnel that includes preparation of a treatment plan that includes the patient's short-term goals and the tasks the patient must perform to complete the short-term goals; the patient's requirements for education, vocational rehabilitation, and employment; and the medical, psycho-social, economic, legal, or other supportive services that a patient needs, conducted by qualified personnel</E>
                        ) and HCPCS code G2077 (
                        <E T="03">Periodic assessment; assessing periodically by qualified personnel to determine the most appropriate combination of services and treatment</E>
                        ). The medical services described by these add-on codes can be furnished by a program physician, a primary care physician or an authorized healthcare professional under the supervision of a program physician or qualified personnel such as nurse practitioners (NPs) and physician assistants (PAs). The other assessments, including psychosocial assessments can be furnished by practitioners who are eligible to do so under state law and their scope of licensure. We noted that to bill for the add-on code, the services need to be medically reasonable and necessary and that OTPs should document the rationale for billing the add-on code in the patient's medical record (84 FR 62647).
                    </P>
                    <P>
                        We have received inquiries from stakeholders related to what activities would qualify to bill the add-on code for periodic assessments, HCPCS code G2077. In the CY 2020 PFS final rule (84 FR 62647), we noted that the add-on code describing periodic assessments can be billed for each periodic assessment performed for patients that require multiple assessments during an episode of care, such as patients who are pregnant or postpartum. We noted that in order to bill for the add-on code, the services would need to be medically reasonable and necessary and that OTPs should document the rationale for billing the add-on code in the patient's medical record. Based on our understanding of the typical resources costs involved in furnishing periodic assessments, we priced HCPCS code G2077 based on a crosswalk to a level 4 office/outpatient E/M visit. Consistent with our understanding of the expected acuity of patients with OUD receiving services at OTPs, including the likelihood of the patient having multiple co-morbidities and presenting with problems that are of moderate to high severity and requiring medical decision making of moderate complexity, as well as the associated payment rate assigned to this code, we believe it is important for the clinician to be able to visually assess the patient as part of any periodic assessment. Therefore, for CY 2021, we are proposing that in order to bill for HCPCS code G2077, a face-to-face medical exam or biopsychosocial assessment would need to have been performed. Accordingly, we are proposing to amend the definition of periodic assessment in § 410.67(b)(7) to 
                        <PRTPAGE P="50208"/>
                        provide that the definition is limited to a face-to-face encounter.
                    </P>
                    <P>Additionally, we note that in the May 8th COVID-19 IFC, CMS revised § 410.67(b)(7) on an interim final basis to allow periodic assessments to be furnished during the PHE for the COVID-19 pandemic via two-way interactive audio-video communication technology and, in cases where beneficiaries do not have access to two-way audio-video communication technology, to permit the periodic assessments to be furnished using audio-only telephone calls rather than via two-way interactive audio-video communication technology, provided all other applicable requirements are met. We believe that allowing periodic assessments to be furnished via two-way interactive audio-video communication technology beyond the conclusion of the PHE for the COVID-19 pandemic would help to expand access to care for patients who may have a difficult time getting to the OTP in person. Therefore, in this proposed rule, we are proposing to revise § 410.67(b)(7) to allow periodic assessments to be furnished via two-way interactive audio-video communication technology, provided all other applicable requirements are met. We note that we are currently permitting the use of audio-only telephone calls to furnish these services during the PHE for the COVID-19 pandemic, because we believe it is important to maintain access to these services while the public is following infection control guidelines to stay at home and practice social distancing, and not all beneficiaries receiving OUD treatment services from OTPs may have access to interactive audio-video communication technology. However, we do not believe this flexibility will be needed in order to ensure access after the PHE ends. Therefore, under this proposal, the flexibility to use audio-only telephone services to furnish periodic assessments would not be permitted once the PHE for the COVID-19 pandemic has ended. We note that we would consider payment for any periodic assessment-related services furnished via audio-only telephone calls to be included in the bundled payment, but that audio-only telephone services would not qualify for billing HCPCS code G2077 after the end of the PHE for the COVID-19 pandemic. We are seeking input from the public on whether we should consider continuing to make add-on payments for audio-only periodic assessments furnished by OTPs after the conclusion of the PHE for the COVID-19 pandemic, and if so, whether the payment rate for audio-only services should reflect any differences in resource costs.</P>
                    <HD SOURCE="HD3">c. Date of Service</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62641), we defined an episode of care as a 1-week (contiguous 7-day) period at § 410.67(b). We have received inquiries related to the date of service used on claims for the weekly bundles and add-on codes, particularly related to an approach that many providers informed us they use, which is to establish a “standard billing cycle” in which episodes of care for all patients at that OTP begin on the same day of the week. We do not believe that the definition of an episode of care that was finalized for CY 2020 precludes the use of a “standard billing cycle.” Therefore, OTPs may choose to apply a standard billing cycle by setting a particular day of the week to begin all episodes of care. In this case, the date of service would be the first day of the OTP's billing cycle. If a beneficiary starts treatment at the OTP on a day that is in the middle of the OTP's standard weekly billing cycle, the OTP may still bill the applicable code for that episode of care provided that the threshold to bill for the code has been met. Alternatively, OTPs may choose to adopt weekly billing cycles that vary across patients. Under this approach, the initial date of service will depend upon the day of the week when the patient was first admitted to the program or when Medicare billing began. Therefore, under this approach of adopting weekly billing cycles that vary across patients, when a patient is beginning treatment or re-starting treatment after a break in treatment, the date of service would reflect the first day the patient was seen and the date of service for subsequent consecutive episodes of care would be the first day after the previous 7-day period ends. For the codes describing add-on services (HCPCS codes G2076-G2080), the date of service should reflect the date that service was furnished; however, if the OTP has chosen to apply a standard weekly billing cycle, the date of service for codes describing add-on services may be the same as the first day in the weekly billing cycle.</P>
                    <P>
                        We note that this approach is consistent with earlier guidance that was issued in the OTP Billing and Payment Fact sheet that is posted on the CMS OTP web page (
                        <E T="03">https://www.cms.gov/files/document/otp-billing-and-payment-fact-sheet.pdf</E>
                        ).
                    </P>
                    <HD SOURCE="HD3">d. Coding</HD>
                    <P>We recognize the importance of allowing OTPs to become accustomed to billing Medicare using the coding that was established in the CY 2020 PFS final rule; however, we remain interested in refining the code set through future rulemaking, including stratifying the coding and associated payment amounts to account for significant differences in resource costs among patients, especially in relation to amounts of expected counseling. In the CY 2020 PFS final rule (84 FR 62645), we finalized an add-on code to describe an adjustment to the bundled payment when additional counseling or therapy services are furnished, HCPCS code G2080. This add-on code may be billed when counseling or therapy services are furnished that substantially exceed the amount specified in the patient's individualized treatment plan. We have received feedback from stakeholders noting a range of OTP attendance patterns that represent a continuum of care and service intensity, noting significant differences in services received during the induction phase versus the maintenance phase. We also understand that patients' needs for service may fluctuate over time, depending on a variety of factors and circumstances. We welcome comments on how we might better account for differences in resource costs among patients over the course of treatment. We will consider the comments received in developing any proposed refinements to our coding policies in future rulemaking.</P>
                    <HD SOURCE="HD3">5. Annual Updates</HD>
                    <P>
                        In the CY 2020 PFS final rule (84 FR 62667 through 62669), we finalized a policy under which the payment for the drug component of episodes of care will be determined using the most recent data available at the time of ratesetting for the applicable calendar year. The payment for the non-drug component of the bundled payment for OUD treatment services will be updated annually based upon the Medicare Economic Index. The list of the payment rates for OUD treatment services furnished by OTPs, with the annual update applied for CY 2021, is available in the file called CY 2021 OTP Proposed Payment Rates on the CMS website under downloads for the CY 2021 PFS proposed rule at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.</E>
                         Additionally, we note that the current rates, as finalized in the CY 2020 PFS final rule, both with and without locality adjustments, can be found on the CMS OTP web page under Billing and Payment at 
                        <E T="03">
                            https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
                            <PRTPAGE P="50209"/>
                            Payment/Opioid-Treatment-Program/billing-payment.
                        </E>
                    </P>
                    <HD SOURCE="HD1">III. Other Provisions of the Proposed Rule</HD>
                    <HD SOURCE="HD2">A. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions, and a Comment Solicitation on Payment for Specimen Collection for Covid-19 Tests</HD>
                    <HD SOURCE="HD3">1. Background on the Clinical Laboratory Fee Schedule</HD>
                    <P>Prior to January 1, 2018, Medicare paid for clinical diagnostic laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS), with certain exceptions, under section 1833(a), (b), and (h) of the Act. Under the previous payment system, CDLTs were paid based on the lesser of: (1) The amount billed; (2) the local fee schedule amount established by the Medicare Administrative Contractor (MAC); or (3) a national limitation amount (NLA), which is a percentage of the median of all the local fee schedule amounts (or 100 percent of the median for new tests furnished on or after January 1, 2001). In practice, most tests were paid at the NLA. Under the previous payment system, the CLFS amounts were updated for inflation based on the percentage change in the Consumer Price Index for All Urban Consumers (CPI-U), and reduced by a multi-factor productivity adjustment and other statutory adjustments, but were not otherwise updated or changed. Coinsurance and deductibles generally do not apply to CDLTs paid under the CLFS.</P>
                    <P>
                        Section 1834A of the Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for CDLTs under the CLFS. In the June 23, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 41036), we published a final rule entitled Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS final rule), that implemented section 1834A of the Act at 42 CFR part 414, subpart G.
                    </P>
                    <P>
                        Under the CLFS final rule, “reporting entities” must report to CMS during a “data reporting period” “applicable information” collected during a “data collection period” for their component “applicable laboratories.” The first data collection period occurred from January 1, 2016 through June 30, 2016. The first data reporting period occurred from January 1, 2017 through March 31, 2017. On March 30, 2017, we announced a 60-day period of enforcement discretion for the application of the Secretary's potential assessment of Civil Monetary Penalties (CMPs) for failure to report applicable information with respect to the initial data reporting period. This announcement is available on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.</E>
                    </P>
                    <P>In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we solicited public comments from applicable laboratories and reporting entities to better understand the applicable laboratories' experiences with data reporting, data collection, and other compliance requirements for the first data collection and reporting periods. We discussed these comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and stated that we would consider the comments for potential future rulemaking or guidance.</P>
                    <P>As part of the CY 2019 Medicare PFS rulemaking, we finalized two changes to the definition of “applicable laboratory” at § 414.502 (see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850; 83 FR 35855 through 35862). First, we excluded Medicare Advantage (MA) plan payments under Part C from the denominator of the Medicare revenues threshold calculation, in an effort to broaden the types of laboratories qualifying as an applicable laboratory. Specifically, excluding MA plan payments could allow additional laboratories of all types serving a significant population of beneficiaries enrolled in Medicare Part C to meet the majority of Medicare revenues threshold and potentially qualify as an applicable laboratory (if they also meet the low expenditure threshold) and report data to CMS during the data reporting period. Because MA plan payments are now excluded from the total Medicare revenues calculation, the denominator amount (total Medicare revenues) would decrease. If the denominator amount decreases, the likelihood increases that a laboratory would qualify as an applicable laboratory. This is because the laboratory's PFS and CLFS revenues are being compared to a lower total Medicare payment amount (than what they would have been compared to if MA plan payments remained in the denominator). Second, consistent with our goal of obtaining a broader representation of laboratories that could potentially qualify as an applicable laboratory and report data we also amended the definition of applicable laboratory to include hospital outreach laboratories that bill Medicare Part B using the CMS-1450 14x Type of Bill.</P>
                    <HD SOURCE="HD2">2. Payment Requirements for Clinical Diagnostic Laboratory Tests</HD>
                    <P>In general, under section 1834A of the Act, the payment amount for each CDLT on the CLFS furnished beginning January 1, 2018, is based on the applicable information collected during the data collection period and reported to CMS during the data reporting period, and is equal to the weighted median of the private payor rates for the test. The weighted median is calculated by arraying the distribution of all private payor rates, weighted by the volume for each payor and each laboratory. The payment amounts established under the CLFS are not subject to any other adjustment, such as geographic, budget neutrality, or annual update, as required by section 1834A(b)(4)(B) of the Act. Additionally, section 1834A(b)(3) of the Act, implemented at § 414.507(d), provides for a phase-in of payment reductions, limiting the amounts the CLFS rates for each CDLT (that is not a new advanced diagnostic laboratory test (ADLT) or new CDLT) can be reduced as compared to the payment rates for the preceding year. Under the provisions enacted by section 216(a) of PAMA, for the first 3 years after implementation (CY 2018 through CY 2020), the reduction cannot be more than 10 percent per year, and for the next 3 years (CY 2021 through CY 2023), the reduction cannot be more than 15 percent per year. Under section 1834A(a)(1) and (b) of the Act, as enacted by PAMA, for CDLTs that are not ADLTs, the data collection period, data reporting period, and payment rate update occur every 3 years. As such, the second data collection period for CDLTs that are not ADLTs occurred from January 1, 2019 through June 30, 2019, and the next data reporting period was scheduled to take place from January 1, 2020 through March 31, 2020, with the next update to the Medicare payment rates for these tests based on that reported applicable information scheduled to take effect as of January 1, 2021.</P>
                    <P>
                        Section 216(a) of PAMA established a new subcategory of CDLTs known as ADLTs, with separate reporting and payment requirements under section 1834A of the Act. As defined in § 414.502, an ADLT is a CDLT covered under Medicare Part B that is offered and furnished only by a single laboratory, and cannot be sold for use by a laboratory other than the single laboratory that designed the test or a successor owner. Also, an ADLT must meet either Criterion (A), which implements section 1834A(d)(5)(A) of the Act, or Criterion (B), which 
                        <PRTPAGE P="50210"/>
                        implements section 1834A(d)(5)(B) of the Act, as follows:
                    </P>
                    <P>
                        • 
                        <E T="03">Criterion (A):</E>
                         The test is an analysis of multiple biomarkers of deoxyribonucleic acid (DNA), ribonucleic acid (RNA), or proteins; when combined with an empirically derived algorithm, yields a result that predicts the probability a specific individual patient will develop a certain condition(s) or respond to a particular therapy(ies); provides new clinical diagnostic information that cannot be obtained from any other test or combination of tests; and may include other assays; or:
                    </P>
                    <P>
                        • 
                        <E T="03">Criterion (B):</E>
                         The test is cleared or approved by FDA.
                    </P>
                    <P>Generally, under section 1834A(d) of the Act, the Medicare payment rate for a new ADLT is equal to its actual list charge during an initial period of 3 calendar quarters. After the new ADLT initial period, ADLTs are paid using the same methodology based on the weighted median of private payor rates as other CDLTs. However, under section 1834A(d)(3) of the Act, updates to the Medicare payment rates for ADLTs occur annually instead of every 3 years.</P>
                    <P>
                        Additional information on the private payor rate-based CLFS is detailed in the CLFS final rule (81 FR 41036 through 41101) and is available on the CMS website at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.html.</E>
                    </P>
                    <HD SOURCE="HD3">3. Statutory Revisions to the Data Reporting Period and Phase-In of Payment Reductions</HD>
                    <P>Section 105(a) of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 116-94, enacted on December 20, 2019), and section 3718 of the Coronavirus Aid, Relief, and Economic Security Act, 2020 (CARES Act) (Pub. L. 116-136, enacted on March 27, 2020), made revisions to the CLFS requirements for the next data reporting period for CDLTs that are not ADLTs under section 1834A of the Act. Additionally, the CARES Act made revisions to the phase-in of payment reductions under section 1834A of the Act. Specifically, section 105(a)(1) of the FCAA amended the data reporting requirements in section 1834A(a) of the Act to delay the next data reporting period for CDLTs that are not ADLTs by 1 year, so that data reporting would be required during the period of January 1, 2021 through March 31, 2021; the 3-year data reporting cycle for CDLTs that are not ADLTs would resume after that data reporting period. Section 105(a)(1) of the FCAA also specified that the data collection period that applies to the data reporting period of January 1, 2021 through March 30, 2021 would be the period of January 1, 2019 through June 30, 2019, which is the same data collection period that would have applied absent the amendments. In addition, section 105(a)(2) of the FCAA amended section 1834A(b)(3) of the Act regarding the phase-in of payment reductions to provide that payments may not be reduced by more than 10 percent as compared to the amount established for the preceding year through CY 2020, and for CYs 2021 through 2023, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year. These statutory changes were consistent with our regulations implementing the private payor rate-based CLFS (81 FR 41036; § 414.507(d)).</P>
                    <P>Subsequently, section 3718 of the CARES Act further amended the data reporting requirements for CDLTs that are not ADLTs and the phase-in of payment reductions under the CLFS. Specifically, section 3718(a) of the CARES Act amended section 1834A(a)(1)(B) of the Act to delay the next data reporting period for CDLTs that are not ADLTs by one additional year, to require data reporting during the period of January 1, 2022 through March 31, 2022. As amended by the CARES Act, section 1834A(a)(1)(B) of the Act now provides that in the case of reporting with respect to CDLTs that are not ADLTs, the Secretary shall revise the reporting period under subparagraph (A) such that—(i) no reporting is required during the period beginning January 1, 2020, and ending December 31, 2021; (ii) reporting is required during the period beginning January 1, 2022, and ending March 31, 2022; and (iii) reporting is required every 3 years after the period described in clause (ii).</P>
                    <P>The CARES Act does not modify the data collection period that applies to the next data reporting period for these tests. Thus, under section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of the FCAA, the next data reporting period for CDLTs that are not ADLTs (January 1, 2022 through March 31, 2022) will be based on the data collection period of January 1, 2019 through June 30, 2019. In § 414.502, the current definition of data collection period is defined as the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data reporting period. Additionally, in § 414.502 the data reporting period is defined as the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to CMS and that follows the preceding data collection period. Unless we revise our current definitions of data collection period and data reporting period, the definitions will be incorrect with regard to the data collection period that applies to the next data reporting period. Therefore, in section III.A.4. of this proposed rule, “Proposed Conforming Regulatory Changes,” we are proposing to revise the definitions of data collection period and data reporting period in § 414.502 to reflect that the data collection period will be January 1, 2019 through June 30, 2019 for the data reporting period of January 1, 2022 through March 31, 2022.</P>
                    <P>Section 3718(b) of the CARES Act further amends the provisions in section 1834A(b)(3) of the Act regarding the phase-in of payment reductions under the CLFS. First, it extends the statutory phase-in of payment reductions resulting from private payor rate implementation by an additional year, that is, through CY 2024. It further amends section 1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent for CY 2021 is 0 percent, meaning that the payment amount determined for a CDLT for CY 2021 shall not result in any reduction in payment as compared to the payment amount for that test for CY 2020. Section 3718(b) of the CARES Act further amends section 1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of 15 percent will apply for CYs 2022 through 2024, instead of CYs 2021 through 2023.</P>
                    <HD SOURCE="HD3">4. Proposed Conforming Regulatory Changes</HD>
                    <P>
                        In accordance with section 105(a) of the FCAA and section 3718 of the CARES Act, we are proposing to make certain conforming changes to the data reporting and payment requirements at 42 CFR part 414, subpart G. Specifically, we are proposing to revise § 414.502 to update the definitions of both the data collection period and data reporting period, specifying that for the data reporting period of January 1, 2022 through March 31, 2022, the data collection period is January 1, 2019 through June 30, 2019. We are also proposing to revise § 414.504(a)(1) to indicate that initially, data reporting begins January 1, 2017 and is required every 3 years beginning January 2022. In addition, we are proposing to make conforming changes to our requirements for the phase-in of payment reductions to reflect the CARES Act amendments. Specifically, we are proposing to revise § 414.507(d) to indicate that for CY 2021, payment may not be reduced by 
                        <PRTPAGE P="50211"/>
                        more than 0.0 percent as compared to the amount established for CY 2020, and for CYs 2022 through 2024, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year.
                    </P>
                    <HD SOURCE="HD3">5. Comment Solicitation on Payment for Specimen Collection for COVID-19 Clinical Diagnostic Tests</HD>
                    <P>
                        In the “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency” interim final with comment period (IFC) (85 FR 19256 through 19258), which published in the April 6, 2020 
                        <E T="04">Federal Register</E>
                        , we established that Medicare will pay a nominal specimen collection fee and associated travel allowance to independent laboratories for the collection of specimens for COVID-19 clinical diagnostic laboratory testing for homebound and non-hospital inpatients. This policy provides independent laboratories with additional resources to provide COVID-19 testing and helps with efforts to limit patients' exposure to the general population and alleviate patients' unease with leaving the home. To identify specimen collection for COVID-19 testing specifically, we established two new level II HCPCS codes, Code G2023 (
                        <E T="03">specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), any specimen source</E>
                        ); and G2024 (
                        <E T="03">specimen collection for severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) (Coronavirus disease [COVID-19]), from an individual in a SNF or by a laboratory on behalf of a HHA, any specimen source</E>
                        ), for independent laboratories to use when billing Medicare for the nominal specimen collection fee for COVID-19 testing for the duration of the COVID-19 PHE.
                    </P>
                    <P>We indicated in the April 6, 2020 IFC that this specimen collection fee policy was established for the duration of the Public Health Emergency (PHE) for the COVID-19 pandemic (85 FR 19256). We are requesting comments on whether we should delete HCPCS Codes G2023 and G2024 once the COVID-19 PHE ends. Comments received may inform a future proposal. Specifically, we are seeking public input on why these codes, and their corresponding payment amounts, which are higher than the nominal fees for specimen collection for other conditions, would be necessary or useful outside of the context of the PHE. We are particularly interested in why separate, increased payment for specimen collection specifically for COVID-19 tests, in contrast to other tests, might be needed following the end of the PHE.</P>
                    <HD SOURCE="HD2">B. OTP Provider Enrollment Regulation Updates for Institutional Claim Submissions</HD>
                    <HD SOURCE="HD3">1. Modifications to OTP Enrollment Process</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>Under 42 CFR 424.510, a provider or supplier must complete, sign, and submit to its assigned Medicare Administrative Contractor (MAC) the Form CMS-855 (OMB Control No. 0938-0685) application to enroll in the Medicare program and obtain Medicare billing privileges. The Form CMS-855, which can be submitted via paper or electronically through the internet-based Provider Enrollment, Chain, and Ownership System (PECOS) process (SORN: 09-70-0532, Provider Enrollment, Chain, and Ownership System), captures information about the provider or supplier that CMS or its MACs reviews and verifies to determine whether the provider or supplier meets all Medicare requirements. (The specific Form CMS-855 application (of which there are several variations) to be completed will depend upon the type of provider or supplier submitting said application.) This process of enrollment helps ensure that: (1) All prospective providers and suppliers are carefully screened and vetted; and (2) unqualified providers and suppliers are kept out of the Medicare program, which helps protect the Trust Funds and Medicare beneficiaries. Indeed, without this process, billions of taxpayer dollars might be paid to fraudulent or otherwise non-compliant parties.</P>
                    <HD SOURCE="HD3">b. Completion of Form CMS-855</HD>
                    <P>Existing § 424.67 outlines a number of enrollment requirements for OTPs. One requirement, addressed in § 424.67(b)(1), is that OTPs must complete the Form CMS-855B application (Medicare Enrollment Application: Clinics/Group Practices and Certain Other Suppliers; OMB #0938-0685) to enroll in Medicare. The reference to the Form CMS-855B in § 424.67(b)(1) was predicated in part on the assumption that OTPs would generally submit the CMS-1500 claim form (Health Insurance Claim Form; OMB Control No.: 0938-1197) to receive payment for their services. However, as mentioned previously in section II.I.4. of this proposed rule, we have received requests to allow OTPs to bill for services on an institutional claim form (specifically, the 837I). To do so, these OTPs would have to enroll in Medicare via the Form CMS-855A (Medicare Enrollment Application for Institutional Providers (OMB #0938-0685)). To account for circumstances where an OTP wishes to pursue Form CMS-855A enrollment for the reason stated above, we propose the following revisions to § 424.67:</P>
                    <P>• Current § 424.67(b)(1) states that a newly enrolling OTP must fully complete and submit the Form CMS-855B application (or its successor application). We propose to revise this paragraph to state that the newly enrolling OTP must fully complete and submit, as applicable, the Form CMS-855A or Form CMS-855B application (or their successor applications).</P>
                    <P>• Existing § 424.67(b)(1)(ii) requires the OTP to certify compliance with the requirements and standards described in paragraphs § 424.67(b) and (d) via the Form CMS-855B and/or the applicable supplement or attachment thereto. We propose to revise this paragraph such that the OTP must certify compliance with the above-referenced requirements and standards via the Form CMS-855A or Form CMS-855B (as applicable) and/or the applicable supplement or attachment thereto.</P>
                    <P>• Existing § 424.67(b)(5) requires the OTP to report on the Form CMS-855B and/or any applicable supplement all OTP staff who meet the definition of “managing employee” in § 424.502. We propose to change this to state that the OTP must report on the Form CMS-855A or Form CMS-855B (as applicable) and/or any applicable supplement all OTP staff who meet the said definition.</P>
                    <P>We believe these revisions would accomplish two objectives. First, they would permit OTPs to submit a Form CMS-855A in lieu of a Form CMS-855B based on their preferred method of billing. Second, they would confirm that the requirements of § 424.67 apply to all OTPs regardless of whether they complete the Form CMS-855A or the Form CMS-855B.</P>
                    <HD SOURCE="HD3">c. Screening Activities Associated With Risk Designation</HD>
                    <P>
                        Section 424.518 outlines provider enrollment screening categories and requirements based on our assessment of the degree of risk of fraud, waste, and abuse posed by a particular category of provider or supplier. In general, the higher the level of risk that a certain provider or supplier type presents, the greater the degree of scrutiny with which we will screen and review enrollment applications submitted by providers or suppliers within that category. There are three levels of screening addressed in § 424.518: Limited; moderate; and high. 
                        <PRTPAGE P="50212"/>
                        Irrespective of which level a provider or supplier type falls within, the MAC performs certain minimum screening functions upon receipt of an initial enrollment application, a revalidation application, or an application to add a new practice location. These include:
                    </P>
                    <P>• Verification that the provider or supplier meets all applicable federal regulations and state requirements for their provider or supplier type.</P>
                    <P>• State license verifications.</P>
                    <P>• Database reviews on a pre- and post-enrollment basis to ensure that providers and suppliers continue to meet the enrollment criteria for their provider or supplier type.</P>
                    <P>Providers and suppliers at the moderate and high categorical risk levels must also undergo a site visit. Moreover, for those in the high categorical risk level, the MAC performs two additional functions under § 424.518(c)(2). First, the MAC requires the submission of a set of fingerprints for a national background check from all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. Second, it conducts a fingerprint-based criminal history record check of the Federal Bureau of Investigation's (FBI) Integrated Automated Fingerprint Identification System on all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. These additional verification activities are intended to correspond to the heightened risk involved with such provider or supplier types.</P>
                    <P>For newly enrolling OTPs, those that have been fully and continuously certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) since October 23, 2018 fall within the moderate level of categorical screening. OTPs that have not been so certified since the aforementioned date are subject to the high screening level. We recognize that certain providers and suppliers have already enrolled as OTPs via the Form CMS-855B—and, accordingly, undergone a site visit and, if applicable, fingerprinting—but would seek to newly enroll via the Form CMS-855A should our proposals be finalized. (Said enrollment would be considered “new” for purposes of enrollment because the OTP would be enrolling via a different variation of the Form CMS-855.) While not seeking to minimize the importance of the enhanced screening activities associated with the moderate and high categorical levels, we do not wish to unduly burden currently enrolled OTPs that would pursue Form CMS-855A enrollment as an OTP. More specifically, we do not believe such OTPs should have to undergo another site visit and, if applicable, fingerprinting when they previously did so as an OTP via their original Form CMS-855B enrollment. This, in our view, would constitute an unnecessary expenditure of CMS, MAC, and OTP resources. We add that the same would hold true if, in the future, an OTP that is enrolled via the Form CMS-855A under revised § 424.67(b) decides to change to a Form CMS-855B enrollment. In both cases, we believe a duplication of effort should be avoided to the extent consistent with safeguarding the integrity of the Medicare program.</P>
                    <P>Existing § 424.67(b)(3) states that an enrolling OTP must successfully complete the assigned categorical risk level screening required under, as applicable, § 424.518(b) and (c) (which outline the screening requirements for newly enrolling parties in, respectively, the moderate and high categorical levels). Given the foregoing discussion, we propose several changes to § 424.67(b)(3). First, we would re-designate existing § 424.67(b)(3) as new § 424.67(b)(3)(i), though with an exception to its requirements. Second, new paragraph (b)(3)(ii) (which would address this exception) would state that currently enrolled OTPs that are changing their OTP enrollment from a Form CMS-855B to a Form CMS-855A, or vice versa, must successfully complete the limited level of categorical screening under § 424.518(a) if the OTP has already completed, as applicable, the moderate or high level of categorical screening under § 424.518(b) or (c), respectively. Third, we propose to redesignate existing § 424.518(a)(1)(xii) through (xvii) as § 424.518(a)(1)(xiii) through (xviii). Fourth, new § 424.518(a)(1)(xii) would add OTPs that fall within the purview of new paragraph (b)(3)(ii) to the provider and supplier types subject to limited risk categorical screening.</P>
                    <HD SOURCE="HD3">d. Additional OTP Enrollment Clarifications Regarding the Form CMS-855A</HD>
                    <P>We propose three additional clarifications related to our previously mentioned OTP enrollment provisions. To incorporate these into § 424.67, we would redesignate existing paragraphs (c), (d), (e), and (f) as paragraphs (d), (e), (f), and (g), respectively. The three clarifications would be included in new paragraph (c).</P>
                    <P>With the redesignation of existing paragraph (d) as paragraph (e), we also propose to change the reference to:</P>
                    <P>• Paragraph (d) in existing paragraph (b)(1)(ii) to paragraph (e).</P>
                    <P>• Paragraph (d)(1) in existing paragraph (d)(2)(i) to paragraph (e)(1) in redesignated paragraph (e)(2)(i).)</P>
                    <HD SOURCE="HD3">(1) Single Enrollment</HD>
                    <P>We propose in new § 424.67(c)(1) that an OTP may only be enrolled as such via the Form CMS-855A or the Form CMS-855B but not both. The OTP, in other words, must opt for either Form CMS-855A enrollment or Form CMS-855B enrollment. This is to help ensure that the OTP does not bill twice for the same service via separate claim vehicles (specifically, the CMS-1500 and the 837I).</P>
                    <HD SOURCE="HD3">(2) Effective Date of Billing</HD>
                    <P>Section 424.520(d) outlines the effective date of billing privileges for newly enrolling OTPs (and certain other provider and supplier types). This date is the later of: (1) The date of the OTP's filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor; or (2) the date that the OTP first began furnishing services at a new practice location. In a similar vein, § 424.521(a) states that OTPs (and certain other provider and supplier types) may retrospectively bill for services when the OTP has met all program requirements (including state licensure requirements), and services were provided at the enrolled practice location for up to—</P>
                    <P>• 30 days prior to their effective date if circumstances precluded enrollment in advance of providing services to Medicare beneficiaries; or</P>
                    <P>• 90 days prior to their effective date if a Presidentially-declared disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 through 5206 (Stafford Act) precluded enrollment in advance of providing services to Medicare beneficiaries.</P>
                    <P>
                        In light of proposed § 424.67(c)(1) (and as further explained in the collection of information section of this proposed rule), we anticipate that a number of OTPs would end their existing enrollment and apply as a new OTP via, as applicable, the Form CMS-855A or Form CMS-855B. Given this, we believe it is important to clarify for stakeholders the new enrollment's effective date of billing. Accordingly, at § 424.67, we propose in new paragraph (c)(2) that if a Form CMS-855B-enrolled OTP changes to a Form CMS-855A enrollment, or vice versa, the effective date of billing that was established for the OTP's prior enrollment under §§ 424.520(d) and 424.521(a) would be applied to the OTP's new enrollment. This would allow OTPs that have been 
                        <PRTPAGE P="50213"/>
                        unable to bill for furnished services via their preferred claim form (and have consequently chosen to delay the submission of these claims for services) to do so retroactive to the effective billing date of its prior enrollment. To illustrate, suppose an OTP initially enrolled via the Form CMS-855B in 2020. The effective date of billing was April 1, 2020. Wishing to submit an 837I claim form for the services it has provided since April 1, 2020 the OTP elects to end its Form CMS-855B enrollment and enroll via the Form CMS-855A pursuant to revised § 424.67. It successfully does the latter in March 2021. Under § 424.67(c)(2), the billing effective date of the Form CMS-855A enrollment would be retroactive to April 1, 2020. We note, however, that the time limits for filing claims found in § 424.44 would continue to apply. Specifically, all Medicare Part A and Part B claims must be filed within 1 calendar year after the date of service unless one of a very limited number of exceptions applies. Switching from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, is not grounds for an exception.
                    </P>
                    <P>We recognize, of course, that not every OTP that seeks to change its enrollment will have chosen to withhold submission of all of its claims under its prior enrollment. (Using our example in the previous paragraph, the OTP may have submitted some claims via the CMS-1500 while planning to eventually submit the remaining ones via the 837I.) Irrespective of this, CMS has long had operational safeguards in place to prevent double-billing for the same service. Said protections would be used in the scenario described in proposed § 424.67(c)(2) so that claims submitted under the prior enrollment could not be resubmitted under the new one.</P>
                    <HD SOURCE="HD3">(3) Application Fee</HD>
                    <P>As stated in § 424.514, prospective and revalidating institutional providers that are submitting a Medicare enrollment application generally must pay the applicable application fee in accordance with § 424.514. (For CY 2020, the fee amount is $595.) We define the term “institutional provider” in § 424.502 as any provider or supplier that submits a paper Medicare enrollment application using the Form CMS-855A, Form CMS-855B (not including physician and non-physician practitioner organizations, which are exempt from the fee requirement if they are enrolling as a physician or non-physician practitioner organization), Form CMS-855S, Form CMS-20134, or an associated internet-based PECOS enrollment application.</P>
                    <P>We have already noted that OTPs currently complete the Form CMS-855B to enroll in Medicare. They are considered “institutional providers” (as defined in § 424.502) and must pay an application fee, a requirement addressed in existing § 424.67(b)(2). Since the existing OTPs referenced in new paragraph (c)(2) would, as stated previously, be enrolling as new providers via the Form CMS-855A or Form CMS-855B (as applicable), we believe they would fall within the scope of both (1) the aforementioned definition of “institutional provider” and (2) § 424.514(a)(1); as described therein, § 424.514(a)(1) applies to prospective institutional providers that are submitting an initial application. To clarify this issue for the OTP community, we propose to add language to § 424.67(b)(2) stating that compliance with the application fee requirements in § 424.514 would also apply to those OTPs enrolling under the circumstances described in § 424.67(c)(2).</P>
                    <P>We emphasize that the flexibilities described in this section III.B. are complementary to those in section II.I. (“Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs))” regarding OTP billing via the 837I. Our OTP enrollment revisions are intended to facilitate greater flexibility for OTPs should the proposals in section II.I. be finalized.</P>
                    <HD SOURCE="HD2">C. Payment for Principal Care Management (PCM) Services in Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <HD SOURCE="HD3">a. RHC and FQHC Payment Methodologies</HD>
                    <P>RHC and FQHC visits generally are face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which time one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners (NPs), physician assistants (PA), certified nurse midwives (CNMs), clinical psychologists (CPs), and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient. A Transitional Care Management (TCM) service can also be an RHC or FQHC visit. In addition, a Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT program may also count as an FQHC visit. Only medically necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel (for example, nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per visit payment.</P>
                    <P>RHCs are paid an all-inclusive rate (AIR) for all medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). In general, the A/B Medicare Administrative Contractor (MAC) calculates the AIR for the year for each RHC by dividing total allowable costs by the total number of visits for all patients. Productivity, payment limits, and other factors are also considered in the calculation. Allowable costs must be reasonable and necessary and may include practitioner compensation, overhead, equipment, space, supplies, personnel, and other costs incident to the delivery of RHC services. The AIR is subject to a payment limit, except for certain provider-based RHCs that have an exception to the payment limit.</P>
                    <P>FQHCs were paid under the same AIR methodology until October 1, 2014, when, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Affordable Care Act), they began to transition to an FQHC PPS system in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF).</P>
                    <HD SOURCE="HD3">b. Care Management Services in RHCs and FQHCs</HD>
                    <P>In the CY 2018 final rule with comment period (83 FR 59683), we finalized revisions to the payment methodology for Chronic Care Management (CCM) services furnished by RHCs and FQHCs and established requirements for general Behavioral Health Integration (BHI) and psychiatric Collaborative Care Management (CoCM) services furnished in RHCs and FQHCs, beginning on January 1, 2019. Specifically, we revised § 405.2464(c) to permit RHCs and FQHCs to bill for care management services (HCPCS codes G0511 and G0512).</P>
                    <P>
                        HCPCS code, G0511, is a General Care Management code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM or general BHI services are furnished to a patient in a calendar month.
                        <PRTPAGE P="50214"/>
                    </P>
                    <P>
                        The payment amount for HCPCS code G0511 is set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS amounts. The 3 codes are CPT 99490 (
                        <E T="03">20 minutes or more of CCM services</E>
                        ), CPT 99487 (
                        <E T="03">60 minutes or more of complex CCM services</E>
                        ), and CPT 99484 (
                        <E T="03">20 minutes or more of BHI services</E>
                        ).
                    </P>
                    <P>
                        In the CY 2019 final rule with comment period, we added CPT code 99491 (
                        <E T="03">30 minutes or more of CCM furnished by a physician or other qualified health care professional</E>
                        ) as a general care management service and included it in the calculation of HCPCS code G0511. Beginning January 1, 2019, the payment for HCPCS code G0511 is set at the average of the national non-facility PFS payment rates for CPT codes 99490, 99487, 99484, and 99491 and is updated annually based on the PFS amounts. Additional information on CCM requirements is available on the CMS Care Management web page at 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html,</E>
                         and on the CMS RHC and FQHC web pages at 
                        <E T="03">https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html</E>
                         and 
                        <E T="03">https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.</E>
                    </P>
                    <HD SOURCE="HD3">2. Proposed Requirements for PCM Services in RHCs and FQHCs</HD>
                    <P>In the CY 2020 PFS final rule with comment (84 FR 62692), we established a separate payment for PCM services. PCM services include comprehensive care management services for a single high-risk disease or complex condition, typically expected to last at least 3 months and may have led to a recent hospitalization, and/or placed the patient at significant risk of death. Beginning January 1, 2020, practitioners billing under the PFS can bill for PCM services using HCPCS codes G2064 or G2065.</P>
                    <P>HCPCS code G2064 is for at least 30 minutes of PCM services furnished by physicians or non-physicians during a calendar month with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been the cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities.</P>
                    <P>HCPCS code G2065 is for at least 30 minutes of PCM services furnished by clinical staff under the direct supervision of a physician or non-physician practitioner with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities.</P>
                    <P>A national stakeholder organization representing rural health clinics has requested that RHCs be allowed to furnish and bill for PCM services. We agree that there can be significant resources involved in care management for a single high risk disease or complex chronic condition, and that the requirements for the new PCM codes are similar to the requirements for the care management services described by HCPCS code G0511. These are services that do not currently meet the requirements for an RHC or FQHC billable visit, and they provide an array of care management services that are not generally included in the RHC AIR or the FQHC PPS. Therefore, we are proposing to add HCPCS codes G2064 and G2065 to G0511 as a comprehensive care management service for RHCs and FQHCs starting January 1, 2021. The payment rate for HCPCS G0511 is the average of the national non-facility PFS payment rate for the RHC and FQHC care management and general behavioral health codes (CPT codes 99490, 99487, 99484, and 99491), and we propose that these 2 new codes be added to the calculation of the G0511 payment rate.</P>
                    <HD SOURCE="HD3">3. Other Options Considered</HD>
                    <P>We also considered creating a separate G code for PCM services. We did not choose this approach because PCM and CCM are similar services and grouping them together is consistent with an integrated approach to care with reduced reporting requirements. As we stated in the CY 2018 PFS final rule, if a new care management code is proposed and subsequently finalized for practitioners billing under the PFS, we would review the new code to determine if it should be included in the calculation of the RHC and FQHC General Care Management Code. The determination of whether a new care management code should be added to the codes used to determine the payment rate is based on the applicability of the service in RHCs and FQHCs, and may result in either an increase or decrease in the payment amount for HCPCS code G0511.</P>
                    <HD SOURCE="HD3">4. Implementation</HD>
                    <P>If this proposal is finalized as proposed, RHCs and FQHCs that furnish qualified PCM services would also be able to bill the services using HCPCS code G0511, either alone or with other payable services on an RHC or FQHC claim for dates of service on or after January 1, 2021. The payment rate for HCPCS code G0511 would continue to be the average of the national non-facility PFS payment rates for the RHC/FQHC care management and general behavioral health codes (CPT codes 99484, 99487, 99490, and 99491). HCPCS G2064 and G2065 would be added to G0511 to calculate a new average for the national non-facility PFS payment rate. The payment rate for HCPCS code G0511 would be updated annually based on the PFS amounts for these codes.</P>
                    <HD SOURCE="HD2">D. Changes to the Federally Qualified Health Center Prospective Payment System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising of the FQHC Market Basket</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>
                        Section 10501(i)(3)(A) of the Affordable Care Act added section 1834(o) of the Act to establish a payment system for the costs of FQHC services under Medicare Part B based on prospectively set rates. In the Prospective Payment System (PPS) for FQHC final rule published in the May 2, 2014 
                        <E T="04">Federal Register</E>
                         (79 FR 25436), we implemented a methodology and payment rates for the FQHC PPS. Beginning on October 1, 2014, FQHCs began to transition to the FQHC PPS based on their cost reporting periods, and as of January 1, 2016, all FQHCs are paid under the FQHC PPS.
                    </P>
                    <P>
                        Section 1834(o)(2)(B)(ii) of the Act requires that the payment for the first year after the implementation year be increased by the percentage increase in the Medicare Economic Index (MEI). Therefore, in CY 2016, the FQHC PPS base payment rate was increased by the MEI. The MEI is based on 2006 data from the American Medical Association (AMA) for self-employed physicians and was used in the PFS sustainable growth rate (SGR) formula to determine the conversion factor for physician service payments. (See the CY 2014 PFS 
                        <PRTPAGE P="50215"/>
                        final rule (78 FR 74264) for a complete discussion of the 2006-based MEI). Section 1834(o)(2)(B)(ii) of the Act also requires that beginning in CY 2017, the FQHC PPS base payment rate will be increased by the percentage increase in a market basket of FQHC goods and services, or if such an index is not available, by the percentage increase in the MEI.
                    </P>
                    <P>Beginning with CY 2017, FQHC PPS payments were updated using a 2013-based market basket reflecting the operating and capital cost structures for freestanding FQHC facilities (hereafter referred to as the FQHC market basket). A complete discussion of the 2013-based FQHC market basket can be found in the CY 2017 PFS final rule (81 FR 80393 through 80403).</P>
                    <P>For this CY 2021 PFS/FQHC proposed rule, we propose to rebase and revise the 2013-based FQHC market basket to reflect a 2017 base year. The proposed 2017-based FQHC market basket is primarily based on Medicare cost report data for FQHCs for 2017, which are for cost reporting periods beginning on and after October 1, 2016, and prior to September 31, 2017. We propose to use data from cost reports beginning in FY 2017 because these data are the latest available complete data for purposes of calculating cost weights for the market basket at the time of rulemaking.</P>
                    <P>In the following discussion, we provide an overview of the proposed FQHC market basket, describe the proposed methodologies for developing the operating and capital portions of the 2017-based FQHC market basket, and provide information on the proposed price proxies. We then present the CY 2021 market basket update based on the proposed 2017-based FQHC market basket.</P>
                    <HD SOURCE="HD3">2. Overview of the 2017-Based FQHC Market Basket</HD>
                    <P>Similar to the 2013-based FQHC market basket, the proposed 2017-based FQHC market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the quantity or mix (that is, intensity) of goods and services purchased over time are not measured. The index itself is constructed using three steps. First, a base period is selected (in this proposed rule, we propose to use 2017 as the base period) and total base period expenditures are estimated for a set of mutually exclusive and exhaustive spending categories, with the proportion of total costs that each category represents being calculated. These proportions are called “cost weights” or “expenditure weights.” Second, each expenditure category is matched to an appropriate price or wage variable, referred to as a “price proxy.” In almost every instance, these price proxies are derived from publicly available statistical series that are published on a consistent schedule (preferably at least on a quarterly basis). Finally, the expenditure weight for each cost category is multiplied by the level of its respective price proxy. The sum of these products (that is, the expenditure weights multiplied by their price levels) for all cost categories yields the composite index level of the market basket in a given period. Repeating this step for other periods produces a series of market basket levels over time. Dividing an index level for a given period by an index level for an earlier period produces a rate of growth in the input price index over that timeframe. As noted above, the market basket is described as a fixed-weight index because it represents the change in price over time of a constant mix (quantity and intensity) of goods and services needed to furnish FQHC services. The effects on total expenditures resulting from changes in the mix of goods and services purchased subsequent to the base period are not measured. For example, a FQHC hiring more nurse practitioners to accommodate the needs of patients would increase the volume of goods and services purchased by the FQHC, but would not be factored into the price change measured by a fixed-weight FQHC market basket. Only when the index is rebased would changes in the quantity and intensity be captured, with those changes being reflected in the cost weights. Therefore, we rebase the market basket periodically so that the cost weights reflect a recent mix of goods and services that FQHCs purchase (FQHC inputs) to furnish inpatient care.</P>
                    <HD SOURCE="HD3">3. Development of the 2017-Based FQHC Market Basket Cost Categories and Weights</HD>
                    <P>We are inviting public comments on our proposed methodology, discussed below, for deriving the proposed 2017-based FQHC market basket.</P>
                    <HD SOURCE="HD3">a. Use of Medicare Cost Report Data</HD>
                    <P>We are proposing a 2017-based FQHC market basket that consists of eleven major cost categories and a residual derived from the 2017 Medicare cost reports (CMS Form 224-14, OMB Control Number 0938-1298) for FQHCs, hereafter referred to as the 2014 Medicare Cost Report form. The eleven cost categories are FQHC Practitioner Wages and Salaries, FQHC Practitioner Employee Benefits, FQHC Practitioner Contract Labor, Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits, Clinical Staff Contract Labor, Non-Health Staff Compensation, Medical Supplies, Pharmaceuticals, Fixed Capital and Moveable Capital. The residual category reflects all remaining costs not captured in the 11 cost categories such as non-medical supplies and utilities for example. We note that for the 2013-based FQHC market basket, we estimated six cost categories from the Medicare cost reports (CMS Form 222-92, OMB Control Number 0938-0107), hereafter referred to as the 1992 Medicare cost report form: FQHC Practitioner Compensation, Clinical Staff Compensation, Non-Health Staff Compensation, Pharmaceuticals, Fixed Capital and Moveable Capital.</P>
                    <P>The resulting 2017-based FQHC market basket cost weights reflect Medicare allowable costs. We define Medicare allowable costs for freestanding FQHC facilities as the total expenses reported on: Worksheet A, Columns 1 and 2, lines 1 through 7 and lines 9 through 12; Worksheet A, Column 1, lines 23 through 36; and Worksheet S3 Part II, Columns 1 and 2, lines 2 through 14. We note that we continue to exclude Professional Liability Insurance (PLI) costs from the total Medicare allowable costs because FQHCs that receive section 330 grant funds also are eligible to apply for medical malpractice coverage under Federally Supported Health Centers Assistance Act (FSHCAA) of 1992 (Pub. L. 102-501) and FSHCAA of 1995 (Pub. L. 104-73 amending section 224 of the Public Health Service Act).</P>
                    <P>Below, we summarize how we derive the eleven major cost category weights. Prior to estimating any costs, we remove any providers that did not report any total gross patient revenues as reported on the FQHC cost report Worksheet F-1, line 1, column 4.</P>
                    <HD SOURCE="HD3">(1) FQHC Practitioner Wages and Salaries Costs</HD>
                    <P>
                        A FQHC practitioner is defined as one of the following occupations: Physicians; nurse practitioners (NPs); physician assistants (PAs); certified-nurse midwife (CNMs); clinical psychologist (CPs); and clinical social workers (CSWs). We propose to derive FQHC Practitioner Wages and Salaries costs as the sum of direct care costs salaries as reported on Worksheet A, column 1, lines 23, 25, 26, 29, 30, and 31. These lines represent the wages and salaries costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. For the 2013-based FQHC market basket, we 
                        <PRTPAGE P="50216"/>
                        estimated FQHC Practitioner Total Compensation costs based on a similar methodology using cost data reported on Worksheet A of the 1992 Medicare cost report form (81 FR 80394) for specific details on the prior methodology.
                    </P>
                    <HD SOURCE="HD3">(2) FQHC Practitioner Employee Benefits Costs</HD>
                    <P>Effective with the implementation of the 2014 Medicare cost report form, we began collecting Employee Benefits and Contract Labor data on Worksheet S-3, part II and propose to derive FQHC Practitioner Employee Benefits costs using data obtained from that worksheet. Approximately 66 percent of FQHCs included in the sample of FQHCs reporting Salary costs also reported data on Worksheet S-3, part II for 2017. We continue to encourage all providers to report these data on the Medicare cost report. Therefore, we propose to calculate FQHC Practitioner Employee Benefits costs using Worksheet S-3, part II data. Specifically, we propose to use data from Worksheet S-3, part II, column 2, lines 2, 3, 4, 7, 8, and 9 to derive FQHC Practitioner Employee Benefits costs. These lines represent the employee benefits costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. Our analysis of the Worksheet S-3, part II data submitted by these FQHCs indicates that we had a large enough sample to enable us to produce a reasonable Employee Benefits cost weight.</P>
                    <P>For the 2013-based FQHC market basket, we did not have data at the level of detail to separately estimate FQHC Practitioner Employee Benefits costs, and instead computed FQHC Practitioner Total Compensation costs, which reflected costs for wages and salaries, employee benefits, and contract labor together. Anytime direct costs can be obtained for a cost category directly from the Medicare Cost Reports we consider that to be a technical improvement to the market basket weight methodology as it allows the index to reflect the relative shares specific to the provider type. Therefore, we believe this proposed method of separately estimating FQHC Practitioner Employee Benefits is a technical improvement over the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">(3) FQHC Practitioner Contract Labor Costs</HD>
                    <P>FQHC Practitioner Contract labor costs are primarily associated with direct patient care services. Contract labor costs for services such as accounting, billing, and legal are estimated using other government data sources as described below. Approximately 60 percent of FQHCs reported contract labor costs on Worksheet S-3, part II, which we believe is an adequate sample size to enable us to produce a reasonable FQHC Practitioner Contract Labor cost weight. Therefore, we propose to derive the FQHC Practitioner Contract Labor costs for the proposed 2017-based FQHC market basket from data reported on Worksheet S-3, part II, column 1, lines 2, 3, 4, 7, 8, and 9. These lines represent the contract labor costs for physicians, PAs, NPs, CNMs, CPs, and CSWs. We also add in the costs for physician services under agreement as reported on Worksheet A, column 2, line 24 to derive the total FQHC Practitioner Contract Labor cost weight in the proposed 2017-based FQHC market basket.</P>
                    <P>For the 2013-based FQHC market basket, we did not have data at the level of detail to separately estimate FQHC Practitioner Contract Labor costs and instead computed FQHC Practitioner Total Compensation costs, which reflected costs for wages and salaries, employee benefits, and contract labor together. As noted previously, anytime direct costs can be obtained for a cost category directly from the Medicare Cost Reports we consider that to be a technical improvement to the market basket weight methodology as it allows the index to reflect the relative shares specific to the provider type. Therefore, we believe this proposed method of separately estimating FQHC Practitioner Contract Labor is a technical improvement over the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">(4) Clinical Staff Wages and Salaries Costs</HD>
                    <P>Clinical Compensation includes any health-related clinical staff who does not fall under the definition of a FQHC Practitioner described in paragraph. We propose to derive Clinical Staff Wages and Salaries costs as the sum of direct care costs salaries as reported on Worksheet A, column 1, lines 27, 28, 32, 33, 34, 35, and 36. These lines represent the wages and salaries costs for visiting registered nurses (RNs), visiting licensed practical nurses (LPNs), laboratory technicians, registered dietician/Certified DSMT/MNT educators, physical therapists (PTs), occupational therapists (OTs), and other allied health personnel.</P>
                    <P>• For the 2013-based FQHC market basket, we estimated a clinical staff total compensation cost based on a similar methodology using cost data reported on Worksheet A of Medicare Cost Report form CMS-222-92, (see 81 FR 80394 for specific details on the prior methodology).</P>
                    <HD SOURCE="HD3">(5) Clinical Staff Employee Benefits Costs</HD>
                    <P>Effective with the implementation of the 2014 Medicare cost report form, we began collecting employee benefits and contract labor data on Worksheet S-3, part II and propose to derive clinical staff employee benefits costs using data obtained from that worksheet. Approximately 64 percent of FQHCs included in the sample of FQHCs reporting salary expenses also reported data on Worksheet S-3, part II for 2017. We continue to encourage all providers to report these data on the Medicare cost report. Therefore, we propose to calculate clinical staff employee benefits costs using Worksheet S-3, part II, column 2, lines 5, 6, 10, 11, 12, 13, and 14. These lines represent the employee benefits costs for visiting RNs, visiting LPNs, laboratory technicians, registered dietician/Certified DSMT/MNT educators, PTs, OTs, and other allied health personnel.</P>
                    <P>• For the 2013-based FQHC market basket, we did not have data at the level of detail to separately estimate clinical staff employee benefits costs and instead computed clinical staff total compensation costs, which reflected costs for wages and salaries, employee benefits, and contract labor together. We believe this proposed method of separately estimating clinical staff employee benefits is a technical improvement over the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">(6) Clinical Staff Contract Labor Costs</HD>
                    <P>We propose to derive the clinical staff contract labor costs for the proposed 2017-based FQHC market basket from data reported on Worksheet S-3, part II, column 1, lines 5, 6, 10, 11, 12, 13, and 14 to derive clinical staff contract labor costs. These lines represent the contract labor costs for visiting RNs, visiting LPNs, laboratory technicians, registered dietician/Certified DSMT/MNT educators, PTs, OTs, and other allied health personnel.</P>
                    <P>
                        For the 2013-based FQHC market basket, we did not have data at the level of detail to separately estimate clinical staff contract labor costs and instead computed clinical staff total compensation costs, which reflected costs for wages and salaries, employee benefits, and contract labor together. We believe this proposed method of separately estimating FQHC clinical staff contract labor is a technical improvement over the 2013-based FQHC market basket.
                        <PRTPAGE P="50217"/>
                    </P>
                    <HD SOURCE="HD3">(7) Non-Health Staff Compensation Costs</HD>
                    <P>Non-Health Staff Compensation includes wage and salary costs for personnel in general service cost centers including: Employee Benefits department; Administrative &amp; General; Plant Operation &amp; Maintenance; Janitorial; Medical Records; Pharmacy; Transportation; and Other General Services. Specifically, non-health staff compensation costs are derived as the sum of compensation costs as reported on Worksheet A, column 1 for lines 3, 4, 5, 6, 7, 9, 10, 11, and 12. Additionally, we add a portion of employee benefit costs reported on Worksheet A, line 3, column 2 accounting for the non-health staff. We estimate the ratio of non-health staff related wages and salaries as a percentage of total wages and salaries. We then apply the percentage of non-health staff related wages and salary costs to the total employee benefits costs (Worksheet A, line 3, column 2) for each FQHC. We believe this is a reasonable estimate of non-health staff employee benefits. We propose to only use the costs from column 1 for most of the general service cost centers other than employee benefits since we believe that there are noncompensation costs reported in column 2 (such as maintenance and janitorial supplies). The remaining other costs for the general service categories are reflected in the remaining proposed cost categories as explained in more detail below.</P>
                    <HD SOURCE="HD3">(8) Pharmaceuticals Costs</HD>
                    <P>We propose to calculate pharmaceuticals costs using the non-salary costs for the pharmacy cost center reported on Worksheet A, column 2, line 9. We propose to exclude the costs for drugs charged to patients as reported on Worksheet A, line 67 since these drugs are not included in the Medicare allowable costs for the FQHC PPS and are separately reimbursed. For the 2013-based FQHC market basket we were not able to exclude non-reimbursable drug costs (such as drugs charged to patient costs) from the pharmacy cost weight as the 1992 Medicare cost report form did not capture these costs separately. We believe our proposed methodology is a technical improvement as it is more consistent with the FQHC PPS reimbursement.</P>
                    <HD SOURCE="HD3">(9) Medical Supplies</HD>
                    <P>We propose to calculate medical supplies costs using the non-salary costs for the medical supplies cost center reported on Worksheet A, column 2, line 10. The medical supplies cost weight for the 2013-based FQHC market basket was derived based on the relative share of the medical supply costs in the MEI since these costs were not separately reported on the 1992 Medicare cost report form (81 FR 80395 through 80396). Since these costs are now directly reported by FQHC providers we believe the proposed method is a technical improvement to the method used in the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">(10) Fixed Capital</HD>
                    <P>We propose that fixed capital costs be equal to costs reported on Worksheet A, line 1, column 2 of the Medicare Cost Report. A similar methodology was used for the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">(11) Moveable Capital Costs</HD>
                    <P>We propose that moveable capital costs be equal to the capital costs as reported on Worksheet A, line 2, column 2. A similar methodology was used for the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">b. Proposed Major Cost Category Computation</HD>
                    <P>After we derive costs for the major cost categories for each provider using the Medicare cost report data as previously described, we propose to trim the data for outliers. For each of the eleven major cost categories, we first are proposing to divide the calculated costs for the category by total Medicare allowable costs calculated for the provider to obtain cost weights for the universe of FQHC providers. For the 2017-based FQHC market basket (similar to the 2013-based FQHC market basket), we propose that total Medicare allowable costs would be equal to the total costs as reported on Worksheet A, Columns 1 and 2, lines 1 through 7 and lines 9 through 12; Worksheet A, Column 1, lines 23 through 36; and Worksheet S3 Part II, Columns 1 and 2, lines 2 through 14.</P>
                    <P>For the FQHC Practitioner Wages and Salaries, FQHC Practitioner Employee Benefits, FQHC Practitioner Contract Labor, Clinical Staff Wages and Salaries, Clinical Staff Employee Benefits, Clinical Staff Contract Labor, Non-Health Staff Compensation, Pharmaceuticals, Medical Supplies, Fixed Capital, and Moveable Capital cost weights, after excluding cost weights that are less than or equal to zero, we propose to then remove those providers whose derived cost weights fall in the top and bottom 5 percent of provider-specific derived cost weights to ensure the exclusion of outliers. A 5 percent trim is the standard trim applied to the mean cost weights in all CMS market baskets and is consistent with the trimming used in the 2013-based FQHC market basket. After the outliers have been excluded, we sum the costs for each category across all remaining providers. We then are proposing to divide this by the sum of total Medicare allowable costs across all remaining providers to obtain a cost weight for the 2017-based FQHC market basket for the given category. This trimming process is done for each cost weight separately.</P>
                    <P>Finally, we propose to calculate the residual “All Other” cost weight that reflects all remaining costs that are not captured in the eleven major cost categories listed. We refer readers to Table 31 for the resulting proposed cost weights for these major cost categories.</P>
                    <GPH SPAN="3" DEEP="274">
                        <PRTPAGE P="50218"/>
                        <GID>EP17AU20.065</GID>
                    </GPH>
                    <P>The total compensation cost weight of 71.6 percent (sum of FQHC Practitioner Compensation, Clinical Compensation, Non-health Staff Compensation) calculated from the Medicare cost reports for the proposed 2017-based FQHC market basket is approximately 3.0 percentage point higher than the total compensation cost weight for the 2013-based FQHC market basket (68.6 percent). The 2017-based cost weight for FQHC Practitioners and Non-Health Staff are each about 2 percentage points lower compared to the 2013-based FQHC market basket, while the clinical staff compensation cost weight is about 7 percentage points higher. Part of the reason for the shift in the weights between compensation categories may be due to the change to the FQHC Medicare cost report form. On the 1992 Medicare cost report form (used for the 2013-based FQHC market basket), there were four open ended “fill-in” categories for healthcare staff costs and costs under agreement. Since we were unable to determine what specific category the “other health care staff” costs should be allocated to (that is, either FQHC practitioner, or clinical staff) we used a methodology where we applied the expenses for the “other health care staff costs” between the categories for FQHC practitioner and clinical staff, based on the relative shares of expenses for both categories, excluding the open-ended fill in lines of Worksheet A, lines 9-11 and line 15. This may have resulted in an over allocation of some of the 2013 expenses to the FQHC Practitioner category relative to the clinical staff. On the 2014 Medicare cost report form, there is no longer an ambiguous category for other direct patient care staff costs.</P>
                    <P>The proposed 2017-based Pharmaceuticals cost weight is roughly 1.2 percentage points lower than the cost weight in the 2013-based FQHC market basket. The pharmaceutical costs included in the weight for 2017-based FQHC market basket includes only non-salary costs reported in Pharmacy (under general services) (Worksheet A, line 9, column 2 on the 2014 Medicare cost report form). We believe the cost share is lower with the new data because there is more specificity on where to report reimbursable and non-reimbursable drugs.</P>
                    <P>As we did for the 2013-based FQHC market basket, we propose to allocate the contract labor cost weight to the Wages and Salaries and Employee Benefits cost weights based on their relative proportions under the assumption that contract labor costs comprise both Wages and Salaries and Employee Benefits for both FQHC Practitioners and Clinical Staff. The contract labor allocation proportion for Wages and Salaries is equal to the Wages and Salaries cost weight as a percent of the sum of the Wages and Salaries cost weight and the Employee Benefits cost weight. This rounded percentage is 82 percent for FQHC Practitioners and 80 percent for clinical staff. Therefore, we propose to allocate 82 percent of the FQHC Practitioner Contract Labor cost weight to the FQHC Practitioner Wages and Salaries cost weight and 18 percent to the FQHC Practitioner Employee Benefits cost weight. Similarly, we propose to allocate 80 percent of the clinical staff contract labor cost weight to the Clinical Staff Wages and Salaries cost weight and 20 percent to the clinical staff employee benefits cost weight. We refer readers to Table 32 that shows the proposed Wages and Salaries and Employee Benefits cost weights after Contract Labor cost weight allocation for the proposed 2017-based FQHC market basket.</P>
                    <GPH SPAN="3" DEEP="98">
                        <PRTPAGE P="50219"/>
                        <GID>EP17AU20.066</GID>
                    </GPH>
                    <HD SOURCE="HD3">c. Derivation of the Detailed Operating Cost Weights</HD>
                    <P>
                        To further divide the “All Other” residual cost weight of 15.5 percent estimated from the 2017 Medicare cost report data into more detailed cost categories, we propose to use the 2012 Benchmark Input-Output (I-O) “Use Tables/Before Redefinitions/Purchaser Value” for NAICS 621100, Offices of Physicians, published by the Bureau of Economic Analysis (BEA). We note that the BEA benchmark I-O data is used to further disaggregate residual expenses in other CMS market baskets. Therefore, we believe the data from this industry are the most technically appropriate for disaggregation of the residual expenses since both physician offices and FQHCs provide similar types of care. These data are publicly available at 
                        <E T="03">https://www.bea.gov/industry/input-output-accounts-data.</E>
                         For the 2013-based FQHC market basket, we used the relative shares of certain categories from the 2006-based MEI (81 FR 80396).
                    </P>
                    <P>
                        The BEA Benchmark I-O data are scheduled for publication every 5 years with the most recent data available for 2012. The 2012 Benchmark I-O data are derived from the 2012 Economic Census and are the building blocks for BEA's economic accounts. Therefore, they represent the most comprehensive and complete set of data on the economic processes or mechanisms by which output is produced and distributed.
                        <SU>30</SU>
                        <FTREF/>
                         BEA also produces Annual I-O estimates. However, while based on a similar methodology, these estimates reflect less comprehensive and less detailed data sources and are subject to revision when benchmark data becomes available. Instead of using the less detailed Annual I-O data, we propose to inflate the 2012 Benchmark I-O data forward to 2017 by applying the annual price changes from the respective price proxies to the appropriate market basket cost categories that are obtained from the 2012 Benchmark I-O data. We repeated this practice for each year. We then calculated the cost shares that each cost category represents of the 2012 data inflated to 2017. These resulting 2017 cost shares were applied to the “All Other” residual cost weight to obtain the detailed cost weights for the proposed 2017-based FQHC market basket. For example, the cost for Medical Equipment represents 7.2 percent of the sum of the “All Other” 2012 Benchmark I-O Offices of Physicians Expenditures inflated to 2017. Therefore, the Medical Equipment cost weight represents 7.2 percent of the proposed 2017-based FQHC market basket's “All Other” cost category (15.5 percent), yielding a Medical Equipment cost weight of 1.1 percent in the proposed 2017-based FQHC market basket (0.072 × 15.5 percent = 1.1 percent).
                    </P>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             
                            <E T="03">http://www.bea.gov/papers/pdf/IOmanual_092906.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Using this methodology, we propose to derive six detailed FQHC market basket cost category weights from the proposed 2017-based FQHC market basket residual cost weight (15.5 percent). These categories are: (1) Utilities; (2) Medical Equipment; (3) Miscellaneous Products; (4) Professional, Scientific, and Technical Services; (5) Administrative Support and Waste Management Services; (6) All Other Services. We note that for the 2013-based FQHC market basket, we had Telephone and Postage cost weights. For the proposed 2017-based FQHC market basket, we propose to include Telephone and Postage costs in the Miscellaneous Products cost weight due to the small amount of costs in this category (each were less than .05 percent).</P>
                    <HD SOURCE="HD3">d. Proposed 2017-Based FQHC Market Basket Cost Categories and Weights</HD>
                    <P>Table 33 shows the proposed cost categories and weights for the proposed 2017-based FQHC market basket compared to the 2013-based FQHC market basket.</P>
                    <GPH SPAN="3" DEEP="371">
                        <PRTPAGE P="50220"/>
                        <GID>EP17AU20.067</GID>
                    </GPH>
                    <HD SOURCE="HD3">4. Selection of Price Proxies</HD>
                    <P>After developing the cost weights for the proposed 2017-based FQHC market basket, we selected the most appropriate wage and price proxies currently available to represent the rate of price change for each expenditure category. For the majority of the cost weights, we base the price proxies on U.S. Bureau of Labor Statistics (BLS) data, as they produce indexes that best meet the criteria of reliability, timeliness, availability, and relevance, and group them into one of the following BLS categories:</P>
                    <P>
                        • 
                        <E T="03">Employment Cost Indexes.</E>
                         Employment Cost Indexes (ECIs) measure the rate of change in employment wage rates and employer costs for employee benefits per hour worked. These indexes are fixed-weight indexes and strictly measure the change in wage rates and employee benefits per hour. ECIs are superior to Average Hourly Earnings (AHE) as price proxies for input price indexes because they are not affected by shifts in occupation or industry mix, and because they measure pure price change and are available by both occupational group and by industry. The industry ECIs are based on the North American Industry Classification System (NAICS) and the occupational ECIs are based on the Standard Occupational Classification System (SOC).
                    </P>
                    <P>
                        • 
                        <E T="03">Producer Price Indexes.</E>
                         Producer Price Indexes (PPIs) measure the average change over time in the selling prices received by domestic producers for their output. The prices included in the PPI are from the first commercial transaction for many products and some services (
                        <E T="03">https://www.bls.gov/ppi/</E>
                        ).
                    </P>
                    <P>
                        • 
                        <E T="03">Consumer Price Indexes.</E>
                         Consumer Price Indexes (CPIs) measure the average change over time in the prices paid by urban consumers for a market basket of consumer goods and services (
                        <E T="03">https://www.bls.gov/cpi/</E>
                        ). CPIs are only used when the purchases are similar to those of retail consumers rather than purchases at the producer level, or if no appropriate PPIs are available.
                    </P>
                    <P>We evaluate the price proxies using the criteria of reliability, timeliness, availability, and relevance:</P>
                    <P>
                        • 
                        <E T="03">Reliability.</E>
                         Reliability indicates that the index is based on valid statistical methods and has low sampling variability. Widely accepted statistical methods ensure that the data were collected and aggregated in a way that can be replicated. Low sampling variability is desirable because it indicates that the sample reflects the typical members of the population. (Sampling variability is variation that occurs by chance because only a sample was surveyed rather than the entire population.)
                    </P>
                    <P>
                        • 
                        <E T="03">Timeliness.</E>
                         Timeliness implies that the proxy is published regularly, preferably at least once a quarter. The market baskets are updated quarterly, and therefore, it is important for the underlying price proxies to be up-to-date, reflecting the most recent data available. We believe that using proxies that are published regularly (at least quarterly, whenever possible) helps to ensure that we are using the most recent data available to update the market basket. We strive to use publications that are disseminated frequently, because we believe that this is an 
                        <PRTPAGE P="50221"/>
                        optimal way to stay abreast of the most current data available.
                    </P>
                    <P>
                        • 
                        <E T="03">Availability.</E>
                         Availability means that the proxy is publicly available. We prefer that our proxies are publicly available because this will help ensure that our market basket updates are as transparent to the public as possible. In addition, this enables the public to be able to obtain the price proxy data on a regular basis.
                    </P>
                    <P>
                        • 
                        <E T="03">Relevance.</E>
                         Relevance means that the proxy is applicable and representative of the cost category weight to which it is applied.
                    </P>
                    <P>The CPIs, PPIs, and ECIs that we have selected meet these criteria. Therefore, we believe that they continue to be the best measure of price changes for the cost categories to which they would be applied.</P>
                    <P>Table 34 lists all price proxies that used in the proposed 2017-based FQHC market basket. Below is a detailed explanation of the price proxies we are proposing for each cost category weight, many of which are the same as those used for the 2013-based FQHC market basket.</P>
                    <HD SOURCE="HD3">a. Price Proxies for the Proposed 2017-Based FQHC Market Basket</HD>
                    <HD SOURCE="HD3">(1) FQHC Practitioner Wages and Salaries</HD>
                    <P>We propose to use the ECI for Wages and Salaries for Private Industry Workers in Professional and Related (BLS series code CIU2010000120000I) to measure price growth of this category. There is no specific ECI for physicians or FQHC Practitioners and, therefore, we propose to use an index that is based on professionals that receive advanced training similar to those performing at the FQHC Practitioner level of care. This index is consistent with the price proxy used to measure wages and salaries inflation pressure for physicians own time in the Medicare Economic Index (MEI) and is based on the MEI technical panel recommendation from 2012 (78 FR 74266 through 74271)). Additionally, this price proxy is consistent with the proxy used for FQHC practitioner compensation in the 2013-based FQHC market basket (81 FR 80397). We note that the 2013-based FQHC market basket has a single cost category for Total Compensation reflecting both wages and salaries and employee benefits costs for FQHC Practitioners and this single compensation category uses the similar price proxy, the ECI Total Compensation for Private Industry Workers in Professional and Related, reflecting both types of compensation costs together rather than separately (81 FR 80397).</P>
                    <HD SOURCE="HD3">(2) FQHC Practitioner Employee Benefits</HD>
                    <P>We propose to use the ECI for Total Benefits for Private Industry Workers in Professional and Related to measure price growth of this category. This ECI is calculated using the ECI for Total Compensation for Private Industry Workers in Professional and Related (BLS series code CIU1016220000000I) and the relative importance of wages and salaries within total compensation. The 2013-based FQHC market basket did not include a separate category for FQHC Practitioner employee benefit costs.</P>
                    <HD SOURCE="HD3">(3) Clinical Staff Wages and Salaries</HD>
                    <P>We propose to use the ECI for Wages and Salaries for all Civilian Workers in Health Care and Social Assistance (BLS series code CIU1026200000000I) to measure the price growth of this cost category. This cost category consists of wage and salary costs for Nurses, Laboratory Technicians, and all other healthcare staff not included in the FQHC Practitioner compensation categories. Based on the clinical staff composition of these workers, we believe that the ECI for health-related workers is an appropriate proxy to measure wage and salary price pressures for these workers. We note that the 2013-based FQHC market basket has a single cost category for Total Compensation reflecting both wages and salaries and employee benefits costs for Clinical Staff and this single compensation category uses the similar price proxy, the ECI Total Compensation for all Civilian Workers in Health Care and Social Assistance, reflecting both types of compensation costs together rather than separately (81 FR 80398).</P>
                    <HD SOURCE="HD3">(4) Clinical Staff Employee Benefits</HD>
                    <P>We propose to use the ECI for Total Benefits for all Civilian Workers in Health Care and Social Assistance to measure price growth of this category. This ECI is calculated using the ECI for Total Compensation for all Civilian Workers in Health Care and Social Assistance (BLS series code CIU1016220000000I) and the relative importance of wages and salaries within total compensation. The 2013-based FQHC market basket did not include a separate category for Clinical Staff employee benefit costs.</P>
                    <HD SOURCE="HD3">(5) Non-Health Staff Compensation</HD>
                    <P>We propose to continue to use the ECI for Total Compensation for Private Industry Workers in Office and Administrative Support (BLS series code CIU2010000220000I) to measure the price growth of this cost category. The Non-health Staff Compensation cost weight is predominately attributable to administrative and facility type occupations, as reported in the data from the Medicare cost reports. This is the same price proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(6) Pharmaceuticals</HD>
                    <P>We propose to continue to use the PPI Commodities for Pharmaceuticals for Human Use, Prescription (BLS series code WPUSI07003) to measure the price growth of this cost category. This price proxy is used to measure prices of Pharmaceuticals in other CMS market baskets, such as 2014-based Inpatient Prospective Payment System and 2014-based Skilled Nursing Facility market baskets. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(7) Utilities</HD>
                    <P>We propose to continue to use the CPI for Fuel and Utilities (BLS series code CUUR0000SAH2) to measure the price growth of this cost category. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(8) Medical Equipment</HD>
                    <P>We propose to continue to use the PPI Commodities for Surgical and Medical Instruments (BLS series code WPU1562) as the price proxy for this category. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(9) Medical Supplies</HD>
                    <P>
                        We propose to continue to use a 50/50 blended index that comprises the PPI Commodities for Medical and Surgical Appliances and Supplies (BLS series code WPU156301) and the CPI-U for Medical Equipment and Supplies (BLS series code CUUR0000SEMG). The 50/50 blend is used in all market baskets where we do not have an accurate split available. We believe FQHCs purchase the types of supplies contained within these proxies, including such items as bandages, dressings, catheters, intravenous equipment, syringes, and other general disposable medical supplies, via wholesale purchase, as well as at the retail level. Consequently, we propose to combine the two aforementioned indexes to reflect those modes of purchase. This is the same blended price proxy used in the 2013-based FQHC market basket (81 FR 80398).
                        <PRTPAGE P="50222"/>
                    </P>
                    <HD SOURCE="HD3">(10) Miscellaneous Products</HD>
                    <P>We propose to use the CPI for All Items Less Food and Energy (BLS series code CUUR0000SA0L1E) to measure the price growth of this cost category. We believe that using the CPI for All Items Less Food and Energy is appropriate as it reflects a general level of inflation. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(11) Professional, Scientific, and Technical Services</HD>
                    <P>We propose to continue to use the ECI for Total Compensation for Private Industry Workers in Professional, Scientific, and Technical Services (BLS series code CIU2015400000000I) to measure the price growth of this cost category. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(12) Administrative and Facilities Support Services</HD>
                    <P>We propose to continue to use the ECI Total Compensation for Private Industry Workers in Office and Administrative Support (BLS series code CIU2010000220000I) to measure the price growth of this cost category. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(13) All Other Services</HD>
                    <P>We propose to continue to use the ECI for Total Compensation for Private Industry Workers in Service Occupations (BLS series code CIU2010000300000I) to measure the price growth of this cost category. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">(14) Fixed Capital</HD>
                    <P>We propose to continue to use the PPI Industry for Lessors of Nonresidential Buildings (BLS series code PCU531120531120) to measure the price growth of this cost category (81 FR 80398). This is the same price proxy used in the 2013-based FQHC market basket. We believe this continues to be the most appropriate price proxy since fixed capital expenses in FQHCs should reflect inflation for the rental and purchase of business office space.</P>
                    <HD SOURCE="HD3">(15) Moveable Capital</HD>
                    <P>We propose to continue to use the PPI Commodities for Machinery and Equipment (BLS series code WPU11) to measure the price growth of this cost category as this cost category represents nonmedical moveable equipment. This is the same proxy used in the 2013-based FQHC market basket (81 FR 80398).</P>
                    <HD SOURCE="HD3">c. Summary of Price Proxies of the Proposed 2017-Based FQHC Market Basket</HD>
                    <P>Table 34 shows the cost categories and associated price proxies for the proposed 2017-based FQHC market basket.</P>
                    <GPH SPAN="3" DEEP="317">
                        <GID>EP17AU20.068</GID>
                    </GPH>
                    <PRTPAGE P="50223"/>
                    <HD SOURCE="HD3">5. Proposed CY 2021 Productivity Adjusted Market Basket Update for FQHCs</HD>
                    <P>For CY 2021 (that is, January 1, 2021 through December 31, 2021), we are proposing to use the proposed 2017-based FQHC market basket increase factor to update the PPS payments to FQHCs. Consistent with CMS practice, we estimated the market basket update for the FQHC PPS based on the most recent forecast from IGI. IGI is a nationally recognized economic and financial forecasting firm with which we contract to forecast the components of the market baskets and multifactor productivity (MFP). We are proposing to use the update based on the most recent historical data available at the time of publication of the final rule. For example, the final CY 2021 FQHC update would be based on the four-quarter moving-average percent change of the 2017-based FQHC market basket through the second quarter of 2020 (based on the final rule's statutory publication schedule). For the proposed rule, we do not have the second quarter of 2020 historical data and, therefore, we will use the most recent projection available.</P>
                    <P>Based on IGI's first quarter 2020 forecast with historical data through the fourth quarter of 2019, the projected proposed 2017-based FQHC market basket increase factor for CY 2021 would be 2.5 percent. For comparison, the 2013-based FQHC market basket update is also projected to be 2.5 percent in CY 2021; this estimate is based on IGI's first quarter 2020 forecast (with historical data through the fourth quarter of 2019). The proposed 2017-based FQHC market basket and the 2013-based FQHC market basket are both projected to grow at the same rate for CY 2021, the difference in the average update factor over the last five historical years (2016-2020) is 0.0 percent.</P>
                    <P>Table 35 compares the proposed 2017-based FQHC market basket updates and the 2013-based FQHC market basket updates for CY 2016 through CY 2023.</P>
                    <GPH SPAN="3" DEEP="203">
                        <GID>EP17AU20.069</GID>
                    </GPH>
                    <P>
                        Section 1834(o)(2)(B)(ii) of the Act describes the methods for determining updates to FQHC PPS payment. We have included a productivity adjustment to the FQHC PPS annual payment update since implementation of the FQHC PPS (81 FR 80393) and we propose to continue to include a productivity adjustment to the proposed 2017-based FQHC market basket. We propose to use the most recent estimate of the 10-year moving average of changes in annual private nonfarm business (economy-wide) multifactor productivity (MFP), which is the same measure of MFP applied to other CMS Market Basket updates including the MEI. The BLS publishes the official measure of private nonfarm business MFP. (See 
                        <E T="03">http://www.bls.gov/mfp</E>
                         for the published BLS historical MFP data). For the final FQHC market basket update, we propose to use the most recent historical estimate of annual MFP as published by the BLS. Generally, the most recent historical MFP estimate is lagged two years from the payment year.
                    </P>
                    <P>
                        Therefore, we propose to use the 2019 MFP as published by BLS in the CY 2021 FQHC market basket update. We note that MFP is derived by subtracting the contribution of labor and capital input growth from output growth. Since at the time of development of the proposed rule the 2019 MFP was not yet published by BLS, we are proposing to use IGI's first quarter 2020 forecast of MFP. A complete description of the MFP projection methodology is available at 
                        <E T="03">http://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/MedicareProgramRatesStats/MarketBasketResearch.html.</E>
                    </P>
                    <P>
                        Using IGI's first quarter 2020 forecast, the productivity adjustment for CY 2021 (the 10-year moving average of MFP for the period ending CY 2019) is projected to be 0.6 percent. Therefore, the proposed CY 2021 productivity-adjusted FQHC Market basket update is 1.9 percent, based on IGI's first quarter 2020 forecast with historical data through the fourth quarter of 2019. This reflects a 2.5-percent increase in the proposed 2017-based FQHC market basket and a 0.6-percent adjustment for productivity. For comparison, if we continue to use the 2013-based FQHC market basket, then the CY 2021 productivity-adjusted FQHC market basket update would also be 1.9 percent (2.5 percent FQHC market basket update less 0.6 percent MFP adjustment). Finally, we are proposing that if more recent data subsequently become available, we would use such data, if appropriate, to determine the CY 2021 market basket update and the MFP adjustment for the final rule.
                        <PRTPAGE P="50224"/>
                    </P>
                    <HD SOURCE="HD2">E. Comprehensive Screenings for Seniors: Section 2002 of the Substance Use-Disorder Prevention That Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)</HD>
                    <P>
                        Opioid overdose deaths continue to impact communities across the United States. In 2018, about 47,000 Americans died as a result of an opioid overdose, where 32 percent of these deaths involved a prescription opioid.
                        <SU>31</SU>
                        <FTREF/>
                         In addition to the risk of death from overdose, opioids carry a number of other health risks, including respiratory depression, drowsiness, confusion, nausea, increased drug tolerance, and physical dependence. An estimated 1.7 million people in the United States have substance use disorders involving prescription opioid pain relievers.
                        <SU>32</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             Wilson N, Kariisa M, Seth P, et al. Drug and Opioid-Involved Overdose Deaths—United States, 2017-2018. MMWR Morb Mortal Wkly Rep 2020;69:290-297.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             Substance Abuse and Mental Health Services Administration. (2019). Key substance use and mental health indicators in the United States: Results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from 
                            <E T="03">https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHNationalFindingsReport2018/NSDUHNationalFindingsReport2018.pdf.</E>
                        </P>
                    </FTNT>
                    <P>CMS has a vital role in addressing opioid use disorder prevention, treatment and recovery. The intent of the SUPPORT Act (Pub. L. 115-271, enacted on October 24, 2018) is to provide for opioid use disorder prevention, treatment and recovery. In section 2002 of the SUPPORT Act, Comprehensive Screening for Seniors, the Congress required the Initial Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV) to include screening for potential substance use disorders (SUDs) and a review of any current opioid prescriptions. We believe that these provisions are complementary to the existing components of the IPPE and AWV. We are proposing to add these new elements to the IPPE and AWV regulations, to draw attention to their importance and fulfil the section 2002 SUPPORT Act requirements. In this proposed rule, we provide background on the IPPE and AWV, discuss how the requirements of the SUPPORT Act are related to the IPPE and AWV, and make proposals to implement these provisions.</P>
                    <HD SOURCE="HD3">1. Background: IPPE and AWV</HD>
                    <HD SOURCE="HD3">a. IPPE Required Elements</HD>
                    <P>The IPPE is defined in section 1861(ww) of the Act and codified in regulations at § 410.16. The IPPE must be performed within 1 year after the effective date of a beneficiary's first Medicare Part B coverage period as stated in section 1861(hhh)(4)(G) of the Act. The IPPE includes all of the following services furnished to an eligible beneficiary by a physician or other qualified nonphysician practitioner (NPP) with the goal of health promotion and disease detection:</P>
                    <P>• Review of the beneficiary's medical and social history with attention to modifiable risk factors for disease, as those terms are defined in § 410.16.</P>
                    <P>• 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 NPP may select from various available standardized screening tests designed for this purpose and recognized by national professional medical organizations.</P>
                    <P>• Review of the beneficiary's functional ability, and level of safety as those terms are defined in § 410.16 based on the use of appropriate screening questions or a screening questionnaire, which the physician or other qualified NPP may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations.</P>
                    <P>• An examination to include measurement of the beneficiary's height, weight, body mass index, 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>• End-of-life planning upon agreement with the individual.</P>
                    <P>• Education, counseling, and referral, as deemed appropriate by the physician or qualified NPP, based on the results of the review and evaluation services described in § 410.16.</P>
                    <P>• Education, counseling, and referral, including a brief written plan such as a checklist provided to the individual for obtaining an electrocardiogram, as appropriate, and the appropriate screening and other preventive services that are covered as separate Medicare Part B benefits.</P>
                    <HD SOURCE="HD3">b. AWV Required Elements</HD>
                    <P>Section 1861(hhh) of the Act expanded Medicare coverage under Part B to include an AWV effective for services furnished on or after January 1, 2011. We codified the AWV at § 410.15.</P>
                    <P>The AWV is a wellness visit that focuses on identification of certain risk factors, personalized health advice, and referral for additional preventive services and lifestyle interventions (which may or may not be covered by Medicare). The elements included in the AWV differ from comprehensive physical examination protocols with which some providers may be familiar since it is a visit that is specifically designed to provide personalized prevention plan services as defined in the Act. The AWV includes a health risk assessment (HRA) and the AWV takes into account the results of the HRA.</P>
                    <P>The AWV may be performed when the beneficiary is no longer within 12 months after the effective date of his or her first Medicare Part B coverage period and when the beneficiary has not received either an IPPE or AWV within the past 12 months. The AWV may be performed by a physician, NPP (physician assistant, nurse practitioner, or clinical nurse specialist), medical professional (including a health educator, a registered dietitian, or nutrition professional, or other licensed practitioner) or a team of such medical professionals, working under the direct supervision of a physician. In summary, the first AWV includes the following:</P>
                    <P>• Review (and administration if needed) of a health risk assessment (as defined in § 410.15).</P>
                    <P>• Establishment of an individual's medical and family history.</P>
                    <P>• Establishment of a list of current providers and suppliers that are regularly involved in providing medical care to the individual.</P>
                    <P>• Measurement of an individual's height, weight, body-mass index (or waist circumference, if appropriate), blood pressure, and other routine measurements as deemed appropriate, based on the beneficiary's medical and family history.</P>
                    <P>• Detection of any cognitive impairment that the individual may have, as that term is defined in § 410.15.</P>
                    <P>
                        • Review of the individual'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 health professional may select from various available standardized screening tests 
                        <PRTPAGE P="50225"/>
                        designed for this purpose and recognized by national medical professional organizations.
                    </P>
                    <P>• Review of the individual's functional ability and level of safety, based on direct observation or the use of appropriate screening questions or a screening questionnaire, which the health professional as defined in § 410.15 may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations.</P>
                    <P>• Establishment of the following:</P>
                    <P>++ A written screening schedule for the individual such as a checklist for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force (USPSTF) and the Advisory Committee on Immunization Practices, and the individual's health risk assessment (as that term is defined in § 410.15), health status, screening history, and age-appropriate preventive services covered by Medicare.</P>
                    <P>++ A list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual, including any mental health conditions or any such risk factors or conditions that have been identified through an initial preventive physical examination (as described under § 410.16), and a list of treatment options and their associated risks and benefits.</P>
                    <P>++ Furnishing of personalized health advice to the individual and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self-management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weight loss, physical activity, smoking cessation, fall prevention, and nutrition.</P>
                    <P>++ At the discretion of the beneficiary, furnish advance care planning services to include discussion about future care decisions that may need to be made, how the beneficiary can let others know about care preferences, and explanation of advance directives which may involve the completion of standard forms.</P>
                    <P>++ Any other element determined appropriate through the national coverage determination process.</P>
                    <P>In summary, subsequent AWVs include the following:</P>
                    <P>• Review (and administration, if needed) of an updated health risk assessment (as defined in § 410.15).</P>
                    <P>• An update of the individual's medical and family history.</P>
                    <P>• An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual as that list was developed for the first AWV providing personalized prevention plan services or the previous subsequent AWV providing personalized prevention plan services.</P>
                    <P>• Measurement of an individual's weight (or waist circumference), blood pressure and other routine measurements as deemed appropriate, based on the individual's medical and family history.</P>
                    <P>• Detection of any cognitive impairment that the individual may have, as that term is defined in § 410.15.</P>
                    <P>• An update to the following:</P>
                    <P>++ The written screening schedule for the individual as that schedule is defined in paragraph (a) of § 410.15 for the first AWV providing personalized prevention plan services.</P>
                    <P>++ The list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual as that list was developed at the first AWV providing personalized prevention plan services or the previous subsequent AWV providing personalized prevention plan services.</P>
                    <P>++ Furnishing of personalized health advice to the individual and a referral, as appropriate, to health education or preventive counseling services or programs as that advice and related services are defined in paragraph (a) of § 410.15.</P>
                    <P>++ At the discretion of the beneficiary, furnish advance care planning services to include discussion about future care decisions that may need to be made, how the beneficiary can let others know about care preferences, and explanation of advance directives which may involve the completion of standard forms.</P>
                    <P>++ Any other element determined appropriate through the national coverage determination process.</P>
                    <HD SOURCE="HD3">2. Section 2002 of the SUPPORT Act Requirement</HD>
                    <P>In section 2002 of the SUPPORT Act, sections 1861(ww) and 1861(hhh)(2) of the Act were amended to include a review of any current opioid prescriptions and screening for potential substance use disorders (SUD) as elements of the IPPE and AWV, effective January 1, 2020.</P>
                    <HD SOURCE="HD3">3. Proposal on Section 2002 of the SUPPORT Act Requirements</HD>
                    <P>We are proposing to add the requirements of section 2002 of the SUPPORT Act to our regulations at § 410.15 and 410.16 for the AWV and IPPE, respectively.</P>
                    <P>Section 2002 of the SUPPORT Act, requires a review of any current opioid prescriptions as part of the IPPE and AWV. Such review includes a review of the potential risk factors to the individual for opioid use disorder, an evaluation of the individual's severity of pain and current treatment plan, educational information on non-opioid treatment options, and a referral to a specialist, as appropriate. Section 2002 of the SUPPORT Act also requires adding an element to the IPPE and AWV to include screening for potential SUDs. Along with the screening for SUD, a referral for treatment, as appropriate, was added to the AWV.</P>
                    <P>The definitions and conditions for and limitations on coverage of the IPPE outlined in § 410.16 includes a review of the beneficiary's medical and social history. The medical history is defined to include a review of current medications, which would include a review of current opioid prescriptions. Furthermore, social history is defined to include, at a minimum, a history of alcohol, tobacco, and illicit drug use. Illicit drug use may include the non-medical use of prescription drugs. The physician or other qualified health professional may then provide education, counseling, and referral, as deemed appropriate, based on the results of the review and evaluation services provided during the IPPE.</P>
                    <P>
                        The definitions and conditions for and limitations on coverage of the AWV in § 410.15 includes a health risk assessment, which entails an evaluation of psychosocial risks, including but not limited to, depression/life satisfaction, stress, anger, loneliness/social isolation, pain, and fatigue. The patient's substance use, if applicable, could be reviewed as part of the health risk assessment. The AWV also covers establishment of, or an update to the individual's medical and family history. The medical history includes medication use, and may have included a review of any opioid prescriptions. The health professional may also establish or update a list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual, including any mental health conditions or any such risk factors or conditions that have been identified through the initial or subsequent AWV 
                        <PRTPAGE P="50226"/>
                        or IPPE, and a list of treatment options and their associated risks and benefits. If the clinician detected, through the above methods for screening, that a patient was at high-risk for substance use disorder in the course of the visit, it would have been appropriate to note in the patient's IPPE written plan or the AWV personalized prevention plan and to have referred the patient for further assessment and treatment.
                    </P>
                    <P>Awareness of a patient's use of substances, including nonmedical use of prescription drugs and illicit drug use, is an important aspect of the IPPE and AWV. In general, screening for potential SUDs may include screening questions, the use of a specific tool, screening for licit and/or illicit drugs (for example, alcohol, non-medical use of prescription opioids, methamphetamine, heroin, cocaine, and other substances), review of the beneficiary's medical and social history and medical records, or prescription drug monitoring program query when clinically indicated. Given the existing elements of the IPPE and AWV, we do not expect the new regulatory elements to add significant burdens on physicians and practitioners who furnish these services because review of medical and social history, risk factor identification, education, counseling, and referrals are already fundamental parts of the IPPE and AWV. The new regulatory elements elevate the importance of physicians' and other qualified health professionals' vigilance in identifying and addressing opioid risks and SUDs in Medicare beneficiaries.</P>
                    <HD SOURCE="HD3">4. Proposed Regulatory Text Changes</HD>
                    <P>We are proposing to add elements to our regulations to reflect the provisions of section 2002 of the SUPPORT Act. Consistent with sections 1861(ww) and 1861(hhh)(2) of the Act, we propose to amend 42 CFR 410.15 and 410.16 by: (1) Adding the term “screening for potential substance use disorders”; (2) Adding the term “a review of any current opioid prescriptions” and its definition; and (3) revising the “Initial Preventive Physical Examination,” “first annual wellness visit providing personalized prevention plan services,” and “subsequent annual wellness visit providing personalized prevention plan services”.</P>
                    <HD SOURCE="HD3">(1) “Screening for Potential Substance Use Disorders”</HD>
                    <P>We propose to revise §§ 410.15 and 410.16 by adding the element “Screening for Potential Substance Use Disorders” and describing the proposed requirement as a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.</P>
                    <HD SOURCE="HD3">(2) Definition of “A Review of Any Current Opioid Prescriptions”</HD>
                    <P>We propose to revise §§ 410.15 and 410.16 by adding the element “a review of any current opioid prescriptions” and defining such term, consistent with section 1861(ww)(4) of the Act, as a review of any current opioid prescriptions, including a review of the potential risk factors to the individual for opioid use disorder, an evaluation of the individuals' severity of pain and current treatment plan, the provision of information on non-opioid treatment options, and a referral to a specialist, as appropriate.</P>
                    <HD SOURCE="HD3">(3) Proposed Changes to the “Initial Preventive Physical Examination,” “First Annual Wellness Visit” and “Subsequent Annual Wellness Visit”</HD>
                    <P>In §§ 410.15 and 410.16, we adopted the components of the IPPE and AWV, consistent with the statutory elements described in sections 1861(ww) and 1861(hhh)(2) of the Act. The initial preventive physical examination, first and subsequent annual wellness visits are meant to represent a beneficiary visit focused on prevention. Among other things, the IPPE and AWV encourages beneficiaries to obtain the preventive services covered by Medicare that are appropriate for them. First and subsequent AWVs also include elements that focus on the furnishing of personalized health advice and referral, as appropriate, to health education, preventive counseling services, or programs aimed at reducing identified risk factors and improving self-management, or community-based lifestyle interventions.</P>
                    <P>We are proposing to revise “initial preventive physical examination,” “first annual wellness visit providing personalized prevention plan services,” and “subsequent annual wellness visit providing personalized prevention plan services” by adding:</P>
                    <P>• In § 410.15(a):</P>
                    <P>++ A revised paragraph (xi) to the definition of the term “First annual wellness visit providing personalized prevention plan services,” and a revised paragraph (ix) to the definition of the term “Subsequent annual wellness visit” that would add furnishing of a review of any current opioid prescriptions as that term is defined in this section.</P>
                    <P>++ A new paragraph (xii) to the definition of “First annual wellness visit providing personalized prevention plan services,” and a new paragraph (x) to the definition of “Subsequent annual wellness visit” that would add screening for potential substance use disorders including a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.</P>
                    <P>++ A new paragraph (xiii) to the definition of “First annual wellness visit providing personalized prevention plan services,” and a new paragraph (xi) to the definition of “Subsequent annual wellness visit” that would add any other element determined appropriate through the national coverage determination process.</P>
                    <P>• In § 410.16:</P>
                    <P>++ A revised paragraph (a)(6) to the definition of “Initial preventive physical examination” that would include a review of any current opioid prescriptions as that term is defined in this section.</P>
                    <P>++ A revised paragraph (a)(7) to the definition of “Initial preventive physical examination” that would add screening for potential substance use disorders to include a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.</P>
                    <P>++ A new paragraph (a)(8) to the definition of “Initial preventive physical examination” that would add, 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>++ A new paragraph (a)(9) to the definition of “Initial preventive physical examination” that would include, education, counseling, and referral, including a brief written plan such as a checklist provided to the individual for obtaining an electrocardiogram, as appropriate, and the appropriate screening and other preventive services that are covered as separate Medicare Part B benefits as described in sections 1861(s)(10), (jj), (nn), (oo), (pp), (qq)(1), (rr), (uu), (vv), (xx)(1), (yy), (bbb), and (ddd) of the Act.</P>
                    <HD SOURCE="HD3">5. Summary</HD>
                    <P>
                        The initial preventive physical examination, first and subsequent annual wellness visits are designed to help prevent disease and disability based on the beneficiary's current health and risk factors. Increased payment values for the IPPE and AWV in alignment with increases to E/M services are being proposed in section II.F. of this proposed rule. Our proposals seek to incorporate the new AWV and IPPE requirements of section 2002 of the SUPPORT Act in a manner that is flexible for clinicians to provide 
                        <PRTPAGE P="50227"/>
                        the care that is most appropriate for their patients. We look forward to receiving public comment on these proposals.
                    </P>
                    <HD SOURCE="HD2">F. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs)</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for incentive payments made to Medicaid EPs and eligible hospitals for the adoption, implementation, upgrade, and meaningful use of Certified EHR Technology (CEHRT). We have implemented these statutory provisions in prior rulemakings to establish the Medicaid Promoting Interoperability Program.</P>
                    <P>Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the Act, and the definition of “meaningful EHR user” in regulations at § 495.4, one of the requirements of being a meaningful EHR user is to successfully report the clinical quality measures selected by CMS to CMS or a state, as applicable, in the form and manner specified by CMS or the state, as applicable. Section 1848(o)(2)(B)(iii) of the Act requires that in selecting electronic clinical quality measures (eCQMs) for EPs to report under the Promoting Interoperability Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required. We have taken steps to align various quality reporting and payment programs that include the submission of eCQMs.</P>
                    <P>In the CY 2020 PFS final rule (84 FR 62568, 62900), we established for 2020 that Medicaid EPs are required to report on any six eCQMs that are relevant to the EP's scope of practice, regardless of whether they report via attestation or electronically. We also adopted the Merit-based Incentive Payment System (MIPS) requirement that EPs report on at least one outcome measure (or, if an applicable outcome measure is not available or relevant, one other high priority measure). We explained that if no outcome or high priority measure is relevant to a Medicaid EP's scope of practice, the EP may report on any six eCQMs that are relevant.</P>
                    <HD SOURCE="HD3">2. eCQM Reporting Requirements for EPs Under the Medicaid Promoting Interoperability Program for 2020</HD>
                    <P>We annually review and revise the list of eCQMs for each MIPS performance year to reflect updated clinical standards and guidelines. In Appendix 1 of this proposed rule, we propose to amend the list of available eCQMs for the CY 2021 performance period. To keep eCQM specifications current and minimize complexity, we propose to align the eCQMs available for Medicaid EPs in 2021 with those available for MIPS eligible clinicians for the CY 2021 performance period. Specifically, we propose that the eCQMs available for Medicaid EPs in 2021 would consist of the list of quality measures available under the eCQM collection type on the final list of quality measures established for the MIPS CY 2021 performance period.</P>
                    <P>In previous years, CMS proposals to align the list of eCQMs for MIPS and the Medicaid Promoting Interoperability Program for EPs received positive comments that indicated that alignment between these two programs would help reduce health care provider reporting burden (84 FR 62900; see also 83 FR 59452, 59702). These comments thus suggest that aligning the eCQM lists might encourage EP participation in the Medicaid Promoting Interoperability Program by giving Medicaid EPs that are also MIPS eligible clinicians the ability to report the same eCQMs for both programs. Not aligning the eCQM lists could lead to increased burden, because EPs might have to report on different eCQMs for the Medicaid Promoting Interoperability Program if they opt to report on newly added eCQMs for MIPS. In addition, we believe that aligning the eCQMs available in each program would help to ensure the most uniform application of up-to-date clinical standards and guidelines possible.</P>
                    <P>We anticipate that this proposal would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, particularly in light of our belief that many EPs would report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on the available eCQMs for 2021. We expect that this proposal would have only a minimal impact on states, by requiring minor adjustments to state systems for 2021 to maintain current eCQM lists and specifications.</P>
                    <P>For 2021, we propose to again require (as we did for 2020) that Medicaid EPs report on any six eCQMs that are relevant to their scope of practice, regardless of whether they report via attestation or electronically. This policy of allowing Medicaid EPs to report on any six measures relevant to their scope of practice would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established at § 414.1335(a)(1). MIPS eligible clinicians who elect to submit eCQMs must generally submit data on at least six quality measures, including at least one outcome measure (or, if an applicable outcome measure is not available, one other high priority measure). We refer readers to § 414.1335(a) for the data submission criteria that apply to individual MIPS eligible clinicians and groups that elect to submit data with other collection types.</P>
                    <P>In addition, as we did for 2020, we propose that for 2021, EPs in the Medicaid Promoting Interoperability Program would be required to report on at least one outcome measure (or, if an outcome measure is not available or relevant, one other high priority measure). This policy would improve alignment with the MIPS quality performance category requirements for eligible clinicians using the eCQM collection type. We also propose that if no outcome or high priority measures are relevant to a Medicaid EP's scope of practice, the clinician may report on any six eCQMs that are relevant, as was the policy in 2020.</P>
                    <P>In the CY 2020 PFS final rule (84 FR 62899-62900), we established the following three methods to identify which of the available measures are high priority measures for EPs participating in the Medicaid Promoting Interoperability Program. We propose to use the same three methods for identifying high priority eCQMs for the Medicaid Promoting Interoperability Program for 2021:</P>
                    <P>• The same set of measures that are identified as high priority measures for reporting on the quality performance category for eligible clinicians participating in MIPS.</P>
                    <P>• All e-specified measures from the previous year's core set of quality measures for Medicaid and the Children's Health Insurance Program (CHIP) (Child Core Set) or the core set of health care quality measures for adults enrolled in Medicaid (Adult Core Set) (hereinafter together referred to as “Core Sets”) that are also included on the MIPS list of eCQMs.</P>
                    <P>
                        Sections 1139A and 1139B of the Act require the Secretary to identify and publish core sets of health care quality measures for child Medicaid and CHIP beneficiaries and adult Medicaid beneficiaries. These measure sets are required by statute to be updated annually and are voluntarily reported by states to CMS. These Core Sets are composed of measures that specifically focus on populations served by the 
                        <PRTPAGE P="50228"/>
                        Medicaid and CHIP programs and are of particular importance to their care. The MIPS eCQM list includes several, but not all, of the measures in the Core Sets. Because the Core Sets are released at the beginning of each year, it is not possible to update the list of high-priority eCQMs with those added to the current year's Core Sets.
                    </P>
                    <P>The eCQMs that would be available for Medicaid EPs to report in 2021, that are both part of the Core Sets and on the MIPS list of eCQMs, and that would be considered high priority measures under our proposal are: CMS2, “Preventive Care and Screening: Screening for Depression and Follow-Up Plan”; CMS122, “Diabetes: Hemoglobin A1c (HbA1c) Poor Control (&gt;9%)”; CMS125, “Breast Cancer Screening”; CMS128, “Anti-depressant Medication Management”; CMS136, “Follow-Up Care for Children Prescribed ADHD Medication (ADD)”; CMS137, “Initiation and Engagement of Alcohol and Other Drug Dependence Treatment”; CMS153, “Chlamydia Screening for Women”; CMS155, “Weight Assessment and Counseling for Nutrition and Physical Activity for Children and Adolescents”; and CMS165, “Controlling High Blood Pressure.”</P>
                    <P>• Through an amendment to § 495.332(f), we gave each state the flexibility to identify which of the eCQMs available for reporting in the Medicaid Promoting Interoperability Program are high priority measures for Medicaid EPs in that state, with review and approval by CMS, through the State Medicaid HIT Plan (SMHP). States are thus able to identify high priority measures that align with their state health goals or other programs within the state.</P>
                    <P>All eCQMs identified via any of these three methods are high priority measures for EPs participating in the Medicaid Promoting Interoperability Program for 2020. As noted above, we propose to use the same three methods for identifying high priority eCQMs for the Medicaid Promoting Interoperability Program for 2021. We invite comments as to whether any of these methods should be altered or removed, or whether any additional methods should be considered for 2021.</P>
                    <P>Finally, we note that the eCQM reporting period in 2021 for EPs in the Medicaid Promoting Interoperability Program is a minimum of any continuous 90-day period within CY 2021, provided that the end date for this period falls before October 31, 2021, or falls before a state-specific alternative date prior to October 31, 2021 that is specified in the SMHP, as described in § 495.332(f)(4). This 2021 eCQM reporting period will help ensure that states can issue all Medicaid Promoting Interoperability Program payments on or before December 31, 2021. (See 83 FR 59452, 59704 through 59706).</P>
                    <HD SOURCE="HD2">G. Medicare Shared Savings Program</HD>
                    <P>
                        On March 23, 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted, followed by enactment of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 2010, which amended certain provisions of the Patient Protection and Affordable Care Act (hereinafter collectively referred to as “the Affordable Care Act”). Section 3022 of the Affordable Care Act amended Title XVIII of the Act (42 U.S.C. 1395 
                        <E T="03">et seq.</E>
                        ) by adding section 1899 to the Act to establish the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among health care providers to improve the quality of care for Medicare fee-for-service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. (See 42 U.S.C. 1395jjj.) Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). Under the Shared Savings Program, providers of services and suppliers that participate in an ACO continue to receive traditional Medicare FFS payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements.
                    </P>
                    <P>Section 1899 of the Act has been amended through subsequent legislation. The requirements for assignment of Medicare FFS beneficiaries to ACOs participating under the program were amended by the 21st Century Cures Act (Pub. L. 114-255). The Bipartisan Budget Act of 2018 (Pub. L. 115-123, enacted on February 9, 2018), further amended section 1899 of the Act to provide for the following: Expanded use of telehealth services by physicians or practitioners participating in an applicable ACO to furnish services to prospectively assigned beneficiaries, greater flexibility in the assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in tracks under retrospective beneficiary assignment a choice of prospective assignment for the agreement period; permitting Medicare FFS beneficiaries to voluntarily identify an ACO professional as their primary care provider and requiring that such beneficiaries be notified of the ability to make and change such identification, and mandating that any such voluntary identification will supersede claims-based assignment; and allowing ACOs under certain two-sided models to establish CMS-approved beneficiary incentive programs.</P>
                    <P>
                        The Shared Savings Program regulations are codified at 42 CFR part 425. The final rule establishing the Shared Savings Program appeared in the November 2, 2011 
                        <E T="04">Federal Register</E>
                         (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; final rule (76 FR 67802) (hereinafter referred to as the “November 2011 final rule”)). A subsequent major update to the program rules appeared in the June 9, 2015 
                        <E T="04">Federal Register</E>
                         (Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; final rule (80 FR 32692) (hereinafter referred to as the “June 2015 final rule”)). The final rule entitled, “Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations—Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations,” which addressed changes related to the program's financial benchmark methodology, appeared in the June 10, 2016 
                        <E T="04">Federal Register</E>
                         (81 FR 37950) (hereinafter referred to as the “June 2016 final rule”)). A final rule, “Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program—Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program—Accountable Care Organizations—Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act”, appeared in the November 23, 2018 
                        <E T="04">Federal Register</E>
                         (83 FR 59452) (herein referred to as the “November 2018 final rule” or the “CY 2019 PFS final rule”). In the November 2018 final rule, we finalized a voluntary 6-month extension for existing ACOs whose participation agreements would otherwise expire on December 31, 2018; allowed beneficiaries greater flexibility in designating their primary care 
                        <PRTPAGE P="50229"/>
                        provider and in the use of that designation for purposes of assigning the beneficiary to an ACO if the clinician they align with is participating in an ACO; revised the definition of primary care services used in beneficiary assignment; provided relief for ACOs and their clinicians impacted by extreme and uncontrollable circumstances in performance year 2018 and subsequent years; established a new Certified Electronic Health Record Technology (CEHRT) use threshold requirement; and reduced the Shared Savings Program quality measure set from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through 59715).
                    </P>
                    <P>
                        A final rule redesigning the Shared Savings Program appeared in the December 31, 2018 
                        <E T="04">Federal Register</E>
                         (Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success and Uncontrollable Circumstances Policies for Performance Year 2017; final rule) (83 FR 67816) (hereinafter referred to as the “December 2018 final rule”). In the December 2018 final rule, we finalized a number of policies for the Shared Savings Program, including a redesign of the participation options available under the program to encourage ACOs to transition to two-sided models; new tools to support coordination of care across settings and strengthen beneficiary engagement; and revisions to ensure rigorous benchmarking.
                    </P>
                    <P>
                        In the interim final rule with comment period (IFC) entitled “Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency”, which appeared in the April 6, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 19230) (hereinafter referred to as the “March 31st COVID-19 IFC”), we removed the restriction which prevented the application of the Shared Savings Program extreme and uncontrollable circumstances policy for disasters that occur during the quality reporting period if the reporting period is extended, to offer relief under the Shared Savings Program to all ACOs that may be unable to completely and accurately report quality data for 2019 due to the public health emergency (PHE) for the COVID-19 pandemic (85 FR 19267 and 19268). In the IFC entitled “Medicare and Medicaid Programs; Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” which appeared in the May 8, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 27573 through 27587) (hereinafter referred to as the “May 8th COVID-19 IFC”), we modified Shared Savings Program policies to: (1) Allow ACOs whose current agreement periods expire on December 31, 2020, the option to extend their existing agreement period by 1-year, and allow ACOs in the BASIC track's glide path the option to elect to maintain their current level of participation for performance year 2021; (2) adjust program calculations to remove payment amounts for episodes of care for treatment of COVID-19; and (3) expand the definition of primary care services for purposes of determining beneficiary assignment to include telehealth codes for virtual check-ins, e-visits, and telephonic communication. We also clarified the applicability of the program's extreme and uncontrollable circumstances policy to mitigate shared losses for the period of the COVID-19 PHE starting in January 2020.
                    </P>
                    <P>We have also made use of the annual CY PFS rules to address quality reporting for the Shared Savings Program and certain other issues. Refer to the CY 2020 PFS proposed rule for a summary of policies finalized in prior rules (84 FR 40705).</P>
                    <P>Policies applicable to Shared Savings Program ACOs for purposes of reporting for other programs have also continued to evolve based on changes in the law. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program (Pub. L. 114-10). In the CY 2017 Quality Payment Program final rule with comment period (81 FR 77008), we established regulations for the Merit-Based Incentive Payment System (MIPS) and Advanced Alternative Payment Models (APMs) and related policies applicable to eligible clinicians who participate in the Shared Savings Program. These policies included requirements for Shared Savings Program ACOs regarding reporting for the MIPS Quality performance category and a policy that gives ACOs full credit for the MIPS Improvement Activities performance category based on their participation in the Shared Savings Program. We believe that the proposed changes would reduce ACO burden by establishing a smaller measure set, out of which ACO would only be required to actively report 3 measures. This would represent a significant reduction in reporting requirements from the 10 measures on which ACOs are currently required to actively report. Reporting for these measures would begin in January 2022, for the 2021 performance year. We believe this timeline would allow organizations sufficient time to prepare to report on the new measure set. In addition, the reporting options for the three ACO-reported measures would leverage existing MIPS collection types and more closely align existing CEHRT and registries used by ACOs and their clinicians, including use of APIs to submit data.</P>
                    <P>As a general summary, in this proposed rule, we are proposing to:</P>
                    <P>• Modify the approach to measuring ACO quality performance under the Shared Savings Program which includes:</P>
                    <P>++ Applying the Alternative Payment Model (APM) Performance Pathway (APP) to Shared Savings Program ACOs.</P>
                    <P>++ Revising the Shared Savings Program Quality Performance Standard.</P>
                    <P>++ Changing the methodology for determining shared savings and shared losses based on ACO quality performance.</P>
                    <P>++ Revising the approach to monitoring ACO quality performance and addressing ACOs that fail to meet the Quality Performance Standard.</P>
                    <P>++ Updating the process used to validate ACO Quality Data Reporting.</P>
                    <P>++ Updating the extreme and uncontrollable circumstances policy as it relates to quality performance.</P>
                    <P>• Update the definition of primary care services used in beneficiary assignment, and codify in regulations the adjustment that is made to an ACO's historical benchmark to reflect any changes to the beneficiary assignment methodology specified in 42 CFR part 425, subpart E, during an ACO's agreement period, including revisions to the definition of primary care services at § 425.402(c).</P>
                    <P>• Revise the policy for determining the amount of repayment mechanism arrangements for certain ACOs renewing to continue their participation under a two-sided model.</P>
                    <HD SOURCE="HD3">1. Quality and Other Reporting Requirements</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>
                        Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. In the November 2011 final rule establishing the Shared Savings Program, we adopted a quality measure set spanning four domains: Patient experience of care, care coordination/patient safety, preventative health, and at-risk population (76 FR 67872 through 
                        <PRTPAGE P="50230"/>
                        67891). Since then, we have updated the measures that comprise the quality performance measure set for the Shared Savings Program through rulemaking in the CY 2015, 2016, 2017, and 2019 PFS final rules (79 FR 67907 through 67920, 80 FR 71263 through 71268, 81 FR 80484 through 80489, and 83 FR 59707 through 59715 respectively).
                    </P>
                    <P>As we stated in the November 2011 final rule (76 FR 67872), our principal goal in selecting quality measures for ACOs has been to identify measures of success in the delivery of high-quality health care at the individual and population levels, with a focus on outcomes. In the CY 2019 PFS final rule, we finalized that for performance years (or a performance period) starting in 2019 and subsequent years, 23 quality measures would be used to determine ACO quality performance (83 FR 59707 through 59715). The information used to determine ACO performance on these quality measures is submitted by the ACO through the CMS Web Interface, calculated by us from administrative claims data, and collected via a patient experience of care survey referred to as the Consumer Assessment of Healthcare Provider and Systems (CAHPS) for ACOs Survey.</P>
                    <P>Eligible clinicians who are participating in an ACO and who are subject to MIPS (MIPS eligible clinicians) are currently scored under the APM scoring standard under MIPS (81 FR 77260). These MIPS eligible clinicians include any eligible clinicians who are participating in an ACO in a track, or payment model within a track (Track 1 and Levels A through D of the BASIC track) of the Shared Savings Program that is not an Advanced APM, as well as those MIPS eligible clinicians participating in an ACO in a track, or payment model within a track (Track 2, Level E of the BASIC track, and the ENHANCED track, or the Medicare ACO Track 1+ Model (Track 1+ Model)) that is an Advanced APM, but who do not become Qualifying APM Participants (QPs) as specified in § 414.1425, and are not otherwise excluded from MIPS.</P>
                    <HD SOURCE="HD3">b. Applying the Alternative Payment Model (APM) Performance Pathway (APP) to Shared Savings Program ACOs</HD>
                    <P>As provided in section 1899(d)(2) of the Act and § 425.502(a) of the Shared Savings Program regulations, ACOs must meet a quality performance standard to qualify to share in savings. In the CY 2017 PFS final rule, we finalized revisions to § 425.502 related to the quality performance standard and minimum attainment, including clarifying that the quality performance standard is the overall standard the ACO must meet to qualify to share in savings; defining the minimum attainment level for pay for performance measures at the 30th percent or 30th percentile of the quality performance benchmark and for pay for reporting measures at the level of complete and accurate reporting; specifying that only pay for performance measures are assessed on a sliding scale while pay for reporting measures earn the maximum number of points for a measure when the minimum attainment level is met (81 FR 80492 through 80494).</P>
                    <P>Currently, the quality performance standard is based on an ACO's experience in the program rather than its financial track. The quality performance standard is currently defined at the level of full and complete reporting (pay-for-reporting (P4R)) for the first performance year of an ACO's first agreement period under the Shared Savings Program. In the second or subsequent years of the ACO's first agreement period and all years of subsequent agreement periods, quality measures are scored as pay-for-performance (P4P) according to the phase-in schedule for the specific measure and the ACO's performance year in the Shared Savings Program:</P>
                    <P>• For all performance years, ACOs must completely and accurately report all quality data used to calculate and assess their quality performance.</P>
                    <P>• CMS designates a performance benchmark and minimum attainment level for each P4P measure and establishes a point scale for the measure. An ACO's quality performance for a measure is evaluated using the appropriate point scale, and these measure-specific scores are used to calculate the final quality score for the ACO.</P>
                    <P>• ACOs must meet minimum attainment (defined as 30 percent or the 30th percentile of the performance benchmark for P4P measures) on at least one measure in each domain to be eligible to share in any savings generated (§ 425.502(d)(2)(iii)(A)).</P>
                    <P>In the CY 2020 PFS proposed rule (84 FR 40709 through 40713), we sought comment on how we might align the Shared Savings Program quality reporting requirements and scoring methodology more closely with the MIPS quality reporting and scoring methodology. We discussed utilizing the MIPS Quality performance category score to adjust shared savings and shared losses under the Shared Savings Program, as applicable. We also sought comment on a possible new approach to determining the threshold for minimum attainment. Under this potential policy, minimum attainment would continue to be defined as complete and accurate reporting for ACOs in their first performance year of their first agreement period, while a MIPS Quality performance category score at or above the 4th decile across all MIPS Quality performance category scores would be required for ACOs in all other performance years under the Shared Savings Program. ACOs with MIPS Quality performance category scores below the 4th decile of all MIPS Quality performance category scores would not meet the quality performance standard for the Shared Savings Program, and thus, would not be eligible to share in savings or would owe the maximum shared losses, if applicable. In addition, we sought comment on a potential policy under which ACOs with quality scores below the 4th decile of all MIPS Quality performance category scores would be subject to compliance actions and possible termination.</P>
                    <P>The majority of feedback received in response to our comment solicitation did not support this approach as it would hold ACOs to a higher standard to be eligible to share in savings, if earned. In addition, commenters that opposed aligning the Shared Savings Program quality score with the MIPS Quality performance category score, stated that significant restructuring of the Shared Savings Program quality performance requirements would introduce more confusion for ACOs that are also transitioning into new tracks under the December 2018 final rule. Commenters also expressed concern regarding the uncertainty associated with such an approach, as we had also proposed extensive revisions to MIPS as the program transitions to MIPS Value Pathways. Furthermore, commenters noted that ACOs are unique in that they are responsible for the total cost of care of their beneficiaries and should not be compared to clinicians in MIPS who are not participating in total cost of care programs.</P>
                    <P>
                        Although we acknowledge the commenters' concerns, we note that section 1899(b)(3)(C) of the Act not only gives us discretion to establish quality performance standards for the Shared Savings Program, but also indicates that we should seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both for purposes of assessing quality of care. The Shared Savings Program is now in its eighth performance year, and 85 percent of ACOs participating in the program are considered PY3 ACOs for purposes of quality reporting, with 65 percent of those ACOs participating in a second or subsequent agreement period. In light of 
                        <PRTPAGE P="50231"/>
                        the maturity of the program and consistent with section 1899(b)(3)(C) of the Act, we believe that it is appropriate to require a higher standard of care in order for ACOs to continue to share in any savings they achieve. In addition, holding ACOs to a higher standard is in line with CMS' goals of incentivizing value-based care and driving the Medicare system to greater value and quality. However, after taking into consideration the stakeholder feedback, we also considered ways to reduce reporting burden, offer more flexibility in the way quality data can be reported and submitted, and create a more meaningful measure set that would focus on population health measures and be more outcome-oriented, while also including patient experience of care metrics.
                    </P>
                    <P>The Alternative Payment Model Performance Pathway (APP) was designed for all MIPS APMs; but, it is also responsive to the concerns raised by commenters in their responses to our solicitation in the CY 2020 PFS proposed rule, while still taking into consideration the maturity of the Shared Savings Program, ACOs' quality performance over time, and the intent of section 1899(b)(3)(C) of the Act. The APP contains a narrower measure set than has previously been used for Shared Savings Program quality measurement, 6 measures versus the current 23 scored measures, and is specifically intended for use in APMs and population health. The design of the APP aligns with stakeholder interests expressed through comments on our solicitation about aligning the Shared Savings Program with MIPS in the CY 2020 PFS proposed rule. These comments suggested adopting a smaller, more focused measure set in recognition of the fact that APM Entities are incentivized through the terms of the respective APMs to improve value. The measure set proposed for the APP aligns with the Meaningful Measures framework by identifying measures that address the highest priorities for quality measurement and improvement, while also reducing reporting burden, promoting alignment of measures and consolidation of reporting requirements across CMS programs moving payment toward value, and identifying for consumers' key quality performance metrics. The measures proposed for inclusion in this set encompass the meaningful measure domains of patient voice, wellness and prevention, seamless communication, chronic disease management, and behavioral health. For these reasons, we believe that the proposed APP, along with the narrower measure set, which comprises it, would be appropriate to assess the quality performance of Shared Savings Program ACOs.</P>
                    <P>The construction of the proposed APP and the proposed measures within it are described in more detail later in this section. A detailed discussion of the proposal for use of the APP for MIPS APMs more generally is found at section III.C.3.b. of this proposed rule.</P>
                    <HD SOURCE="HD3">(1) APM Performance Pathway for Shared Savings Program ACOs</HD>
                    <P>In response to stakeholder feedback and in order to improve alignment and integration with the Quality Payment Program policies and operations, align with CMS' Meaningful Measure Framework, increase participation in APMs and Advanced APMs by reducing reporting burden, and raise the quality performance standard under the Shared Savings Program, we are proposing to revise the Shared Savings Program quality performance standard effective for performance year 2021 and subsequent performance years. This proposed revision would align the Shared Savings Program quality performance standard with the proposed APP under the Quality Payment Program as participants in the Shared Savings Program would be required to report quality for purposes of the Shared Savings Program via the APP, which is described in more detail in section III.C.3.b. of this proposed rule. At a high level, the APP would replace the current Shared Savings Program quality measure set to streamline reporting requirements for Shared Savings Program ACOs and would be a complementary path to the MIPS Value Pathways. The APP is designed to reduce reporting burden, create new scoring opportunities for participants in MIPS APMs, and encourage participation in APMs.</P>
                    <P>Under this new approach, ACOs would only need to report one set of quality metrics that would satisfy the reporting requirements under both MIPS and the Shared Savings Program. There would not be separate quality reporting requirements under the Shared Savings Program, as under this proposed new approach the quality measures reported for purposes of the APP would be used to determine the quality performance of the ACO for purposes of the Shared Savings Program, which is used for purposes of calculating shared savings and also shared losses, where applicable. We believe this approach of streamlining the quality reporting requirements under the Shared Savings Program while maintaining alignment with the Quality Payment Program will help ACOs and their participating providers and suppliers dedicate their finite resources to engaging in efforts to improve quality and reduce costs for their assigned beneficiary population. In addition, we believe that using a single methodology to measure quality performance under both the Shared Savings Program and MIPS would allow ACOs to better focus on increasing the value of healthcare, improving care, and engaging patients. It would also reduce burden as ACOs would be able to track to a smaller set of measures under a unified scoring methodology.</P>
                    <P>Under the APP proposed in section III.C.3.b. of this proposed rule, eligible clinicians in Shared Savings Program ACOs would continue to receive full credit for the improvement activities performance category in 2021 based on their performance of activities required under § 425.112 of the Shared Savings Program regulations, as they do under current MIPS scoring policy. Eligible clinicians participating in the Shared Savings Program are not currently assessed on the MIPS Cost performance category as these eligible clinicians are already subject to cost and utilization performance assessments as part of the Shared Savings Program. Therefore, the cost performance category would continue to be weighted at zero percent. The four categories in the proposed APP framework would be weighted as follows: Quality: 50 percent; PI: 30 percent; IA: 20 percent; and Cost: 0 percent.</P>
                    <P>
                        Under the APP proposed in section III.C.3.b. of this proposed rule, the MIPS Quality performance category score would be calculated for ACOs based on MIPS benchmarks, which are used for other non-ACO group and individual reporters and reflect the method of data submission (for example, eCQM measures have benchmarks calculated using EHR data). ACOs would be scored on the measures they report and would receive zero points for those measures they do not report. For example, if an ACO reported all three measures it is actively required to report but did not field a CAHPS for MIPS survey measure, the ACO would receive zero points for the CAHPS for MIPS survey measure, and that zero would be included in its MIPS Quality performance category score, along with its performance rates on the three measures it did actively report as well as the two claims-based measures included in the APP measure set. This approach aligns with scoring under MIPS, rather than the current Shared Savings Program quality performance scoring methodology, which uses quality benchmarks established specifically for the Shared 
                        <PRTPAGE P="50232"/>
                        Savings Program and awards zero points for quality for ACOs that report some but not all of the required measures. We believe that this approach would be less punitive for ACOs than the current quality performance standard, under which ACOs that fail to completely report all quality measures receive a zero score for quality. We also believe that alignment with the MIPS scoring methodology would reduce the burden on ACOs of tracking to two different scoring methodologies. However, if an ACO does not report any of the three APP measures it is required to actively report and does not field a CAHPS for MIPS survey the ACO would not meet the quality performance standard for purposes of the Shared Savings Program and would not be able to share in savings and would owe maximum losses, if applicable. If an ACO does not report any of the three measures it is required to actively report and does not field a CAHPS for MIPS survey, we do not believe that the remaining two claims-based measures in the APP core measure set would be sufficient to assess the quality of care provided by an ACO to its assigned beneficiaries and would likely not allow the ACO to achieve a MIPS Quality performance category score at or above the 40th percentile. Under this proposal, there would be no quality “phase in.” All ACOs, regardless of performance year and agreement period, would be scored on all the measures in the APP for purposes of the Shared Savings Program quality performance standard.
                    </P>
                    <P>For MIPS scoring purposes, an ACO that fails to report via the APP would receive a zero in the Quality performance category under MIPS. If an ACO fails to report via the APP on behalf of its ACO participants then the ACO participants could report outside the ACO, on behalf of the MIPS eligible clinicians who bill through the TIN of the ACO participant and receive a MIPS Quality performance category score calculated at the ACO participant level. If ACO participants report outside the ACO via the APP, they would continue to get full credit for IA based on ACO participation. If ACO participants choose to report outside the ACO via a different MIPS reporting option, then regular MIPS scoring rules would apply (that is, automatic full credit for I.A. and zero cost category weight would not be applied).</P>
                    <P>Under this proposal, for performance year 2021 and subsequent performance years, ACOs would be assessed on a smaller measure set. The measures ACOs would be scored on would decrease from 23 measures to 6 measures and the number of measures on which ACOs would be required to actively report would be reduced from 10 to 3.</P>
                    <P>ACOs would report under the APP on the following 3 measures:</P>
                    <P>• Quality ID#: 001: Diabetes: Hemoglobin A1c (HbA1c) Poor Control (&gt;9%);</P>
                    <P>• Quality ID#: 134 Preventive Care and Screening: Screening for Depression and Follow-Up Plan; and</P>
                    <P>• Quality ID#: 236 Controlling High Blood Pressure.</P>
                    <P>ACOs would report these measures via a submission method of their choice that aligns with the MIPS data submission types for groups at § 414.1325(c) (direct, login and upload, or a third-party intermediary, described at § 414.1400, submitting on behalf of the ACO). As discussed in section IV.A.3.c.(1) of this proposed rule, we are proposing to remove the CMS Web Interface from the MIPS data submission types for groups beginning with the 2021 MIPS performance year. Medicare Part B claims is not an available submission type for ACOs as it is limited to TINs consisting of 15 or fewer eligible clinicians. ACOs would receive a score of between 3 to 10 points for each measure that meets the data completeness and case minimum requirements, which would be determined by comparing measure performance to established benchmarks. In addition, ACOs would need to field a CAHPS for MIPS survey and would be measured on two claims-based measures: The Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for the Merit-Based Incentive Payment Program (MIPS) Eligible Clinician Groups; and the All-Cause Unplanned Admissions for Patients with Multiple Chronic Conditions (MCC). Please see Table 36 and section III.C.3.b. of this proposed rule for full details on the measures proposed under the APP framework.</P>
                    <GPH SPAN="3" DEEP="305">
                        <PRTPAGE P="50233"/>
                        <GID>EP17AU20.070</GID>
                    </GPH>
                    <P>As noted above, the measures proposed for inclusion in the measure set for the APP align with the Meaningful Measures framework by identifying the highest priorities for quality measurement and improvement with the goals of reducing burden, promoting alignment, moving payment toward value, and identifying key quality performance metrics for consumers. The proposed measures encompass the meaningful measure domains of patient voice, wellness and prevention, seamless communication, chronic disease management, and behavioral health. We also believe that the measures included in the APP are appropriate to assess the quality performance of Shared Savings Program ACOs as they focus on the management of chronic health conditions that are high priority and have high prevalence among the population of Medicare beneficiaries assigned to ACOs. We also believe that the measure set chosen for inclusion within the APP would move the quality measure set used in the Shared Savings Program toward a more outcome based, primary care focused measure set. In addition to creating a pathway that would reduce reporting burden for ACOs and allow their participating MIPS eligible clinicians to meet requirements under MIPS through a smaller measure set, requiring ACOs to report through the APP would also eliminate differences in the way ACOs are scored under the Shared Savings Program, as compared to the way their MIPS eligible clinicians are scored under MIPS.</P>
                    <P>We note that under the current Shared Savings Program quality scoring methodology, the CAHPS for ACOs survey is counted as ten separate measures, while under the APP, the CAHPS for MIPS survey would be counted as one. We continue to value the patient voice and believe it should play a significant role in quality scoring. Using the CAHPS for MIPS survey would achieve that goal while further aligning the way in which the quality performance of ACOs and their MIPS eligible clinicians is scored under the Shared Savings Program and under MIPS, respectively. Under the current Shared Savings quality scoring methodology, the 10 CAHPS for ACOs survey measures are scored as one domain, which makes up 25 percent of the Shared Savings Program quality score. In contrast, under our proposed approach, the CAHPS for MIPS survey would be counted as one measure out of the 6 measures that would be included in the calculation of the ACO's quality score under the APP. Both of these approaches have a similar weighting, which maintains the relevance of patient voice. We believe that the proposed approach under the APP of combining the CAHPS survey measures into a single measure for quality scoring purposes would allow Shared Savings Program ACOs to effectively target resources toward improving their assigned beneficiaries' experience of care in the areas for improvement on which they choose to focus, rather than having to track to ten separate survey measures, as is currently required by the CAHPS for ACOs used under the Shared Savings Program. We believe this approach strikes the right balance in reducing burden on ACOs and their participating providers and suppliers while preserving the patient's voice.</P>
                    <P>
                        Shared Savings Program ACOs are currently required to report on a set of ten measures via the CMS Web Interface. While these measures were appropriate for use in the program in the past because they are primary care focused, we now recognize that the majority of the measures have highly clustered performance. This means that they cannot meaningfully distinguish quality performance across groups or ACOs. We recognize the value in the use of primary care-focused measures and in developing the proposed measure set for use under the APP, we have sought to preserve the measures we believe most reflect high priority quality measurement areas while also placing more emphasis on outcome-based claims measures, which minimize 
                        <PRTPAGE P="50234"/>
                        reporting burden and reflect greater opportunity for improvement.
                    </P>
                    <P>
                        In addition to the measures listed in Table 36, based on recommendations from MedPAC in its 2015 Report to Congress: Medicare and the Health Care Delivery System,
                        <SU>33</SU>
                        <FTREF/>
                         we are considering adding a “Days at Home” measure that is currently under development, to the APP core measure set in future years, once it has been through the MAP pre-rulemaking process. Any future additions to the measure set, including to add a “Days at Home” measure would be proposed and finalized through notice and comment rulemaking.
                    </P>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             
                            <E T="03">http://medpac.gov/docs/default-source/reports/june-2015-report-to-the-congress-medicare-and-the-health-care-delivery-system.pdf.</E>
                        </P>
                    </FTNT>
                    <P>We welcome public comment on our proposal to apply the APP framework to determine the quality performance of Shared Savings Program ACOs.</P>
                    <P>In addition, we note that we have received feedback from a few ACOs, including ACOs that have a significant number of beneficiaries in long-term care facilities or who are chronically ill or high-risk home bound patients, that the measures ACOs are required to report are not always applicable to their patient population. Although we are proposing to require ACOs to report via the APP, we are also seeking comment on an alternative approach that could be used in the event the three measures ACOs are required to actively report on are not applicable to their beneficiary population and there are more appropriate measure available under MIPS. Under this alternate approach, ACOs could opt out of the APP and report to MIPS as an APM entity. If the ACO decides to report as an APM entity to MIPS outside of the APP, CAHPS for MIPS would become optional; however, the ACO would be required to report PI and IA and would also be subject to cost under MIPS. In the event an ACO decides to report as an APM entity to MIPS outside the APP, we would use the ACO's MIPS Quality performance category score to determine if the ACO met the Shared Savings Program quality performance standard.</P>
                    <P>We seek comment on this alternative reporting approach for ACOs in the event the three measures ACOs are required to actively report are not applicable to their beneficiary population.</P>
                    <HD SOURCE="HD3">c. Shared Savings Program Quality Performance Standard</HD>
                    <P>The quality performance standard is the minimum performance level ACOs must achieve in order to share in any savings earned, avoid maximum losses under certain payment tracks, and avoid quality-related compliance actions. We are proposing to increase the level of quality performance that would be required for all ACOs to meet the Shared Savings Program quality performance standard. We believe the proposed changes would simplify the Shared Savings Program quality performance standard and are also consistent with the statutory requirement that we seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures or both (section 1899(b)(3)(C) of the Act). We are proposing to increase the quality performance standard for all ACOs to achievement of a quality performance score equivalent to the 40th percentile or above across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. We are excluding entities/providers eligible for facility-based scoring from the overall MIPS quality score because facility-based scoring is determined using the Hospital Value Based Purchasing (HVBP) Total Performance Score (TPS) which includes quality and cost.</P>
                    <P>Given that the statute requires that we seek to increase the quality performance standard over time, we believe changing the quality performance standard from the 30th percentile on one measure in each domain to a requirement that ACOs achieve a quality performance score equivalent to the 40th percentile or above across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring, is the next incremental step in increasing the quality performance standard. Under the current Shared Savings Program quality measurement methodology, 99.6 percent or 546 ACOs participating in the program in 2018 met the quality performance standard of complete and accurate reporting for ACOs in the first year of their first agreement period or the 30th percentile on one measure in each domain, for ACOs in their second or subsequent years of participation in the program. Of these ACOs, 425 were ACOs in second or subsequent years of participation in the program for which most quality measures were scored as pay-for-performance (P4P). We analyzed quality measure data from 2018 to simulate how many ACOs would achieve a quality performance score that was at or above the 40th percentile of MIPS Quality performance category scores. Based on our analysis using 2018 data to simulate 2021 MIPS Quality performance category scores, we estimate 95 percent of ACOs would achieve a quality performance score at or above the 40th percentile across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scores. We recognize that this impact could change if the 40th percentile across all MIPS Quality performance category scores improves relative to ACOs' quality performance scores, or alternatively if ACOs, particularly ACOs at risk of failing, respond to the methodology change by boosting their performance. The impact could range from 98 percent of ACOs achieving a quality performance score at or above the 40th percentile to 92 percent of ACOs reflecting the respective extreme scenarios assumed in the previous sentence.</P>
                    <P>Eligible clinicians participating in Shared Savings Program ACOs who obtain QP status would continue to be exempt from MIPS, and therefore, would not be subject to APP scoring under MIPS. For eligible clinicians in an ACO that is participating in a track (or payment model within a track) that is an Advanced APM who do not meet the threshold to earn QP status but do meet the lower payment and patient count threshold to achieve Partial QP status, the ACO can elect to report on behalf of the Partial QPs, and the Partial QPs would be subject to a MIPS payment adjustment under the APP framework. Conversely, if an ACO does not elect to report for the Partial QPs, they would not receive a MIPS score or payment adjustment and would have no reporting responsibilities for MIPS. Utilizing the MIPS Quality performance category scoring methodology to assess the quality performance for purposes of the Shared Savings Program of ACOs participating in tracks (or payment models within a track) that qualify as an Advanced APM would not change whether the eligible clinicians participating in the ACO obtain QP status and are excluded from MIPS, nor would it change the ACO participant TINs' eligibility to receive Advanced APM incentive payments.</P>
                    <P>
                        We propose to specify in a new section of the Shared Savings Program regulations at § 425.510, policies on the application of the APP to Shared Savings Program ACOs for performance years beginning on or after January 1, 2021. This new section would include a general provision specifying that CMS establishes quality performance measures to assess the quality of care furnished by the ACO. If the ACO demonstrates to CMS that it has satisfied the quality performance 
                        <PRTPAGE P="50235"/>
                        requirements, and meets all other applicable requirements, the ACO is eligible to receive shared savings. This general provision also indicates that CMS seeks to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. This new section of the regulations would also specify the requirement that ACOs must report quality data via the APP established under § 414.1367 according to the method of submission established by CMS. In addition, this new section of the regulation would also specify that CMS retains the right to audit and validate quality data reported by an ACO according to § 414.1390 of this chapter.
                    </P>
                    <P>We also propose to specify in a new section of the Shared Savings Program regulations at § 425.512 provisions for determining the ACO quality performance standard for performance years beginning on or after January 1, 2021. We propose to specify that the quality performance standard is the overall standard the ACO must meet in order to be eligible to receive shared savings for a performance year. Further, we propose to specify that for all ACOs, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367, according to the method of submission established by CMS and achievement of a quality performance score equivalent to the 40th percentile or above across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. In addition, we propose to specify that if an ACO does not report any of the three of the measures ACOs are actively required to report and does not field a CAHPS survey, the ACO would not meet the quality performance standard.</P>
                    <P>In addition, we propose to modify the existing Shared Savings Program regulation at § 425.508, on incorporating quality reporting requirements related to the Quality Payment Program. We propose to add a provision applicable to 2021 and subsequent performance years, which specifies that ACOs must submit quality data via the APP established under § 414.1367 to satisfactorily report on behalf of the eligible clinicians who bill under the TIN of an ACO participant for purposes of the MIPS Quality performance category. We also propose related technical and conforming modifications to § 425.508.</P>
                    <P>We seek comment on our proposal to revise the Shared Savings Program quality performance standard.</P>
                    <HD SOURCE="HD3">d. Use of ACO Quality Performance in Determining Shared Savings and Shared Losses</HD>
                    <P>Section 1899(d)(1)(A) of the Act specifies an ACO is eligible to receive a shared savings payment for a portion of the savings generated for Medicare, provided that the ACO meets both the quality performance standards established by the Secretary and achieves the required level of savings against its historical benchmark. Section 1899(d)(2) of the Act provides the authority for the actual payments for shared savings under the Shared Savings Program. Specifically, if an ACO meets the quality performance standards established by the Secretary (according to section 1899(b)(3) of the Act), and meets the savings requirements, a percent (as determined appropriate by the Secretary) of the difference between the estimated average per capita Medicare expenditures in the year, adjusted for beneficiary characteristics, and the benchmark for the ACO, may be paid to the ACO as shared savings and the remainder of the difference shall be retained by the Medicare program. The Secretary is required to establish limits on the total amount of shared savings paid to an ACO. We have also incorporated performance-based risk in the form of shared losses into certain financial models using the authority under section 1899(i)(3) of the Act to use other payment models.</P>
                    <P>The Shared Savings Program's one-sided shared savings only models, and two-sided shared savings and shared losses models are specified in subpart G of the Shared Savings Program regulations. For agreement periods beginning on July 1, 2019, and in subsequent years, eligible ACOs may participate under either: (1) The BASIC track, which includes a glide path consisting of five levels (Levels A through E) that allows eligible ACOs to begin under a one-sided model (Level A or Level B) and incrementally phases-in higher levels of risk and potential reward (Levels C, D, or E) (§ 425.605); or (2) the ENHANCED track, a two-sided model with the highest level of risk and potential reward (§ 425.610). Further, according to the May 8th COVID-19 IFC (85 FR 27574 and 27575), ACOs that entered a first or second agreement period with a start date of January 1, 2018, whose participation agreements expire December 31, 2020, may elect to extend their agreement period for an optional fourth performance year, spanning January 1, 2021, to December 31, 2021. This includes ACOs that entered agreement periods under Track 1 (a one-sided model), Track 2 (a two-sided model), and the ENHANCED track. Further, this option to elect a 12-month extension of the agreement period also applies to ACOs participating in the Track 1+ Model whose participation agreements expire December 31, 2020.</P>
                    <P>
                        Under the Shared Savings Program regulations, for both one-sided models and two-sided models, CMS uses the ACO's quality performance to determine the ACO's eligibility to receive shared savings, and the rate at which ACOs share in these savings. We base the final shared savings rate on the ACO's quality performance. For ACOs meeting the quality performance standard, the final shared savings rate is equal to the product of the ACO's quality score and the maximum sharing rate. The maximum sharing rate is specific to the ACO's track/level of participation as follows: 50 percent for ACOs participating in Track 1; 
                        <SU>34</SU>
                        <FTREF/>
                         60 percent for ACOs participating in Track 2; 
                        <SU>35</SU>
                        <FTREF/>
                         40 percent for ACOs participating in Level A or Level B of the BASIC track; 
                        <SU>36</SU>
                        <FTREF/>
                         and 50 percent for ACOs participating in Levels C, D, or E of the BASIC track; 
                        <SU>37</SU>
                        <FTREF/>
                         and 75 percent for ACOs participating in the ENHANCED track.
                        <SU>38</SU>
                        <FTREF/>
                         The upside of the Track 1+ Model is based on Shared Savings Program Track 1; therefore, a maximum sharing rate of 50 percent applies to Track 1+ Model ACOs.
                        <SU>39</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             Refer to § 425.604(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Refer to § 425.606(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Refer to § 425.605(d)(1)(i)(A), (d)(1)(ii)(A).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Refer to § 425.605(d)(1)(iii)(A), (d)(1)(iv)(A), (d)(1)(v)(A).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             Refer to § 425.610(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             Refer to the Track 1+ Model Participation Agreement, available at 
                            <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Depending on the track, the ACO's quality performance may also be used to determine the amount of the ACO's shared losses, for ACOs under two-sided models. ACOs participating in the Track 1+ Model, and Level C, D, or E of the BASIC track are subject to a fixed shared loss rate (also referred to as the loss sharing rate) of 30 percent regardless of quality performance.
                        <SU>40</SU>
                        <FTREF/>
                         Under Track 2 and the ENHANCED track, the shared loss rate is calculated as one minus the ACO's final shared savings rate based on quality performance, up to a maximum of 60 percent or 75 percent, respectively, and the shared loss rate 
                        <PRTPAGE P="50236"/>
                        may not be less than 40 percent for both tracks.
                        <SU>41</SU>
                        <FTREF/>
                         For ENHANCED track ACOs, this 40 percent minimum shared loss rate is expressly stated in the current regulations, whereas for Track 2 ACOs, it is the implicit minimum shared loss rate as calculated based on the inverse of the maximum final shared savings rate for the track. Track 2 and ENHANCED track ACOs that do not meet the quality performance standard for the performance year will be accountable for shared losses based on the highest shared loss rate for their track.
                    </P>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Provisions specifying the shared loss rate for two-sided models of the BASIC track are specified in § 425.605(d)(1)(iii)(C), (d)(1)(iv)(C), (d)(1)(v)(C). The shared loss rate applicable to Track 1+ Model ACOs is specified in the Track 1+ Model Participation Agreement.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             Refer to §§ 425.606(f), 425.610(f).
                        </P>
                    </FTNT>
                    <P>In light of the proposed changes to the Shared Savings Program's quality performance standard addressed elsewhere in section III.G.1. of this proposed rule, we also propose modifications to the regulations that specify the circumstances under which an ACO will qualify for a shared savings payment based on its quality performance and the determination of the rate at which the ACO will share in savings based on its quality performance.</P>
                    <P>For all tracks, we propose to specify, in revisions to the regulations, the requirements that must be met for an ACO to qualify for a shared savings payment for performance years beginning on or after January 1, 2021. We propose that to qualify for shared savings, an ACO must meet the minimum savings rate requirements established for the track/level, meet the proposed quality performance standard described in section III.G.1.c. of this proposed rule, and otherwise maintain its eligibility to participate in the Shared Savings Program under part 425. We propose to revise §§ 425.604(c) (Track 1), 425.605(c) (BASIC track), 425.606(c) (Track 2), and 425.610(c) (ENHANCED track) to reflect these requirements.</P>
                    <P>We also propose revisions to the provisions establishing the final sharing rate for all tracks. We propose that for performance years beginning on or after January 1, 2021, if an ACO that is otherwise eligible to share in savings meets the proposed quality performance standard as described in section III.G.1.c. of this proposed rule, the ACO will share in savings at the maximum sharing rate according to the applicable financial model, up to the performance payment limit. We propose that if the ACO fails to meet the proposed quality performance standard, the ACO would be ineligible to share in savings. We propose to specify these policies in revisions to the provisions governing Track 1 (§ 425.604(d)), the BASIC track (§ 425.605(d)(1)(i)(A) (Level A), (d)(1)(ii)(A) (Level B), (d)(1)(iii)(A) (Level C), (d)(1)(iv)(A) (Level D), (d)(1)(v)(A) (Level E)), Track 2 (§ 425.606(d)), and the ENHANCED track (§ 425.610(d)).</P>
                    <P>We also propose modifications to the methodology for determining shared losses under Track 2 and the ENHANCED track, for performance years beginning on or after January 1, 2021, to account for the proposed revisions to the quality performance standard. If the ACO meets the quality performance standard as proposed (see section III.G.1.c. of this proposed rule), we would determine the shared loss rate as follows:</P>
                    <P>
                        • 
                        <E T="03">Step 1:</E>
                         Calculate the quotient of the MIPS quality performance category points earned divided by the total MIPS quality performance category points available.
                    </P>
                    <P>
                        • 
                        <E T="03">Step 2:</E>
                         Calculate the product of the quotient described in step 1 and the sharing rate for the relevant track, either 60 percent for Track 2 or 75 percent for the ENHANCED track.
                    </P>
                    <P>
                        • 
                        <E T="03">Step 3:</E>
                         Calculate the shared loss rate as 1 minus the product determined in step 2. Consistent with the existing structure of the financial models: Under Track 2, the shared loss rate may not exceed 60 percent, and may not be less than 40 percent; under the ENHANCED track, the shared loss rate may not exceed 75 percent, and may not be less than 40 percent.
                    </P>
                    <P>Under this proposed approach, for an ACO that meets the quality performance standard we would take into consideration the ACO's quality score when determining the ACO's share of losses. An ACO with a higher quality score would owe a lower amount of losses compared to an ACO with an equivalent amount of losses but a lower quality score, so long as the ACO's quality score results in a shared loss rate within the range between the minimum shared loss rate (40 percent) and the maximum shared loss rate (60 percent under Track 2, or 75 percent under the ENHANCED track). To the extent the ACO's quality score results in a shared loss rate outside these limits, the shared loss rate is set to the minimum or maximum rate (as applicable). We also propose to revise the regulation at § 425.606(f) to expressly state both the minimum and maximum shared loss rates for Track 2.</P>
                    <P>We propose that if the ACO fails to meet the quality performance standard as proposed (see section III.G.1.c. of this proposed rule), the shared loss rate would be 60 percent under Track 2 or 75 percent under the ENHANCED track. We believe this approach would maintain symmetry with the proposed approach to determining shared savings under Track 2 and the ENHANCED track based on quality performance. Thus, an ACO that fails to meet the quality performance standard would be ineligible to share in savings and would owe the maximum amount of shared losses.</P>
                    <P>We propose to specify these provisions for determining the shared loss rate under Track 2 and the ENHANCED track, for performance years beginning on or after January 1, 2021, through modifications to the regulations at §§ 425.606(f) and 425.610(f). We also propose technical and conforming changes to these provisions for clarity, and to specify that the current policy would continue to apply for purposes of determining the shared loss rate for Track 2 ACOs and ENHANCED track ACOs for performance years (or a performance period) beginning on or before January 1, 2020.</P>
                    <HD SOURCE="HD3">e. Compliance With the Quality Performance Standard</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>As discussed in more detail in section III.G.1.c. of this proposed rule, the quality performance standard is the minimum performance level ACOs must achieve in order to share in any savings earned, avoid maximum losses under certain payment tracks, and avoid quality-related compliance actions. Section 1899(d)(4) of the Act authorizes the Secretary to terminate an agreement with an ACO that does not meet the established quality performance standards. Through earlier rulemaking we established an approach to enforce ACO compliance with the quality performance standards, as specified in the Shared Savings Program regulations at § 425.316 (see 76 FR 67951, 80 FR 32818 and 32819, 81 FR 80492 through 80494).</P>
                    <P>To identify ACOs that do not meet the established quality performance standards, we review the ACO's quality data submission. Under our current policies, as specified in § 425.316(c), if an ACO does not meet quality performance standards or fails to report on one or more quality measures, in addition to actions set forth at §§ 425.216 and 425.218, we will take the following actions:</P>
                    <P>
                        • The ACO may be given a warning for the first time it fails to meet the minimum attainment level on at least 70 percent of the measures, as determined under § 425.502, in one or more domains and may be subject to a corrective action plan (CAP). CMS may forgo the issuance of the warning letter 
                        <PRTPAGE P="50237"/>
                        depending on the nature and severity of the noncompliance and instead subject the ACO to actions set forth at § 425.216 or immediately terminate the ACO's participation agreement under § 425.218.
                    </P>
                    <P>• The ACO's compliance with the quality performance standards will be re-evaluated the following year. If the ACO continues to fail to meet the quality performance standards in the following year, the agreement will be terminated.</P>
                    <P>• An ACO will not qualify to share in savings in any year it fails to report accurately, completely, and timely on the quality performance measures.</P>
                    <P>Further, according to § 425.224(b), in evaluating the eligibility of a renewing ACO or re-entering ACO to enter a new participation agreement with CMS for participation in the Shared Savings Program, we consider the ACO's history of noncompliance with the program's quality performance standard. For evaluating ACOs that entered into a participation agreement for a 3-year period, we consider whether the ACO failed to meet the quality performance standard during 1 of the first 2 performance years of the previous agreement period. For evaluating ACOs that entered into a participation agreement for a period longer than 3 years, we consider whether the ACO failed to meet the quality performance standard for 2 consecutive performance years and was terminated as specified in § 425.316(c)(2), or whether the ACO failed to meet the quality performance standard for 2 or more performance years of the previous agreement period, regardless of whether the years were consecutive.</P>
                    <P>The terms “renewing ACO” and “re-entering ACO” are defined in the regulations at § 425.20. We define renewing ACO to mean an ACO that continues its participation in the program for a consecutive agreement period, without a break in participation, because it is either: (1) An ACO whose participation agreement expired and that immediately enters a new agreement period to continue its participation in the program; or (2) an ACO that terminated its current participation agreement under § 425.220 and immediately enters a new agreement period to continue its participation in the program. We define re-entering ACO to mean an ACO that does not meet the definition of a renewing ACO and meets either of the following conditions: (1) Is the same legal entity as an ACO that previously participated in the program and is applying to participate in the program after a break in participation, because the ACO's participation agreement expired without having been renewed, or the ACO's participation agreement was terminated under § 425.218 or § 425.220; or (2) is a new legal entity that has never participated in the Shared Savings Program and is applying to participate in the program and more than 50 percent of its ACO participants were included on the ACO participant list under § 425.118, of the same ACO in any of the 5 most recent performance years prior to the agreement start date.</P>
                    <HD SOURCE="HD3">(2) Proposed Revisions</HD>
                    <P>We have revisited the provisions of § 425.316(c) on monitoring compliance with quality reporting and performance requirements in light of our proposed modifications to the quality performance standard. We propose to modify the introductory text at § 425.316(c) to state that we will review an ACO's submission of quality measurement data to identify ACOs that are not meeting the applicable quality performance standard under §§ 425.500 or 425.512. Under the provision, as revised, we would retain the discretion to request additional documentation from an ACO, ACO participants, or ACO providers/suppliers. Further, we believe that in conjunction with our proposed changes to the quality performance standard, it is appropriate to strengthen our policies for compliance with the quality performance standard by broadening the conditions under which CMS may terminate an ACO's participation agreement when the ACO demonstrates a pattern of failure to meet the quality performance standard.</P>
                    <P>As currently structured, the regulation at § 425.316 does not specify what actions CMS will take when an ACO fails to meet the quality performance standard for multiple, nonconsecutive performance years, or 2 consecutive performance years that span 2 agreement periods (that is, the last performance year of an agreement period and the first performance year of the subsequent agreement period). Accordingly, we are proposing a new approach that CMS would follow to monitor for and address an ACO's continued noncompliance with the applicable quality performance standard for performance years beginning on or after January 1, 2021. Noncompliance with the quality performance standard during earlier performance years would continue to be subject to the rules currently set forth at § 425.316(c)(1) through (3), which we propose would be consolidated at § 425.316(c)(1). For performance years beginning on or after January 1, 2021, we propose that when CMS determines an ACO fails to meet the quality performance standard (as described in section III.G.1.c. of this proposed rule), CMS may take the actions prior to termination set forth at § 425.216, and may terminate the ACO's participation agreement according to § 425.218. In addition to the actions set forth at §§ 425.216 and 425.218, we propose to adopt a specific approach that CMS would follow to monitor for and address an ACO's continued noncompliance with the quality performance standard.</P>
                    <P>We propose that ACOs exhibiting a pattern of failure to meet the quality performance standard will be terminated from the program. Specifically, we propose to terminate an ACO's participation agreement when the ACO fails to meet the quality performance standard for 2 consecutive performance years within an agreement period or fails to meet the quality performance standard for any 3 performance years within an agreement period, regardless of whether the years are in consecutive order. We also propose that we will terminate the participation agreement of a renewing ACO or a re-entering ACO if the ACO fails to meet the quality performance standard for 2 consecutive performance years across 2 agreement periods, specifically the last performance year of the ACO's previous agreement period and the first performance year of the ACO's new agreement period. In addition, we propose that we will terminate the participation agreement of a renewing ACO or a re-entering ACO if the ACO fails to meet the quality performance standard for the last performance year of the ACO's previous agreement period and this occurrence was either the second consecutive performance year of failed quality performance or the third nonconsecutive performance year of failed quality performance during the previous agreement period. We propose to amend § 425.316(c)(2) to reflect this new approach.</P>
                    <P>
                        Our proposal to terminate an ACO if it fails to meet the quality performance standard for 2 consecutive performance years within an agreement period is consistent with our current approach. However, we also propose to terminate an ACO's participation agreement if the ACO fails to meet the quality performance standard for any 3 performance years within an agreement period, regardless of whether these years are in consecutive order. In the December 2018 final rule (83 FR 67831), we extended participation agreements from 3-years to 5-years. ACOs participating under a 5-year agreement period may show a pattern of failure to 
                        <PRTPAGE P="50238"/>
                        meet the quality performance standard in performance years that are not consecutive. Therefore, we believe it is important to continue to monitor ACOs throughout their 5-year agreement period and if an ACO fails to meet the quality performance standard for 3 nonconsecutive performance years we propose to terminate their participation agreement.
                    </P>
                    <P>Additionally, we are concerned that a renewing ACO's quality performance results for the last performance year of the current agreement period will not be available for us to consider in reviewing the ACO's application to renew its agreement, as currently provided in § 425.224(b)(1)(ii)(A). We have a similar concern with respect to some re-entering ACOs (particularly, an ACO that notifies CMS of its decision to terminate its participation agreement and subsequently submits an application to re-enter the program for the next start date following the effective date of its termination). To prevent these ACOs from remaining in the program, despite a pattern of noncompliance with the quality performance standard, we propose that if we determine that the last performance year of the ACO's previous agreement period was either the second consecutive performance year of failed quality performance or the third nonconsecutive performance year of failed quality performance during the prior agreement period, CMS would terminate the ACO's new participation agreement. For example, if an ACO failed to meet the quality performance standard in the first, third and fifth performance years of a 5-year agreement period, or failed to meet the quality performance standard in the fourth and fifth performance years of a 5-year agreement period, results for the fifth performance year would not be available until after the ACO has renewed and entered a new agreement period. In both examples, we would anticipate determining during the first performance year of the ACO's new agreement period that the ACO had failed to meet the quality performance standard for the last performance year of its previous agreement period. Therefore, CMS would terminate the ACO's new participation agreement during the first performance year of that agreement period.</P>
                    <P>Furthermore, we are concerned an ACO could have a pattern of failing to meet the quality performance standard for consecutive years spanning 2 agreement periods. Therefore, if a renewing or re-entering ACO fails to meet the quality performance standard for 2 consecutive performance years across 2 agreement periods (the last performance year of the ACO's previous agreement period and the first performance year of the ACO's new agreement period), we propose to terminate the ACO's participation agreement. We would anticipate that quality performance results for the ACO's first performance year of its new agreement period would be available during the second performance year of the ACO's new agreement period. Therefore, CMS would terminate the ACO's new participation agreement during the second performance year of the new agreement period.</P>
                    <P>We recognize there is additional complexity in the application of these policies to a new ACO that is identified as a re-entering ACO because of its ACO participants' prior participation in another Shared Savings Program ACO. Under the proposed approach, we would apply to the re-entering ACO the other ACO's quality performance for previous years (prior to the start of the re-entering ACO's agreement period) and would terminate the re-entering ACO if the other ACO is determined to have failed to meet the quality performance standard in 2 consecutive performance years within an agreement period, or if the other ACO is determined to have failed to meet the quality performance standard for 3 performance years (in nonconsecutive order) within an agreement period. Consistent with the proposed approach, this could occur in circumstances when the other ACO's most recent performance year of failed quality performance is determined after the start of the new, re-entering ACO's agreement period. Further, under the proposed approach, we would also consider whether the other ACO failed to meet the quality performance standard in the most recent performance year prior to the start of the new, re-entering ACO's agreement period, and whether the new, re-entering ACO also fails to meet the quality performance standard for its first performance year. Because these 2 performance years of failed quality performance would be consecutive, we would terminate the participation of the new, re-entering ACO.</P>
                    <P>Because a significant percentage of the ACO participants in the new, re-entering ACO were previously participating in this other ACO, we believe it is appropriate to hold the new, re-entering ACO accountable for the quality performance of the other ACO. According to the definition of re-entering ACO, more than 50 percent of the entity's ACO participants must have participated together in the same ACO within a 5-performance year lookback period. As a result, over half of the new, re-entering ACO's ACO participants can be considered to have contributed to the failed quality performance of this other ACO. If we were to disregard the recent failed quality performance of this other ACO, these ACO participants would be allowed to continue participation in the Shared Savings Program as part of the new, re-entering ACO, and potentially take advantage of program flexibilities, despite a pattern of noncompliance with the quality performance standard.</P>
                    <P>We propose implementing these policies starting with performance year 2021 and subsequent years. We acknowledge that an ACO currently participating under a performance agreement spanning 5-years could fail the quality performance standard for a performance year starting in 2019 under § 425.502. The same ACO could then again fail the quality performance standard under the proposed § 425.512 in performance years 2021 and 2023. In this scenario, the ACO will have failed the quality performance standards for 3 nonconsecutive years under the same agreement period, but the ACO would not be terminated in this scenario because the proposed policies would apply starting with performance year 2021. However, if the ACO decides to apply as a renewing or re-entering ACO, we would review its history of noncompliance with the requirements of the Shared Savings Program as provided under § 425.224(b)(1) when determining whether to approve its application.</P>
                    <P>Under the current regulation at § 425.316(c)(3), an ACO will not qualify to share in savings in any year in which it fails to report accurately, completely, and timely on the quality performance measures. Consistent with the proposed revisions to the quality performance standard under the Shared Savings Program discussed in section III.G.1.c. of this proposed rule, we propose to specify in the proposed new provision at § 425.512 that, for performance years beginning on or after January 1, 2021, an ACO will not qualify to share in savings in any year it fails to meet the quality performance standard.</P>
                    <P>
                        The termination of an ACO's participation agreement for failure to meet the quality performance standard under the proposed approach described in this section of the proposed rule, would also make the ACO subject to the payment consequences of early termination as specified in § 425.221(b). Under § 425.221(b)(1)(ii), if the participation agreement is terminated at any time by CMS under § 425.218, the ACO is not eligible to receive shared 
                        <PRTPAGE P="50239"/>
                        savings for the performance year during which the termination becomes effective. Under § 425.221(b)(2)(ii)(B), an ACO participating under a two-sided model whose participation agreement is terminated by CMS under § 425.218 is liable for a pro-rated share of any shared losses determined for the performance year during which the termination becomes effective. These policies would apply whenever an ACO is terminated for non-compliance with the quality performance standard in accordance with § 425.316(c).
                    </P>
                    <P>We propose to revise § 425.316(c) to incorporate this proposed approach for monitoring ACO compliance with the quality performance standard for performance years beginning on or after January 1, 2021. We also propose to make other technical and conforming changes to the regulations at § 425.316(c). In particular, we propose to amend the existing provisions for monitoring ACO compliance with the quality performance standards to specify that those provisions are applicable to performance years (or a performance period) beginning on or before January 1, 2020.</P>
                    <P>We also continue to believe in the importance of considering an ACO's history of noncompliance with the quality performance standard in evaluating the eligibility of a renewing ACO or a re-entering ACO to enter a new agreement period under the Shared Savings Program. In light of our proposed changes to § 425.316(c), we propose to make conforming changes to § 425.224(b)(1)(ii)(A), which authorizes CMS to approve or deny a renewing ACO's or re-entering ACO's application to participate in the Shared Savings Program based on an evaluation of the ACO's history of non-compliance with the quality performance standard. Specifically, we propose to revise § 425.224(b)(1)(ii)(A) to state that as part of its evaluation of a renewing or re-entering ACO's history of noncompliance with the requirements of the Shared Savings Program, we will evaluate whether the ACO demonstrated a pattern of failure to meet the quality performance standards or met any of the criteria for termination under §§ 425.316(c)(1)(ii) or 425.316(c)(2)(ii).</P>
                    <HD SOURCE="HD3">f. Updating the Process Used To Validate ACO Quality Data Reporting</HD>
                    <P>In the CY 2017 PFS final rule, we finalized modifications to the quality measures validation audit process. These modifications changed the overall audit process from a 3-phased medical record review to an audit conducted in a single phase. Under our current process, if selected for an audit, an ACO must provide beneficiary medical records data to substantiate the quality data reported by the ACO. As part of the audit, CMS calculates an overall audit match rate, which is derived by dividing the total number of audited records that match the information reported in the CMS Web Interface by the total number of the medical records audited. For example: (1) If the ACO has an audit match rate of 90 percent or above it will pass the audit; (2) if the ACO has an audit match rate of less than 90 percent, but greater than 80 percent, the ACO may be required to submit a CAP under § 425.216 for CMS approval; (3) if the ACO has an audit match rate of less than 80 percent, absent unusual circumstances, we will adjust the ACO's overall quality score proportional to the ACO's audit match rate, which may have implications for the ACO's financial reconciliation.</P>
                    <P>Under our proposal to align the quality reporting requirements under the Shared Savings Program with quality reporting under the APP framework, we believe it would be appropriate to also align with the MIPS Data Validation and Audit (DVA) process (§ 414.1390). Rather than continuing to validate ACO quality data reporting under the Shared Savings Program, we believe that it would be more appropriate for MIPS to validate the data submitted by ACOs for the three measures in the APP framework, as ACOs will be able to select the submission method for these measures and the MIPS DVA is based on submission method. We believe streamlining the approach to data validation and audit would minimize administrative burden associated with the audit for ACOs as they would only need to track to one validation process, and for ACOs in a track (or payment model within a track) that does not meet the definition of an Advanced APM, the results of the audit would be applicable for purposes of both the Shared Savings Program and MIPS.</P>
                    <P>We propose to address the audit and validation of data used to determine the ACO's quality performance in a new provision we are proposing to add to the Shared Savings Program regulations at § 425.510(c). Specifically, we propose that CMS would retain the right to audit and validate the quality data reported by an ACO under § 425.510(b) according to § 414.1390.</P>
                    <HD SOURCE="HD3">g. Changes to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2021</HD>
                    <P>
                        As discussed in section III.G.1.c. of this proposed rule, we are proposing to make changes to the quality performance standard for the Shared Savings Program for the performance year beginning on January 1, 2021, and subsequent performance years. However, we continue to believe it is appropriate to adjust the quality performance scores for ACOs affected by extreme and uncontrollable circumstances. Accordingly, we propose to update the extreme and uncontrollable circumstances policy under the Shared Savings Program consistent with our proposal to align the quality reporting requirements for the Shared Savings Program with the proposed APP. Specifically, for performance year 2021 and subsequent performance years, we would set the minimum quality performance score for an ACO affected by an extreme and uncontrollable circumstance during the performance year, including the applicable quality data reporting period for the performance year, to equal the 40th percentile MIPS Quality performance category score. If the ACO is able to report quality data and meet the MIPS data completeness and case minimum requirements, we would use the higher of the ACO's MIPS Quality performance category score or the 40th percentile MIPS Quality performance category score. If an ACO is unable to report quality data and meet the MIPS Quality data completeness and case minimum requirements due to an extreme and uncontrollable circumstance, we would apply the 40th percentile MIPS Quality performance category score. We believe this approach is appropriate as it aligns with the threshold for meeting the quality performance standard allowing impacted ACOs to share in savings at their maximum sharing rate. We acknowledge that using the 40th percentile may not offer the same level of protection for ACOs incurring losses that would receive the higher of their ACO quality score or the mean ACO score under the current policy. Our simulation of the 2018 MIPS quality data shows that the mean MIPS quality performance category score is between the 45th and 46th percentile, which is lower than the ACO quality mean score under the current scoring methodology. However, for ACOs in Track 2 and the ENHANCED track under which shared losses are determined based in part on an ACO's quality performance, ACOs are also afforded relief from shared losses through the application of the extreme and uncontrollable circumstances policy under which shared losses are reduced based on the percentage of the year and percentage of assigned beneficiaries impacted by an 
                        <PRTPAGE P="50240"/>
                        extreme and uncontrollable circumstance.
                    </P>
                    <P>Under the proposed revisions to the quality reporting requirements, we will no longer generate a CMS Web Interface quality reporting sample for ACOs because ACOs will no longer be reporting measures via the Web Interface; therefore, we propose to determine the percentage of the ACO's performance year assigned beneficiary population that was affected by an extreme and uncontrollable circumstances based on the quarter four list of assigned beneficiaries, rather than the list of assigned beneficiaries used to generate the Web Interface quality reporting sample, which is currently used. We believe that using the quarter four list of assigned beneficiaries is an appropriate alternative because the file is generated after the end of the fourth quarter and would offer a more complete representation of the population of assigned beneficiaries that reside in an area that is impacted by an extreme and uncontrollable circumstance during the performance year. We seek comment on these proposed revisions to the extreme and uncontrollable circumstances policy for performance year 2021 and subsequent performance years.</P>
                    <P>In addition, we are soliciting comment on a potential alternative extreme and uncontrollable circumstances policy for performance year 2022 and subsequent years that would continue to incentivize reporting but also acknowledge the challenges presented by extreme and uncontrollable circumstances. We are considering creating an extreme and uncontrollable circumstances methodology that would adjust the amount of shared savings determined for affected ACOs that complete quality reporting but do not meet the quality performance standard or that are unable to complete quality reporting. This methodology would be similar to the methodology currently used to adjust for extreme and uncontrollable circumstances when calculating the amount of shared losses for impacted ACOs. Under this alternative approach, instead of determining that ACOs are affected by an extreme and uncontrollable circumstances if 20 percent of their beneficiaries or their legal entity are located in an area impacted by an extreme and uncontrollable circumstance and determining shared savings using the higher of the ACO's own quality score and the mean ACO quality score, we would determine shared savings for an affected ACO by multiplying the maximum possible shared savings the ACO would be eligible to receive based on its financial performance and track (or payment model within a track) by the percentage of the total months in the performance year affected by an extreme and uncontrollable circumstance, and the percentage of the ACO's assigned beneficiaries who reside in an area affected by an extreme and uncontrollable circumstance. To illustrate this potential approach, we provide an example of a hypothetical ACO, ACO A, which in this example was impacted by an extreme and uncontrollable circumstance that lasted for six months of the year and during that time, 50 percent of its assigned beneficiaries resided in the impacted area. For this example, we assume that ACO A did not quality report and would have earned $100,000 in shared savings if it had met the quality performance standard. In this example, we would multiply the percentage of the total months in the performance year impacted by the extreme and uncontrollable circumstance by the percentage of the ACO's assigned beneficiaries who resided in the impacted area by the amount of shared savings if the ACO had met the quality performance standard; 0.50 * 0.50 * $100,000 = $25,000. Under this alternative, ACO A's shared savings would be $25,000.</P>
                    <P>As another example, if ACO B were impacted by an extreme and uncontrollable circumstance for nine months of the year, had 50 percent of its assigned beneficiaries residing in the impacted area, and did report quality data but did not meet the quality performance standard of a score equivalent to a MIPS Quality performance category score at the 40th percentile, and ACO B would have earned $100,000 in shared savings if it had met the quality performance standard; 0.75 * 0.50 * $100,000 = $37,500. Under this alternative, ACO B's shared savings would be $37,500.</P>
                    <P>As illustrated by the above examples, under this potential future approach, the amount of shared savings that an ACO impacted by an extreme and uncontrollable circumstance would be eligible to receive would be greater than the amount an ACO that was not disaster impacted would be eligible to receive if it did not report quality or did report quality but did not obtain a score equivalent to a MIPS Quality performance category score at or above the 40th percentile. An ACO that was not disaster impacted and that either did not report quality or did report quality but did not obtain a quality performance category score equivalent to or higher than a MIPS Quality performance category score at or above the 40th percentile would not meet the quality performance standard and would not be eligible to receive any shared savings. In contrast, an ACO impacted by an extreme and uncontrollable circumstance would be eligible to receive an adjusted amount of shared savings, even if it did not quality report or did report quality but had a quality performance score that was lower than the 40th percentile of MIPS Quality performance category scores. The final amount of shared savings would be dependent on the degree to which the ACO's assigned beneficiaries were disaster impacted during the relevant performance year.</P>
                    <P>If an ACO impacted by an extreme and uncontrollable circumstance does not report quality or does not meet the quality performance standard of a quality performance score equivalent to a MIPS Quality performance category score at or above the 40th percentile and owes shared losses, then the existing extreme and uncontrollable circumstances methodology that applies when calculating the amount of shared losses would help to mitigate those losses. We note that historically the majority of disaster-impacted ACOs report quality. For example, for performance years (or a performance period) starting in 2019, when all ACOs were determined to be impacted by the PHE for COVID-19, which was declared during the quality reporting period, 98.7 percent of ACOs completely reported via the CMS Web interface. Given the historically high rates of quality reporting by ACOs impacted by extreme and uncontrollable circumstances and the fact that, under our proposed revisions to the quality performance standard, ACOs would share in the maximum level of savings available under their track (or payment model within a track) if they meet the quality performance standard, we believe it is important to consider an extreme and uncontrollable circumstances policy that looks at the actual impact of an extreme and uncontrollable circumstance on a disaster-impacted ACO, and provides for an adjusted amount of shared savings if the ACO does not report or does not meet the quality performance standard.</P>
                    <P>We seek comment on this potential alternative extreme and uncontrollable circumstances policy for future years.</P>
                    <P>
                        We propose to specify our proposed policies for addressing the effect of extreme and uncontrollable circumstances on ACO quality performance for performance year 2021 and subsequent performance years in the proposed new provision at 
                        <PRTPAGE P="50241"/>
                        § 425.512. In addition, we propose to include policies that parallel the existing policies, as specified in § 425.502(f), for determining when an extreme and uncontrollable circumstance has occurred and identifying affected ACOs. In particular, we propose to include a provision, similar to the current provision at § 425.502(f)(1), to establish our policies for determining whether an ACO has been an affected by an extreme and uncontrollable circumstance. We also propose to include a provision, similar to the provision at § 425.502(f)(2), to establish the policies that would apply for calculating an affected ACO's quality performance score. Similar to the existing provision at § 425.502(f)(3), we propose to specify that we would apply determinations made under the Quality Payment Program with respect to whether an extreme and uncontrollable circumstance has occurred, and the affected areas. Consistent with the existing policy under § 425.502(f)(4), this new provision would also specify that we have sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred, the percentage of the ACO's assigned beneficiaries residing in the affected areas, and the location of the ACO legal entity.
                    </P>
                    <HD SOURCE="HD3">h. Proposed Technical Changes To Incorporate References to Revised Quality Performance Standard</HD>
                    <P>We propose to make certain technical, conforming changes to the following provisions to reflect our proposal to add new sections of the regulations at § 425.510 on the application of the APP to Shared Savings Program ACOs for performance years beginning on or after January 1, 2021, and § 425.512 on determining the ACO quality performance standard for performance years beginning on or after January 1, 2021.</P>
                    <P>• Under subpart A, which specifies general provisions governing the Shared Savings Program:</P>
                    <P>++ In § 425.100(b), the general description of ACOs that are eligible to receive payments for shared savings under the program would be revised for clarity and to add a reference to § 425.512. In the description of the quality performance standard that must be met for the ACO to be receive payment for shared savings, we propose to specify that the quality performance standards established under § 425.500 are applicable for performance years (or a performance period) beginning on or before January 1, 2020, and that the proposed quality performance standard under § 425.512 is applicable for performance years beginning on or after January 1, 2021.</P>
                    <P>++ In § 425.112(b)(2)(i), the provision specifying the ACO must have processes to promote patient engagement including to address compliance with patient experience of care survey requirements, would be revised to add a reference to § 425.510.</P>
                    <P>• Under subpart C, which governs application procedures and the participation agreement, we would add a reference to § 425.510 in the provision at § 425.200(d) specifying that ACOs must submit measures in the form and manner required by CMS.</P>
                    <P>• Under subpart D, which specifies program requirements and beneficiary protections, we would add a reference to § 425.510 in § 425.302(a)(1) specifying requirements for data submission and certification.</P>
                    <P>• Under subpart G, which specifies the program's financial models for determining shared savings and shared losses (as applicable), we propose to revise the description of program requirements that phase-in over multiple agreement periods in § 425.600(f)(4). Under the proposed revisions to the quality performance standard, measurement of an ACO's quality performance would no longer phase-in over the course of the ACO's first agreement period from pay-for-reporting in the first performance year to pay-for-performance in all subsequent performance years; rather, all ACOs, regardless of performance year and agreement period, would be scored on all the measures in the APP. Therefore, we propose to revise § 425.600(f)(4)(i) to specify that the reference to the quality performance standard as described in § 425.502(a) is applicable for performance years (or a performance period) beginning on or before January 1, 2020.</P>
                    <P>• Under subpart I, which governs the reconsideration review process, we would add references to § 425.510, § 425.512, or both to § 425.800(a)(1), (a)(2) and (a)(6).</P>
                    <HD SOURCE="HD3">2. Revisions to the Definition of Primary Care Services Used in Shared Savings Program Beneficiary Assignment</HD>
                    <HD SOURCE="HD3">a. Healthcare Common Procedure Coding System (HCPCS) and Current Procedural Terminology (CPT) Codes Used in Assignment</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>Section 1899(c)(1) of the Act, as amended by the 21st Century Cures Act and the Bipartisan Budget Act of 2018, provides that for performance years beginning on or after January 1, 2019, the Secretary shall assign beneficiaries to an ACO based on their utilization of primary care services provided by a physician who is an ACO professional and all services furnished by Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs). However, the statute does not specify which kinds of services may be considered primary care services for purposes of beneficiary assignment.</P>
                    <P>In the November 2011 final rule (76 FR 67853), we established the initial list of services, identified by CPT and HCPCS codes, that we considered to be primary care services. In that final rule, we indicated that we intended to monitor CPT and HCPCS codes and would consider making changes to the definition of primary care services to add or delete codes used to identify primary care services, if there were sufficient evidence that revisions were warranted. We have updated the list of primary care service codes in subsequent rulemaking to reflect additions or modifications to the codes that have been recognized for payment under the Medicare PFS and to incorporate other changes to the definition of primary care services for purposes of the Shared Savings Program.</P>
                    <P>In the June 2015 final rule (80 FR 32746 through 32748), we expanded the definition of primary care services to include two transitional care management (TCM) codes (CPT codes 99495 and 99496), and one chronic care management (CCM) code (CPT 99490). As discussed in the final rule, the TCM codes were established to pay a patient's physician or practitioner to coordinate the patient's care in the 30 days following a hospital or SNF stay. Including these codes in the definition of primary care services reflects our belief that the work of community physicians and practitioners in managing a patient's care following discharge from a hospital or nursing facility (NF) to ensure better continuity of care for these patients and help reduce avoidable readmissions is a key aspect of primary care.</P>
                    <P>In the CY 2016 PFS final rule (80 FR 71270 through 71273), we revised the definition of primary care services to exclude services billed under CPT codes 99304 through 99318, containing the place of service 31 modifier specifying that the service was furnished in a SNF. We also revised the definition of primary care services to include claims submitted by Electing Teaching Amendment (ETA) hospitals.</P>
                    <P>
                        In the CY 2018 PFS final rule, we revised the definition of primary care services to include three additional CCM service codes, 99487, 99489, and 
                        <PRTPAGE P="50242"/>
                        G0506, and four behavioral health integration (BHI) service codes, G0502, G0503, G0504 and G0507 (82 FR 53212 and 53213). We further revised the definition of primary care services in the November 2018 final rule. In the November 2018 final rule, we added new codes to the definition of primary care services (CPT codes 99497, 99498, 96160, 96161, 99354, and 99355, and HCPCS codes G0444, G0442, and G0443), and revised how we determine whether services identified by CPT codes 99304 through 99318 were furnished in a SNF (83 FR 59964 through 59968).
                    </P>
                    <P>For performance years beginning on January 1, 2019, and subsequent performance years, we defined primary care services in §  425.400(c)(1)(iv) for purposes of assigning beneficiaries to ACOs under §  425.402 as the set of services identified by the following HCPCS/CPT codes:</P>
                    <P>
                        <E T="03">CPT codes:</E>
                    </P>
                    <P>(1) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient).</P>
                    <P>(2) 99304 through 99318 (codes for professional services furnished in a NF; services identified by these codes furnished in a SNF are excluded).</P>
                    <P>(3) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit).</P>
                    <P>(4) 99341 through 99350 (codes for evaluation and management services furnished in a patients' home for claims identified by place of service modifier 12).</P>
                    <P>(5) 99487, 99489 and 99490 (codes for chronic care management).</P>
                    <P>(6) 99495 and 99496 (codes for transitional care management services).</P>
                    <P>(7) 99497 and 99498 (codes for advance care planning).</P>
                    <P>(8) 96160 and 96161 (codes for administration of health risk assessment).</P>
                    <P>(9) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure; when the base code is also a primary care service code).</P>
                    <P>(10) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services).</P>
                    <P>
                        <E T="03">HCPCS codes:</E>
                    </P>
                    <P>(1) G0402 (the code for the Welcome to Medicare visit).</P>
                    <P>(2) G0438 and G0439 (codes for the annual wellness visits).</P>
                    <P>(3) G0463 for services furnished in ETA hospitals.</P>
                    <P>(4) G0506 (code for chronic care management).</P>
                    <P>(5) G0444 (codes for annual depression screening service).</P>
                    <P>(6) G0442 (code for alcohol misuse screening service).</P>
                    <P>(7) G0443 (code for alcohol misuse counseling service).</P>
                    <P>In the May 8th COVID-19 IFC (85 FR 27582 through 27586), we revised the regulations to add § 425.400(c)(2), specifying the definition of primary care services for purposes of beneficiary assignment for the performance year starting on January 1, 2020, and for any subsequent performance year that starts during the COVID-19 PHE defined in § 400.200, to include the foregoing codes specified in §  425.400(c)(1)(iv), as well as specified codes for remote evaluations, virtual check-ins, e-visits, and telephone evaluation and management services.</P>
                    <HD SOURCE="HD3">(2) Proposed Revisions</HD>
                    <P>Based on feedback from ACOs and our further review of the HCPCS and CPT codes currently recognized for payment under the PFS, we believe it would be appropriate to amend the definition of primary care services used in the Shared Savings Program assignment methodology to include certain additional codes and make other technical changes to the definition of primary care services, for use in determining beneficiary assignment for the performance year starting on January 1, 2021, and subsequent performance years.</P>
                    <P>We propose to revise the definition of primary care services in the Shared Savings Program regulations to include the following additions: (1) Online digital evaluation and management CPT codes 99421, 99422, and 99423; (2) assessment of and care planning for patients with cognitive impairment CPT code 99483; (3) chronic care management code CPT code 99491; (4) non-complex chronic care management HCPCS code G2058 and its proposed replacement CPT code, if finalized through the CY 2021 PFS rulemaking; (5) principal care management HCPCS codes G2064 and G2065; and (6) psychiatric collaborative care model HCPCS code GCOL1, if finalized through the CY 2021 PFS rulemaking.</P>
                    <P>The following provides additional information about the CPT and HCPCS codes that we are proposing to add to the definition of primary care services used in assignment:</P>
                    <P>
                        • 
                        <E T="03">Online Digital Evaluation and Management Services</E>
                          
                        <E T="03">(CPT codes 99421, 99422, and 99423):</E>
                         In the CY 2020 PFS final rule (84 FR 62797), we finalized payment for new online digital assessment services, also referred to as “E-Visits,” beginning in CY 2020 for practitioners billing under the PFS. These services are non-face-to-face, patient-initiated communications using online patient portals. These digital assessment services are for established patients who require a clinical decision that otherwise typically would have been provided in the office. Practitioners who may independently bill Medicare for evaluation and management (E/M) services (for instance, physicians and NPs) can bill the following codes:
                    </P>
                    <P>
                        ++ 
                        <E T="03">99421</E>
                          
                        <E T="03">(Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 5-10 minutes.)</E>
                    </P>
                    <P>
                        ++ 
                        <E T="03">99422</E>
                          
                        <E T="03">(Online digital evaluation and management service, for an established patient, for up to 7 days cumulative time during the 7 days; 11-20 minutes.)</E>
                    </P>
                    <P>
                        ++ 
                        <E T="03">99423</E>
                          
                        <E T="03">(Online digital evaluation and management service, for an established patient, for up to 7 days, cumulative time during the 7 days; 21 or more minutes.)</E>
                    </P>
                    <P>In the May 8th COVID-19 IFC (85 FR 27583), we stated that we believe it is appropriate to include these CPT and HCPCS codes in the definition of primary care services used for assignment for PY 2020 and any subsequent performance year that starts during the COVID-19 PHE because the services represented by these codes are being used in place of similar E/M services, the codes for which are already included in the list of codes used for assignment. We also explained our belief that it is important to include these services in our assignment methodology because we determine assignment to ACOs based upon where beneficiaries receive the plurality of their primary care services or whether they have designated an ACO professional as their primary clinician, responsible for their overall care, and hold ACOs accountable for the resulting assigned beneficiary population. Subsequent to the publication of the May 8th COVID-19 IFC, we have determined, based on the justification above, that these codes should be included in the definition of primary care services under § 425.400(c) permanently for purposes of determining beneficiary assignment for the performance year starting on January 1, 2021, and subsequent performance years, and should not be linked to the duration of the COVID-19 PHE.</P>
                    <P>
                        • 
                        <E T="03">Assessment of and care planning for patients with cognitive impairment</E>
                          
                        <E T="03">(CPT code 99483):</E>
                         In the CY 2017 PFS final rule (81 FR 80252-54), we finalized a G-code that would provide separate payment to recognize the work of a physician (or other appropriate 
                        <PRTPAGE P="50243"/>
                        billing practitioner) in assessing and creating a care plan for beneficiaries with cognitive impairment, such as from Alzheimer's disease or dementia, at any stage of impairment, G0505 (
                        <E T="03">Cognition and functional assessment using standardized instruments with development of recorded care plan for the patient with cognitive impairment, history obtained from patient and/or caregiver, in office or other outpatient setting or home or domiciliary or rest home</E>
                        ). In the CY 2018 PFS final rule (82 FR 53077), we deleted the interim HCPCS code G0505 and replaced it with CPT code 99483 (
                        <E T="03">Assessment of and care planning for a patient with cognitive impairment, requiring an independent historian, in the office or other outpatient, home or domiciliary or rest home, with all of the following required elements: Cognition-focused evaluation including a pertinent history and examination; Medical decision making of moderate or high complexity; Functional assessment (e.g., Basic and Instrumental Activities of Daily Living), including decision-making capacity; Use of standardized instruments for staging of dementia (e.g., Functional Assessment Staging Test [FAST], Clinical Dementia Rating [CDR]); Medication reconciliation and review for high-risk medications; Evaluation for neuropsychiatric and behavioral symptoms, including depression, including use of standardized screening instrument(s); Evaluation of safety (e.g., home), including motor vehicle operation; Identification of caregiver(s), caregiver knowledge, caregiver needs, social supports, and the willingness of caregiver to take on caregiving tasks; Development, updating or revision, or review of an Advance Care Plan; Creation of a written care plan, including initial plans to address any neuropsychiatric symptoms, neuro-cognitive symptoms, functional limitations, and referral to community resources as needed (e.g., rehabilitation services, adult day programs, support groups) shared with the patient and/or caregiver with initial education and support. Typically, 50 minutes are spent face-to-face with the patient and/or family caregiver).</E>
                    </P>
                    <P>CPT code 99483 includes the same elements included in the Level 5 E/M service CPT code 99215, such as, a comprehensive history, comprehensive exam, and high complexity medical decision-making. CPT code 99215 is included in the definition of primary care services used for assignment. Accordingly, we believe it would be appropriate to also include CPT code 99483 in the definition of primary care services used for assignment under § 425.400(c) for the performance year starting on January 1, 2021, and subsequent performance years.</P>
                    <P>
                        • 
                        <E T="03">Chronic Care Management (CPT code 99491):</E>
                         In the CY 2019 PFS final rule (83 FR 59577), we finalized CPT code 99491 (
                        <E T="03">Chronic care management services, provided personally by a physician or other qualified healthcare professional, at least 30 minutes of physician or other qualified health care professional time, per calendar month, with the following required elements: Multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient, chronic conditions place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; comprehensive care plan established, implemented, revised, or monitored).</E>
                         This code requires two or more chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline, and that a comprehensive care plan has been established, implemented, revised or monitored by the billing practitioner for such patient. In earlier rulemaking, we finalized the inclusion of CCM CPT codes 99487, 99489, and 99490 (codes for chronic care management) in the definition of primary care services for the Shared Savings Program. Refer to the June 2015 final rule (80 FR 32746 through 32748), and CY 2018 PFS final rule (82 FR 53212 through 53213). “Non-complex” CCM services (CPT codes 99490 and 99491), and “complex” CCM services (CPT codes 99487 and 99489) share a common set of service elements, including the following: (1) Initiating visit, (2) structured recording of patient information using certified electronic health record technology (EHR), (3) 24/7 access to physicians or other qualified health care professionals or clinical staff and continuity of care, (4) comprehensive care management including systematic assessment of the patient's medical, functional, and psychosocial needs, (5) comprehensive care plan including a comprehensive care plan for all health issues with particular focus on the chronic conditions being managed, and (6) management of care transitions. They differ in the amount of clinical staff service time provided, the involvement and work of the billing practitioner, and the extent of care planning performed.
                        <SU>42</SU>
                        <FTREF/>
                         CPT code 99491 includes only time that is spent personally by the billing practitioner. Clinical staff time is not counted towards the required time threshold for reporting this code, whereas CPT codes 99487, 99489, and 99490 include time spent directly by the billing practitioner and by other clinical staff that counts toward the threshold clinical staff time required to be spent during a given month. Accordingly, CPT code 99491 cannot be reported for a beneficiary by a billing practitioner in the same month as CCM codes 99487, 99489, or 99490. Therefore, we believe it would be appropriate to propose to include CCM CPT code 99491 in the definition of primary care services under § 425.400(c) for the performance year starting on January 1, 2021, and subsequent performance years, in order to capture these CCM services when attributing beneficiaries to an ACO.
                    </P>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Refer to CMS Medicare Learning Network, MLN Booklet “Chronic Care Management Services” (ICN MLN909188, July 2019); available at: 
                            <E T="03">https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ChronicCareManagement.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        • 
                        <E T="03">Non-Complex CCM (HCPCS code G2058 and its proposed replacement CPT code):</E>
                         In the CY 2020 PFS final rule (84 FR 62690), we finalized the creation of HCPCS code G2058 
                        <E T="03">(Chronic care management services, each additional 20 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (List separately in addition to code for primary procedure). (Do not report G2058 for care management services of less than 20 minutes additional to the first 20 minutes of chronic care management services during a calendar month). (Use G2058 in conjunction with 99490). (Do not report 99490, G2058 in the same calendar month as 99487, 99489, 99491))</E>
                         for additional time spent beyond the initial 20 minutes included in the current coding for CCM services. As described elsewhere in this proposed rule, we are proposing the adoption of the permanent CPT code to replace HCPCS code G2058. As described in previous rulemaking, practitioners who choose to use G2058 can report the initial 20 minutes of non-complex CCM under CPT code 99490 and receive increased payment for their work under HCPCS code G2058 (84 FR 62690). Since CPT code 99490 is currently included in the Shared Savings Program's definition of primary care services under § 425.400(c)(1)(iv), we are proposing to add G2058 to the definition, effective for performance years starting on or after January 1, 2021, because the services furnished during the additional time billed under HCPCS code G2058, would be expected to be substantially similar to the services furnished under CPT code 99490, and thus should also be 
                        <PRTPAGE P="50244"/>
                        considered for purposes of assignment under § 425.400 for the performance year starting on January 1, 2021, and subsequent performance years. If the proposal to adopt the permanent CPT code to replace HCPCS code G2058 is finalized, we would instead include that CPT code in the definition of primary care services used for purposes of assignment under § 425.400(c) for the performance year starting on January 1, 2021, and subsequent performance years.
                    </P>
                    <P>
                        • 
                        <E T="03">Principal Care Management (HCPCS codes G2064 and G2065):</E>
                         The CY 2020 PFS final rule (84 FR 62692 through 62697) introduced two new HCPCS codes (G2064 and G2065) for Principal Care Management (PCM) services. G2064 
                        <E T="03">(Comprehensive care management services for a single high-risk disease, e.g., principal care management, at least 30 minutes of physician or other qualified health care professional time per calendar month with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been the cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities),</E>
                         for use by physicians and non-physician practitioners (NPPs), and G2065 
                        <E T="03">(Comprehensive care management for a single high-risk disease services, e.g. principal care management, at least 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month with the following elements: One complex chronic condition lasting at least 3 months, which is the focus of the care plan, the condition is of sufficient severity to place patient at risk of hospitalization or have been cause of a recent hospitalization, the condition requires development or revision of disease-specific care plan, the condition requires frequent adjustments in the medication regimen, and/or the management of the condition is unusually complex due to comorbidities),</E>
                         for use by clinical staff.
                    </P>
                    <P>We expect that most services billed under these codes will be billed by specialists who are focused on managing patients with a single complex chronic condition requiring substantial care management. HCPCS code G2064 would be reported when, during the calendar month, at least 30 minutes of physician or other qualified health care professional time is spent on comprehensive care management for a single high-risk disease or complex chronic condition. HCPCS code G2065 would be reported when, during the calendar month, at least 30 minutes of clinical staff time is spent on comprehensive management for a single high-risk disease or complex chronic condition. Comprehensive care management codes require patients to have two or more chronic conditions and are primarily billed by practitioners who are managing a patient's total care over a month, including primary care practitioners and some specialists, such as cardiologists or nephrologists. By contrast, PCM services involve care management services for one serious chronic condition, typically expected to last between 3 months and a year, or until the death of the patient, that may have led to a recent hospitalization, and/or places the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. Specifically, we stated in the CY 2020 PFS final rule (84 FR 62693 through 62697) that we agree that the relativity between CCM CPT codes 99490 and 99491 should be preserved in PCM HCPCS codes G2064 and G2065 and crosswalked the relative value units for G2064 and G2065 to 99491 and 99490, respectively. Due to the similarity between the description of the PCM and CCM services, both of which involve non-face-to-face care management services, we finalized that the full CCM scope of service requirements apply to PCM, including documenting the patient's verbal consent in the medical record. CCM services billed under code 99490 are currently included in the Shared Savings Program's definition of primary care services under § 425.400(c)(1)(iv), and as discussed previously, we are proposing to include CCM services billed under code 99491 for performance years starting on or after January 1, 2021; therefore, for the foregoing reasons, we also propose to add G2064 and G2065 to the definition of primary care services for the performance year starting on January 1, 2021, and subsequent performance years.</P>
                    <P>
                        • 
                        <E T="03">Psychiatric collaborative care model HCPCS code GCOL1:</E>
                         In the CY 2017 PFS final rule (81 FR 80230-36), we established G-codes used to bill for monthly services furnished using the Psychiatric Collaborative Care Model (CoCM), an evidence-based approach to behavioral health integration that enhances “usual” primary care by adding care management support and regular psychiatric inter-specialty consultation. These G-codes were replaced by CPT codes 99484, 99492, 99493, and 99494, which we established for payment under the PFS in the CY 2018 PFS final rule (82 FR 53077 and 53078).
                    </P>
                    <P>
                        Elsewhere in this proposed rule, we are proposing to add a new HCPCS code GCOL1 
                        <E T="03">(Initial or subsequent psychiatric collaborative care management, first 30 minutes in a month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional)</E>
                         in response to stakeholders who have requested additional coding to capture shorter increments of time spent, for example, when a patient is seen for services, but is then hospitalized or referred for specialized care, and the number of minutes required to bill for services using the current coding is not met. Specifically, we are proposing to establish a G-code to describe 30 minutes of behavioral health care manager time. This code would describe one-half of the time described by the existing code that describes subsequent months of CoCM services, CPT code 99493 (
                        <E T="03">Subsequent psychiatric collaborative care management, first 60 minutes in a subsequent month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional, with the following required elements:</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Tracking patient follow-up and progress using the registry, with appropriate documentation; participation in weekly caseload consultation with the psychiatric consultant;</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Ongoing collaboration with and coordination of the patient's mental health care with the treating physician or other qualified health care professional and any other treating mental health providers;</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Additional review of progress and recommendations for changes in treatment, as indicated, including medications, based on recommendations provided by the psychiatric consultant;</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies;</E>
                    </P>
                    <P>
                        • 
                        <E T="03">Monitoring of patient outcomes using validated rating scales; and</E>
                    </P>
                    <P>
                        <E T="03">
                            • Relapse prevention planning with patients as they achieve remission of symptoms and/or other treatment goals 
                            <PRTPAGE P="50245"/>
                            and are prepared for discharge from active treatment
                        </E>
                        ).
                    </P>
                    <P>Because CPT code 99493 is currently included in the Shared Savings Program's definition of primary care services under § 425.400(c)(iv), we believe it is appropriate to add GCOL1 to the definition since the services furnished under this proposed new code would be expected to be substantially similar to the services furnished under CPT code 99493. Accordingly, contingent upon its finalization, we propose to add HCPCS code GCOL1 to the definition of primary care services for purposes of assignment under § 425.400 for the performance year starting on January 1, 2021, and subsequent performance years.</P>
                    <P>
                        In the May 8th COVID-19 IFC (85 FR 27583), we revised the definition of primary care services used in the Shared Savings Program assignment methodology for the performance year starting on January 1, 2020, and for any subsequent performance year that starts during the PHE for the COVID-19 pandemic, as defined in §  400.200, to include the following additions: (1) HCPCS code G2010 (
                        <E T="03">remote evaluation of patient video/images</E>
                        ); (2) HCPCS code G2012 (
                        <E T="03">virtual check-in</E>
                        ); and (3) CPT codes 99441, 99442, and 99443 (
                        <E T="03">telephone evaluation and management services</E>
                        ).
                    </P>
                    <P>
                        We considered adding HCPCS codes G2010 
                        <E T="03">(Remote evaluation of recorded video and/or images submitted by an established patient (e.g., store and forward), including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment)</E>
                         and G2012 
                        <E T="03">(Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report E/M services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion)</E>
                         to the definition of primary care services for purposes of assignment under § 425.400 for the performance year starting on January 1, 2021, and subsequent performance years; however, while we recognize the importance of the flexibility these HCPCS codes provide during the PHE, we do not believe they should be added to definition of primary care services for purposes of assignment under § 425.400 on a permanent basis. In the context of the PHE for the COVID-19 pandemic, when brief communications with practitioners and other non-face-to-face services could mitigate the need for an in-person visit that could represent an exposure risk for vulnerable patients, health care providers, and individuals in the community, we concluded that it was appropriate to include HCPCS codes G2010 and G2012 in the definition of primary care services used in assignment. However, outside the context of the PHE for the COVID-19 pandemic, we expect that these monitoring/check-in services for established patients will no longer replace primary care services because these separately billable brief communication-technology based services describe a check-in directly with the billing practitioner to assess whether an office visit is needed. When the PHE for the COVID-19 pandemic ends, these services would likely be replaced by an in-person primary care visit on which assignment would be based.
                    </P>
                    <P>We seek comment on this issue and on the alternative approach of permanently including HCPCS codes G2010 and G2012 in the definition of primary care services used in assignment. We will consider the comments received in developing our policies for the final rule.</P>
                    <P>
                        We note that we did not consider including CPT codes 99441, 99442, and 99443 in the definition of primary care services at § 425.400(c) on a permanent basis. Telephone evaluation and management services CPT codes 99441 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion.</E>
                        ); 99442 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion.</E>
                        ); and 99443 (
                        <E T="03">Telephone evaluation and management service by a physician or other qualified health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion.</E>
                        ) are non-covered services when not provided during the PHE for the COVID-19 pandemic, as defined in §  400.200, and so could not be included in the definition of primary care services for purposes of assignment outside the context of the PHE.
                    </P>
                    <P>
                        We also propose to modify the definition of primary care services for purposes of assignment in the Shared Savings Program regulations to exclude advance care planning CPT code 99497 and the add-on code 99498 when billed in an inpatient care setting, for use in determining beneficiary assignment for the performance year starting on January 1, 2021, and subsequent performance years. In the November 2018 final rule (83 FR 59964 through 59968), we finalized the inclusion of CPT code 99497 and the add-on code 99498 in the definition of primary care services. We did not propose any exceptions to place of service or provider type because there are no facility setting limitations or provider specialty limitations on these codes.
                        <SU>43</SU>
                        <FTREF/>
                         We have since received feedback from an ACO that, by not restricting place of service when using advance care planning codes in assignment, our methodology may inappropriately assign beneficiaries. Specifically, we are concerned that the inclusion of these CPT codes when the services are provided in an inpatient care setting may result in beneficiaries being assigned based on inpatient care rather than based on primary care by their regular health care providers. Based on an initial analysis using calendar year 2019 claims data, we observed the following frequencies for occurrence of place of service code 21, which identifies the place of service as an inpatient hospital, with CPT codes 99497 and 99498 in Part B claims: Over 13 percent of approximately 1.6 million Part B claims for CPT code 99497 had place of service code 21; over 48 percent of approximately 43,000 Part B claims for CPT code 99498 had place of service code 21. Operationally, we would exclude advanced care planning services claims billed under CPT codes 99497 and 99498 from use in the assignment methodology when there is 
                        <PRTPAGE P="50246"/>
                        an inpatient facility claim in our claims files with dates of service that overlap with the date of service for the professional service billed under CPT code 99497 or add-on code 99498. A similar operational approach is currently used to exclude certain codes for professional services furnished in a SNF pursuant to § 425.400(c)(1)(iv)(A)(
                        <E T="03">2</E>
                        ), as described elsewhere in this section of this proposed rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             Refer to CMS, Medicare Learning Network, “Advance Care Planning” (ICN MLN909289, August 2019); available at 
                            <E T="03">https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AdvanceCarePlanning.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We are also seeking comment on an alternative method for determining operationally whether advance care planning services are provided in an inpatient care setting. Specifically, we seek comment on whether to exclude advance care planning services identified by CPT code 99497 or add-on code 99498, or both, reported on claims with place of service code 21, which identifies the place of service as an inpatient hospital.
                        <SU>44</SU>
                        <FTREF/>
                         Based on initial analysis, we determined that this alternative approach would capture slightly fewer claims for advance care planning, compared to the proposed approach. We will consider any comments received on this alternative approach in developing our policies for the final rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             See for example, CMS.gov, Place of Service Code Set (updated October 2019); available at 
                            <E T="03">https://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.</E>
                        </P>
                    </FTNT>
                    <P>
                        We propose to specify a revised definition of primary care services in a new provision of the Shared Savings Program regulations at §  425.400(c)(1)(v) to include the list of HCPCS and CPT codes specified in §  425.400(c)(1)(iv) with the proposed additional CPT and HCPCS codes, and reflecting the proposal to exclude advance care planning codes when provided in an inpatient setting in the new provision at §  425.400(c)(1)(v)(A)(
                        <E T="03">12</E>
                        ). We also propose that the new provision in §  425.400(c)(1)(v) would reflect technical modifications to the previously finalized descriptions of the CPT and HCPCS codes for consistency and clarity, including grammatical updates and ordering the codes sequentially. We propose the new provision at §  425.400(c)(1)(v) would be applicable for use in determining beneficiary assignment for the performance year starting on January 1, 2021, and subsequent performance years. Further, we propose technical modifications to the introductory text in §  425.400(c)(1)(iv) to specify the applicability of this provision for determining beneficiary assignment for performance years (or a performance period) during 2019 and performance year 2020.
                    </P>
                    <P>We seek comment on these proposed changes to the definition of primary care services used for assigning beneficiaries to Shared Savings Program ACOs for the performance year starting on January 1, 2021, and subsequent performance years. We also welcome comments on any other existing HCPCS or CPT codes, and new HCPCS or CPT codes proposed elsewhere in this proposed rule, that we should consider adding to the definition of primary care services for purposes of assignment in future rulemaking.</P>
                    <P>We note that, under § 425.212, an ACO is subject to all regulatory changes that become effective during the agreement period, with the exception of the following program areas, unless otherwise required by statute: (1) Eligibility requirements concerning the structure and governance of ACOs; and (2) calculation of sharing rate. As we have explained in earlier rulemaking, consistent with our authority under section 1899(d)(1)(B)(ii) of the Act to adjust the benchmark for beneficiary characteristics and other factors as the Secretary determines appropriate, CMS adjusts an ACO's historical benchmark to account for any regulatory changes affecting assignment during the agreement period (80 FR 32730 through 32732). Accordingly, if we finalize any of the proposed changes to the definition of primary care services discussed in section III.G.2. of this proposed rule for purposes of beneficiary assignment applicable for the performance year starting on January 1, 2021, and subsequent performance years, we will adjust ACOs' historical benchmarks to account for these changes. Although it has been our historical practice to make these adjustments, the regulations establishing our benchmarking methodology do not explicitly describe these adjustments. We believe it is timely to propose conforming revisions to the regulations in §§ 425.601(a)(9), 425.602(a)(8), and 425.603(c)(8), to specify that CMS will adjust the ACO's historical benchmark to reflect any changes to the beneficiary assignment methodology specified in 42 CFR part 425, subpart E during an ACO's agreement period including revisions to the definition of primary care services in § 425.400(c). Further, in light of these proposed changes, we propose to make certain other technical changes to §§ 425.601, 425.602, and 425.603 for clarity and internal consistency.</P>
                    <HD SOURCE="HD3">b. Exclusion From Assignment of Certain Services Reported by FQHCs or RHCs When Furnished in Skilled Nursing Facilities (SNFs)</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>
                        As we described in section III.G.2.a.(1) of this proposed rule, under the Shared Savings Program, we define primary care services in §  425.400(c)(1) and §  425.400(c)(2) for purposes of assigning beneficiaries to ACOs under §  425.402 as the set of services identified by the specified HCPCS and CPT codes. In the November 2018 final rule (83 FR 59965 through 59968), we finalized a policy, specified in the regulation at § 425.400(c)(1)(iv)(A)(
                        <E T="03">2</E>
                        ) and effective for performance years starting on January 1, 2019, and subsequent performance years, to exclude services billed under CPT codes 99304 through 99318 when such services are furnished in a SNF. As described in the earlier rulemaking, CPT codes 99304 through 99318 are used for reporting E/M services furnished by physicians and other practitioners in a SNF or NF (83 FR 59964).
                    </P>
                    <P>In the November 2018 final rule, we explained our operational approach to excluding CPT codes 99304 through 99318 from use in the assignment methodology when such services are furnished in a SNF. We explained that we would exclude professional services claims billed under CPT codes 99304 through 99318 from use in the assignment methodology when there is a SNF facility claim in our claims files with dates of service that overlap with the date of service for the professional service (83 FR 59967). This exclusion methodology replaced the prior approach, established through earlier rulemaking (80 FR 71271 and 71272), which excluded from the definition of primary care services claims billed under CPT codes 99304 through 99318 when the claim included the place of service code 31 modifier, specifying that the service was furnished in a SNF.</P>
                    <P>
                        In earlier rulemaking (see for example, 83 FR 59964 and 59965), we have explained our belief that excluding from assignment certain services rendered to beneficiaries during a SNF stay is appropriate because it helps to ensure that beneficiaries who receive care in a SNF are assigned to ACOs based on care received from primary care professionals in the community (including nursing facilities), who are typically responsible for providing care to meet the primary care needs of these beneficiaries. We previously explained that SNF patients are shorter stay patients who are generally receiving continued acute medical care and 
                        <PRTPAGE P="50247"/>
                        rehabilitative services. Although their care may be coordinated during their time in the SNF, they are then transitioned back into the community to the primary care professionals who are typically responsible for providing care to meet their primary care needs.
                    </P>
                    <P>Section 1899(c)(1) of the Act, as amended by the 21st Century Cures Act and the Bipartisan Budget Act of 2018, requires the Secretary to assign beneficiaries to ACOs participating in the Shared Savings Program based not only on their utilization of primary care services furnished by ACO professionals who are physicians but also on their utilization of services furnished by FQHCs and RHCs, effective for performance years beginning on or after January 1, 2019. The statute provides the Secretary with broad discretion to determine how to incorporate services provided by FQHCs and RHCs into the Shared Savings Program beneficiary assignment methodology.</P>
                    <P>In earlier rulemaking, we established and modified special assignment conditions for FQHCs and RHCs (see for example, 82 FR 53210 through 53212). According to § 425.404(b), for performance years starting on January 1, 2019, and subsequent performance years, under the assignment methodology in § 425.402, CMS treats a service reported on an FQHC or RHC claim as a primary care service performed by a primary care physician. Therefore, according to the Shared Savings Program's step-wise claims-based assignment methodology, as specified in § 425.402(b), all services furnished by an FQHC or RHC to a beneficiary eligible for assignment to an ACO are considered in the first step of the assignment methodology. As specified in § 425.402(b)(3), under this first step, a beneficiary eligible for assignment is assigned to an ACO if the allowed charges for primary care services furnished to the beneficiary by primary care physicians who are ACO professionals and non-physician ACO professionals in the ACO are greater than the allowed charges for primary care services furnished by primary care physicians, nurse practitioners, physician assistants, and clinical nurse specialists who are ACO professionals in any other ACO, or not affiliated with any ACO and identified by a Medicare-enrolled billing TIN.</P>
                    <P>Currently, the exclusion from beneficiary assignment of professional services claims with CPT codes 99304 through 99318, when there is an overlapping SNF stay, does not apply to services billed through FQHCs/RHCs. Because FQHC/RHC claims are submitted to CMS using institutional claim forms, we currently do not exclude these FQHC/RHC claims from assignment when a service billed under CPT codes 99304 through 99318 is provided concurrently with a SNF stay, as when claims for services billed under these codes are submitted by physicians and other practitioners. Rather, consistent with the requirement in § 425.404(b), we consider all FQHC/RHC claims for purposes of beneficiary assignment.</P>
                    <HD SOURCE="HD3">(2) Proposal</HD>
                    <P>An ACO has raised concerns that our methodology for excluding primary care services billed under CPT codes 99304 through 99318 from use in beneficiary assignment when provided during a beneficiary's stay in a SNF does not apply to these services when billed by FQHCs. The ACO described a circumstance where ACO professionals, billing through ACO participant FQHCs, submitted claims using CPT codes 99304 through 99318 for services provided to patients in SNFs. Specifically, the ACO participant FQHCs' physicians provided services billed under these codes to beneficiaries in community SNFs. Following discharge from the SNF, these beneficiaries returned to receiving care from their regular primary care physicians (outside the ACO). However, because the SNF exclusion for services billed under CPT codes 99304 through 99318 does not apply to services furnished by FQHCs/RHCs, these beneficiaries were assigned to the ACO in which the FQHC was an ACO participant based on the services rendered in the SNF. We believe this result is contrary to the original intention of our policy of excluding claims billed under CPT codes 99304 through 99318 for professional services furnished during a SNF stay from consideration in the assignment methodology, as described in the background for this section.</P>
                    <P>Section 1899(c)(1) of the Act provides discretion for the Secretary to determine the appropriate method to utilize services provided by FQHCs and RHCs in conducting assignment for performance years beginning on or after January 1, 2019. We believe it is important to exclude claims for FQHC and RHC services that include CPT codes 99304 through 99318 from use in assignment when there is a SNF facility claim in our claims files with a date of service that overlaps with the date of FQHC or RHC services. Consistent with the previously established exclusion for claims billed under these codes when the services are provided to beneficiaries with an overlapping SNF stay, we believe it is important to exclude the same services from use in assignment when they are furnished by physicians and NPPs billing through an FQHC or RHC to beneficiaries in a SNF. This approach would better recognize that beneficiaries who receive care from physicians and NPPs billing through an FQHC or RHC during a SNF stay are expected to return to receiving primary care from the health care professionals typically responsible for meeting their primary care needs when they transition back into the community.</P>
                    <P>Therefore, we propose to revise the existing exclusion for professional services billed under CPT codes 99304 through 99318 that are furnished in a SNF to include services reported on an FQHC or RHC claim that includes CPT codes 99304 through 99318, when those services are furnished in a SNF. Operationally, the exclusion would occur when the following conditions are met:</P>
                    <P>(1) Either a professional service is billed under CPT codes 99304 through 99318, or an FQHC/RHC submits a claim including a qualifier CPT code 99304 through 99318; and</P>
                    <P>(2) A SNF facility claim is in our claims files with dates of service that overlap with the date of service for the professional service or FQHC/RHC service.</P>
                    <P>
                        As discussed in section III.G.2.a.(2) of this proposed rule, we are proposing to incorporate the revised definition of primary care services in a new provision of the Shared Savings Program regulations at §  425.400(c)(1)(v), applicable for use in determining beneficiary assignment for the performance year starting on January 1, 2021, and subsequent performance years. As part of this revised definition, we propose to incorporate the proposed revisions to the exclusion for CPT codes 99304 through 99318 when services are furnished in a SNF at §  425.400(c)(1)(v)(A)(
                        <E T="03">3</E>
                        ) to extend the exclusion to services identified by these codes reported on an FQHC or RHC claim when furnished in a SNF. This revision would also be applicable to determining assignment for the performance year starting on January 1, 2021, and subsequent performance years.
                    </P>
                    <P>
                        As we explained in section III.G.2.a.(2) of this proposed rule, we adjust the ACO's historical benchmark for changes in the program's assignment methodology occurring during the ACO's agreement period. If we finalize the proposed exclusion from beneficiary assignment of services reported by FQHCs or RHCs on claims that include CPT codes 99304 through 99318, when 
                        <PRTPAGE P="50248"/>
                        furnished in a SNF, we will adjust ACOs' historical benchmarks to account for these changes.
                    </P>
                    <P>Further, we believe the existing process is appropriately excluding from assignment professional services billed under CPT codes 99304 through 99318 when these services are provided to beneficiaries receiving SNF services in swing beds in Critical Access Hospitals (CAHs) or Electing Teaching Amendment (ETA) hospitals. Based on our operational experience:</P>
                    <P>• We exclude professional services billed under CPT codes 99304 through 99318 when such services are furnished for care of a beneficiary in a CAH swing bed; however, relatively few claims are identified for exclusion on this basis.</P>
                    <P>• We do not believe that ETA hospitals are billing for services furnished to beneficiaries in a SNF or swing bed setting by physicians and other practitioners that have reassigned their billing rights to ETA hospitals.</P>
                    <P>However, we solicit comment on whether additional exceptions are needed to ensure that all claims for services that include CPT codes 99304 through 99318 are excluded from assignment when those services are furnished to a beneficiary receiving SNF care, including when these professional services are billed by a Method II CAH or ETA hospital.</P>
                    <HD SOURCE="HD3">3. Reducing the Amount of Repayment Mechanisms for Eligible ACOs</HD>
                    <HD SOURCE="HD3">a. Background</HD>
                    <P>
                        An ACO that will participate in a two-sided model must demonstrate that it has established an adequate repayment mechanism to provide CMS assurance of its ability to repay shared losses for which the ACO may be liable upon reconciliation for each performance year. The requirements for an ACO to establish and maintain an adequate repayment mechanism are described in § 425.204(f), and we have provided additional program guidance on repayment mechanism arrangements.
                        <SU>45</SU>
                        <FTREF/>
                         We established the repayment mechanism requirements through earlier rulemaking,
                        <SU>46</SU>
                        <FTREF/>
                         and most recently modified the repayment mechanism requirements in the December 2018 final rule (83 FR 67928 through 67938).
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             Medicare Shared Savings Program, Repayment Mechanism Arrangements, Guidance Document, available at 
                            <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Repayment-Mechanism-Guidance.pdf</E>
                             (herein Repayment Mechanism Arrangements Guidance).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             See 76 FR 67937 through 67940 (establishing the requirement for Track 2 ACOs). See 80 FR 32781 through 32785 (adopting the same general requirements for Track 3 ACOs with respect to the repayment mechanism and discussing modifications to reduce burden of the repayment requirements on ACOs).
                        </P>
                    </FTNT>
                    <P>According to § 425.204(f)(4)(iv), in the case of an ACO that has submitted a request to renew its participation agreement and wishes to use its existing repayment mechanism to establish its ability to repay any shared losses incurred for performance years in the new agreement period, the amount of the repayment mechanism must be equal to the greater of the following: (1) The amount calculated by CMS in accordance with § 425.204(f)(4)(ii) at the time of renewal application; or (2) the repayment mechanism amount that the ACO was required to maintain during the last performance year of the participation agreement it seeks to renew. This approach ensures that a renewing ACO would remain capable of repaying losses incurred under its old agreement period (83 FR 67931). Based on our operational experience with implementing these policies, of 55 renewing two-sided model ACOs for a July 1, 2019, or January 1, 2020 start date, 43 ACOs (or 78.2 percent) elected to continue use of their existing repayment mechanism, and 22 (or 51.2 percent) of these ACOs had a higher existing repayment mechanism amount compared to the amount calculated for the new agreement period (determined at the time of renewal application).</P>
                    <P>Alternatively, to meet the requirements of § 425.204(f), a renewing ACO could establish a new repayment mechanism arrangement to support its participation in its new agreement period, in addition to maintaining its existing repayment mechanism. This option allows an ACO to establish a repayment mechanism to support its new agreement period at a potentially different amount (determined according to § 425.204(f)(4)(ii)) than the amount of the existing arrangement. However, under this approach there is a period of time during which the ACO must maintain multiple repayment mechanisms. The ACO must maintain the repayment mechanism established to support the ACO's previous agreement period until the term of the repayment mechanism arrangement expires, or conditions arise to allow for termination of the repayment mechanism according to § 425.204(f)(6)(iv) (see 83 FR 67933 through 67936). Once the repayment mechanism for the previous agreement period is closed, the ACO would only be required to maintain the repayment mechanism arrangement applicable to its current agreement period. An ACO could use this option to establish a repayment mechanism at a relatively lower amount (if applicable) for its current agreement period, while maintaining and eventually closing-out a repayment mechanism at a relatively higher amount needed for its previous agreement period.</P>
                    <P>As specified under § 425.204(f)(4)(iii), for agreement periods beginning on or after July 1, 2019, CMS recalculates the ACO's repayment mechanism amount before the second and each subsequent performance year in the agreement period based on the certified ACO participant list for the relevant performance year. We require an increase in the repayment mechanism amount if the recalculated repayment mechanism amount exceeds the existing repayment mechanism amount by at least 50 percent or $1,000,000, whichever is the lesser value. Under § 425.204(f)(4)(iii), an ACO cannot decrease the amount of its repayment mechanism during its agreement period as a result of changes in its composition.</P>
                    <P>In implementing the revised repayment mechanism rules, we have discovered some unintended consequences. Specifically, under § 425.204(f)(4), a renewing ACO that chooses to retain its higher repayment mechanism for a new agreement period might never be able to reduce its repayment mechanism even after the ACO has paid any shared losses incurred for performance years in the previous agreement period. Moreover, the ACO would have to maintain the higher repayment mechanism amount in future agreement periods unless the ACO opts to establish a new repayment mechanism. We did not intend this result.</P>
                    <P>More generally, based on our operational experience, many ACOs fully repay shared losses without use of their repayment mechanism arrangement. For example, of the eleven ACOs that owed shared losses for performance year 2018, CMS used the repayment mechanism for one ACO to support recoupment. Considering this experience, which suggests there may be low risk to the Shared Savings Program by allowing lower repayment mechanism amounts, and the potential reduction in burden on ACOs by lower repayment mechanism amounts, we believe it is appropriate to revisit the policies requiring renewing ACOs to retain higher repayment amounts when these amounts may no longer be needed to support their continued participation.</P>
                    <HD SOURCE="HD3">b. Proposed Revisions</HD>
                    <P>
                        We propose to establish two policies that would allow certain ACOs to benefit from a lower repayment mechanism amount than would otherwise be required under the current 
                        <PRTPAGE P="50249"/>
                        regulations. The first policy would apply prospectively to any renewing ACO that uses an existing repayment mechanism to establish its ability to repay any shared losses incurred for performance years in its new agreement period. The second policy would permit certain ACOs whose agreement periods began July 1, 2019 or January 1, 2020 to elect to reduce the amount of their repayment mechanisms.
                    </P>
                    <P>For a renewing ACO that wishes to use its existing repayment mechanism to establish its ability to repay any shared losses incurred for performance years in the new agreement period, we propose to discontinue the policy specified under § 425.204(f)(4)(iv), which requires such an ACO to maintain its existing repayment mechanism amount if it is higher than the repayment mechanism amount calculated for the new agreement period in accordance with § 425.204(f)(4)(ii). We propose to revise the regulations to specify that we will determine the repayment mechanism amount for an ACO applying to renew its participation for an agreement period only according to the methodology currently specified in § 425.204(f)(4)(ii). Under this proposed approach, a renewing ACO that wishes to use its existing repayment mechanism to establish its ability to repay any shared losses incurred for performance years in the new agreement period would be required to have a repayment mechanism amount equal to the lesser of the following: (1) 1 percent of the total per capita Medicare Parts A and B FFS expenditures for the ACO's assigned beneficiaries, based on expenditures for the most recent calendar year for which 12 months of data are available; or (2) 2 percent of the total Medicare Parts A and B FFS revenue of its ACO participants, based on revenue for the most recent calendar year for which 12 months of data are available.</P>
                    <P>As specified in the May 8th COVID-19 IFC (85 FR 27574 and 27575), we are forgoing the application cycle for the January 1, 2021 start date. Therefore, if finalized, this proposed policy for determining the repayment mechanism amount for renewing ACOs would apply with the application cycle for an agreement period starting on January 1, 2022, and in subsequent years.</P>
                    <P>A renewing ACO could still choose to establish a new repayment mechanism arrangement for the amount calculated at the time of the renewal application to support its participation in its new agreement period and maintain its existing repayment mechanism at the previously required amount. Once the conditions arise for termination of the repayment mechanism arrangement supporting the ACO's previous agreement period, according to § 425.204(f)(6)(iv), only the arrangement supporting the ACO's current agreement period would remain.</P>
                    <P>We believe this proposed approach would reduce burden by allowing renewing ACOs that wish to continue use of their existing repayment mechanism to decrease their repayment mechanism amount if a higher amount is not needed to support their new agreement period. This proposal would prevent a higher repayment mechanism amount from following the ACO from one agreement period to the next, as is the case with the current approach. Further, an ACO would no longer need to establish another repayment mechanism for the ACO's new agreement period to ultimately get relief from the higher amount of its existing repayment mechanism arrangement, which the ACO would need to maintain until the conditions arise allowing for termination.</P>
                    <P>We recognize this proposal would reduce the amount available to support repayment of shared losses. The typical timing of issuance to ACOs of financial reconciliation, which includes performance results and written notification from CMS of the amount of shared losses owed (if any), is in the summer following the conclusion of the performance year. Renewing ACOs permitted to reduce the amount of their existing repayment mechanism may be notified of shared losses owed for their most recent prior performance year during the application review period and would be in the process of paying shared losses within 90 days of written notification from CMS of the amount owed (according to §§ 425.605(e)(3), 425.606(h)(3), 425.610(h)(3)). Further, at the time of renewal application, the ACO would be completing the last performance year of its existing agreement period, and financial reconciliation results for this performance year would likely be available during the summer of the ACO's first performance year of its new agreement period.</P>
                    <P>However, we believe this risk to CMS noted above is mitigated for a number of reasons. The Shared Savings Program's existing policies require ACOs to pay shared losses, in full, within 90 days of written notification from CMS of the amount owed (according to §§ 425.605(e)(3), 425.606(h)(3), 425.610(h)(3)). ACOs have an interest in fully paying the amount of shared losses owed within the 90-day payment window to remain in compliance with the Shared Savings Program's requirements and avoid compliance actions including involuntary termination from the program. CMS may terminate an ACO's participation agreement for reasons including, but not limited to, non-compliance with requirements in 42 CFR part 425 (§ 425.218(b)(1)), such as failure to repay shared losses owed according to the program's regulations and may take pre-termination actions as described in § 425.216. Under § 425.221(b)(2)(ii)(B), an ACO under a two-sided model whose participation agreement is terminated by CMS under § 425.218 is liable for a pro-rated share of any shared losses determined for the performance year during which the termination becomes effective. ACOs must also repay shared losses owed to avoid accruing interest on any amount that remains unpaid after the 90-day payment window, and referral of an unpaid debt to the Department of Treasury for collection. Based on our operational experience, nearly all ACOs fully repay shared losses without use of their repayment mechanism arrangement.</P>
                    <P>Nevertheless, we are considering finalizing a policy that would require a renewing ACO to maintain its existing, higher repayment mechanism amount until the ACO has fully repaid the amount of shared losses determined to be owed for the most recent performance year for which financial reconciliation results are available. Under this approach, for instance, § 425.204(f)(4)(iv) would remain unchanged, and we would amend § 425.204(f)(4)(iii) to add a provision permitting a renewing ACO to reduce the amount of its repayment mechanism if, upon renewal of its participation agreement, it chose to use its existing repayment mechanism to demonstrate its ability to pay shared losses in the new agreement period, and was required under § 425.204(f)(4)(iv) to maintain its existing repayment mechanism at the amount applicable to the last performance year of the previous agreement period instead of the lower amount calculated for the new agreement period.</P>
                    <P>
                        The Shared Savings Program regulations do not address the opportunity for a re-entering ACO, defined according to § 425.20, to use a repayment mechanism arrangement established to support its participation in an earlier agreement period to also support its participation in a new agreement period. We are considering finalizing provisions in the Shared Savings Program regulations specifying the conditions under which a re-entering ACO may use an existing 
                        <PRTPAGE P="50250"/>
                        repayment mechanism arrangement to support its participation in a subsequent agreement period in the Shared Savings Program. Specifically, we are considering specifying a re-entering ACO identified as the same legal entity as an ACO that previously participated in the program may use its existing repayment mechanism to support its participation in a new agreement period in the Shared Savings Program. Since an individual ACO, identified as a legal entity, enters into a repayment mechanism arrangement with a financial institution, we do not believe this option for continued use of an existing repayment mechanism would be feasible for (and therefore would not be applicable to) a new legal entity identified as a re-entering ACO because more than 50 percent of its ACO participants were included on the ACO participant list under § 425.118, of the same ACO in any of the 5 most recent performance years prior to the agreement start date. Further, we are considering specifying the same requirements would apply to both a renewing ACO, and a re-entering ACO identified as the same legal entity that previously participated in the Shared Savings Program (either an ACO whose participation agreement expired without having been renewed, or an ACO whose participation agreement was terminated under § 425.218 or § 425.220), for permitting use of an existing repayment mechanism arrangement to support the ACO's participation in a new agreement period in the Shared Savings Program.
                    </P>
                    <P>We also propose to establish a policy that allows certain ACOs a one-time opportunity to decrease the amount of their repayment mechanisms. Under this proposal, an ACO that renewed its agreement period beginning on July 1, 2019, or January 1, 2020, may elect to decrease the amount of its repayment mechanism if (1) upon renewal, it elected to use an existing repayment mechanism to establish its ability to repay any shared losses incurred in its new agreement period and the amount of that repayment mechanism was greater than the repayment mechanism amount estimated for the ACO's new agreement period; and (2) the recalculated repayment mechanism amount for performance year 2021 is less than the existing repayment mechanism amount. We note that this proposal would not need to be finalized if we finalize our alternate proposal to modify § 425.204(f)(4)(iii) as described above. The purpose of this new opportunity is to let any ACO that renewed for an agreement period beginning on July 1, 2019, or beginning on January 1, 2020, decrease its repayment mechanism amount before it seeks to renew its agreement under the new proposed policy, which if finalized, would be the first opportunity for the ACO to reduce its repayment mechanism amount.</P>
                    <P>To determine if an ACO that renewed for an agreement period beginning on July 1, 2019, or beginning on January 1, 2020, is eligible for the one-time opportunity to lower its repayment mechanism amount we propose to compare the recalculated amount of the ACO's repayment mechanism based on its certified ACO participant list for performance year 2021, calculated according to § 425.204(f)(4)(iii), to the ACO's existing repayment mechanism amount. If the recalculated repayment mechanism amount for performance year 2021 is less than the existing repayment mechanism amount, the ACO would be eligible to decrease the amount of its repayment mechanism to the recalculated amount. Under this approach, we would permit a decrease in the repayment mechanism amount even for relatively small differences in dollar amounts. An ACO may wish to maintain the existing amount of its repayment mechanism arrangement, particularly if the cost to the ACO of amending the arrangement outweighs the potential benefit of a nominal decrease in the amount of the repayment mechanism.</P>
                    <P>We propose that CMS would notify the ACO in writing that the ACO may elect to decrease the amount of its repayment mechanism. If our proposal is finalized, to allow a one-time opportunity for a repayment mechanism decrease by eligible ACOs that renewed for an agreement period beginning on July 1, 2019, or beginning on January 1, 2020, we anticipate we would notify an ACO of its opportunity to reduce its repayment mechanism amount after the start of performance year 2021. We also propose that an ACO must submit such election, together with revised repayment mechanism documentation, in a form and manner and by a deadline specified by CMS. CMS would review the revised repayment mechanism documentation and may reject the election if the repayment mechanism documentation does not comply with the requirements of § 425.204(f).</P>
                    <P>Regarding the timeframe for an ACO to elect to decrease the amount of its repayment mechanism, we may require (for example) that an ACO submit its election, together with revised repayment mechanism documentation, within 30 days from the date of the written notice from CMS, particularly if prompt election is needed to ensure compliance with other program requirements. For instance, CMS may notify the ACO of its opportunity to decrease the amount of its repayment mechanism after using the ACO's existing repayment mechanism to support repayment of shared losses. In this case, prompt notification by the ACO of its election to decrease the amount of its repayment mechanism may be necessary if the ACO seeks to replenish the amount of its repayment mechanism to the permitted lower amount within the 90-day replenishment period according to § 425.204(f)(5), as discussed elsewhere in this section of this proposed rule. However, we recognize that there may be circumstances that necessitate a longer timeframe.</P>
                    <P>We propose to amend § 425.204(f)(4)(iv) to specify in paragraph (f)(4)(iv)(A) the proposed, revised methodology for determining the repayment mechanism amount for renewing ACOs that seek to use their existing repayment mechanism to support their continued participation in their new agreement period. We propose to add provisions in § 425.204(f)(4)(iv)(B) establishing policies that would allow eligible ACOs with July 1, 2019, or January 1, 2020 start dates to elect to lower the amount of their repayment mechanism arrangements.</P>
                    <P>
                        We propose to amend § 425.204(f)(5), requiring an ACO to replenish the amount of funds available through the repayment mechanism within 90 days of use of the arrangement to repay any portion of shared losses, to specify that the resulting amount available through the repayment mechanism must be at least the amount specified by CMS in accordance with § 425.204(f)(4). For example, these revisions would allow an eligible ACO, that renewed its agreement period beginning on July 1, 2019, or January 1, 2020, to replenish the repayment mechanism to the lower amount determined by CMS, according to the proposed approach described in this section of this proposed rule. This proposed revision may also be relevant to a renewing ACO that is seeking to use its existing repayment mechanism to support its participation in its new agreement period. Specifically, if the renewing ACO's existing repayment mechanism is used to support payment of shared losses, based on financial reconciliation results available at the time of renewal application, CMS may permit the renewing ACO to replenish the amount of its existing repayment mechanism to the lower amount determined to be applicable for the ACO's new agreement period.
                        <PRTPAGE P="50251"/>
                    </P>
                    <P>We also propose technical changes to § 425.204(f)(3)(iv) for clarity. This provision specifies that an ACO that has submitted a request to renew its participation agreement must submit as part of the renewal request documentation demonstrating the adequacy of the repayment mechanism that could be used to repay any shared losses incurred for performance years in the next agreement period, and describes the conditions under which an ACO may use its current repayment mechanism to apply to the new agreement period. For clarity, we propose to specify under this provision that the duration of the existing repayment mechanism must be revised to comply with § 425.204(f)(6)(ii), and the amount of the repayment mechanism must comply with § 425.204(f)(4).</P>
                    <P>Further, we propose that an ACO must demonstrate the adequacy of its repayment mechanism prior to any change in the terms and type of the repayment mechanism. Based on our operational experience, ACOs periodically request to close-out their existing repayment mechanisms and establish new repayment mechanisms to support their continued participation under a two-sided model. We have typically permitted these requests, under the following circumstances: We first ensure the ACO's new repayment mechanism meets the program's requirements and is fully executed; and then we permit cancellation of the repayment mechanism arrangement(s) being replaced. Further, when reviewing requested modifications to repayment mechanism documentation it is our practice to ensure that all the terms of the repayment mechanism are compliant with the program's policies. Therefore, we propose to revise the regulations in § 425.204(f)(3)(i) through (iii) to further specify that an ACO must demonstrate the adequacy of its repayment mechanism prior to any change in the terms and type of the repayment mechanism.</P>
                    <HD SOURCE="HD3">4. Applicability of Policies to Track 1+ Model ACOs</HD>
                    <P>The Track 1+ Model was established under the Innovation Center's authority at section 1115A of the Act, to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care for Medicare, Medicaid, and Children's Health Insurance Program beneficiaries. The Track 1+ Model, which is a time-limited model that began on January 1, 2018, is based on Shared Savings Program Track 1, but tests a payment design that incorporates more limited downside risk, as compared to Track 2 and the ENHANCED track. We discontinued all future application cycles for the Track 1+ Model, as explained in earlier rulemaking (83 FR 68032 and 68033). As of January 1, 2020, there were 20 Track 1+ Model ACOs participating in performance year 3 of a 3-year agreement under the model. In the May 8th COVID-19 IFC (85 FR 27574 and 27575), we explained that we are forgoing the application cycle for a January 1, 2021 start date. To avoid a gap in participation for ACOs whose agreement period would otherwise end on December 31, 2020, we revised § 425.200(b)(3)(ii) to allow these ACOs to elect to extend their agreement period for an optional fourth performance year. Therefore, Track 1+ Model ACOs, among other ACOs whose agreement periods expire December 31, 2020, are eligible to voluntarily elect a 1-year extension of their agreement period for a fourth performance year from January 1, 2021, to December 31, 2021.</P>
                    <P>
                        ACOs approved to participate in the Track 1+ Model are required to agree to the terms and conditions of the model by executing a Track 1+ Model Participation Agreement. See 
                        <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/track-1plus-model-par-agreement.pdf.</E>
                         Track 1+ Model ACOs are also required to have been approved to participate in the Shared Savings Program (Track 1) and to have executed a Shared Savings Program Participation Agreement. As indicated in the Track 1+ Model Participation Agreement, in accordance with our authority under section 1115A(d)(1) of the Act, we have waived certain requirements of the Shared Savings Program that otherwise would be applicable to ACOs participating in Track 1 of the Shared Savings Program, as necessary for purposes of testing the Track 1+ Model, and established alternative requirements for the ACOs participating in the Track 1+ Model. Unless stated otherwise in the Track 1+ Model Participation Agreement, the requirements of the Shared Savings Program under 42 CFR part 425 continue to apply. Consistent with § 425.212, Track 1+ Model ACOs generally are subject to all applicable regulatory changes, including but not limited to changes to the regulatory provisions referenced within the Track 1+ Model Participation Agreement that become effective during the term of the ACO's Shared Savings Program Participation Agreement and Track 1+ Model Participation Agreement, unless otherwise specified through rulemaking or amendment to the Track 1+ Model Participation Agreement. We note that the terms of the Track 1+ Model Participation Agreement also permit the parties (CMS and the ACO) to amend the agreement at any time by mutual written agreement.
                    </P>
                    <P>Therefore, unless specified otherwise, the proposed changes to the Shared Savings Program regulations in this proposed rule that are applicable to Shared Savings Program ACOs within a current agreement period would apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 1, so long as the applicable regulation has not been waived under the Track 1+ Model. Similarly, to the extent that certain requirements of the regulations that apply to ACOs under Track 2 or the ENHANCED track have been incorporated for ACOs in the Track 1+ Model under the terms of the Track 1+ Model Participation Agreement, any proposed changes to those regulations discussed in this proposed rule would also apply to ACOs in the Track 1+ Model in the same way that they apply to ACOs in Track 2 or the ENHANCED track. For example, the following proposed policies would apply to Track 1+ Model ACOs, if finalized:</P>
                    <P>• The application of the APP framework to determine the quality performance of Shared Savings Program ACOs (section III.G.1.c. of this proposed rule).</P>
                    <P>• The revisions to the Shared Savings Program quality performance standard. Specifically, under the proposed approach, the quality performance standard for Track 1+ Model ACOs would be set at a quality score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores (section III.G.1.c. of this proposed rule).</P>
                    <P>• The modifications to the regulations under § 425.604(c) specifying the circumstances under which a Track 1 ACO will qualify to receive a shared savings payment (section III.G.1.d. of this proposed rule).</P>
                    <P>• The modifications to the regulations under § 425.604(d) governing the determination of the final sharing rate for Track 1 ACOs (section III.G.1.d. of this proposed rule).</P>
                    <P>
                        • The modifications to § 425.316 to allow CMS to identify ACOs that are not meeting the proposed, revised quality performance standard, and to require these ACOs to take actions to address their poor quality performance or face termination of their Shared Savings Program participation agreement (section III.G.1.e. of this proposed rule).
                        <PRTPAGE P="50252"/>
                    </P>
                    <P>• The modifications to the policies governing the audit and validation of data used to determine the ACO's quality performance. Specifically, under the proposed new provision of the regulations at § 425.510(c), CMS would retain the right to audit and validate the quality data reported by an ACO according to § 414.1390 (section III.G.1.f. of this proposed rule).</P>
                    <P>• The proposed new provision of the regulations at § 425.512(b) to address the effect of extreme and uncontrollable circumstances on ACOs' quality performance (section III.G.1.g. of this proposed rule).</P>
                    <P>• The revisions to the definition of primary care services used in beneficiary assignment. If finalized, the revised definition would be applicable to Track 1+ Model ACOs for the performance year starting on January 1, 2021, and we would adjust the Track 1+ ACO's historical benchmark to reflect these policies (section III.G.2 of this proposed rule).</P>
                    <P>• The proposed changes to the CAHPS for ACOs reporting requirements for performance year 2020 (section III.I.1 of this proposed rule).</P>
                    <HD SOURCE="HD2">H. Notification of Infusion Therapy Options Available Prior to Furnishing Home Infusion Therapy Services</HD>
                    <P>Section 5012 of the 21st Century Cures Act (Cures Act) (Pub. L. 114-255; enacted December 13, 2016) created a separate Medicare Part B benefit under section 1861(s)(2)(GG) and section 1861(iii) of the Act to cover home infusion therapy-associated professional services for certain drugs and biologicals administered intravenously or subcutaneously through a pump that is an item of durable medical equipment, effective for January 1, 2021. Section 5012 of the Cures Act also added section 1834(u) to the Act, which establishes the payment and related requirements for home infusion therapy under this benefit. Section 1834(u)(6) of the Act requires that, prior to the furnishing of home infusion therapy to an individual, the physician who establishes the plan of care described in section 1861(iii)(1) of the Act shall provide notification (in a form, manner, and frequency determined appropriate by the Secretary) of the options available (such as home, physician's office, hospital outpatient department) for the furnishing of infusion therapy under this part.</P>
                    <P>We recognize there are several possible forms, manners, and frequencies that physicians may use to notify patients of their infusion therapy treatment options. We solicited comments in the CY 2020 PFS proposed rule (84 FR 40716) and the CY 2020 HH PPS proposed rule (84 FR 34694), regarding the appropriate form, manner, and frequency that any physician must use to provide notification of the treatment options available to their patient for the furnishing of infusion therapy (home or otherwise) under Medicare Part B. We also invited comments on any additional interpretations of this notification requirement. We summarized the comments received in the CY 2020 PFS final rule (84 FR 62568) and the CY 2020 HH PPS final rule (84 FR 60478), and we stated we would take these comments into consideration as we continue developing future policy through notice-and-comment rulemaking.</P>
                    <P>Many commenters stated that physicians already routinely discuss the infusion therapy options with their patients and annotate these discussions in their patients' medical records. For home infusion therapy services effective beginning CY 2021, physicians are to continue with the current practice of discussing options available for furnishing infusion therapy under Part B and annotating these discussions in their patients' medical records prior to establishing a home infusion therapy plan of care. We are not proposing to create a mandatory form nor are we otherwise proposing to require a specific manner or frequency of notification of options available for infusion therapy under Part B prior to establishing a home infusion therapy plan of care, as we believe that current practice provides appropriate notification. However, if current practice is later found to be insufficient in providing appropriate notification to patients of the available infusion options under Part B, we may consider additional requirements regarding this notification in future rulemaking. We are referring stakeholders to the CY 2020 HH PPS final rule (84 FR 60478) for further information regarding the policies on home infusion therapy services beginning CY 2021 and for subsequent years.</P>
                    <HD SOURCE="HD2">I. Modifications to Quality Reporting Requirements and Comment Solicitation on Modifications to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2020</HD>
                    <P>
                        Following the hurricanes and wildfires during 2017, we issued an IFC, entitled “Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017,” which appeared in the December 26, 2017 
                        <E T="04">Federal Register</E>
                         (82 FR 60912) (hereinafter referred to as the “December 2017 IFC”). The December 2017 IFC established a policy for determining quality performance scores for ACOs, when the ACO or its participating providers and suppliers were impacted by extreme and uncontrollable circumstances such as hurricanes, wildfires, or other triggering events, in performance year 2017, including the applicable quality reporting period for the performance year if the quality reporting period was not extended. In the CY 2019 PFS final rule, we extended the policies finalized in 2017 to performance year 2018 and subsequent performance years. In the March 31st COVID-19 IFC (85 FR 19267 and 19268), we updated the extreme and uncontrollable circumstances policy to eliminate the restriction that the policy applies only if the quality reporting period is not extended.
                    </P>
                    <P>We determine whether an ACO has been impacted by an extreme and uncontrollable circumstance using the following criteria:</P>
                    <P>• 20 Percent or more of the ACO's assigned beneficiaries reside in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance (§ 425.502(f)(1)(i)).</P>
                    <P>• The ACO's legal entity is physically located in an area identified as being affected by an extreme and uncontrollable circumstance under the Quality Payment Program (§ 425.502(f)(1)(ii)).</P>
                    <P>Under the current regulation at § 425.502(f)(2), ACOs that meet one or both of the above criteria will have their quality performance score set equal to the mean quality performance score for all Shared Savings Program ACOs for the relevant performance year. However, if the ACO completely and accurately reports all quality measures, we use the higher of the ACO's quality performance score or the mean quality performance score for all Shared Savings Program ACOs to calculate the ACO's quality performance score.</P>
                    <P>The Public Health Emergency (PHE) for the COVID-19 pandemic applies to all counties in the United States, therefore for performance year 2020 all ACOs are considered to be affected by an extreme and uncontrollable circumstance.</P>
                    <HD SOURCE="HD3">1. Proposed Changes to the CAHPS for ACOs Reporting Requirements for Performance Year 2020 </HD>
                    <P>
                        In the March 31st COVID-19 IFC, we made updates to the Part C and Part D Star Rating Systems for 2021 and 2022 based on concerns that the COVID-19 pandemic would pose significant 
                        <PRTPAGE P="50253"/>
                        challenges and safety concerns in successfully completing the CAHPS survey. It was noted that many of the survey administration protocols could not be completed remotely, requiring staff to work in mail facilities and call centers where telephone interviewers assemble in close quarters to perform the telephone administration of the survey. Accordingly, to be in compliance with social distancing, travel bans, quarantine, and promoting health and safety of all involved in CAHPS data collection, we amended regulations in parts 417, 422, and 423 to eliminate requirements for collection of CAHPS data in 2020 (85 FR 19271 and 19272).
                    </P>
                    <P>The Shared Savings Program quality measure set for performance year 2020 includes 10 measures that are collected through the CAHPS for ACOs survey. The timeline for the CAHPS for ACOs survey includes: (1) Vendor training in late spring, (2) ACO vendor selection in early summer, and (3) data collection beginning in late fall. The PHE may affect both the PY 2020 CAHPS for ACOs sample frame and the administration of the PY 2020 survey. The CAHPS for ACO sample frame can include beneficiaries who are assigned to an ACO based on having received the plurality of their primary care visits from ACO professionals in that ACO or voluntary alignment to the ACO. Under our current process, the PY 2020 CAHPS for ACOs survey sample frame will be constructed based on primary care visits of assigned beneficiaries from July 2019 through June 2020.</P>
                    <P>
                        We are concerned that the mix of beneficiaries included in the PY 2020 sample frame may be impacted by the COVID-19 pandemic because the time period used to identify eligible beneficiaries based on primary care visits overlaps with the PHE for the COVID-19 pandemic. Beneficiaries may be assigned to an ACO based on both in person office and telehealth primary care visits; however, during the pandemic, many beneficiaries may defer or skip primary care visits. As a result, the pandemic could reduce the pool of beneficiaries available for assignment to the ACO and eligible for the survey sample. The sampling methodology requires a beneficiary to have at least two primary care service visits, as well as meet other sampling criteria such as a visit with a primary care clinician or a specialist that provides primary care services used in assignment who delivered the plurality of primary care services (that is, the beneficiary's focal provider). In addition, the survey is typically administered in late fall of the performance year and beneficiaries are asked if they received health care from their focal provider in the last 6 months, if they answer no they skip over the survey questions evaluating the provider and office staff. Given our concerns regarding the decrease in primary care services in 2020, many beneficiaries could potentially have no office visits with their focal provider during this 6-month period and would be unable to fully complete the survey. A recent Commonwealth Health Study 
                        <SU>47</SU>
                        <FTREF/>
                         showed that the number of primary care (in person or telehealth) visits were down by about 31 percent in the 2nd quarter of 2020 despite an upward trend in telehealth visits. Some ACOs have noted a significant decline in primary care service visits in the months used to produce the sample. This is supported by preliminary claims data that shows primary care services furnished by ACO professionals in Shared Savings Program ACOs were down by 26 percent from January-May 2020 and shows a greater decrease in visits from January-April, 2020. The decrease was observed even following the addition of codes for certain telehealth and virtual services to the ACO assignment specifications in the May 8th COVID-19 IFC (85 FR 27583 through 27586). We continue to monitor the impact that the changing mix of in person and telehealth visits has on assignment of beneficiaries to ACOs and any subsequent impact on sampling both in terms of the impact on the number of beneficiaries and composition of the beneficiary population assigned to an ACO.
                    </P>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">https://www.commonwealthfund.org/publications/2020/jun/impact-covid-19-pandemic-outpatient-visits-practices-adapting-new-normal.</E>
                        </P>
                    </FTNT>
                    <P>Additionally, the atypical pattern of primary care utilization in past months potentially introduces non-random differences in the patient pool used to assess ACOs in 2020 compared to prior years. The current survey instrument may not accurately measure the shifts in care caused by the pandemic, such as increased use of telehealth creating the potential for under-reporting of experience. Patient experience for an atypical period of care may result in patient reports of experiences substantially different from previous years making it difficult to determine if observed differences are due to changes in the quality of care or due to pandemic-related changes in utilization or care delivery, compromising the use of the data to measure performance improvement over time. For example, 2020 patient reports and ratings of care may be more affected by general shortages of personnel and capacity rather than by the quality of care delivered by physicians and other staff.</P>
                    <P>Furthermore, even though the administration of the CAHPS for ACOs survey does not occur until late fall of PY 2020, we do not know how long the COVID-19 PHE will be in place or the long-term impacts of the PHE on the CAHPS for ACOs survey administration. The pandemic may negatively impact survey administration procedures and response rates. Vendor-specific revisions to the survey protocol may be warranted, such as allowing mail-only surveys, which could introduce a lack of standardization in survey administration, affecting the comparability of data collected by different vendors and could lead to decreased response rates affecting performance scores.</P>
                    <P>Taken together, the potential negative impacts of the COVID-19 pandemic detailed above could affect the size and generalizability of the survey sample, standardization of survey administration, and the utility of the data for purposes of measuring patient experience and performance improvement, thus leading to challenges in benchmarking and computing quality improvement scores for 2020.</P>
                    <P>We note that absent this proposal, all ACOs would be required to administer the CAHPS for ACOs survey and pay to contract with a CAHPS vendor, regardless of the impact of the PHE. The change in the number of visits and the resulting sampling impact will vary for ACOs based on their location. If ACOs have sample sizes less than the target sample size of 860 beneficiaries, all eligible beneficiaries would be included in the survey sample; therefore, ACOs could potentially be paying for a vendor and receiving CAHPS for ACOs scores that do not reflect the care provided by ACO providers/suppliers. In contrast, the CAHPS for MIPS survey is voluntary and MIPS groups and virtual groups may still choose to register to field a MIPS for CAHPS survey. MIPS groups that register for the CAHPS for MIPS survey and do not meet minimum sample requirements are not eligible to administer the survey.</P>
                    <P>
                        Accordingly, in an effort to maintain consistency with public safety determinations made for the CAHPS survey that is used in Part C and Part D Star Ratings Systems in the March 31st COVID-19 IFC and address concerns about the negative impacts of COVID-19 on sample size and performance scores, we are proposing to modify our regulations to remove the requirement that ACOs field a CAHPS for ACOs survey for performance year 2020. Instead, we propose that ACOs 
                        <PRTPAGE P="50254"/>
                        would automatically receive full points for each of the CAHPS survey measures within the patient/caregiver experience domain for performance year 2020. We acknowledge that this proposal is retroactive for performance year 2020. However, section 1871(e)(1)(A) of the Act allows for retroactive application of a substantive change when the failure to apply the change retroactively would be contrary to the public interest. Based on the concerns described above, we believe it is in the public interest not to require ACOs to field the CAHPS for ACOs survey. Accordingly, we propose to amend § 425.500(d) to add language stating that for performance year 2020 we waive the CAHPS for ACOs reporting requirement and will give all ACOs automatic credit for the CAHPS for ACOs survey measures.
                    </P>
                    <P>We seek comment on our proposal to waive the CAHPS for ACOs reporting requirement and to give ACOs automatic credit for the CAHPS for ACOs survey measures for performance year 2020. For instance, we would be interested in hearing from ACOs and beneficiaries if there are other ways to conduct the survey that would mitigate the concerns listed above.</P>
                    <HD SOURCE="HD3">2. Comment Solicitation on Modifications to the Extreme and Uncontrollable Circumstances Policy for Performance Year 2020</HD>
                    <P>Multiple stakeholders have expressed concerns about the potential adverse impacts of the PHE for COVID-19 on ACOs, suggesting that we not use performance year 2020 data to assess the quality performance of ACOs, consider holding clinicians harmless from quality assessment and reporting, suspend quality data submission, or make the 2020 performance year a pay-for-reporting year to allow for an ongoing focus on quality while recognizing the unusual circumstances presented this year.</P>
                    <P>We understand stakeholders' concerns, but we believe that ACOs should be in a position to report CMS Web Interface measures for PY 2020 beginning in January 2021. All ACOs were determined to be impacted by the PHE for COVID-19, which was declared during the quality reporting period for performance years starting in 2019. However, 98.7 percent of ACOs completely reported CMS Web interface measures for 2019, including all 65 ACOs that were also impacted by a natural disaster during 2019 or the quality reporting period. We want to encourage reporting for performance year 2020 while still being cognizant of the impacts that the PHE for COVID-19 could have on quality reporting and quality performance. Accordingly, we believe the proposal described above that would give ACOs automatic full credit for the CAHPS for ACOs survey measures, in addition to our current extreme and uncontrollable circumstances policy, offers relief to ACOs for performance year 2020. All 10 CAHPS for ACOs survey measures are in one of the four domains used to calculate an ACO's quality performance score. This means 25 percent of an ACO's quality performance score for performance year 2020 would come from receiving full credit on the CAHPS for ACOs survey measures. In addition, each of the other three domains has at least one or more measures that is pay-for-reporting in performance year 2020, resulting in over 50 percent of the measures (14 out of 23) being assigned full points if the ACO completely and accurately reports quality data. Furthermore, for ACOs in their second or subsequent performance year, there is at least one measure in each domain that ACOs could receive full points for, providing they completely report quality data, ensuring they would achieve the minimum attainment level on at least one measure in each domain as required under § 425.502(d)(2)(iii) to be eligible to share in any savings. We believe this may address some of the concerns expressed by stakeholders about 2020 quality performance, as noted above. We believe it is in the public interest that we strongly encourage ACOs to report quality data because ACOs could otherwise share in any savings earned without being held accountable for the quality of care that they provide to the more than 11 million beneficiaries who receive care through Shared Savings Program ACOs. In addition to incentivizing the reporting of quality of care measures, we believe that it is critical to incorporate ACO performance on those measures into quality performance scoring for performance year 2020 in a meaningful way that also considers the impact of the current PHE.</P>
                    <P>However, we are also seeking comment on a potential alternative approach to scoring ACOs under the extreme and uncontrollable circumstances policy for performance year 2020 that we considered proposing. The intent of the Shared Savings Program extreme and uncontrollable circumstances policy is to mitigate any negative impact of an extreme and uncontrollable circumstance on an ACO's quality performance or ability to report quality data to CMS and the resultant effect on financial reconciliation due to emergency circumstances outside of the ACO's control. Changes in healthcare utilization during 2020 may impact sampling and ACO performance on the quality measures for reasons that include: (1) Increased healthcare utilization due to COVID-19; (2) reduced or delayed non-COVID-19 care due to advice to patients to delay routine and/or elective care; and (3) changes in non-COVID-19 inpatient utilization due to crowd-out. For the reasons enumerated above, we believe that the PHE for COVID-19 creates uncertainty regarding performance rates on the ACO quality measures for performance year 2020. Due to the changes in the healthcare landscape and the increased burden they present in providing care for all patients during the PHE for COVID-19, we recognize that the mean ACO performance rate in 2020 could be lower than it was in previous performance years. We therefore considered whether assigning the higher of an ACO's own 2020 quality score or the 2020 ACO mean to those ACOs that do not completely report quality and those whose quality score falls below the mean in 2020, consistent with our current extreme and uncontrollable circumstances policy, may disadvantage ACOs. Accordingly, below we are seeking comment on a potential change to the existing extreme and uncontrollable circumstances policy that we considered proposing.</P>
                    <P>
                        The potential alternative modification we considered would be similar to the current policy, but would use the higher of an ACO's 2020 quality performance score or its 2019 quality performance score for ACOs that completely report quality data for 2020. For new ACOs that completely report quality data, we would continue to score them as pay-for-reporting and assign a quality score of 100 percent. ACOs that do not complete quality reporting would receive the 2020 ACO mean quality score as provided in § 425.502(f)(2). We believe that the potential change to use the higher of an ACO's 2020 quality performance score or its 2019 quality performance score, for ACOs that do completely report quality data for performance year 2020, could help to mitigate the impact of the PHE for COVID-19 on ACOs that report, but are not able to perform well during 2020. We also believe that assigning the 2020 ACO quality mean to ACOs that do not complete quality reporting would incentivize reporting by new ACOs that would receive 100 percent if they complete reporting, as well as by ACOs in their second or subsequent performance years that would have an 
                        <PRTPAGE P="50255"/>
                        opportunity to receive a score that could be higher than the 2020 mean if they complete quality reporting.
                    </P>
                    <P>As mentioned above, 98.7 percent of ACOs reported quality data for performance year 2019 despite being impacted by the PHE for COVID-19 during the 2019 CMS Web Interface data submission period. We note that preliminary data indicate that the 2019 mean ACO quality score will be 92 percent, which is comparable to the mean ACO quality scores from prior years. For example, the 2018 mean ACO Quality Score was 93 percent. As a result, we expect that for some ACOs in their second or subsequent performance year with consistently above average quality scores, assigning their 2019 quality performance score would result in a higher quality performance score for 2020 than the 2020 ACO mean quality score. However, as noted in section VIII.H.8. of this proposed rule, the proposed full credit for the CAHPS for ACOs measures that is described above would advantage all ACOs relative to applying only our current extreme and uncontrollable circumstances policy to mitigate the impact of the PHE for COVID-19.</P>
                    <P>We are soliciting comments on the following potential modifications to the extreme and uncontrollable circumstances policy for performance year 2020:</P>
                    <P>(1) If an ACO in a second or subsequent performance year completely and accurately reports the CMS Web Interface measures for performance year 2020, the ACO will receive the higher of its performance year 2020 ACO quality performance score that would include automatic full credit for the CAHPS for ACOs survey measures, as proposed in this section, or the score used in 2019 for purposes of financial reconciliation. For re-entering ACOs that terminated in their second or subsequent agreement period, the ACO will receive the higher of its most recent prior ACO quality performance score or its 2020 quality performance score.</P>
                    <P>(2) If an ACO in a second or subsequent performance year or a re-entering ACO that terminated in its second or subsequent agreement period does not completely and accurately report the CMS Web Interface measures for performance year 2020, the ACO will receive the 2020 ACO mean quality performance score.</P>
                    <P>(3) If an ACO in its first performance year in the program or a re-entering ACO that terminated in its first agreement period and is now in its first performance year of a new agreement period completely and accurately reports the CMS Web Interface measures, it will receive a quality performance score of 100 percent that reflects automatic full credit for the CAHPS for ACO survey measures, as proposed in this section.</P>
                    <P>(4) If an ACO in its first performance year or a re-entering ACO that terminated in its first agreement period and is now in its first performance year of a new agreement period, does not completely and accurately report the CMS Web Interface measures for performance year 2020, it will receive the 2020 mean ACO quality performance score.</P>
                    <P>We believe this potential alternative of modifying the extreme and uncontrollable circumstances policy to the higher of an ACO's 2020 quality performance score or its 2019 quality performance score would encourage all ACOs to report quality for performance year 2020, while also offering additional protections for ACOs in the event that quality performance scores for 2020 are adversely affected by the PHE for COVID-19. We believe this approach could help to address concerns about the potential for lower quality performance during performance year 2020 by continuing to benefit ACOs that perform well during 2020, and mitigating the impact for those that do not. ACOs that do not completely report quality would receive the 2020 mean ACO quality score, as provided under the current extreme and uncontrollable circumstances policy in § 425.502(f). As noted earlier, more than half of the measures in the Shared Savings Program quality measure set are pay-for-reporting for all ACOs for performance year 2020, which is higher than in previous years, and we believe this should also help to mitigate concerns regarding quality performance. Nevertheless, we recognize that the mean ACO quality performance rate in 2020 could be lower than it was in previous performance years. As a result, we believe this alternative could provide an incentive to encourage ACOs to completely and accurately report quality because they would be eligible to receive a score that may be higher than the 2020 ACO mean quality score. Accordingly, we seek comment on the potential modification to the extreme and uncontrollable circumstances policy for performance year 2020, as described above.</P>
                    <HD SOURCE="HD2">J. Proposal To Remove Selected National Coverage Determinations</HD>
                    <P>
                        In the August 7, 2013 
                        <E T="04">Federal Register</E>
                         notice (78 FR 48164), we established the current procedures for requesting a National Coverage Determination (NCD) or reconsideration of an existing NCD. We described how the public may participate in the NCD process during the indicated comment period(s). We also established an expedited administrative process, using specific criteria, to remove NCDs older than 10 years, thereby allowing the local Medicare Administrative Contractors (MAC) to determine coverage.
                    </P>
                    <P>We are now proposing to use the rulemaking process to continue to use the criterion established in 2013 to regularly identify and remove NCDs that no longer contain clinically pertinent and current information, in other words those items and services that no longer reflect current medical practice, or that involve items or services that are used infrequently by beneficiaries. We are proposing this change of vehicle because removing a NCD changes a substantive legal standard related to Medicare coverage and payment for items and services under section 1871(a)(2) of the Act. Eliminating an NCD for items and services that were previously covered means that the item or service will no longer be automatically covered by Medicare (42 CFR 405.1060). Instead, the coverage determinations for those items and services will be made by MACs. On the other hand, if the previous NCD barred coverage for an item or service under title XVIII (that is, national noncoverage NCD), a MAC would now be able to cover the item or service if the MAC determined that such action was appropriate under the statute. Removing a national non-coverage NCD may permit access to technologies that may now be beneficial for some uses. As the scientific community continues to conduct research which produces new evidence, the evidence base we previously reviewed may have evolved to support other policy conclusions.</P>
                    <P>Per the guidance issued in the 2013 notice, we may consider an older NCD for removal if, among other things, any of the following circumstances apply:</P>
                    <P>• We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.</P>
                    <P>• The technology is generally acknowledged to be obsolete and is no longer marketed.</P>
                    <P>• In the case of a noncoverage NCD based on the experimental status of an item or service, the item or service in the NCD is no longer considered experimental.</P>
                    <P>• The NCD has been superseded by subsequent Medicare policy.</P>
                    <P>
                        • The national policy does not meet the definition of an “NCD” as defined in sections 1862(l) or 1869(f) of the Act.
                        <PRTPAGE P="50256"/>
                    </P>
                    <P>• The benefit category determination is no longer consistent with a category in the Act.</P>
                    <P>We are interested in public comments that may identify other reasons for proposing to remove NCDs. We are also interested in whether the time-based threshold of “older” which was designated as 10 years in the 2013 notice continues to be appropriate or whether stakeholders believe a shorter period of time or some other threshold criterion unrelated to time is more appropriate.</P>
                    <P>The process of removal does not result in an NCD as that term is defined in sections 1869(f) and 1862(l) of the Act because there would be no uniform national decision about whether or not the particular item or service would be covered under Title XVIII of the Act. Rather, the initial coverage decision which is normally made for a specific beneficiary who has already received an item or service and has submitted a Medicare claim would be made by local contractors. For the reasons outlined above, we believe that allowing local contractor flexibility in these cases better serves the needs of the Medicare program and its beneficiaries.</P>
                    <P>
                        Since the 2013 notice, we have removed NCDs on two occasions. First, in November 2013, we proposed 10 NCDs for expedited removal. After reviewing the comments, we issued a final decision memorandum in December 2014, removing 7 NCDs and retaining three. We last proposed removal of NCDs in March of 2015, proposing to remove 2 NCDs. Based on the comments, we removed one NCD and retained one. The proposals and final decisions related to these removals are located in the Medicare Coverage Database, available at 
                        <E T="03">https://www.cms.gov/medicare-coverage-database/indexes/medicare-coverage-documents-index.aspx?MCDIndexType=7&amp;mcdtypename=Expedited+Process+to+Remove+National+Coverage+Determinations&amp;bc=AgAAAAAAAAAAAA%3d%3d&amp;.</E>
                    </P>
                    <P>
                        It has been 5 years since we last evaluated older NCDs for removal. We continue to recognize the need to periodically review our policies and processes to ensure that we remain effective and efficient as well as open and transparent. We are aware that clinical science and technology evolve and that items and services that were once considered state-of-the-art or cutting edge may be replaced by more beneficial technologies or clinical paradigms. Additionally, proactively removing obsolete broad non-coverage NCDs removes barriers to innovation and reduces burden for stakeholders and CMS. In light of the Supreme Court's decision in 
                        <E T="03">Azar</E>
                         v. 
                        <E T="03">Allina Health Services,</E>
                         587 U.S. ___, 139 S. Ct. 1804 (2019)), we have determined it would be appropriate to use the notice and comment rulemaking procedures described in section 1871(a)(2) of the Act to remove outdated or unnecessary NCDs.
                    </P>
                    <P>In Table 37, we list the NCDs that we propose to remove. In addition to conducting an internal review to identify appropriate NCDs for removal, we received removal requests from a variety of external stakeholders, such as medical specialty societies, device manufacturers, beneficiaries, physicians and providers, and other interested individuals. Additionally, some of these topics were brought to our attention by the MAC medical directors. We solicit comment on the nine NCDs discussed in Table 37, as well as comments recommending other NCDs for CMS to consider for future removal.</P>
                    <GPH SPAN="3" DEEP="158">
                        <GID>EP17AU20.071</GID>
                    </GPH>
                    <P>
                        The following outlines each NCD and provides a summary of the rationale for removal. Each of the current NCDs below may be found in the Medicare National Coverage Determinations Manual located at 
                        <E T="03">https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/internet-Only-Manuals-IOMs-Items/CMS014961.</E>
                    </P>
                    <HD SOURCE="HD3">1. NCD #20.5 Extracorporeal Immunoadsorption (ECI) Using Protein A Columns (01/01/2001)</HD>
                    <P>
                        • 
                        <E T="03">Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        • 
                        <E T="03">Rationale:</E>
                         Extracorporeal immunoadsorption (ECI), using Protein A columns, has been developed for the purpose of selectively removing circulating immune complexes (CIC) and immunoglobulins (IgG) from patients in whom these substances are associated with their diseases. The technique involves pumping the patient's anticoagulated venous blood through a cell separator from which 1-3 liters of plasma are collected and perfused over adsorbent columns, after which the plasma rejoins the separated, unprocessed cells and is re-transfused to the patient. ECI has been used to treat some diseases of inflammatory and autoimmune etiology. External stakeholders suggested this NCD may be outdated, with the therapeutic use of ECI constrained by the parameters of the NCD as the evidentiary base has continued to evolve. Also, the service is a specific type of therapeutic apheresis for the treatment of rheumatoid arthritis under certain conditions. The stakeholders recommended that this NCD should be removed in conjunction with removing NCD #110.14 Apheresis, which is discussed below. Removing the outdated CMS NCD for ECI and leaving 
                        <PRTPAGE P="50257"/>
                        it to contractor discretion would provide flexibility for coverage considerations that are more responsive to the evolving evidentiary base improving appropriate access for Medicare beneficiaries.
                    </P>
                    <HD SOURCE="HD3">2. NCD #30.4 Electrosleep Therapy</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         The technology is generally acknowledged to be obsolete and is no longer marketed.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         External stakeholders suggested this NCD may be outdated. This NCD predates the current NCD public notice standards and has no decision memorandum, no evidence review, and no bibliography. Additionally, the term “Electrosleep therapy” appears to be outdated, superseded by “cranial electrotherapy stimulators (CES).” In addition to a change in nomenclature, FDA's class level assigned to CES has also changed over time for indications of anxiety and/or insomnia, although not for depression. Given that the therapeutic area has progressed and “Electrosleep Therapy” does not have the same applicability, we propose to remove this NCD allowing local contractor discretion to consider coverage of newer technologies.
                    </P>
                    <HD SOURCE="HD3">3. NCD #100.9 Implantation of Gastroesophageal Reflux Device (06/22/1987)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         External stakeholders suggested this NCD may be outdated. The 1987 Noncoverage NCD was determined based on a different device, the Angelchik device, which was a device implanted around the esophagus (under the diaphragm and above the stomach) that was secured by a circumferential tie strap. Implantable treatment for GERD initiated with Angelchik prosthetic rings came under scrutiny for high dysphagia rates and migration of the implant. It was removed from the market in 1990. New FDA market authorized devices for the indication of GERD have emerged since that time. However, some devices have a limited evidence base with respect to improving long-term patient outcomes. Nonetheless, there may be a role for implantable devices in the treatment of reflux. We believe that local contractor discretion provides an immediate avenue to potential coverage in appropriate candidates. Therefore, we believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <HD SOURCE="HD3">4. NCD #110.14 Apheresis (Therapeutic Pheresis) (7/30/1992)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         Apheresis (also known as pheresis or therapeutic pheresis) is a medical procedure utilizing specialized equipment to remove selected blood constituents (plasma, leukocytes, platelets, or cells) from whole blood. The remainder is re-transfused into the person from whom the blood was taken. The apheresis NCD predates the current NCD public notice standards. No evidence review was published for this NCD to justify the specific list of conditions covered. Since the NCD is silent on non-coverage, the NCD is vague and open to interpretation and may not be applied uniformly. Furthermore, the scope of indications for apheresis has continued to develop since the origin of the NCD. Removing the outdated CMS NCD for apheresis and leaving it to contractor discretion will provide flexibility for coverage considerations that are more responsive to the evolving evidentiary base improving appropriate access for Medicare beneficiaries.
                    </P>
                    <HD SOURCE="HD3">5. NCD #110.19 Abarelix for the Treatment of Prostate Cancer (3/15/2005)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         The technology is generally acknowledged to be obsolete and is no longer marketed.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         Abarelix was approved in the Unites States in 2003 for restricted use as palliative treatment in men with advanced symptomatic prostate cancer and experiencing select complications (described in the FDA labeling). However, in response to reports of systemic allergic reactions, the GnRH antagonist, Abarelix, was voluntarily withdrawn from the U.S. market in 2005. Because Abarelix is no longer marketed in the U.S., the NCD no longer contains clinically pertinent and current information and should be removed.
                    </P>
                    <HD SOURCE="HD3">6. NCD #190.1 Histocompatability Testing (08/01/1978)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        • 
                        <E T="03">Rationale:</E>
                         Histocompatibility testing involves matching or typing of the human leucocyte antigen (HLA) proteins. External stakeholders suggested that the texts within this NCD are now less frequently utilized and raised concerns of reducing provider burden as adjudication of the claims for certain diagnoses requires submission of medical records for each person tested. The techniques have evolved from conventional HLA cross-matching to include a range of techniques with different levels of matching, including HLA genotyping assays (polymerase chain reaction sequence-specific primer [PCR-SSP], sequence-specific oligonucleotide probe (SSOP), and sequence-based techniques [SBT] including next generation sequencing). Therefore, clinicians need to make sophisticated assessments related to the indication, their access to histocompatibility testing approaches, and appropriate avenues for billing. We propose removing this NCD which originated around conventional HLA cross-matching. This would allow local contractors discretion to accommodate clinical flexibility to better serve the needs of the Medicare program and its beneficiaries while streamlining and simplifying the billing and claims processing.
                    </P>
                    <HD SOURCE="HD3">7. NCD #190.3 Cytogenetic Studies (7/16/1998)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         The NCD has been superseded by subsequent Medicare policy.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         Cytogenetics involves examining stained chromosomes, and distinct chromosomal bands, to help identify structural abnormalities in chromosomes that might correspond to poor health outcomes. However, direct DNA analyses through DNA sequencing, such as Next Generation Sequencing (NGS) (
                        <E T="03">https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=372</E>
                        ), allows providers to read the exact order of nucleotide molecules that comprise DNA, enhancing the sensitivity and specificity in identifying abnormalities in the genetic sequence. As a result, the focus of NCDs has generally shifted from cytogenetic studies to genetic sequencing when detailed genetic information is of interest.
                    </P>
                    <HD SOURCE="HD3">8. NCD #220.2.1 Magnetic Resonance Spectroscopy (09/10/2004)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         MRS can determine the relative concentrations and physical properties of a variety of biochemicals and has the potential to probe a wide 
                        <PRTPAGE P="50258"/>
                        range of metabolic pathways in different human tissue. Although MRS is mostly used in assessing brain tissue, it also offers potential applicability to breast, prostate, hepatic, and other cancers. External stakeholders suggested this NCD may be outdated, noting the 2004 broad noncoverage determination for all indications was based on evidentiary review for one limited indication, the diagnosis of brain tumors. As the scientific evidence evolves and the clinical utility develops across various indications, the restrictive scope of the 2004 NCD may prohibit appropriate local coverage determinations.
                    </P>
                    <HD SOURCE="HD3">9. NCD #220.6.16 FDG PET for Inflammation and Infection (03/19/2008)</HD>
                    <P>
                        <E T="03">• Circumstances/criterion:</E>
                         We believe that allowing local contractor discretion to make a coverage decision better serves the needs of the Medicare program and its beneficiaries.
                    </P>
                    <P>
                        <E T="03">• Rationale:</E>
                         The decision to use FDG PET for inflammation and infection is multifactorial and depends on: Whether conventional diagnostics have been unsuccessful, the stage of the underlying pathophysiological condition in the affected tissues, and the sensitivity and specificity of FDG PET to inform the differential diagnosis or course of disease, among other factors. For some inflammatory and infectious conditions, there is no overall agreement in the current literature about the added value of FDG PET for this indication. Conversely, leaving such determinations to local contractor discretion builds in flexibility to tailor coverage decisions to the pertinent facts of a patient's case and considering any added benefit of FDG PET in establishing a diagnosis and treatment plan that might link the PET imaging to an improved patient outcome.
                    </P>
                    <P>In summary, we solicit comment on the proposal to remove each of the nine NCDs, as well as comments recommending other NCDs for CMS to consider for future removal. Additionally, we solicit public comments that may identify other reasons for proposing to remove NCDs. We solicit comments on whether the time-based threshold of “older” which was designated as 10 years in the 2013 notice continues to be appropriate or whether stakeholders believe a shorter period of time or some other threshold criterion unrelated to time is more appropriate. We request commenters include a rationale to support their comments. We will use the public comments to help inform our decision to take one of three actions on the nine NCDs proposed for removal:</P>
                    <P>• Remove the NCD, as proposed, allowing for coverage to be determined by the MACs.</P>
                    <P>• Retain the current policy as an NCD.</P>
                    <P>• Reconsider the NCD. Comments suggesting that the NCD should be revised, rather than eliminated, should include previously unreviewed evidence in order to support a change in national coverage.</P>
                    <HD SOURCE="HD2">K. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Since Part D was signed into law in 2003, electronic prescribing (e-prescribing or e-Rx) has been optional for physicians and pharmacies for prescriptions made for covered Part D drugs. However, Part D sponsors offering drug plans have been required to have the electronic capabilities to support electronic prescribing. We understand that issuing this regulation would uniquely affect physicians, although it may impact other prescribers under Part D. Given the majority of affected parties are physicians, we seek to use the CY 2020 PFS rulemaking to gain the insight and perspective of providers.</P>
                    <P>
                        We track the volume of electronic prescriptions for controlled and non-controlled substances through our prescription drug event (PDE) processing system for Part D program claims. We have collected data on controlled substances and non-controlled substances since the United States' Drug Enforcement Administration (DEA) permitted the practice in 2010.
                        <SU>48</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             See 75 FR 16284, including revisions adopted to 21 CFR 1304.04.
                        </P>
                    </FTNT>
                    <P>However, while electronic prescribing has increased, the health care system faces a new threat. The United States is currently responding to an outbreak of respiratory disease caused by a novel (new) coronavirus now detected in 50 States and the District of Columbia. This virus has been named “severe acute respiratory syndrome coronavirus 2” (“SARS-CoV-2”), and the disease it causes has been named “coronavirus disease 2019” (“COVID-19”). In January 2020, the Secretary determined that a Public Health Emergency (PHE) exists for the United States to aid the nation's health care community in responding to COVID-19 (hereafter referred to as the PHE for the COVID-19 pandemic) and on April 21, 2020, the Secretary renewed, effective April 26, 2020, the determination that a PHE exists. In March, 2020, President Trump declared the COVID-19 pandemic a national emergency. Certain individuals, including older adults and persons with chronic conditions, who comprise a predominance of the Medicare beneficiary population, are at elevated risk of more severe illness and potential death from COVID-19. As a result of the PHE for the COVID-19 pandemic, and as the nation reopens, some individuals, such as those who are at high risk, may continue to practice self-isolation and social distancing.</P>
                    <P>
                        We have implemented many regulatory and policy actions to swiftly aid the nation's healthcare system to effectively address the COVID-19 pandemic. These actions include new flexibilities for telehealth and other electronic technologies 
                        <SU>49</SU>
                        <FTREF/>
                         to ease the burden on providers and assure appropriate care in a range of settings for beneficiaries. Also, the DEA has adopted certain new temporary flexibilities to allow DEA-registered practitioners to prescribe controlled substances without having to interact in person with patients, effective for the duration of the PHE for the COVID-19 pandemic.
                        <SU>50</SU>
                        <FTREF/>
                         For example, during the PHE for the COVID-19 pandemic, DEA permits DEA registered prescribers to issue controlled substance prescriptions to telemedicine patients who they have not seen in person under certain conditions, permits early refills of controlled substances permissible under state law, and allows prescribers to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance. DEA's COVID-19 information page is available at 
                        <E T="03">https://www.deadiversion.usdoj.gov/coronavirus.html.</E>
                         The DEA has acknowledged the prevalence of paper prescribing and attempted to address some of the hardships it poses for prescribers and patients during the PHE for the COVID-19 pandemic.
                    </P>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             See 
                            <E T="03">https://www.cms.gov/files/document/covid-19-physicians-and-practitioners.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             See 
                            <E T="03">https://www.deadiversion.usdoj.gov/GDP/(DEA-DC-023)(DEA075)Decision_Tree_(Final)_33120_2007.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We believe that social distancing is, in part, responsible for the increase in electronic prescribing for controlled substances (EPCS) during this PHE for the COVID-19 pandemic. In 2020, EPCS has increased to 50 percent of all PDEs being prescribed as compared to 38 percent in 2019.
                        <SU>51</SU>
                        <FTREF/>
                         With the use of electronic prescribing, a patient and provider can conduct a visit via 
                        <PRTPAGE P="50259"/>
                        telehealth and then have the prescription electronically transmitted to the pharmacy without having to see each other in-person and risk transmitting COVID-19. Some insurers, including Part D plans, may be permitting medication refills, including for controlled substances, earlier than usual or for a more extended period of time than was previously allowed. Pharmacies that were not previously doing so may deliver medications, or deliver at no charge, and communities and individuals have worked together to design ways for vulnerable persons to continue to receive access to prescribed medications in tandem with these new government and private sector flexibilities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             Based on Prescription Drug Event data processed through April 30, 2020.
                        </P>
                    </FTNT>
                    <P>The DEA is also involved in regulating EPCS. In 2010, the DEA issued the “Electronic Prescriptions for Controlled Substances” interim final rule with request for comment (75 FR 16236) (hereinafter referred to as the “2010 DEA EPCS interim final rule”) that provided practitioners with the option of writing prescriptions for controlled substances electronically. The rule also permitted pharmacies to receive, dispense, and archive these electronic prescriptions. Any electronic controlled substance prescription issued by a practitioner must meet the requirements in the 2010 DEA EPCS interim final rule. We note that not all electronic prescribing systems currently meet the DEA's requirements.</P>
                    <P>
                        Since the issuance of the 2010 DEA EPCS interim final rule, we have seen a steady increase in the volume of controlled substance prescriptions submitted electronically. States have instituted electronic prescribing requirements; some include penalties for not using e-prescribing for controlled substances. As of 2020, all states in the U.S., and Washington DC allow electronic prescribing of controlled substances for schedules II through V.
                        <SU>52</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             Schedule I drugs are not included in EPCS discussions because they have no currently accepted medical use. See 
                            <E T="03">https://www.deadiversion.usdoj.gov/schedules/#define</E>
                             for additional detail on definitions of controlled substances.
                        </P>
                    </FTNT>
                    <P>
                        EPCS provides multiple advantages over the traditional processing of paper prescriptions.
                        <E T="51">53 54 55 56 57 58</E>
                        <FTREF/>
                         In addition to improving workflow efficiencies, electronic prescribing of controlled substances can deter and help detect prescription fraud and irregularities by requiring an extra layer of identity proofing, two-factor authentication and digital signature processes. It can also provide more timely and accurate data than paper prescriptions by avoiding data entry errors and pharmacy calls to a prescriber to clarify written instructions. By allowing for the direct transmission of EPCSs between providers and pharmacies or facilities, EPCS may also reduce the burden on prescribers who need to coordinate and manage paper prescriptions between staff, patients, facilities, other care sites, and pharmacies. In addition, EPCS (dispensed medication) data is transmitted to Prescription Drug Monitoring Programs (PDMPs), which can help inform providers of patients' medication history and can aid in clinical decision making at the time of prescribing and/or before the medication is dispensed by a pharmacy. It is also important to continue the assurance of privacy and security in the prescribing process, such as by controlling prescriber access through improved identity controls and authentication protocols. EPCS can also assure prescribers' identity more easily and may permit a single workflow for prescribing both controlled and non-controlled drugs, improving the overall prescribing process.
                        <SU>59</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             Phillips 
                            <E T="03">et al.,</E>
                             “Market Guide for Identity Proofing and Corroboration.” April 24, 2018. Gartner, Inc. Retrieved from 
                            <E T="03">https://www.fedscoop.com/gartner-guide-identity-proofing-corroboration-2018/</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>54</SU>
                             Ryan, D. “FinCEN: Know Your Customer Requirements.” February 7, 2016. Harvard Law School Forum on Corporate Governance. Retrieved from 
                            <E T="03">https://corpgov.law.harvard.edu/2016/02/07/fincen-know-your-customer-requirements/#2b</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>55</SU>
                             Nix, M. “Five Questions: Ken Whittemore Talks Past, Present &amp; Future of E-Prescribing Controlled Substances.” March 31, 2020. SureScripts. Retrieved from 
                            <E T="03">https://surescripts.com/news-center/intelligence-in-action/opioids/five-questions-ken-whittemore-talks-past-present-future-of-e-prescribing-controlled-substances?utm_campaign=IIApercent2FBlogpercent20Subscription&amp;utm_source=hs_email&amp;utm_medium=email&amp;utm_content=85955401&amp;_hsenc=p2ANqtz-8xs36u7xTFZ-ieOxJk3309SApbE7to_fnk1SZvz2jqwz0pA3k7TtW9byiOq2zBlheLInMOeajCMCKeQUTzcEDP79HEaeXI52QiadhAYAWU3Px2eZc&amp;_hsmi=85955401</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>56</SU>
                             Zhang et al. “T2FA: Transparent Two-Factor Authentication.” June 15, 2018. IEEE Access. Retrieved from 
                            <E T="03">https://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&amp;arnumber=8386653</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>57</SU>
                             Konoth R.K., Van Der Veen V., Bos H. (2017) How Anywhere Computing Just Killed Your Phone-Based Two-Factor Authentication. In: Grossklags J., Preneel B. (eds) Financial Cryptography and Data Security. FC 2016. Lecture Notes in Computer Science, vol. 9603. Springer, Berlin, Heidelberg. Retrieved from 
                            <E T="03">https://link.springer.com/chapter/10.1007 percent2F978-3-662-54970-4_24</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>58</SU>
                             Cal and Zhu. “Fraud detections for online businesses: a perspective from blockchain technology.” 
                            <E T="03">Financial Innovation</E>
                             (2016) 2:20. Retrieved from 
                            <E T="03">https://link.springer.com/content/pdf/10.1186/s40854-016-0039-4.pdf</E>
                             on April 30, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             HHS Office of the National Coordinator, The ONC Doctors' Perspective: Electronic Prescribing of Controlled Substances (EPCS) Is on the Rise, and We Must Work Together to Address Barriers to Use: 
                            <E T="03">https://www.healthit.gov/buzz-blog/health-it/the-onc-doctors-perspective-electronic-prescribing-of-controlled-substances-epcs-is-on-the-rise-and-we-must-work-together-to-address-barriers-to-use.</E>
                        </P>
                    </FTNT>
                    <P>From the patient standpoint, EPCS may reduce the logistical burden on patients who may otherwise be required to make multiple trips between providers and pharmacies to transport paper prescriptions when filling time-sensitive prescriptions while in pain or otherwise in need of medical treatment with controlled substances. EPCS can lessen the time needed to obtain prescriptions by minimizing trips to the physician to pick up paper prescriptions for refills and minimize transportation costs to and from the provider's office. EPCS identity and security requirement also assure prescribers, patients, and pharmacies that prescriptions are processed as intended. In addition to helping with the reduction in fraud previously described, EPCS minimizes the likelihood that prescriptions have been tampered with, since electronic prescriptions are securely transmitted directly to the pharmacy from health information technology, which minimizes the likelihood of exposure to patients or other third parties.</P>
                    <HD SOURCE="HD3">2. The Current EPCS Environment</HD>
                    <P>
                        Based on a published report of 2019 data reflecting the majority of prescribing activities across the country,
                        <SU>60</SU>
                        <FTREF/>
                         97 percent of U.S. pharmacies were capable of processing EPCSs, yet only 49 percent of prescribers were capable of electronically prescribing controlled substances. The same report showed that 38 percent of controlled substance prescriptions were electronically prescribed, while 85 percent of non-controlled substances were electronically prescribed. Pain management specialists appear to be using electronic prescribing more often for opioids than other prescribers, and family practitioners are using electronic prescribing for opioids less often. Electronic prescribing also varies across practice size and ownership and among physicians who practice in groups owned by a health plan, health maintenance organizations (HMOs), hospital, or other healthcare entity. Use of the technology does not vary 
                        <PRTPAGE P="50260"/>
                        significantly between rural and urban areas, but it does vary between states.
                        <SU>61</SU>
                        <FTREF/>
                         Based on our analysis of the issue and conversations with the industry, we believe that this is associated with differences in regulations, penalties, waivers, populations, and culture.
                    </P>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             Surescripts. “National Progress Report 2019.” March 2020. Retrieved from 
                            <E T="03">https://surescripts.com/docs/default-source/national-progress-reports/7398_ab-v2_2019-npr-brochure.pdf</E>
                             on April 20, 2020.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             HHS Office of the National Coordinator, The ONC Doctors' Perspective: Electronic Prescribing of Controlled Substances (EPCS) Is on the Rise, and We Must Work Together to Address Barriers to Use: 
                            <E T="03">https://www.healthit.gov/buzz-blog/health-it/the-onc-doctors-perspective-electronic-prescribing-of-controlled-substances-epcs-is-on-the-rise-and-we-must-work-together-to-address-barriers-to-use.</E>
                        </P>
                    </FTNT>
                    <P>
                        The reasons for this disparity between capability and practice are varied. There may be challenges associated with clinicians' ability to electronically prescribe controlled substances within their normal workflow, reluctance to alter workflow habits, or reluctance to use new technology, but at this point, as mentioned earlier, most pharmacies are capable of processing EPCS. Some prescribers may rely on health care groups, clinics, and hospital systems to implement the necessary technology. There are also costs associated with the adoption of technology, which can disproportionately impact small or rural practices or pharmacies. Though EPCS uptake continues to grow in physicians and pharmacies,
                        <E T="51">62 63 64</E>
                        <FTREF/>
                         clear gaps remain between capacity and adoption of electronic prescribing of controlled substances.
                    </P>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             Burger, M. “Accelerating ePrescribing for Controlled Substances.” HIT Perspectives: Controlled Substances, February 2014. Retrieved from 
                            <E T="03">https://www.pocp.com/hitperspectives-controlled-substances/</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>63</SU>
                             Imambaccus N., Glace S., Heath R. Increasing the uptake of electronic prescribing in primary care. BMJ Quality Improvement Reports 2017;6:u212185. w4870. doi:10.1136/bmjquality.u212185.w4870. Retrieved from 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5457970/pdf/bmjqir.u212185.w4870.pdf</E>
                             on April 30, 2020.
                        </P>
                        <P>
                            <SU>64</SU>
                             Monegain, B. “E-prescribing takes off like a rocket.” Healthcare IT News, June 18, 2015. Retrieved from 
                            <E T="03">https://www.healthcareitnews.com/news/e-prescribing-takes-rocket</E>
                             on April 30, 2020.
                        </P>
                    </FTNT>
                    <P>
                        Substantial adoption of EPCS has occurred in the thirteen states that require it.
                        <SU>65</SU>
                        <FTREF/>
                         Some states have chosen to use penalties to increase prescribers' compliance with EPCS requirements. For example, New York mandated EPCS with a penalty for non-compliance and subsequently experienced an EPCS adoption rate for controlled substances of nearly 99 percent for pharmacies and 82 percent for prescribers in 2019.
                        <SU>66</SU>
                        <FTREF/>
                         We do not currently impose penalties for providers prescribing controlled substances under the Part D program who do not use e-prescribing. Rather, Part D plans may reject improper transactions or transactions that did not adhere to the CMS transaction standards.
                    </P>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             Arizona, Connecticut, Florida, Indiana, Iowa, Maine, Minnesota, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, and Virginia have adopted mandates that will be in effect in 2020. DrFirst. Mandates Driving EPCS and PDMP Utilization. Accessed April 29, 2020. 
                            <E T="03">https://drfirst.com/resources/regulatory-mandates/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             Surescripts, 2019 National Progress Report. Accessed April 29, 2020. 
                            <E T="03">https://naspa.us/wp-content/uploads/2020/04/7398_2019-NPR-Brochure-Web-Final.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. E-Prescribing Standards</HD>
                    <P>
                        CMS adopted the first set of standards for e-prescribing for Part D, the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Version 5, Release 0 in the Medicare Program; E-Prescribing and the Prescription Drug Program, Final Rule, in 2005.
                        <SU>67</SU>
                        <FTREF/>
                         Since then CMS has continued to adopt updated e-prescribing standards 
                        <SU>68</SU>
                        <FTREF/>
                         with the most recent standard described in a final rule published April 16, 2018 where we finalized an update of the Part D standards to NCPDP SCRIPT standard version 2017071 for e-Rx and medication history, effective January 1, 2020 (83 FR 16440).
                    </P>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             See 70 FR 67568.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             CMS regulations adopting updated versions of the NCPDP SCRIPT standard: 73 FR 18918 (NCPDP SCRIPT version 8.1); and 77 FR 688892 (NCPDP SCRIPT version 10.6).
                        </P>
                    </FTNT>
                    <P>We currently require that Part D plans support the NCPDP SCRIPT standard version 2017071 for certain defined e-prescribing transactions as finalized in the “Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program” final rule (83 FR 16440). This requirement became effective on January 1, 2020. Under CMS regulations, prescribers are required to use this standard when conducting e-prescribing for covered Part D drugs for Part D eligible individuals.</P>
                    <HD SOURCE="HD3">4. SUPPORT Act Requirements</HD>
                    <P>Section 2003 of the SUPPORT Act generally mandates that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions, which HHS may specify. Section 2003 of the SUPPORT Act requires that the Secretary use rulemaking to specify circumstances and processes by which the Secretary may waive the EPCS requirement and provides the Secretary with authority to enforce and specify appropriate penalties for non-compliance with EPCS. The SUPPORT Act specifies some circumstances under which the Secretary may waive the electronic prescribing requirement with respect to controlled substances that are covered Part D drugs and also permits HHS to develop other appropriate exceptions. The circumstances that are listed in the statute under which the Secretary may waive the EPCS requirement are at section 1860D-4(e)(7) of the Act, as added by section 2003 of the SUPPORT Act, and include:</P>
                    <P>• A prescription issued when the practitioner and dispensing pharmacy are the same entity;</P>
                    <P>• A prescription issued that cannot be transmitted electronically under the most recently implemented version of the National Council for Prescription Drug Programs SCRIPT Standard;</P>
                    <P>• A prescription issued by a practitioner who received a waiver or a renewal thereof for a period of time as determined by the Secretary, not to exceed one year, from the requirement to use electronic prescribing due to demonstrated economic hardship, technological limitations that are not reasonably within the control of the practitioner, or other exceptional circumstance demonstrated by the practitioner;</P>
                    <P>• A prescription issued by a practitioner under circumstances in which, notwithstanding the practitioner's ability to submit a prescription electronically as required by this subsection, such practitioner reasonably determines that it would be impractical for the individual involved to obtain substances prescribed by electronic prescription in a timely manner, and such delay would adversely impact the individual's medical condition involved;</P>
                    <P>• A prescription issued by a practitioner prescribing a drug under a research protocol;</P>
                    <P>• A prescription issued by a practitioner for a drug for which FDA requires a prescription to contain elements that are not able to be included in electronic prescribing, such as a drug with risk evaluation and mitigation strategies that include elements to assure safe use;</P>
                    <P>• A prescription issued by a practitioner—</P>
                    <P>++ For an individual who receives hospice care under this title; and</P>
                    <P>++ That is not covered under the hospice benefit under this title; and</P>
                    <P>• A prescription issued by a practitioner for an individual who is—</P>
                    <P>++ A resident of a nursing facility (as defined in section 1919(a)); and</P>
                    <P>
                        ++ Dually eligible for benefits under this title and title XIX.
                        <PRTPAGE P="50261"/>
                    </P>
                    <P>In the Medicare Program: Electronic Prescribing for Controlled Substances; Request for Information, we are requesting feedback on the appropriate waivers and whether CMS should impose penalties for noncompliance with the EPCS mandate in its rulemaking, and what should be the penalties. We plan on using the important public feedback we receive from the Request for Information in future standalone rulemaking.</P>
                    <HD SOURCE="HD3">5. Proposed Timeframe for EPCS Adoption</HD>
                    <P>Section 2003 of the SUPPORT Act mandates that EPCS begin on January 1, 2021. Due to this statutory mandate coupled with the aforementioned advantages provided by EPCS, we encourage all prescribers to conduct EPCS as soon as is feasible for them.</P>
                    <P>
                        We believe that although EPCS is ultimately more efficient, implementing EPCS does take additional time and resources. Prescribers must follow all the DEA guidance established by the DEA and summarized at 
                        <E T="03">https://deadiversion.usdoj.gov/ecomm/e_rx/.</E>
                         The requirements for individual practitioners and those enrolled in group practices vary but in general, a prescriber will need to make sure that their current ePrescribing software can support EPCS and is accredited by the DEA accordingly. In addition, before providers are approved for EPCS, their identity must be validated, including that they are authorized to prescribe controlled substances, and that their DEA number and license are in good standing. This step is required even if they are already prescribing controlled substances on paper. They must also get two-factor authentication in place which can be accomplished through include a combination of passwords, tokens, mobile phones, smart cards, and/or fingerprint biometrics. The providers must often have approved software configured to process EPCS which may require another set of permissions. Once that's completed, providers can process electronic prescriptions of controlled substances using the agreed upon two-factor authentication for each transaction. There are software and workflow training involved at each step of the process. When writing prescriptions, they must talk to their patients about e-prescribing, so their patients are aware of the general mechanics of how it is conducted.
                    </P>
                    <P>We also recognize that the current PHE for the COVID-19 pandemic presents additional EPCS challenges for some prescribers. We have seen that those prescribers who had already implemented EPCS capabilities have been able to increase the number of prescriptions electronically prescribed during the PHE. However, other provider groups have indicated that they do not anticipate being able to reschedule the EHR upgrades necessary to implement EPCS for at least three to four months, at which point practice resource limitations could make it difficult to deploy the necessary upgrades in a compressed timeframe. Other physician practices have indicated that complying with established EPCS identify proofing processes may be difficult because key personnel are unavailable or working offsite. We are sympathetic to the unique challenges faced by prescribers during this PHE for the COVID-19 pandemic. We also recognize the importance of EPCS and the statutory mandate. We believe that requiring EPCS by January 1, 2022 strikes the balance between not providing too large of a burden on providers and helping ensure that the benefits of EPCS are leveraged expeditiously. Furthermore, requiring EPCS by January 1, 2022 would allow time to solicit and consider important feedback from the previously discussed Request for Information that is necessary for implementation of the EPCS requirements for waivers from the requirements and penalties. This includes soliciting feedback from prescribers that we do not directly regulate under MA, and/or Part D, and who are not enrolled in Medicare or Medicaid. Section 1860D-4(e)(2)(E) of the Act requires the Secretary to adopt electronic standards for mandatory use by Part D plans. However, prior to the SUPPORT Act, which modified ePrescribing requirements with respect to schedules II through V controlled substances, all ePrescribing has been optional for physicians. As stated above, the statute provides the Secretary with the authority to develop any exceptions to EPCS that might be warranted, and to enforce and specify appropriate penalties for non-compliance with the requirement. We do not have an existing process for imposing penalties on non-compliant prescribers with respect to EPCS. In developing an entirely new penalty process we must make sure that it enforces the new EPCS requirement, allows for exceptions only when needed, but does not reduce beneficiary's access to needed drugs. Separate from this rule, we intend to conduct future standalone rulemaking that would address these topics.</P>
                    <P>Based on these considerations, we are proposing to amend § 423.160(a) by adding the requirement that all prescribers conduct electronic prescribing of Schedule II, III, IV, and V controlled substances using the NCPDP SCRIPT 2017071 standard by January 1, 2022, except in circumstances in which the Secretary waives the requirement. We are proposing that prescribers must use the NCPDP SCRIPT 2017071 standard because they are already required to use this standard when conducting e-prescribing for covered Part D drugs for Part D eligible individuals, and we believe that prescribers should use the same standard for their electronic prescribing of controlled substances.</P>
                    <P>We understand that the proposal to require electronic prescribing for controlled substances for covered Part D drugs under a prescription drug plan or MA-PD plan would uniquely affect physicians. As a result, we seek to gain the insight and perspective of prescribers and others. We welcome comments on this proposal, including the feasibility for prescribers to meet the proposed January 1, 2022 deadline. We are also soliciting comments regarding the impact of this proposal on overall interoperability and the impact on medical record systems. Finally, we are interested in receiving comments on whether the proposed change would be significant enough for a January 1 implementation date, which is required for all significant changes affecting Part D plans.</P>
                    <HD SOURCE="HD2">L. Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Medicare Part B covers drugs under a limited drug benefit that includes drugs and biologicals defined in section 1861(t) of the Act. Medicare Part B drugs and biologicals fall into three general categories: Drugs and biologicals furnished incident to a physician's services, drugs and biologicals administered via a covered item of durable medical equipment (DME), and other drugs and biologicals specified by statute. Payment amounts for most separately payable Medicare Part B drugs and biologicals are determined using the methodology in section 1847A of the Act, and in many cases, payment is based on the Average Sales Price (ASP) plus a statutorily mandated 6 percent add-on.</P>
                    <P>
                        Drugs (not including biologicals or biosimilar biological products, as defined in section 1847A of the Act) paid using the methodology in section 1847A of the Act fall into two broad and mutually exclusive categories: Multiple 
                        <PRTPAGE P="50262"/>
                        source drugs and single source drugs. These terms are defined in statute and are further discussed in this section and the next section. In most cases the distinction between the multiple source drugs and single source drugs is fairly straightforward and is made as outlined in program instruction published in 2007 (
                        <E T="03">https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/Downloads/051807_coding_annoucement.pdf</E>
                        ): The payment limit under section 1847A of the Act for that biological product or single source drug is based on the pricing information for products produced or distributed under the applicable FDA approval. However, for a subset of drug products approved through the pathway established under section 505(b)(2) of the FFDCA, the distinction is less straightforward.
                    </P>
                    <P>The drug approval pathway established under section 505(b)(2) of the FFDCA has existed since 1984, before the ASP payment methodology was established. The section 505(b)(2) pathway is provided for applications that contain full reports of investigations of safety and effectiveness, where at least some of the information for an approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. An application submitted pursuant to section 505(b)(2) (which we refer to as a “section 505(b)(2) application”) may rely on FDA's finding of safety and/or effectiveness for a listed drug (an approved drug product) or published literature provided that such reliance is scientifically justified and the section 505(b)(2) applicant complies with the applicable statutory and regulatory requirements, including patent certification if appropriate. Unlike an ANDA for a generic drug, a 505(b)(2) application is not required to have the same labeling as the listed (approved) drug(s) that the application relied upon. However, some drugs approved through the pathway established under section 505(b)(2) of the FFDCA (which we refer to as “section 505(b)(2) drug products”) share significant portions of the FDA-approved labeling with the listed (approved) drug(s) that the application submitted through section 505(b)(2) relied upon, for example prescribing information on safety, efficacy, and pharmacokinetics. In some cases, the section 505(b)(2) drug product shares significant portions of labeling with generic drugs that are paid as multiple source drugs under section 1847A of the Act. Examples of situations where a section 505(b)(2) drug product shares similar labeling to listed (approved) products include a sterile injectable drug product that had been sold as a lyophilized powder in a vial and was then approved for sale as a concentrated liquid in a vial, as well as a ready-to-use IV bag.</P>
                    <P>The number of drugs approved through the pathway established under section 505(b)(2) has been growing, from about 40 per year from 2011 to 2016, to about 60 in 2017, and 70 in 2018. Some of these approvals include drugs paid under Part B. Although we have assigned some section 505(b)(2) drug products to separate single source billing and payment codes, our payment approach for newly marketed section 505(b)(2) drug products, where an existing multiple source code descriptor describes the section 505(b)(2) drug product accurately, and where the active ingredient(s), the drug name, and portions of the prescribing information correspond to existing products that are assigned to and paid under a multiple source drug code, has been to assign the section 505(b)(2) drug products to the existing multiple source code. We believe that this approach, as described in more detail below, is consistent with statutory language in section 1847A of the Act. The definition of multiple source drug at section 1847A(c)(6)(C) of the Act states in part that for a multiple source drug, there are two or more drug products which are rated as therapeutically equivalent (under the FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”). For purposes of Part B drug payment under section 1847A of the Act, we interpret this to mean that if there is an existing HCPCS billing code that includes two or more drug products which are rated therapeutically equivalent and meets the remaining conditions of the definition of a multiple source drug, that billing and payment code is a multiple source drug code, and the section 505(b)(2) drug product meets the definition of a multiple source drug in section 1847A(c)(6)(C) of the Act. The statutory language in sections 1847A(b)(3) and (6) of the Act provides discretion for CMS to assign additional drug products to a multiple source drug code. In other words, if a multiple source drug code exists, CMS is permitted to assign other multiple source drug products to that code for the purpose of payment as a multiple source drug under section 1847A of the Act. We note that if the drug product is described by a multiple source code, it meets the definition of multiple source drug at section 1847A(c)(6)(C) of the Act, and it does not meet the definition of a single source drug at section 1847A(c)(6)(D) of the Act, because the definition of a single source drug expressly excludes a multiple source drug in section 1847A(c)(6)(D)(ii) of the Act.</P>
                    <P>CMS has assigned section 505(b)(2) drug products to existing multiple source drug codes for Part B payment under section 1847A of the Act in limited situations, that is, where an existing multiple source code descriptor describes the section 505(b)(2) drug product, the active ingredient(s) correspond to one another, the section 505(b)(2) drug product's labeling, particularly the prescribing information, includes information (such as the drug description, dosage and administration, pharmacokinetics, and indications) from other drug products that are paid under the multiple source drug code, and the section 505(b)(2) drug product can be used and prescribed in a manner similar to other products in the multiple source drug code. This information is used to determine whether the section 505(b)(2) drug product can be billed and paid using the existing multiple source drug code. The determination is based on the discussion in the previous paragraph, that is, if there is an existing HCPCS billing code that includes two or more drug products which are rated therapeutically equivalent and meet the remaining conditions of the definition of a multiple source drug, that billing and payment code is a multiple source drug code. Consistent with the statutory language in sections 1847A(b)(3) and (6) of the Act, which provides discretion for CMS to assign additional drug products to a multiple source drug code, a section 505(b)(2) drug product can be assigned to the multiple source drug code. The section 505(b)(2) product assigned to the multiple source drug code meets the definition of a multiple source drug in section 1847A(c)(6)(C) of the Act. Thus, for the purpose of payment under Medicare Part B, the section 505(b)(2) drug product can be billed and paid under that existing multiple source code. However, in situations where there is no existing multiple source drug code that describes a section 505(b)(2) drug product, the section 505(b)(2) drug product is typically assigned to its own single source code.</P>
                    <HD SOURCE="HD3">2. Multiple Source Drug and Single Source Drug Codes</HD>
                    <P>
                        Section 1847A of the Act uses the terms drug and drug product. Consistent with the statutory definitions discussed at section 1847A(c)(6)(C) and (D) of the Act and program instruction published in 2007 (
                        <E T="03">
                            https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/
                            <PRTPAGE P="50263"/>
                            Downloads/051807_coding_annoucement.pdf
                        </E>
                        ), we have applied the terms multiple source drug and single source drug at the billing and payment code level, meaning that “drug” corresponds to a HCPCS or other applicable billing code and its descriptor, which typically includes the active ingredient(s) of the drug. The term “drug product” corresponds to individual packages of the drug as identified by the National Drug Code or other applicable alternative identifier.
                    </P>
                    <P>The terms multiple source drug and single source drug are defined, respectively, in section 1847A(c)(6)(C) and (D) of the Act. Section 1847A(c)(6)(C) of the Act states that multiple source drug means, for a calendar quarter, a drug for which there are two or more drug products which are rated as therapeutically equivalent (under FDA's most recent publication of “Approved Drug Products with Therapeutic Equivalence Evaluations”); are pharmaceutically equivalent and bioequivalent, as determined by the FDA; and are sold or marketed in the United States during the quarter. Sections 1847A(c)(6)(E) and (F) of the Act establish conditions under which pharmaceutical equivalence and bioequivalence are met. The definition of multiple source drug in section 1847A of the Act can be interpreted to mean that once a multiple source drug code exists—that is, once there are two or more drug products that are therapeutically equivalent, pharmaceutically equivalent and bioequivalent, and CMS has assigned them to a multiple source drug code—then a subsequent product of the same drug—that is, a product that corresponds to the multiple source drug code's descriptor—can be assigned to such code even if the subsequent drug product is not, itself, therapeutically equivalent, bioequivalent or pharmaceutically equivalent. This is because in this case, the drug is multiple source, meaning that there are two or more products which are rated as therapeutically equivalent of that drug, as evidenced by the fact that the existing products are already assigned to the multiple source drug code. Once a drug product is assigned to a multiple source drug code, the product would not be assigned to a single source drug code because the definition of single source drug at section 1847A(c)(6)(D)(ii) of the Act states, in part, that a single source drug is a drug which is not a multiple source drug. Thus, when assigning drug products to multiple source and single source drug codes for the purpose of payment under section 1847A of the Act, we consider whether the product is described by an existing multiple source drug code first, and if the product is assigned to an existing multiple source drug code, its payment allowance will be determined based on the volume-weighted average ASPs of all drug products assigned to the code, rather than based solely on its own ASP (for example under a new single source code).</P>
                    <P>Sections 1847A(b)(3) and (6) of the Act provide that payment for multiple source drugs is determined for all drug products included within the same multiple source drug billing and payment code. For multiple source drugs, we calculate a volume weighted average sales price across all drug products assigned to a billing and payment code. This typically means that the ASP-based payment amount for a multiple source drug code includes generic and branded drug products within an individual code.</P>
                    <P>
                        Consistent with sections 1847A(b)(3) and (6) of the Act and our interpretation of the definition of multiple source drug in section 1847A(c)(6) of the Act, we assign certain section 505(b)(2) drug products to existing multiple source drug codes. We determine whether to assign section 505(b)(2) drug products to multiple source or single source drug codes by comparing information about the section 505(b)(2) drug product to the descriptors for existing multiple source codes to which the drug products may be assigned for the purposes of payment amount determinations under section 1847A of the Act, as well as information about products already assigned to that descriptor. This information includes the products' active ingredients and labeling, particularly the prescribing information and, if necessary, additional sources such as the FDA's Approval Summary Review, which is a part of the FDA's application review files and is available at 
                        <E T="03">https://www.accessdata.fda.gov/scripts/cder/daf/,</E>
                         and drug compendia. The FDA's Approval Summary review can provide additional details about information that is found in the drug's labeling and prescribing information and other compendia can supplement the information that is found in labeling and provide information about off label use of a drug.
                    </P>
                    <P>Our case by case determination about the assignment of certain section 505(b)(2) drug products to existing multiple source drug codes is based on the factors described in further detail in the bullet points below: First, the products' active ingredient(s), drug name and description; second, the products' labeling information; third, how they are ordered (prescribed) and used clinically. These factors are assessed as a whole, using the information (for example, active ingredient, labeling, compendia, and FDA Approval summary), to determine whether an existing multiple source drug code describes a section 505(b)(2) drug product and whether the product can be assigned to an existing multiple source drug code for the purpose of payment under section 1847A of the Act. The determination is based on the following:</P>
                    <P>• The active ingredient and drug name of the section 505(b)(2) drug product and other drug products in an existing multiple source drug code.</P>
                    <P>• The drug description and indications, particularly whether differences such as the salt form, additional ingredients, or uses exist.</P>
                    <P>The two bullet points above identify the section 505(b)(2) drug product and multiple source drug code and establish what is being compared so that the determination can proceed, if necessary. For example, if the active ingredients and drug names do not correspond, there would not be a reason to assign the section 505(b)(2) drug product to the multiple source drug code or to proceed further. We also note that the active ingredient of a drug is often included in the HCPCS code descriptor that is used to bill a drug product and to pay for it under section 1847A of the Act. The drug description is used, if necessary, to clarify what the actual active ingredient(s) are, whether there are minor differences, such as salt forms and other inactive ingredients that may affect how the product is used. This information may be helpful when considered with the information in the next two groups of bullet points as we consider labeling and uses of the drug products.</P>
                    <P>• The labeling information (and if necessary other material from sources such as the FDA's Application Review Files, including the FDA's Approval Summary Review and drug compendia), particularly pharmacokinetics, indications, adverse reactions, drug interactions, contraindications, warnings, precautions and clinical studies.</P>
                    <P>
                        The bullet point above allows us to determine whether the same information, for example the same studies, were used to support the approval of the section 505(b)(2) drug product and to gauge how much of the labeling information from existing multiple source drug products appears in the section 505(b)(2) drug product's labeling. This information also supports the determination in the next bullet 
                        <PRTPAGE P="50264"/>
                        point. The more labeling information that a section 505(b)(2) drug product has in common with drug products in an existing multiple source drug code, the more likely it is that the existing code describes the section 505(b)(2) drug product, such that CMS will assign it to that multiple source drug code for the purpose of payment under section 1847A of the Act.
                    </P>
                    <P>• The dosage and administration, pharmacokinetics, indications, contraindications, warnings, drug interactions, and adverse reactions.</P>
                    <P>The bullet point above allows us to determine whether the section 505(b)(2) drug product is ordered and used in patient care in the same way as products assigned to a multiple source drug billing code. The dosage and administration, pharmacokinetics, and indications are particularly important because we consider whether a prescriber writes a prescription for the section 505(b)(2) drug product in the same way as drug products assigned to a multiple source drug code and whether the products could be used for the same uses. Typically, a prescription includes the following information: The drug, dose, route, and frequency. The quantity of a drug (or duration of therapy) and refills are also a part of a prescription, but are less of a factor for Part B where most drugs are used incident to a physician's services. Typically, drugs used incident to a physician's services are administered and billed as a very limited number of doses, often just one, are administered during a service, and the drug is not dispensed for the patient for use over an extended time period beyond an office visit or outpatient hospital visit. The elements in the bullet point reflect how a drug is used and administered in the care of patients and in turn determine how billing for the drug is accomplished; that is, whether an existing code descriptor describes a section 505(b)(2) drug product and can be used to bill for it.</P>
                    <P>As a simple example of our approach, if the active ingredient, dose, route and frequency of the section 505(b)(2) drug product are the same as those for drug products in a multiple source drug code, then it is likely that an existing code descriptor describes a section 505(b)(2) drug product and can be used to bill for it. The information does not have to be an exact match, for example different uses of a drug product may require different doses, routes or frequencies. However, if the section 505(b)(2) drug product and the multiple source drug products in the existing multiple source drug code could both be used for the same indication (potentially by way of off-label use), then billing for both with the existing HCPCS code would still be feasible. In such situations, similarities between labeling information such as whether the same studies were used to establish pharmacokinetic parameters may factor into the assessment. In summary, the information is used as a whole to determine whether the existing multiple source drug HCPCS code descriptor describes the section 505(b)(2) drug product or if a new HCPCS code would be needed describe the product for payment under Part B.</P>
                    <P>The information described in the bullet points above is usually sufficient for our determinations, but from time to time we may reach out to the drug manufacturer, seek post marketing data, or literature sources for additional information to assist us with understanding the information in the bullet points above and to assist with determinations in complicated situations, for example where indications vary, but it appears that the section 505(b)(2) drug product could still be used, administered and billed in the same manner as drug products assigned to an existing multiple source drug code.</P>
                    <P>We are aware that some section 505(b)(2) drug products are very different from previously approved products that may be used to support their approval. We do not assign all section 505(b)(2) drug products to existing multiple source drug codes. In circumstances where an existing code does not describe the section 505(b)(2) drug product and use of the existing code would not be suitable for billing and payment of the section 505(b)(2) product under Part B based on the assessment described above, the section 505(b)(2) drug product would not be assigned to the existing multiple source drug code. The following examples illustrate how we distinguish section 505(b)(2) drug products that are assigned to an existing multiple source drug code from those that are not. If a section 505(b)(2) drug product has the same active ingredient, same dose and dosing interval, and prescribing information and includes the same clinical studies (for example, the same patient number, same response rates and same adverse reaction frequencies) as drug products assigned to an existing multiple source drug code, the section 505(b)(2) drug product would be assigned to the multiple source code. However, if the section 505(b)(2) drug product has different pharmacokinetics, for example if it is a sustained release version of a drug that permits less frequent dosing compared to drug products in an existing multiple source drug code, or if the section 505(b)(2) drug product has additional active ingredients not found in the drug products in an existing multiple source drug code, the section 505(b)(2) drug product would not be described by the existing multiple source drug code. As a result, it would not be considered a multiple source drug under section 1847A(c)(6)(C) because there would not be at least two drug products for that drug that are therapeutically equivalent, pharmaceutically equivalent and bioequivalent; thus, the section 505(b)(2) drug product would be considered a single source drug and typically assigned to a single source drug code.</P>
                    <HD SOURCE="HD3">3. Proposal To Codify Existing Policy for Section 505(b)(2) Drug Products</HD>
                    <P>
                        Our approach (described in section 2) for the payment of section 505(b)(2) drug products has been in place for at least 12 years, and it is also consistent with the concept of paying similar amounts for similar services. It is based on the definitions of multiple source drug and single source drug in sections 1847A(c)(6)(C) and (D) of the Act and authority to assign drug products to billing and payment codes in sections 1847A(b)(3) and (6) of the Act as discussed in the sections above. A number of section 505(b)(2) drug products that are described by an existing multiple source drug code are priced significantly higher than comparable products. Two recently introduced section 505(b)(2) drug products that appear to be comparable to drug products in existing multiple source drug codes (using the approach described in the section earlier) have Medicare payment allowances that are approximately 10 times higher than that of the existing multiple source code. We believe that assigning section 505(b)(2) drug products that are described by existing multiple source drug HCPCS codes to those existing HCPCS codes is consistent with efforts to curb drug prices while limiting opportunities to “game the regulatory process and the patent system in order to unfairly maintain monopolies.” 
                        <SU>69</SU>
                        <FTREF/>
                         Our approach also encourages competition among products that are competitors—that is, when they are described by one billing code and share similar labeling.
                    </P>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             
                            <E T="03">https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-blueprint-lower-drug-prices/.</E>
                        </P>
                    </FTNT>
                    <P>
                        We are concerned about high payments for section 505(b)(2) drug products if they are assigned to unique separate HCPCS codes despite being described by existing multiple source 
                        <PRTPAGE P="50265"/>
                        drug codes. We are also concerned about the effect of high payment amounts on individual beneficiaries' cost sharing payments for these products.
                    </P>
                    <P>We propose to continue assigning certain section 505(b)(2) drug products to existing multiple source drug codes if the section 505(b)(2) products are described by existing multiple source drug codes consistent with our interpretation of the definition of multiple source drug in section 1847A(c)(6)(C) of the Act and the approach described above. As discussed in the previous section, where a section 505(b)(2) product is not itself therapeutically equivalent, pharmaceutically equivalent, or bioequivalent, as determined by FDA, to another drug product, we would nonetheless consider it to meet the definition of multiple source drug if, based on an assessment of its active ingredient, labeling, compendia, and other information, the product is described by the code descriptor for an existing multiple source drug code. That is, we would assess the section 505(b)(2) drug product's active ingredient(s), drug name, and description, whether the section 505(b)(2) drug product's labeling, particularly the prescribing information, includes information from other drug products that are paid under the multiple source drug code, and whether the section 505(b)(2) drug product is used and prescribed in a manner similar to other products in the multiple source drug code, in order to determine whether the section 505(b)(2) drug product is described by an existing multiple source drug code. We would not assign all section 505(b)(2) drug products to multiple source codes and would not assign section 505(b)(2) drug products to a single source drug code exclusively made up of single source drug products. We would also reevaluate and potentially revise previous payment (and coding) decisions to maintain consistency with our proposed approach, if finalized. Consistent with these proposals, we propose to revise the definition of multiple source drug in regulation text at 42 CFR 414.902 by amending the regulation text to state that multiple source drugs may include drug products described under section 505(b)(2) of the FFDCA and adding § 414.904(k) that describes the framework for our determination as discussed in this section of the preamble. We welcome comments on our proposals.</P>
                    <HD SOURCE="HD2">M. Updates to Certified Electronic Health Record Technology Due to the 21st Century Cures Act Final Rule</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5, enacted February 17, 2009) authorized incentive payments to eligible professionals, eligible hospitals and critical access hospitals (CAHs), and Medicare Advantage (MA) organizations to promote the adoption and meaningful use of Certified Electronic Health Record Technology (CEHRT). In 2010, the Office of the National Coordinator for Health Information Technology (ONC) launched the Health IT Certification Program (Certification Program) to provide for the certification of health IT. Requirements for certification are based on standards, implementation specifications, and certification criteria adopted by the Secretary. The Certification Program supports the use of certified health IT under the programs that we administer, including, but not limited to, the Promoting Interoperability Programs (previously known as the Medicare and Medicaid EHR Incentive Programs), the Quality Payment Program (QPP), and the Hospital Inpatient Quality Reporting (IQR) Program. While these programs continue to require the use of certified health IT, the use of certified health IT has expanded to other government and non-government programs. Since 2019, for the Promoting Interoperability Programs and QPP, we have required the use of CEHRT as defined at 42 CFR 495.4 and 414.1305, respectively, which generally consists of EHR technology (which could include multiple technologies) certified under the Certification Program that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 170.102) and has been certified to certain other 2015 Edition health IT certification criteria as specified in the definition. Similarly, the Hospital IQR Program began requiring that hospitals use only 2015 Edition certification criteria for CEHRT with the CY 2019 reporting period/FY 2021 payment determination (83 FR 41607).</P>
                    <P>
                        The 21st Century Cures Act final rule that appeared in the May 1, 2020 
                        <E T="04">Federal Register</E>
                         (85 FR 25642 through 25961) finalized a number of updates to the 2015 Edition of health IT certification criteria (hereinafter referred to as the 2015 Edition Cures Update). We believe these updates to the 2015 Edition will enhance interoperability and patients' access to their electronic health information, consistent with section 4006(a) of the 21st Century Cures Act. The 21st Century Cures Act final rule both revises and adds new certification criteria that establish the capabilities and related standards and implementation specifications for the certification of health IT, as well as removing certain criteria. In this proposed rule, we propose to require that technology used to meet the CEHRT definitions must be certified in accordance with the updated certification criteria in the 21st Century Cures Act final rule.
                    </P>
                    <P>The 2015 Edition Cures Update represents a limited set of changes relative to the overall set of health IT certification criteria that we currently require for the Promoting Interoperability Programs and QPP. These changes incorporate certain technical standards, including an e-prescribing standard required for alignment with other CMS programs, and other technical updates to existing 2015 Edition functionality that is already being used by many healthcare providers. For instance, updates to 2015 Edition certification criteria that referenced the Common Clinical Data Set (CCDS) regulatory definition to reference instead the United States Core Data for Interoperability (USCDI) standard do not require extensive changes to user-facing aspects of health IT already certified to these criteria (85 FR 25665).</P>
                    <P>
                        For 2019 and subsequent years, the CEHRT definitions for the Promoting Interoperability Programs at § 495.4, and for QPP at § 414.1305, require the use of EHR technology certified under the Certification Program that meets the 2015 Edition Base EHR definition at § 170.102, and has been certified to certain other 2015 Edition health IT certification criteria as specified in the definitions, including criteria necessary to be a meaningful EHR user under the Promoting Interoperability Programs, and criteria necessary to report on applicable objectives and measures specified for the MIPS advancing care information performance category (now known as the Promoting Interoperability performance category). These updates finalized by ONC in the 21st Century Cures Act final rule impact criteria in the different elements of the CEHRT definitions, including certification criteria included in the 2015 Edition Base EHR definition for the Promoting Interoperability Program and the Quality Payment Program, as well as certification criteria necessary to be a meaningful EHR user under the Promoting Interoperability Programs, and criteria necessary to report on applicable objectives and measures 
                        <PRTPAGE P="50266"/>
                        specified for the MIPS Promoting Interoperability performance category.
                    </P>
                    <P>The 21st Century Cures Act final rule specified a number of timelines and compliance dates for health IT developers related to the 2015 Edition Cures Update. The rule finalized the removal of several certification criteria from the 2015 Edition that were also included in the Base EHR definition, upon the effective date of the final rule (June 30, 2020). For other certification criteria, the final rule finalized a limited period during which ONC-Authorized Certification Bodies (ONC-ACBs) may continue to issue certificates for these criteria to health IT developers, after which certification will no longer be available.</P>
                    <P>Where the 21st Century Cures Act final rule finalized updates to existing 2015 Edition criteria, or introduced new 2015 Edition criteria, ONC generally finalized that health IT developers will have 24 months from the publication date of the rule (until May 2, 2022) to make technology available that is certified to the updated, or new criteria. During this period, health IT developers are expected to continue supporting technology certified to the prior version of the certification criteria for use by their customers prior to implementing updates, and healthcare providers participating in the Promoting Interoperability Programs and QPP may use such technology for the purposes of these programs while working with health IT developers to implement updates in a manner that best meets their needs.</P>
                    <P>
                        On April 21, 2020, in response to the COVID-19 public health emergency, ONC announced additional flexibility for health IT developers subject to the policies in the 21st Century Cures Act final rule (
                        <E T="03">https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf</E>
                        ). Specifically, ONC announced that it will exercise enforcement discretion regarding new requirements in the 21st Century Cures Act final rule until three months after each initial compliance date or timeline. During this period of enforcement discretion, healthcare providers participating in the Promoting Interoperability Programs and QPP would continue to be able to use technology certified to the 2015 Edition criteria that has not been updated yet.
                    </P>
                    <P>Below, we provide an overview of updates in the ONC 21st Century Cures Act final rule that impact certification criteria included in the CEHRT definitions, and discuss associated timelines finalized in the 21st Century Cures Act final rule.</P>
                    <P>The 21st Century Cures Act final rule finalized removing the following criteria from the 2015 Edition of certification criteria upon the effective date of the final rule (June 30, 2020), which included removing these criteria from the 2015 Edition Base EHR definition (85 FR 25657-25660):</P>
                    <P>• “Problem list” at § 170.315(a)(6);</P>
                    <P>• “medications” at § 170.315(a)(7);</P>
                    <P>• “medication allergies” at § 170.315(a)(8); and</P>
                    <P>• “smoking status” at § 170.315(a)(11).</P>
                    <P>The final rule noted that functionality associated with these criteria is now widespread among health IT products, and is expected to remain in products absent certification. Accordingly, ONC sought to reduce burden associated with the certification program by removing these criteria (85 FR 25657 through 25660).</P>
                    <P>The 21st Century Cures Act final rule also removed the “data export” criterion at § 170.315(b)(6) from the Base EHR definition upon the effective date of the final rule (June 30, 2020) (85 FR 25668). However, this criterion will continue to be available for certification for 36 months after the publication date of the final rule. The 21st Century Cures Act final rule established a new criterion “electronic health information export” at § 170.315(b)(10). This new criterion requires a certified health IT module to electronically export all electronic health information (EHI), as defined in § 171.102, that can be stored at the time of certification by the product of which the health IT module is a part. A health IT developer of a certified health IT products which, at the time presented for certification, electronically stores EHI must certify such products to this new criterion and make these products available to their customers within 36 months after the publication of the 21st Century Cures Act final rule (by May 2, 2023). However, the new EHI Export criterion is not included in the Base EHR definition (85 FR 25690), and it is not associated with any objectives or measures in the Promoting Interoperability Programs or MIPS.</P>
                    <P>In the 21st Century Cures Act proposed rule, ONC proposed to remove several additional certification criteria associated with measures under the Promoting Interoperability Programs and MIPS from the 2015 Edition:</P>
                    <P>• “Drug-formulary and preferred drug list checks” at § 170.315(a)(10);</P>
                    <P>• “secure messaging” at § 170.315(e)(2); and</P>
                    <P>• “patient-specific education resource” at § 170.315(a)(13).</P>
                    <FP>However, in order to allow participants in the Medicaid Promoting Interoperability Program to continue to have access to technology meeting 2015 Edition certification criteria for CEHRT required to be able to meet the measures for that program, ONC stated in the 21st Century Cures Act final rule that ONC-ACBs may continue to issue certificates for these criteria until January 1, 2022 (85 FR 25660 through 25662).</FP>
                    <P>Specifically, we note that the latter two criteria are necessary for participants to meet two of the measures in the Medicaid Promoting Interoperability Program. The “secure messaging” criterion at § 170.315(e)(2) is required to meet Objective 6 (Coordination of Care through Patient Engagement) and Measure 2 (Secure Messaging) (80 FR 62852). Similarly, the “patient-specific education resource” at § 170.315(a)(13) is necessary to fulfill the requirements of Objective 5 (Patient Electronic Access to Health Information) and Measure 2 (Patient-Specific Education) (80 FR 62846). We are not proposing any changes to these measures, as the final year of the Medicaid Promoting Interoperability Program is 2021. Based on the phased approach that ONC finalized, Medicaid EPs may keep CEHRT that has been certified to those two criteria in 2021, which will enable them to report on these measures for the 2021 Medicaid Promoting Interoperability Program EHR reporting period. Health IT developers are encouraged to maintain the certified functionality for those two criteria through 2021, even if they move forward with updates to other criteria. Furthermore, the Secure Messaging measure is one of three measures within Objective 6, and EPs need only meet two of the measures (42 CFR 495.24(d)(6)(i)(B)). Even without the secure messaging functionality, an EP could meet the other two measures and fulfill the objective. There is no similar option for the Patient-Specific Education measure, which is required to meet Objective 5.</P>
                    <P>The “drug-formulary and preferred drug list checks” criterion is also currently associated with measures under the e-prescribing objective for the Medicare Promoting Interoperability Program and MIPS (80 FR 62882 and 83 FR 59817). As discussed below, since ONC will retire this criterion after January 1, 2022, this criterion would no longer be required for reporting e-prescribing measures for the Medicare Promoting Interoperability Program and MIPS, beginning in CY 2021 (85 FR 25678).</P>
                    <P>
                        The 21st Century Cures Act final rule also finalized updates to a number of certification criteria which are currently associated with objectives and measures 
                        <PRTPAGE P="50267"/>
                        under the Promoting Interoperability Program, as well as criteria that are included in the 2015 Edition Base EHR definition. In general, ONC finalized that health IT developers have 24 months from the publication date of the final rule to make technology certified to these updated criteria available to their customers (until May 2, 2022). During this time, developers are expected to continue supporting technology certified to the prior version of certification criteria for use by their customers.
                    </P>
                    <P>The 21st Century Cures Act final rule updated several criteria to include references to the USCDI standard instead of the existing CCDS definition (85 FR 25670), and implemented related technical updates (85 FR 25671). These include the following criteria that may be applicable for a healthcare provider's technology to satisfy the CEHRT definitions:</P>
                    <P>• “Transitions of care” at § 170.315(b)(1);</P>
                    <P>• “clinical information reconciliation and incorporation” at § 170.315(b)(2);</P>
                    <P>• “view, download, and transmit to 3rd party” at § 170.315(e)(1);</P>
                    <P>• “transmission to public health agencies—electronic case reporting” at § 170.315(f)(5); and</P>
                    <P>• “application access—all data request” at § 170.315(g)(9).</P>
                    <P>
                        The USCDI standard establishes a set of data classes and constituent data elements required to support interoperability nationwide and is designed to be expanded in an iterative and predictable way over time.
                        <SU>70</SU>
                        <FTREF/>
                         In finalizing version 1 of the USCDI, the 21st Century Cures Act final rule added three new data classes, “allergies and intolerances,” “clinical notes,” and “provenance;” and added several additional elements to “patient demographics” that were not defined in the CCDS (85 FR 25912).
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             For more information about the USCDI, see 
                            <E T="03">https://www.healthit.gov/isa/united-states-core-data-interoperability-uscdi.</E>
                        </P>
                    </FTNT>
                    <P>With respect to the use of secure, standards-based APIs, the 21st Century Cures Act final rule finalized a new standards-based API criterion at §  170.315(g)(10), “standardized API for patient and population services,” which requires the use of FHIR Release 4 and several implementation specifications (85 FR 25742). Developers must make technology certified to this criterion available 24 months after the publication of the final rule (by May 2, 2022). This criterion replaces the existing “application access—data category request” certification criterion at §  170.315(g)(8). However, ONC-ACBs may continue to issue certificates for §  170.315(g)(8) for 24 months after the publication date of the final rule, permitting certification to both criteria during this transition period. The 21st Century Cures Act final rule also added the new API criterion at §  170.315(g)(10) to the 2015 Edition Base EHR definition.</P>
                    <P>The 21st Century Cures Act final rule also revised the “electronic prescribing” criterion at § 170.315(b)(3) to reference the NCPDP SCRIPT standard version 2017071 (85 FR 25678). As with the other updated criteria above, health IT developers have until 24 months after publication of the final rule (until May 2, 2022), to make technology certified to the updated criterion available to their customers. However, we note that ONC has discontinued certification of new products to the former electronic prescribing criterion using the NCPDP SCRIPT standard version 10.6, in order to align with CMS requirements for use of the updated NCPDP SCRIPT standard under Part D, adopted as of January 1, 2020 (85 FR 25679). Products that were previously certified may maintain certification status for up to 24 months as they are updating their products, and healthcare providers may continue to use these certified health IT modules for CMS program participation.</P>
                    <P>Finally, the 21st Century Cures Act final rule updated the certification criterion for clinical quality measures “Clinical Quality Measures (CQMs)—Report” at § 170.315(c)(3), which is included in the CEHRT definitions (85 FR 25686). These updates remove the HL7 QRDA standard requirements from the criterion, and instead require support for the CMS QRDA Implementation Guides, upon the effective date of the final rule (June 30, 2020).</P>
                    <P>For further discussion, we refer readers to the 21st Century Cures Act final rule at 85 FR 25642 through 25961.</P>
                    <P>As noted above, in general, health IT developers have up to 24 months from May 1, 2020 to make technology certified to the updated criteria available to their customers, plus the additional three-month period during which ONC will exercise enforcement discretion around compliance dates finalized in the 21st Century Cures Act final rule in response to the COVID-19 PHE. As a result, where the 21st Century Cures Act final rule requires health IT developers to make technology meeting new and updated certification criteria available by May 2, 2022, developers taking advantage of enforcement discretion would be permitted to delay making updated certified technology available until August 2, 2022. After this date, technology that has not been updated in accordance with the 2015 Edition Cures Update will no longer be considered certified.</P>
                    <P>
                        ONC expects that developers will introduce these updates into certified health IT products in the manner most appropriate for their customers, including through the course of normal maintenance, and developers are required to notify customers when technology certified to the updated criteria is available (85 FR 25642). As discussed in the 21st Century Cures Act final rule (85 FR 25666), healthcare providers may use the Certified Health IT Product List (CHPL) to identify the specific certification status of a product at any given time. The CHPL will distinguish existing 2015 Edition certification criteria from the new or revised criteria adopted in the 21st Century Cures Act final rule by referring to the new or revised criteria as the 2015 Edition Cures Update, allowing healthcare providers to identify if and when a specific Health IT Module has been updated. (
                        <E T="03">https://chpl.healthit.gov/</E>
                        )
                    </P>
                    <HD SOURCE="HD3">2. Updates to Certified Electronic Health Record Technology Requirements in the Promoting Interoperability Program, and Quality Payment Program Due to the 21st Century Cures Act Final Rule</HD>
                    <P>In consideration of the updates made to the certification criteria as described in section III.N.1 of this proposed rule, we propose that the technology used by healthcare providers to satisfy the definitions of CEHRT at §§ 495.4 and 414.1305 must be certified under the Certification Program in accordance with the updated 2015 Edition of health IT certification criteria as finalized in the 21st Century Cures Act final rule (85 FR 25642). This would include technology used to meet the 2015 Edition Base EHR definition at § 170.102, technology certified to the criteria necessary to be a meaningful EHR user under the Promoting Interoperability Programs, and technology certified to the criteria necessary to report on applicable objectives and measures specified for the MIPS Promoting Interoperability performance category, as specified in the CEHRT definitions.</P>
                    <P>
                        As discussed above, the 21st Century Cures Act final rule finalized certain compliance dates for health IT developers, as well as establishing which versions of certification criteria meet certification requirements under the Certification Program for healthcare providers, based on those compliance dates. In other words, the 21st Century Cures Act final rule established 
                        <PRTPAGE P="50268"/>
                        timelines for (1) a transition period where technology certified to not-yet updated or updated versions of the same certification criteria would be considered certified, and (2) the date for which technology certified to only the updated version would be considered certified. A healthcare provider must use technology that is certified under the ONC Health IT Certification Program to meet the CEHRT definitions. Therefore, we propose that healthcare providers participating in the Promoting Interoperability Programs or QPP would be required to use only technology that is considered certified under the ONC Health IT Certification Program according to the timelines finalized in the Cures Act final rule.
                    </P>
                    <P>For updated and new certification criteria included in the CEHRT definitions in §§ 495.4 and 414.1305, ONC has finalized that health IT may be certified to the current 2015 Edition certification criteria or the 2015 Edition Cures Update for a period of 24 months, as described in timelines finalized in the 21st Century Cures Act final rule (85 FR 25670). ONC then announced an additional 3 months during which ONC will exercise enforcement discretion in response to the COVID-19 PHE and continue to allow health IT certified to either version of the criteria to be considered certified. Therefore, under our proposal, during that same time period (up to 27 months from May 1, 2020, or until August 2, 2022), program participants may use technology certified to either version and that health IT will be considered certified under the ONC Health IT Certification Program.</P>
                    <P>While the 21st Century Cures Act final rule did not finalize a new Edition of certification criteria, this approach is similar to the prior policy for transition periods between Editions. For example, during the transition period in which the ONC Health IT Certification Program included both the 2014 Edition and the 2015 Edition, a health IT module certified to either Edition was considered certified and could be used by healthcare providers to meet the CEHRT definitions and demonstrate meaningful use (for instance, see 82 FR 38490 for a discussion of the CY 2018 transition between the 2014 and 2015 Editions for eligible hospitals and CAHs). After the end of the transition period, only health IT certified to the 2015 Edition could be used by healthcare providers to meet the CEHRT definitions and demonstrate meaningful use, and health IT modules certified to only the 2014 Edition were no longer considered certified under the ONC Health IT Certification Program.</P>
                    <P>In the same manner, after the current transition period ends in which health IT certified to either the existing 2015 Edition certification criteria or the 2015 Edition Cures Update criteria is considered certified, healthcare providers must use technology certified to only the updated version of the certification criteria finalized in the 21st Century Cures Act final rule to meet the CEHRT definitions and demonstrate meaningful use.</P>
                    <P>We provide the following discussion to support further understanding of how our proposals would impact healthcare providers with regard to the CEHRT definitions at §§ 495.4 and 414.1305 and demonstrating meaningful use. If our proposal is finalized, healthcare providers would only be able to use CEHRT that has been certified to the 2015 Edition Cures Update in order for a measure action to count in the numerator during a performance period after August 2, 2022 (reflecting the 24-month compliance deadlines finalized in the 21st Century Cures Act final rule, and the additional 3-month period of enforcement discretion described above). On or prior to August 2, 2022, healthcare providers participating in the Medicare Promoting Interoperability Program and QPP would be able to continue to use technology meeting existing 2015 Edition criteria to meet the CEHRT definition and to support program participation. During this period, healthcare providers could work with their health IT developers to plan for implementing CEHRT that meets the 2015 Edition Cures Update as soon as health IT developers make updated technology available. We believe this approach to updating the current 2015 Edition would allow healthcare providers and health IT developers adequate time to implement updates and plan for an effective transition, including planning ahead for reporting measure results to CMS for program participation.</P>
                    <P>For instance, during the CY2022 performance year, if a healthcare provider is implementing updates in a phased approach, they could plan to use a combination of updated and non-updated certified health IT for a 90-day reporting period prior to August 2, 2022, and then complete their first reporting period using only updated health IT modules in CY 2023. Similarly, if a healthcare provider planned to update all of their certified technology at one time and to engage in a more extensive testing and implementation period during CY 2022, they may also wish to complete a 90-day reporting period for CY 2022 prior to August 2 using non-updated health IT, and then complete their first reporting period using only updated health IT modules in CY 2023. If a healthcare provider moved to updated certified health IT prior to August 2, including for a reporting period in CY 2020 or CY 2021, they would be able to use the updated technology for a 90-day reporting period at any point, and would not be required to wait until after August 2, 2022.</P>
                    <P>Healthcare providers should refer to certification criteria and Conditions and Maintenance of Certification requirements in 45 CFR part 170 for details about the updated certification criteria and timelines for health IT developers associated with the criteria. These ONC Health IT Certification Program regulations specify the requirements for what health IT developers must make available to customers and associated timelines.</P>
                    <P>
                        In previous rulemaking, to assist readers in identifying the requirements of CEHRT for the Promoting Interoperability Program and the MIPS Promoting Interoperability performance category objectives and measures, we provided tables identifying the 2015 Edition certification criteria required to meet those objectives and measures (for instance, see 83 FR 59817 for the MIPS Promoting Interoperability performance category). We note two instances in which updates in the 21st Century Cures Act final rule will affect information we have provided in past rulemaking regarding the certification criteria which support specific Promoting Interoperability objectives and measures. First, we note that the 21st Century Cures Act final rule is retiring the “drug-formulary and preferred drug list checks” criterion at § 170.315(a)(10), which is currently identified as supporting measures under the e-prescribing objective (80 FR 62882 and 83 FR 59817). ONC has finalized that health IT may be certified to this criterion only until January 1, 2022. (85 FR 25667) We believe the removal of this criterion from the Certification Program will have negligible impact on healthcare providers. As discussed in prior rulemaking related to the use of these functionalities by participants in CMS programs, healthcare providers have noted that while formulary checks are a promising approach, the utility of the specific functionality that is certified is not necessarily consistently applicable for all prescriptions (80 FR 62833). In addition, as it does not remove the product from the market, any healthcare providers who are using the current functionality may continue to use the technology for their purposes. Accordingly, we note that this certification criterion would no longer 
                        <PRTPAGE P="50269"/>
                        be associated with the measures under the e-prescribing objective for the Promoting Interoperability Programs and MIPS, beginning with the CY 2021 performance period.
                    </P>
                    <P>Second, under the new API certification criterion, “standardized API for patient and population services” at § 170.315(g)(10), which requires the use of FHIR Release 4, health IT developers have 24 months from the publication date of the 21st Century Cures Act final rule to make technology available that is certified to this new criterion, which is part of the 2015 Edition Base EHR definition. After 24 months, ONC will retire the current “application access—data category request” at § 170.315(g)(8), which is currently identified as supporting the “Provide Patients Electronic Access to Their Health Information” measure (80 FR 62882 and 83 FR 59817). As discussed above, health IT meeting either criteria will be considered certified during the 24-month period. Table 38 shows that either the existing criterion at § 170.315(g)(8), or the newly finalized criterion at § 170.315(g)(10), could be used by healthcare providers to complete the actions of the “Provide Patients Electronic Access to Their Health Information” measure for the Promoting Interoperability Programs and MIPS. Allowing healthcare providers the flexibility of using EHR technology that is certified to either criterion during this 2-year transition period would allow early adopters of the newly finalized criterion at § 170.315(g)(10), as well as those using technology meeting the existing certification criterion, to be able to meet the requirements of the Promoting Interoperability Programs and MIPS.</P>
                    <P>In light of the changes described above with respect to the “E-prescribing” and “Provide Patients Electronic Access to Their Health Information” measures and objectives for the Medicare Promoting Interoperability Program and the MIPS Promoting Interoperability performance category, we are including Table 38, which provides details on the measures for the Promoting Interoperability Program for eligible hospitals and CAHs and the MIPS Promoting Interoperability performance category and the certification criteria that support each measure. We also include in Table 38 the certification criteria which support reporting of eCQMs. We note that Table 38 is only applicable for the measures under the Medicare Promoting Interoperability Program and for the Promoting Interoperability performance category of MIPS, and that Table 38 does not include all of the updated certification criteria included in the CEHRT definition as discussed in this proposed rule. For further discussion of changes to criteria under the CEHRT definition, we refer readers to the 21st Century Cures Act final rule (85 FR 25667).</P>
                    <GPH SPAN="3" DEEP="439">
                        <PRTPAGE P="50270"/>
                        <GID>EP17AU20.072</GID>
                    </GPH>
                    <P>Last, we are proposing to revise two definitions of under § 414.1305. First, under the definitions of CEHRT, we propose to replace the reference to the “Advancing Care Information” performance category with the “Promoting Interoperability” performance category, to reflect the performance category name change that we made previously (83 FR 59785). Second, under the definition of Meaningful EHR user for MIPS, we propose to replace the reference to the “Advancing Care Information” performance category with the “Promoting Interoperability” performance category, to reflect the performance category name change that we made previously (83 FR 59785).</P>
                    <P>We believe each of these proposals supports our focus on promoting interoperability and continued alignment, and would reduce healthcare provider burden while providing flexibility to pursue innovative applications that improve care delivery. We are seeking public comment on all of the proposals discussed above.</P>
                    <HD SOURCE="HD3">3. Proposed Changes to Certification Requirements Under the Hospital IQR Program Due to the 21st Century Cures Act</HD>
                    <HD SOURCE="HD3">a. Background and Previously Finalized Certification Requirements</HD>
                    <P>
                        To measure the quality of hospital inpatient services, we implemented the Hospital IQR Program, previously referred to as the Reporting Hospital Quality Data for Annual Payment Update (RHQDAPU) Program. We refer readers to the FY 2010 IPPS/LTCH PPS final rule (74 FR 43860 through 43861) and the FY 2011 IPPS/LTCH PPS final rule (75 FR 50180 through 50181) for detailed discussions of the history of the Hospital IQR Program, including the statutory history, and to the FY 2015 IPPS/LTCH PPS final rule (79 FR 50217 through 50249), the FY 2016 IPPS/LTCH PPS final rule (80 FR 49660 through 49692), the FY 2017 IPPS/LTCH PPS final rule (81 FR 57148 through 57150), the FY 2018 IPPS/LTCH PPS final rule (82 FR 38326 through 38328 and 82 FR 38348), the FY 2019 IPPS/LTCH PPS final rule (83 FR 41538 through 41609), and the FY 2020 IPPS/LTCH PPS final rule (84 FR 42448 through 42509) for the measures we have previously adopted for the Hospital IQR Program measure set for the FY 2022 payment determination and subsequent years. We also refer readers to 42 CFR 412.140 for Hospital IQR Program regulations.
                        <PRTPAGE P="50271"/>
                    </P>
                    <P>The Hospital IQR Program strives to put patients first by empowering patients to make decisions about their own healthcare along with their clinicians using information from data driven insights that are increasingly aligned with meaningful quality measures. We support technology that reduces burden and allows clinicians to focus on providing high quality healthcare for their patients. We also support innovative approaches to improve quality, accessibility, and affordability of care, while paying particular attention to improving clinicians' and beneficiaries' experiences when interacting with CMS programs. In combination with other efforts across the Department of Health and Human Services, we believe the Hospital IQR Program incentivizes hospitals to improve healthcare quality and value, while giving patients the tools and information needed to make the best decisions for themselves. The Hospital IQR Program measures assess clinical processes, patient safety and adverse events, patient experiences with care, care coordination, and clinical outcomes, as well as cost of care.</P>
                    <P>For each Hospital IQR Program payment determination, we require that hospitals submit data on each specified measure in accordance with the measure's specifications for a particular period. Hospital IQR Program file format requirements have progressed over time to support quality reporting based on data submitted from EHRs that use relevant, up-to-date, standards-based structured data capture. We updated our requirements with the adoption of new Editions of certified health IT, originally requiring hospitals submitting eCQM data to use the 2014 Edition certification criteria for CEHRT (79 FR 50252) and evolving to the current requirement that hospitals use 2015 Edition certification criteria for CEHRT for reporting eCQMs and hybrid measures (83 FR 41604 through 41607, and 84 FR 42507). In order to ease the transition between Editions of certified health IT, the Hospital IQR Program offered flexibility in file submission requirements, allowing the use of either the 2014 Edition or the 2015 Edition for multiple reporting periods (80 FR 49705 through 49708; 81 FR 57169 through 57170; 82 FR 38397 through 38391). As we stated in the FY 2017 IPPS/LTCH PPS final rule (81 FR 57111), our goal is to align electronic quality measure requirements of the Hospital IQR Program with various other Medicare and Medicaid programs, including those authorized by the Health Information Technology for Economic and Clinical Health (HITECH) Act, as much as feasible so that the reporting burden on healthcare providers will be reduced (82 FR 38392). In the past we noted that aligning the eCQM submission requirements of the Hospital IQR Program and the Promoting Interoperability Programs reduces burden for hospitals as they may report once and fulfill the requirements of both programs (84 FR 42599). We intend to continue to align the eCQM reporting requirements for the Hospital IQR Program and Promoting Interoperability Programs to reduce reporting burden (84 FR 42598 through 42601; 82 FR 38479).</P>
                    <HD SOURCE="HD3">b. Proposed Changes</HD>
                    <P>Recently, through the 21st Century Cures Act final rule published on May 1 2020, ONC updated the 2015 Edition of health IT certification criteria (“2015 Edition Cures Update”). Specifically, the 21st Century Cures Act final rule finalized updates to existing 2015 Edition criteria and introduced new 2015 Edition criteria. As noted above in section III.N.1, in general, health IT developers have up to 24 months from May 1, 2020 to make technology certified to the updated and/or new criteria available to their customers. During this period, health IT developers are expected to continue supporting technology certified to the prior version of the certification criteria for use by their customers prior to updating their products (85 FR 25642 through 25961).</P>
                    <P>
                        In April 2020, ONC announced its intention to exercise enforcement discretion as to the compliance dates finalized in the 21st Century Cures Act final rule.
                        <SU>71</SU>
                        <FTREF/>
                         As a result, where the 21st Century Cures Act final rule requires health IT developers to make technology meeting new and updated certification criteria available by May 2, 2022, developers taking advantage of enforcement discretion may be permitted to delay making updated certified technology available until August 2, 2022. After that date, technology that has not been updated in accordance with the 2015 Edition Cures Update will no longer be considered certified.
                    </P>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             
                            <E T="03">https://www.healthit.gov/cures/sites/default/files/cures/2020-04/Enforcement_Discretion.pdf.</E>
                        </P>
                    </FTNT>
                    <P>Given the Hospital IQR Program's history of updating file submission requirements, we understand that transitioning to technology certified to a new Edition, or to an updated version of the same Edition of certification criteria, can be complex. Nevertheless, we believe that there are many benefits to using relevant, up-to-date, standards-based structured data capture with an EHR to support electronic clinical quality measurement. In addition, we believe it is important to continue to align with the eCQM reporting requirements for the Promoting Interoperability Programs (82 FR 38479, 84 FR 42598).</P>
                    <P>In this proposed rule for the Hospital IQR Program beginning with the CY 2020 reporting period/FY 2023 payment determination and for subsequent years, we are proposing to expand flexibility to allow hospitals to use either: (1) Technology certified to the 2015 Edition criteria for CEHRT as was previously finalized in the FY 2019 IPPS/LTCH final rule (83 FR 41537-41608), or (2) technology certified to the 2015 Edition Cures Update standards as finalized in the 21st Century Cures Act final rule(85 FR 25642 through 25961). We also refer readers to sections III.N.1 and III.N.2 for background and more details about the 2015 Edition Cures Update. We are proposing to adopt this flexible approach in order to encourage hospitals to implement the most up-to-date, standards-based structured data capture while also maintaining alignment with the Promoting Interoperability Program proposal. This proposal would allow hospitals that are early adopters of health IT certified to the 2015 Edition Cures Update criteria for CEHRT to implement those changes while still meeting Hospital IQR Program requirements. As mentioned above, in the 21st Century Cures Act final rule, ONC finalized that health IT developers will have 24 months from the publication date of the rule (that is, until May 2, 2022) to make technology available that is certified to the updated, or new criteria. We will revisit this topic in future rulemaking as necessitated by additional changes by ONC (for example should ONC only allow certification under the 2015 Edition Cures Update). We are seeking public comment on our proposal.</P>
                    <P>
                        We note that, among other changes and of particular relevance to hospitals that participate in the Hospital IQR Program, the ONC 21st Century Cures Act final rule revises the clinical quality measurement criterion at § 170.315(c)(3) to refer to CMS QRDA Implementation Guides and removes the Health Level 7 (HL7®) QRDA standard requirements (85 FR 25645). Under the Hospital IQR Program, we previously encouraged health IT developers to test any updates on an annual basis, including any updates to the eCQMs and eCQM reporting requirements for the Hospital IQR Program based on the CMS QRDA I Implementation Guide for Hospital Quality Reporting (CMS Implementation Guide for QRDA) (82 FR 38393). The 
                        <PRTPAGE P="50272"/>
                        CMS Implementation Guide for QRDA, program specific performance calculation guidance, and eCQM electronic specifications and guidance documents are available on the eCQI Resource Center website at 
                        <E T="03">https://ecqi.healthit.gov/.</E>
                         To be clear, the 21st Century Cures Act final rule removes the HL7® QRDA standards from the relevant health IT certification criteria, which now refers directly to the CMS Implementation Guides for QRDA standards bringing their requirements into closer alignment with what we encourage under the Hospital IQR Program. Based on our data, the majority of Hospital IQR Program participants already use the CMS QRDA I Implementation Guide for Hospital Quality Reporting for submission of eCQMs to the Hospital IQR Program. We believe this update results in health IT developers no longer needing to maintain certification to the Health Level 7 (HL7®) QRDA base standards in addition to using the CMS QRDA I Implementation Guide for the Hospital IQR Reporting.
                    </P>
                    <HD SOURCE="HD2">N. Proposal To Establish New Code Categories</HD>
                    <HD SOURCE="HD3">1. Background</HD>
                    <P>Currently, there are four existing HCPCS Level II codes for buprenorphine/naloxone products (J0572-J0575), which describe groupings of products by different strengths as indicated on their FDA labels. When many payers assign a single payment rate to a single code, they typically do so under the expectation that the products can be substituted for one another in most clinical scenarios. We have received feedback from stakeholders that there is variability in bioequivalence between the products within the range of strengths listed in each code descriptor, meaning that products within a current code are not necessarily substitutes for one another, that is, they are not therapeutically equivalent. Therefore, to facilitate more accurate coding and more specific reporting of the variety of buprenorphine/naloxone products on the market, we are proposing an expanded series of codes to identify buprenorphine/naloxone products.</P>
                    <P>Specifically, we propose to establish 15 new code categories for use to report all currently marketed buprenorphine/naloxone products, based on strength as well as therapeutic equivalence reflected in Table 39.</P>
                    <GPH SPAN="3" DEEP="286">
                        <GID>EP17AU20.073</GID>
                    </GPH>
                    <P>As the existing 4 codes would be replaced with more specific codes in the new code series, we also propose to discontinue the existing codes in Table 40.</P>
                    <GPH SPAN="3" DEEP="85">
                        <GID>EP17AU20.074</GID>
                    </GPH>
                    <PRTPAGE P="50273"/>
                    <P>The new code series would permit physicians and clinics to accurately bill insurers for the drug and dose utilized. For example, state Medicaid agencies would be able to more easily identify the drug dispensed, which would facilitate more efficient and accurate rebate invoicing for the Medicaid Drug Rebate Program. The expanded code series would also facilitate more specific and meaningful tracking of utilization of buprenorphine/naloxone products within and across their respective health insurance programs. We note that these coding proposals do not change Medicare coverage or payment policies for oral or sublingual buprenorphine codes. The drug products described by these codes are not separately payable under Medicare Part B.</P>
                    <HD SOURCE="HD2">O. Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy</HD>
                    <P>We propose to amend our regulation at § 410.79(e) to create more flexible MDPP policies that will apply during certain emergencies (Emergency Policy). In addition, we propose to amend § 424.210 to modify the definition of “beneficiary engagement period” and to address beneficiary engagement incentives that are furnished to MDPP beneficiaries who are receiving MDPP services virtually pursuant to the Emergency Policy.</P>
                    <HD SOURCE="HD3">1. Proposed Changes to § 410.79(b)</HD>
                    <P>Through this proposed rule, we are proposing to amend the Medicare Diabetes Prevention Program (MDPP) expanded model to revise certain MDPP policies adopted in the March 31st COVID-19 IFC (85 FR 19230) that would apply during the remainder of the COVID-19 Public Health Emergency (PHE) and/or any future emergency period, and in an emergency area, as such terms are defined in section 1135(g) of the Act, where the Secretary has authorized section 1135 waivers for such emergency area and period (hereinafter referred to as an “1135 waiver event”) where such 1135 waiver event may cause a disruption to in-person MDPP services (hereinafter referred to as an “applicable 1135 waiver event”). We propose that we would determine that an 1135 waiver event could disrupt in-person MDPP services if MDPP suppliers would likely be unable to conduct classes in-person, or MDPP beneficiaries would likely be unable to attend in-person classes, for reasons related to health, safety, or site availability or suitability. Health and safety reasons may include avoiding the transmission of contagious diseases, compliance with laws and regulations during an 1135 waiver event, or the physical safety of MDPP beneficiaries or MDPP coaches as defined in § 424.205(a), during an 1135 waiver event. We propose that if we determine that an 1135 waiver event may disrupt in-person MDPP services, we would notify all impacted MDPP suppliers via email and other means as appropriate. Such notice would include the effective date when flexibilities described in § 410.79(e) would be available. We propose that the applicable 1135 waiver event would end on the earlier of the end of the emergency period (as defined in section 1135(g) of the Act) or the date we determine that the 1135 waiver event no longer disrupts in-person MDPP services under the proposed standard described above.</P>
                    <P>We temporarily amended the MDPP expanded model to revise certain MDPP policies in the March 31st COVID-19 IFC. These changes apply only during the COVID-19 PHE. The March 31st COVID-19 IFC permits certain beneficiaries to obtain the set of MDPP services more than once per lifetime, waives the 5 percent weight loss eligibility requirements, and allows certain MDPP suppliers to either pause the delivery of services or deliver virtual MDPP sessions on a temporary basis. We believe that establishing an Emergency Policy that applies more broadly will improve the current flexibilities for the remainder of the COVID-19 PHE and provide MDPP suppliers and MDPP beneficiaries with flexibilities to address any future applicable 1135 waiver events.</P>
                    <P>The proposed changes herein would preserve the March 31st COVID-19 IFC MDPP flexibilities and apply them to future 1135 waiver events, provide for additional flexibilities that would apply during the COVID-19 PHE and future 1135 waiver events, clarify certain policies adopted in the IFC, and end a flexibility that would become unnecessary in light of our other proposals. If finalized, the proposed flexibilities would supersede the flexibilities finalized in the March 31st COVID-19 IFC for the COVID-19 PHE, if the PHE is still in place when the CY 2021 PFS final rule becomes effective. If finalized, the proposed changes would be available to all future applicable 1135 waiver events, effective January 1, 2021.</P>
                    <P>We are proposing these changes to address MDPP supplier and MDPP beneficiary needs in response to the COVID-19 PHE and any future 1135 waiver events that result in an interruption to expanded model services delivered by MDPP suppliers and preventing MDPP beneficiaries from attending in-person sessions. Throughout the original rulemaking for the MDPP expanded model, we sought to ensure that the set of MDPP services would be delivered in-person, in a classroom-based setting, within an established timeline. During that rulemaking, CMS prioritized establishing a structured service that, when delivered within the confines of the rule, would create the least risk of fraud and abuse, increase the likelihood of success for beneficiaries, and maintain the integrity of the data collected for evaluation purposes. Based on lessons learned during the COVID-19 PHE, we propose to allow temporary flexibilities that prioritize availability and continuity of services for MDPP suppliers and beneficiaries affected by extreme and uncontrollable circumstances that CMS determines may disrupt in-person MDPP services during an applicable 1135 waiver event using the standard articulated above. The overall intent of the proposed Emergency Policy is to minimize disruption of services for MDPP suppliers and beneficiaries.</P>
                    <P>
                        The flexibilities proposed in this rule would be applicable to all MDPP beneficiaries and MDPP suppliers (as such terms are defined in § 410.79(b)). Although our Emergency Policy will permit MDPP services to be furnished entirely on a virtual basis, our Emergency Policy does not permit an MDPP supplier to furnish MDPP services virtually during the COVID-19 PHE or an applicable 1135 waiver event unless the MDPP supplier's preliminary or full CDC DPRP recognition authorizes the supplier to furnish services in-person. The MDPP supplier requirements at § 424.205 set forth parameters for suppliers to enroll in Medicare, including having any preliminary recognition established by the CDC for the purposes of the DPRP or full CDC DPRP recognition. The DPRP refers to a program administered by the CDC that recognizes organizations that are able to furnish the National Diabetes Prevention Program (National DPP) services, follows a CDC-approved curriculum, and meets CDC's performance standards and reporting requirements. The CDC assigns to each DPRP-recognized supplier an organizational code that specifies the service delivery mode (for example, in-person, online, distance learning, or combination). Because MDPP services are covered under Medicare only when they are furnished at least in part in-person, a supplier that does not have an organizational code authorizing in-person services (“virtual-only suppliers”) may not provide MDPP 
                        <PRTPAGE P="50274"/>
                        services, either virtually or in-person. We do not believe it is appropriate to permit virtual-only suppliers to furnish MDPP services when the proposed Emergency Policy is in effect. This is because MDPP suppliers must remain prepared to resume delivery of MDPP services in-person when the proposed Emergency Policy is no longer in effect. Given the difficulty of predicting when the COVID-19 PHE or any applicable 1135 waiver event will end, virtual-only suppliers may not have sufficient time to obtain the CDC's authorization to furnish in-person services. Permitting virtual-only suppliers to furnish MDPP services during the COVID-19 PHE or an applicable 1135 waiver event could disrupt the provision of services to MDPP beneficiaries when services must resume on an in-person basis.
                    </P>
                    <P>We are proposing to amend the MDPP regulations to provide for certain changes, including allowing MDPP suppliers to start new cohorts and allowing MDPP suppliers to either deliver MDPP services virtually or suspend in-person services and resume services at a later date during an applicable 1135 waiver event. In addition, these proposed changes permit certain MDPP beneficiaries to obtain the set of MDPP services more than once per lifetime, for the limited purposes of allowing a suspension in service due to an applicable 1135 waiver event and to provide the flexibilities that will allow MDPP beneficiaries to maintain eligibility for MDPP services despite a break in attendance.</P>
                    <P>In the March 31st COVID-19 IFC, we stated that we would allow MDPP suppliers to either deliver MDPP services virtually or suspend in-person services and resume services at a later date. In addition, we also provided in the March 31st COVID-19 IFC that the once per lifetime requirement waiver is only applicable to MDPP beneficiaries whose sessions were suspended or cancelled due to the PHE (that is, MDPP beneficiaries who were receiving the set of MDPP services as of March 1, 2020). However, we do not believe it is necessary to permit all MDPP beneficiaries to restart the set of MDPP services in all applicable 1135 waiver events, particularly if they elect to continue to receive services virtually. Therefore, we are proposing that MDPP beneficiaries who elect to receive MDPP services virtually in accordance with the MDPP Emergency Policy are not eligible to restart the set of MDPP services at a later date. This proposed policy would ensure that MDPP beneficiaries who continue to receive the set of MDPP services virtually during in an applicable 1135 waiver event cannot repeat the set of MDPP services at a later date, in accordance with the general once per lifetime limitation for the set of MDPP services established in § 410.79(c)(1)(i)(B).</P>
                    <P>We propose the following approach for permitting MDPP beneficiaries to resume or restart the set of MDPP services in the event in-person sessions are suspended, and the MDPP beneficiary does not elect to receive MDPP services virtually. MDPP beneficiaries who are in the first 12 months of the set of MDPP services as of the start of an applicable 1135 waiver event would be eligible to restart the set of MDPP services either at the beginning, or resume with the most recent attendance session of record, after the applicable 1135 waiver event has ended. MDPP beneficiaries who are in the second year of the set of MDPP services as of the start of the 1135 waiver event, would only be permitted to resume the set of MDPP services with the most recent attendance session of record. MDPP beneficiaries who are in the second year of the set of MDPP services would not be allowed to restart the set of MDPP services at the beginning.</P>
                    <P>We do not believe allowing MDPP beneficiaries who are already in the ongoing maintenance phase of MDPP to restart from the beginning aligns with the performance-based payment strategy upon which the expanded model relies to achieve savings. MDPP suppliers with beneficiaries who have successfully completed over half of the set of MDPP services have already benefited from the bulk of the permitted total performance-based payments. Allowing MDPP beneficiaries in the ongoing maintenance interval phase to restart the expanded model would result in an MDPP supplier being reimbursed for close to double the intended payment amount. Not only might this have a negative impact on the long term expanded model savings, this could result in beneficiaries being unfairly coerced into electing to start over instead of resuming the set of MDPP services where they left off. This proposal would apply prospectively only—that is, under the current MDPP regulations, as implemented in the IFC, we waived the once per lifetime requirement for MDPP beneficiaries who were receiving the set of MDPP services as of March 1, 2020 and whose sessions were suspended or canceled due to the COVID-19 PHE to obtain the set of MDPP services more than once per lifetime by electing to restart the set of MDPP services or resume with the most recent attendance session of record. We would retain that flexibility for those MDPP beneficiaries who were receiving the set of MDPP services as of March 1, 2020, as specified in current § 410.79(e)(3)(iii), which we are proposing to revise and renumber as § 410.79(e)(vi)(A). Finally, we propose that beneficiaries who elect to suspend the set of MDPP services at the start of an 1135 waiver event and subsequently choose to restart the MDPP set of services at the beginning or to resume with the most recent attendance session of record, may only make such an election once per 1135 waiver event. This proposed policy intends to ensure that MDPP beneficiaries may not suspend and re-start the MDPP set of services multiple times during the same 1135 waiver event, which would be contrary to the overall goal of the MDPP Emergency Policy, and to the goals of the MDPP expanded model as a whole.</P>
                    <P>
                        We are proposing that the limit placed on the number of virtual make-up sessions described at § 410.79 would not apply during the remainder of the COVID-19 PHE or during any future applicable 1135 waiver event, so long as the virtual services are furnished in a manner that is consistent with the CDC DPRP standards for virtual sessions, follow the CDC-approved National DPP curriculum requirements, and the supplier has an in-person DPRP organizational code. We propose to amend the regulations to clarify that all sessions, including the first core session, may be offered virtually, not as “virtual make-up sessions,” but as a virtual class consistent with the in-person class curriculum, during the remainder of the COVID-19 PHE and any future applicable 1135 waiver event. The MDPP supplier could still only furnish a maximum of one session on the same day as a regularly scheduled session and a maximum of one virtual make-up session per week to the MDPP beneficiary. We propose that virtual sessions may be furnished to achieve both attendance goals and achieve weight-loss goals in the event that a qualifying weight measurement was obtained by one of the methods described herein. We propose that an MDPP supplier may offer to an MDPP beneficiary: 16 virtual sessions offered weekly during the core session period; 6 virtual sessions offered monthly during the core maintenance session interval periods; and 12 virtual sessions offered monthly during the ongoing maintenance session interval periods. MDPP suppliers may only furnish a maximum of one regularly scheduled session virtually and a maximum of one virtual make-up session per week to an MDPP beneficiary. This proposed rule 
                        <PRTPAGE P="50275"/>
                        would increase the number of allowable virtual core sessions from 15 to 16. This change is due to the added proposed flexibility to allow MDPP suppliers to obtain weight measurements remotely (as described below) and to deliver the first core session virtually.
                    </P>
                    <P>
                        Under these temporary flexibilities, we propose that the requirement for in-person attendance at the first core-session would not apply. We propose that during the remainder of the COVID-19 PHE and any future applicable 1135 waiver events, MDPP suppliers may obtain weight measurements from MDPP beneficiaries through the following methods: (1) In-person, when the weight measurement can be obtained safely and in compliance with all applicable laws and regulations; (2) via digital technology, such as scales that transmit weights securely via wireless or cellular transmission (commonly referred to as “Bluetooth
                        <E T="51">TM</E>
                         enabled”); or (3) self-reported weight measurements from a participant's own at-home digital scale. We propose that self-reported weights must be submitted via video, by the MDPP beneficiary to the MDPP supplier. The video must clearly document the weight of the MDPP beneficiary as it appears on his/her digital scale on the date associated with the billable MDPP session. Due to this additional flexibility, we propose that the waiver of the minimum weight loss requirements for beneficiary eligibility in the ongoing maintenance session intervals described in § 410.14(g)(3)(iv) of the March 31st COVID-19 IFC (85 FR 19230) be ended. Thus, effective January 1, 2021, all MDPP beneficiaries would be required to achieve and maintain the required 5 percent weight loss goal in order to be eligible for the ongoing maintenance sessions, even if the COVID-19 PHE remains in place as of that date.
                    </P>
                    <P>We are proposing to amend our regulation at § 410.79(e). We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">2. Proposed Changes to § 424.210</HD>
                    <P>Under § 424.210(b), an MDPP supplier may furnish in-kind beneficiary engagement incentives to an MDPP beneficiary if certain requirements are satisfied. Among other requirements, the in-kind item or service must be furnished only during the “engagement incentive period.” The definition of “engagement incentive period” at § 424.210(a) states that the period begins when an MDPP supplier furnishes any MDPP service to an MDPP eligible beneficiary, and it ends on the earliest of the following: (1) When the MDPP services period ends as described in § 410.79(c)(3); (2) when the MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier; or (3) The MDPP supplier has not had direct contact, either in-person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period. We recognize that the disruption to MDPP services caused by an applicable 1135 waiver event may cause an MDPP supplier not to have contact with an MDPP beneficiary for more than 90 consecutive calendar days. Therefore, we propose to amend the definition of “engagement incentive period” to further qualify when the period ends in the case of the COVID-19 PHE or an applicable 1135 waiver event. Specifically, we propose to amend paragraph (iii) in the definition to state that the MDPP supplier has not had direct contact, either in person by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period, unless the lack of direct contact is due to the suspension or cancellation of MDPP services under § 410.79(e) and the MDPP services are eventually resumed or restarted in accordance with § 410.79(e).</P>
                    <P>We solicit comments on when the engagement incentive period should end if the MDPP services are not eventually resumed. We are considering whether we should deem the incentive engagement period to end if the applicable 1135 waiver event or COVID-19 PHE remains in effect for a certain period of time, such as one year. At that point, for purposes of beneficiary engagement incentives, it may be more appropriate to terminate the engagement incentive period and permit a new engagement incentive period to begin if services are resumed or restarted in accordance with § 410.79(e). Alternatively, we note that the engagement incentive period can also end when the MDPP supplier knows that the MDPP beneficiary will no longer be receiving services from the MDPP supplier. We solicit comments on whether that provision eliminates any need to further clarify in regulation text when the engagement incentive period ends if MDPP services are not eventually resumed or restarted.</P>
                    <P>We also propose to amend § 424.210(b) to add a requirement governing the provision of an in-kind item or service as a beneficiary engagement incentive during the COVID-19 PHE or during an applicable 1135 waiver event. Specifically, we propose that if the item or service is furnished during the COVID-19 PHE or an 1135 waiver event that CMS has determined may disrupt in-person MDPP services, and the item or service is furnished to an MDPP beneficiary who is receiving MDPP services virtually, the MDPP beneficiary must be capable of using the item or service during the COVID-19 PHE or the 1135 waiver event, as applicable. We propose this requirement to deter abuse and to ensure that the incentives furnished during an 1135 waiver event will achieve their intended purpose and serve the goals of the MDPP expanded model. Some examples of usable beneficiary engagement incentives include vouchers for healthy food, wearable technology or “wearables” used to monitor an MDPP beneficiary's health such as heart rate, calories burned, or steps walked; examples of unusable beneficiary engagement incentives during an 1135 waiver event include gym memberships during lockdowns and stay-at-home orders. We solicit comments on whether this additional requirement is necessary in light of other requirements set forth in § 424.210(b).</P>
                    <P>Finally, for purposes of the proposed requirement at § 424.210(b)(9), we propose to define “COVID-19 Public Health Emergency” to mean the emergency period and emergency area, as such terms are defined in section 1135(g) of the Act, related to the COVID-19 pandemic declared by the Secretary on January 27, 2020. Similarly, we propose to define “1135 waiver event” to mean an emergency period and emergency area, as such terms are defined in section 1135(g) of the Act, for which the Secretary has authorized waivers under section 1135 of the Act. These definitions are consistent with how we propose to define the terms for purposes of § 410.79(e).</P>
                    <HD SOURCE="HD1">IV. Quality Payment Program</HD>
                    <HD SOURCE="HD2">A. CY 2021 Updates to the Quality Payment Program</HD>
                    <HD SOURCE="HD3">1. Executive Summary</HD>
                    <HD SOURCE="HD3">a. Overview</HD>
                    <P>
                        This section of the proposed rule sets forth proposed changes to the Quality Payment Program starting January 1, 2021, except as otherwise noted for specific provisions. The 2021 performance period/2023 payment year of the Quality Payment Program continues a transition as we build on the first few years of implementation of the Quality Payment Program to better focus our measurement efforts and to 
                        <PRTPAGE P="50276"/>
                        reduce barriers to entry into Advanced APMs.
                    </P>
                    <P>
                        Participation in the Quality Payment Program rose in the second year. We saw 98 percent of eligible clinicians participate in MIPS in 2018 with 889,995 eligible clinicians receiving a payment adjustment, which exceeded our 2017 participation rates. In addition, 98 percent of eligible clinicians participating in MIPS received a positive payment adjustment for 2020 based on 2018 performance year results. Regarding performance in Advanced APMs, for the 2018 QP Performance Period, 183,306 eligible clinicians earned Qualifying APM Participant (QP) status while another 47 eligible clinicians earned partial QP status.
                        <SU>72</SU>
                        <FTREF/>
                         We are still finalizing 2019 numbers given the extended time period for 2019 data submission, a flexibility provided due to the COVID-19 public health emergency, and will provide updates later this year. We plan to continue developing Quality Payment Program policies that more effectively reward high-quality treatment of patients and increase opportunities for Advanced APM participation. We are moving forward with MIPS Value Pathways (MVPs) policy development as MVPs allow for a more cohesive participation experience by connecting activities and measures from the 4 MIPS performance categories that are relevant to a specialty, medical condition, or a particular population being cared for. The MVPs use promoting interoperability as a foundational element and incorporate population health claims-based measures as feasible along with relevant measures and activities for the quality, cost, and improvement activities performance categories. We intended to begin transitioning to MVPs in the 2021 MIPS performance year; however, due to the 2019 Novel Coronavirus (COVID-19) pandemic public health emergency and resultant need for clinician focus on the response, our timeline has changed accordingly such that the proposal for initial MVPs will be delayed until at least the 2022 performance year. We support clinicians on the front lines by providing burden relief via extreme and uncontrollable circumstances policy exceptions for 2019 (85 FR 19277 through 19278) and 2020 (84 FR 62568). We are proposing to reduce the 2023 MIPS payment year performance threshold in section IV.A.3.e.(3) of this proposed rule, and are continuing to consider the extraordinary health system stresses resulting from the COVID-19 PHE as we propose 2021 performance year/2023 payment year policies for the Quality Payment Program.
                    </P>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             2018 QPP Performance Data Infographic and 
                            <E T="03">https://www.cms.gov/blog/2018-quality-payment-program-qpp-performance-results.</E>
                        </P>
                    </FTNT>
                    <P>
                        As we make long-term improvements, evolve MIPS policies, and plan to implement MVPs in the future, we are supporting our objectives within the Patients Over Paperwork initiative and the National Quality Roadmap.
                        <E T="51">73 74</E>
                        <FTREF/>
                         In carrying out these initiatives, we are removing regulatory obstacles that get in the way of health care clinicians spending time with patients. As we develop MVP policies, we look to reduce MIPS reporting burden and increase efficiencies.
                    </P>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             
                            <E T="03">https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.</E>
                        </P>
                        <P>
                            <SU>74</SU>
                             
                            <E T="03">https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        On May 15, 2020 the National Quality Roadmap was published by the Department of Health and Human Services (
                        <E T="03">https://www.hhs.gov/sites/default/files/national-health-quality-roadmap.pdf</E>
                        ) as directed by Executive Order 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First. The purpose of the Roadmap is to improve patient outcomes through enhanced effectiveness and efficiency of the healthcare quality system. The Roadmap is a means to accelerate change and advance the Administration's goals of “improving transparency, reducing provider burden, allowing informed consumer decision-making, and ultimately improving the health of all Americans”. The Roadmap, which provides a public-private partnership opportunity, describes a strategy for establishing, adopting, and publishing common quality measurements, aligning inpatient and outpatient measures, and eliminating low-value or counterproductive measures. Specific actions are identified to drive change through coordinated governance and oversight, modernized data collection and reporting, and aligned measures reformation in federal quality programs. One of the actions called for is a systematic review of federal quality reporting and value-based payment programs, to identify opportunities leading to recommendations to reduce burden, promote efficiency and effectiveness, and accelerate the shift to value. The Roadmap also calls for stakeholder engagement through public convening and a Request for Information. Actions will be undertaken with the underpinning of the following principles:
                    </P>
                    <FP SOURCE="FP-1">• Quality Information is Available and Meaningful</FP>
                    <FP SOURCE="FP-1">• Balance Administrative Burden with the Goal of Obtaining Meaningful Information</FP>
                    <FP SOURCE="FP-1">• Alignment of Measurement Priorities</FP>
                    <FP SOURCE="FP-1">• Cohesive Measurement Stewardship</FP>
                    <FP SOURCE="FP-1">• Reward Innovation and Improvement</FP>
                    <FP SOURCE="FP-1">• Leverage What Works and Reform the Rest</FP>
                    <P>The planned implementation of MVPs is noted in the Roadmap and we look forward to recommendations resulting from other Roadmap activities for streamlining quality reporting and value-based purchasing programs that can inform the implementation of the MVPs and promote alignment of quality measures across Federal programs.</P>
                    <P>
                        As we work within MIPS to reduce barriers to clinician participation in Advanced APMs and meet CMS pay for value objectives, we are aligned with the Health Care Payment Learning &amp; Action Network goal to accelerate the percentage of health care payments tied to quality and value in each market segment through the adoption of two-sided risk APMs.
                        <SU>75</SU>
                        <FTREF/>
                         MVPs will link quality and cost performance measurement and help clinicians begin to assess their ability to take on risk as in APMs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             
                            <E T="03">https://hcp-lan.org/.</E>
                        </P>
                    </FTNT>
                    <P>
                        In the May 1, 2020 
                        <E T="04">Federal Register</E>
                        , HHS published two transformative rules: The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program final rule (85 FR 25642 through 25961); and the Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-facilitated Exchanges, and Health Care Providers final rule (85 FR 25510 through 25640) that will give patients unprecedented safe, secure access to their health data. The two rules implement interoperability and patient access provisions of the bipartisan 21st Century Cures Act (Cures Act) and support the MyHealthEData initiative. MyHealthEData is designed to empower patients around a common aim, giving every patient access to their medical information so they can make better healthcare decisions. We expect that these rules, once implemented, will complement our future MVPs in providing more meaningful information to clinicians and patients.
                        <PRTPAGE P="50277"/>
                    </P>
                    <HD SOURCE="HD3">b. Summary of Major Proposals</HD>
                    <HD SOURCE="HD3">(1) Major MIPS Proposals</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62948), we finalized a definition of a MIPS Value Pathway (MVP) as a subset of measures and activities established through rulemaking. The MIPS program aims to drive value through the collection, assessment, and public reporting of data that informs and rewards the delivery of high-value care. Within MIPS we intend to pay for health care services in a way that drives value by linking performance on cost, quality, and the patient's experience of care. We believe implementing the MVP framework will move MIPS along the “path to value,” transforming the MIPS program by better informing and empowering patients to make decisions about their healthcare and helping clinicians to achieve better outcomes, and by promoting robust and accessible healthcare data, and interoperability. In the CY 2020 PFS proposed rule (84 FR 40732 through 40745), we offered our vision of an MVP framework for a new evolution of the MIPS program based on this concept.</P>
                    <P>We have built the MIPS program to provide broad flexibility for clinician choice of measures and activities, data collection and submission types, and individual or group level participation. While these flexibilities contributed to very high participation levels, we believe the flexibility has inadvertently resulted in a complex MIPS experience for clinicians that is not producing the level of robust clinician performance information we envision that would meet patient needs and support clinician care improvements. We have heard from clinicians that MIPS requirements are confusing, burdensome, and that it is difficult to choose measures from the several hundred MIPS and QCDR quality measures that are meaningful to their practices and have a direct benefit to patients. We have also heard concerns from stakeholders that MIPS does not allow for sufficient differentiation of performance across practices due to clinician quality measure selection bias. These aspects detract from the program's ability to effectively measure and compare performance, provide meaningful feedback, and incentivize quality. MVPs are intended to lead to a simplified MIPS clinician experience, improve value, reduce burden, and better inform patient choice in selecting clinicians. We noted that the MVP framework would connect measures and activities across the 4 MIPS performance categories, incorporate a set of administrative claims-based quality measures that focus on population health, provide data and feedback to clinicians, and enhance information provided to patients. We posed a set of questions intended to help us to implement this vision as part of future rulemaking. We received extensive comments on these issues and are using those comments to guide the transition into this new framework. We intend to focus the future of MIPS on MVP implementation. We have limited our 2021 performance year proposals in light of the COVID-19 pandemic to promote program stability and lessen any distraction as clinicians focus on responding to this public health emergency. We are proposing policies in section IV.A.3. of this proposed rule related to:</P>
                    <FP SOURCE="FP-1">• Developing MVPs</FP>
                    <FP SOURCE="FP-1">• Introducing the APM Performance Pathway (APP) for APM participant MIPS eligible clinicians to report to MIPS</FP>
                    <FP SOURCE="FP-1">• Updating the MIPS performance measures and activities; cost and quality category weights; and scoring policies</FP>
                    <FP SOURCE="FP-1">• Terminating the APM scoring standard</FP>
                    <HD SOURCE="HD3">(a) MIPS Value Pathways and APM Performance Pathway</HD>
                    <P>In this proposed rule, we propose updated MVP framework guiding principles in section IV.A.3.a.(1) of this proposed rule and MVP development criteria and processes in section IV.A.3.a.(2) of this proposed rule as we look towards the 2022 performance period to begin MVP implementation. We are also proposing in section IV.A.3.b. of this proposed rule an APP to start on January 1, 2021 that aligns with the MVP concept. The APP would be a voluntary pathway for reporting and scoring under MIPS that would allow APM participants to report a single quality measure set with broad applicability, receive an improvement activities credit, and have the cost performance category reweighted. We propose MIPS performance category weighting and scoring in the APP and a scoring hierarchy that recognizes the APP in section IV.A.3.e.(2) of this proposed rule. We are also proposing in section IV.A.3.c.(5)(a) of this proposed rule to eliminate the APM scoring standard for the 2021 performance year beginning January 1, 2021. This would allow APM participants to participate in MIPS as individuals, groups, Virtual Groups, or APM Entities, and they could report through any MIPS reporting and scoring pathway, see section IV.A.3.b.(3) of this proposed rule. We are also proposing in section IV.A.3.c.(5)(e) of this proposed rule, an extreme and uncontrollable circumstances exception policy that would be applicable to APM Entities beginning with the 2022 MIPS payment year.</P>
                    <P>In response to our MVP RFI in the 2020 PFS proposed rule (84 FR 40732 through 40745), we received a number of comments about the opportunity to participate in the development of MVPs and concerns about the speed of a transition to a new MVP framework. We have taken these concerns into consideration in sections IV.A.3.a.(2) and IV.A.3.a.(3) of this proposed rule when developing the policies proposed in this proposed rule. We had stated our intent to begin the transition to MVPs in the 2021 performance year by introducing initial MVPs, however, due to the 2019 Novel Coronavirus (COVID-19) pandemic Public Health Emergency (PHE), our timeline has changed. As we move forward with the transformation of the MIPS program in a manner that does not take away from the nation's response to the COVID-19 pandemic, we have limited our MVP-related proposals in this year's rule to those necessary for the collaborative development of MVPs. In section IV.A.3.a.(1) of this proposed rule, we propose to update the MVP guiding principles to respond to RFI suggestions and to reflect the ongoing evolution of MVP policies and further definition of the MVP framework.</P>
                    <P>We propose in section IV.A.3.a.(2) of this proposed rule, a process for collaboration on the development of MVPs, building on our discussions with clinician experts to develop a proposed list of MVPs for future MIPS rulemaking. We believe that collaboration with clinician experts will build a more cohesive and comprehensive set of MVPs. We propose a process for MVP candidate submissions in section IV.A.3.a.(2)(a)(iii) of this rule.</P>
                    <P>We recognize that the transition to MVPs will take time and will continue to evaluate the readiness of clinicians in making this transition, while balancing our strong interest in improving measurement and making MIPS more focused on value. We seek comment on our MVP criteria and MVP development process policies that will be considered for the final rule. For instance, we seek comment in section IV.A.3.a.(2) of this proposed rule on the proposed MVP co-development criteria, patient involvement, and MVP QCDR measures inclusion parameters.</P>
                    <HD SOURCE="HD3">(b) Other MIPS and APM Proposals</HD>
                    <P>
                        Although we look to move MIPS towards the future with the MVP 
                        <PRTPAGE P="50278"/>
                        framework, in this year's proposed rule we propose to make what we believe are necessary Web Interface and quality measure updates, in sections IV.A.3.c.(1)(c) and IV.A.3.c.(1)(d) of this proposed rule, respectively. Additionally, we propose in section IV.A.3.d.(1)(b) of this proposed rule to maintain policies for scoring quality measures based on achievement as well as policies for measures that do not meet case minimum, data completeness requirements, or have a benchmark. For the Promoting Interoperability performance category, we are proposing a new optional measure. We are not proposing changes to scoring policies for the cost or improvement activities categories. We have heard repeatedly in response to each of our proposed rules that clinicians value stability in the program so as to not have to learn new program requirements each year and seek to limit the number of policy proposals for the 2021 MIPS performance year.
                    </P>
                    <P>Additionally, we wish to highlight the following proposals for changes to MIPS beginning in the 2021 performance period.</P>
                    <P>• We propose in section IV.A.3.c.(1)(c) of this proposed rule to sunset the CMS Web Interface submission method under MIPS for groups and virtual groups in 2021 due to low MIPS participant utilization and the Medicare Shared Savings Program's discontinuation of Web Interface submission method.</P>
                    <P>• We propose in section IV.A.3.c.(1)(d) of this proposed rule to incorporate 2 new administrative claims outcome quality measures, address substantive changes to 112 existing MIPS quality measures, address changes to specialty sets, remove measures from specific specialty sets, and remove 14 quality measures from the MIPS program. We are proposing a total of 206 quality measures starting in the 2021 performance year.</P>
                    <P>• We propose in sections IV.A.3.c.(1)(e) and IV.A.3.c.(2)(b) of this proposed rule, inclusion of services provided via telehealth in quality and cost measurement, respectively, given the recent rise in volume of telehealth services.</P>
                    <P>• We propose in section IV.A.3.c.(2)(a) of this proposed rule, that the cost performance category will make up 20 percent of a MIPS eligible clinician's final score for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act, and the quality performance category weight would be 40 percent and 30 percent for each of those years, respectively (see section IV.A.3.c.(1)(b) of this proposed rule). For the 2023 MIPS payment year, we propose performance category redistribution policies in section IV.A.3.d.(2)(b)(iii) of this proposed rule similar to the redistribution policies as finalized for the 2022 MIPS payment year, with the modification that we will not redistribute more weight to the cost performance category in the final scoring calculation.</P>
                    <P>• We propose in section IV.A.3.c.(3)(b) of this proposed rule, beginning with the CY 2021 performance period and future years, we are proposing: (1) Changes to the Annual Call for Activities: An exception to the nomination period timeframe during a PHE; and a new criterion for nominating new improvement activities; (2) a process for HHS-nominated improvement activities; and (3) to modify two existing improvement activities.</P>
                    <P>• We propose in section IV.A.3.c.(4) of this proposed rule, to establish a performance period for the Promoting Interoperability performance category of a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year, for the 2024 MIPS payment year and each subsequent MIPS payment year; to update two Promoting Interoperability measures; and to continue reweighting the Promoting Interoperability performance category for non-physician MIPS eligible clinicians for the 2021 performance period. We propose at section IV.A.3.c.(4)(c)(ii) of this proposed rule a new Promoting Interoperability performance category Health Information Exchange (HIE) bi-directional exchange measure that would allow an eligible clinician to attest to participation in bi-directional exchange through an HIE using CEHRT functionality.</P>
                    <P>• We propose in section IV.A.3.d.(1)(b) of this proposed rule continuation of quality category scoring and bonus policies, adding flexibility for when measure specification or coding changes occur during the performance year, and continuing improvement scoring of the quality performance category comparing clinicians to a 30 percent baseline score if clinicians scored 30 percent or less. We propose in sections IV.A.3.d.(1)(b)(ii) and IV.A.3.d.(1)(b)(v) of this proposed rule benchmark and topped out scoring policy criteria options that are responsive to potential low reporting rates for the 2019 performance year due to the national public health emergency for COVID-19. We propose in section IV.A.3.d.(1)(b)(iii) of this proposed rule, a provision for an exception to the 20-case minimum for all administrative claims-based measures to allow scoring of measures that meet the specified case minimum.</P>
                    <P>• We propose in section IV.A.3.d.(2)(a)(iii) of this proposed rule to increase the maximum number of points available for the complex patient bonus for the 2020 performance period/2022 MIPS payment year due to the anticipated increase in patient complexity resulting from the national public health emergency for COVID-19.</P>
                    <P>• We propose in section IV.A.3.e.(3) of this proposed rule to reduce the performance threshold for the 2021 MIPS performance period/2023 MIPS payment year from 60 points—finalized in the CY 2020 PFS rule (84 FR 63037)—to 50 points in recognition of the COVID-19 impact on clinicians.</P>
                    <P>• We propose in section IV.A.3.g. of this proposed rule to modify third party intermediary requirements and remedial action and termination.</P>
                    <P>• We propose in section IV.A.4.b. and IV.A.4.c. of this proposed rule to clarify the APM Incentive Payment amount calculation basis and propose a hierarchy for recipient TIN affiliation identification when making the APM Incentive Payment. We also propose policies in section IV.A.4.c. of this proposed rule for MIPS eligible clinician scoring and a process for requesting updated APM Incentive Payment information in situations where a payee TIN cannot be identified, and to address situations where the QP's APM Incentive Payment was determined based solely on supplemental services payments and no Medicare claims for covered professional services were submitted during the incentive payment base period.</P>
                    <P>• We propose in section IV.A.4.e. of this proposed rule a change to the methodology for addressing prospectively aligned beneficiaries for Threshold Score calculations and QP determinations and to establish a targeted review process for QP determinations.</P>
                    <HD SOURCE="HD3">(2) Terms and Definitions</HD>
                    <P>In addition, in § 414.1305, we are proposing to update the definitions of the following terms:</P>
                    <FP SOURCE="FP-1">• Attestation (revision)</FP>
                    <FP SOURCE="FP-1">• Certified Electronic Health Record Technology (CEHRT) (revision)</FP>
                    <FP SOURCE="FP-1">• Collection type (revision)</FP>
                    <FP SOURCE="FP-1">• Full TIN APM (deletion)</FP>
                    <FP SOURCE="FP-1">
                        • Low volume threshold (revision)
                        <PRTPAGE P="50279"/>
                    </FP>
                    <FP SOURCE="FP-1">• Meaningful EHR user for MIPS (revision)</FP>
                    <FP SOURCE="FP-1">• MIPS APM (revision)</FP>
                    <FP SOURCE="FP-1">• Physician Compare (addition)</FP>
                    <FP SOURCE="FP-1">• Primary Care Services (addition)</FP>
                    <FP SOURCE="FP-1">• Submission type (revision)</FP>
                    <FP>These terms and definitions are discussed in the relevant sections of this proposed rule.</FP>
                    <HD SOURCE="HD3">3. MIPS Program Details</HD>
                    <HD SOURCE="HD3">a. Transforming MIPS: MIPS Value Pathways</HD>
                    <HD SOURCE="HD3">(1) Overview</HD>
                    <P>In this proposed rule, we are proposing updates to the MIPS Value Pathways (MVP) guiding principles (here in section IV.A.3.a.(1) of this proposed rule) and MVP development criteria and process (section IV.A.3.a.(2) of this proposed rule) that would guide MVP implementation beginning with the 2022 MIPS performance period/2024 MIPS payment year. We finalized in the CY 2020 PFS final rule (84 FR 62946) the definition of an MVP at § 414.1305 as “a subset of measures and activities established through rulemaking” and requested comments in a request for information (RFI) on a wide-ranging set of issues related to the eventual implementation of this concept within the MIPS program. We received RFI comments on many components of the MVP framework including the guiding principles, how MVPs and measures/activities are developed, and the transition and timeline to MVPs. The RFI comments have helped shape the following proposals for MVP implementation.</P>
                    <P>In the CY 2020 PFS final rule, we stated our intent to apply the MVP framework in the 2021 performance year (84 FR 62946); however, due to the COVID-19 pandemic national public health emergency, our timeline has changed (see section IV.A.3.a.(3) of this proposed rule). We want to move forward with the transformation of the MIPS program in a manner that does not take away from the nation's response to the COVID-19 pandemic, and so have limited our MVP related proposals in this rule to guidance necessary for the collaborative development of MVPs. We are deferring further MVP implementation to a future year. In particular, we now intend to propose an initial set of MVPs and implementation policies in our CY 2022 rulemaking cycle. We continue to envision a transformed MIPS program that increasingly makes MVPs available to clinicians with a burden reduction focus.</P>
                    <P>We intend to implement the MVPs while maintaining the MIPS participation options established through rulemaking for MIPS performance years 1 through 5. For purposes of this discussion, we refer to the established MIPS participation options collectively as “traditional MIPS”.</P>
                    <P>As described in earlier rulemaking (84 FR 40732 through 40734), we are moving to MVPs to improve value, reduce burden, help patients compare clinician performance to inform patient choice in selecting clinicians, and reduce barriers to movement into APMs. We refer to “value” as a measurement of quality and patient experience of care as related to cost, and intend to promote value by paying for health care services in a manner that directly links performance on cost, quality, and the patient's experience of care. The MVP framework will move MIPS forward on the path to value through connecting the MIPS performance categories and by better informing and empowering patients to make decisions about their healthcare and helping clinicians to achieve better outcomes using robust and accessible healthcare data and interoperability.</P>
                    <P>We believe that MVPs can help address previous feedback from clinicians that MIPS is too complex and burdensome. Feedback related to confusing MIPS requirements, inadequate alignment of the MIPS performance categories, need for better performance comparability across all clinicians and for more meaningful data for patients has informed development of the MVP framework. MVPs will make MIPS more meaningful by allowing a more cohesive participation experience by connecting activities and measures from the 4 MIPS performance categories that are relevant to a patient population, standardizing performance measurement of a specialty or a medical condition, and reducing the siloed nature of the traditional MIPS participation experience. We intend that MVPs help clinicians and practices prepare to take on and manage financial risk, as in Advanced APMs, as they build out their quality infrastructures that align with the MIPS performance categories and gain experience with cost measurement. Performance measure reporting for specific populations as in MVPs encourages practices to build an infrastructure with capabilities to compile and analyze population health data, a critical capability in assuming and managing risk. We believe that experience with MVPs, in which there is aligned measurement of quality (of care and of experience of care) and cost, continuous improvement/innovation within the practice, and efficient management and transfers of information, will help remove barriers to APM participation.</P>
                    <P>
                        See infographic at 
                        <E T="03">https://qpp.cms.gov/mips/mips-value-pathways</E>
                         that provides an overview of our vision for the MIPS path to value future state. As shown in the infographic, MIPS is currently comprised of four siloed performance categories with many measure and activity choices (see left column of infographic), higher reporting burden and performance measurement that is not meaningfully aligned. An intermediate step (see middle column of infographic) is to move to value via building an MVP framework that is cohesive (connects the performance categories), lowers reporting burden, and focuses MIPS participation around MVPs that are meaningful to clinicians' practices, specialty or public health priority. The MVP framework incorporates a foundational layer consisting of Promoting Interoperability and administrative claims-based quality measures focused on population health, provides data and feedback to clinicians, and enhances information provided to patients. When MVPs are fully implemented (see right column of infographic), we envision a MIPS that is simplified, increases the voice of the patient, and facilitates movement into APMs. Over time we intend to provide greater amounts of population health measurement data using administrative claims information while decreasing the amount of clinician reported measurement data used for MIPS. To help realize these objectives, we are engaging with clinician professional organizations and front-line clinicians to develop the MVPs and proposing MVP development criteria and process as described in section IV.A.3.a.(2) of this proposed rule.
                    </P>
                    <P>
                        We envision that MVPs will be optional for clinicians when the included measures and activities within the MVP are applicable and available to their practice. Over the course of future performance periods as we transition to MVPs, the traditional MIPS participation option will continue to be available. We believe MVP reporting will reduce selection burden associated with choosing MIPS quality measures and activities to report; reduce reporting burden associated with fewer MIPS quality measures, cost measures and/or improvement activities to report than the traditional MIPS participation method; and further align across performance categories the measures and activities identified by specialists and patients as being meaningful and relevant. We intend to build a robust inventory of MVPs which are 
                        <PRTPAGE P="50280"/>
                        meaningful to clinicians and expect that in the future we may propose that all MIPS eligible clinicians would be required to participate in MIPS either through an MVP or an APM Performance Pathway (APP) as discussed in section IV.A.3.b. of this rule.
                    </P>
                    <P>We listed MVP guiding principles in the CY2020 PFS proposed rule (84 FR 40734) to define MVPs. We are proposing updating the guiding principles from the CY 2020 PFS proposed rule (84 FR 40734) to incorporate RFI comments and the evolution of the MVP framework. In response to the RFI, a few commenters specifically voiced their support of the stated MVP guiding principles. A few commenters suggested we expand the guiding principles to include patient focused wording because they believed the guiding principles, as written, may be applicable only to clinicians. Other suggestions were to: Include a statement supporting physicians and other clinicians to be assessed on MVPs that reflect their specialty training, sub-specialization and their individual or group priorities; remove “eliminating burden related to selection of measures” as a principle and instead allow some choice; consider the site of service in the comparative data; consider evidence-based guidelines as an MVP development resource; have comparable reporting burden in all MVPs; use social risk stratification and consider social determinants of health; supplement Principle 3 by stating explicitly “high priority areas of morbidity and mortality”; and add alignment with other payment programs. One commenter acknowledged the benefit of comparative data but opposed any system that would come at the expense of physicians having to pay to collect and submit data on measures they do not find meaningful.</P>
                    <P>We propose changes to the MVP guiding principles as shown below. We propose to modify the first guiding principle by adding wording to further emphasize that MVP measures and activities are linked collectively and they enhance each other to the degree possible by adding the words “connected, complementary” to describe the MVP “sets of measures and activities that are meaningful to clinicians.” In addition, we propose to change “simplify scoring” to “align scoring” in the first guiding principle to acknowledge that as we initially transition to MVPs, we will not simplify but rather align scoring policies as we continue to have traditional MIPS available. We continue to include scoring simplification as part of our long-term vision and will consider ways to simplify as MVPs become widely available.</P>
                    <P>With regard to the commenter suggestion to add in clinician choice and to remove wording “eliminating burden related to selection of measures”, the degree of choice of measures and activities within MVPs will be limited as we strive for standardization; however, we are proposing removing from the first guiding principle the qualification for burden reduction, “related to selection of measures”, as we also intend to reduce reporting burden.</P>
                    <P>We have provided information about clinicians and groups on Physician Compare for a few years, beginning with the CY 2017 final rule (81 FR 77390 through 77398). Because so many clinicians participate in MIPS as groups, whereby the data received is for the overall performance of the group and not any specific individual clinicians, Medicare patients are not always able to learn information about their individual clinician, which we believe would be valuable in selecting a clinician for their care. In the CY 2020 PFS proposed rule we discussed our intent to put patients first and provide the information they need to be active decision-makers in their care and the resultant need for more comprehensive performance data at the individual clinician level (84 FR 40734). Whenever feasible, the MIPS program should provide meaningful information at the individual clinician level. We believe an appropriate step is the collection and assessment of more clinician or specific specialty information from multispecialty groups.</P>
                    <P>Therefore, we are proposing to update the second guiding principle to specify allowing the option of subgroup reporting for MVPs, which would permit subgroups of clinicians to select relevant MVP(s) to report measures and activities that are meaningful to their practices and to patients. As more MVPs become available, groups will be able to continue to participate in MIPS via subgroups to more fully reflect the breadth of services provided by the various clinician types within the group. Though we acknowledge that subgroup reporting is not currently an option for groups to use when reporting to MIPS, we believe that it is important to recognize and include multispecialty practices in guiding principle number 2 as we believe subgroup reporting will be crucial to MVP reporting in future years. Subgroup reporting would be a step towards individual reporting and would improve the meaning and robustness of the performance data used to incentivize high quality and cost-effective care and better provide information that patients can use to select clinicians.</P>
                    <P>As MVPs are intended to promote value and help patients with choosing clinicians, we agree with commenters that additional wording around the patient focus of MVPs in the guiding principles would further the point that engaging patients in their care, beyond informed consent, is paramount in the MVP Framework. Therefore, we propose to update guiding principle 3 to say that MVP measures should be selected to include the patient voice wherever possible. MVPs should support proactive communication and partnered decision-making between healthcare providers and patients, families, and caregivers and reinforce a care relationship that is based on trust and inclusion of individual values and beliefs. Along the lines of providing better information for patients, as stated above we propose to add wording to the guiding principle number 2 to highlight the importance of more comprehensive multispecialty reporting from subgroups as a step in improving comparative performance data.</P>
                    <P>We recognize some of the comments are aimed at ensuring high quality measures are used in MVPs. As we agree with commenters regarding strengthening the caliber of MVP measures, we are proposing to add a reference at guiding principle 3 to the Meaningful Measures framework to inform MVP measure selection.</P>
                    <P>We propose to add a new fifth guiding principle pointing to an important Meaningful Measures element of our future vision for reducing MVP reporting burden; the use of digital performance measure data submission technologies to indicate our commitment to leveraging digital innovations that reduce MIPS related clinician burden. Digital Quality Measures (dQMs) originate from sources of health information that are captured and can be transmitted electronically and via interoperable systems. Examples of digital sources include electronic health records (EHR), health information exchanges (HIEs), clinical registries, case management systems, electronic administrative claims systems, electronically submitted assessment data, and wearable devices. Electronic clinical quality measures or eCQMs (data derived from electronic medical records) are a subset of dQMs. The new proposed guiding principle reads, MVPs should support the transition to digital quality measures.</P>
                    <P>
                        Regarding the MVP guiding principles commenter suggestion to add the idea that MVPs will allow clinicians to be 
                        <PRTPAGE P="50281"/>
                        assessed according to their specialty and their individual or group priorities, we are not adding this wording as an MVP may focus on a condition or episode of care rather than a specialty; rather clinicians should be electing available MVPs that align with their priorities rather than us matching MVPs to individual practice priorities. The first guiding principle states MVPs should contain sets of measures and activities that are meaningful to clinicians (84 FR 40734). We believe this sufficiently addresses the commenter's suggestion. We did not include the commenter suggestion to add “morbidity and mortality” wording as we do not want to restrict what we mean by “high priority measures” to only morbidity and mortality measures. Regarding the equity comment, MVPs will provide comparative performance data that measures clinicians fairly and our policies at every level are developed and implemented to treat clinicians equitably. We are not adding new wording referring to alignment with other payment programs as we already refer to our intent that MVPs reduce barriers to APM participation in the guiding principles.
                    </P>
                    <P>After review and consideration of RFI comments, we are retaining guiding principle 4 (84 FR 40734) and proposing to update guiding principles 1, 2, 3 and 5, as shown in italics, so that the guiding principles for MVPs reflect the following:</P>
                    <P>
                        1. MVPs should consist of limited, 
                        <E T="03">connected complementary</E>
                         sets of measures and activities that are meaningful to clinicians, which will reduce clinician burden, 
                        <E T="03">align</E>
                         scoring, and lead to sufficient comparative data.
                    </P>
                    <P>
                        2. MVPs should include measures and activities that would result in providing comparative performance data that is valuable to patients and caregivers in evaluating clinician performance and making choices about their care; 
                        <E T="03">MVPs will enhance this comparative performance data as they allow subgroup reporting that comprehensively reflects the services provided by multispecialty groups.</E>
                    </P>
                    <P>
                        3. MVPs should include measures 
                        <E T="03">selected using the Meaningful Measures approach and, wherever possible, the patient voice must be included,</E>
                         to encourage performance improvements in high priority areas.
                    </P>
                    <P>4. MVPs should reduce barriers to APM participation by including measures that are part of APMs where feasible, and by linking cost and quality measurement.</P>
                    <P>
                        5. 
                        <E T="03">MVPs should support the transition to digital quality measures.</E>
                    </P>
                    <P>In section IV.A.3.a.(2)of this proposed rule, we describe our proposed method of creating MVPs. We intend to grow the number of available MVPs using the processes described in that section, maximizing our opportunity for expert input on the most meaningful measures and activities.</P>
                    <P>We continue our efforts to improve the healthcare of Medicare patients by allowing clinicians to focus on providing care for their patients and the measures and activities that best reflect their care. We look forward to continuing to work with stakeholders to improve the program and implement the vision of MVPs.</P>
                    <HD SOURCE="HD3">(2) MVP Development</HD>
                    <HD SOURCE="HD3">(a) Process of Developing MVPs</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62948), we finalized at § 414.1305 the definition of a “MIPS Value Pathway” to mean a subset of measures and activities established through rulemaking. We also clarified our intention to develop MVPs, to the extent feasible, in collaboration with stakeholders (84 FR 62947). Commenters urged us to work in tandem with clinicians and specialty societies to develop MVPs (84 FR 62948) and have supported the development of MVPs with robust stakeholder input and feedback opportunities. Stakeholders have also clearly emphasized the need for input during the design and implementation of MVPs. We believe it is important to emphasize that the transition to MVPs must occur gradually, without immediate elimination of the current MIPS program, as we continue to work collaboratively with stakeholders regarding MVP development. As MVPs are developed collaboratively with stakeholders, they must be created utilizing a consistent set of parameters and criteria, to ensure that MVPs are constructed and implemented in a uniform manner. In addition, we believe it is important to outline the methods in which collaboration and engagement may occur with stakeholders. Lastly, we intend on formulating a standardized process in which stakeholders can submit formal MVP candidates for CMS' consideration.</P>
                    <HD SOURCE="HD3">(i) MVP Development Criteria</HD>
                    <P>In response to the RFI in the CY 2020 PFS final rule, we have received stakeholder comments that supported the move to MVPs with considerations to departing from the traditional reporting requirements of the existing MIPS program, such as reporting 6 quality measures for the Quality performance category. We had also received stakeholder comments through the RFI that supported the use of electronically available measures such as eCQMs and the use of QCDR measures to the extent feasible. Stakeholders also noted that it is important that the collection type of quality measures be considered as MVPs are designed. As a part of the MVP development process, consideration should be given to the four performance categories in MIPS, and whether the MVP has a clearly defined intent, offers value, and opportunity for improvement. We believe that as a part of MVP development, it is important to clearly identify linkages between the measures and activities within an MVP which will demonstrate the relevancy of measures and activities to the clinicians being captured within the MVP. Furthermore, as MVPs are developed it is important to factor in the appropriateness of the measures and activities being included and the comprehensibility of the MVP to clinicians and patients. Lastly, considerations must be given to existing criteria for measure and activity inclusion or removal, as established for each of the performance categories. For example, as described in the CY 2019 PFS final rule (83 FR 59763) for the quality performance category, quality measures that are identified as extremely topped out (reaching an average performance rate between 98 to 100 percent) will likely be removed from the program. We refer readers to the CY 2020 PFS final rule (84 FR 62949 through 63006) for discussion of previously finalized measure and activity requirements across the Quality, Cost, Improvement Activity, and Promoting Interoperability performance categories. In addition, we also refer readers to section IV.A.3.c. of this proposed rule for updates to the respective performance categories. Therefore, beginning with the 2022 MIPS performance period, we propose to develop and select MVPs using the following criteria:</P>
                    <P>• Utilization of Measures and Activities across Performance Categories:</P>
                    <P>(a) MVPs should include measures and activities from the Quality, Cost, and Improvement Activities performance categories.</P>
                    <P>(b) MVPs should include the entire set of Promoting Interoperability (PI) measures.</P>
                    <P>• Intent of Measurement:</P>
                    <P>(a) What is the intent of the MVP?</P>
                    <P>
                        (b) Is the intent of the MVP the same at the individual clinician and group level?
                        <PRTPAGE P="50282"/>
                    </P>
                    <P>(c) Are there opportunities to improve the quality of care and value in the area being measured?</P>
                    <P>(d) Why is the topic of measurement meaningful to clinicians?</P>
                    <P>(e) Does the MVP act as a vehicle to incrementally phase clinicians into APMs? How so?</P>
                    <P>(f) Is the MVP reportable by small and rural practices? Does the MVP consider reporting burden to those small and rural practices?</P>
                    <P>(g) Which Meaningful Measure Domain(s) does the MVP address?</P>
                    <P>• Measure and Activity Linkages with the MVP:</P>
                    <P>(a) How do the measures and activities within the proposed MVP link to one another? (For example, do the measures and activities assess different dimensions of care provided by the clinician?)</P>
                    <P>(b) Are the measures and activities related or a part of the care cycle or continuum of care offered by the clinicians?</P>
                    <P>(c) Why are the measures and activities most meaningful to the specialty?</P>
                    <P>• Appropriateness:</P>
                    <P>(a) Is the MVP reportable by multiple specialties? If so, has the MVP been developed collaboratively across specialties?</P>
                    <P>(b) Are the measures clinically appropriate for the clinicians being measured?</P>
                    <P>(c) Do the measures capture a clinically definable population of clinicians and patients?</P>
                    <P>(d) Do the measures capture the care settings of the clinicians being measured?</P>
                    <P>(e) Prior to incorporating a measure in an MVP, is the measure specification evaluated, to ensure that the measure is inclusive of the specialty or sub-specialty?</P>
                    <P>• Comprehensibility:</P>
                    <P>(a) Is the MVP comprehensive and understandable by the clinician or group?</P>
                    <P>(b) Is the MVP comprehensive and understandable by patients?</P>
                    <P>• Incorporation of the Patient Voice:</P>
                    <P>(a) Does the MVP take into consideration the patient voice? How?</P>
                    <P>(b) Does the MVP take into consideration patients in rural and underserved areas?</P>
                    <P>(c) How are patients involved in the MVP development process?</P>
                    <P>(d) To the extent feasible, does the MVP include patient-reported outcome measures, patient experience measures, and/or patient satisfaction measures?</P>
                    <P>• Measures and Improvement Activities Considerations: MIPS Quality Measures.</P>
                    <P>We are not prescriptive on the number of quality measures that are included in an MVP. In selecting quality measures, we do believe that consideration should be given to the following:</P>
                    <P>
                        (a) Do the quality measures included in the MVP meet the existing quality measure inclusion criteria? 
                        <E T="03">(For example, does the measure demonstrate a performance gap?)</E>
                    </P>
                    <P>(b) Have the quality measure denominators been evaluated to ensure the eligible population is consistent across the measures and activities within the MVP?</P>
                    <P>(c) Have the quality measure numerators been assessed to ensure the measure is applicable to the MVP topic?</P>
                    <P>(d) To the extent feasible, does the MVP include outcome measures, or high priority measures in instances where outcome measures are not available or applicable? We encourage stakeholders to utilize our established pre-rulemaking processes, such as the Call for Measures, described in the CY 2020 PFS final rule (84 FR 62953 through 62955) to develop outcome measures relevant to their specialty if outcome measures currently do not exist and for eventual inclusion into an MVP.</P>
                    <P>(e) To the extent feasible, does the MVP include electronically specified clinical quality measures?</P>
                    <P>(f) To the extent feasible, does the MVP avoid including quality measures that are topped out?</P>
                    <P>(g) What collection types are the measures available through?</P>
                    <P>(h) What role does each quality measure play in driving quality care and improving value within the MVP? Provide a rationale as to why each quality measure was selected.</P>
                    <P>(i) How do the selected quality measures relate to other measures and activities in the other performance categories?</P>
                    <P>(j) To the extent feasible, specialty and sub-specialty specific quality measures are incorporated into the MVP. Broadly applicable (cross-cutting) quality measures may be incorporated if relevant to the clinicians being measured.</P>
                    <P>• Measures and Improvement Activities Considerations: Cost Measures:</P>
                    <P>(a) What role does the cost measure(s) play in driving quality care and improving value within the MVP? Provide a rationale as to why each cost measure was selected.</P>
                    <P>(b) How does the selected cost measure(s) relate to other measures and activities in other performance categories?</P>
                    <P>(c) If there are not relevant cost measures for specific types of care being provided (for example, conditions or procedures), does the MVP include broadly applicable cost measures (that are applicable to the type of clinician)?</P>
                    <P>(d) What additional cost measures should be prioritized for future development and inclusion in the MVP?</P>
                    <P>• Measures and Improvement Activities Considerations: Improvement Activities:</P>
                    <P>(a) What role does the improvement activity play in driving quality care and improving value within the MVP? Provide a rationale as to why each improvement activity was included.</P>
                    <P>(b) Describe how the improvement activity can be used to improve the quality of performance in clinical practices for those clinicians who would report this MVP.</P>
                    <P>(c) Does the improvement activity complement and/or supplement the quality action of the measures in the MVP, rather than duplicate it?</P>
                    <P>(d) To the extent feasible, does the MVP include improvement activities that can be conducted using CEHRT functions? The use of improvement activities that specify the use of technologies will help to further align with the CEHRT requirement under the Promoting Interoperability performance category.</P>
                    <P>(e) If there are not relevant specialty or sub-specialty specific improvement activities, does the MVP includes broadly applicable improvement activities (that is applicable to the clinician type) are used?</P>
                    <P>• Measures and Improvement Activities Considerations: Promoting Interoperability (PI) Measures:</P>
                    <P>(a) Must include the full set of PI measures.</P>
                    <P>
                        The MVP development criteria was developed primarily with consideration with the MVP guiding principles, discussed above. In addition, we considered the spectrum of measures and activities available for MVP development, and the criteria used to include measures and activities within each of the respective performance categories. Through the collaborative process of co-developing MVPs with stakeholders, we have realized how crucial it is to establish a set of MVP development criteria that would standardize what is expected of MVPs and provide our evaluation criteria in a transparent manner. We believe that the aforementioned criteria will lead to the development of MVPs in a manner that is consistent and reliable. We seek comment on the MVP development criteria.
                        <PRTPAGE P="50283"/>
                    </P>
                    <HD SOURCE="HD3">(ii) Capturing the Patient Voice</HD>
                    <P>As a part of the MVP development process, we believe that it is important to develop MVPs in a manner that takes into consideration the patient's experience, satisfaction, and outcomes. We believe that MVPs should be constructed in a manner that should not only be understood by clinicians, but by patients who may use the ascertained information to make informed decisions regarding their health care providers. Therefore, beginning with the 2022 performance period, we propose that stakeholders that are developing MVPs to submit to CMS as candidate MVPs should include patients as a part of the MVP development process. Stakeholders should incorporate patients and/or patient representatives through means that may include, but are not limited to technical expert panels or an advisory committee as they work to construct their candidate MVPs prior to reaching out to CMS with a candidate submission. The process of involving patients as a part of the stakeholder's MVP development would be considered a pre-requisite for CMS to consider the candidate MVP for the upcoming performance period. By including patients and/or patient representatives in the MVP development process, we believe that patients will be able to voice how to make the outcomes of measurement meaningful to them. In addition to including patients as a part of the MVP development process, we encourage stakeholders to utilize several approaches to incorporate the patient perspective, such as using focus groups, in-depth interviews with patients, and informal listening sessions, to the extent feasible, for a comprehensive patient perspective. We seek comments on this proposal.</P>
                    <HD SOURCE="HD3">(iii) Candidate MVP Co-Development, Solicitation Process, and Evaluation</HD>
                    <P>Through the Request for Information (RFI) on transforming MIPS in the CY 2020 PFS final rule we have learned of stakeholders interests in participating in the MVP development process. In summer 2019, we held numerous focus groups with front-line clinicians, specialty societies, advocacy groups, QCDRs, registries, and health IT vendors to listen to what stakeholders were looking for in regards to program simplification, burden reduction, and the intent of MVPs. In response to the CY 2020 PFS final rule, we received several requests from stakeholders who wanted to discuss their perspectives on MVPs and in some cases, walk us through potential MVP candidates from their specialty. Based on continuous stakeholder interest, we believe that a process must be implemented to ensure that stakeholder engagement and collaboration in the development of MVPs is consistent from an overall perspective.</P>
                    <P>To consider MVP candidates developed by stakeholders, we believe it is important to implement a streamlined approach to receive and evaluate potential MVPs. Therefore, beginning with the 2022 performance period, we propose that stakeholders should formally submit their MVP candidates formally utilizing a standardized template, which will be published in the QPP resource library for our consideration for future implementation. Stakeholders should submit all information including a description of how their MVP abides by the MVP development criteria as described in section IV.A.3.a.(2)(a)(i) of this proposed rule, and provide rationales as to why specific measures and activities were chosen to construct the MVP. We believe the utilization of a standardized template would help stakeholders understand what information is needed to evaluate the feasibility of the candidate MVP.</P>
                    <P>On an annual basis, we intend on hosting a public facing MVP development webinar, to remind stakeholders of MVP development criteria, the timeline, and process in which to submit a candidate MVP. While we believe that engagement with stakeholders regarding MVP candidates may occur on a rolling basis throughout the year, at CMS' discretion we will determine if an MVP is ready for inclusion in the upcoming performance period. As MVP candidates are received, they will be reviewed, vetted, and evaluated by CMS and our contractors. We intend on utilizing the MVP development criteria (discussed above) to determine if the candidate MVP is feasible. In addition to the MVP development criteria listed above, we will also vet the quality and cost measures from a technical perspective to validate that the coding in the quality measures and cost measure(s) include the clinician type being measured, and whether all potential specialty specific quality measures or cost measures were considered, with the most appropriate included. We may reach out to the stakeholder on an as-needed basis, should questions arise as we review. In addition, in continuing collaborative efforts, once we complete our internal evaluation, we will reach out to select stakeholders whose candidate MVP may be feasible for the upcoming performance period, to schedule a feedback loop meeting to discuss our feedback, and next steps that may include recommended modifications to the MVP candidate. Since MVPs must be established through rulemaking, as described at § 414.1305, CMS will not communicate to the stakeholder whether an MVP candidate has been approved, disapproved, or is being considered for a future year, prior to the publication of the proposed rule. We seek comment on the proposed process to solicit MVP candidates. In addition, we seek comment on how we could make this process more transparent in future years, for stakeholders that collaborate to develop MVP candidates and other MIPS stakeholders, should we consider the utilization of an advisory committee or technical expert panel to review MVP candidates, or the review of MVP candidates by an interdisciplinary committee, similar to what is used for the MIPS quality measures under the Call for Measures or a public process such as the NQF convened Pre-rulemaking process? We believe that integrating these steps into the process could provide greater transparency, however we are concerned that integrating these steps could further delay the incorporation of MVPs into the MIPS program. We seek feedback on the issue of furthering transparency into the MVP development process vs. timeliness of introducing MVPs into the MIPS program. Are stakeholders concerned with the possibility of delayed MVP implementation if these additional methods of review are implemented? If so, what are some strategies CMS should consider if we decide to implement additional methods of allowing public commentary on potential MVP candidates?</P>
                    <HD SOURCE="HD3">(b) Implementing Meaningful Measures in MVPs</HD>
                    <HD SOURCE="HD3">(i) Incorporating Population Health Measures Into MVPs</HD>
                    <P>
                        In the CY 2020 PFS proposed rule (84 FR 40742 through 40743), we expressed our interest in incorporating population health measures calculated from administrative claims-based data as a part of the foundational layer within MVPs, in an effort to improve patient outcomes, reduce reporting burden and costs, better align clinician quality improvement efforts, and increase alignment with APMs and other payer performance measurement. Through the RFI, stakeholders expressed concerns with including population health measures due to concerns with reliability, validity, attribution, unintended consequences and/or risk adjustment of claims-based population health measures. We understand 
                        <PRTPAGE P="50284"/>
                        stakeholder concerns around the population health measures that were previously considered, and are looking into ways to address and mitigate those concerns. We also received some support from stakeholders who agreed that population health measures will reduce administrative burden with the belief that these measures are not any less relevant to specialists. In MIPS, we currently have one administrative-claims based measure, the All-cause Hospital Readmission measure, which is calculated and scored for groups with 16 or more clinicians that meet a 200-patient case minimum, as described in the CY 2017 Quality Payment Program final rule (81 FR 77300). As described in Appendix 1 of this proposed rule, we are proposing to replace the All-cause Hospital Readmission measure with a Hospital-Wide, 30-day, All-Cause Unplanned Readmission (HWR) Rate for the Merit-Based Incentive Payment System Program (MIPS) Eligible Clinician Groups because the re-specified measure promotes a system level approach by clinicians, with a focus on high risk conditions such as COPD and heart failure. We refer readers to Appendix 1 of this proposed rule for detailed discussion of the newly proposed measure.
                    </P>
                    <HD SOURCE="HD3">(ii) Incorporating QCDR Measures Into MVPs</HD>
                    <P>
                        In the CY 2020 PFS final rule, we sought comments from stakeholders as to whether QCDR measures should be considered for integration within MVPs. Stakeholders were generally supportive of including QCDR measures within MVPs, but others expressed concern that including QCDR measures within MVPs would require clinicians to use certain third party intermediaries which may cause additional burden for clinicians who may need to change their current reporting method and undertake additional costs associated with reporting through QCDRs. Under the existing MIPS program and as described at § 414.1330(a)(2), for a MIPS payment year, we can use approved QCDR measures as described under § 414.1400 to assess performance in the quality performance category. We continue to believe that the development of QCDR measures by QCDRs is important as it provides measures that are relevant, applicable, and meaningful to clinicians, and addresses gaps that are not addressed by measures available through the MIPS quality measure inventory. In envisioning MVP development for the 2022 performance period and future years, we believe it is important to consider the opportunity to include QCDR measures within MVPs. Prior to consideration of including the QCDR measure within a candidate MVP, QCDR measures must meet all existing criteria under § 414.1400(b)(3) and the criteria described at § 414.1400(b)(3)(v)(C)(
                        <E T="03">4</E>
                        ) that QCDR measures should be fully tested at the clinician level prior to the QCDR measure being included in an MVP. We refer readers to section IV.A.3.g.(2)(b)(iv) of this proposed rule for additional discussion of this requirement.
                    </P>
                    <P>With regards to the timeline to which MVPs and QCDR measures may be established, we have identified differences with the timelines that each of these processes follow. As described in the CY 2020 PFS final rule (84 FR 62948), we finalized the definition of an MVP at § 414.1305 to mean a MIPS Value Pathway is a subset of measures and activities established through rulemaking. Furthermore, as described in the CY 2019 PFS final rule (83 FR 59900) and at § 414.1400(b)(1), entities that wish to self-nominate as a QCDR and submit QCDR measures for CMS consideration must do so within the 60-day self-nomination period that begins on July 1 of the calendar year prior to the applicable performance period and ending on September 1 of the same year. QCDR measures are typically reviewed and approved in the preceding months after the close of the self-nomination period. Therefore, we propose that beginning with the with the 2022 performance period, only QCDR measures that were approved in the previous year may be considered for inclusion within a candidate MVP. Furthermore, we propose that the QCDR measures included within a candidate MVP must meet the existing criteria that are currently established at § 414.1400(b)(3). In the traditional MIPS program, entities that meet the QCDR definition can develop QCDR measures to fulfill the quality performance category reporting requirements. We believe that QCDR measures can continue to fulfill the reporting requirements of the quality performance category within MVPs. Candidate MVPs should be submitted utilizing the process as described in section IV.A.3.a.(2)(a) of this proposed rule. Candidate MVPs that are approved for inclusion in the upcoming performance period must be proposed and finalized through notice-and-comment rulemaking. Candidate MVPs that include QCDR measures will also need to be proposed and finalized through notice-and-comment rulemaking in order to be available for reporting in the upcoming performance period. Therefore, in instances where MVPs are finalized through notice-and-comment rulemaking with QCDR measures, those QCDR measures would be eligible for 2-year QCDR measure approval as described at § 414.1400(b)(3)(vi).</P>
                    <P>In the CY 2018 PFS final rule (82 FR 53813), we finalized that beginning with the 2018 performance period and for future program years, that QCDRs may seek permission from another QCDR to use an existing QCDR measure that is owned by another QCDR.</P>
                    <HD SOURCE="HD3">(e) Reporting of MVPs Through Third Party Intermediaries</HD>
                    <P>Through the MIPS program, QCDRs, qualified registries, and Health IT vendors support the reporting of the Quality, Promoting Interoperability, and Improvement Activity performance categories, as proposed and codified at § 414.1400(a)(2). We believe that third party intermediaries who support the aforementioned performance categories are able to support MVPs, since they will be comprised of measures and activities from these performance categories, as well as cost measures that are calculated by CMS (thereby requiring no additional effort by third party intermediaries). We believe allowing third party intermediaries to support MVPs will offer eligible clinicians and groups additional methods to report an MVP. We refer readers to section IV.A.3.g. of this proposed rule for additional discussion of these proposals.</P>
                    <P>Since QCDR and qualified registry applicants would be submitting their self-nomination application prior to the publication of the final rule, we will work to establish a process to allow QCDRs and qualified registries to identify and select which MVPs they can support following the publication of the final rule, if we finalize this policy. We seek comments on this proposal.</P>
                    <HD SOURCE="HD3">(6) Transition to MVPs</HD>
                    <HD SOURCE="HD3">(a) Timeline for MVP Implementation</HD>
                    <P>
                        In response to the RFI in the CY 2020 PFS final rule, we have received comments from stakeholders that indicated a gradual implementation of MVPs. Through the MVP development process, we seek to collaborate with stakeholders in the development of MVPs that are meaningful and applicable to clinicians and groups. Therefore, we understand the need for an incremental approach as we transition eligible clinicians and groups to MVP reporting as they are implemented. In light of the COVID-19 pandemic, we have decided to delay the implementation of MVPs, and revisit 
                        <PRTPAGE P="50285"/>
                        potential MVP implementation through future rulemaking, possibly beginning with the 2022 performance period. Although we believe in the importance of transforming the MIPS program to create greater meaning for clinicians, we understand that there are clinicians who are on the frontlines taking care of COVID-19 patients that should not be burdened with having to learn a new method of reporting for the MIPS program at this time. Overall, our goal is to gradually implement MVPs for all MIPS eligible clinicians and groups overtime, to ensure that MVPs are designed and available in a manner relevant to clinicians. We intend to continue to work closely with stakeholders to develop MVPs that are relevant to various specialties, and understand that a level of flexibility is needed to allow for meaningful reporting.
                    </P>
                    <HD SOURCE="HD3">b. APM Performance Pathway</HD>
                    <HD SOURCE="HD3">(1) Overview</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62568), we finalized the MIPS Value Pathway framework as a means of reducing reporting burden, increasing meaningful measurement, and continuing to encourage movement through MIPS away from fee-for-service (FFS) payments and towards APMs. Burden reduction and meaningful measurement are important goals in relation to all eligible clinicians, and we recognize that the best means for achieving these goals may be different for MIPS eligible clinicians not yet joined an APM than for those MIPS eligible clinicians who already are participating in APMs and therefore have different reporting obligations. This is particularly true for eligible clinicians in Advanced APMs who are subject to MIPS either because they are Partial QPs for a year and elect to participate in MIPS or because they fall below the applicable Partial QP threshold for a performance year.</P>
                    <P>We are proposing at § 414.1367 to establish an APM Performance Pathway (APP) under MIPS beginning in the 2021 MIPS performance year, designed to provide a predictable and consistent MIPS reporting standard to reduce reporting burden and encourage continued APM participation.</P>
                    <HD SOURCE="HD3">(2) Applicability</HD>
                    <P>We propose that the APP will be in effect beginning January 1, 2021, and would be an optional MIPS reporting and scoring pathway for MIPS eligible clinicians identified on the Participation List or Affiliated Practitioner List of any APM Entity participating in any MIPS APM on any of the four snapshot dates (March 31, June 30, August 31, and December 31) during a performance period, beginning in the 2021 MIPS performance period.</P>
                    <HD SOURCE="HD3">(a) Reporting Through the APM Performance Pathway</HD>
                    <P>Individual MIPS eligible clinicians who are participants in MIPS APMs may report through the APP at the individual level. Groups and APM Entities may report through the APP on behalf of their constituent MIPS eligible clinicians; however, the final score earned by the group through the APP would be applied only to those MIPS eligible clinicians who appear on a MIPS APM's Participation List or Affiliated Practitioner List on one or more snapshot dates. The final score applied to each individual MIPS eligible clinician would be the highest available final score for that clinician (TIN/NPI), or a Virtual Group score, if applicable, as discussed at IV.A.3.e. of this proposed rule.</P>
                    <P>As described further in section III.G.1. of this proposed rule, ACOs participating in the Medicare Shared Savings Program would be required to report through the APP for purposes of assessing their quality performance for that program, but MIPS eligible clinicians participating in these ACOs also would have the option of reporting outside the APP, or within it at an individual or group level, for purposes of being scored under MIPS, like all other MIPS APM participants. As the APP would be optional for purposes of MIPS scoring, under the proposal MIPS APM participants would be able to report through the APP or through any other available MIPS reporting mechanism they chose.</P>
                    <P>We refer readers to section IV.A.3.e. of this proposed rule for information concerning our proposed changes to the hierarchy that will apply when more than one final score is associated with a TIN/NPI.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(b) MIPS APMs</HD>
                    <P>We propose to amend our definition of MIPS APM at § 414.1305 as an APM that meets the criteria in § 414.1367(b). We also propose to codify the following MIPS APM criteria at the new § 414.1367(b). We are proposing to maintain two criteria for MIPS APMs that currently are included at §§ 414.1370(b)(1) and (3) respectively, namely that: (1) An APM Entity participates in the APM under an agreement with CMS or through a law or regulation; and (2) the APM bases payment on quality measures and cost/utilization. However, under the proposed policy, for purposes of the MIPS performance period we would not depend on the availability of quality measure data reported directly to the APM, and we are not proposing to continue requiring that MIPS APMs be in operation and therefore collecting quality data for the entirety of the performance period. We also note that currently, to be a MIPS APM, § 414.1370(b)(2) requires that an APM must be designed such that its APM Entities include at least one MIPS eligible clinician on a Participation List, and does not include APMs that use only Affiliated Practitioner Lists. However, we believe that because we are not proposing to require reporting through the APP be done exclusively at the APM Entity level, it is not necessary to limit use of the APP to APM Entities alone. Therefore, we are proposing to expand the definition of MIPS APM to include those APMs in which there is only an Affiliated Practitioner List and that otherwise meet these proposed MIPS APM criteria.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(3) MIPS Performance Category Scoring in the APM Performance Pathway</HD>
                    <P>In general, MIPS reporting and scoring requirements are applicable to all MIPS eligible clinicians, including those reporting through the proposed APP. However, the following reporting and scoring rules would apply only to those MIPS eligible clinicians, groups, or APM entities reporting through the APP.</P>
                    <HD SOURCE="HD3">(a) Quality Performance Category</HD>
                    <P>We are proposing that, beginning in the 2021 performance period, MIPS eligible clinicians scored under the APP would be scored on the quality measure set finalized for such MIPS performance period.</P>
                    <P>For PY 2021, we are proposing the measures listed in Table 41 to be used for purposes of quality performance category scoring for the APP.</P>
                    <GPH SPAN="3" DEEP="236">
                        <PRTPAGE P="50286"/>
                        <GID>EP17AU20.075</GID>
                    </GPH>
                    <P>For those MIPS eligible clinicians, groups, or APM Entities for whom a given measure is unavailable due to the size of the available patient population or who are otherwise unable to meet the minimum case threshold for a measure, we are proposing to remove such measure from the quality performance category score for such MIPS eligible clinician, group, or APM Entity.</P>
                    <P>For MIPS eligible clinicians, groups, or APM Entities reporting through the APP, we are proposing to not apply the quality measure scoring cap at § 414.1380(b)(1)(iv) in the event that a measure in the APP measure set is determined to be topped out. Because the measure set is fixed, we do not believe it is appropriate to limit the maximum quality performance category available to them. Should an APP measure be determined to be topped out, we would at that time consider amending the APP quality measure set through future rulemaking, if appropriate.</P>
                    <P>We seek comment on this proposal.</P>
                    <P>In the CY 2020 PFS proposed rule, we sought comment on aligning the Shared Savings Program version of the Multiple Chronic Conditions (MCC) measure (that is, the ACO MCC) with the MIPS version of the MCC measure (see 84 FR 40711 and 40712). We noted that the MIPS MCC claims-based measure is similar to the ACO MCC currently used to assess ACO quality under the Shared Savings Program. The MIPS MCC and ACO MCC measures are similar because they both target patients with multiple chronic conditions, but the cohort, outcome, and risk model for the MIPS MCC measure varies from the ACO MCC measure. The cohort for the ACO MCC measure includes eight conditions whereas the MIPS MCC measure includes nine conditions, with the additional condition being diabetes. The ACO MCC measure does not adjust for social risk factors whereas the MIPS MCC measure adjusts for two area-level social risk factors: (1) AHRQ socioeconomic status (SES) index; and (2) specialist density.</P>
                    <P>
                        In 2019, we added a revised MCC measure to the 2019 Measure under Consideration list for the Shared Savings Program for consideration by the Measure Applications Partnership (MAP) Clinician Workgroup. The revised MCC measure specifications aligned with the MIPS MCC measure by: (1) Adding a diabetes cohort; (2) excluding any admissions within 10 days of discharge from a hospital, skilled nursing facility, or acute rehabilitation facility; and (3) adjusting for the AHRQ SES index and specialist density social risk factors. The only remaining difference between the MIPS and Shared Savings Program versions of the measure would be attribution, which is program-specific. Attribution for Shared Savings Program ACOs uses the Shared Savings Program beneficiary assignment methodology, which emphasizes primary care. During the MAP discussion it was noted that the original ACO MCC measure has been in use in the Shared Savings Program since 2015, and the MAP expressed no concerns with respect to feasibility and implementation of the revised MCC measure. A measure has high reliability if it produces consistent results from multiple measurements, in other words, it reflects a signal, rather than random error associated with measurement. Reliability values range between zero (all error, little signal) to 1.0 (no error, all signal).
                        <SU>76</SU>
                        <FTREF/>
                         The median signal-to-noise reliability for all Shared Savings Program ACOs in 2018 was 0.96 ranging from 0.12 to 1.00 (IQR: 0.94-0.98), indicating an overall excellent reliability of the measure.
                        <SU>77</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             Adams, John L., Ateev Mehrotra, and Elizabeth A. McGlynn, Estimating Reliability and Misclassification in Physician Profiling. Santa Monica, CA: RAND Corporation, 2010. 
                            <E T="03">https://www.rand.org/pubs/technical_reports/TR863.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             CMS used the 2018 Shared Savings Program ACO beneficiary assignment data to test the revised MCC measure. Here, reliability refers to measure score reliability of the revised MCC measure.
                        </P>
                    </FTNT>
                    <P>
                        The MAP final recommendation for this measure was “conditional support for rulemaking.” 
                        <SU>78</SU>
                        <FTREF/>
                         We intend to take the revised measure through the National Quality Forum (NQF) endorsement process in 2020. Because the revisions would make the ACO MCC measure more aligned with the MIPS version and given the support received from the MAP, we propose to include the revised All-Cause Unplanned Admissions for Patients with Multiple Chronic Conditions measure in the APP measure set to be reported on by any Medicare ACO.
                    </P>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             
                            <E T="03">https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&amp;ItemID=91911.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Cost</HD>
                    <P>
                        In the CY 2017 Quality Payment Program final rule (81 FR 77256, 77265), we finalized at § 414.1370(g)(2) to waive the cost performance category under waiver authority at section 1115A(d)(1) of the Act for CMS Innovation Center 
                        <PRTPAGE P="50287"/>
                        APMs, and at section 1899(f) of the Act for the Medicare Shared Savings Program. We are proposing to continue to waive the cost performance category under the same authorities because: (1) APM entities in MIPS APMs already are subject to cost performance assessment under their APMs, as the MIPS APM criteria would continue to include the assessment of participants based on cost; (2) MIPS APMs may measure cost performance in different ways than MIPS, for example, by basing cost on total cost of care, which measures a broader scope of cost or resource use than would necessarily be reflected in the narrower claims-based accountability standard under MIPS; and (3) MIPS APMs may attribute beneficiaries differently from MIPS for purposes of measuring cost, leading to an unpredictable degree of overlap between the sets of beneficiaries for whom the MIPS eligible clinicians would be responsible under their APM and under MIPS. We believe that with an APM Entity's finite resources for engaging in efforts to improve quality and lower costs for a specified beneficiary population under the APM, it is necessary to give the APM Entity the ability to identify a single beneficiary population to prioritize in its cost-saving efforts so that the goals and evaluation associated with the APM are as clear and free of confounding factors as possible. With this flexibility, MIPS eligible clinicians who are attempting to strategically transform their respective practices would not jeopardize their ability to succeed in either MIPS or under the terms of their APM. Therefore, by participating through the APP, the APM participant may indicate their intent to focus their resources on the beneficiary population and services identified by the terms of the APM rather than the population and services they would have been responsible for under the MIPS cost performance category. We seek comment on this proposal.
                    </P>
                    <HD SOURCE="HD3">(c) Improvement Activities</HD>
                    <P>We are proposing to assign a score for the Improvement Activities performance category for each MIPS APM, and that score will be applied to participant MIPS eligible clinicians reporting through the APP. In an effort to further reduce reporting burden for MIPS eligible clinicians in MIPS APMs and to better recognize improvement activities work performed through participation in MIPS APMs, we are proposing to assign a baseline score for each MIPS APM based on the improvement activity requirements of the particular MIPS APM. CMS would review the MIPS APM's requirements in relationship to activities specified under the generally applicable MIPS improvement activities performance category and assign for each MIPS APM an improvement activities performance category score that is applicable to all MIPS eligible clinicians reporting through the APP who are participants in the MIPS APM. To develop the improvement activities score for MIPS APMs, we would compare requirements of the APM with the list of Improvement Activities, described in § 414.1355(a), for the applicable year, and score those improvement activities as they would otherwise be scored according to § 414.1380(b)(3). Thus, points assigned to an APM participant MIPS eligible clinician participating in MIPS through the APP would be based, at least in part, on the documented terms and requirements of participation in the MIPS APM, such as under a participation agreement or regulation. In the event a MIPS APM participant does not actually perform an activity for which Improvement Activities credit would otherwise be assigned under this proposal, the MIPS APM participant would not receive credit for the associated Improvement Activity.</P>
                    <P>We would publish the assigned improvement activities scores for each MIPS APM on the CMS website prior to the beginning of the MIPS performance period. In the event that the assigned score for a MIPS APM does not represent the maximum improvement activities score, we propose that MIPS eligible clinicians reporting through the APP would have the opportunity to report additional improvement activities that then would be applied towards their scores.</P>
                    <P>We note that under section 1848(q)(5)(c)(ii) of the Act, a MIPS eligible clinician in an APM for a performance period automatically earns a minimum score of one half of the highest potential score for the improvement activities category for their participation in an APM for the performance period. Additionally, under section 1848(q)(5)(c)(i) of the Act, MIPS eligible clinicians participating in a patient-centered medical home model or comparable specialty practice, as determined by the Secretary for a performance period, automatically earn the highest potential score for the improvement activities category. These baseline scores would be automatically applied for all MIPS eligible clinicians who participate in an APM in accordance with § 414.1380(b)(3)(i) and (ii), respectively.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(d) Promoting Interoperability</HD>
                    <P>We propose that the Promoting Interoperability performance category score would be reported and calculated in the same manner described at § 414.1375. We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(4) APP Performance Category Weights</HD>
                    <P>We are proposing to continue to waive the requirement to weight each MIPS performance category as described in section 1848(q)(5)(E) of the Act using the waiver authority in sections 1115A(d)(1) and 1899(f) of the Act for CMS Innovation Center APMs and the Medicare Shared Savings Program, respectively. For reasons described in section IV.B.3.ii. of this proposed rule, we believe it is necessary to waive the cost performance category for MIPS eligible clinicians reporting to MIPS through the APP. As a result, it also would be necessary to waive the requirement to weight each MIPS performance category as described in section 1848(q)(5)(E) of the Act and to redistribute the cost performance category weight to the remaining performance categories to be scored for APM participants reporting through the APP.</P>
                    <P>We are proposing to reweight the performance categories for APM participants reporting through the APP to:</P>
                    <P>• Quality: 50 percent.</P>
                    <P>• Cost: 0 percent.</P>
                    <P>• Promoting Interoperability: 30 percent.</P>
                    <P>• Improvement Activities: 20 percent.</P>
                    <P>We believe these weights are appropriate as they generally align with the relative performance category weights under MIPS and MVPs in circumstances where the cost performance category has been reweighted to zero percent of the final score, and the cost performance category weight has been distributed proportionately among the remaining performance categories.</P>
                    <P>We propose to codify this proposal at § 414.1367(d)(1). We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(a) Reweighting a Performance Category</HD>
                    <P>
                        We recognize that there are certain circumstances when a MIPS eligible clinician, group, or APM Entity may be unable to complete reporting to MIPS due to, for example, extreme and uncontrollable circumstances, hardship, or the unavailability or inapplicability of measures due to practice size or other data limitations. Therefore, under the authority provided in section 1848(q)(5)(F) of the Act, it may become 
                        <PRTPAGE P="50288"/>
                        necessary to reweight one or more performance categories.
                    </P>
                    <P>In a case where the Promoting Interoperability performance category is reweighted to zero percent, we are proposing to reweight the quality performance category to 75 percent and the Improvement Activities performance category to 25 percent.</P>
                    <P>In a situation where the quality performance category is reweighted to zero percent, we are proposing to reweight the Promoting interoperability performance category to 75 percent and the improvement activities performance category to 25 percent.</P>
                    <P>We believe that these distributions appropriately value performance categories that require reporting on measures and measuring improvement, without disproportionately emphasizing one performance category over another. Furthermore, these performance category weights will contribute to a unified performance category reweighting policy throughout MIPS in the event of an Extreme and uncontrollable circumstance that requires the reweighting of cost and any other MIPS performance category.</P>
                    <P>We propose to codify this policy at § 414.1367(d)(2). We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(5) Scoring for APM Participants Reporting Through the APP</HD>
                    <P>We propose that final scoring for APM participants reporting to MIPS through the APP would follow the same methodology as established for MIPS generally at § 414.1380. Specifically, we would continue to score each performance category and multiply each performance category score by the applicable performance category weight, and then calculate the sum of each weighted performance category score and apply any applicable adjustments.</P>
                    <P>We propose to codify this policy at § 414.1367(e).</P>
                    <HD SOURCE="HD3">(6) Performance Feedback for APM Participants Reporting Through the APP</HD>
                    <P>We propose to make performance feedback available to MIPS eligible clinicians reporting through the APP according to the methods applicable to all MIPS eligible clinicians, as described in the 2017 QPP final rule (81 FR 77347).</P>
                    <HD SOURCE="HD3">c. MIPS Performance Category Measures and Activities</HD>
                    <P>(1) Quality Performance Category</P>
                    <P>(a) Background</P>
                    <P>We refer readers to §§ 414.1330 through 414.1340 and the CY 2018 Quality Payment Program final rule (82 FR 53626 through 53641) for our previously established policies regarding the quality performance category.</P>
                    <P>In the CY 2021 PFS proposed rule, we propose to:</P>
                    <P>• Weigh the quality performance category at 40 percent for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year, at § 414.1330(b)(4) and (5), respectively.</P>
                    <P>• Sunset the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians starting with the 2021 performance period.</P>
                    <P>• Make changes to the MIPS quality measure set as described in Appendix 1 of this proposed rule, including addition of new measures, updates to specialty sets, removal of existing measures, and substantive changes to existing measures.</P>
                    <P>• Establish separate performance periods specific to administrative claims measures at § 414.1320(d)(1).</P>
                    <P>• Make changes to the CAHPS for MIPS survey to address the increased use of telehealth care.</P>
                    <P>• Expand telehealth codes used in beneficiary assignment for the CAHPS for MIPS beginning with the 2021 survey.</P>
                    <HD SOURCE="HD3">(b) Weight in the Final Score</HD>
                    <P>Section 1848(q)(5)(E)(i)(I) of the Act, provides that 30 percent of the final score shall be based on performance for the quality performance category, in which the percentage points attributed to the final score for the quality and cost performance categories will both be equivalent at 30 percent, totaling 60 percent of the final score. The percentage points attributed to both the quality and cost performance categories are in tandem. For each year within the first five years of the MIPS program, the quality performance category performance percentage can be increased to more than 30 percent of the final score. The percentage increase of the quality performance category is equivalent to the decrease of the cost performance category.</P>
                    <P>As discussed in section IV.A.2.c.(2)(a) of this proposed rule, we propose to weight the cost performance category at 20 percent for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year. Accordingly, we are proposing to establish the weight of the quality performance category for the 2023 and 2024 MIPS payment years. At § 414.1330(b)(4), the percentage points attributed to performance in the quality performance category would comprise 40 percent of a MIPS eligible clinician's final score for the 2023 MIPS payment year and at § 414.1330(b)(5), the percentage points attributed to performance in the quality performance category would comprise 30 percent of a MIPS eligible clinician's final score for the 2024 MIPS payment year and future years.</P>
                    <P>We believe that being transparent in how both the quality and cost performance category weights would be modified over the next two years of the program will allow stakeholders to better plan and anticipate how the performance category scores would be calculated in future for MIPS eligible clinicians, groups, and virtual groups as we incrementally adjust the final score weights for the quality and cost performance categories. We solicit public comment on our proposals to incrementally reduce the weight of the quality performance category as we incrementally increase the weight of the cost performance category. Particularly, our proposal to adjust the percentage points attributed to the final score in the quality performance category to be comprised of 40 percent for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year and future years.</P>
                    <HD SOURCE="HD3">(c) Groups and Virtual Groups Reporting via the CMS Web Interface</HD>
                    <P>
                        At § 414.1335(a)(2), the CMS Web Interface measures is a collection type in which groups and virtual groups with 25 or more eligible clinicians are able to report data on a set of pre-determined quality measures. For the 2020 performance periods, the total number of CMS Web Interface measures required to complete reporting on is 10 CMS Web Interface measures (83 FR 59713 through 79715 and 59756). Each CMS Web Interface measure must have complete reporting (no partial reporting) on all 10 measures while quality measures in other collection types require the reporting of fewer measures. The reporting requirements for the CMS Web Interface measures are more stringent than other collection types for the quality performance category, which include reporting on a larger set of measures and a higher data completeness rate. At § 414.1335(a)(1)(i), it is established that groups and virtual groups reporting quality measures using non-CMS Web Interface measures collection types (such as Qualified Registries, Qualified Clinical Data Registries (QCDRs), electronic health records (EHRs), and Medicare Part B claims) are required to report on a minimum of 6 quality measures, including at least one outcome measure. The data completeness criteria for reporting 
                        <PRTPAGE P="50289"/>
                        quality measures for Qualified Registry measures, QCDR measures, EHR measures, and Medicare Part B claims measures has a lower threshold compared to the CMS Web Interface measures. The data completeness criteria for the CMS Web Interface measures requires groups and virtual groups to report on the first 248 consecutively ranked beneficiaries in the sample for each measure (and if the sample of eligible assigned beneficiaries is less than 248, then the group or virtual group must report on 100 percent of assigned beneficiaries), and at least one measure for which there is Medicare patient data (at §§ 414.1335(a)(2) and 414.1340(c)). For the 2020 performance period, the data completeness criteria threshold for Qualified Registry measures, QCDR measures, EHR measures, and Medicare Part B claims measures is 70 percent of the MIPS eligible clinician, group, or virtual group's patients (and applicable Medicare Part B patients for Medicare Part B claims measures) that meet the measure's denominator criteria (at §§ 414.1340(a)(3) and 414.1340(b)(3)). Thus, groups and virtual groups submitting quality data through the CMS Web Interface measures report on a significantly larger number of patients compared to other collection types and such patients are identified in a sample by us (at § 414.1340(c)).
                    </P>
                    <P>In section III.G.1.c. of this proposed rule, we discuss our proposal to revise the Medicare Shared Savings Program quality performance standard and align with the APP framework. With the proposed modifications to the Medicare Shared Savings Program quality performance standard, which include a proposal to transition to an APP for ACOs starting with the 2021 performance period as outlined in section III.G.1.b.(1) of this proposed rule, we conducted an assessment of the utilization of the CMS Web Interface measures as a collection type for groups and virtual groups participating in MIPS. As noted above, we recognize that the CMS Web Interface reporting requirements, which include the reporting on a larger set of measures and a higher data completeness rate, are more stringent than other collection types available under MIPS. Similar to the Medicare Shared Savings Program, for purposes of MIPS, we strive to align CMS Web Interface requirements across programs, where appropriate and applicable; reduce burden to MIPS eligible clinicians; create robust and meaningful quality measure sets that promote outcome based measures; and offer quality measures that are able to adequately and effectively assess performance such as ensuring that topped out measures are removed.</P>
                    <P>In assessing the utilization of the CMS Web Interface by groups and virtual groups, there has been a substantial decrease in participation each year since the inception of MIPS in the 2017 performance year. From the 2017 to 2019 performance years, the number of groups eligible to report quality measures via the CMS Web Interface (groups registered to utilize the CMS Web Interface) decreased by approximately 45 percent. Similarly, the number of groups utilizing the CMS Web Interface as a collection type has decreased by approximately 40 percent from the 2017 to 2019 performance years. It is not clear as to why groups and virtual groups are not seeking to participate in MIPS by submitting quality data for CMS Web Interface Measures. There could be various reasons explaining the decrease in CMS Web Interface participation such as MIPS offering several collection types that can be utilized by any individual MIPS eligible clinician, group, or virtual group to meet program requirements; the CMS Web Interface measure reporting requirements may be burdensome compared to other collection types/submission types; the measure set is limited to primary care; groups and virtual groups may have a preference to select their own measures to have performance assessed instead of a pre-determined measure set; or as a result of the CMS Web Interface measures being topped out, it may deter groups and virtual groups from participating because they would not fiscally benefit to be compared and assessed when there is little or no data variation in performance across ACOs, groups, and virtual groups.</P>
                    <P>Given the above factors, we considered the following two options in our assessment: Continue the utilization of the CMS Web Interface measures solely for groups and virtual groups while ACOs transition to APP participation; or sunset the utilization for the CMS Web Interface measures as a collection type for groups and virtual groups. Groups and virtual groups account for less than 20 percent of organizations utilizing the CMS Web Interface measures while ACOs participating in the Medicare Shared Savings Program or Next Generation ACO Model account for more than 80 percent. With an expected 80 percent reduction if our proposed revisions to the quality performance standard under the Shared Savings Program are finalized and a continued decrease in groups and virtual groups seeking to report quality data on CMS Web Interface measures, it is not fiscally viable, feasible, or sustainable for MIPS to continue to make available the CMS Web Interface measures as a collection type/submission type. A reduction in the number of organizations submitting quality data on CMS Web Interface measures does not equate to the reduction in direct costs associated with operating and maintaining the CMS Web Interface measures. To operate and maintain the CMS Web Interface measures solely for groups and virtual groups, there would be an increase in cost and needed resources under MIPS associated with the items such as the establishment and maintenance of CMS Web Interface benchmarks, assignment and sampling, technical support, and education and outreach; thus, there would be proportionally higher costs associated with the operationalization and maintenance of the CMS Web Interface with a significantly smaller number of groups and virtual groups utilizing the CMS Web Interface measures as a collection type/submission type.</P>
                    <P>In assessing the second option to sunset the CMS Web Interface measures as a collection type starting with the 2021 performance year, we would be aligning with the Medicare Shared Savings Program proposal to no longer utilize the CMS Web Interface as a means for assessing and scoring ACOs, groups, and virtual groups under the CMS Web Interface measures. We recognize that the sunset of the CMS Web Interface for groups and virtual groups may be burdensome to current groups and virtual groups submitting quality data on CMS Web Interface measures. Such groups and virtual groups would need to select a different collection type/submission type and redesign their systems to be able to interact with the new collection type/submission type. The timeframe for groups and virtual groups to select a new collection type/submission type and redesign their systems may be perceived as burdensome.</P>
                    <P>
                        We believe that groups and virtual groups would be able to select a different collection type/submission type, including at least 6 quality measures that are similar to previously established CMS Web Interface measures and reflect their specialty, and prepare for the 2021 reporting period in advance of the reporting period starting in January of 2022. While there may be an initial increase in burden for current groups and virtual groups utilizing the CMS Web Interface measures having to transition to the utilization of a different collection type/submission type, we 
                        <PRTPAGE P="50290"/>
                        recognize that we would also be reducing reporting requirements by no longer requiring groups and virtual groups to have to completely report on all pre-determined 10 CMS Web Interface measures; groups and virtual groups would be able to select their own measures to report, would be reporting data on at least 6 measures, and data completeness threshold would be 70 percent for each measure, which is a reduction in program requirements compared to completed reporting required for all CMS Web Interface measures. We believe that groups and virtual groups would be able to transition to the utilization of an available alternative collection type for the 2021 performance period. The type of data collected by groups and virtual groups for the 2020 performance period would be able to be captured by one of the available collection types such as an eCQM or MIPS CQM for the 2021 performance period. The 10 CMS Web Interface measures that are required for reporting under the 2020 performance period have an eCQM and MIPS CQM equivalent measure. For the 2021 performance period, there are 10 eCQMs and 9 CQMs that are equivalent to the 10 CMS Web Interface measures. We believe that groups and virtual groups would be able to identify at least 6 equivalent eCQMs or MIPS CQMs (or a combination) that capture the same type of data collected for the measures used in the CMS Web Interface. Also, such transition for groups and virtual groups could potentially be more beneficial. For example, if a measure from a different collection type (for example, MIPS CQMs) meets data completeness but may not meet case minimum, the measure would receive a score of 3; whereas, under the CMS Web Interface, any measure that did not meet reporting requirements would receive a score of 0.
                    </P>
                    <P>
                        The sunset of the CMS Web Interface measures would reduce burden on groups and virtual groups while aligning program requirements and scoring policies for MIPS and the Medicare Shared Savings Program, and removing CMS Web Interface measures that do not provide a meaningful means of assessing performance across groups, virtual groups, and ACOs. With the CMS Web Interface measures being topped out as noted above, we strive to remove measures that are topped out and establish a set of robust and meaningful measure sets that are available under the other collection types. We believe that the benefits groups and virtual groups would reap from transitioning to the utilization of other collection types starting with the 2021 performance year outweigh the initial disruption that would be experienced when the CMS Web Interface measures would be sunset. Based on our assessment, we are proposing at § 414.1325(c)(1) 
                        <E T="03">et seq.</E>
                         to sunset the CMS Web Interface measures as a collection type/submission type starting with the 2021 performance period. Specifically, at § 414.1305, we are proposing to modify the definition of the terms collection type and submission type to remove the CMS Web Interface measures as an available option starting with the 2023 payment year. We propose to modify the definition of collection type to mean a set of quality measures with comparable specifications and data completeness criteria, as applicable, including, but not limited to: Electronic clinical quality measures (eCQMs); MIPS Clinical Quality Measures (MIPS CQMs); QCDR measures; Medicare Part B claims measures and for the 2019 through 2022 MIPS payment years, CMS Web Interface measures; the CAHPS for MIPS survey; and administrative claims measures. We propose to revise the definition of “submission type” to mean the mechanism by which the submitter type submits data to CMS, including, but not limited to: Direct; log in and upload; log in and attest; Medicare Part B claims; and for the 2019 through 2022 MIPS payment years, the CMS Web Interface. We solicit comment on this proposal.
                    </P>
                    <HD SOURCE="HD3">(d) Selection of MIPS Quality Measures</HD>
                    <P>Previously finalized MIPS quality measures can be found in the CY 2020 PFS final rule (84 FR 63205 through 63513); CY 2019 PFS final rule (83 FR 60097 through 60285); CY 2018 Quality Payment Program final rule (82 FR 53966 through 54174); and in the CY 2017 Quality Payment Program final rule (81 FR 77558 through 77816). Proposed changes to the MIPS quality measure set as described in Appendix 1 of this proposed rule, include the following: Addition of new measures; updates to specialty sets; removal of existing measures, and substantive changes to existing measures. For the 2021 performance period, we are proposing a measure set of 206 MIPS quality measures.</P>
                    <P>The new MIPS quality measures proposed for inclusion in MIPS for the 2021 performance period and future years are found in Table Group A of Appendix 1 of this proposed rule. For the 2021 performance year, we are proposing 2 new administrative claims outcome measures. In addition to the establishment of new individual MIPS quality measures, we also develop and maintain specialty measure sets to assist MIPS eligible clinicians with selecting quality measures that are most relevant to their scope of practice. Our proposals for modifications to existing specialty sets and new specialty sets are outlined in Table Group B of Appendix 1 of this proposed rule. Specialty sets may include: New measures, previously finalized measures with modifications, previously finalized measures with no modifications, the removal of certain previously finalized quality measures, or the addition of existing MIPS quality measures. Please note that the specialty and subspecialty sets are not inclusive of every specialty or subspecialty.</P>
                    <P>
                        On January 6, 2020,
                        <SU>79</SU>
                        <FTREF/>
                         we announced that we would be accepting recommendations for potential new specialty measure sets or revisions to existing specialty measure sets for year 5 of MIPS under the Quality Payment Program. These recommendations were based on the MIPS quality measures finalized in the CY 2019 PFS final rule, the 2019 Measures Under Consideration list, and provides recommendations to add or remove the current MIPS quality measures from existing specialty sets, or provides recommendations for the creation of new specialty sets. All specialty set recommendations submitted for consideration were assessed and vetted, and as a result, the recommendations that we agree with are being proposed in this proposed rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             Listserv messaging was distributed through the Quality Payment Program listserv on January 6, 2020, titled: “CMS is Soliciting Stakeholder Recommendations for Potential Consideration of New Specialty Measure and/or Revisions to the Existing Specialty Measure Sets for the 2021 Program Year of Merit-based Incentive Payment System (MIPS).”
                        </P>
                    </FTNT>
                    <PRTPAGE P="50291"/>
                    <P>In addition to establishing new individual MIPS quality measures and modifying existing specialty sets and new specialty sets as outlined in Tables Group A and Group B of Appendix 1 of this proposed rule, we refer readers to Table Group C of Appendix 1 of this proposed rule for a list of quality measures and rationales for removal. For the 2021 performance period, we are proposing to remove 14 MIPS quality measures: 2 MIPS quality measures that are extremely topped out; 1 MIPS quality measure that is duplicative to another current quality measure; 1 MIPS quality measure that is duplicative to one of the new proposed MIPS quality measures; 2 MIPS quality measures that do not align with the Meaningful Measures Initiative; 5 MIPS quality measures that are no longer stewarded or maintained; 1 MIPS quality measure that does not meet current clinical guidelines; and 2 MIPS quality measures that are under the topped out lifecycle. We have continuously communicated to stakeholders our desire to reduce the number of process measures within the MIPS quality measure set. We believe our proposal to remove the quality measures outlined in Table Group C will lead to a more parsimonious inventory of meaningful, robust measures in the program, and that our approach to remove measures should occur through an iterative process that will include an annual review of the quality measures to determine whether they meet our removal criteria.</P>
                    <P>Lastly, MIPS quality measures with proposed substantive changes can be found in Table Group D of Appendix 1 of this proposed rule. We are proposing substantive changes to 112 MIPS quality measures. On an annual basis, we review the established MIPS quality measure inventory to consider updates to the measures. Possible updates to measures may be minor or substantive. Section 1848(q)(2)(D)(i)(II)(cc) of the Act requires all substantive measure changes to be proposed and identified through notice-and-comment rulemaking. In the CY 2017 Quality Payment Program final rule (81 FR 77137), we determined that substantive changes to measures (that is, measure specifications, measure title, and domain modifications) would be identified during the rulemaking process while maintenance changes that do not substantively change the intent of the measure (that is, updated diagnosis and procedure codes, definitions, and changes to patient population exclusions) would not be included in the rulemaking process.</P>
                    <P>We note that changes to measure Q134, Prevention Care and Screening: Screening for Depression and Follow-Up Plan (eCQM Specifications and CMS Web Interface Measure Specifications collection types), specifically the removal of SNOMED codes, were published in the eCQI Resource Center and the Value Set Authority Center (in May of 2018 for the eCQM Specifications) and on the CMS website (in December of 2018 for the CMS Web Interface Measure Specifications). While the current cycle of measure updates to MIPS quality measures is separate from the eCQM annual update process, we inadvertently recognized such update allowed MIPS eligible clinicians to meet performance of a follow-up plan by rescreening the patient who has a positive depression screen with an additional standardized depression screening tool. The change to the measure was continued for CY 2020. As a result, such changes were not identified during the CY 2019 PFS or CY 2020 PFS rulemaking cycles. The changes to measure Q134 (eCQM Specifications and CMS Web Interface Measure Specifications collection types) impact performance periods starting with 2019. For the 2019 and 2020 performance periods, measure Q134 applicable to the eCQM Specifications and CMS Web Interface Measures Specifications will be suppressed from scoring. To adequately capture the substantive changes to measure Q134 (eCQM Specifications and CMS Web Interface Measure Specifications collection types) through rulemaking for the 2021 performance period, we are identifying the substantive changes for this MIPS quality measure as outlined in Table Group D of Appendix 1 of this proposed rule.</P>
                    <HD SOURCE="HD3">(e) MIPS Performance Period</HD>
                    <HD SOURCE="HD3">(i) Establishing Separate Performance Periods for Administrative Claims Measures Under the Quality Performance Category Beginning With the 2023 MIPS Payment Year</HD>
                    <P>In the CY 2019 PFS final rule (83 FR 59745), we established at § 414.1320(d)(1) that beginning with the 2022 MIPS payment year, the performance period for the quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year. We noted that we established a one year performance period for measures in the quality performance category because a 1-year performance period would provide statistically larger sample sizes and more accurate and actionable information. As discussed in Table Group A of Appendix 1 of this proposed rule, we propose to add a new administrative claims measure of risk-standardized complication rate following elective primary total hip arthroplasty and/or total knee arthroplasty. This measure was developed and tested using a performance period that was longer than a full calendar year in order to provide larger sample sizes, and more accurate and actionable information. Beginning with the 2021 performance year, this measure would have a 3-year performance period (consecutive 36-month timeframe) that would start on October 1 of the calendar year 3 years prior to the applicable performance year and conclude on September 30 of the calendar year of the applicable performance year, and proceeding with a 3-month numerator assessment period (capturing complication outcomes) followed by a 2-month claims run-out period. For example, the 3-year (36 consecutive months) performance period for this measure would span from October 1, 2018 to September 30, 2021 with a 90-day numerator assessment period followed by a 60-day claims run-out period.</P>
                    <P>
                        To account for this measure and other future administrative claims measures that may have a performance period differing from 1 full calendar year, we propose to modify the definition of the performance period for the quality and cost performance categories at § 414.1320(d)(1) to be as follows: Beginning with the 2023 MIPS payment year, the performance period for the quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year, except as otherwise specified for administrative claims-based measures in the MIPS final list of quality measures described in § 414.1330(a)(1). We note that while we have established a single performance period for measures and activities within each performance category in the MIPS program, we have established measure-specific performance periods in other programs, such as in the hospital value-based purchasing program, which includes measures of various performance periods (84 FR 42394 through 42395). We continue to believe that establishing a single performance period for measures requiring the submission of data optimizes operational efficiency for MIPS eligible clinicians, groups, and virtual groups that submit data on such measures. However, administrative 
                        <PRTPAGE P="50292"/>
                        claims measures (proposal to add 2 new administrative claims measures found in Table Group A of Appendix 1 of this proposed rule: Hospital-Wide, 30-Day, All-Cause Unplanned Readmission (HWR) Rate, and Risk-standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA)); and proposal to remove the All-Cause Readmission measure found in Table Group C of Appendix 1 (was the only administrative claims-based measure) do not require the submission of data and are calculated by CMS based on administrative data. Thus, we believe that a different performance period should be considered on a measure-by-measure level for administrative claims measures. We seek public comment on our proposal to modify the definition of performance period for the quality and cost performance categories that would establish a separate performance period for administrative claims measures under the quality performance category.
                    </P>
                    <HD SOURCE="HD3">(f) Quality Data Submission Criteria</HD>
                    <HD SOURCE="HD3">(i) Performance Criteria for Quality Measures for Groups Electing To Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey</HD>
                    <P>We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53629 through 53632) for previous finalized policies for the CAHPS for MIPS survey, specifically regarding the Summary Survey Measures (SSMs).</P>
                    <P>To address the PHE for the COVID-19 pandemic and the increased use of telehealth care, we propose the following changes to our policies related to the CAHPS for MIPS Survey:</P>
                    <P>• We propose to integrate one telehealth item into the CAHPS for MIPS Survey. Specifically, we propose to add a survey-based measure on telehealth that assesses patient-reported usage of telehealth services (for example, phone or video visit) to the performance year 2021 CAHPS for MIPS Survey.</P>
                    <P>• We also propose revisions to the CAHPS for MIPS Survey cover page to include a reference to care received in telehealth settings. This may help to ensure that patients who respond to the survey are reflecting on experiences of the care they received via telehealth in their responses. We are considering such changes for the performance year 2021 CAHPS for MIPS Survey administration.</P>
                    <P>To clarify the instructions in the CAHPS for MIPS Survey, we propose revisions to the instructions in the “Your Care From Specialists in the Last 6 Months” section of the CAHPS for MIPS Survey to clarify the inclusion of the provider named in Question 1 of the survey. We are considering such changes for the performance year 2021 CAHPS for MIPS Survey administration.</P>
                    <P>We refer readers to the Collection of Information Requirements section VI. of this rule for additional information.</P>
                    <HD SOURCE="HD3">(ii) CAHPS for MIPS Patient Assignment</HD>
                    <P>Section 1834(m) of the Act specifies the payment amounts and circumstances under which Medicare makes payment for a discrete set of services, all of which must ordinarily be furnished in-person, when they are instead furnished using interactive, real-time telecommunication technology. When furnished under the telehealth rules, these specified Medicare telehealth services are reported using the same codes used for the “face-to-face” services, but are furnished using audio/video, real-time, interactive communications technology instead of in person. As such, the majority of the codes for primary care services included in the additional telehealth services added in the March 31st COVID-19 IFC for purposes of the PHE for COVID-19 pandemic are already included in the definition of primary care services for purposes of the MIPS assignment methodology for the CAHPS for MIPS survey (82 FR 77168 through 77169; and 82 FR 53646 through 53647). At § 414.1305, we are proposing to codify the definition of primary care services for purposes of MIPS assignment methodology for the CAHPS for MIPS survey as follows:</P>
                    <P>• CPT codes:</P>
                    <P>++ 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient); 99304 through 99318 (codes for professional services furnished in a nursing facility, excluding professional services furnished in a SNF for claims identified by place of service (POS) modifier 31); 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit); 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by POS modifier 12); 99487, 99489, and 99490 (codes for chronic care management); and 99495 and 99496 (codes for transitional care management services); and</P>
                    <P>++ Beginning with the 2023 MIPS payment year, 99421, 99422, and 99423 (codes for online digital evaluation and management services (e-visit)); 99441, 99442, and 99443 (codes for telephone evaluation and management services); and 96160 and 96161 (codes for Administration of Health Risk Assessment).</P>
                    <P>• HCPCS codes:</P>
                    <P>++ G0402 (code for the Welcome to Medicare visit); and G0438 and G0439 (codes for the annual wellness visits); and</P>
                    <P>++ Beginning with the 2023 MIPS payment year, G2010 (code for remote evaluation of patient video/images); and G2012 (code for virtual check-in).</P>
                    <P>In the March 31st COVID-19 IFC, we also established flexibilities and separate payment for certain services that are furnished virtually using communication technologies, but that are not considered Medicare telehealth services such as virtual check-ins and e-visits. We also established separate payment for telephone E/M services codes during the PHE. The communications technology-based services (CTBS) and the telephone E/M services are not currently included in the MIPS assignment methodology for the CAHPS for MIPS survey.</P>
                    <P>We believe it is critical to include codes for CTBS and telephone E/M services, as identified and discussed later in this section, in the definition of primary care services to ensure these services are included in our determination of where beneficiaries receive the plurality of their primary care for purposes of beneficiary assignment. Such inclusion ensures that the assignment methodology appropriately reflects the expanded use of technology that is helping people who need routine care during the PHE for the COVID-19 pandemic and allowing vulnerable beneficiaries and beneficiaries with mild symptoms to remain in their homes, while maintaining access to the care they need. By including services provided virtually, either through telehealth or other uses of communications technology, we would ensure that this care is appropriately reflected in our consideration of the plurality of care used to assign beneficiaries to groups and virtual groups.</P>
                    <P>
                        We have added new services to the separately billable CTBS under the Physician Fee Schedule over the past several years and a result of the PHE, we expect that the utilization of communications technology-based services will substantially increase during the PHE for the COVID-19 pandemic and thereafter. We believe that clinicians are increasingly using such services as a key component of their ongoing primary care. In an effort to address the PHE and use of telehealth, and to maintain alignment with the Shared Savings Program, we propose to integrate the same telehealth 
                        <PRTPAGE P="50293"/>
                        CPT and HCPCS codes that are used for purposes of assigning beneficiaries to Shared Savings Program ACOs into the set of primary care service codes that are used for patient assignment to MIPS groups. We are proposing to revise the definition of primary care services used in the MIPS assignment methodology for the 2021 CAHPS for MIPS survey, and for any subsequent performance year, to include the following additions: (1) CPT codes: 99421, 99422, and 99423 (codes for online digital E/M services (e-visits)); 99441, 99442, and 99443 (codes for telephone E/M services); and 96160 and 96161 (codes for administration of health risk assessment); and (2) HCPCS codes: G2010 (code for remote evaluation of patient video/images) and G2012 (code for virtual check-in). It should be noted that the proposed inclusion of such codes in the MIPS assignment methodology for the CAHPS for MIPS survey aligns with the definition of primary care services used for purposes of beneficiary assignment under the Medicare Shared Savings Program, which was amended in the May 8th COVID IFC to ensure these codes would be included in determining beneficiary assignment for performance year 2020 and any subsequent performance year that starts during the PHE for the COVID-19 pandemic (85 FR 27583). We refer readers to the May 8th COVID-19 IFC (85 FR 27582 through 27586) for a detailed description of the codes that were added to the definition of primary care services under the Medicare Shared Savings Program. We also refer readers to the 2018 PFS final rule (82 FR 53007 through 53011) for a detailed description of the primary care services codes for Administration of Health Risk Assessment.
                    </P>
                    <P>The services represented by the codes listed above are being used in place of similar E/M services, the codes for which are already included in the list of codes used for assignment. As a result, we believe these services are an important component of primary care and it is appropriate to include these codes in the definition of primary care services used for assignment for the CAHPS for MIPS survey. It should be noted that the remote evaluation of patient video/images and virtual check-in codes, and the online digital E/M service (e-visit) codes are not separately billable by a clinician if they are related to a visit within the past 7 days or lead to a visit within the following 24 hours or next available appointment. The only codes that are newly billable during the PHE for the COVID-19 pandemic pertain to the telephone E/M services.</P>
                    <P>We believe that clinicians are increasingly using communications technology-based services as a key component of their ongoing primary care. We expect that the utilization of such services will substantially increase not only during the PHE for the COVID-19 pandemic, but also thereafter. Accordingly, we propose to include virtual primary care visits and telehealth visits to determine patient assignment to groups for purposes of the CAHPS for MIPS Survey for 2021 and subsequent performance years.</P>
                    <HD SOURCE="HD3">(2) Cost Performance Category</HD>
                    <P>We refer readers to the CY 2017 and CY 2018 Quality Payment Program final rules, and the CY 2019 and CY 2020 PFS final rules (81 FR 77162 through 77177, 82 FR 53641 through 53648, 83 FR 59765 through 59776, and 84 FR 62959 through 62968, respectively) for a description of the statutory basis and existing policies pertaining to the cost performance category.</P>
                    <P>In this proposed rule, we are proposing to weight the cost performance category at 20 percent for MIPS payment year 2023 and 30 percent for MIPS payment year 2024 and all subsequent MIPS payment years.</P>
                    <HD SOURCE="HD3">(a) Weight in the Final Score</HD>
                    <P>Under section 1848(q)(5)(E)(i)(II)(aa) of the Act, in general, 30 percent of the MIPS final score shall be based on the cost performance category. However, section 1848(q)(5)(E)(i)(II)(bb) of the Act gives the Secretary discretion with respect to the weight of the cost performance category for the first 5 years of MIPS. Specifically, under that section, for the first year for which the MIPS applies to payments (the 2019 MIPS payment year), not more than 10 percent of the MIPS final score shall be based on the cost performance category; and for each of the second, third, fourth, and fifth years for which the MIPS applies to payments (the 2020, 2021, 2022, and 2023 MIPS payment years, respectively), not less than 10 percent and not more than 30 percent of the MIPS final score shall be based on the cost performance category. Additionally, section 1848(q)(5)(E)(i)(II)(bb) of the Act states that it shall not be construed as preventing the Secretary from adopting a 30 percent weight for the second, third, fourth, or fifth year if the Secretary determines, based on information posted under section 1848(r)(2)(I) of the Act, that sufficient cost measures are ready for adoption for use under the cost performance category for the relevant performance period. The weights adopted in prior rulemaking for the cost performance category are codified under § 414.1350(d).</P>
                    <P>In the CY 2020 PFS proposed rule (84 FR 40752), we proposed to incrementally increase the weight of the cost performance category from the existing weight of 15 percent for the 2021 MIPS payment year to 30 percent beginning with the 2024 MIPS payment year as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act. We proposed to incrementally increase the weight of the cost performance category by 5 standard increments each year through the 2024 MIPS payment year, reflecting a weight of 20 percent for the 2022 MIPS payment year, 25 percent for the 2023 MIPS payment year, and 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year (84 FR 40752 through 40753).</P>
                    <P>As cost measures are still being developed, we recognized that clinicians may not have the same level of familiarity or understanding of cost measures as they do with the comparable quality measures. To implement a gradual and predictable approach of increasing the weight of the cost performance category each year would provide clinicians with adequate time to prepare for a 30 percent weight and enable clinicians to gain experience with the cost measures while they represent a smaller portion of the MIPS final score. We recognized that there may be greater understanding of the measures in the cost performance category as clinicians obtain more experience with the measures (84 FR 62959).</P>
                    <P>After considering the comments we received, we did not finalize our proposals, and instead established at § 414.1350(d)(3) that the weight of the cost performance category will remain at 15 percent of the MIPS final score for MIPS payment years 2021 and 2022 (84 FR 62961). We stated that we expected to propose a weight for the cost performance category for the 2023 MIPS payment year in the CY 2021 PFS proposed rule.</P>
                    <P>
                        In developing this proposed rule, we considered a range of numerical options for the weight of the cost performance category for the 2023 MIPS payment year, with the intention of reaching a weight of 30 percent no later than the 2024 MIPS payment year as required by the statute. The first option we considered was to maintain the cost performance category weight at the status quo for an additional year, in which it would remain at 15 percent for the 2023 MIPS payment year and then increase to 30 percent beginning with the 2024 MIPS payment year, which would be a 15 percent increase in the weight from 2023 to 2024. We considered such option as a result of the 
                        <PRTPAGE P="50294"/>
                        COVID-19 public health emergency in order to not increase the weight of the cost performance category during an unprecedented time. However, by maintaining the weight at 15 percent for the 2023 MIPS payment year, the weight would increase two-fold to 30 percent beginning with the 2024 MIPS payment year, which we believe would pose a significant burden to stakeholders and would eliminate any transition of an incremental increase in the cost performance category weight. We believe that the first option would be more burdensome than beneficial to clinicians as they continue to gain more experience with the cost measures and mitigate through the COVID-19 public health emergency.
                    </P>
                    <P>The second option we considered was to increase the weight from 15 percent for MIPS payment years 2021 and 2022 to 20 percent for the 2023 MIPS payment year in order to provide a minimal transition that would enable clinicians to continue to become familiar with the cost measures and be prepared for the final increase in the weight of the cost performance category from 20 percent to 30 percent beginning with the 2024 MIPS payment year. We believe that such approach would allow us to reach the statutorily required weight of 30 percent by the 2024 MIPS payment year while providing clinicians with an eased incremental transition starting with the 2023 MIPS payment year and accounting for the consequential impact of the increased clinical costs associated with the COVID-19 public health emergency. For the 2023 MIPS payment year, we sought to identify a smaller increase in weight while enabling clinicians to gain more experience and familiarity with the cost measures amidst the mitigation of the COVID-19 public health emergency.</P>
                    <P>After considering these options, we are proposing to establish at § 414.1350(d)(4) the weight of the cost performance category to be 20 percent of the MIPS final score for the 2023 MIPS payment year and at § 414.1350(d)(5) the weight of the cost performance category to be 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year.</P>
                    <P>We solicit public comment on our proposal, the other options we considered, and any additional options for the weight of the cost performance category that commenters believe we should consider, such as a 22.5 percent weight for the 2023 MIPS payment year and a 30 percent weight beginning with the 2024 MIPS payment year (a 7.5 percent increase for each year). In general, we prefer to consider whole numbers for performance category weights, but are interested in obtaining feedback from commenters on the weighing of the cost performance category to have an increase of 7.5 percent for 2 consecutive years for the 2023 and 2024 MIPS payment years.</P>
                    <HD SOURCE="HD3">(b) Addition of Telehealth Services to Previously Established Measures for the Cost Performance Category Beginning With the 2021 Performance Period</HD>
                    <P>
                        For the 2021 performance period and future performance periods, we propose to add costs associated with telehealth services to the previously established cost measures. For each cost measure, the telehealth services we propose to add are directly relevant to the intent of the measure. We refer readers to Table 47 in the CY 2020 PFS final rule (84 FR 62979) for a summary list of the cost measures that have been established for the 2021 performance period and future performance periods, as well as the related discussions in the CY 2019 PFS final rule (83 FR 59767 through 83 FR 59774) and the CY 2020 PFS final rule (84 FR 62962 through 62979). Many services included on the Medicare telehealth service list are billed as telehealth services through the use of a modifier appended to the same code that is used when the service is furnished in person. These codes are already included in the cost measures; however, the additional codes we propose to add are not currently included for a few reasons. First, some codes we propose to add to the cost measures were newly included on the Medicare telehealth services list through the March 31st COVID-19 IFC (85 FR 19230) and subsequent sub-regulatory processes as established in the May 8th COVID-19 IFC (85 FR 27550). Second, some codes we propose to add were not previously considered for inclusion because they were not billed widely enough to be found in empirical claims-based data. This is because our approach for determining clinically related services to include in cost measures, which we established in the CY 2019 PFS final rule (83 PFS 59767 through 59771), relies on empirical data to examine existing practice patterns, in addition to clinical expertise. Having observed an increase in the use of these codes, including those that existed before the public health emergency, we are proposing to add them to adapt the measures to this change in practice patterns. The codes we propose to add represent service categories already captured in the measures (
                        <E T="03">e.g.,</E>
                         E/M, follow up consultation following hospital discharge); thus, we do not consider their addition to alter the intent of the measures or capture a new category of costs. Updated measure specifications with the added telehealth codes are available on the CMS website at 
                        <E T="03">http://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback.</E>
                    </P>
                    <P>We solicit public comment on this proposal.</P>
                    <HD SOURCE="HD3">(3) Improvement Activities Performance Category</HD>
                    <HD SOURCE="HD3">(a) Background</HD>
                    <P>For previous discussions on the background of the improvement activities performance category, we refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77178), the CY 2018 Quality Payment Program final rule (82 FR 53648 through 53661), the CY 2019 PFS final rule (83 FR 59776 through 59777), and the CY 2020 PFS final rule (84 FR 62980 through 62990). We also refer readers to § 414.1305 for the definition of improvement activities and attestation, § 414.1320(b)(2) for the performance period, § 414.1325 for the data submission requirements, § 414.1355 for the inventory and final score, § 414.1360 for the data submission criteria, § 414.1365 for the subcategories, § 414.1380 for the scoring, § 414.1380(b)(3)(i) through (iii) for weighting, § 414.1380(b)(3)(iv) and § 414.1380(b)(3)(x) for patient-centered medical home, § 414.1380(b)(3)(vii) for exceptions, and § 414.1380(b)(3)(ix) for APM.</P>
                    <P>In this proposed rule, beginning with the CY 2021 performance period and future years, we are proposing: (1) Changes to the Annual Call for Activities: An exception to the nomination period timeframe during a PHE; and a new criterion for nominating new improvement activities; (2) a process for HHS-nominated improvement activities; and (3) to modify two existing improvement activities. These proposals are discussed in more detail in this proposed rule.</P>
                    <HD SOURCE="HD3">(b) Improvement Activities Inventory</HD>
                    <HD SOURCE="HD3">(i) Annual Call for Activities</HD>
                    <P>
                        In the CY 2017 Quality Payment Program final rule (81 FR 77190), for the transition year of MIPS, we implemented the initial improvement activities Inventory and took several steps to ensure it was inclusive of activities in line with statutory and program requirements. For Year 2, we provided an informal process for submitting new improvement activities or modifications for potential inclusion in the comprehensive improvement activities Inventory for the Quality Payment Program Year 2 and future 
                        <PRTPAGE P="50295"/>
                        years through subregulatory guidance (
                        <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf</E>
                        ). In the CY 2018 Quality Payment Program final rule (82 FR 53656 through 53659), for Year 3 and future years, we finalized a formal Annual Call for Activities process for adding possible new activities or providing modifications to the current activities in the improvement activities Inventory, including information required to submit a nomination form similar to the one we utilized for Year 2 (82 FR 53656 through 53659). It is important to note that in order to submit a request for a new activity or a modification to an existing improvement activity the stakeholder must submit a nomination form available at 
                        <E T="03">www.qpp.cms.gov</E>
                         during the Annual Call for Activities.
                    </P>
                    <HD SOURCE="HD3">(A) Timeframe for the Annual Call for Activities</HD>
                    <HD SOURCE="HD3">(aa) Currently Adopted Timeframe</HD>
                    <P>
                        In the CY 2017 Quality Payment Program final rule (81 FR 77190), for the transition year of MIPS, we implemented the initial improvement activities Inventory and took several steps to ensure it was inclusive of activities in line with statutory and program requirements. For Year 2, we provided an informal process for submitting new improvement activities or modifications for potential inclusion in the comprehensive improvement activities Inventory for the Quality Payment Program Year 2 and future years through subregulatory guidance (
                        <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf</E>
                        ). In the CY 2018 Quality Payment Program final rule (82 FR 53656 through 53659), for Year 3 and future years, we finalized a formal Annual Call for Activities process for adding possible new activities or providing modifications to the current activities in the improvement activities Inventory, including information required to submit a nomination form similar to the one we utilized for Year 2 (82 FR 53656 through 53659). It is important to note that in order to submit a request for a new activity or a modification to an existing improvement activity the stakeholder must submit a nomination form available at 
                        <E T="03">www.qpp.cms.gov</E>
                         during the Annual Call for Activities.
                    </P>
                    <P>In the CY 2019 PFS final rule (83 FR 59781 through 59782), we finalized to change the performance year for which nominations of prospective new and modified improvement activities would apply, such that beginning with the CY 2019 performance period and for future years, improvement activities nominations received in a particular year will be vetted and considered for the next year's rulemaking cycle for possible implementation in a future year. In addition, we finalized to change the submission timeframe for the Annual Call for Activities from February 1st through March 1st to February 1st through June 30th, providing approximately 4 additional months for stakeholders to submit nominations beginning with the CY 2019 performance period.</P>
                    <HD SOURCE="HD3">(bb) Proposed Exception During Public Health Emergencies</HD>
                    <P>
                        The COVID-19 pandemic was deemed a public health emergency (PHE) by the Secretary of the Department of Health and Human Services. Information regarding the PHE for the COVID-19 pandemic is available at 
                        <E T="03">https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.</E>
                         This unprecedented PHE has brought to our attention the necessity of having the flexibility to consider nominations of new improvement activities to the Inventory outside the established Annual Call for Activities nomination period. We believe having the flexibility to consider nominations during a PHE is important because of the nature of a PHE; we want the ability to consider relevant improvement activities while the emergency is ongoing. We refer readers to the CY 2019 PFS final rule (83 FR 59779) for a complete definition of PHE and its application to inclusion criteria for new improvement activities.
                    </P>
                    <P>Therefore, beginning with the CY 2021 performance period, we are proposing to make an exception to the established timeframe, such that during a PHE, stakeholders can nominate improvement activities outside of the established Annual Call for Activities timeframe. Instead of only accepting nominations and modifications submitted February 1st through June 30th each year, we would accept nominations for the duration of the PHE as long as the improvement activity is still relevant. No other aspects of the Annual Call for Activities process would be affected (for example, criteria for nominating improvement activities, considerations for selection of improvement activities, or weighting policies would all still apply). We continue to believe it is important for stakeholders to be able to comment on improvement activities. Therefore, any improvement activity considered for inclusion in the Inventory would still be finalized through a future rulemaking. We invite public comments on our proposal.</P>
                    <HD SOURCE="HD3">(B) Criteria for Nominating New Improvement Activities</HD>
                    <P>In the CY 2019 PFS final rule (83 FR 59778 through 59779), we adopted one new criterion and removed a criterion from the improvement activities nomination criteria. We also clarified our considerations in selecting improvement activities.</P>
                    <HD SOURCE="HD3">(aa) Currently Adopted Criteria</HD>
                    <P>In the CY 2017 Quality Payment Program final rule (81 FR 77190 through 77195), we discussed guidelines for the selection of improvement activities. In the CY 2018 Quality Payment Program final rule, we formalized the Annual Call for Activities process for Year 3 and future years and added additional criteria; stakeholders should apply one or more of the below criteria when submitting nominations for improvement activities (82 FR 53660). In addition, in the CY 2019 PFS final rule (83 FR 59779) we finalized to add a “public health emergency as determined by the Secretary” to the criterion below.</P>
                    <P>• Relevance to an existing improvement activities subcategory (or a proposed new subcategory);</P>
                    <P>• Importance of an activity toward achieving improved beneficiary health outcomes;</P>
                    <P>• Importance of an activity that could lead to improvement in practice to reduce health care disparities;</P>
                    <P>• Aligned with patient-centered medical homes;</P>
                    <P>• Focus on meaningful actions from the person and family's point of view;</P>
                    <P>• Support the patient's family or personal caregiver;</P>
                    <P>• Representative of activities that multiple individual MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);</P>
                    <P>• Feasible to implement, recognizing importance in minimizing burden, especially for small practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;</P>
                    <P>• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes;</P>
                    <P>• Include a public health emergency as determined by the Secretary; or</P>
                    <P>• CMS is able to validate the activity.</P>
                    <HD SOURCE="HD3">(bb) Proposed New Criteria</HD>
                    <P>
                        In addition to the aforementioned considerations, when considering 
                        <PRTPAGE P="50296"/>
                        improvement activities for possible inclusion in MIPS, we propose that beginning with the 2021 Call for Activities, MIPS improvement activities submitted should be linked to existing and related quality and cost measures, as applicable and feasible. Stakeholders that select this particular criteria would be required to provide a rationale describing how they believe their improvement activity correlates to other performance category measures as a part of the Call for Activities. We believe that when possible, it is important to establish a strong linkage between quality, cost, and improvement activities.
                    </P>
                    <P>Therefore, we are proposing to adopt an additional criterion entitled “Include activities which can be linked to existing and related MIPS quality and cost measures, as applicable and feasible” to the criteria for nominating new improvement activities beginning with the CY 2021 performance period and future years. If our proposal to add one criterion is adopted as proposed, stakeholders should apply one or more of the below criteria when submitting nominations for improvement activities beginning with the CY 2021 performance period and future years:</P>
                    <P>• Relevance to an existing improvement activities subcategory (or a proposed new subcategory);</P>
                    <P>• Importance of an activity toward achieving improved beneficiary health outcomes;</P>
                    <P>• Importance of an activity that could lead to improvement in practice to reduce health care disparities;</P>
                    <P>• Aligned with patient-centered medical homes;</P>
                    <P>• Focus on meaningful actions from the person and family's point of view;</P>
                    <P>• Support the patient's family or personal caregiver;</P>
                    <P>• Representative of activities that multiple individual MIPS eligible clinicians or groups could perform (for example, primary care, specialty care);</P>
                    <P>• Feasible to implement, recognizing importance in minimizing burden, especially for small practices, practices in rural areas, or in areas designated as geographic HPSAs by HRSA;</P>
                    <P>• Evidence supports that an activity has a high probability of contributing to improved beneficiary health outcomes;</P>
                    <P>• Include a public health emergency as determined by the Secretary;</P>
                    <P>• Include activities which can be linked to existing and related MIPS quality and cost measures, as applicable and feasible; or</P>
                    <P>• CMS is able to validate the activity.</P>
                    <P>We invite public comment on our proposal.</P>
                    <HD SOURCE="HD3">(ii) HHS-Nominated Improvement Activities</HD>
                    <HD SOURCE="HD3">(A) Background</HD>
                    <P>
                        As stated above in section IV.A.3.c.(3)(b)(i)(A)(bb) of this proposed rule titled “Proposed Exception During Public Health Emergencies,” this unprecedented PHE has brought to our attention the necessity of having the flexibility to consider nominations of new improvement activities to the Inventory outside the Annual Call for Activities nomination period and process.” We also believe that we should have the flexibility to nominate activities from within HHS. The federal government is uniquely positioned to quickly address administration goals versus the public sector in pertinent areas that may have national impact to improve the health care system. For example, CMS has established the CMS Strategic Initiatives which provides 16 distinct focus areas including Patients over Paperwork. The CMS Strategic Initiatives focus areas aim to empower patients and unleash innovation while transforming the health care system. We believe that goals such as the CMS Strategic Initiatives deliver better value and results for patients through competition and innovation. To accomplish goals included in agency-wide plans, such as the CMS Strategic Initiatives, there are instances when it is necessary to accept HHS-nominated improvement activities outside of the Call to advance these type of goals in an expedited manner. We refer readers to 
                        <E T="03">https://www.cms.gov/About-CMS/Story-Page/our-16-strategic-initiatives</E>
                         for more information about CMS strategic initiatives and to 
                        <E T="03">https://www.cms.gov/About-CMS/story-page/patients-over-paperwork</E>
                         for more information about Patients over Paperwork.
                    </P>
                    <HD SOURCE="HD3">(B) Proposed HHS-Nominated Improvement Activities Process</HD>
                    <P>Beginning with the CY 2021 performance period and future years, we propose that we would consider HHS-nominated improvement activities all year long in order to address HHS initiatives in an expedited manner. These HHS-nominated improvement activities would be subject to the same criteria for nominating new improvement activities as discussed above in section IV.A.3.c.(3)(b)(i)(B) of this proposed rule titled “Criteria for Nominating New Improvement Activities.” In addition, the HHS-nominated activity would need to apply the criteria of: “aligned with at least one of the HHS goals, when feasible and appropriate” to the nominated activity. Further, the HHS-nominated improvement activity would be assessed for the most appropriate subcategory; we refer readers to § 414.1355(c).</P>
                    <P>We continue to believe it is important for stakeholders to be able to comment on these HHS-nominated improvement activities. Thus, we would propose any HHS-nominated improvement activities through rulemaking. In such proposal, we would specifically request comment on whether stakeholders agree the activities improve clinical practice or care delivery. We invite public comments on our proposal.</P>
                    <HD SOURCE="HD3">(iii) Proposed Changes to the Improvement Activities Inventory</HD>
                    <P>
                        In the CY 2018 Quality Payment Program final rule (82 FR 53660), we finalized that we would establish improvement activities through notice-and-comment rulemaking. We refer readers to Table H in the Appendix of the CY 2017 Quality Payment Program final rule (81 FR 77177 through 77199), Tables F and G in the Appendix of the CY 2018 Quality Payment Program final rule (82 FR 54175 through 54229), Tables X and G in the Appendix 2 of the CY 2019 PFS final rule (83 FR 60286 through 60303), and Tables A, B, and C in the Appendix 2 of the CY 2020 PFS final rule (84 FR 63514 through 63538) for our previously finalized improvement activities Inventory. We also refer readers to the Quality Payment Program website at 
                        <E T="03">https://qpp.cms.gov/</E>
                         for a complete list of the most current list of improvement activities. In this proposed rule, we are proposing to modify two existing improvement activities for the CY 2021 performance period and future years. We refer readers to Appendix 2 of this proposed rule for further details. We are not proposing to remove any previously adopted improvement activities. We invite public comments on our proposals.
                    </P>
                    <HD SOURCE="HD3">(4) Promoting Interoperability</HD>
                    <HD SOURCE="HD3">(a) Background</HD>
                    <P>
                        Section 1848(q)(2)(A) of the Act includes the meaningful use of certified electronic health record technology (CEHRT) as a performance category under the MIPS. As required by sections 1848(q)(2) and (5) of the Act, the four performance categories of the MIPS shall be used in determining the MIPS final score for each MIPS eligible clinician. In general, MIPS eligible clinicians will be evaluated under all four of the MIPS performance categories, including the Promoting Interoperability performance category.
                        <PRTPAGE P="50297"/>
                    </P>
                    <HD SOURCE="HD3">(b) Promoting Interoperability Performance Category Performance Period</HD>
                    <P>As finalized in the CY 2020 PFS final rule at § 414.1320(f)(1) (84 FR 62992), for purposes of the 2023 MIPS payment year, the performance period for the Promoting Interoperability performance category is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. Thus, for the 2023 MIPS payment year, the performance period for the Promoting Interoperability performance category is a minimum of a continuous 90-day period within CY 2021, up to and including the full CY 2021 (January 1, 2021 through December 31, 2021).</P>
                    <P>For the 2024 MIPS payment year and each subsequent MIPS payment year, we are proposing to add § 414.1320(g)(1), which would establish a performance period for the Promoting Interoperability performance category of a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. This proposal aligns with the proposed EHR reporting period in CY 2022 for the Medicare Promoting Interoperability Program for eligible hospitals and CAHs (85 FR 32853). We believe this would be an appropriate performance period because it would offer stability and consistency for eligible clinicians reporting for the Promoting Interoperability performance category.</P>
                    <P>We are requesting comments on this proposal.</P>
                    <HD SOURCE="HD3">(c) Promoting Interoperability Performance Category Measures for MIPS Eligible Clinicians</HD>
                    <HD SOURCE="HD3">(i) Proposed Changes to the Query of Prescription Drug Monitoring Program (PDMP) Measure Under the Electronic Prescribing Objective</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 62992 through 62994), we finalized that the Query of PDMP measure under the Electronic Prescribing objective is optional and eligible for 5 bonus points in CY 2020. However, we have continued to receive substantial feedback from health IT developers and clinicians that the flexibility currently included in the measure presents unintended challenges such as significant burden associated with IT system design and additional development needed to accommodate the measure and any future changes to it. Since publication of the CY 2020 PFS final rule, stakeholders have continued to express concern that it is still too premature to require the Query of PDMP measure and score it based on performance in CY 2021.</P>
                    <P>
                        We agree with stakeholders that PDMPs are still maturing in their development and use. PDMPs vary among the states and are not linked at this time to one another or to a larger national system.
                        <SU>80</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             
                            <E T="03">https://namsdl.org/topics/pdmp/</E>
                             and 
                            <E T="03">https://www.pdmpassist.org/content/pdmp-maps-and-tables.</E>
                        </P>
                    </FTNT>
                    <P>Stakeholders also mentioned the challenge posed by the current lack of integration of PDMPs into the EHR workflow. Historically, health care providers have had to go outside of the EHR workflow in order to separately log in to and access the state PDMP. In addition, stakeholders noted the wide variation in whether PDMP data can be stored in the EHR. By integrating PDMP data into the health record, health care providers can improve clinical decision making by utilizing this information to identify potential opioid use disorders, inform the development of care plans, and develop effective interventions.</P>
                    <P>ONC recently engaged in an assessment to better understand the current state of policy and technical factors impacting PDMP integration across states. This assessment explored factors like PDMP data integration, standards, and hubs used to facilitate interstate PMDP data exchange, access permissions, and laws and regulations governing PDMP data storage. The assessment revealed ambiguous or non-existent policies regarding PDMP placement in health IT systems, interpretation of PDMP data, and PDMP access roles. In addition, variability in standards and hubs used to facilitate interstate PMDP data exchange, as well as to store and report PDMP data, contribute to the complexity of PDMPs.</P>
                    <P>The SUPPORT for Patients and Communities Act, enacted in 2018, is an important investment in combating the opioid epidemic. Several of the provisions of the SUPPORT for Patients and Communities Act address opioid use disorder prevention, recovery, and treatment including increased access to evidence-based treatment and follow-up care, through legislative changes specific to the Medicare and Medicaid programs. Specifically, with respect to PDMPs, the SUPPORT for Patients and Communities Act included new requirements and federal funding for PDMP enhancement, integration, and interoperability, and established mandatory use of PDMPs by certain Medicaid providers, in an effort to help reduce opioid misuse and overprescribing, and in an effort to help promote the overall effective prevention and treatment of opioid use disorder.</P>
                    <P>Section 5042(a) of the SUPPORT Act added section 1944 to the Act, titled “Requirements relating to qualified prescription drug monitoring programs and prescribing certain controlled substances.” Subsection (f) of section 1944 of the Act increased Medicaid FFP rates during FY 2019 and FY 2020 for certain state expenditures to design, develop, or implement a qualified PDMP (and to make subsequent connections to such program). As a condition of this enhanced FFP, states must meet the conditions described in paragraph (f)(2) regarding agreements with contiguous states. There are currently a number of states that have used or are seeking to use, this enhanced FFP.</P>
                    <P>
                        Under section 1944(b)(1) of the Act, to be a qualified PDMP, a PDMP must facilitate access by a covered provider to the following information (at a minimum) about a covered individual, in as close to real-time as possible: Information regarding the prescription drug history of a covered individual with respect to controlled substances; the number and type of controlled substances prescribed to and filled for the covered individual during at least the most recent 12-month period; and the name, location, and contact information of each covered provider who prescribed a controlled substance to the covered individual during at the least the most recent 12-month period. Under section 1944(b)(2) of the Act, a qualified PDMP must also facilitate the integration of the information described in section 1944(b)(1) of the Act into the workflow of a covered provider, which may include the electronic system used by the covered provider for prescribing controlled substances. CMS issued additional guidance to states about the enhanced FFP authorized by the SUPPORT for Patients and Communities Act, which is available at 
                        <E T="03">https://www.medicaid.gov/sites/default/files/Federal-Policy-Guidance/Downloads/faq051519.pdf.</E>
                    </P>
                    <P>Additionally, we note that section 7162 of the SUPPORT for Patients and Communities Act supports PDMP integration as part of the CDC's grant programs aimed at efficiency and enhancement by states, including improvement in the intrastate and interstate interoperability of PDMPs.</P>
                    <P>
                        In support of efforts to expand the use of PDMPs, there are currently a number of federally supported activities underway aimed at developing a more robust and standardized approach to EHR-PDMP integration. Partners 
                        <PRTPAGE P="50298"/>
                        including CMS, CDC, ONC, and private sector stakeholders are focused on developing and refining standard-based approaches to enable effective integration into clinical workflows, exploring emerging technical solutions to enhance access and use of PDMP data, and providing technical resources to a variety of stakeholders to advance and scale the interoperability of health IT systems and PDMPs. For instance, stakeholders are working to map the NCPDP SCRIPT standard version 2017071 and the 2015 ASAP Prescription Monitoring Program Web Service standard version 2.1A to the HL7® FHIR® standard version R4.
                        <SU>81</SU>
                        <FTREF/>
                         These mapping efforts are currently targeting completion by the summer of 2020 after which the standard would be balloted. Moreover, a number of enhancements to PDMPs are occurring across the country, including enhancements to RxCheck which is a federally supported interstate exchange hub for PDMP data.
                        <SU>82</SU>
                        <FTREF/>
                         In addition, the ONC Interoperability Standards Advisory (ISA) 
                        <SU>83</SU>
                        <FTREF/>
                         includes monitoring of current and emerging standards related to PDMP and opioid use disorder (OUD) data capture and exchange that would allow a health care provider to request a patient's medication history from a state PMDP.
                        <SU>84</SU>
                        <FTREF/>
                         We believe these standards and technical approaches are likely to rapidly reach maturity and support adoption across health care system stakeholders.
                    </P>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             
                            <E T="03">http://hl7.org/fhir/us/meds/pdmp.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             See 
                            <E T="03">https://www.pdmpassist.org/RxCheck.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             
                            <E T="03">https://www.healthit.gov/isa/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             See 
                            <E T="03">https://www.healthit.gov/isa/allows-a-provider-request-a-patients-medication-history-a-state-prescription-drug-monitoring.</E>
                        </P>
                    </FTNT>
                    <P>In addition to monitoring activities which can provide a stronger technical foundation for a measure focused on PDMP use, we also requested comments in the 2020 PFS proposed rule on alternative measures designed to advance clinical goals related to the opioid crisis (84 FR 40767 through 40769). Specifically, we sought public comment on the development of potential measures for consideration for the Promoting Interoperability performance category that are based on existing efforts to measure clinical and process improvements specifically related to the opioid epidemic, including opioid quality measures endorsed by the National Quality Forum (NQF) and CDC Quality Improvement (QI) opioid measures based on CDC guidelines around prescribing practices. The latter of these includes the use of electronically specific CDS to support OUD prevention and treatment best practices and the integration of a PDMP query as a part of specific clinical workflows. We stated that these measures relate to a range of activities that hold promise in combatting the opioid epidemic as part of OUD prevention and treatment best practices, that they can be supported using CEHRT, and that they may include the use of PDMP queries as a tool within the broader clinical workflows. We continue to evaluate the comments received in response to this request, and will explore how measures such as those discussed may help participants to better understand the relationship between the measure description and the use of health IT to support the actions of the measures related to opioid use.</P>
                    <P>We understand that there is wide variation across the country in how health care providers are implementing and integrating PDMP queries into health IT and clinical workflows, and that it could be burdensome for health care providers if we were to narrow the measure to specify a single approach to EHR-PDMP integration at this time. At the same time, we have heard extensive feedback from EHR developers that incorporating the ability to count the number of PDMP queries in CEHRT would require more robust certification specifications and standards. These stakeholders state that health IT developers may face significant cost burdens under the current flexibility allowed for health care providers if they either fully develop numerator and denominator calculations for all the potential use cases and are required to change the specification at a later date. Stakeholders have noted that the costs of additional development will likely be passed on to health care providers without additional benefit as this development would be solely for the purpose of calculating the measure rather than furthering the clinical goal of the measure.</P>
                    <P>Given current efforts to improve the technical foundation for EHR-PDMP integration, the continued implementation of the SUPPORT for Patients and Communities Act (in particular, its provisions specific to Medicaid providers and qualified PDMPs), our ongoing review of alternative measure approaches, and stakeholder concerns as previously discussed about the current readiness across states for implementation of the existing measure, we believe that additional time is needed prior to requiring a Query of PDMP measure for performance-based scoring. While we appreciate the concerns that stakeholders have shared, we believe that this measure can play an important role in helping to address the opioid crisis. Maintaining it as an optional measure eligible for bonus points signals to the clinician and developer community that this is an important measure which addresses a current gap that can help to spur development and innovation to reduce the barriers and challenges reported to CMS.</P>
                    <P>Therefore, we are proposing for the performance period in CY 2021 to maintain the Electronic Prescribing objective's Query of PDMP measure as optional. Continuing to include the measure as optional for the performance period in CY 2021 would allow time for further progress around EHR-PDMP integration efforts minimizing the burden on MIPS eligible clinicians while still providing an opportunity for capable implementers to report on and earn bonus points for fulfilling the optional measure.</P>
                    <P>
                        We are also proposing for the performance period in CY 2021 to increase the amount of the bonus points for the Query of PDMP measure from 5 points to 10 points to reflect the importance of this measure and to further incentivize clinicians to perform queries of PDMPs. We believe that this increase would support the President's National Drug Control Strategy 
                        <SU>85</SU>
                        <FTREF/>
                         that is trying to increase data sharing and integration. As stated in the strategy, a PDMP is a proven means to increase accountability in opioid prescribing practices by providing information that allows for the coordination of multiple medications, as well as to prevent adverse drug interactions. PDMPs increase patient safety by assisting prescribers in the identification of patients who have multiple prescriptions for controlled substances or may be misusing or overusing them. Expanding the use of PDMPs is a fundamental element of this strategy to stop opioid abuse, and ensure the safe, legal, and responsible prescribing of opioids for those who need them. We believe that improving prescribing practices by use of PDMPs will help reduce hospitalizations, Emergency Department visits, and family crises associated with the opioid epidemic. The proposed increase in bonus points for the Query of PDMP measure reflects our desire to increase the use of PDMPs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             
                            <E T="03">https://www.whitehouse.gov/wp-content/uploads/2020/02/2020-NDCS.pdf</E>
                            .
                        </P>
                    </FTNT>
                    <PRTPAGE P="50299"/>
                    <HD SOURCE="HD3">We invite comments of these proposals.</HD>
                    <HD SOURCE="HD3">2. Health Information Exchange Objective</HD>
                    <HD SOURCE="HD3">a. Support Electronic Referral Loops by Receiving and Incorporating Health Information Measure</HD>
                    <P>In the CY 2019 PFS final rule (83 FR 59807 through 59812), we established a new Support Electronic Referral Loops by Receiving and Incorporating Health Information measure by combining the Request/Accept Summary of Care measure and the Clinical Information Reconciliation measure. In establishing the new measure, we did not change the specifications or actions associated with the two combined measures, which address receiving an electronic summary of care record and conducting reconciliation of the summary of care record. However, the name of the measure includes the word “incorporating” which is not always required to increment the numerator of the measure. Instead, clinical information reconciliation must be completed using CEHRT for the following three clinical information sets: (1) Medication; (2) Medication Allergy; and (3) Current Problem List. Thus, to better reflect specific actions required by the measure's numerator and denominator, we are proposing to replace the word “incorporating” with the word “reconciling” in the name of the measure. The new name would read: Support Electronic Referral Loops by Receiving and Reconciling Health Information measure.</P>
                    <P>We invite comment on this proposal.</P>
                    <HD SOURCE="HD3">b. Engagement in Bi-Directional Exchange Through Health Information Exchange (HIE)</HD>
                    <P>In the CY 2020 PFS proposed rule (84 FR 40781), we discussed the concept of MIPS eligible clinicians earning credit in the Promoting Interoperability performance category by attesting to health IT or interoperability activities in lieu of reporting on specific measures. In this proposed rule, we are seeking to build on the feedback received in prior rulemaking by proposing an alternative measure for bidirectional exchange through a HIE under the Health Information Exchange objective.</P>
                    <P>
                        HIEs allow for the sharing of health information among clinicians, hospitals, care coordinators, labs, radiology centers, and other health care providers through secure, electronic means so that healthcare providers can have the benefit of the most recent information available from other health care providers. HIEs allow for broader interoperability beyond one health system or point-to-point connections among payers, patients, and health care providers. By enabling bi-directional exchange of information between health care providers and aggregating data across providers with disparate systems, HIEs can bring together the information needed to create a true longitudinal care record and support improved care coordination by facilitating timely access to robust health information across care settings. Bi-directional exchange means that the clinician's EHR is enabled to allow for querying and sharing data by sending, receiving, and incorporating data via an HIE for every patient. Healthcare quality and public health outcomes have been shown in multiple studies to experience a beneficial effect from health information exchanges with improved medication reconciliation, improved immunization and health record completeness, and improved population level immunization rates.
                        <SU>86</SU>
                        <FTREF/>
                         Another study has shown that if every clinician who submits claims under Medicare Part B 
                        <SU>87</SU>
                        <FTREF/>
                         were connected to an HIE, Medicare would have saved $63 million annually for each therapeutic procedure performed at a physician's office due to the reduction in duplicate procedures,
                        <SU>88</SU>
                        <FTREF/>
                         while other research has shown a decrease in emergency department utilization and improved care process when using an HIE.
                        <SU>89</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             
                            <E T="03">https://academic.oup.com/jamia/article/25/9/1259/4990601:</E>
                             ibid.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             
                            <E T="03">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Physician_FAQ.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             
                            <E T="03">https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2971503:</E>
                             University of Connecticut School of Business Research Paper No. 17-03 “
                            <E T="03">Do Health Information Exchanges Deter Repetition of Medical Services?”</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             
                            <E T="03">https://pubmed.ncbi.nlm.nih.gov/27521368/:</E>
                             Journal of the American Medical Informatics Association. 2017 Apr 1;24(e1):e103-e110. doi: 10.1093/jamia/ocw116. “
                            <E T="03">Health Information Exchange Associated With Improved Emergency Department Care Through Faster Accessing of Patient Information From Outside Organizations”.</E>
                        </P>
                    </FTNT>
                    <P>
                        HIE services are available from many organizations today, which may be referred to as HIEs or health information organizations (HIOs). State and regional HIEs have a long history of connecting health care providers caring for a common patient population across a specified geographic area. These HIEs represent a significant public investment, with $564 million in federal funding provided as part of the 2009 HITECH Act, ongoing state funding and support from CMS under both 42 CFR 495.322 and 42 CFR part 433 subpart C.
                        <SU>90</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             
                            <E T="03">https://protect2.fireeye.com/url?k=d8978709-84c28e1a-d897b636-0cc47adb5650-e634c1ba410d0153&amp;u=https://www.healthit.gov/sites/default/files/reports/finalsummativereportmarch_2016.pdf.</E>
                        </P>
                    </FTNT>
                    <P>These state and regional HIEs typically obtain not just EHR-generated data, but a broader array of ADT (admit, discharge, transfer) feeds and lab feeds as they build on local relationships and have similar but not identical capabilities with several models of data storage and a variety of business models. In addition to these initiatives, many EHR vendors are participating in the development of national-level networks designed to ensure their customers can share information with customers of other vendors. Geographically-based exchanges have also begun to address national-level exchange, with efforts designed to link state and regional networks so that health care providers can obtain information on individual patients wherever they receive care throughout the United States.</P>
                    <P>
                        Recent data indicate that there is wide availability of HIEs across the nation, yet gaps remain. Forthcoming analysis of a recent survey of HIEs found that 45 states, including DC, were covered by one or more operational HIOs that reported a statewide catchment area. Moreover, 81 percent (or 2,770) of health service areas (HSAs) in the United States were in the catchment area of at least one operational HIE effort and 32 percent of HSAs had more than one operational HIE effort.
                        <SU>91</SU>
                        <FTREF/>
                         Despite the widespread availability of HIE services; however, HIE participation data suggests there are still significant opportunities to increase health care provider engagement with HIEs. For instance, in a 2018 survey, 73 percent of hospitals reported participating in either a state, regional, or local HIE. When national HIE networks as well as state, regional, and local networks, 15 percent of hospitals reported not participating in any type of HIE.
                        <SU>92</SU>
                        <FTREF/>
                         While it is more difficult to assess individual clinicians' current participation in HIEs, data from the forthcoming survey noted above found that, among the HIEs surveyed, 76 percent reported that independent physician practices or practice groups contributed data to the HIE, while 89 percent reported that providers viewed data in the HIE, suggesting additional incentives may help to spur greater engagement with available HIEs.
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             Forthcoming analysis of survey conducted under Contract No. HHSP233201700049C, OMB Control No: 0955-0019.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             “State of Interoperability among U.S. Non-federal Acute Care Hospitals in 2018” ONC Data Brief No. 51, March 2020. See 
                            <E T="03">https://www.healthit.gov/sites/default/files/page/2020-03/State-of-Interoperability-among-US-Non-federal-Acute-Care-Hospitals-in-2018.pdf.</E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="50300"/>
                    <P>We believe that incentivizing participation in HIEs that support bi-directional exchange will contribute to a longitudinal care record for the patient and facilitate enhanced care coordination across settings. The use of an HIE means that essential health information is available for care team members even in the case of referrals the clinician may not be aware of, or for instances where the clinician is contributing to the patient's record, but may not be the health care provider making the referral. In these instances, such transitions may or may not be able to be automatically identified by an EHR for inclusion in the denominators of the two existing measures associated with the HIE objective for the Promoting Interoperability performance category. For example, consider a patient who has a hospital emergency room visit in January 2020 and receives a prescription, then goes to her primary care physician appointment in March 2020 without notifying the primary care physician of the hospital visit or the new medication. The primary care physician refers the patient to a specialist and the specialist receives and reconciles the patient's data from her primary care physician records. In this scenario, the hospital may not have had access to the patient's health record from the primary care physician, and the primary care physician and the specialist may not have access to the data from the hospital including essential information like an update to current medications. We note that there was a Conditions of Participation (CoP) policy related to patient event notifications finalized in the Patient Access and Interoperability rule (85 FR 25584 through 25603). However, the new CoP would not require the hospitals to share the clinically relevant information specified in this example. The CoP requirement only specifies a minimal set of information for inclusion in a notification (patient's name, treating practitioner name, and sending institution name) and does not include the standardized clinical data that hospitals must share electronically using CEHRT in order to participate in the Promoting Interoperability program. For instance, the clinical data specified in the “transitions of care” criterion at 45 CFR 170.315(b)(1), which is currently the United States Core Data for Interoperability (USCDI) or Common Clinical Data Set (CCDS) (see 85 FR 25670). Moreover, if the patient were to have another emergent issue and require emergency room care, the situation becomes further compounded. For this scenario, if the hospital, primary care physician, and specialist participated in a bi-directional exchange with a health information network, each health care provider from the hospital to the specialist would have access to all of the patient's records that may be critical for patient care and safety. Under the existing measures for the HIE objective, only the known transition of care from primary care physician to specialist would be included in the denominator. However, under the proposed alternative measure for bi-directional exchange through a HIE, we would incentivize the clinician to engage in health information exchange for care coordination that includes these additional transitions and referrals as well as other potential scenarios: Where the recipient of the transition of care may be unknown; Where the eligible clinician may not be the referring health care provider; where the transition of care may happen outside the scope of the performance period; or where the patient was not seen by the eligible clinician during the performance period. In this way, the eligible clinician or group's action to engage in bi-directional exchange through an HIE would allow each health care provider to contribute to the longitudinal care record in a manner that supports a wide range of transitions and referrals beyond those currently reflected in the measure denominators. This engagement supports robust health information exchange without placing burden on the clinician or the patient to be individually accountable to facilitate exchange via multiple (and potentially unknown) point-to-point connections.</P>
                    <P>The current COVID-19 PHE has further highlighted the need to encourage interoperable HIE infrastructure and bi-directional exchange across the country that can ensure patients, health care providers, and public health authorities have the data they need to support quality care. In addition to supporting general care coordination, HIEs can specifically support the PHE response by: Enabling enhanced use of telehealth and telemedicine for obtaining and aggregating patient information including when the patient's health care provider(s) may not be known.</P>
                    <P>In response to the PHE, CMS has taken steps to significantly expand access to services via telehealth, by increasing flexibility around the use of telehealth. HIEs can support patient care by ensuring health care providers are able to access patient data in support of a telehealth encounter or subsequent in-person visit with either an established or new health care provider. Particularly for visits with a new health care provider, the HIE may provide an option for health care providers to access critical health information. In addition, HIEs can support telehealth visits for screening, evaluation, and event notification for care team members for patients that have been exposed, tested, quarantined etc. HIEs, can ensure information about testing results is available to support the immediate and longer term health and clinical needs of an individual. HIEs offer a rich source of health data to support these interactions and can be utilized by health care providers who may not have direct exchange capabilities, but operate as part of the same care team. HIEs also support these use cases in ways that direct exchange cannot, by facilitating aggregation of data from multiple sources where `point to point' exchange may be infeasible.</P>
                    <P>
                        <E T="03">• Proposed New Measure:</E>
                         In order to incentivize MIPS eligible clinicians to engage in bi-directional exchange through an HIE, we are proposing to add the following new measure under the HIE objective beginning with the performance period in 2021: Health Information Exchange (HIE) Bi-Directional Exchange measure. We propose to add this new HIE Bi-Directional Exchange measure to the HIE objective as an optional alternative to the two existing measures: The Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. We are proposing that clinicians either may report the two existing measures and associated exclusions OR may choose to report the new measure. We propose that the HIE Bi-Directional Exchange measure would be worth 40 points. In no case could more than 40 points be earned for the HIE objective. We are proposing the HIE Bi-Directional Exchange measure would be reported by attestation and would require a yes/no response. As we believe that fulfillment of this measure is an extremely high value action, a “yes” response would enable the clinician to earn the 40 points allotted to the HIE objective. We propose that clinicians would attest to the following:
                    </P>
                    <P>++ I participate in an HIE in order to enable secure, bi-directional exchange to occur for every patient encounter, transition or referral, and record stored or maintained in the EHR during the performance period.</P>
                    <P>
                        ++ The HIE that I participate in is capable of exchanging information across a broad network of unaffiliated exchange partners including those using disparate EHRs, and does not engage in 
                        <PRTPAGE P="50301"/>
                        exclusionary behavior when determining exchange partners.
                    </P>
                    <P>++ I use the functions of CEHRT for this measure, which may include technology certified to criteria at 45 CFR 170.315(b)(1), (b)(2), (g)(8), or (g)(10).</P>
                    <P>We believe it is appropriate for the new optional measure to serve as an alternative measure of performance on health information exchange since, in order to successfully meet the measure, an eligible clinician would be required to meet an overall standard of performance on health information exchange that is broader than the denominators and numerators of the current measures. To successfully attest to the new measure the eligible clinician or group must establish the technical capacity and workflows to engage in bi-directional exchange via an HIE for all patients seen by the eligible clinician and for any patient record stored or maintained in their EHR. This includes querying for or receiving health information for all new and existing patients seen by the eligible clinician, as well as sending or sharing information for all new and existing patients seen by the eligible clinician regardless of known referral or transition status, or the timing of any potential transition or referral. The proposed requirement to query for or receive health information for all new and existing patients is broader than the current Support Electronic Referral Loops by Receiving and Incorporating Health Information measure, which includes only new patients and known transitions or referrals received that occur during the performance period. Similarly, the proposed requirement to send or share information for all new and existing patients represents a broader scope than the current Support Electronic Referral Loops by Sending Health Information measure which includes only known transitions of care or referrals made that occur during the performance period. In addition, such bi-directional engagement would facilitate exchange of information for patient records stored or maintained in the clinician's EHR, even when the patient does not have an encounter or is not seen by the eligible clinician during the performance period, and for which the clinician has no active transition or referral during the performance period. This proposed requirement is likewise more expansive than the denominators of either measure.</P>
                    <P>Relative to the numerators for the current measures, the new optional measure would require that bi-directional engagement occurs for all patients and for all patient records without exclusion, exception, or allowances made for partial credit. This is similar to achieving a score of 100 percent on both the Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure, while additionally completing required actions for additional exchange cases not included in the existing denominators. Finally, while we believe this optional measure would establish a high performance standard with respect to information sharing, we also believe that availability of this optional measure would reduce current reporting burden associated with the program, as eligible clinicians choosing to report on the measure would not be required to report on the two existing numerator/denominator measures.</P>
                    <P>While we believe there are a significant number of HIEs across the country that would meet the standards described in the attestation statements, some HIE arrangements may not have the capacity to enable bi-directional exchange for every patient transition or referral made by a clinician, and thus would not meet the standard described in the attestation statements required to fulfill the measure. For instance, we would exclude exchange networks that only support information exchange between affiliated entities, such as health care providers that are part of a single health system, or networks that only facilitate sharing between health care providers that use the same EHR vendor.</P>
                    <P>To successfully attest to this measure, the eligible clinician must use the capabilities defined for CEHRT to engage in bi-directional exchange via the HIE, which includes exchanging the clinical data within the CCDS or USCDI. This is consistent with both of the existing measures under the Health Information Exchange objective, which require the use of CEHRT to create a C-CDA document, which includes the clinical data within the CCDS or the USCDI. We believe there are numerous certified health IT capabilities which can support bi-directional exchange with a qualifying HIE. For instance, participants may interact with an HIE by using technology certified to the criterion at § 170.315(b)(1) to transmit C-CDAs to the HIE. Participants could also utilize API technology certified to either the criterion at §§ 170.315(g)(8) or (g)(10) as recently finalized in the 21st Century Cures Act final rule (85 FR 25742), to enable an HIE to obtain data in the CCDS or USCDI from a participant's EHR. As noted in section III.M of this proposed rule, the 21st Century Cures Act final rule states that these criteria may refer to either the CCDS or USCDI for a period of 24 months following the publication of the Cures Act final rule (85 FR 25669). After this time, only technology certified to criteria referencing the USCDI would be considered certified under the ONC Certification Program. We recognize that HIEs are currently interacting with health care providers using certified health IT in a variety of ways, and believe that we should allow for substantial flexibility in how health care providers use certified health IT to exchange data using HIE.</P>
                    <P>We note that none of the actions required to attest to this measure are intended to conflict with a patient's rights or covered entities (for example, health care provider's) requirements/responsibilities under the HIPAA Privacy Rule, as set out at 45 CFR parts 160 and 164. The HIPAA Privacy Rule permits but does not require covered health care entities to get patient consent before using or disclosing PHI for treatment, payment, and health care operations. Although HIPAA does not require the health care entities offer patients a choice about the sharing of their PHI, many entities and states have adopted policies or laws that require patient consent. HIPAA is designed to work in tandem with more privacy protective policies. Moreover, we understand that different HIEs that enable exchange in the manner described may have different policies related to confidentiality of patient information based on local circumstances and requirements. Nothing in the attestation statements for this measure are intended to conflict with individual HIE policies that may exist in these areas, or prevent eligible clinicians from complying with these policies as a condition of their participation in the HIE.</P>
                    <P>We are not proposing an exclusion for this new measure as this measure would be an optional alternative measure to be reported instead of the Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. The exclusions would still be available for the Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure.</P>
                    <P>
                        We invite comments on these proposals, and whether commenters believe such an optional measure would incentivize eligible clinicians to participate in HIEs while establishing a high performance standard for sharing 
                        <PRTPAGE P="50302"/>
                        information with other clinicians. We are also seeking comment on the proposed attestation statements for the optional measure. For instance:
                    </P>
                    <P>• Do these statements reflect appropriate expectations about information exchange capabilities for eligible clinicians that engage with HIEs capable of facilitating widespread exchange with other health care providers?</P>
                    <P>• How should CMS effectively identify those HIEs that can support the widespread exchange with other health care providers?</P>
                    <P>• How are eligible clinicians currently using CEHRT to exchange information with HIEs, and do the proposed attestation statements allow for different ways health care providers are connecting with HIEs utilizing certified health IT capabilities?</P>
                    <HD SOURCE="HD3">(d) Scoring Methodology</HD>
                    <HD SOURCE="HD3">(1) Changes to the Scoring Methodology for the 2021 Performance Period</HD>
                    <P>Table 42 reflects the Promoting Interoperability performance category objectives and measures for CY 2021 if the proposed changes discussed earlier in this section are adopted as final, including the proposed name change to the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure and the continuation of the optional Query of PDMP measure for CY 2021.</P>
                    <GPH SPAN="3" DEEP="250">
                        <GID>EP17AU20.076</GID>
                    </GPH>
                    <HD SOURCE="HD3">(e) Additional Considerations</HD>
                    <HD SOURCE="HD3">(1) Nurse Practitioners, Physician Assistants, Clinical Nurse Specialists, and Certified Registered Nurse Anesthetists</HD>
                    <P>In 2018 rulemaking (83 FR 59818 through 59819), we discussed our belief that certain types of MIPS eligible clinicians (NPs, PAs, CNSs, and CRNAs) may lack experience with the adoption and use of CEHRT. Because many of these non-physician clinicians were or are not eligible to participate in the Medicare or Medicaid EHR Incentive Program (now known as the Promoting Interoperability Program), we stated that we have little evidence as to whether there are sufficient measures applicable and available to these types of MIPS eligible clinicians under the advancing care information (now known as Promoting Interoperability) performance category. We established a policy at § 414.1380(c)(2)(i)(A)(5) for the performance periods in 2017 through 2020 under section 1848(q)(5)(F) of the Act to assign a weight of zero to the Promoting Interoperability performance category in the MIPS final score if there are not sufficient measures applicable and available to NPs, PAs, CRNAs, and CNSs. We will assign a weight of zero only in the event that an NP, PA, CRNA, or CNS does not submit any data for any of the measures specified for the Promoting Interoperability performance category, but if they choose to report, they will be scored on the Promoting Interoperability performance category like all other MIPS eligible clinicians and the performance category will be given the weighting prescribed by section 1848(q)(5)(E) of the Act.</P>
                    <P>
                        As in past years, we intend to use data from prior performance periods to further evaluate the participation of NPs, PAs, CRNAs, and CNSs in the Promoting Interoperability performance category and consider for subsequent years whether the measures specified for this category are applicable and available to these MIPS eligible clinicians. We have analyzed the data submitted for the 2017 performance period for the Promoting Interoperability performance category and have discovered that the vast majority of MIPS eligible clinicians submitted data as part of a group. Although we are pleased that MIPS eligible clinicians utilized the option to submit data as a group, it does limit our ability to analyze data at the individual NPI level. For the 2017 performance period, approximately 4 percent of MIPS eligible clinicians who are NPs, PAs, CRNAs, or CNSs submitted data individually for MIPS, and more than two-thirds of them did not submit data for the Promoting Interoperability performance category. For the 2018 performance period, approximately 34percent of MIPS eligible clinicians who are NPs, PAs, CRNAs, or CNSs 
                        <PRTPAGE P="50303"/>
                        submitted data individually for the Promoting Interoperability performance category. In addition, the majority of MIPS eligible clinicians reported data for the Promoting Interoperability performance category for the 2017 and 2018 performance periods using the transition measure set. This set is unavailable for the 2019 performance period, which may result in fewer MIPS eligible clinicians reporting data for Promoting Interoperability performance category. Further, due to the 2019 Novel Coronavirus (COVID-19), we anticipate that many MIPS eligible clinicians may not report data for the 2019 performance period, although we do not expect to know the full impact on reporting for the Promoting Interoperability performance category until fall 2020.
                    </P>
                    <P>Since 2017 we have included a solicitation for new measures for the Promoting Interoperability performance category in the annual Call for Measures. We have received many suggestions for new measures. We have not received any suggestions for new measures for NPs, PAs, CRNAs, CNSs or any other non-physician practitioners, which may continue to limit their ability to successfully report for the Promoting Interoperability performance category.</P>
                    <P>
                        For these reasons, we are proposing to continue the existing policy of reweighting the Promoting Interoperability performance category for NPs, PAs, CRNAs, and CNSs for the performance period in 2021, and to revise § 414.1380(c)(2)(i)(A)(
                        <E T="03">5</E>
                        ) to reflect this proposal. We are requesting public comments on this proposal.
                    </P>
                    <HD SOURCE="HD3">(2) Physical Therapists, Occupational Therapists, Qualified Speech-Language Pathologists, Qualified Audiologists, Clinical Psychologists, and Registered Dieticians or Nutrition Professionals</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 63003 through 63004), we adopted a policy at § 414.1380(c)(2)(i)(A)(4) to apply the same policy we adopted for NPs, PAs, CNSs, and CRNAs to other types of MIPS eligible clinicians who are non-physician practitioners (physical therapists, occupational therapists, qualified speech-language pathologist, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals) for the performance period in 2020. We stated that because many of these clinician types were or are not eligible to participate in the Medicare or Medicaid Promoting Interoperability Program, we have little evidence as to whether there are sufficient measures applicable and available to them under the Promoting Interoperability performance category.</P>
                    <P>For the reasons discussed in section IV.A.2.c.4.(b) of this proposed rule, for the performance period in 2021, we are proposing to continue the existing policy of reweighting the Promoting Interoperability performance category for physical therapists, occupational therapists, qualified speech-language pathologist, qualified audiologists, clinical psychologists, and registered dieticians or nutrition professionals, and to revise § 414.1380(c)(2)(i)(A)(4) to reflect this proposal. We invite comments on this proposal.</P>
                    <HD SOURCE="HD3">(f) Future Direction of the Promoting Interoperability Performance Category</HD>
                    <P>In future years of the Promoting Interoperability performance category, we will continue to consider changes which support a variety of HHS goals as previously stated (84 FR 62991 through 62992), including: Reducing administrative burden; supporting alignment with the Medicare Promoting Interoperability Program; supporting alignment with the 21st Century Cures Act; advancing interoperability and the exchange of health information; and promoting innovative uses of health IT. More specifically under the 21st Century Cures Act, we will look at and take under consideration potential areas of overlap as we continue to align, pending implementation of the statute. This may include, but is not limited to, Information Blocking, future growth of PDMP, the use of USCDI, FHIR, and updates to 2015 Edition health IT certification criteria and the ONC Health IT Certification Program. We believe maintaining our focus on promoting interoperability, alignment, and simplification will reduce health care provider burden while allowing flexibility to pursue innovative applications that improve care delivery. For more detailed information, refer to the [21st Century Cures Act final rule (85 FR 25642 through 25961)] and Interoperability and Patient Access final rule (85FR 25510 through 25640). We also refer readers to section III.M. of this proposed rule for discussion of our proposal to modify the CEHRT definition as defined for the Quality Payment Program under § 414.1305.</P>
                    <HD SOURCE="HD3">(5) APM Entity Groups and APM Scoring Standard for MIPS Eligible Clinicians Participating in MIPS APMs</HD>
                    <HD SOURCE="HD3">(a) Overview</HD>
                    <P>The APM scoring standard, codified at § 414.1370, is the MIPS scoring methodology applicable for MIPS eligible clinicians participating in a MIPS APM for the applicable MIPS performance period. As discussed in the CY 2017 Quality Payment Program final rule (81 FR 77246), the APM scoring standard was designed to reduce reporting burden for participants in MIPS APMs by eliminating the need for such MIPS eligible clinicians to submit data for both MIPS and their respective APMs, and to ensure that these eligible clinicians were not assessed in multiple ways on the same performance activities. We also believed that the APM scoring standard would encourage APM participation and support the goal of encouraging APM participants to better manage care for patients within their respective APM Entities by tying their MIPS performance scores together.</P>
                    <P>As we have gained experience in implementing the APM scoring standard, we have learned that it is infeasible to fully implement it as it was originally designed, as was discussed in the CY 2020 PFS final rule (84 FR 63007). Public comments on the CY 2020 revised APM scoring standard finalized in the CY 2020 PFS final rule (84 FR 63010), and most comments in response to the request for comments on APM scoring beyond 2020, made clear that the complexity of the APM scoring standard and its inflexibility in adapting to changes in APM participation and design have resulted in confusion and unintended additional burden for APM Entities and their participant MIPS eligible clinicians.</P>
                    <P>With this insight in mind, and with the goal of better aligning MIPS reporting rules for all MIPS eligible clinicians, including those in MIPS APMs, we are proposing to terminate the APM scoring standard as described at § 414.1370, effective January 1 of the 2021 performance year, by amending that regulation accordingly.</P>
                    <P>We further propose in section III.C.3. of this proposed rule, effective January 1, 2021, to establish a MIPS APM Performance Pathway and scoring rules that would be available for MIPS reporting for MIPS eligible clinicians in MIPS APMs.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(b) APM Entity Groups</HD>
                    <P>
                        We are proposing to terminate the APM scoring standard effective January 1, 2021, however, beginning with the 2021 performance period, we propose to retain certain APM Entity group reporting policies that were established and finalized for reporting and scoring under MIPS beginning with the 2021 performance period. Therefore, we are proposing to redesignate in part the regulation that describes APM Entity group determinations, from 
                        <PRTPAGE P="50304"/>
                        § 414.1370(e) to § 414.1317, and to title that section “APM Entity Groups.”
                    </P>
                    <P>In addition, because we are proposing to no longer rely on quality measures reported to an APM, as is required under the existing APM scoring standard, we no longer believe that there is substantial risk of the MIPS final scores being inappropriately influenced by MIPS eligible clinicians moving into or out of APM Entities late in the performance year, which was the impetus for the full-TIN APM policy. Therefore, we are proposing to end the full-TIN APM policy currently codified at § 414.1370(e)(1), which allows for an APM Entity group to include eligible clinicians on the Participation List in a full-TIN APM on December 31 of the MIPS Performance Period only if the APM is a full-TIN APM as defined at § 414.1305. We also propose that MIPS eligible clinicians identified on the Participation List or Affiliated Practitioner List of any APM Entity participating in any MIPS APM on any of the three snapshot dates (March 31, June 30, August 31), as well as December 31 during a performance period, beginning in the 2021 MIPS performance period, would be considered participants in an APM Entity group. As these proposals would eliminate the need for the term “full TIN APM,” we also propose to delete the defined term “full TIN APM” from § 414.1305.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(c) APM Entity Group Eligibility</HD>
                    <P>In the absence of the APM scoring standard and mandatory reporting to MIPS through the APM Entity group, it would no longer be necessary to conduct low-volume threshold determinations at the APM Entity group level. Therefore, along with the termination of the APM scoring standard under § 414.1370, we also propose to terminate, effective January 1, 2021, the use of APM Entity level low-volume threshold determinations and remove the term APM Entity group from the definition of the low-volume threshold at § 414.1305, with corresponding changes to applicability at § 414.1310(b)(1).</P>
                    <P>Going forward, we would apply the same rules for MIPS eligibility to APM participants as to other MIPS eligible clinicians. For example, if an eligible clinician who is a participant in a MIPS APM is below the low-volume threshold he or she would not be required to report to MIPS as an individual; however, if the group TIN of which that eligible clinician is a part is MIPS eligible and does report to MIPS, that eligible clinician would be treated as a MIPS eligible clinician for purposes of MIPS scoring and payment adjustments, and would receive the higher of the group score and any available APM Entity group score. APM Entity reporting, in and of itself, would not confer MIPS eligibility to an eligible clinician who would otherwise be excluded from MIPS.</P>
                    <HD SOURCE="HD3">(d) APM Entity Group Scoring</HD>
                    <P>Consistent with our past approach under APM scoring standard at § 414.1370(f), we are proposing at § 414.1317(b) that the MIPS final score calculated for the APM Entity would be applied to each MIPS eligible clinician in the APM Entity group. The MIPS payment adjustment would be applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity group.</P>
                    <P>Similar to our past approach under the APM scoring standard at § 414.1370(g)(4)(ii) and (iii), as originally discussed and finalized in the CY 2017 Quality Payment Program final rule (81 FR 77268), we are proposing at § 414.1317(b)(1) that in all cases where an APM Entity reports to MIPS, but a performance category's data submission cannot be made at the APM Entity level, each MIPS eligible clinician in the APM Entity group would be assigned the highest available score for that performance category (either the individual or TIN-level score), and the scores for all MIPS eligible clinicians in the APM Entity group would be averaged in order to calculate the APM Entity level performance category score. In the event that a MIPS eligible clinician in an APM Entity receives an exception from the reporting requirements, such eligible clinician would be assigned a null score when CMS calculates the APM Entity's performance category score.</P>
                    <P>Similar to our past approach under the APM scoring standard at § 414.1370(g)(1)(iv), we are proposing at § 414.1317(b)(2) that for an APM Entity for which CMS calculated a total performance category score for one or more participants in the APM Entity for the preceding MIPS performance period, CMS would calculate an improvement score for each performance category for which a previous year's total performance category score is available as specified in § 414.1380(b). Note that unlike § 414.1370(g)(1)(iv), proposed § 414.1317(b)(2) would not be limited to the quality performance category, but would apply to any performance category.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(e) Reweighting Based on Extreme and Uncontrollable Circumstances for APM Entity Groups</HD>
                    <P>Section 414.1380(c)(2)(i) allows for the submission of an application to CMS to request reweighting of one or more MIPS performance categories due to extreme and uncontrollable circumstances. We are proposing that an APM Entity may submit such an application beginning with the 2020 performance period/2022 MIPS payment year, at § 414.1317(b)(3). The request for reweighting in the application would apply for all four MIPS performance categories and all MIPS eligible clinicians in the APM Entity group. If the request for reweighting is approved by CMS, this would result in MIPS eligible clinicians participating in the APM Entity being excepted from MIPS reporting requirements for the applicable performance period, and the APM Entity would receive a final score equal to the performance threshold. Such request for reweighting would be approved or denied in its entirety.</P>
                    <P>We considered allowing an APM Entity to submit an application to request reweighting for individual performance categories, but rejected this approach. We believe the amount of complexity at the intersection of the various performance category submission and scoring requirements, submitter types, and exception applications for MIPS eligible clinicians could place a burden on these clinicians and their representatives to continually invest in understanding their shifting obligations under such an approach. Furthermore, operationalizing a policy where an APM Entity would have the ability to request and receive reweighting for one or more, but not all, performance categories would be prone to error. In addition, such a piecemeal approach to addressing extreme and uncontrollable circumstances likely would cause scoring delays that could result in CMS being unable to timely provide performance feedback and payment adjustment information to all MIPS eligible clinicians.</P>
                    <P>We also are proposing at § 414.1317(b)(3)(i) that an APM Entity must demonstrate in its application to CMS that greater than 75 percent of its participant MIPS eligible clinicians would be eligible for reweighting the Promoting Interoperability performance category for the applicable performance period.</P>
                    <P>
                        Due to the unique and complex relationship between an APM Entity and its individual participant MIPS eligible clinicians, we believe it is 
                        <PRTPAGE P="50305"/>
                        appropriate to offer an APM Entity the opportunity to apply for reweighting based on extreme and uncontrollable circumstances for all performance categories, including the Promoting Interoperability performance category, rather than collecting Promoting Interoperability hardship exception applications from each MIPS eligible clinician in the APM Entity group as is currently required However, we believe that setting a 75 percent threshold for the Promoting Interoperability performance category is appropriate as a means of assuring that the request for reweighting is only granted in cases where absent the reweighting, it would be impossible to calculate a score for that performance category that is truly representative of the APM Entity group's performance. We are proposing a 75 percent threshold because such threshold is consistent with the Promoting Interoperability performance category reweighting policy for groups of hospital-based MIPS eligible clinicians and non-patient facing MIPS eligible clinicians, which similarly could face an administrative burden in attempting to secure approvals for individual reweighting requests for each MIPS eligible clinician in such groups. We recognize that as a result of the variety of participation requirements of different APMs, APM Entity groups may be composed of a wide range of health care provider types and sites of service. We believe that scoring an entire APM Entity as the result of a single MIPS eligible clinician's submission of data for the Promoting Interoperability performance category could place an extreme administrative burden on APM Entity groups, and could potentially create unintended consequences for APM participation decisions among MIPS eligible clinicians.
                    </P>
                    <P>In addition, we propose at § 414.1317(b)(3)(ii) that if CMS approves the request for reweighting based on an APM Entity's application, and if MIPS data are submitted for the APM Entity for the applicable performance period, all four of the MIPS performance categories still would be reweighted for the APM Entity group notwithstanding the data submission. The data submission would not effectively void the request for reweighting and its approval. We are proposing this policy because we do not believe it would be appropriate or desirable for an individual MIPS eligible clinician or for a group TIN with no direct affiliation with an APM Entity to accidentally override an APM Entity's application. This could happen if the MIPS eligible clinician or group TIN reports to MIPS either out of an abundance of caution or on behalf of a MIPS eligible clinician who is not in the APM Entity, but happens to share a billing TIN with an eligible clinician who is in the APM Entity. We also recognize that there may be circumstances where an APM may require some form of quality reporting for purposes of the APM itself, such as is required for Shared Savings Program ACOs as described in section II.G. of this proposed rule, but that in complying with such requirement an APM Entity may also be submitting quality performance category data that would result in scoring for purposes of MIPS when that APM Entity group would otherwise have been excepted from MIPS reporting.</P>
                    <P>We note that under this proposal and the proposed changes to the MIPS scoring hierarchy, described in section IV.A.3.e. of this proposed rule, reporting done by a MIPS eligible clinician or group would result in a MIPS final score for only that MIPS eligible clinician or group, which may be used to determine a MIPS eligible clinician's payment adjustment.</P>
                    <P>Finally, to the extent that these proposed policies would constitute a change to the MIPS scoring or payment methodology for the 2022 MIPS payment adjustment after the start of the 2020 performance period, we believe that, consistent with section 1871(e)(1)(A)(ii) of the Act, it would be contrary to the public interest not to establish these policies because of the COVID-19 PHE. We believe that the intersection of the 2020 APM scoring standard rules and the extreme and uncontrollable circumstances policies being put in place by APMs themselves in response to the COVID-19 PHE, such as the changes being proposed for participants in the Shared Savings Program in section III.I.1. of this proposed rule, would make obtaining reweighting under MIPS based on extreme and uncontrollable circumstances unusually burdensome absent these proposed changes. For instance, the Shared Savings Program will continue to require the submission of quality performance data by participating ACOs, and that data would be eligible to be used for MIPS quality scoring absent this proposal, which would have the result of not allowing Shared Savings Participants the option to take advantage of extreme and uncontrollable circumstances policies that are available to other MIPS eligible clinicians. This policy change is necessary to give participants in the Shared Savings Program the opportunity to request reweighting of the MIPS performance categories in the event that they believe the data reported for purposes of the Shared Savings Program do not adequately reflect the performance of the ACO Entity for purposes of MIPS quality performance category scoring.</P>
                    <P>We seek comment on our proposals discussed above.</P>
                    <HD SOURCE="HD3">d. MIPS Final Score Methodology</HD>
                    <HD SOURCE="HD3">(1) Performance Category Scores</HD>
                    <HD SOURCE="HD3">(a) Background</HD>
                    <P>For the 2023 MIPS payment year, we intend to continue to build on the scoring methodology we finalized for prior years. The scoring methodology allows for accountability and alignment across the performance categories and minimizes burden on MIPS eligible clinicians. We are maintaining many of our scoring policies, focusing on only making proposals to maintain stability. Specifically, we are proposing the following:</P>
                    <P>• To implement scoring flexibility for quality measures with specification or coding changes during the performance year.</P>
                    <P>• To implement benchmark and topped out scoring policies that are responsive to potential low reporting rates for the 2019 performance year due to the national public health emergency (PHE) for the COVID-19 pandemic.</P>
                    <P>• To implement scoring for all administrative claims-based measures.</P>
                    <P>• To continue policies for scoring quality measures based on achievement as well as policies for measures that do not meet case minimum, data completeness requirements, or have a benchmark.</P>
                    <P>• To continue bonuses in the quality performance category.</P>
                    <P>• To continue improvement scoring of the quality performance category comparing clinicians to a 30 percent baseline score if clinicians scored 30 percent or less.</P>
                    <P>We are not proposing changes to scoring policies for the cost, improvement activities and Promoting Interoperability performance categories.</P>
                    <P>
                        We have maintained our approach that MIPS eligible clinicians are scored against performance standards for each performance category and receive a final score, comprised of their performance category scores, and calculated according to the final score methodology. We refer readers to § 414.1380 for general policies on scoring. We refer readers to section IV.A.3.c.(5)(a) of this proposed rule for the discussion of our proposal to remove the APM scoring standard and section IV.A.3.b of this proposed rule 
                        <PRTPAGE P="50306"/>
                        for information on the APM Performance Pathway scoring.
                    </P>
                    <HD SOURCE="HD3">(b) Scoring the Quality Performance Category for the Following Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, QCDR Measures, CMS Web Interface Measures, the CAHPS for MIPS Survey Measure and Administrative Claims Measures</HD>
                    <P>We refer readers to § 414.1380(b)(1) for our policies regarding quality measure benchmarks, calculating total measure achievement and measure bonus points, calculating the quality performance category percent score, including achievement and improvement points, and the small practice bonus (81 FR 77276 through 77308, 82 FR 53716 through 53748, 83 FR 59841 through 59855, and 84 FR 63011 through 63018). We are proposing to maintain many policies finalized in prior years to retain stable scoring in MIPS with minimal new proposals as we transition to MVPs.</P>
                    <P>Please refer to section IV.A.3.c.(1)(b) of this proposed rule for more information about our proposal to sunset the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians starting with the 2021 performance period. If the proposal is finalized, scoring policies proposed for the 2021 performance period will not be applicable to CMS Web Interface as a collection type.</P>
                    <HD SOURCE="HD3">(i) Scoring Flexibility for Changes That Impact Quality Measures During the Performance Period</HD>
                    <P>We are proposing to expand the list of reasons that a quality measure may be impacted during the performance period in addition to revising when we would allow scoring of the measure with a performance period truncation (to 9 months) or the complete suppression of the measure if 9 months of data are not available. We have previously established policies to provide scoring flexibilities in instances in which changes to measures during the performance period have impacted clinicians' ability to submit the quality measures for the entire 12-month performance period because of an ICD-10 coding change or when there are clinical guideline changes that could result in patient harm, or otherwise provide misleading results and render the measure no longer comparable to the historic benchmark. Specifically, in the CY 2018 Quality Payment Program Final rule (82 FR 53714 through 53716), we finalized that, beginning with the 2018 MIPS performance period, we will assess performance on measures considered significantly impacted by ICD-10 coding changes during the performance period based only on the first 9 months of the 12-month performance period. We believe that 9 months of data is sufficient to assess performance when 12 months of data is not available. We finalized that we would publish a list of measures requiring a 9-month assessment period on the CMS website by October 1st of the performance period if technically feasible, but no later than the beginning of the data submission period (for example, January 2, 2021 for the 2020 performance period). We refer readers to § 414.1380(b)(1)(viii) for more on our policy for scoring flexibility for ICD-10 changes.</P>
                    <P>In the CY 2019 Quality Payment final rule (83 FR 59845 through 59847),we finalized policies beginning with the 2021 MIPS payment year to reduce the total available measure achievement points from the quality performance category by 10 points for MIPS eligible clinicians for each measure submitted that is significantly impacted by clinical guideline changes or other changes when we believe adherence to the guidelines in the existing measures could result in patient harm or otherwise no longer be comparable to a historic benchmark. We refer readers to § 414.1380(b)(1)(vii)(A) for more information on the scoring flexibility policy.</P>
                    <P>We propose beginning with the 2021 performance period, a policy to truncate the performance period or suppress a quality measure if CMS determines that revised clinical guidelines, measure specifications or codes impact clinician's ability to submit information on the measure or may lead to potentially misleading results. Based on the timing of the changes to clinical guidelines, measure specifications or codes, we would assess the measure on 9 months of data, and if 9 consecutive months of data are not available, we would suppress the measure by reducing the total available measure achievement points from the quality performance category by 10 points for each measure submitted that is impacted.</P>
                    <P>In addition to ICD-10 and clinical guideline changes, we believe that there may be instances when there are changes after the final approval of quality measures including changes to the measure specification, or updates to coding that may lead to misleading results. If there are no concerns with potential patient harm, we would like the ability to assess performance on the quality measure (not including the change) if we have sufficient data. Depending on the timing of the change during the performance period we would like to assess performance on the quality measure; we believe we can assess performance if we have 9 months of data and should suppress the measure if we have less than 9 months of data.</P>
                    <P>We will examine quality measures that are impacted by changes during the performance period to determine how the change may impact our ability to assess performance on the measure. Potential changes that may impact quality measures during the performance period include updates to clinical guidelines or measure specifications, such as revisions to medication lists, codes and clinical actions. For example, the introduction of a new drug class after the performance period began, would not be captured as numerator compliant by an existing measure specification but may meet the intent of the measure and its associated clinical actions. Assessment of clinician's performance on the measure would be hampered by the fact that the measure specification would not be able to be updated to collect information and assess performance related to use of the medication from the new drug class. As reflected at sections 1848(q)(2)(D)(1) and 1848(q)(2)(D)(1)(II)(cc) of the Act, quality measures adopted under MIPS, including substantive updates must be made through notice and comment rulemaking.</P>
                    <P>
                        Additionally, we may examine a quality measure to determine if the change impacts the ability of clinicians to submit the measure, including the number of encounters a clinician may be able to submit, the number of clinicians who may be able to submit the measure, and the proportion of clinicians from a specialty who may be able to submit the measure. We would also assess if the change to a code would potentially lead to misleading results. For example, changes that impact the clinicians' ability to report a measure include changes to Common Procedural Technology (CPT) codes and the Healthcare Common Procedure Coding System (HCPCS) codes during the performance period, which may potentially produce misleading results. We believe that code changes that impact a clinician's ability to report a measure will be rare events, however, mid-year changes to CPT and HCPCS codes can be unanticipated when a clinician selects a quality measure and may introduce an additional burden if the clinician is unable to submit the quality measure.
                        <PRTPAGE P="50307"/>
                    </P>
                    <P>When possible, we want an approach that allows us to score a quality measure even when there has been a change to the measure outside of the clinician's control during the performance period. We have finalized a policy that allows scoring on the first 9 months of data for a 12-month performance period data when there are ICD-10 code changes (82 FR 53714 through 53716). We assess performance on the first 9 months of performance data in the case of ICD-10 changes, which happen predictably in October on an annual basis, allowing us to truncate and remove the last quarter of the performance period from our assessment. However, we cannot anticipate when there will be a change to clinical guidelines, measure specifications, an inadvertent deletion, or revision of a code. These types of changes do not occur on an annual basis, and do not follow a predictable, consistent timeline. We become aware of changes to measures from feedback from clinicians, third parties and measure stewards. Updates to codes, which may not happen at a predictable time, may significantly impact how many cases a clinician can report and how a clinician performs on a measure. We want to account for instances such as coding changes during the performance period, in which scoring should be applied to the first 9 months of data from the performance period. If 9 consecutive months of data from the performance period is not available, we would have the ability to suppress the measure by reducing the total available measure achievement points from the quality performance category by 10 points for MIPS eligible clinicians for each measure submitted that is significantly impacted.</P>
                    <P>Therefore, we propose beginning with the 2021 performance period, a policy to truncate the performance period or suppress a quality measure if CMS determines revised clinical guidelines, measure specifications or codes impact the clinician's ability to submit the measure or may lead to potentially misleading results. Under this proposal we would maintain the flexibility to assess the measure on 9 months of data when available. Under the proposal we would suppress the measure if 9 consecutive months of data are not available. We propose that we would publish a list of measures requiring a 9-month assessment period on the CMS website as soon as technically feasible, but no later than the beginning of the data submission period (for example, January 2, 2021 for the 2020 performance period).</P>
                    <P>Accordingly, we propose to consolidate § 414.1380(b)(1)(vii)(A) and (b)(1)(viii) at § 414.1380(b)(1)(vii)(A). The consolidated paragraph would provide that for each submitted measure that is impacted by significant changes that CMS determines may result in patient harm or misleading results, performance on the measure is assessed based on data for 9 consecutive months of the applicable CY performance period. If such data are not available, the total available measure achievement points are reduced by 10 points. For purposes of this paragraph § 414.1380(b)(1)(vii)(A), “significant changes” means changes to codes (including ICD-10, CPT, and HCPCS), clinical guidelines, or measure specifications. We will publish a list of all measures scored under this paragraph § 414.1380(b)(1)(vii)(A) on the CMS website as soon as technically feasible, but by no later than the beginning of the data submission period at § 414.1325(e)(1).</P>
                    <HD SOURCE="HD3">(ii) Quality Measure Benchmarks</HD>
                    <P>We refer readers to the CY 2017, CY 2018, CY 2019, and CY 2020 Quality Payment Program final rules (81 FR 77277 through 77282, 82 FR 53699 through 53718, 83 FR 59841 through 59842, and 84 FR 63014 through 63016, respectively) for our previously established benchmarking policies.</P>
                    <P>In the CY 2017 QPP final rule (81 FR 77277 through 77282), we finalized that we would use performance in the baseline period to set benchmarks for the quality performance category, with the exception of new quality measures, quality measures that lack historical data, or where we do not have comparable data from the baseline period, for which we would set the benchmarks using performance in the performance period. We defined the baseline period to be the 12-month CY that is 2 years prior to the performance period for the MIPS payment year. For example, for CY 2021 performance period, the baseline period would be CY 2019 which is 2 years prior to the CY 2021 performance period (81 FR 77277). Additionally, we further clarified that CMS can establish benchmarks either by the applicable baseline or performance period in the CY 2019 final rule (83 FR 59842), where we finalized the terminology change amending § 414.1380(b)(1)(ii) to remove the mention of each individual benchmark and instead state that benchmarks will be based on collection type, from all available sources, including MIPS eligible clinicians and APMs, to the extent feasible, during the applicable baseline or performance period.</P>
                    <P>Because of the flexibility provided to MIPS eligible clinicians to allow for no data submission for the 2019 performance period (see 85 FR 19277 through 19278), we may not have as representative of a sample of data as we would have had without the national PHE for COVID-19. Therefore, we want to revisit our benchmarking policy for the 2021 performance period. We anticipate that we may have a gap in our data due to potentially receiving fewer submissions for CY 2019 which could skew the benchmarking results, as the triggering of this policy no longer requires clinicians to submit data. We believe this gap in data could result in different distributions of scores from what we normally see, thus skewing the benchmarks when using CY 2019 baseline period for the CY 2021 performance period. As a result, we considered two benchmarking options for CY 2021 performance period.</P>
                    <P>We intend to use performance period benchmarks for the CY 2021 performance period in accordance with § 414.1380(b)(1)(ii). This would mean that benchmarks for the CY 2021 performance period are based on the actual data submitted during the CY 2021 performance period. We believe that using performance period benchmarks for the year where we are facing gaps in baseline data will allow us to ensure that we continue to have reliable and accurate data. We recognize that this methodology would not allow clinicians to know the benchmarks ahead of the performance period, but we believe that using the most current information has the potential to provide more accurate results for benchmarking purposes for CY 2021 performance period and could capture any changes in care that have occurred as a result of the national PHE for COVID-19.</P>
                    <P>
                        We are seeking feedback on the criteria for using data from the 2019 MIPS performance period to calculate CY 2021 benchmarks. We also, as an alternative to performance period benchmarks, considered, and request stakeholder comments and feedback on, utilizing the historic benchmarks from the 2020 MIPS performance period (which are based on submissions for CY 2018 MIPS performance period) for the CY 2021 performance period. We believe that this option would allow clinicians to continue to receive advance notice for quality performance category measures so that MIPS eligible clinicians can set a clear performance goal for these measures for CY 2021 performance period. However, we remain concerned that utilizing outdated data could also potentially result in distributions of scores used for benchmarks that no longer reflect the standard of care.
                        <PRTPAGE P="50308"/>
                    </P>
                    <HD SOURCE="HD3">(iii) Minimum Case Requirements</HD>
                    <P>In the CY 2017 Quality Payment program final rule (81 FR 77287 to 77289) we finalized that we will use 20 cases as the case minimum for all quality measures, with the exception of the all-cause hospital readmission measure which has a minimum of 200 cases. As proposed in Table Group A within Appendix 1, the hospital-wide readmission measure is replacing the all-cause readmission measure and an additional administrative claims-based measure for hip/knee complications is being added to the program. In the case of the hospital-wide readmission measure, the case minimum will remain the same at 200 cases and will only apply to groups. For the new hip/knee complication measure, a case minimum of 25 is proposed and is applicable for individuals and groups. We propose to amend § 414.1380(b)(1)(i) to clarify how administrative claims measures are scored. We propose to amend § 414.1380(b)(1)(iii) to reflect that, except for administrative claims measures, the minimum case requirement is 20 cases. For each administrative claims-based measure, the minimum case requirement is specified in the annual list of MIPS measures.</P>
                    <HD SOURCE="HD3">(iv) Assigning Quality Measure Achievement Points</HD>
                    <P>We refer readers to § 414.1380(b)(1)(i) for more details on our policies for scoring performance on quality measures (81 FR 77276 through 77307, 82 FR 53694 through 53701, 83 FR 59841 through 59856, and 84 FR 63011 through 63019).</P>
                    <HD SOURCE="HD3">(A) Scoring Measures Based on Achievement</HD>
                    <P>We previously established at § 414.1380(b)(1)(i) a global 3-point floor for each scored quality measure, as well as for the hospital readmission measure (if applicable) for the 2019 through 2022 MIPS payment years. MIPS eligible clinicians receive between 3 and 10 measure achievement points for each submitted measure that can be reliably scored against a benchmark, which requires meeting the case minimum and data completeness requirements. In the CY 2017 Quality Payment Program final rule (81 FR 77282), we established that measures with a benchmark based on the performance period (rather than on the baseline period) would continue to receive between 3 and 10 measure achievement points for performance periods after the first transition year. For measures with benchmarks based on the baseline period, we stated that we would revisit the 3-point floor in future years.</P>
                    <P>For the 2023 MIPS payment year, we propose to again apply a 3-point floor for each measure that can be reliably scored against the benchmark. As we move towards the MVP framework discussed in section IV.A.3.a.(1) of this proposed rule, we anticipate we will be able to score quality measures from 1 to 10 for measures in MVPs and as such will revisit and possibly remove the 3-point floor for traditional MIPS in future years. As a result, we will wait until there is further policy development under the MVP framework before proposing to remove the 3-point floor. Accordingly, we propose to revise § 414.1380(b)(1)(i) to remove the years 2019 through 2022 and adding in its place the years 2019 through 2023 to provide that for the 2019 through 2023 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340.</P>
                    <HD SOURCE="HD3">(B) Scoring Measures That Do Not Meet Case Minimum, Data Completeness, and Benchmark Requirements</HD>
                    <P>We refer readers to § 414.1380(b)(1)(i)(A) and (B) for more on our scoring policies for a measure that is submitted but is unable to be scored because it does not meet the required case minimum, does not have a benchmark, or does not meet the data completeness requirement (84 FR 63012).</P>
                    <P>In the 2017 QPP final rule (81 FR 77288) and the 2018 QPP final rule (82 FR 53727), we identified “classes of measures” which were intended to characterize measures for the ease of discussion. Class 1 measures are measures that can be scored based on performance because they have a benchmark, meet the case minimum and data completeness requirements. Class 2 measures are measures that cannot be scored based on performance because they do not have a benchmark or do not meet the case minimum which is generally 20 cases. Class 3 measures are measures that do not meet the data completeness requirement. We also noted that policies for Class 2 and Class 3 measures would not apply to measures submitted with the CMS Web Interface or administrative claims-based measures.</P>
                    <P>
                        We are not proposing to modify how we score these measures within MIPS, as we consider policies for transitioning to MVPs described in section IV.A.3.a.(3) of this proposed rule. For class 2 measures, for the 2023 MIPS payment year, we propose to again apply the special scoring policies for measures that meet the data completeness requirement but do not have a benchmark, due to fewer than 20 individual clinicians or groups adequately reporting the measure, or meet the case minimum requirement. Accordingly, we propose to revise § 414.1380(b)(1)(i)(A)(
                        <E T="03">1</E>
                        ) to remove the years 2019 through 2022 and add in its place the years 2019 through 2023 to provide that except as provided in paragraph (b)(1)(i)(A)(2) (which relates to CMS Web Interface measures and administrative claims-based measures), for the 2019 through 2023 MIPS payment years, MIPS eligible clinicians would receive 3 measure achievement points for each submitted measure that meets the data completeness requirement, but does not have a benchmark or meet the case minimum requirement.
                    </P>
                    <P>A summary of the proposed policies for the CY 2021 MIPS performance period is provided in Table 43.</P>
                    <GPH SPAN="3" DEEP="314">
                        <PRTPAGE P="50309"/>
                        <GID>EP17AU20.077</GID>
                    </GPH>
                    <HD SOURCE="HD3">(v) Assigning Measure Achievement Points for Topped Out Measures</HD>
                    <P>We refer readers to § 414.1380(b)(1)(iv) for our previously finalized policies regarding the identification of topped out measures and § 414.1380(b)(1)(iv)(B) for our finalized policies regarding the scoring of topped out measures. Under § 414.1380(b)(1)(iv), we will identify topped out measures in the benchmarks published for each Quality Payment Program year. Under § 414.1380(b)(1)(iv)(B), beginning with the 2021 MIPS payment year, measure benchmarks (except for measures in the CMS Web Interface) that are identified as topped out for 2 or more consecutive years will receive a maximum of 7 measure achievement points beginning in the second year the measure is identified as topped out (82 FR 53726 through 53727).</P>
                    <P>As noted in section IV.A.3.d.(1)(b)(ii) of this proposed rule, we are using performance period benchmarks for the 2021 MIPS performance period, which will mean we would not be able to publish measures that are topped out prior to the 2021 MIPS performance period. That also means we would not be able to identify those that have been topped-out for 2 or more consecutive years for purposes of the topped out scoring of 7 measure achievement points. We believe it is still important to retain a topped out scoring cap of 7 measure achievement points so that clinicians have incentives to pick alternate measures that are not topped out. We also appreciate that a measure may not always be topped out and we believe that if a measure is not topped out in the 2021 performance period benchmark, then it should have the ability to achieve up to 10 measure achievement points.</P>
                    <P>Therefore, for the 2021 MIPS performance period, as an exception from the general rule at § 414.1380(b)(1)(iv)(B) we propose at § 414.1380(b)(1)(iv)(B)(1) to apply the 7 measures achievement point cap to measures that meet the following two criteria. The first criterion would be that the measures have been topped out for 2 or more periods based on the published 2020 MIPS performance period historic benchmarks (which are based on submissions for the 2018 MIPS performance period). The second criterion would be the measures remain topped out after the 2021 MIPS performance period benchmarks have been calculated. We believe these two criteria collectively would provide clinicians the information to know prior to the 2021 MIPS performance period which measures would have the topped-out scoring applied but would also account for the scenario where a measure is no longer topped out. We would not limit the number of measure achievement points for measures that have not been topped out for at least two years as published in the 2020 MIPS performance period historic benchmarks.</P>
                    <HD SOURCE="HD3">(vi) Incentives To Report High-Priority Measures</HD>
                    <P>We refer readers to § 414.1380(b)(1)(v)(A) for our previously finalized policies regarding incentives to report high priority measures. In the CY 2017 Quality Payment Program final rule (81 FR 77293), we established the scoring policies for high priority measure bonus points to encourage the selection of additional high-priority and outcome measures that impact beneficiaries and were closely aligned to our measurement goals. In the CY 2019 PFS final rule (83 FR 59850), we discontinued awarding measure bonus points to CMS Web Interface reporters for reporting high priority measures since CMS Web Interface reporters have no choice in measures.</P>
                    <P>
                        We stated in the CY 2019 PFS proposed and final rules (83 FR 35950, 59851) that as part of our move towards fully implementing high value measures, we believe that bonus points 
                        <PRTPAGE P="50310"/>
                        for high priority measures for all collection types may no longer be needed, and as a result, we intended to consider in future rulemaking whether to modify our scoring policy to no longer offer high priority bonus points after the 2021 MIPS payment year. We noted in the CY 2019 PFS final rule (83 FR 59851) that measure bonus points were created as transition policies which were not meant to continue through the life of the program. We believe with the finalized framework for transforming MIPS through MVPs (84 FR 62948), we will find ways in the future to emphasize high priority measures without needing to incentivize with bonus points. As a result, we will wait until there is further policy development under the MVP framework before proposing to remove our policy of assigning bonus points for high priority measures.
                    </P>
                    <P>
                        In this proposed rule, we propose to maintain the cap on measure points for reporting high priority measures for the 2023 MIPS payment year. Accordingly, we propose to revise § 414.1380(b)(1)(v)(A)(
                        <E T="03">1</E>
                        )(
                        <E T="03">ii</E>
                        ) to remove the years 2019 through 2022 and adding in its place the years 2019 through 2023 to provide that through the 2023 MIPS payment year, the total measure bonus points for high priority measures cannot exceed 10 percent of the total available measure achievement points.
                    </P>
                    <HD SOURCE="HD3">(vii) Incentives To Use CEHRT To Support Quality Performance Category Submissions</HD>
                    <P>Section 1848(q)(5)(B)(ii) of the Act requires the Secretary to encourage MIPS eligible clinicians to report on applicable quality measures through the use of CEHRT. In the CY 2017 Quality Payment Program final rule (81 FR 77297), we established the measure bonus point and bonus cap for using CEHRT for end-to-end reporting. We refer readers to § 414.1380(b)(1)(v)(B) for our previously finalized policies regarding measure bonus points for end-to-end electronic reporting. We believe with the framework for transforming MIPS through MVPs discussed in the CY 2020 PFS proposed rule (84 FR 40739) and in section IV.A.3.a.(1) of this proposed rule, we will find ways to incorporate digital measures without needing to incentivize end-to-end reporting with bonus points. In the CY 2018 Quality Payment Program final rule (82 FR 53636), we encouraged stakeholders to consider electronically specifying their quality measures as eCQMs, to encourage clinicians and groups to move towards the utilization of electronic reporting. As noted in the CY 2019 PFS final rule (83 FR 59851), bonus points were created as transition policies which were not meant to continue through the life of the program. As a result, we will wait until there is further policy development under the finalized MVP framework (84 FR 62948) before proposing to remove our policy of assigning bonus points for end-to-end electronic reporting.</P>
                    <P>
                        In this proposed rule, we propose to continue to assign and maintain the cap on measure bonus points for end-to-end electronic reporting for the 2023 MIPS payment year. Accordingly, we propose to revise § 414.1380(b)(1)(v)(B)(
                        <E T="03">1</E>
                        )(
                        <E T="03">i</E>
                        ) to remove the years 2019 through 2022 and add in its place the years 2019 through 2023 to provide that for the 2019 through 2023 MIPS payment years, the total measure bonus points for measures submitted with end-to-end electronic reporting cannot exceed 10 percent of the total available measure achievement points.
                    </P>
                    <HD SOURCE="HD3">(viii) Improvement Scoring for the MIPS Quality Performance Category Percent Score</HD>
                    <P>
                        We refer readers to § 414.1380(b)(1)(vi)(C)(
                        <E T="03">4</E>
                        ) for more on our policy stating that for the 2020 through 2022 payment years, for the purpose of improvement scoring, we will assume a quality performance category achievement percent score of 30 percent in the previous year if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year.
                    </P>
                    <P>
                        In this proposed rule, we propose to continue our previously established policy for improvement scoring for the 2023 MIPS payment years and to revise § 414.1380(b)(1)(vi)(C)(
                        <E T="03">4</E>
                        ) to remove the phrase “2020 through 2022 MIPS payment year” and adding in its place the phrase “2020 through 2023 MIPS payment years” to indicate that for each MIPS payment year through 2023, we will assume a quality performance category achievement percent score of 30 percent in the previous year if a MIPS eligible clinician earned a quality performance category score less than or equal to 30 percent in the previous year. Specifically, for the 2023 MIPS payment year, we would compare the MIPS eligible clinician's quality performance category achievement percent score for the 2021 MIPS performance period to an assumed quality performance category achievement percent score of 30 percent if the MIPS eligible clinician earned a quality performance score less than or equal to 30 percent for the 2020 MIPS performance period.
                    </P>
                    <HD SOURCE="HD3">(2) Calculating the Final Score</HD>
                    <P>For a description of the statutory basis and our policies for calculating the final score for MIPS eligible clinicians, we refer readers to § 414.1380(c) and the discussion in the CY 2017 and CY 2018 Quality Payment Program final rules, and the CY 2019 and CY 2020 PFS final rules (81 FR 77319 through 77329, 82 FR 53769 through 53785, 83 FR 59868 through 59878, 84 FR 63020 through 63031, respectively). In this rule, we propose to continue the complex patient bonus for the 2023 MIPS payment year, and we also propose to modify the complex patient bonus for the 2022 MIPS payment year as established in prior rulemaking due to the national public health emergency for COVID-19. In addition, we propose performance category redistribution policies for the 2023, 2024, and future MIPS payment years. These proposals are discussed in more detail in this section of the proposed rule.</P>
                    <HD SOURCE="HD3">(a) Complex Patient Bonus</HD>
                    <HD SOURCE="HD3">(i) Background</HD>
                    <P>
                        Section 1848(q)(1)(G) of the Act requires us to consider risk factors in our MIPS scoring methodology. Specifically, it provides that the Secretary, on an ongoing basis, shall, as the Secretary determines appropriate and based on an individual's health status and other risk factors, assess appropriate adjustments to quality measures, cost measures, and other measures used under MIPS; and assess and implement appropriate adjustments to payment adjustments, final scores, scores for performance categories, or scores for measures or activities under MIPS. In doing so, the Secretary is required to take into account the relevant studies conducted under section 2(d) of the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act)) (Pub. L. 113-185, enacted on October 6, 2014) and, as appropriate, other information, including information collected before completion of such studies and recommendations. In the CY 2018 Quality Payment Program final rule, under the authority in section 1848(q)(1)(G) of the Act, we established at § 414.1380(c)(3) a complex patient bonus of up to 5 points to be added to the final score for the 2020 MIPS payment year (82 FR 53771 through 53776). In subsequent rulemaking, we continued the complex patient bonus at § 414.1380(c)(3) for the 2021 and 2022 MIPS payment years (83 FR 59870 and 84 FR 63023). We refer readers to these final rules for additional details on the background, statutory authority, policy 
                        <PRTPAGE P="50311"/>
                        rationale, and calculation of the complex patient bonus.
                    </P>
                    <P>We intended for this bonus to serve as a short-term strategy to address the impact patient complexity may have on MIPS scoring while we continue to work with stakeholders on methods to account for patient risk factors. The overall goal, when considering a bonus for complex patients, is two-fold: (1) To protect access to care for complex patients and provide them with excellent care; and (2) to avoid placing MIPS eligible clinicians who care for complex patients at a potential disadvantage while we review the completed studies and research to address the underlying issues. We used the term “patient complexity” to take into account a multitude of factors that describe and have an impact on patient health outcomes; such factors include the health status and medical conditions of patients, as well as social risk factors. We believe that as the number and intensity of these factors increase for a single patient, the patient may require more services, more clinician focus, and more resources in order to achieve health outcomes that are similar to those who have fewer factors. In developing the policy for the complex patient bonus, we assessed whether there was a MIPS performance discrepancy by patient complexity using two well-established indicators in the Medicare program: Medical complexity as measured through Hierarchical Condition Category (HCC) risk scores, and social risk as measured through the proportion of patients with dual eligible status (82 FR 53771 through 53776).</P>
                    <HD SOURCE="HD3">(ii) Complex Patient Bonus for the 2023 MIPS Payment Year</HD>
                    <P>We intended the complex patient bonus as a short-term solution to address the impact patient complexity may have on MIPS scoring. However, we currently do not believe we have sufficient information available to develop a long-term solution to account for patient risk factors in MIPS that we could include in this proposed rule for the 2023 MIPS payment year. In the CY 2020 PFS proposed and final rules, we considered whether newly available data from the Quality Payment Program still supported the complex patient bonus at the final score level. More specifically, within the data analysis, we did not observe a consistent linear relationship for any reporting type or complexity measure, HCC risk score or dual eligible status (84 FR 40793 through 40795 and 84 FR 63021 through 63023). However, we only have a few years of data and believe that more recent data may bring different results than the findings we explained in detail in the CY 2020 PFS final rule. We refer readers to the CY 2020 PFS final rule for further details on the methodology and findings (84 FR 63021 through 63023).</P>
                    <P>As stated previously in this proposed rule, section 1848(q)(1)(G) of the Act requires us to take into account the relevant studies conducted under section 2(d) of the IMPACT Act and, as appropriate, other information, including information collected before completion of such studies and recommendations. ASPE completed its first report in December 2016, which examined the effect of individuals' socioeconomic status on quality, resource use, and other measures under the Medicare program, and included analyses of the effects of Medicare's current value-based payment programs on providers serving socially at-risk beneficiaries and simulations of potential policy options to address these issues. We also noted, in the CY 2020 PFS final rule, that a second ASPE report on social risk factors within CMS value-based purchasing programs was expected. This second report was publicly released in June 2020 which builds on the analyses included in the initial report and provides additional insight for addressing risk factors in MIPS and other value-based payment programs. As we continue to review the analyses and findings of the report, we intend to consider its recommendations, along with any updated data that would become available, for future rulemaking. Hence, based on our data analysis from the CY 2020 PFS final rule (84 FR 63022) and the lack of currently available additional data sources, for the 2021 MIPS performance period/2023 MIPS payment year, we propose to continue the complex patient bonus as finalized for the 2020 MIPS performance period/2022 MIPS payment year and to revise § 414.1380(c)(3) accordingly. We plan to continue working with ASPE, the public, and other key stakeholders on this important issue to identify longer term policy solutions that achieve the goals of attaining health equity for all beneficiaries, minimizing unintended consequences, and will propose modifications to the complex patient bonus in future rulemaking as appropriate.</P>
                    <HD SOURCE="HD3">(iii) Complex Patient Bonus for the 2022 MIPS Payment Year</HD>
                    <P>
                        In this section of the proposed rule, we discuss our proposal to modify the complex patient bonus for the 2022 MIPS payment year in response to the national public health emergency for COVID-19. In the CY 2020 PFS final rule, we continued the complex patient bonus for the 2020 performance period/2022 MIPS payment year (84 FR 63021 through 63023). More specifically, we continued to utilize our two established complexity indicators, HCC risk scores and dual eligible status, because we believed that they continued to account for the multitude of factors that describe and have an impact on patient health outcomes. Further, risk scores are based on a beneficiary's age and sex; whether the beneficiary is eligible for Medicaid, first qualified for Medicare on the basis of disability, or lives in an institution (usually a nursing home); and the beneficiary's diagnoses from the previous year.
                        <SU>93</SU>
                        <FTREF/>
                         Additionally, the HCC model also accounts for the number of conditions a beneficiary has, making an adjustment as the number of diseases or conditions increases, and includes additional diagnosis codes related to mental health and substance use disorders, and chronic kidney disease.
                        <SU>94</SU>
                        <FTREF/>
                         However, due to the national public health emergency for COVID-19 during performance period 2020, we believe we need to re-evaluate the previously established policy for the complex patient bonus for the 2022 MIPS payment year. We acknowledge that there are direct effects of COVID-19 for those patients who have the disease and indirect effects of COVID-19 for other patients, including increased complexity and barriers such as postponing care, accessing care in a different way (for example, via telecommunications), and disruptions to lab results and medications, which are not accounted for in our existing final score calculations using these complexity indicators. We realize that the first year of the novel virus may add complexity that we have not already captured via the complex patient bonus. This complexity includes patients who have gotten sick, as well as patients who may now have complications or other factors because of delayed care or disruptions to lab services or medications due to COVID-19. Government guidelines, such as the Center for Disease Control and Prevention guidance on “Groups at Higher Risk for Severe Illness”, indicate that COVID-19 patients who are already 
                        <PRTPAGE P="50312"/>
                        high-risk due to pre-existing medical conditions are at further risks of increased COVID-19 related hospitalizations and mortality.
                        <SU>95</SU>
                        <FTREF/>
                         Further, literature also indicates that those patients who are already high-risk due to social factors are also at further risk of serious illness related to COVID-19.
                        <SU>96</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             CMS, Medicare Fee-For-Service Provider Utilization &amp; Payment Data Physician and Other Supplier Public Use File: A Methodological Overview”: 
                            <E T="03">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Medicare-Physician-and-Other-Supplier-PUF-Methodology.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             CMS, “Report to Congress: Risk Adjustment in Medicare Advantage”: 
                            <E T="03">https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/RTC-Dec2018.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             CDC, “Groups at Higher Risk for Severe Illness”: 
                            <E T="03">https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/groups-at-higher-risk.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             Kaiser Family Foundation, “Low-Income and Communities of Color at Higher Risk of Serious Illness if Infected with Coronavirus”: 
                            <E T="03">https://www.kff.org/coronavirus-covid-19/issue-brief/low-income-and-communities-of-color-at-higher-risk-of-serious-illness-if-infected-with-coronavirus/.</E>
                        </P>
                    </FTNT>
                    <P>
                        Further, during this time, hospitals reported that medical systems delayed and canceled care, resulting in reduced utilization of healthcare services and a changing care delivery system.
                        <SU>97</SU>
                        <FTREF/>
                         Although access to Medicare telehealth services was expanded so that beneficiaries could receive a wider range of services from clinicians without having to travel to a healthcare facility,
                        <SU>98</SU>
                        <FTREF/>
                         this only partially filled the gap in services from the reduction in delivery of care, as not all specialties can utilize telehealth. We recognize the increased challenges of providing care to complex patients in the context of the national public health emergency for COVID-19. Patients with comorbidities (as measured by HCC risk score) and social risk (measured by dual eligible status) are disproportionately likely to be severely affected by COVID-19.
                        <E T="51">99 100 101</E>
                        <FTREF/>
                         More specifically, findings from our recently released data reinforces previous findings by the Centers for Disease Control and Prevention that older Americans and those with chronic health conditions are at the highest risk for COVID-19. The data also show that COVID-19 has disproportionately impacted lower income adults, further confirming longstanding healthcare disparities in dual eligible populations.
                        <SU>102</SU>
                        <FTREF/>
                         Additionally, in light of the care delivery changes, we believe clinicians may see patients in 2020, with medical or social risk factors, whose health conditions may have been exacerbated due to delayed care. Patients with comorbidities and social risk are likely to suffer adverse outcomes due to delaying or not receiving care.
                        <E T="51">103 104 105</E>
                        <FTREF/>
                         Given that the limited available literature and data on COVID-19 suggests that patients with social risk factors or underlying conditions have increased complexity, we believe that our existing complexity indicators, HCC risk score and dual eligibility, could serve as a proxy for capturing increased complexity due to the pandemic.
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             American Hospital Association, “Hospitals and Health Systems Face Unprecedented Financial Pressures Due to COVID-19”: 
                            <E T="03">https://www.aha.org/guidesreports/2020-05-05-hospitals-and-health-systems-face-unprecedented-financial-pressures-due.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             CMS, “Medicare Telemedicine Healthcare Provider Fact Sheet”: 
                            <E T="03">https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             The Journal of the American Medical Association Network, “Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area”: 
                            <E T="03">https://jamanetwork.com/journals/jama/fullarticle/2765184.</E>
                        </P>
                        <P>
                            <SU>100</SU>
                             Morbidity and Mortality Weekly Report/CDC COVID-19 Response Team, “Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions Among Patients with Coronavirus Disease 2019—United States, February 12-March28, 2020”: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7119513/pdf/mm6913e2.pdf.</E>
                        </P>
                        <P>
                            <SU>101</SU>
                             The Commonwealth Fund, “Assessing Underlying State Conditions and Ramp-Up Challenges for the COVID-19 Response”: 
                            <E T="03">https://www.commonwealthfund.org/publications/issue-briefs/2020/mar/assessing-underlying-state-conditions-and-ramp-challenges-covid.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             CMS, “Medicare COVID-19 Data Release Blog”: 
                            <E T="03">https://www.cms.gov/blog/medicare-covid-19-data-release-blog.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             Kaiser Health News, “Nearly Half of American Delayed Medical Care Due to Pandemic”: 
                            <E T="03">https://khn.org/news/nearly-half-of-americans-delayed-medical-care-due-to-pandemic/.</E>
                        </P>
                        <P>
                            <SU>104</SU>
                             The British Medical Journal, “Delayed presentation of acute ischemic strokes during the COVID-19 crisis”: 
                            <E T="03">https://jnis.bmj.com/content/early/2020/05/27/neurintsurg-2020-016299.</E>
                        </P>
                        <P>
                            <SU>105</SU>
                             U.S. National Library of Medicine National Institutes of Health, “Hospitalization for Ambulatory-care-sensitive Conditions in Taiwan Following the SARS Outbreak: A Population-based Interrupted Time Series Study”: 
                            <E T="03">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7135451/.</E>
                        </P>
                    </FTNT>
                    <P>Currently, the complex patient bonus is worth up to 5 points. However, given the anticipated increase in complexity due to the national public health emergency for COVID-19, we propose at § 414.1380(c)(3)(iv) that for the CY 2020 performance period/2022 MIPS payment year, the complex patient bonus would be calculated pursuant to the existing formulas in §§ 414.1380(c)(3)(i) and (ii), and the resulting numerical value would then be multiplied by 2, but the complex patient bonus cannot exceed 10. The doubled numerical value (subject to the 10-point cap) would be added to the final score. Additionally, we propose to revise § 414.1380(c)(3)(iii) to state that the complex patient bonus cannot exceed 5.0 except as provided in § 414.1380(c)(3)(iv). Under this proposal, clinicians could receive up to 10 complex patient bonus points added to their final score. For example, if a MIPS eligible clinician were to receive 4 complex patient bonus points under the existing formulas, the MIPS eligible clinician would receive 8 complex patient bonus points (doubling the bonus points) under our proposal for the CY 2020 performance period/2022 MIPS payment year. In instances where clinicians would have received the maximum of 5 complex patient bonus points, they would receive the maximum of 10 complex patient bonus points under our proposal for the CY 2020 performance period/2022 MIPS payment year. To the extent that this proposed change constitutes a change to the MIPS scoring or payment methodology for the 2022 MIPS payment adjustment after the start of the 2020 performance period, we believe that, consistent with section 1871(e)(1)(A)(ii) of the Act, it would be contrary to the public interest not to account for increased patient complexity due to the national public health emergency for COVID-19. We believe it would be contrary to the public interest if MIPS scores do not adequately recognize this increased patient complexity that could not have been accounted for during the CY 2020 rulemaking. More specifically, currently we are unable to measure the magnitude of the direct and indirect effects of the COVID-19 pandemic on MIPS scores, and we remain concerned about potentially misidentifying poor performance with regard to the care delivered in CY 2020 due to the national PHE. Hence, we believe this approach of doubling the complex patient bonus recognizes the difficulty of managing complex patients during the pandemic and lowers the risk of inaccurately identifying a clinician as a “poor performer” when the underlying issue is caring for increasingly complex patients due to both direct and indirect effects of COVID-19.</P>
                    <P>
                        Due to limited data available related to the pandemic, it is difficult to gauge whether our proposal would be artificially increasing MIPS final scores or not providing enough flexibility to clinicians to account for increased patient complexity during the CY 2020 performance period. Given the challenges we assume clinicians may be facing, we believe doubling the complex patient bonus would be a reasonable and operationally feasible approach. In developing our proposal, we considered several alternatives, including maintaining the complex patient bonus as it currently is (up to 5 points) as well as whether it would be appropriate to triple (up to 15 points) the complex patient bonus. However, due to the limited data available, we decided not to propose those options as we were concerned that an approach of tripling the bonus could artificially increase final scores and maintaining the current 
                        <PRTPAGE P="50313"/>
                        bonus (up to 5 points) may not be sufficient to account for the increased patient complexity during the CY 2020 performance period. Additionally, we believe that by doubling the complex patient bonus, clinicians whose MIPS performance may be negatively affected by the challenges of caring for a complex patient population during a pandemic will be less likely to have the maximum negative adjustment due to circumstance beyond their control.
                    </P>
                    <P>We also considered whether we should add a new indicator of patient complexity, such as establishing a threshold for the percentage of patients with COVID-19. We were concerned about this alternative approach for two reasons. First, we do not believe the effects of COVID-19 are limited to those patients who are experiencing the illness. Second, we are uncertain of the consistency of diagnosis coding for both patients who are experiencing the illness or who are being treated for the sequelae of the illness.</P>
                    <P>We request comments on our proposal, the alternatives we considered, and any other approaches to account for patient complexity during the public health emergency that commenters believe we should consider, as well as alternative data sources for patient complexity.</P>
                    <HD SOURCE="HD3">(b) Final Score Performance Category Weights</HD>
                    <HD SOURCE="HD3">(i) General Weights</HD>
                    <P>Section 1848(q)(5)(E)(i) of the Act specifies weights for the performance categories included in the MIPS final score: In general, 30 percent for the quality performance category; 30 percent for the cost performance category; 25 percent for the Promoting Interoperability performance category; and 15 percent for the improvement activities performance category. For more of the statutory background and descriptions of our current policies, we refer readers to the CY 2017 through CY 2018 Quality Payment Program final rules, and CY 2019 through CY 2020 PFS final rules (81 FR 77320 through 77329, 82 FR 53779 through 53785, 83 FR 59870 through 59878, and 84 FR 62950 through 84 FR 62959, respectively). In section IV.A.3.c.(2)(a) of this proposed rule, we propose that the cost performance category would make up 20 percent of a MIPS eligible clinician's final score for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year. In section IV.A.3.c.(1) of this proposed rule, we propose the quality performance category would thus make up 40 percent of a MIPS eligible clinician's final score for the 2023 MIPS payment year and 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year. Table 44 summarizes the proposed weights for each performance category.</P>
                    <GPH SPAN="3" DEEP="108">
                        <GID>EP17AU20.078</GID>
                    </GPH>
                    <HD SOURCE="HD3">(ii) Flexibility for Weighting Performance Categories</HD>
                    <P>Under section 1848(q)(5)(F) of the Act, if there are not sufficient measures and activities applicable and available to each type of MIPS eligible clinician involved, the Secretary shall assign different scoring weights (including a weight of zero) for each performance category based on the extent to which the category is applicable to the type of MIPS eligible clinician involved and for each measure and activity with respect to each performance category based on the extent to which the measure or activity is applicable and available to the type of MIPS eligible clinician involved. Under section 1848(q)(5)(B)(i) of the Act, in the case of a MIPS eligible clinician who fails to report on an applicable measure or activity that is required to be reported by the clinician, the clinician must be treated as achieving the lowest potential score applicable to such measure or activity. In this scenario of failing to report, the MIPS eligible clinician generally would receive a score of zero for the measure or activity, which would contribute to the final score for that MIPS eligible clinician. Under certain circumstances, however, a MIPS eligible clinician who fails to report could be eligible for an assigned scoring weight of zero percent and a redistribution of the performance category weights. For a description of our existing policies for reweighting performance categories, please refer to § 414.1380(c)(2) and the CY 2020 PFS final rule (84 FR 63023 through 63027).</P>
                    <HD SOURCE="HD3">(iii) Redistributing Performance Category Weights</HD>
                    <P>
                        In the CY 2017 through CY 2018 Quality Payment Program final rules, and CY 2019 through CY 2020 PFS final rules (81 FR 77325 through 77329, 82 FR 53783 through 53785, 83 FR 59876 through 59878, and 84 FR 63027 through 63031), and at § 414.1380(c)(2)(ii), we established policies for redistributing the weights of performance categories in the event that a scoring weight different from the generally applicable weight is assigned to a category or categories. Under these policies, we generally redistribute the weight of a performance category or categories to the quality performance category because of the experience MIPS eligible clinicians have had reporting on quality measures under other CMS programs. For the 2020 MIPS performance period and 2022 MIPS payment year, we did not redistribute performance category weights to improvement activities, except for the scenario where the only two performance categories being scored are improvement activities and cost (84 FR 63028). Also for that year in scenarios when the cost performance category weight is redistributed while the Promoting Interoperability performance category weight is not, we redistributed a portion of the cost performance category weight to the Promoting Interoperability performance category, as well as to the quality performance category (84 FR 63027). As stated in CY 2020 PFS final rule, we continue to believe this redistribution policy is appropriate given our focus on working with the Office of the National 
                        <PRTPAGE P="50314"/>
                        Coordinator for Health IT (ONC) on implementation of the interoperability provisions of the 21st Century Cures Act (the Cures Act) (Pub. L. 115-233, enacted on December 13, 2016) to ensure seamless but secure exchange of health information for clinicians and patients and emphasize the importance of interoperability without overwhelming the contribution of the quality performance category to the final score (84 FR 63027).
                    </P>
                    <P>In section IV.A.3.c.(2)(a) of this proposed rule, we are proposing a weight for the cost performance category of 20 percent for the 2023 MIPS payment year. For the 2023 MIPS payment year, we propose similar redistribution policies as finalized for the 2022 MIPS payment year, with minor modifications to account for the cost performance category being 20 percent. Under this proposal, we would once again only redistribute weight to the cost performance category in cases when the cost and improvement activities performance categories are the only categories scored (each of these performance categories would be 50 percent in this scenario). We do not believe it is appropriate to redistribute more weight to the cost performance category, because cost would not yet be at the maximum weight specified by the statute (30 percent), and because clinicians still have relatively limited experience being scored on and receiving feedback on cost measures compared with quality measures. Our proposed redistribution policies for the 2023 MIPS payment year, which we propose to codify at § 414.1380(c)(2)(ii)(E), are included in Table 45.</P>
                    <GPH SPAN="3" DEEP="228">
                        <GID>EP17AU20.079</GID>
                    </GPH>
                    <P>In section IV.A.3.c.(2)(a) of this proposed rule, we are proposing to weight the cost performance category at 30 percent for the 2024 MIPS payment year and each subsequent MIPS payment year, as required by section 1848(q)(5)(E)(i)(II)(aa) of the Act. Given that 2024 would be the first year that cost would be set at the maximum weight prescribed by the statute, we do not believe it would be prudent to begin redistributing more weight to cost for the 2024 MIPS payment year, except in cases when only the cost and improvement activities performance categories are scored. For the improvement activities performance category, we are only assessing whether a MIPS eligible clinician completed certain activities (83 FR 59876 through 59878). Because MIPS eligible clinicians will have had several years of experience reporting under MIPS, we continue to believe that it is important to prioritize performance on measures that show a variation in performance, rather than the activities under the improvement activities performance category, which are based on attestation of completion. We believe this helps to reduce incentives to not report measures for the quality performance category in circumstances when a clinician may be able to report but chooses not to do so. For example, when a clinician may be able to report on quality measures, but chooses not to report because they are located in an area affected by extreme and uncontrollable circumstances as identified by CMS and qualify for reweighting under § 414.1380(c)(2)(i)(A)(8). Therefore, we continue to believe that weighting the cost and improvement activities performance categories each at 50 percent would be an appropriate balance (84 FR 63027). As for the other reweighting scenarios, we plan to revisit our redistribution policies in future rulemaking and may consider redistributing more weight to the cost performance category after clinicians have more experience with cost being weighted at 30 percent. Our proposed redistribution policies for the 2024 MIPS payment year, which we propose to codify at § 414.1380(c)(2)(ii)(F), are included in Table 46.</P>
                    <GPH SPAN="3" DEEP="228">
                        <PRTPAGE P="50315"/>
                        <GID>EP17AU20.080</GID>
                    </GPH>
                    <HD SOURCE="HD3">e. MIPS Payment Adjustments</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>For our previously established policies regarding the final score hierarchy used to determine MIPS payment adjustments, we refer readers to the CY 2020 PFS final rule (84 FR 63031 through 63045), CY 2019 PFS final rule (83 FR 59878 through 59894), CY 2018 Quality Payment Program final rule (82 FR 53785 through 53799) and CY 2017 Quality Payment Program final rule (81 FR 77329 through 77343). We are proposing to modify these policies: (1) To reflect the discontinuation of the APM scoring standard and the addition of the APM Performance Pathway (APP), both as proposed in section IV.A.2.b.(5) of this proposed rule; (2) to set the performance threshold at 50 points for the 2023 MIPS payment year, instead of 60 points as previously finalized; and (3) to potentially revisit and revise the prior estimate of the performance threshold for the 2024 MIPS payment year.</P>
                    <HD SOURCE="HD3">(2) Final Score Hierarchy Used in Payment Adjustment Calculation</HD>
                    <P>In some cases, a TIN/NPI could have more than one final score associated with it from a performance period, if the MIPS eligible clinician submitted multiple data sets. In the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787), we established the following final score hierarchy that applies as displayed in Table 47 when more than one final score is associated with a TIN/NPI.</P>
                    <GPH SPAN="3" DEEP="199">
                        <GID>EP17AU20.081</GID>
                    </GPH>
                    <P>
                        With the proposed discontinuation of the APM scoring standard and addition of the APP in section IV.A.2.b.(5) of this proposed rule, we are proposing to modify the existing final score hierarchy beginning with the 2021 performance period/2023 MIPS payment year. In the CY 2018 Quality Payment Program final rule (82 FR 53785 through 53787), we finalized prioritizing the APM Entity final score over any other score for a TIN/NPI by using the waiver authority for Innovation Center models under section 1115A(d)(1) of the Act and the Shared Savings Program waiver authority under section 1899(f) of the Act to waive section 1848(q)(5)(I)(i)(I) and (II) of the Act so that we could use 
                        <PRTPAGE P="50316"/>
                        the APM Entity final score instead of the virtual group final score for a TIN/NPI. This hierarchy was intended to incentivize APM participation; however, we are proposing to terminate the APM scoring standard in section IV.A.2.b.(5) of this proposed rule, and while we believe it is important to still encourage movement to APMs, we do not believe that prioritizing an APM Entity score over other reported MIPS data would necessarily further our goal of increasing APM participation. The proposed modifications to the final score hierarchy would include MIPS eligible clinicians who are reporting through the APP, which is designed to provide a predictable and consistent MIPS reporting standard to reduce reporting burden and encourage continued APM participation. MIPS eligible clinicians who are already participating in APMs, and therefore, have different reporting obligations than MIPS eligible clinicians who have not already taken that step, can opt to report through the APP and receive an APP final score that may be used in the MIPS payment adjustment calculation. Beginning with the 2021 performance period/2023 MIPS payment year, if a TIN/NPI has a virtual group final score associated with it, we propose to use the virtual group final score to determine the MIPS payment adjustment. If a TIN/NPI does not have a virtual group final score associated with it, we propose to use the highest available final score associated with the TIN/NPI to determine the MIPS payment adjustment. This proposal is consistent with section 1848(q)(5)(I)(i) of the Act, which requires us to prioritize a virtual group final score over other final scores such as individual and group scores (82 FR 53786). We believe that using the highest final score available regardless of how the clinician chose to submit data to MIPS would benefit all MIPS eligible clinicians. For example, we have noticed some instances where prioritizing the APM Entity final score over other final scores has resulted in some clinicians not receiving the highest final score associated with their TIN/NPI, which may have the unintended consequence of moving clinicians away from APM participation. As we seek to move more clinicians into APMs, we believe using their highest score regardless of participation method would benefit all MIPS eligible clinicians. With the establishment of MVPs, we intend to revisit policies regarding the final score hierarchy used for payment adjustment determinations in future rulemaking.
                    </P>
                    <P>Table 48 illustrates the proposed modified final score hierarchy.</P>
                    <GPH SPAN="3" DEEP="119">
                        <GID>EP17AU20.082</GID>
                    </GPH>
                    <HD SOURCE="HD3">(3) Establishing the Performance Threshold</HD>
                    <P>Under section 1848(q)(6)(D)(i) of the Act, for each year of MIPS, the Secretary shall compute a performance threshold with respect to which the final scores of MIPS eligible clinicians are compared for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act for a year. The performance threshold for a year must be either the mean or median (as selected by the Secretary, and which may be reassessed every 3 years) of the final scores for all MIPS eligible clinicians for a prior period specified by the Secretary.</P>
                    <P>Section 1848(q)(6)(D)(iii) of the Act includes a special rule for the initial 2 years of MIPS, which requires the Secretary, prior to the performance period for such years, to establish a performance threshold for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act and an additional performance threshold for purposes of determining the additional MIPS payment adjustment factors under section 1848(q)(6)(C) of the Act, each of which shall be based on a period prior to the performance period and take into account data available for performance on measures and activities that may be used under the performance categories and other factors determined appropriate by the Secretary. Section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 amended section 1848(q)(6)(D)(iii) of the Act to extend the special rule to apply for the initial 5 years of MIPS instead of only the initial 2 years of MIPS.</P>
                    <P>In addition, section 51003(a)(1)(D) of the Bipartisan Budget Act of 2018 added a new clause (iv) to section 1848(q)(6)(D) of the Act, which includes an additional special rule for the third, fourth, and fifth years of MIPS (the 2021 through 2023 MIPS payment years). This additional special rule provides, for purposes of determining the MIPS payment adjustment factors under section 1848(q)(6)(A) of the Act, in addition to the requirements specified in section 1848(q)(6)(D)(iii) of the Act, the Secretary shall increase the performance threshold for each of the third, fourth, and fifth years to ensure a gradual and incremental transition to the performance threshold described in section 1848(q)(6)(D)(i) of the Act (as estimated by the Secretary) with respect to the sixth year (the 2024 MIPS payment year) to which the MIPS applies.</P>
                    <P>In the CY 2020 PFS final rule (84 FR 63031 through 63037) at § 414.1405(b)(7) and § 414.1405(b)(8), we finalized the performance thresholds for the 2022 and 2023 MIPS payment years at 45 and 60 points, respectively, an increase of 15 points each year until the 2024 MIPS payment year, where we estimated the performance threshold would be 74.01 points (based on actual year 1 performance data and estimates for the third and fourth years) as depicted in Table 49. However, we also stated that we may revisit the performance threshold for the 2023 MIPS payment year in future rulemaking, if we receive additional data that changes our estimate of the performance threshold for the 2024 MIPS payment year.</P>
                    <GPH SPAN="3" DEEP="129">
                        <PRTPAGE P="50317"/>
                        <GID>EP17AU20.083</GID>
                    </GPH>
                    <P>We believe that we should reexamine the performance threshold for year 5 (2021 performance period/2023 MIPS payment year) due to the disruptions caused by the COVID-19 Public Health Emergency (PHE). We anticipate some clinicians not having sufficient measures and activities available to participate for the fourth year (2020 performance period/2022 MIPS payment year) and opting to use flexibilities provided for MIPS participation through the extreme and uncontrollable circumstances and hardship exception policies. Furthermore, in considering the effect of the PHE on clinicians, we believe that this is enough of a disruption to revisit the performance threshold for year 5, especially for clinicians who are unable to participate in year 4 due to the PHE.</P>
                    <P>Clinicians who are unable to participate in the fourth year of MIPS due to the COVID-19 PHE, would face an abrupt and large increase in the performance threshold if they return to full participation in the fifth year, lacking the opportunity to work to improve performance. We considered a range of performance threshold values for the fifth year, from 50 to 60 points, and believe that a performance threshold above 50 could be challenging for clinicians affected by the PHE, especially those with small practices. Preliminary analysis has shown that when applying a performance threshold of 50 points to the data we received from the 2021 regulatory impact analysis described in section VIII.F.16. of this proposed rule, around 31,376 TIN/NPIs (or 5.6 percent of MIPS eligible clinicians) would have payments adjustments that go from negative to positive with a performance threshold of 50 points compared to 60 points. For example, analysis shows with the previously finalized performance threshold of 60 points, 24.4 percent of engaged small practices would receive a negative payment adjustment, whereas with a performance threshold of 50 points, 18.8 percent of engaged small practices would receive a negative payment adjustment. In analyzing the range of performance threshold values and the impact on high performers (analysis detailed in section VIII.F.16.b. of this proposed rule), we saw that in setting the performance threshold at 50 points, the maximum payment adjustment is 6.89 percent whereas when setting the performance threshold at 60 points, the maximum payment adjustment is 7.36 percent, a decrease in percentage by 0.47. To continue to incentivize high performers, we are not revisiting the additional performance threshold, which is set at 85 points for year 5. We are proposing to set the performance threshold at 50 points for the 2023 MIPS payment year, instead of 60 points as previously finalized at § 414.1405(b)(8). The performance threshold would remain at 30 points in the third year, increase to 45 points in the fourth year, and increase to 50 points in the fifth year. The increase between the third and fifth year would total 20 points. Additionally, and as discussed in more detail below in our discussion of revising the prior estimate of the performance threshold for the 2024 MIPS payment year, we are open to considering alternatives for the performance threshold for the 2023 MIPS payment year. We request comments on the proposed performance threshold of 50 points, the range of values we considered, and any alternatives that commenters believe we should consider for the performance threshold for the 2023 MIPS payment year.</P>
                    <P>Table 50 depicts the performance threshold for the 2019 MIPS payment year through 2024 MIPS payment year, including the potential change to the performance threshold for the fifth year.</P>
                    <GPH SPAN="3" DEEP="245">
                        <PRTPAGE P="50318"/>
                        <GID>EP17AU20.084</GID>
                    </GPH>
                    <P>At the time of publication of this proposed rule, we do not have actual performance scores and other data for year 3 (2019 performance period/2021 MIPS payment year). In the event this information becomes available with sufficient time to inform our policy decisions for the final rule, we propose to revisit and potentially revise in the final rule our prior estimate of 74.01 points for the performance threshold for the 2024 MIPS payment year.  We anticipate that the actual performance scores for the 2019 performance period/2021 MIPS payment year may be different than the estimates that we published in our regulatory impact analysis estimate (84 FR 63033) because the COVID-19 PHE occurred during the data submission period. We also expect that the 2019 performance period data may be unusual due to the PHE occurring during the submission period. We request comments on our proposal to revisit and potentially revise our prior estimate of the performance threshold for year 6. In particular, we seek comment on what indicators (for example, if the distribution of scores is skewed due to the PHE), if any, should be used to evaluate whether or not the 2019 performance period data are appropriate to use to revise our prior estimate.</P>
                    <P>Lastly, in the event that we decide to revise our prior estimate of the performance threshold for the 2024 MIPS payment year (either higher or lower) in the final rule, we propose to consider the revised estimate when we decide on an appropriate numerical value for the performance threshold for the 2023 MIPS payment year. As an example, if we believe that the estimate for the 2024 MIPS payment year performance threshold should be higher than 74.01 (say 80 or 85 points), then we anticipate the performance threshold for the 2023 MIPS payment year would be higher than 50 (likely 55 points, 60 points) to reflect the change in the estimate. We seek to ensure a gradual and incremental transition to the estimated performance threshold for the 2024 MIPS payment year, and thus, we believe that we should take into account the revised estimate when determining the performance threshold for the 2023 MIPS payment year. We request comments on our proposal to consider the revised estimate for the 2024 MIPS payment year when we select a performance threshold for the 2023 MIPS payment year.</P>
                    <HD SOURCE="HD3">(4) Example of Adjustment Factors</HD>
                    <P>Figure A provides an illustrative example of how various final scores would be converted to a MIPS payment adjustment factor and potentially an additional MIPS payment adjustment factor, using the statutory formula and based on our proposed policies for the 2023 MIPS payment year. In Figure A, the performance threshold is set at 50 points. The applicable percentage is 9 percent for the 2023 MIPS payment year. The MIPS payment adjustment factor is determined on a linear sliding scale from zero to 100, with zero being the lowest possible score which receives the negative applicable percentage (negative 9 percent for the 2023 MIPS payment year) and resulting in the lowest payment adjustment, and 100 being the highest possible score which receives the highest positive applicable percentage and resulting in the highest payment adjustment. However, there are two modifications to this linear sliding scale. First there is an exception for a final score between zero and one-fourth of the performance threshold (zero and 12.5 points based on the proposed performance threshold of 50 points for the 2023 MIPS payment year). All MIPS eligible clinicians with a final score in this range would receive the lowest negative applicable percentage (negative 9 percent for the 2023 MIPS payment year). Second, the linear sliding scale line for the positive MIPS payment adjustment factor is adjusted by the scaling factor, which cannot be higher than 3.0.</P>
                    <P>If the scaling factor is greater than zero and less than or equal to 1.0, then the MIPS payment adjustment factor for a final score of 100 would be less than or equal to 9 percent. If the scaling factor is above 1.0 but is less than or equal to 3.0, then the MIPS payment adjustment factor for a final score of 100 would be greater than 9 percent.</P>
                    <P>
                        Only those MIPS eligible clinicians with a final score equal to 50 points (which is the proposed performance threshold) would receive a neutral MIPS payment adjustment. Because the performance threshold is 50 points, we anticipate that more clinicians will receive a positive adjustment than a negative adjustment and that the scaling factor would be less than 1 and the MIPS payment adjustment factor for each MIPS eligible clinician with a final 
                        <PRTPAGE P="50319"/>
                        score of 100 points would be less than 9 percent. 
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="449">
                        <GID>EP17AU20.000</GID>
                    </GPH>
                    <P>Table 51 illustrates the changes in payment adjustment based on the final policies from the CY 2020 PFS final rule (84 FR 63031 through 63045) for the 2022 and 2023 MIPS payment year and the changes potentially modifying the performance threshold for the 2023 MIPS payment year discussed in this proposed rule, as well as the applicable percent required by section 1848(q)(6)(B) of the Act.</P>
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                    </GPH>
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                        <GID>EP17AU20.086</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">f. Review and Correction of MIPS Final Score</HD>
                    <HD SOURCE="HD3">(1) Feedback and Information To Improve Performance</HD>
                    <P>Under section 1848(q)(12)(A)(i) of the Act, we are at a minimum required to provide MIPS eligible clinicians with timely (such as quarterly) confidential feedback on their performance under the quality and cost performance categories beginning July 1, 2017, and we have discretion to provide such feedback regarding the improvement activities and Promoting Interoperability performance categories. In the CY 2018 Quality Payment Program final rule (82 FR 53799 through 53801), we finalized that on an annual basis, beginning July 1, 2018, performance feedback will be provided to MIPS eligible clinicians and groups for the quality and cost performance categories, and if technically feasible, for the improvement activities and advancing care information (now called the Promoting Interoperability) performance categories.</P>
                    <P>
                        On July 1, 2018, we provided the first performance feedback for the Quality Payment Program. The second performance feedback was provided on July 1, 2019. However, for this year due to the Public Health Emergency (PHE) and COVID-19, we wish to inform stakeholders that we may provide performance feedback after July 1, 2020 (that is, performance feedback based on data submitted for the performance period in 2019). Although we aim to provide performance feedback on or around July 1 of each year, it is possible that the release date could be later than July 1 depending on the circumstances. At this time, we estimate that we will provide performance feedback in late July or early August, although this timeframe may be subject to change. Please refer to 
                        <E T="03">qpp.cms.gov</E>
                         for more information.
                    </P>
                    <HD SOURCE="HD3">g. Third Party Intermediaries</HD>
                    <P>We refer readers to §§ 414.1305 and 414.1400, the CY 2017 Quality Payment Program final rule (81 FR 77362 through 77390), the CY 2018 Quality Payment Program final rule (82 FR 53806 through 53819), the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS final rule (84 FR 63049 through 63080), and the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595) for our previously established policies regarding third party intermediaries.</P>
                    <P>In this proposed rule, we propose to make several changes to requirements for (1) third party intermediaries generally, (2) QCDRs, (3) qualified registries, and (4) remedial action.</P>
                    <HD SOURCE="HD3">(1) Generally</HD>
                    <HD SOURCE="HD3">(a) Requirements for MIPS Performance Categories That Must Be Supported by Third Party Intermediaries</HD>
                    <P>We refer readers to § 414.1400(a)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364) and as further revised in the CY 2019 PFS final rule (83 FR 60088) and CY 2020 PFS final rule (84 FR 63049 through 63052) at § 414.1400(a)(2) for our current policy regarding the types of MIPS data third party intermediaries may submit. Through this proposed rule, we intend on clarifying our requirements of QCDRs, qualified registries, and health IT vendors with regards to submitting data for purposes of the MIPS program through revisions to our regulation codified at § 414.1400(a)(2), particularly for those third party intermediaries who are interested in supporting MVPs in the future. Therefore we propose to revise § 414.1400(a)(2) as follows:</P>
                    <P>Except as provided under § 414.1400(a)(2)(ii), QCDRs, qualified registries, and health IT vendors must be able to submit data for all of the following MIPS performance categories:</P>
                    <P>• Quality, except:</P>
                    <P>++ The CAHPS for MIPS survey; and</P>
                    <P>
                        ++ For qualified registries and health IT vendors, QCDR measures;
                        <PRTPAGE P="50322"/>
                    </P>
                    <P>• Improvement activities; and</P>
                    <P>• Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT; however, a third party intermediary may be excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)(4) or (5) or § 414.1380(c)(2)(i)(C)(1) through (7) or § 414.1380(c)(2)(i)(C)(9).</P>
                    <FP>Health IT vendors that do not support MVPs, must be able to submit data for at least one of the MIPS performance categories described above. We request comments on these proposals.</FP>
                    <HD SOURCE="HD3">(i) Reporting MVPs Through Third Party Intermediaries</HD>
                    <P>We refer readers to section IV.A.3.a. of this proposed rule where we discuss reporting MVPs through third party intermediaries and our proposal that QCDRs, qualified registries, and health IT vendors who support the Quality, Promoting Interoperability, and Improvement Activities performance categories may also support the reporting of MVPs.</P>
                    <HD SOURCE="HD3">(ii) Reporting APM Performance Pathway (APP) Through Third Party Intermediaries</HD>
                    <P>We refer readers to section IV.A.3.b. of this proposed rule where we discuss beginning with the CY MIPS 2023 payment year, MIPS eligible clinicians scored under the APP would be scored on the quality measure set finalized for that MIPS performance period. Three quality measures (Quality ID# 001: Diabetes: Hemoglobin A1c (HbA1c) Poor Control (&gt;9%), Quality ID#: 134: Preventive Care and Screening: Screening for Depression and Follow-Up Plan, and Quality ID# 236: Controlling High Blood Pressure) are proposed to be reported using the MIPS CQM and eCQM collection types.</P>
                    <HD SOURCE="HD3">(b) Approval Criteria for Third Party Intermediaries</HD>
                    <HD SOURCE="HD3">(i) Background</HD>
                    <P>We refer readers to § 414.1400(a)(4), the CY 2019 PFS final rule (83 FR 59894 through 59895, 60088), the CY 2020 PFS final rule (84 FR 63052 through 63053), and the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595) for previously finalized policies related to the approval criteria for third party intermediaries.</P>
                    <HD SOURCE="HD3">(ii) Proposed New Approval Considerations—Past Performance and Conduct</HD>
                    <P>During past years of the MIPS program we have encountered third party intermediaries failing to meet program requirements and engaging in other conduct that could harm the integrity of the MIPS program. Some examples of third party intermediaries failing to meet program requirements include, but are not limited to: Failing to meet requirements to submit data for a performance category; failing to provide services throughout the entire performance period and applicable data submission period; and providing data that is not true, accurate, or complete. Additionally, we have also encountered third party intermediaries who have provided inaccurate information to the clinicians and groups they support regarding the obligation to submit data to CMS that are true, accurate and complete. For example, we are aware of third party intermediaries offering services and tools to eligible clinicians that encourage the selection of misrepresentative data, commonly referred to as “cherry-picking,” to maximize scores.</P>
                    <P>In preparation for future years of the program, we believe it is important to disapprove third party intermediaries that have demonstrated their failure to comply with program requirements or have provided inaccurate information regarding MIPS program requirements to clinicians. We are concerned with the potential adverse program effect of this conduct, such as delayed and erratic reporting if third party intermediaries fail to support MIPS reporting for the entire performance period and reporting period, and the possibility of inaccurate data submissions. As a result, we believe it is important to consider these factors when making determination regarding whether to approve a third party intermediary for future participation in the MIPS program.</P>
                    <P>Therefore, we are proposing to amend the current § 414.1400(a)(4) to propose a new paragraph at § 414.1400(a)(4)(ii):</P>
                    <P>The determination of whether to approve an entity as a third party intermediary for a MIPS performance period may take into account: (1) Whether the entity failed to comply with the requirements of this section for any prior MIPS payment year for which it was approved as third party intermediary; and (2) whether the entity provided inaccurate information regarding the requirements of this subpart to any eligible clinician. We intend on utilizing all available information to make these approval determinations, including without limitation, information collected through compliance audits under our existing audit authority as described in § 414.1400(g). Third party intermediaries may be selected during the performance period to be audited for a given requirement. As a part of our outreach to a selected third party intermediary, we intend on providing additional direction with regards to the timeline and information needed for the audit. The results of the audit will be reviewed to inform future approval of a third party intermediary, and if remedial action is warranted, we will utilize our existing authority as described in § 414.1400(f). We believe use of this information in approval determinations will help reduce the risk of third party intermediaries that are unreliable, thereby avoiding a possible increase in burden to clinicians who may inadvertently select an unreliable third party intermediary for purposes of reporting for the MIPS program. We request comments on our proposals; specifically, we request comments on whether there are other factors that should inform our considerations when approving third party intermediaries.</P>
                    <HD SOURCE="HD3">(iii) Third Party Intermediary Training and Support</HD>
                    <P>In the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77374) and (81 FR 77384 through 77386), we established our expectation that QCDRs and qualified registries perform certain functions related to data submission. One of those expectations is participation in ongoing support conference calls hosted by CMS (approximately one call per month) and an in-person kick-off meeting (if held) at our headquarters in Baltimore, MD. (81 FR 77368) and (81 FR 77384). The purpose of these meetings is to provide approved QCDRs program updates from subject matter experts who work across the Quality Payment Program. At these meetings, CMS subject matter experts and our contractors provide approved QCDRs and qualified registries with updates, answer questions, and provide technological demonstrations. In light of the PHE for the COVID-19 pandemic and consistent with the goal of infection control, we have reevaluated our expectations and have decided to adopt a policy allowing for flexibility moving forward. With the health and safety of our stakeholders in mind, we believe virtual meetings would be sufficient when in-person meetings are not possible.</P>
                    <P>
                        In the CY 2017 Quality Payment Program final rule (81 FR 77377 through 77382), we stated our expectations for health IT vendors that serve as third party intermediaries by obtaining data from the CEHRT of a MIPS eligible clinician and submitting such data to CMS for participation in MIPS. For further discussion of CEHRT we refer readers to sections III.M.3 and 
                        <PRTPAGE P="50323"/>
                        IV.A.3.g.(1)(iv) of this proposed rule. Because the submission requirements and policies that may be added or modified from year to year have the potential to alter expectations for all third party intermediaries, we believe that mandatory meetings and training calls would also be appropriate for health IT vendors that will serve as third party intermediaries. Hosting training calls for health IT vendors would give us an opportunity to provide a review of requirements, answer questions, and explain updates to the annual submission process and other policies as applicable. Thus, we are proposing for the requirement that third party intermediaries participate in an annual meeting and training calls as deemed necessary by CMS include those third party intermediaries that are health IT vendors. We are soliciting comments on the best method to reach health IT vendors so that we can invite them to required meetings and share additional information. We are considering listserv communications through the QPP listserv but would welcome suggestions for other communication mechanisms.
                    </P>
                    <P>We previously finalized the CMS-approved survey vendor approval criteria in § 414.1400(e) as discussed in the CY 2018 PFS final rule (83 FR 59907 through 59908). Among the approval criteria, § 414.1400(e)(3) established the requirement that the entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors. We continue to believe these previously finalized requirements are of importance to CMS-approved survey vendors, such as CAHPS for MIPS vendors. In addition, because the submission requirements and policies that may be added or modified from year to year have the potential to alter expectations for all third party intermediaries, we believe that the proposed requirement that third parties intermediaries participate in an annual meeting and training calls as deemed necessary by CMS should also be applicable to CMS-approved survey vendors.</P>
                    <P>In summary, we believe making support calls and trainings mandatory for all third-party intermediaries will provide an abundance of value to all approved third party intermediaries themselves, as well as to the MIPS program and the clinicians who rely on third party intermediaries to make complete, accurate, usable and timely data on their behalf. We believe uniformly codifying this language is appropriate to hold all third party intermediaries accountable for the training and support. Therefore, we propose to codify at § 414.1400(a)(4)(iii) that beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS. We affirm that, in addition to the obligations under this proposal, CMS-approved survey vendors must also continue to meet the requirements at § 414.1400(e)(3).</P>
                    <HD SOURCE="HD3">(iv) Future Safeguards for All Third Party Intermediaries</HD>
                    <P>We understand our obligation to ensure the integrity of the MIPS program and we continue to assess opportunities to strengthen program safeguards. Certain safeguards apply to all third party intermediaries, including those described in § 414.1400(a), (f), and (g). As discussed in this proposed rule, we are proposing additional program safeguards in regard to data validation audit and targeted audit requirements that would apply specifically to QCDRs and qualified registries, respectively found in section IV.A.3.g.(2)(a) and section IV.A.3.g.(3) of this proposed rule. These proposals would require QCDRs and qualified registries to conduct validation on data prior to the data being submitted to CMS for purposes of the MIPS program. We have limited these proposals to QCDRs and qualified registries at this time, but as described further below we solicit feedback on expanding these requirements to all third party intermediaries through future rulemaking.</P>
                    <P>The Office of the National Coordinator for Health Information Technology's (ONC) Health IT Certification Program provides for the certification of certain health IT. The requirements for ONC certification are based on standards, implementation specifications, and certification criteria adopted by the Secretary. The Quality Payment Program has adopted a definition of certified electronic health record technology (CEHRT) at § 414.1305.</P>
                    <P>For discussion of proposed revisions to the CEHRT definition adopted for the Quality Payment Program we refer readers to section III.M. of this proposed rule.</P>
                    <P>It is important to note that a health IT vendor which acts as a third party intermediary for purposes of the MIPS program may or may not be the same entity as a health IT developer which certifies health IT products as part of the certification program. While health IT developers may act as third party intermediaries for their customers, other service providers who do not develop health IT products may also assist MIPS eligible clinicians by submitting data obtained from CEHRT on their behalf and thereby function as a health IT vendor for purposes of the MIPS program. Furthermore, the entities that are not health IT developers must only submit data on behalf of eligible clinicians that has already been captured and calculated using the functions of CEHRT. Unlike QCDRs and Qualified Registries, third party intermediaries that are health IT vendors may or may not also possess expertise related to quality improvement and analysis/validation of clinical quality data, and we do not currently require these organizations to attest that they possess these capabilities.</P>
                    <P>We are increasingly aware of data integrity issues that have impacted data submitted by health IT vendors that obtain data from MIPS eligible clinician's CEHRT and serve as a third party intermediaries to submit this data on behalf of MIPS eligible clinicians. We are aware of instances in which health IT vendors have submitted data that are inaccurate and unusable. These data issues may result in improper payments or otherwise undercut the integrity of the MIPS program. In some instances, data issues caused by health IT vendors may have downstream negative impacts to the clinicians whose data the health IT vendor is submitting, such as negative payment adjustments and inaccurate data publically posted on the Physician Compare internet website of the Centers for Medicare &amp; Medicaid Services (or a successor website).</P>
                    <P>
                        Although we are not proposing to add data validation requirements for health IT vendors at this time, we are considering ways to impose such requirements in the future. We are soliciting comment on whether we should impose data validation requirements on health IT vendors as part of the third party intermediary approval process and if so, how the data validation requirements for health IT vendors should differ, if at all, from those proposed for QCDRs and Qualified Registries. We believe that potentially requiring health IT vendors to validate the data they submit to us for purposes of the MIPS program will lead to the submission of data that can be considered more reliable and accurate. Therefore, we seek comment on the future application of such requirements on health IT vendors and if there are factors unique to health IT vendors that should be considered when developing 
                        <PRTPAGE P="50324"/>
                        such a policy. For instance, we are seeking to further understand where data quality issues may arise in data submitted by health IT vendors on behalf of MIPS eligible clinicians. We are also seeking comment on whether health IT vendors currently submitting data on behalf of MIPS eligible clinicians possess the capabilities to engage in the data validation processes we are proposing for QCDRs and Qualified Registries. We are also seeking comment regarding the burden on health IT vendors of adopting the data validation requirements as proposed for QCDRs and qualified registries and whether the imposition of these requirements on health IT vendors would discourage health IT vendors from serving as third party intermediaries. We also would welcome input as to whether alternative requirements for health IT vendors would impose a less burden on these third parties' intermediaries while still ensuring that the data submitted is accurate and complete. Finally, we are interested in how any future data validation processes should impact certification under the ONC Health IT Certification Program for health IT developers who also serve as a health IT vendor third party intermediary for the purposes of MIPS.
                    </P>
                    <P>For CMS-approved survey vendors, such as CAHPS for MIPS vendors, we are also not proposing any new data validation requirements at this time. In the CY 2018 PFS final rule (83 FR 59907 through 59908) we previously finalized requirements at § 414.1400(e) that address the validity of data submitted to CMS for CMS-approved survey vendors. Specifically, we previously finalized at § 414.1400(e)(4) that as a condition of approval the entity must have submitted a quality assurance plan and other materials relevant to survey administration, as determined by CMS, including cover letters, questionnaires and telephone scripts. We believe this previously finalized requirement at § 414.1400(e) is sufficient to address potential concerns about the accuracy of data submitted by survey vendors; however, we solicit feedback on whether the audit requirements in this proposal should be expanded to include survey vendors.</P>
                    <HD SOURCE="HD3">(2) Qualified Clinical Data Registries (QCDRs)</HD>
                    <P>We generally refer readers to section 1848(m)(3)(E) of the Act, as added by section 601(b)(1)(B) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240, enacted January 2, 2013), which requires the Secretary to establish requirements for an entity to be considered a Qualified Clinical Data Registry (QCDR) and a process to determine whether or not an entity meets such requirements. We refer readers to section 1848(m)(3)(E)(i)(v) of the Act, the CY 2019 PFS final rule (83 FR 60088), the CY 2020 PFS final rule (84 FR 63053 through 63058), May 8th COVID-19 IFC-2 (85 FR 27594 through 27595) and § 414.1400(a)(4) through (b) for previously finalized policies about third party intermediaries generally and QCDRs specifically. In this proposed rule, we propose a technical update to § 414.1400(b) title to rename it from “QCDR approval criteria” to “QCDRs”, to better align the title with the content of the regulation. In addition, we are proposing policies related to QCDR: (1) Data validation audits and targeted audits; and (2) measure requirements. These are discussed in detail below.</P>
                    <HD SOURCE="HD3">(a) Data Validation Audit and Targeted Audit Requirements</HD>
                    <P>In the CY 2017 Quality Payment Program final rule, we discussed our expectation that QCDRs and qualified registries would conduct validation on the data they intend on submitting for the MIPS performance period (81 FR 77366 through 77367) and provide the results of the data validation to CMS in the form of a data validation execution report by May 31st of the year following the performance period. Our intention was to establish our expectation that QCDRs would establish a process to assess whether the data are true, accurate, and complete prior to submitting them to CMS for purposes of the MIPS program. We believe it is important to establish a requirement that QCDRs conduct data validation to ensure they are actively monitoring the data they submit to CMS for purposes of a pay-for-performance program. In instances where a QCDR discovers data are inaccurate or incomplete, the entity must correct the issue prior to submitting the data to CMS in order to provide accurate certification in accordance with § 414.1400(a)(5). A QCDR that submits a false certification submits data that is inaccurate, unusable or otherwise compromised to CMS for purposes of the MIPS program may be subject to remedial action or termination under § 414.1400(f). We believe requiring QCDRs to validate the accuracy of the data they are submitting is an important safeguard to promote accurate payments under the MIPS program. Therefore, in this proposed rule, we propose to codify at § 414.1400(b)(2)(iv) and (v) requirements beginning with the 2023 MIPS payment year as condition of approval each QCDR must conduct annual data validation audits and if one or more deficiencies or data errors are identified the QCDR must also conduct targeted audits. We also propose specific obligations for those audits as discussed below.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(A), that the QCDR must conduct data validation for the payment year prior to submitting any data for that payment year to CMS for purposes of the MIPS program. We believe it is important for QCDRs to conduct validation audits to identify and fix concerns regarding data accuracy prior to submitting data to us, including potential issues related to data aggregation and calculation. Conducting the data validation prior to data submission will lead to data being more reliable and promote compliance with the requirement of data being true, accurate, and complete. In the CY 2017 Quality Payment Program final rule, we described this auditing using the term randomized audit (81 FR 77366). In this proposed rule, we are proposing instead to refer to this audit as the data validation audit in an effort to be abundantly clear regarding our expectations that the QCDR will purposefully construct a sample and conduct an audit that complies with specific regulatory requirements and also to distinguish these audits from the targeted audits discussed below and proposed at § 414.1400(b)(2)(v).</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(B), the QCDR must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories. We believe that it is important that data validation be done across all performance categories for which the QCDR submits data since QCDRs must attest that data submitted to CMS is true, accurate, and complete and data for each of these performance categories can influence score calculation and payment adjustments.</P>
                    <P>
                        • We propose to codify at § 414.1400(b)(2)(iv)(C), that the QCDR must conduct data validation on data for each submitter type for which it will submit data, including if applicable MIPS eligible clinicians, groups, virtual groups, voluntary participants, and opt-in participants. We believe it is important for the data submitted to CMS be accurate for all clinicians and groups for which the QCDR intends on submitting data to the MIPS program, regardless of whether they are required to participate, have opted in, or have chosen to voluntarily participate. Therefore, we propose to require that 
                        <PRTPAGE P="50325"/>
                        the data validation audits should account for all types of submitters that are utilizing the QCDR to submit data to CMS for purposes of the MIPS program. We note the importance of validating data for all submitter types regardless of its use for payment or public reporting. Even clinicians who voluntarily report to MIPS and whose data are not used for payment purposes could have their data publically posted on the Physician Compare website. We believe all data the QCDR submits, regardless of its use for payment or public reporting, should be true, accurate, and complete.
                    </P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(D) that the QCDR must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed. If the data a QCDR intends to submit to CMS for purposes with the MIPS program are to demonstrate that a clinician did a particular clinical activity or achieved a particular clinical outcome, we believe meaningful validation of such data requires the QCDR to use clinical documentation to confirm that the activity occurred or was performed.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(E) that the QCDR shall conduct each data validation audit using a sampling methodology that meets the following requirements:</P>
                    <P>++ Uses a sample size of at least 3 percent of the TIN/NPIs for which the QCDR will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the QCDR must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the QCDR may use a sample size of 50 TIN/NPIs.</P>
                    <P>++ Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients.</P>
                    <P>We believe the aforementioned sampling methodology is appropriate for multiple reasons. First, the sampling methodology criteria are consistent with the methodology established under the legacy Physician Quality Reporting System (PQRS) program and as described in the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367). As this methodology has been used for many years under the legacy program, we believe stakeholders are well versed in executing data validation audits using this sampling methodology. Second, the proposed methodology accounts for QCDRs and qualified registries of varying sizes. Data validation requires a level of effort on the part of the QCDR to execute a data validation plan, identify a sample, and collect information for purposes of chart review; therefore, we are cognizant that requiring a larger sample size would create additional burden on QCDRs and clinicians to account for a larger volume in TIN/NPIs and medical records for review.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(F) that each QCDR data validation audit must include the following:</P>
                    <P>++ Verification of the eligibility status of each eligible clinician, group, virtual group, opt-in participant, and voluntary participant. We believe that it is important for the QCDR to track the eligibility status of each clinician and group that wishes to use a third party intermediary to report, because accurate information regarding eligibility is important to ensuring payment adjustments are properly applied. Furthermore, verification of eligibility status is consistent with the requirement for QCDRs to track opt-in participants, as described at § 414.1400(a)(4)(iv) and in the context of clinicians who voluntarily report to MIPS helps ensure the accuracy of data publically posted on the Physician Compare internet website of the Centers for Medicare &amp; Medicaid Services (or a successor website).</P>
                    <P>++ Verification of the accuracy of Tax Identification Numbers (TINs) or National Provider Identifiers (NPIs). Correct TINs and NPIs are critical to ensure data submitted by the QCDR are attributed to the correct clinicians and groups. Inaccurate NPIs or TINs may lead to inadvertent downstream impacts to the way clinicians and groups are scored, and assigned a payment adjustment.</P>
                    <P>++ Calculation of reporting and performance rates (for example, formulas included in the quality measure specifications). QCDRs must follow the measure specifications when calculating reporting and performance rates. Calculations that deviate the formulas included in the quality measure specifications undercut efforts to ensure data are consistent, reliable, and have been calculated in a uniform manner.</P>
                    <P>++ Verification that only MIPS quality measures and QCDR measures that are relevant to the performance period will be utilized for MIPS submission. Measure specifications for the MIPS quality measures and QCDR measures go through maintenance on an annual basis. Use of outdated measure specifications would likely result in the QCDR submitting inaccurate or compromised data for the clinicians and groups they support. While not all measures go through substantive changes on an annual basis, there are changes to codes that do occur annually that should be accounted for when programing measures. Therefore, we believe it is important that QCDRs are utilizing the most current version of the measure specification, relevant to the performance period in which they are participating.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(iv)(G), that in a form and manner and by a deadline specified by CMS, the QCDR must report the results of each data validation audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or data error, and how and when each deficiency or data error type was corrected. We believe it is important that the results of the data validation be shared with us in order for us to understand the types of issues the QCDRs have encountered and what resolutions were executed to fix the issues. The information provided will help us track frequently occurring issues which may be identified as an area to provide further education. It is our belief that the report will be largely comprised of issues that were identified and resolved. However, if an issue has been identified and could not be resolved, we would want to understand what the issue is and why it could not be resolved. We emphasize that all data submitted to CMS by a QCDR on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge as described in § 414.1400(a)(5). If a QCDR submits a false certification or data that are data that are inaccurate, unusable, or otherwise compromised, the QCDR may be subject to remedial action or termination as described at § 414.1400(f).</P>
                    <P>
                        • We propose to codify at § 414.1400(b)(2)(v)(A), that if a data validation audit under § 414.1400(b)(2)(iv) identifies one or more deficiency or data error, the QCDR must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. We believe targeted audits are important to further evaluate the impact of deficiencies or data errors to the cohort of clinicians and groups that the QCDR intends to submit data for, and for QCDRs to determine the 
                        <PRTPAGE P="50326"/>
                        reason the deficiency or data error occurred.
                    </P>
                    <P>• We propose to codify at § 414.1400(b)(2)(v)(B), that the QCDR must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year. To promote the accuracy of the data submitted to the MIPS program for the payment year and to reduce the risk that the agency initiates payment calculations in reliance on inaccurate data, it is important for the QCDR to conduct required targeted audits and correct any deficiencies and data errors identified through those audits prior to submitting the data to CMS.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(v)(C), the QCDR must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (b)(2)(iv)(E). The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified.</P>
                    <P>We believe the sampling methodology we are proposing for data validation audits is equally appropriate for the conduct of targeted audits. We believe that adopting the same methodology for both audit types would be less burdensome on QCDRs than requiring these entities to apply a separate sampling methodology for their targeted audits. Provided that data in the sample for the targeted audit does not overlap with the data that was reviewed in the data validation audit, we believe the targeted audit would provide the QCDR with a reasonable perspective into impact and root cause of deficiencies and data errors across the data to be submitted without imposing the burden that would result from maintaining a separate sampling methodology for targeted audits.</P>
                    <P>• We propose to codify at § 414.1400(b)(2)(v)(D), in a form and manner and by a deadline specified by CMS, the QCDR must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected. As is the case with the results of data validation audits, we believe it is important that the results of the targeted audits be shared with us in order for us to understand the types of issues the QCDRs have encountered and what resolutions were executed to fix the issues. The information provided will help us track frequently occurring issues which may be identified as an area to provide further education.</P>
                    <P>We request comments on the aforementioned proposals, including whether stakeholders are concerned with implementing these policies for the 2023 MIPS payment year, and if so, what barriers do they believe they would face in implementing these requirements.</P>
                    <HD SOURCE="HD3">(b) QCDR Measures</HD>
                    <P>We refer readers to § 414.1400(b), the CY 2017 Quality Payment Program final rule (81 FR 77374 through 77375), the CY 2018 Quality Payment Program final rule (82 FR 53813 through 53814), the CY 2019 PFS final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 FR 63058 through 63074), and the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595) for where we previously finalized standards and criteria for QCDR measures. In this proposed rule, we are proposing modifications to previously finalized QCDR measure requirements. While we understand the level of time and work needed to meet these requirements, we would not be grandfathering in previously approved QCDR measures.</P>
                    <HD SOURCE="HD3">(i) QCDR Measure Considerations and Requirements for Approval or Rejection</HD>
                    <P>We refer readers to § 414.1400(b)(3), the CY 2020 PFS final rule (84 FR 63059 through 63073) for our previously finalized policies related to the QCDR measure considerations and requirements for approval or rejection. Through education and outreach, we have heard stakeholders' concerns about the complexity of reporting when there is a large inventory of QCDR measures to choose from, and believe our proposals in this proposed rule will help to refocus measures to those most meaningful to a clinician's scope of practice.</P>
                    <P>In this proposed rule, we are proposing to modify a few QCDR measure requirements: Measures in MVPs; measure testing; duplicative QCDR measures; and collection of data. These proposals are discussed in detail below.</P>
                    <HD SOURCE="HD3">(A) QCDR Measures in MVPs</HD>
                    <P>We refer readers to section IV.A.3.a. of this proposed rule, where we discuss the inclusion of QCDR measures in MVPs, at CMS discretion, beginning with the 2024 MIPS payment year. While we acknowledge and appreciate the level of innovation that QCDRs have put forward as they have developed and implemented QCDR measures, we note the differences between the QCDR measures utilized in the existing MIPS reporting method versus that of MVP reporting. In the current MIPS program, clinicians and groups may select to report on measures from a large library of what is available through the MIPS quality measure inventory and that of the QCDR measures available, if they choose to report through a QCDR. In our gradual transition to MVPs, we move to subsets of measures and activities, where clinicians may have a more focused selection of items to report on.</P>
                    <P>For that reason, it is important that the measures included in an MVP are reliable, feasible, and valid as to not inadvertently cause a clinician or group an issue with submission, calculation, and scoring of a given measure. We refer readers to our discussion below about measure testing requirements for QCDR measures in MVPs.</P>
                    <HD SOURCE="HD3">(B) Measure Testing Requirements</HD>
                    <P>
                        In the CMS Blueprint,
                        <SU>106</SU>
                        <FTREF/>
                         measure testing enables a measure developer to assess the suitability of the quality measure's technical specifications and acquire empirical evidence to help assess the strengths and weaknesses of a measure with respect to the NQF Measure Evaluation Criteria and Guidance for Evaluating Measures for Endorsement. Information gathered through measure testing is part of full measure development, and this information can be used in conjunction with expert judgment to evaluate a measure. For Blueprint purposes, measure testing refers to testing quality measures, including the components of the quality measures, such as the data elements, the instruments, and the performance score.
                    </P>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             
                            <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        We refer readers to the CY 2019 PFS final rule, where we gave notice to the public that we were considering proposing to require reliability and feasibility testing as an added criterion for a QCDR measure to be considered for MIPS in future rulemaking (83 FR 59901 through 59902). After consideration of the previous public comments received, and our priority to ensure that all measures available in MIPS are reliable and valid thereby reducing reporting burden on eligible clinicians and groups, we finalized a requirement to require all QCDR measures to be fully developed and tested, with complete testing results at the clinician level, beginning with the CY 2023 payment year in the CY 2020 PFS final rule (84 FR 40816). Subsequently, due to the 
                        <PRTPAGE P="50327"/>
                        PHE for the COVID-19 pandemic, we delayed this requirement by 1 year in the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595). In the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595), we finalized at § 414.1400(b)(3)(v)(C) beginning with the CY 2024 MIPS payment year, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination. However, based on subsequent stakeholder feedback on the level of burden, the limited amount of time, and costs associated with measure testing after the CY 2020 PFS final rule published, we are proposing to both further modify our QCDR measure testing policy generally and add testing policies for QCDR measures that are being considered for inclusion in MVPs.
                    </P>
                    <P>We continue to believe that reliable, valid measures with robust testing with empirical data should be used in quality evaluation and payment programs. However, we want to balance those interests with stakeholders' concerns. Therefore, we propose a gradual approach to have fully tested QCDR measures within the MIPS program. We want to emphasize that we still believe that all QCDR measures should be fully tested, particularly as we rely on the data from these measures to score clinicians which impact their final score and associated MIPS payment adjustments, and as we seek to utilize QCDR measures in MVPs, as described in section IV.A.3.a and below of this proposed rule. We propose at § 414.1400(b)(3)(v)(C)(1) that, generally, to be approved for the 2024 MIPS payment year, a QCDR measure must be face valid. To be approved for the 2025 MIPS payment year and future years, a QCDR measure must be face valid for the initial MIPS payment year for which it is approved and fully tested for any subsequent MIPS payment year for which it is approved. Therefore, we propose to revise § 414.1400(b)(3)(v)(C) to account for an incremental approach to require fully tested QCDR measures. We discuss requirements for QCDR measures considered for inclusion in an MVP separately. This is discussed in more detail below.</P>
                    <HD SOURCE="HD3">(i) Proposed Requirements for Existing Measures</HD>
                    <P>
                        We propose that QCDR measures that were previously approved for the CY 2022 MIPS payment year, would be required to, at a minimum, be face valid prior to being self-nominated for the CY 2024 MIPS payment year. Face validity is defined in the CMS Measures Blueprint 
                        <SU>107</SU>
                        <FTREF/>
                         as the following: The extent to which a test appears to cover the concept it purports to measure “at face value.” It is a subjective assessment by experts of whether the measure reflects the quality of care (for example, the utilization of a current clinical guideline to frame the measure, such as using the blood pressure guideline of &lt;140/90 is a marker of quality).
                    </P>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             
                            <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.</E>
                        </P>
                    </FTNT>
                    <P>In addition, we propose that these measures, which were approved for the preceding MIPS performance year with face validity (that is, CY 2024 MIPS payment year), would be required to be fully tested prior to being self-nominated for any subsequent performance periods (that is, CY 2025 MIPS payment year and beyond) in order to be considered for inclusion in the MIPS program.</P>
                    <P>
                        In the CY 2019 PFS final rule, we referred readers to the CMS Blueprint for the CMS Measures Management System (available at 
                        <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf</E>
                        ) for a definition of “fully developed with completed testing results at the clinician level” (84 FR 40817). Our Blueprint discusses both alpha and beta testing (Blueprint 15.0 September 2019 Page 207-208). To avoid any potential confusion, we are clarifying in this proposed rule that for purposes of QCDR measures, we would expect QCDR measures to complete beta testing to be considered fully tested. Beta testing is defined in the CMS Measures Blueprint 
                        <SU>108</SU>
                        <FTREF/>
                         as the following: Beta testing (that is, field testing) generally occurs after initial technical specifications have been developed and is usually larger in scope than alpha testing. In addition to gathering further information about feasibility, beta tests serve as the primary means to assess scientific acceptability and usability of a measure. For example, beta testing allows for an enhanced evaluation of a measure's importance, including evaluation of performance thresholds, disparities analysis, and outcome variation. It helps in looking for opportunities for improvement in the population, which aids in measuring the QCDR measure's importance for reasons that include evidence collection to measure variability among comparison groups, to demonstrate the measure is not topped-out where most groups achieve similarly high performance levels approaching the measure's maximum possible value. We refer readers to the CMS Blueprint for the CMS Measures Management System at 
                        <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf</E>
                         for additional details regarding beta testing.
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             
                            <E T="03">https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Blueprint.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(ii) Proposed Requirements for New QCDR Measures</HD>
                    <P>We propose that for a new QCDR measure to be approved for the 2024 MIPS payment year, a QCDR measure must be face valid; to be approved for the 2025 MIPS payment year and future years, a QCDR measure must be face valid for the initial MIPS payment year for which it is approved and fully tested for any subsequent MIPS payment year for which it is approved.</P>
                    <P>For example, for the CY 2026 MIPS payment year (the 2024 performance period), the self-nomination application period would open on July 1, 2023 and close on September 1, 2023. A QCDR that self-nominates a new QCDR measure by September 1, 2023 would need to complete face validity measure testing prior to submission in order for the measure to be considered for the CY 2026 MIPS payment year. If that new QCDR measure is approved for the CY 2026 MIPS payment year, it would need to be fully tested by the next self-nomination date for the CY 2027 MIPS payment year (by no later than September 1, 2024 for the 2025 performance period). QCDR measures that are not fully tested by the second year of the measure's life in MIPS (that is, second self-nomination date), would not be considered for approval for the second year.</P>
                    <P>
                        We recognize that not all QCDR measures currently approved would continue in the program due to business decisions by each QCDR. We acknowledge that there is a cost involved with full testing of quality measures (see 84 FR 63173); however, we believe it is important that all measures used within the MIPS program are fully tested and reliable. We believe this incremental approach in testing would allow QCDRs time to plan appropriately to complete measure testing in a timely, efficient, and effective manner. However, we do encourage QCDRs to submit fully-tested QCDR measures to the extent possible, as we have a strong preference for QCDR measures that are fully tested versus those that have only completed face validity testing.
                        <PRTPAGE P="50328"/>
                    </P>
                    <HD SOURCE="HD3">(iii) Proposed Requirements for QCDR Measures Considered for MVP</HD>
                    <P>As an additional layer, we are also proposing § 414.1400(b)(3)(v)(c)(2) that in order for a QCDR measure to be considered for inclusion in an MVP for the 2024 MIPS payment year and future years, a QCDR measure must be fully tested. We believe it is imperative to ensure that QCDR measures are fully tested before being included in an MVP. Unlike traditional MIPS, where clinicians and groups may choose from a large inventory of measures to report on for purposes of the quality performance category, the MVPs seek to create a focused selection of measures and activities relevant to a specific clinical topic. Since clinicians and groups who choose to report on MVPs will be reporting on a subset of measures and activities, there will be heavy reliance on the QCDR measures being reliable, valid, and feasible for reporting purposes.</P>
                    <P>We request comments on our proposals.</P>
                    <HD SOURCE="HD3">(C) Duplicative QCDR Measures</HD>
                    <P>Throughout previous rulemaking cycles, we have communicated our desire to eliminate duplicative QCDR measures in the MIPS program, as it is counterintuitive to the Meaningful Measure Initiative (84 FR 63068). One of the methods we previously suggested to address duplicative measures is measure harmonization, as discussed in the CY 2020 PFS final rule (84 FR 63068 through 63070). We have received comments and questions from stakeholders, requesting clarification for us to define what we mean by measure harmonization.</P>
                    <P>In this rule, we intend on clarifying that to mean measures for which previously identified areas of duplication with other approved QCDR measures or MIPS quality measures have been addressed. To be clear with our intent, we are proposing to revise previously codified policies that refer to measure harmonization with this updated terminology.</P>
                    <P>Therefore, we propose to revise § 414.1400(b)(3)(v)(E), to state, beginning with the 2022 MIPS payment year, CMS may provisionally approve the individual QCDR measures for 1 year with the condition that QCDRs address certain areas of duplication with other approved QCDR measures or MIPS quality measures in order to be considered for the program in subsequent years. If such areas of duplication are not addressed, CMS may reject the duplicative QCDR measure.</P>
                    <P>In addition, we propose to revise § 414.1400(b)(3)(vi) to state, beginning with the 2023 MIPS payment year, QCDR measures may be approved for 2 years, at CMS discretion by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke a QCDR measure's second year approval, if the QCDR measure is found to be: Topped out; duplicative of a more robust measure; reflects an outdated clinical guideline; or if the QCDR self-nominating the QCDR measure is no longer in good standing.</P>
                    <P>Furthermore, we propose to remove two previously codified policies that we have identified as areas of redundancy. We propose to remove § 414.1400(b)(3)(vii)(H), which states whether the previously identified areas of duplication have been addressed as requested, and to remove § 414.1400(b)(3)(vii)(L), which states whether the existing approved QCDR measure is no longer considered robust, in instances where new QCDR measures are considered to have a more vigorous quality actions, where CMS preference is to include the new QCDR measure rather than requesting QCDR measure harmonization. We believe the previously finalized regulatory text under § 414.1400(b)(3)(vii)(A), which states QCDR measures that are duplicative, or identical to other QCDR measures or MIPS quality measures currently in the program will address instances where areas of duplication amongst QCDR measures are not addressed or where a QCDR measure approved for a previous year is duplicative with a QCDR measure approved for the current year.</P>
                    <P>As a result of the proposed removals of two previously codified policies, as stated in the above paragraph, we are proposing technical updates to re-number the regulation text to reflect these removals. Therefore, in § 414.1400(b)(3)(vii), we propose to redesignate paragraphs (I), (J), (K), (M), and (N) as paragraphs (H), (I), (J), (K) and (L), respectively.</P>
                    <HD SOURCE="HD3">(D) Collection of Data on QCDR Measure</HD>
                    <P>In the CY 2020 PFS final rule (84 FR 63067 through 63068), we finalized at § 414.1400(b)(3)(v)(D) that beginning with the 2021 performance period, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period. For reasons discussed in the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595), we delayed implementation of this policy by 1 year, as described at § 414.1400(b)(3)(v)(D), beginning with the CY 2022 performance period, QCDRs are required to collect data on a QCDR measure, appropriate to the measure type, prior to submitting the QCDR measure for CMS consideration during the self-nomination period. We are not proposing any changes in this proposed rule.</P>
                    <HD SOURCE="HD3">(3) Qualified Registries</HD>
                    <P>We refer readers to §§ 414.1305 and 414.1400, the CY 2018 Quality Payment Program final rule (82 FR 53815 through 53818), CY 2019 PFS final rule proposed rule (83 FR 59906), and the CY 2020 PFS final rule (84 FR 40819 through 40820) for our previously finalized policies regarding qualified registries. In this proposed rule, we propose a technical update to the title at § 414.1400(c) to rename it from “qualified registry approval criteria” to “qualified registries”, to better align the title with the content of the regulation. In addition, in this proposed rule, we propose requirements related to data validation audits and targeted audits.</P>
                    <P>
                        In the CY 2017 Quality Payment Program final rule, we discussed our expectation related to QCDRs and qualified registries would conduct validation on the data they intend on submitting for the MIPS performance period (81 FR 77384 through 77386) and provide the results of the data validation to CMS in the form of a data validation execution report by May 31st of the year following the performance period. Our intention was to establish our expectation that qualified registries would establish a process to assess whether the data are true, accurate, and complete prior to submitting them to CMS for purposes of the MIPS program. We believe it is important to establish a requirement that qualified registries conduct data validation to ensure they are actively monitoring the data they submit to CMS for purposes of a pay-for-performance program. In instances where a qualified registry discovers data are inaccurate or incomplete, the entity must correct the issue prior to submitting the data to CMS in order to provide accurate certification in accordance with § 414.1400(a)(5). A qualified registry that submits a false certification submits data that is inaccurate, unusable or otherwise compromised to CMS for purposes of the MIPS program may be subject to remedial action or termination under § 414.1400(f). We believe requiring qualified registries to validate the accuracy of the data they are submitting is an important safeguard to promote accurate payments under the MIPS program. Therefore, in this proposed rule, we propose at § 414.1400(c)(2)(iii) 
                        <PRTPAGE P="50329"/>
                        and (iv) requirements beginning with the 2023 MIPS payment year as condition of approval each qualified registry must conduct annual data validation audits and if one or more deficiencies or data errors are identified the qualified registry must also conduct targeted audits. We also propose specific obligations for those audits as discussed below.
                    </P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(A), the qualified registry must conduct their data validation audits prior to submitting any data to CMS for purposes of the MIPS program. We believe it is important for qualified registries to conduct validation audits to identify and fix concerns regarding data accuracy prior to submitting data to us, including potential issues related to data aggregation and calculation. Conducting the data validation prior to data submission will lead to data being more reliable and promote compliance with the requirement of data being true, accurate, and complete. In the CY 2017 Quality Payment Program final rule, we described this auditing using the term randomized audit (81 FR 77384). In this proposed rule, we are proposing instead to refer to this audit as the data validation audit in an effort to be abundantly clear regarding our expectations that the qualified registry will purposefully construct a sample and conduct and audit that complies with specific regulatory requirements and also to distinguish these audits from the targeted audits discussed below and proposed at § 414.1400(c)(2)(v).</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(B), the qualified registry must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories. We believe that it is important that data validation be done across all performance categories for which the qualified registry submits data since qualified registries must attest that data submitted to CMS is true, accurate, and complete and data for each of these performance categories can influence score calculation and payment adjustments.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(C), that the qualified registry must conduct data validation on data for each submitter type for which it will submit data, including if applicable MIPS eligible clinicians, groups, virtual groups, voluntary participants, and opt-in participants. We believe it is important for the data submitted to CMS be accurate for all clinicians and groups for which the qualified registry intends on submitting data to the MIPS program, regardless of whether they are required to participate, have opted in, or have chosen to voluntarily participate. Therefore, we propose to require that the data validation audits should account for all types of submitters that are utilizing the qualified registry to submit data to CMS for purposes of the MIPS program. We note the importance of validating data for all submitter types regardless of its use for payment or public reporting. Even clinicians who voluntarily report to MIPS and whose data are not used for payment purposes could have their data publically posted on the Physician Compare website. We believe all data the qualified registry submits, regardless of its use for payment or public reporting, should be true, accurate, and complete.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(D) that the qualified registry must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed. If the data a qualified registry intends to submit to CMS for purposes with the MIPS program are to demonstrate that a clinician did a particular clinical activity or achieved a particular clinical outcome, we believe meaningful validation of such data requires the qualified registry to use clinical documentation to confirm that the activity occurred or was performed.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(E), the qualified registry shall conduct each data validation audit using a sampling methodology that meets the following requirements:</P>
                    <P>++ Uses a sample size of at least 3 percent of the TIN/NPIs for which the qualified registry will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the qualified registry must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the qualified registry may use a sample size of 50 TIN/NPIs.</P>
                    <P>++ Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients.</P>
                    <P>We believe the aforementioned sampling methodology is appropriate for multiple reasons. First, the sampling methodology criteria are consistent with the methodology established under the legacy Physician Quality Reporting System (PQRS) program and as described in the CY 2017 Quality Payment Program final rule (81 FR 77366 through 77367). As this methodology has been used for many years under the legacy program, we believe stakeholders are well versed in executing data validation audits using this sampling methodology. Second, the proposed methodology accounts for QCDRs and qualified registries of varying sizes. Data validation requires a level of effort on the part of the qualified registry to execute a data validation plan, identify a sample, and collect information for purposes of chart review; therefore, we are cognizant that requiring a larger sample size would create additional burden on qualified registries and clinicians to account for a larger volume in TIN/NPIs and medical records for review.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(F) that each qualified registry data validation audit must include the following:</P>
                    <P>++ Verification of the eligibility status of each eligible clinician, group, virtual group, opt-in participant, and voluntary participant. We believe that it is important for the qualified registry to track the eligibility status of each clinician and group that wishes to use a third party intermediary to report, because accurate information regarding eligibility is important to ensuring payment adjustments are properly applied. Furthermore, verification of eligibility status is consistent with the requirement for qualified registries to track opt-in participants, as described at § 414.1400(a)(4)(iv) and in the context of clinicians who voluntarily report to MIPS helps ensure the accuracy of data publically posted on the Physician Compare website (or a successor website) of the CMS website.</P>
                    <P>++ Verification of the accuracy of Tax Identification Numbers (TINs) or National Provider Identifiers (NPIs). Correct TINs and NPIs are critical to ensure data submitted by the qualified registry are attributed to the correct clinicians and groups. Inaccurate NPIs or TINs may lead to inadvertent downstream impacts to the way clinicians and groups are scored, and assigned a payment adjustment.</P>
                    <P>
                        ++ Calculation of reporting and performance rates (for example, formulas included in the quality measure specifications). Qualified registries must follow the measure specifications when calculating reporting and performance rates. Calculations that deviate the formulas included in the quality measure specifications undercut efforts to ensure 
                        <PRTPAGE P="50330"/>
                        data are consistent, reliable, and have been calculated in a uniform manner.
                    </P>
                    <P>++ Verification that only MIPS quality measures and qualified registry measures that are relevant to the performance period will be utilized for MIPS submission. Measure specifications for the MIPS quality measures and qualified registry measures go through maintenance on an annual basis. Use of outdated measure specifications would likely result in the qualified registry submitting inaccurate or compromised data for the clinicians and groups they support. While not all measures go through substantive changes on an annual basis, there are changes to codes that do occur annually that should be accounted for when programing measures. Therefore, we believe it is important that qualified registries are utilizing the most current version of the measure specification, relevant to the performance period in which they are participating.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iii)(G), that in a form and manner and by a deadline specified by CMS, the qualified registry must report data validation results, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or data error, and how and when each deficiency or data error type was corrected. We believe it is important that the results of the data validation be shared with us in order for us to understand the types of issues the qualified registries have encountered and what resolutions were executed to fix the issues. The information provided will help us track frequently occurring issues which may be identified as an area to provide further education. It is our belief that the report will be largely comprised of issues that were identified and resolved. However, if an issue has been identified and could not be resolved, we would want to understand what the issue is and why it could not be resolved. We emphasize that all data submitted to CMS by a qualified registry on behalf of a MIPS eligible clinician, group or virtual group must be certified by the third party intermediary as true, accurate, and complete to the best of its knowledge as described in § 414.1400(a)(5). If a qualified registry submits a false certification or data that are data that are inaccurate, unusable, or otherwise compromised, the qualified registry may be subject to remedial action or termination as described at § 414.1400(f).</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iv)(A) that if a data validation audit under § 414.1400(c)(2)(iii) identifies one or more deficiency or data error, the qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year. We believe targeted audits are important to further evaluate the impact of deficiencies or data errors to the cohort of clinicians and groups that the qualified registry intends to submit data for, and for qualified registries to determine the reason the deficiency or data error occurred.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iv)(B), that the qualified registry must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year. To promote the accuracy of the data submitted to the MIPS program for the payment year and to reduce the risk that the agency initiates payment calculations in reliance on inaccurate data, it is important for the qualified registry to conduct required targeted audits and correct any deficiencies and data errors identified through those audits prior to submitting the data to CMS.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iv)(C), the qualified registry must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (c)(2)(iii)(E). The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified. We believe the sampling methodology we are proposing for data validation audits is equally appropriate for the conduct of targeted audits. We believe that adopting the same methodology for both audit types would be less burdensome on qualified registries than requiring these entities to apply a separate sampling methodology for their targeted audits. Provided that data in the sample for the targeted audit does not overlap with the data that was reviewed in the data validation audit, we believe the targeted audit would provide the qualified registry with a reasonable perspective into impact and root cause of deficiencies and data errors across the data to be submitted without imposing the burden that would result from maintaining a separate sampling methodology for targeted audits.</P>
                    <P>• We propose to codify at § 414.1400(c)(2)(iv)(D), in a form and manner and by a deadline specified by CMS, the qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each error type was corrected. As is the case with the results of data validation audits, we believe it is important that the results of the targeted audits be shared with us in order for us to understand the types of issues the qualified registries have encountered and what resolutions were executed to fix the issues. The information provided will help us track frequently occurring issues which may be identified as an area to provide further education.</P>
                    <P>We request comments on the aforementioned proposals, including whether stakeholders are concerned with implementing these policies for the 2023 MIPS payment year, and if so, what barriers do they believe they would face in implementing these requirements.</P>
                    <HD SOURCE="HD3">(4) Remedial Action and Termination of Third Party Intermediaries</HD>
                    <P>We refer readers to § 414.1400(f), the CY 2017 Quality Payment Program final rule (81 FR 77548), CY 2019 PFS final rule (83 FR 59908 through 59910), and the CY 2020 PFS final rule (84 FR 63077 through 63080) for previously finalized policies for remedial action and termination of third party intermediaries.</P>
                    <P>
                        As described in § 414.1400(f)(1)(i), the remedial actions CMS may take against a third party intermediary including requiring the third party intermediary to submit to CMS by a date specified by the agency a corrective action plan (CAP) to address the identified deficiencies or data issue, including that actions it will take to prevent the deficiencies or data issues from recurring. To clarify expectations and create consistency in the content of the CAPs provide by third party intermediaries, we are proposing to revise and elaborate on the obligations for a CAP. Specifically, we propose to modify § 414.1400(f)(1)(i) such that, unless different or additional information is specified by CMS, the CAP submitted by the third party intermediary must address four issues: (1) The issues that contributed to the non-compliance; (2) the impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program; (3) the corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved will not 
                        <PRTPAGE P="50331"/>
                        recur in the future and (4) the detailed timeline for achieving compliance with the applicable requirements.
                    </P>
                    <P>We believe these four elements are generally warranted in each instance in which a CAP is required. First, any meaningful efforts at corrective action necessitate an understanding of what needs to be corrected. Therefore, we propose at § 414.1400(f)(1)(i)(A) to require that each third party intermediary be required to articulate the issues that contributed to the non-compliance. The third party intermediary must articulate what factors cause it to fail in its obligation to meet program requirements. For example, a survey vendor subject to remedial action for not completing vendor trainings would be required to explain what factors lead to its failure to complete training. We believe this analysis will allow third party intermediary to improve their processes to better meet existing requirements and will allow CMS to better understand what operational and other challenges third party intermediaries face in meeting program requirements. Second, depending on the circumstances, non-compliance by a third party intermediary may affect an uncertain number of clinicians and groups and has the potential to implicate substantial program dollars. Accordingly, we propose at § 414.1400(f)(1)(i)(B) to require that a third party intermediary subject to a CAP disclose to CMS the impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program. We believe this information regarding the scope of harms is necessary for the agency to assess the full program impact of the non-compliance. Furthermore, we believe it is important for the CAP to include this impact information regardless of the clinician's participation status, because non-compliance may have programmatic implications even if it does not affect payment, such as for data posted on the Physician Compare website. Third, meaningful remedial action requires the identification of specific action steps both to address prior harm but to protect against future harms. Therefore, we propose at § 414.1400(f)(1)(i)(C) that a third party intermediary subject to a CAP must address the corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future. The third party intermediary will be expected to follow through with the implementation of the corrective actions and to see that the issue has been corrected permanently. It is important for us to understand in detail what actions the third party intermediary will take to resolve the issue and to evaluate the effectiveness of the proposed solution for long-term sustainability. Fourth, non-compliance must be resolved methodically and timely. Therefore, we propose at § 414.1400(f)(1)(i)(D) that each CAP must include the detailed timeline for achieving compliance with the applicable requirements. We invite public comments on these proposed revisions to our requirements for correction action plans.</P>
                    <HD SOURCE="HD3">h. Public Reporting on Physician Compare</HD>
                    <P>
                        For previous discussions on the background of Physician Compare, we refer readers to the CY 2016 PFS final rule (80 FR 71116 through 71123), the CY 2017 Quality Payment Program final rule (81 FR 77390 through 77399), the CY 2018 Quality Payment Program final rule (82 FR 53819 through 53832), the CY 2019 PFS final rule (83 FR 59910 through 59915), the CY 2020 PFS final rule (84 FR 63080 through 63083), and the Physician Compare Initiative website at 
                        <E T="03">https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/physician-compare-initiative/.</E>
                    </P>
                    <HD SOURCE="HD3">(1) Definitions &amp; Proposed Regulation Text Changes</HD>
                    <P>
                        Physician Compare (
                        <E T="03">http://www.medicare.gov/physiciancompare</E>
                        ) draws its operating authority from section 10331(a)(1) of the Affordable Care Act, which defines the term “Physician Compare” to mean the internet website developed under this section of the statute. Physician Compare has continued to pursue a phased approach to public reporting under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. Section 104(f)(2) of the MACRA defines the term “Physician Compare” to mean the Physician Compare internet website on the CMS (or a successor) website. To more completely and accurately reference the website for which CMS will post information available for public reporting, in accordance with section 104(f)(2) of the MACRA, we propose to define Physician Compare at § 414.1305 to mean the Physician Compare internet website of the Centers for Medicare &amp; Medicaid Services (or a successor website). We seek comment on this proposal. For ease of reference, we will use the term “Physician Compare” in this proposed rule.
                    </P>
                    <HD SOURCE="HD3">4. APM Incentive Payment</HD>
                    <HD SOURCE="HD3">(a) Overview</HD>
                    <P>Under the Quality Payment Program, Qualifying APM Participants (QPs) receive a 5 percent APM Incentive Payment in payment years 2019 through 2024. In the CY 2017 Quality Payment Program final rule (81 FR 77480 through 77489), we finalized at § 414.1450(d) that this payment is made based on the clinician's QP status in the QP Performance Period that is 2 years prior (for example, the 2021 payment will correspond to the 2019 performance year), and at § 414.1450(b)(1) that the payment is equal to 2 percent of the estimated aggregate amount of payments for covered professional services in the base period (the year between the QP performance and payment years). We finalized at § 414.1450(c)(1) that the APM Incentive Payment amount is made to the TIN associated with the Advanced APM Entity through which an eligible clinician becomes a QP during the QP Performance Period. Under § 414.1450(c)(3), if an eligible clinician becomes a QP through participation in multiple Advanced APMs, CMS divides the APM Incentive Payment proportionally between the TINs associated with the QP's participation in each Advanced APM based on payments for covered professional services during the QP Performance Period. In addition, under § 414.1450(c)(2), we finalized that if the QP is no longer affiliated with the TIN associated with the QP's participation in the APM Entity, the APM Incentive Payment is made to the TIN listed on the NPI's CMS-588 Electronic Funds Transfer (EFT).</P>
                    <P>
                        In our first year making the APM Incentive Payment, we experienced operational limitations that made it difficult in certain cases to distribute the payment to a current billing organization associated with the QP according to the current regulations. In particular, we encountered challenges when QPs are no longer affiliated with the TIN associated with the QP's participation in the APM Entity through which they attained QP status, and when we were unable to make the APM Incentive Payment to the TIN listed on the eligible clinician's CMS-588 EFT Application form. In certain circumstances, it has been challenging to locate accurate billing organizations for some QPs 2 years after they earned QP status. For example, we have encountered situations such as inaccurate or missing billing 
                        <PRTPAGE P="50332"/>
                        associations for the QP because the QP has changed their primary billing TIN between the performance and the payment year, or the billing TIN through which the QP attained QP status is not the TIN through which CMS payments are processed, and so it is not possible for CMS to know that the two are in fact connected.
                    </P>
                    <HD SOURCE="HD3">(b) APM Incentive Payment Amount</HD>
                    <P>In the first Quality Payment Program final rule (81 FR 77480), we finalized at § 414.1450(b)(1) through (3) how we calculate the amount of the APM Incentive Payment. Specifically, we finalized that: (1) The amount of the APM Incentive Payment is equal to 5 percent of the estimated aggregate payments for covered professional services as defined in section 1848(k)(3)(A) of the Act furnished during the incentive payment base period (that is, the calendar year immediately preceding the payment year); (2) the estimated aggregate payment amount for covered professional services includes all such payments to the QP (NPI) via any and all of their TIN/NPI combinations; and (3) in calculating the estimated aggregate payment for a QP, CMS uses claims submitted for covered professional services with dates of service from January 1 through December 31 of the incentive payment base period.</P>
                    <P>In this proposed rule, we are clarifying that the APM Incentive Payment amount is calculated based on the paid amount of the applicable claims for covered professional services that are subsequently aggregated to calculate the estimated aggregate payments. We are proposing to amend our regulation at § 414.1450(b)(1) to reflect that clarification.</P>
                    <P>Section 1833(z)(1)(A) of the Act specifies that the APM Incentive Payment is equal to 5 percent of the estimated aggregate payments for covered professional services as defined in section 1848(k)(3) of the Act. Because the APM Incentive Payment is a percentage of the estimated aggregate payments made, it would not be appropriate to calculate the APM Incentive Payment based on amounts that were allowed, but not actually paid by Medicare, for such covered professional services.</P>
                    <P>We also note that, as provided in § 414.1450(b)(4) and (5), we exclude certain payments and adjustments, including the MIPS payment adjustments, when calculating the APM Incentive Payment amount.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">(c) APM Incentive Payment Recipient</HD>
                    <P>Under our current policy as finalized at § 414.1450(c), CMS first seeks to disburse the APM Incentive Payment to the TIN associated with the QP's participation with the APM Entity in the Advanced APM through which they earned QP status. If the QP is no longer affiliated with that TIN, we seek to disburse the APM Incentive Payment to the TIN listed on the eligible clinician's CMS-588 EFT form on the date that we make the payment. And if the eligible clinician becomes a QP through participation in multiple Advanced APMs, we seek to divide the APM Incentive Payment proportionally, based on payments for covered professional services during the QP Performance Period, and to make proportional payment to each of the TINs associated with the QP's participation with the APM Entity or APM Entities in the Advanced APMs.</P>
                    <P>It is still our intention to reward achievement of QP status through participation in Advanced APMs by seeking to disburse APM Incentive Payments to TINs that are affiliated with an APM Entity through which the QP has achieved QP status, as is described in the CY 2017 Quality Payment Program final rule (81 FR 77847). However, after our first year of making APM Incentive Payments, we have learned that the amount of time between when an eligible clinician earns QP status and when APM Incentive Payments are made makes it difficult to ensure that payments can be made for these QPs in a routine and efficient manner. For example, in the space of 2 years between making QP determinations and APM Incentive Payments, eligible clinicians may change TINs, join new TINs, join new APM Entities, remain in the same APM Entity under a new billing TIN, leave Medicare altogether, or make other potential changes impacting their relationship with the Medicare program. CMS receives updated records of these changes when APM participants update their payment information through the internet based Provider Enrollment, Chain and Ownership system (PECOS) or a CMS-588 EFT Application, and subsequent updates to APM Participation Lists and Affiliated Practitioner Lists, although we note that such updates are not consistently and timely made across APM participants, as we originally believed, and therefore such lists have variable reliability. Further, on our own end, if we limit our initial search for the party or parties to which we should make the APM Incentive Payment to only the TIN or TINs through which the eligible clinician earned QP status, as is specified in our regulations at § 414.1450(c)(1) and (3), when the QP has made changes to their TIN affiliations, we might limit our opportunities to make the APM Incentive Payment to a more current TIN with which the QP is affiliated at the time we make the APM Incentive Payment. If we limit the TINs to which we will make the APM Incentive Payment to only those through which a QP was billing at the time they achieved QP status, we might be unable to identify any TIN to which we would make a payment for that QP during the payment year, or payments may be significantly delayed as a result, even in cases where a current payee TIN is available.</P>
                    <P>Therefore, we are proposing to establish in our regulation at § 414.1450(c) a revised approach to identifying the TIN(s) to which we make the APM Incentive Payment. This approach would involve looking at a QP's relationship with their TIN(s) over time, as well as considering the relationship the TIN(s) have with the APM Entity or Entities through which the eligible clinician earned QP status, or other APM Entities the QP may have joined in the interim. We believe that this revised approach will enable CMS to more accurately identify TINs with which QPs are currently receiving other Medicare payments, and through which they would likely anticipate receiving their APM Incentive Payment. This approach would also prioritize, when the QP is no longer affiliated with the original TIN through which they achieved QP status, identifying and paying TINs with which QPs are affiliated at the time the APM Incentive Payment is made, thereby reducing the potential burden on payee TINs to find QPs no longer affiliated with them in order to disburse the APM Incentive Payment amount, as well as reducing uncertainty and delays for the QPs themselves as they anticipate their APM Incentive Payment.</P>
                    <P>
                        We are also proposing to introduce a cutoff date of November 1 of each payment year, or 60 days from the day on which we make the initial round of APM Incentive Payments, whichever is later, as a point in time after which CMS will no longer accept new helpdesk requests from QPs or their representatives who have not received their payments. There may be scenarios where we are unable to identify any appropriate TIN to which the APM Incentive Payment should be made, such as when the QP is no longer participating in Medicare, the QP has 
                        <PRTPAGE P="50333"/>
                        recently reassigned his or her billing rights, or where a payment TIN may be undergoing business transformations such that payment information changes during the payment year. In these cases, it is our goal to make correct payments for the relevant QPs as soon as feasible. In order to do so, it is necessary to establish a date after which we will not consider additional inquiries or additional information from QPs or their representatives for purposes of disbursing remaining APM Incentive Payments for the payment year.
                    </P>
                    <P>In order to improve and expand the ways we identify the TIN(s) to which we would make the APM Incentive Payment for a QP in a more timely and efficient manner, we propose to sequentially apply the hierarchy in the following paragraph and to amend § 414.1450(c) of our regulations to reflect such hierarchy. We propose to begin at the first step in the hierarchy, and if we are unable to identify one or more TINs with which the QP has a current affiliation at this step, we move to the next and successive steps of the hierarchy until we do identify one or more TINs with which the QP is currently affiliated at the time we are distributing APM Incentive Payments. When we identify one or more TINs with which the QP is affiliated at a step, we would make the APM Incentive Payment to those TINs. We further propose that if we identify more than one TIN at the applicable step in the hierarchy, we will divide the APM Incentive Payment proportionally between such TINs based on the relative paid amount for Part B covered professional services that are billed through each such TINs. We propose the hierarchy to be:</P>
                    <P>(1) Any TIN associated with the QP that, during the QP Performance Period, is associated with an APM Entity through which the eligible clinician achieved QP status;</P>
                    <P>(2) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity through which the eligible clinician achieved QP status;</P>
                    <P>(3) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity participating in an Advanced APM through which the eligible clinician had achieved QP status;</P>
                    <P>(4) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated in an APM Entity in an Advanced APM;</P>
                    <P>(5) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in any track of the APM through which the eligible clinician achieved QP status;</P>
                    <P>(6) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in an APM other than an Advanced APM;</P>
                    <P>(7) Any TIN associated with the QP that submitted a claim for covered professional services furnished by the QP during the APM Incentive Payment base period, even if such TIN has no relationship to any APM Entity or APM; then</P>
                    <P>(8) If we have not identified any TIN associated with the QP to which we can make the APM Incentive Payment, we will attempt to contact the QP via a public notice to request their Medicare payment information. The QPs identified in the public notice, or any other eligible clinicians who believe that they are entitled to an APM Incentive Payment must then notify CMS of their claim as directed in the public notice by November 1 of the payment year, or 60 days after CMS announces that initial payments for the year have been made, whichever is later. After that time, any claims by a QP to an APM Incentive Payment will be forfeited for such payment year.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(d) Eligible Clinicians With No Covered Professional Services in the Incentive Payment Base Period</HD>
                    <P>In our experience calculating the APM Incentive Payments, it has come to our attention that there is a cohort of eligible clinicians who have been determined to be QPs for a year, and for whom an APM Incentive Payment has been calculated and in some cases paid, despite the fact that these eligible clinicians did not bill for any Part B covered professional services during the incentive payment base period. This situation arises in cases where an APM Entity is paid under the terms of the APM for supplemental services on behalf of an eligible clinician who is on their Participation List. This can occur because, for purposes of calculating the APM Incentive Payment, such supplemental service payments as described in § 414.1450(b)(7) of our regulations are considered covered professional services for purposes of calculating the APM Incentive Payment.</P>
                    <P>This scenario creates difficulty when CMS attempts to make the APM Incentive Payment for the QP because there are no relevant claims in our database indicating a TIN to which we should make the APM Incentive Payment. We believe this situation is largely the result of clerical errors or delays, either in updates to the APM's Participation List that is submitted to CMS by APM participants, or through more general processes used to update an eligible clinician's Medicare enrollment information. We remind our enrolled physicians, practitioners, group practices and other suppliers that it is their responsibility, in accordance with their APM participation and their Medicare enrollment agreement, to routinely update their APM participation lists that they submit directly to their APMs, as well as their lists of enrolled providers assigned to their organization and associated TINs, either through the internet-based PECOS or using a CMS-855F Form. Any payments resulting from a failure to make such updates may be considered fraud, waste, or abuse.</P>
                    <P>However, in the event that a QP's APM Incentive Payment was calculated based solely on supplemental services payments and no Medicare claims for covered professional services furnished by the QP were submitted during the incentive payment base period, we would categorically assign these QPs to the list of QPs that will be given public notice requesting updated payment information within 90 days, as described in the proposed regulation at § 414.1450(c)(8). We believe that in many if not most of these cases, such individuals have retired or otherwise ceased participation in Medicare; however, we recognize that there may be scenarios under which such individuals remain active, and our proposal is meant to provide an opportunity for such clinicians to identify their current billing affiliation(s) or otherwise identify a TIN to which the APM Incentive Payment should be made.</P>
                    <P>We seek comment on this proposal.</P>
                    <HD SOURCE="HD3">d. Qualifying APM Participant (QP) and Partial QP Determinations</HD>
                    <HD SOURCE="HD3">(1) Overview</HD>
                    <P>In the CY 2017 Quality Payment Program final rule (81 FR 77433 through 77450), we finalized policies relating to QP and Partial QP determinations. In the CY 2019 PFS final rule (83 FR 59923 through 59925), we finalized additional policies relating to QP determinations and the Partial QP election to report to MIPS.</P>
                    <P>In this proposed rule, we are proposing to:</P>
                    <P>• Update the methodology for addressing prospectively aligned beneficiaries for Threshold Score calculations and QP determinations.</P>
                    <P>• Establish a Targeted Review process for QP Determinations.</P>
                    <P>
                        Additionally, we are clarifying our policies on Advanced APM 
                        <PRTPAGE P="50334"/>
                        determinations and QP determinations in light of questions that may arise based on the effects of the COVID-19 PHE.
                    </P>
                    <P>Finally, we are soliciting comment on whether to allow an APM Entity to make the Partial QP election on behalf of all of the APM Entity's participating eligible clinicians.</P>
                    <HD SOURCE="HD3">(2) Background</HD>
                    <P>In the CY 2017 Quality Payment Program final rule (81 FR 77439 through 77440), we finalized that QP determinations would first be made at the APM Entity level, after which we would make further QP determinations at the individual level for eligible clinicians who are either: (1) Participating in multiple Advanced APM Entities, none of which meet the QP threshold as a group; or (2) on an Affiliated Practitioner List that is the list used for the QP determination when there are no eligible clinicians on a Participation List for the APM Entity (81 FR 77439 through 77443). As such, the QP determination at the APM Entity level generally applies to all the individual eligible clinicians who are on a Participation List of the Advanced APM. The QP determination Threshold Score calculations are aggregated using data for all eligible clinicians participating in the APM Entity on each snapshot date (March 31, June 30, August 31) during the QP Performance Period. If the APM Entity's Threshold Score meets the relevant QP threshold, all individual eligible clinicians in that APM Entity would receive the same QP determination, applied at the NPI level, for the relevant performance year (PY).</P>
                    <HD SOURCE="HD3">(3) Attribution of Prospectively Attributed Beneficiaries in QP Threshold Score Calculations</HD>
                    <P>When making QP determinations, we include information for all attribution-eligible beneficiaries in the denominator of the patient count and payment amount methods used to calculate QP Threshold Scores as set forth in § 414.1435. “Attribution-eligible beneficiary” is a term defined in our regulation at § 414.1305, and the definition is generally based on the attribution methodology and rules for the particular Advanced APM. We have specified at § 414.1435(b)(3) that a beneficiary may be counted only once in the numerator and denominator for a single APM Entity group, and at § 414.1435(b)(4) that a beneficiary may be counted multiple times in the numerator and denominator for multiple different APM Entity groups.</P>
                    <P>When making QP determinations, at the APM Entity or individual eligible clinician level, we begin by calculating Threshold Scores which are the ratio of the payment amounts or patient counts for “attributed beneficiaries” to the payment amounts or patient counts for “attribution eligible beneficiaries.” If this ratio (the Threshold Score) for the eligible clinician or APM Entity level, as applicable, meets or exceeds the relevant QP thresholds described at § 414.1430(a), the relevant eligible clinicians will have attained QP status for a year. It has come to our attention that under our current methodology for calculating Threshold Scores, we include attribution-eligible beneficiaries in the denominator of the calculation for some APM Entities for whom those same beneficiaries could never be included in the numerator. This may happen in a scenario where a beneficiary is prospectively attributed to an APM Entity and as a result is precluded by the applicable rules for one or more APMs from attribution to other APM Entities in certain other APMs.</P>
                    <P>For example, the Shared Savings Program offers the option for ACOs to select prospective beneficiary assignment, and prospective beneficiary alignment is also used in the Direct Contracting Model and Next Generation ACO Model. When beneficiaries are prospectively attributed to an ACO in one of these APMs, under the rules of precedence within the APMs themselves, those beneficiaries are generally not available for attribution to participants in some other APMs, including other ACOs with retrospective attribution methodologies. However, the population of attribution-eligible beneficiaries for APM Entities in these other APMs still includes those prospectively aligned beneficiaries. This could have the effect of disadvantaging the APM Entities to which the beneficiaries may never be attributed, because their ratio of attributed beneficiaries to attribution-eligible beneficiaries will be lower, for reasons entirely outside the control of the relevant eligible clinicians and APM Entities.</P>
                    <P>Therefore, we propose to amend § 414.1435(c)(1) of our regulations and add a new paragraph § 414.1435(c)(1)(i) to specify that beneficiaries who have been prospectively attributed to an APM Entity for a QP Performance Period will be excluded from the attribution-eligible beneficiary count for any other APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity's attributed beneficiary list. The effect of this proposed policy would be to remove such prospectively attributed beneficiaries from the denominators when calculating Threshold Scores for APM Entities or individual eligible clinicians in Advanced APMs that align beneficiaries retrospectively, thereby preventing dilution of the Threshold Score for the APM Entity or individual eligible clinician in an Advanced APM that uses retrospective attribution.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(3) Targeted Review of QP Determinations</HD>
                    <HD SOURCE="HD3">(i) Overview</HD>
                    <P>We are proposing at § 414.1455(b) to establish a targeted review process for limited circumstances surrounding QP determinations. This targeted review process would provide a systematic opportunity for eligible clinicians to bring to our attention potential clerical errors we may have made, and for us to review and make corrections if warranted. We also propose that, after the conclusion of the time period for targeted review, there would be no further review of our QP determination with respect to an eligible clinician for the QP Performance Period.</P>
                    <P>We note that, consistent with section 1833(z)(4) of the Act and under § 414.1455(a) of our regulations, there is no administrative or judicial review under sections 1869 or 1878 of the Act or otherwise, of the determination that an eligible clinician is a QP or Partial QP under § 414.1425, that an APM Entity is an Advanced APM Entity under § 414.1410, or of the determination of the amount of the APM Incentive Payment under § 414.1450.</P>
                    <HD SOURCE="HD3">(ii) Scope of Targeted Review</HD>
                    <P>
                        We propose at § 414.1455(b)(1) that an eligible clinician or APM Entity may request targeted review of a QP or Partial QP determination only if they believe in good faith that, due to a CMS clerical error, an eligible clinician was omitted from a Participation List used for purposes of QP determinations. If we determine that we made such a clerical error, we believe that it would be appropriate, and we are proposing to assign to the erroneously omitted eligible clinician the most favorable QP status that was determined at the APM Entity level on any snapshot dates for the relevant QP Performance Period on which the eligible clinician participated in the APM Entity. We believe that this policy is appropriate in these circumstances because, as a result of a CMS clerical error, the eligible clinician was not provided the opportunity to become a QP based on the level of payment amounts or patient counts 
                        <PRTPAGE P="50335"/>
                        through an Advanced APM for an APM Entity with which they were associated.
                    </P>
                    <P>Alternatively, if we were to instead recalculate an APM Entity's Threshold Scores for one or more of the snapshot dates in the relevant QP Performance Period, and the Threshold Scores no longer met the applicable QP threshold(s), that outcome could affect all of the eligible clinicians in the APM Entity group, removing their QP status. However, the affected eligible clinicians in the APM Entity group are likely to have acted in accordance with our CMS's notification of their prior QP determination, and not have prepared for or reported to MIPS. In correcting our own clerical error with respect to some eligible clinicians, we do not believe it would be appropriate to revisit our prior QP determinations for a broader set of eligible clinicians, thereby potentially disadvantaging those eligible clinicians in MIPS scoring through no fault of their own.</P>
                    <P>We are proposing to not conduct targeted review of potential omissions from Affiliated Practitioner Lists, as QP determinations for eligible clinicians on an Affiliated Practitioner List are made at the individual eligible clinician level for each of the QP Performance Period snapshots. As such, we would not have completed a QP determination for the QP Performance Period in question for the individual eligible clinician who has been identified prior to the targeted review if that eligible clinician was indeed omitted due to CMS clerical error. We recognize that this circumstance may occur, however, we believe this to be an infrequent occurrence. Additionally, such calculations would not be operationally feasible in order to make the APM Incentive Payment in a timely manner.</P>
                    <P>We note that we are not proposing to accept targeted review requests to correct omissions from Participation Lists of Other Payer Advanced APMs, as those lists are provided to us directly by eligible clinicians and Other Payer Advanced APMs. As such, any clerical error would not be the fault of CMS.</P>
                    <HD SOURCE="HD3">(iii) Targeted Review Process</HD>
                    <P>In general, we propose to align this targeted review process with the MIPS targeted review process as codified at § 414.1385. We believe that this general alignment is appropriate and will reduce the likelihood of confusion and burden on eligible clinicians and APM Entities. We propose to revise § 414.1455 of our regulations by redesignating the current preclusion of administrative or judicial review under § 414.1455(a) and (b) to § 414.1455(a)(1) and (2) and to codify our targeted review policy at § 414.1455(b).</P>
                    <P>We propose to specify at § 414.1455(b) that either an eligible clinician or APM Entity may submit a request for targeted review. We also propose that all requests for targeted review must be submitted during the targeted review request submission period, which is a 60-day period that begins on the day CMS makes available the MIPS payment adjustment factors for the MIPS payment year as described at § 414.1385(a)(2) of our regulations. The targeted review request submission period may be extended as specified by CMS. We also propose that all requests for targeted review must be submitted in accordance with the form and manner specified by CMS.</P>
                    <P>We propose that a request for targeted review may be denied if the request is duplicative of another request for a targeted review; the request for targeted review is not submitted during the targeted review request submission period; or the request is outside the scope of the targeted review, as specified in § 414.1455(b)(1). If the targeted review request is denied, there will be no change to either the QP or Partial QP determination. If the targeted review request is approved, we would assign the most favorable Threshold Score and corresponding QP status of the APM Entity in which such eligible clinician participates.</P>
                    <P>We propose that we will respond to each request for targeted review timely submitted and determine whether a targeted review is warranted.</P>
                    <P>We propose that a request for targeted review may include additional information in support of the request at the time it is submitted. If CMS requests additional information from requests additional information from the eligible clinician or the APM Entity group that is the subject of a request for targeted review, it must be provided and received by CMS within 30 days of CMS's request. Non-responsiveness to CMS' request for additional information may result in a final decision based on the information available, although another non-duplicative request for a targeted review may be submitted before the end of the targeted review request submission period.</P>
                    <P>We propose that if targeted review requests reveal a pattern of CMS error with impacts that extend beyond the eligible clinician or clinicians who submitted such targeted review requests, we would correct any additional errors that we identify regardless of whether a targeted review was submitted for the other eligible clinicians affected.</P>
                    <P>We propose that decisions based on the targeted review are final, and there is no further administrative review or appeal or judicial review.</P>
                    <P>We seek comment on these proposals.</P>
                    <HD SOURCE="HD3">(4) COVID-19 Public Health Emergency (PHE) Advanced APM determination and QP Determinations</HD>
                    <HD SOURCE="HD3">(i) Advanced APM Determinations</HD>
                    <P>We anticipate that the COVID-19 PHE, as defined in 42 CFR 400.200, may result in CMS making changes to aspects of some APMs. For example, CMS may publish regulations or amend APM Participation Agreements to address issues that arise as a result of the COVID-19 PHE.</P>
                    <P>Due to the COVID-19 PHE and the urgent need to address changes to certain APMs during CY 2020 to respond to the extreme shifts in the healthcare delivery system, CMS is exercising its enforcement discretion in connection with Advanced APM determinations. Specifically, CMS will not reconsider the Advanced APM determinations of APMs which have already been evaluated and determined to meet the Advanced APM criteria for CY 2020, even in the event that the APMs make changes to their governing documents or operations in such a way that, if there were a redetermination, they would no longer meet the criteria to be an Advanced APM. Furthermore, we will evaluate all APMs in future years with the understanding that any provisions of the Participation Agreement or governing regulation designed in response to the COVID-19 PHE will not be considered to the extent they would prevent the APM from meeting the Advanced APM criteria for a year.</P>
                    <P>We note that the following APMs are considered Advanced APMs for 2020:</P>
                    <P>• Bundled Payments for Care Improvement Advanced Model;</P>
                    <P>• Comprehensive Care for Joint Replacement Payment Model (CEHRT Track);</P>
                    <P>• Comprehensive Primary Care Plus Model;</P>
                    <P>• Comprehensive ESRD Care Model (LDO arrangement and Non LDO Two Sided Risk Arrangement);</P>
                    <P>• Maryland Total Cost of Care Model (Care Redesign Program; Maryland Primary Care Program);</P>
                    <P>• Medicare Shared Savings Program (Track 2, Track 3, Basic Track Level E, and the ENHANCED Track);</P>
                    <P>• Medicare Accountable Care Organization (ACO) Track 1+ Model;</P>
                    <P>• Next Generation ACO Model;</P>
                    <P>
                        • Oncology Care Model (Two-Sided Risk Arrangements);
                        <PRTPAGE P="50336"/>
                    </P>
                    <P>• Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).</P>
                    <HD SOURCE="HD3">(ii) QP Determinations</HD>
                    <P>We also understand that the COVID-19 PHE may lead the adoption of an earlier end date for certain APMs based on amendments to the APM's governing documentation, such as a Participation Agreement. For example, an Advanced APM governed by a Participation Agreement was originally scheduled to end on December 31, 2020, and the amended Participation Agreement may revise the ending date to July 1, 2020. In the event that such changes are made to a Participation Agreement to modify the end date of an Advanced APM in response to the COVID-19 PHE, we would not consider this to be a termination from an Advanced APM under § 414.1425(c)(5) or (6) of our regulations. As such, we would not revoke the QP status of eligible clinician participants in the Advanced APM on that basis.</P>
                    <P>We are aware that circumstances resulting from the COVID-19 PHE could affect the results of QP and Partial QP determinations for the 2020 QP Performance Period, as compared to what those determinations would otherwise be in absence of the COVID-19 PHE.</P>
                    <P>However, after considering whether changes in our methodology to address the PHE were warranted, we determined that any change to the QP determination methodology could have unintended negative consequences for Advanced APM participants as practice patterns have shifted even in areas with a low volume of COVID-19 cases. We note that with the duration, scope, and severity of the PHE being unknown, it is impossible to predict the potential impact both in terms of scale and which providers may be most likely to be affected. As such, we are concerned that making changes to the QP determination methodology would be more likely to inadvertently pick winners (those who would benefit from the change in methodology by achieving higher scores) and losers (those who would score better under our normal methodology than under a changed one) than it would be to generate relief from the PHE across the board. We also anticipate that there would be significant challenges resulting from modifying QP calculations with so many unknown variables at play, and are concerned that any changes to our methodology could result in delays in the timing of our announcing QP status.</P>
                    <P>We also believe Advanced APM participants benefit from timely and predictable QP determinations. With all of these considerations in mind, we are clarifying that, apart from the exercise of enforcement discretion explained above, we will continue to perform QP determinations as established in our regulations at §§ 414.1305, 414.1425, 414.1430, 414.1435, and 414.1440 for the 2020 QP Performance Period, without modifications to address the COVID-19 PHE.</P>
                    <HD SOURCE="HD3">(5) Partial QP Election To Report MIPS</HD>
                    <P>We anticipate there may be an increase in the number of eligible clinicians who are determined to be Partial QPs in the 2021 QP Performance Period in comparison to the 2020 QP Performance Period, due to the increase in the QP thresholds. Beginning in the CY 2021 QP Performance Period, as provided at § 414.1430(a) of our regulations for the Medicare option, the QP payment amount threshold increases from 50 percent to 75 percent, while the QP patient count threshold increases from 35 percent to 50 percent. While the Partial QP thresholds for the Medicare option also increase, based on historical performance we expect a greater number of Partial QPs based on performance in the CY 2021 QP Performance Period than for the prior QP Performance Period. As provided in § 414.1310(b)(2), Partial QPs who do not elect to participate in MIPS as a MIPS eligible clinician are excluded from MIPS, and thus, not subject to the MIPS reporting requirements or payment adjustments. To date our method of contacting Partial QPs has been to send a letter to the APM Entity's contact listed with the APM. As such, we are considering options to make the Partial QP election process less burdensome.</P>
                    <P>We are requesting comment on whether to allow an APM Entity to make the Partial QP election on behalf of all of the individual eligible clinicians associated with such APM Entity. We believe that allowing an APM Entity to make a single election on behalf of all of its eligible clinicians may help to simplify such elections, particularly for those eligible clinicians who will be Partial QPs for the first time because of the increasing QP thresholds in 2021. We also believe that allowing an APM Entity to make the Partial QP election for its eligible clinicians could reduce burden for individual eligible clinicians and allow APM Entities to have a centralized source of feedback as to the statuses of their individual eligible clinician participants.</P>
                    <P>However, we acknowledge that allowing APM Entities to make elections on behalf of eligible clinicians would create the possibility that we could receive conflicting election responses from different parties. Specifically, we are interested in receiving comments, feedback, and recommendations for how to address: (1) Conflicting responses either from an APM Entity and an individual or from two or more different APM Entities (eligible clinicians often participate with more than one APM Entity); and (2) situations where the eligible clinician is participating in more than one APM Entity and we do not receive elections from all parties.</P>
                    <P>In the case where an APM Entity election conflicts with that of an individual eligible clinician, we believe it would be most appropriate to follow the individual eligible clinician's election, as that election would apply at the NPI level across all of their TIN/NPI combinations, and in recognition that the eligible clinician has taken the opportunity to express their preference. Similarly, if we were to receive an election for an eligible clinician from one APM Entity in which the eligible clinician participates but not all such APM Entities, and the individual clinician does not make an election, we believe it would be appropriate to apply the election we received for the eligible clinician across all their TIN/NPI combinations. However, if multiple APM Entities make elections that are not in agreement, and the individual eligible clinician does not make an election, there is no clearly appropriate course of action as to which election to follow, and therefore we solicit comments detailing how we might go about applying conflicting Partial QP elections for an eligible clinician made by more than one APM Entity.</P>
                    <P>We seek public comment on whether to allow Partial QP elections to be made by APM Entities on behalf of all eligible clinicians within the APM Entity, and how to handle potentially conflicting elections.</P>
                    <HD SOURCE="HD1">V. Planned 30-Day Delayed Effective Date for the Final Rule</HD>
                    <P>We are committed to ensuring that we fulfill our statutory obligation to update the PFS as required by law and are working diligently in that regard. We ordinarily provide a 60-day delay in the effective date of final rules after the date they are issued in accord with the Congressional Review Act (CRA) (5 U.S.C. 801(a)(3)). However, 5 U.S.C. 808(2) provides that, if an agency finds good cause that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the rule shall take effect at such time as the agency determines.</P>
                    <P>
                        The United States is responding to an outbreak of respiratory disease caused by a novel (new) coronavirus that has 
                        <PRTPAGE P="50337"/>
                        now been detected in more than 190 locations internationally, including in all 50 States and the District of Columbia. The virus has been named “SARS CoV 2” and the disease it causes has been named “coronavirus disease 2019” (abbreviated “COVID 19”).
                    </P>
                    <P>On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO) declared the outbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, 2020, Health and Human Services Secretary, Alex M. Azar II, declared a PHE for the United States to aid the nation's healthcare community in responding to COVID-19. On March 11, 2020, the WHO publicly characterized COVID-19 as a pandemic. On March 13, 2020 the President of the United States declared the COVID-19 outbreak a national emergency.</P>
                    <P>Due to CMS prioritizing efforts in support of containing and combatting the COVID-19 PHE, and devoting significant resources to that end, the work needed on the PFS payment rule will not be completed in accordance with our usual schedule for this rulemaking, which aims for a publication date of at least 60 days before the start of the fiscal year to which it applies. Up to an additional 30 days may be needed to complete the work needed on this payment rule. The PFS payment rule is necessary to annually review and update the payment systems, and it is critical to ensure that the payment policies for these systems are effective on the first day of the fiscal year to which they are intended to apply.</P>
                    <P>
                        Therefore, due to CMS prioritizing efforts in support of containing and combatting the COVID-19 PHE, and devoting significant resources to that end, we expect that we will determine, pursuant to 5 U.S.C. 808(2), that the PFS final rule will be effective 30 days after publication; it would be impracticable and contrary to the public interest for CMS to do otherwise. Accordingly, we also do expect to provide a 30-day delay in the effective date of the final rule in accordance with the Administrative Procedure Act (5 U.S.C. 553(d)), which ordinarily requires a 30-day delay in the effective date of a final rule from the date of its public availability in the 
                        <E T="04">Federal Register</E>
                        , and section 1871(e)(1)(B)(i) of the Act, which generally prohibits a substantive rule from taking effect before the end of the 30-day period beginning on the date of its public availability.
                    </P>
                    <HD SOURCE="HD1">VI. Collection of Information Requirements</HD>
                    <P>
                        Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        ), we are required to publish a 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. For the purposes of the PRA and this section of the preamble, collection of information is defined under 5 CFR 1320.3(c) of OMB's implementing regulations.
                    </P>
                    <P>To fairly evaluate whether an information collection should be approved by OMB, PRA section 3506(c)(2)(A) 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 burden estimates.</P>
                    <P>• The quality, utility, and clarity of the information to be collected.</P>
                    <P>• Our effort to minimize the information collection burden on the affected public, including the use of automated collection techniques.</P>
                    <P>We are soliciting public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements.</P>
                    <HD SOURCE="HD2">A. Wage Estimates</HD>
                    <P>
                        To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2019 National Occupational Employment and Wage Estimates for all salary estimates (
                        <E T="03">http://www.bls.gov/oes/current/oes_nat.htm</E>
                        ). In this regard, Table 52 presents the mean hourly wage, the cost of fringe benefits and overhead (calculated at 100 percent of salary), and the adjusted hourly wage.
                    </P>
                    <GPH SPAN="3" DEEP="283">
                        <PRTPAGE P="50338"/>
                        <GID>EP17AU20.087</GID>
                    </GPH>
                    <P>As indicated, we adjusted our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.</P>
                    <P>For the CY 2019 and CY 2020 PFS final rules, we used the BLS wage rate for “Physicians and Surgeons” (occupation code 29-1060) to estimate the burden for Physicians. In BLS' most recent set of occupational wage rates dated May 2019, they have discontinued this occupation in their wage data. As a result, in order to estimate the burden for Physicians, we are using a rate of $212.78/hr which is the average of the mean wage rates for Anesthesiologists; Family Medicine Physicians; General Internal Medicine Physicians; Obstetricians and Gynecologists; Pediatricians, General; Physicians, All Other; and Ophthalmologists, Except Pediatric; Psychiatrists; and Surgeons, Except Ophthalmologists [($251.66/hr + $205.06/hr + $193.70/hr + $224.62/hr + $177.32/hr + $195.62/hr + $211.96/hr + $242.34/hr) ÷ 8].</P>
                    <HD SOURCE="HD2">B. Proposed Information Collection Requirements (ICRs)</HD>
                    <HD SOURCE="HD3">1. ICRs Regarding Modifications to OTP Enrollment Process (§ 424.67)</HD>
                    <P>The following proposed requirement and burden changes will be submitted to OMB for approval under control numbers 0938-0685 and 0938-1377 (respectively, CMS-855A and CMS-855B).</P>
                    <HD SOURCE="HD3">a. Form CMS-855B Completion—Estimates in November 15, 2019 Final Rule</HD>
                    <P>In the aforementioned November 15, 2019 final rule (84 FR 62568), we prepared estimates of the hour and cost burdens to OTPs in completing the Form CMS-855B (Medicare Enrollment Application Clinics/Group Practices and Certain Other Suppliers). We are restating them in the current proposed rule to help stakeholders better understand the burdens associated with our proposed changes to § 424.67.</P>
                    <P>Based on SAMHSA statistics and our internal data, we estimated in the November 15, 2019 final rule, that: (1) About 1,700 certified and accredited OTPs were eligible for Medicare enrollment; and (2) 200 OTPs would become certified by SAMHSA in the next 3 years (or roughly 67 per year). This brought the total number of OTPs eligible to enroll during this 3-year period to approximately 1,900.</P>
                    <P>We projected that it would take each OTP an average of 3 hours to obtain and furnish the required information on the Form CMS-855B and a new supplement thereto designed to capture data unique to OTPs. Per our experience, we believed that the OTP's medical secretary would secure and report the data on the Form CMS-855B and supplement. We estimated that this task would take approximately 2.5 hours, of which about 30 minutes would involve completion of the supplement. In addition, a health diagnosing and treating practitioner of the OTP would review and sign the form, a process we estimated would take 30 minutes.</P>
                    <P>
                        Using BLS' May 2018 wage estimates, we consequently projected a first-year burden of 5,301 hours (1,767 entities × 3 hr) at a cost of $244,146 [1,767 entities ((2.5 hr × $35.66/hr) + (0.5 hr × $98.04/hr))]; a second-year burden of 201 hours (67 entities × 3 hr) at a cost of $9,257 [67 entities × ((2.5 hr × $35.66/hr) + (0.5 hr $98.04/hr))]; and a third-year burden of 198 hours [66 entities × 3 hr) at a cost of $9,119 (66 entities × ((2.5 hr × $35.66/hr) + (0.5 hr × $98.04/hr))]. In aggregate, we estimated a total 3-year burden of 5,700 hours (5,301 hr + 201 hr + 198 hr) at a cost of $262,522 ($244,146 + $9,257 + $9,119). When averaged over the typical 3-year OMB approval period, we estimated an annual burden of 1,900 hours (5,700 hr/3) at a cost of $87,507 ($262,522/3).
                        <PRTPAGE P="50339"/>
                    </P>
                    <HD SOURCE="HD3">b. Proposed Revisions to § 424.67</HD>
                    <HD SOURCE="HD3">(1) Completion of Form CMS-855A</HD>
                    <P>We foresee three main implications associated with our proposed changes to § 424.67. First, newly enrolling OTPs would be able to complete and submit a Form CMS-855A (Medicare Enrollment Application—Institutional Providers) instead of a Form CMS-855B. Second, we anticipate that numerous OTPs that are currently enrolled via the Form CMS-855B would terminate the latter enrollments and complete/submit a Form CMS-855A application in order to bill for OTP services via the 837I. (As stated in proposed/revised § 424.67(c), an OTP cannot be enrolled via both the Form CMS-855A and Form CMS-855B; it must choose one of these two enrollment mechanisms.) Third, it is possible that some OTPs that enroll using the Form CMS-855A (pursuant to revised § 424.67(b)) would later change their enrollment to a Form CMS-855B.</P>
                    <P>In preparing the following OTP enrollment estimates, we: (1) Reviewed internal PECOS and billing data concerning existing OTP Form CMS-855 enrollments and claim submissions; and (2) considered feedback recently received from the OTP community regarding potential billing and enrollment options. Based on this, we project that over the first 3 years of our proposed changes to § 424.67:</P>
                    <P>• Roughly one-half (or 33) of the previously estimated 67 annually enrolling OTPs (that is, in Years 2 and 3 and beyond) would elect to complete a Form CMS-855A rather than a Form CMS-855B.</P>
                    <P>• Approximately 300 currently enrolled OTPs would change their enrollment from a Form CMS-855B to a Form CMS-855A.</P>
                    <P>• About 10 OTPs that enroll using the Form CMS-855A would later change their enrollment to a Form CMS-855B.</P>
                    <HD SOURCE="HD3">(a) New OTPs Enrolling via the Form CMS-855A</HD>
                    <P>We estimate that it would take each OTP approximately 4 hours to secure and provide the relevant data on the Form CMS-855A and the new supplement thereto (which would capture OTP-specific information). Consistent with our experience, the OTP's medical secretary would obtain and report information on the Form CMS-855A and supplement, a task that would take roughly 3.5 hours (about 30 minutes of which would involve completion of the supplement). A health diagnosing and treating practitioner of the OTP would spend 30 minutes reviewing and signing the form.</P>
                    <P>Given the preceding data, we project an annual burden for new OTPs seeking to complete a Form CMS-855A of 132 hours (4 hr × 33 OTPs) at a cost of $5,855 (33 OTPs × ((3.5 hr × $36.62/hr) + (0.5 hr × $98.52/hr)). Since these OTPs would not be completing the Form CMS-855B as originally anticipated in the November 15, 2019 final rule and approved by OMB in that rule's collection of information request, we must revise the Form CMS-855B estimates identified therein. Using the hour and wage burdens from that rule, we project a Form CMS-855B annual burden reduction of 99 hours (33 OTPs × 3 hr) at a cost of $4,560 (33 OTPs × (2.5 hr × $35.66/hr) + (0.5 hr × $98.04/hr)).</P>
                    <HD SOURCE="HD3">(b) Enrolled OTPs Transitioning to Form CMS-855A or Form CMS-855B Enrollment</HD>
                    <P>As already mentioned, we believe that roughly:</P>
                    <P>++ 300 currently enrolled OTPs would change their enrollment from a Form CMS-855B to a Form CMS-855A.</P>
                    <P>++ 10 OTPs that enroll using the Form CMS-855A would later change their enrollment to a Form CMS-855B.</P>
                    <P>
                        This would involve the OTP's: (1) Completion of a Form CMS-855A or Form CMS-855B application as a new enrollment; and (2) reporting the voluntary termination of its existing Form CMS-855 enrollment via the latter form (
                        <E T="03">i.e.,</E>
                         if the OTP is ceasing its Form CMS-855B enrollment, it would report this via a Form CMS-855B voluntary termination submission).
                    </P>
                    <HD SOURCE="HD3">(i) Transition to Form CMS-855A Enrollment</HD>
                    <P>Under our previously mentioned Form CMS-855A hour and wage estimates, we project a total burden for new Form CMS-855A enrollments pursuant to revised § 424.67(b) of 1,200 hours (300 OTPs × 4 hr) at a cost of $53,229 (300 OTPs × ((3.5 hr × $36.62/hr) + (0.5 hr × $98.52/hr)). Regarding voluntary terminations (and consistent with previous ICR estimates for reporting this type of Form CMS-855B transaction), the typical burden is 15 minutes. Of this time period, a medical secretary spends 12 minutes completing the relevant sections of the Form CMS-855 while a health diagnosing and treating practitioner takes 3 minutes to review and sign the form. This would result in a total burden of 75 hours (300 OTPs × 0.25 hr) at a cost of $3,675 (300 OTPs × ((0.2 hr × $36.62/hr) + (0.05 hr × $98.52/hr)).</P>
                    <P>We believe that the burden described in the previous paragraph would be incurred exclusively in the first year following our proposed changes; it is very likely these OTPs would wish to pursue Form CMS-855A enrollment as soon as possible in order to bill via the 837I. Accordingly, the average annual burden in the first 3 years would be as follows:</P>
                    <P>• Form CMS-855A—400 hours (1,200 hr/3) at a cost of $17,743 ($53,229/3).</P>
                    <P>• Form CMS-855B—25 hours (75 hr/3) at a cost of $1,225 ($3,675/3).</P>
                    <HD SOURCE="HD3">(ii) Transition to Form CMS-855B Enrollment</HD>
                    <P>In line with our hour and wage estimates previously referenced in this section IV.B.1, we project a total burden for new Form CMS-855B enrollments under § 424.67(c)(2) of 30 hours (10 OTPs × 3 hr) at a cost of $1,480 (10 OTPs × ((2.5 hr × $36.62/hr) + (0.5 hr × $98.52/hr)). Concerning Form CMS-855A voluntary terminations (and using the time burdens identified earlier), we estimate a total burden of 2.5 hours (10 OTPs × 0.25 hr) at a cost of $123 (10 OTPs × ((0.2 hr × $36.62/hr) + (0.05 hr × $98.52/hr)).</P>
                    <P>We anticipate that changes to a Form CMS-855B would occur in the second and third years following the effective date of our revisions. This is because Year 1 would mostly involve these new OTPs enrolling for the first time via the Form-855A; only in the succeeding two years would they switch to a Form CMS-855B enrollment. We thus project that the average annual burden in the first 3 years would be as follows:</P>
                    <P>• Form CMS-855B—10 hours (30 hr/3) at a cost of $469 ($1,408/3).</P>
                    <P>• Form CMS-855A—0.8 hours (2.5 hr/3) at a cost of $41 ($123/3).</P>
                    <P>(2) Total Annual Burden</P>
                    <P>In light of foregoing estimates, and when averaged over the typical 3-year OMB approval period, we estimate the following:</P>
                    <P>• Form CMS-855A—The total annual increased burden would be 533 hours (132 hr + 400 hr + 0.8 hr) at a cost of $23,639 ($5,855 + $17,743 + $41).</P>
                    <P>• Form CMS-855B—We project a reduction in annual burden of −64 hours (−99 hr−25 hr−10 hr) and $2,866 (−$4,560−$1,225−$469).</P>
                    <HD SOURCE="HD3">(3) Application Fee</HD>
                    <P>
                        Under § 424.67(b)(2), an enrolling OTP must comply with the application fee requirements in § 424.514. This means, in short, that an OTP must pay the required application fee as part of the enrollment process. The application fee does not meet the definition of a “collection of information” and, as such, is not subject to the requirements of the PRA. Although we did not set out such burden under this section of the 
                        <PRTPAGE P="50340"/>
                        preamble, the cost is included under the Regulatory Impact Analysis section.
                    </P>
                    <HD SOURCE="HD3">(4) Fingerprinting</HD>
                    <P>We discussed in section III.B. of this proposed rule that certain OTPs are subject to the high-risk level of categorical screening under § 424.518. Said screening includes the submission of a set of fingerprints (via FBI Applicant Fingerprint Card FD-258) for a national background check from all individuals who maintain a 5 percent or greater direct or indirect ownership interest in the provider or supplier. In the November 15, 2019 final rule, we calculated the hour and cost burden associated with this activity, basing our estimates on an anticipated 1,900 total OTP enrollees over the 3-year period following publication of that rule.</P>
                    <P>We do not believe our proposed revisions to § 424.67 would involve any additional or reduced fingerprinting burden for two reasons. First, we are proposing in revised § 424.67(b)(3)(ii) that, in effect, Form CMS-855B-enrolled OTPs that are changing to a Form CMS-855A enrollment need only undergo the limited level of categorical screening (§ 424.518) if they have (as part of their Form CMS-855 enrollment) already successfully completed the moderate or high level of categorical screening under that same regulatory section. Since completion of moderate or high level screening (as applicable) would have been required for Form CMS-855B OTP enrollment, these OTPs (previously estimated at 300 total) would not have to again undergo fingerprinting as part of their Form CMS-855A enrollment. Second, and with the exception of the 300 new enrollments mentioned in the previous sentence, we do not foresee additional enrolling OTPs beyond: (1) The 1,900 which we estimated in the November 15, 2019 final rule; and (2) the roughly 67 newly enrolling OTPs in Year 2 and Year 3 and annually thereafter. In other words, the only change we project would be in the type of Form CMS-855 application these OTPs may complete, not the number of anticipated enrollees. As such, the total fingerprinting burden would not change.</P>
                    <HD SOURCE="HD3">2. ICRs Regarding the Medicare Shared Savings Program (42 CFR Part 425)</HD>
                    <P>Section 1899(e) of the Act provides that chapter 35 of title 44 of the U.S.C., which includes such provisions as the PRA, shall not apply to the Shared Savings Program. Accordingly, we are not setting out burden under the authority of the PRA. Please refer to sections VIII.H.7. and VIII.H.8. of this proposed rule for a discussion of the impacts associated with this rule's proposed changes to the Shared Savings Program's quality reporting requirements.</P>
                    <HD SOURCE="HD3">3. ICRs Regarding the Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan § 423.160(a)</HD>
                    <P>The following requirements and burden will be submitted to OMB for approval under control number 0938-0763 (CMS-R-262).</P>
                    <P>We are proposing to implement section 2003 of the SUPPORT for Patients and Communities Act, which requires that the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program beginning January 1, 2021, subject to any exceptions, which HHS may specify. We are proposing that prescribers be required to use the NCPDP SCRIPT 2017071 standard for Electronic Prescription for Controlled Substances (EPCS) prescription transmissions.</P>
                    <P>Based on internal 2019 CMS data, the transaction costs for the current process is approximately $2,855,390.85 [560,430 authorizations * 0.5 (accounting for one transaction since manual authorization takes 2 transactions) * $10.19 per manual authorization]) per year. Should we finalize this requirement after reviewing comments received in response to this proposed rule and the Request for Information entitled “Medicare Program: Electronic Prescribing for Controlled Substances; Request for Information,” the total annual cost for conducting the process electronically using the standard that we propose is $526,804.20($1.88 * 0.5 * 560,430 authorizations). This amounts to an annual savings of $2,328,586.65 ($2,855,390.85 − $526,804.20).</P>
                    <P>In the first year of implementation, we expect that prescribers would have to revise their policies and procedures and-train staff on this new requirement. Based on our conversations with the industry, we understand that because electronic prescribing is so widespread and vendors train the staff directly and set-up their systems, we estimate that this transition could be completed with a one-time burden of 5 hours at $36.62/hr by an Administrative Assistant or Medical Secretary. However, we seek comment on this assumption.</P>
                    <P>Based on internal CMS data, there are 425,000 Part D prescribing practices. Based on the increasing rate of doctors conducting e-prescribing thus far and the benefits of e-prescribing, in light of the current social distancing guidelines, we estimate that by January 1 2022, 65 percent of Part D prescribers will have electronic prescribing capabilities absent the requirement. Therefore, the one-time burden to implement this provision is 743,750 hours (148,750 prescribers * 5 hr) at a cost of $27,236,125 (743,750 hr * $36.62/hr). Based on the modeling that we have seen, we have found that EHR companies provide the initial set-up of e-prescribing software free of charge, provided the prescribers pay the per transaction cost of $1.88 mentioned previously. However, we seek comment on this assumption and all other assumption in this burden estimate.</P>
                    <P>Therefore, the total costs of the existing ePA activity is $2,855,390.85 per year as compared to $526,804.20 for using the standard. This amounts to an annual savings of $2,328,586.65 in prescriber expenses with the first year resulting in an added cost of $24,907,538.35 ($27,236,125−$2,328,586.65)</P>
                    <HD SOURCE="HD3">4. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) Expanded Model</HD>
                    <P>In section III.P. of this proposed rule, we propose policies necessary to allow certain flexibilities for Medicare enrolled MDPP suppliers and eligible beneficiaries in the MDPP Expanded Model during a public health emergency. Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model, from the provisions of the PRA.</P>
                    <HD SOURCE="HD3">5. The Quality Payment Program (42 CFR Part 414 and Section IV. of this Proposed Rule)</HD>
                    <P>The following QPP-specific ICRs reflect this rule's proposed policy changes and policies that have been finalized in our CY 2017 and 2018 Quality Payment Program final rules (81 FR 77008 and 82 FR 53568, respectively), and our CY 2019 and CY 2020 PFS final rules (83 FR 59452 and 84 FR 62568, respectively).</P>
                    <HD SOURCE="HD3">a. Background</HD>
                    <HD SOURCE="HD3">(1) ICRs Associated With MIPS and Advanced APMs</HD>
                    <P>
                        The Quality Payment Program is comprised of a series of ICRs associated with MIPS and Advanced APMs. The MIPS ICRs consist of: Registration for virtual groups (see section VI.B.5.b of this proposed rule); QCDR self-nomination applications and other requirements (see section VI.B.5.c.(2) of this proposed rule); qualified registry self-nomination applications and other 
                        <PRTPAGE P="50341"/>
                        requirements (see section VI.B.5.c.(3) of this proposed rule); CAHPS survey vendor applications (see section VI.B.5.c.(4) of this proposed rule); Open Authorization credentialing and token request process (see section VI.B.5.d of this proposed rule); Quality Payment Program Identity Management Application Process (see section VI.B.5.e.(3) of this proposed rule); quality performance category data submission by Medicare Part B claims collection type (see section VI.B.5.e.(4) of this proposed rule), QCDR and MIPS CQM collection type (see section VI.B.5.e.(5) of this proposed rule), and eCQM collection type (see section VI.B.5.e.(6) of this proposed rule); CAHPS for MIPS survey beneficiary participation (see section VI.B.5.e.(7) of this proposed rule); group registration for CAHPS for MIPS survey (see section VI.B.5.e.(8) of this proposed rule); call for quality measures (see section VI.B.5.f of this proposed rule); reweighting applications for Promoting Interoperability and other performance categories (see section VI.B.5.g.(2) of this proposed rule); Promoting Interoperability performance category data submission (see section VI.B.5.g.(3) of this proposed rule); call for Promoting Interoperability measures (see section VI.B.5.h of this proposed rule); improvement activities performance category data submission (see section VI.B.5.i of this proposed rule); nomination of improvement activities (see section VI.B.5.j of this proposed rule); nomination of MVPs (see section VI.B.5.k of this proposed rule); and opt-out of Physician Compare for voluntary participants (see section VI.B.5.o of this proposed rule).
                    </P>
                    <P>The ICRs for Advanced APMs consist of: Partial Qualifying APM Participant (QP) election (section VI.B.5.m of this proposed rule); Other Payer Advanced APM identification: Payer Initiated and Eligible Clinician Initiated Processes (sections VI.B.5.n.(1) and (2) of this proposed rule); and submission of data for QP determinations under the All-Payer Combination Option (section VI.B.5.n.(3) of this proposed rule).</P>
                    <HD SOURCE="HD3">(2) Summary of Quality Payment Program Changes: MIPS</HD>
                    <P>Two of our currently approved MIPS ICRs [(1) quality performance category data submission by CMS Web Interface collection type and (2) group registration for the CMS Web Interface] are being removed while five MIPS ICRs [(1) quality performance category data submission by QCDR and MIPS CQM collection type, (2) quality performance category data submission by eCQM collection type, (3) CAHPS for MIPS survey beneficiary participation, (4) nomination of improvement activities, and (5) reweighting applications for Promoting Interoperability and other performance categories] show changes in burden due to proposed policies. In aggregate, we estimate the proposed policies will result in a net decrease in burden of −5,488 hours and −$488,115. The proposal discussed in section IV.A.3.c.(1)(c) of this proposed rule to sunset the CMS Web Interface measures as a collection type/submission type starting with the 2021 performance period will result in removal of the quality performance category data submission by CMS Web Interface collection type and group registration for the CMS Web Interface ICRs. The same proposal will increase the number of respondents for both the MIPS CQM and QCDR and eCQM collection types for the quality performance category as we assume respondents who previously submitted via the CMS Web Interface collection type will alternatively utilize one of these collection types to submit quality data. The proposal discussed in section IV.A.3.c.(1)(e)(i) of this proposed rule to add a survey-based measure on telehealth that assesses patient-reported usage of telehealth services to the CAHPS for MIPS Survey will increase the time required for beneficiaries to respond to the survey by 0.2 minutes (0.0033 hours) per beneficiary. The proposal discussed in section IV.A.3.c.(3)(b)(i)(B)(bb) of this proposed rule to require nominated improvement activities to be linked to existing and related quality and cost measures, as applicable and feasible will increase the time by 1 hour per improvement activity nominated. Finally, the proposal discussed in section IV.A.3.c.(5)(e) of this proposed rule to allow APM Entities the ability to submit an extreme and uncontrollable circumstances exception application will increase our estimated number of respondents by 7 APM Entities. The remaining changes to our currently approved burden estimates are adjustments due to the use of updated data sources available at the time of publication of this proposed rule.</P>
                    <P>We have also added two new ICRs (Open Authorization (OAuth) Credentialing and Token Request Process (see section VI.B.5.d, below) and the Nomination of MVPs (see section VI.B.5.k, below). The Open Authorization (OAuth) Credentialing and Token Request Process ICR reflects the burden associated with the availability of a new process for all submitter types to request approval to submit data via direct upload to CMS. The Nomination of MVPs reflects the burden associated with a new process available for all stakeholders to nominate MVPs for inclusion in the Quality Payment Program.</P>
                    <P>We are not making any changes or adjustments to the following ICRs: Registration for virtual groups, CAHPS survey vendor applications, Quality Payment Program Identity Management Application Process, group registration for CAHPS for MIPS survey; call for MIPS quality measures; and call for Promoting Interoperability measures. See section VI.B.5. of this proposed rule for a summary of the ICRs, the overall burden estimates, and a summary of the assumption and data changes affecting each ICR.</P>
                    <P>The accuracy of our estimates of the total burden for data submission under the quality, Promoting Interoperability, and improvement activities performance categories may be impacted due to two primary reasons. First, we are unable to predict with 100 percent certainty who will be a QP. New eligible clinician participants in Advanced APMs who become QPs would be excluded from MIPS reporting requirements and payment adjustments, and as such, unlikely to report under MIPS; while some current Advanced APM participants may end participation such that the APM Entity's eligible clinicians would not be QPs for a year based on § 414.1425(c)(5), and thus be required to report under MIPS. Second, it is difficult to predict what Partial QPs, who can elect whether to report to MIPS, will do in the 2021 MIPS performance period compared to the 2018 MIPS performance period, and therefore, the actual number of Advanced APM participants and how they elect to submit data may be different than our estimates. However, we believe our estimates are the most appropriate given the available data.</P>
                    <HD SOURCE="HD3">(3) Summary of Quality Payment Program Changes: Advanced APMs</HD>
                    <P>
                        For these ICRs (identified above under, “ICRs Associated with MIPS and Advanced APMs”), the changes to currently approved burden estimates are adjustments based on updated projections for the 2021 MIPS performance period. We are not making any changes to the Other Payer Advanced APM identification: Eligible Clinician Initiated Process and submission of Data for QP determinations under the All-Payer Combination Option ICRs.
                        <PRTPAGE P="50342"/>
                    </P>
                    <HD SOURCE="HD3">(4) Framework for Understanding the Burden of MIPS Data Submission</HD>
                    <P>Because of the wide range of information collection requirements under MIPS, Table 53 presents a framework for understanding how the organizations permitted or required to submit data on behalf of clinicians vary across the types of data, and whether the clinician is a MIPS eligible clinician or other eligible clinician voluntarily submitting data, MIPS APM participant, or an Advanced APM participant. As shown in the first row of Table 53, MIPS eligible clinicians that are not in MIPS APMs and other clinicians voluntarily submitting data will submit data either as individuals, groups, or virtual groups for the quality, Promoting Interoperability, and improvement activities performance categories. Note that virtual groups are subject to the same data submission requirements as groups, and therefore, we will refer only to groups for the remainder of this section unless otherwise noted. Because MIPS eligible clinicians are not required to submit any additional information for assessment under the cost performance category, the administrative claims data used for the cost performance category is not represented in Table 53.</P>
                    <P>For MIPS eligible clinicians participating in MIPS APMs, the organizations submitting data on behalf of MIPS eligible clinicians will vary between performance categories and, in some instances, between MIPS APMs. As discussed in section IV.A.3.b. of this proposed rule, for clinicians in APM Entities, the APM Performance Pathway is available for both ACO and non ACOs to submit quality data. Due to data limitations and our inability to determine who would use the APM Performance Pathway versus the traditional MIPS submission mechanism for the 2021 MIPS performance period, we assume ACO APM Entities will submit data through the APM Performance Pathway and non-ACO APM Entities would participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity.</P>
                    <P>For the Promoting Interoperability performance category, group TINs may submit data on behalf of eligible clinicians in MIPS APMs, or eligible clinicians in MIPS APMs may submit data individually. For the improvement activities performance category, we will assume no reporting burden for MIPS APM participants. In the CY 2017 Quality Payment Program final rule, we described that for MIPS APMs, we compare the requirements of the specific MIPS APM with the list of activities in the Improvement Activities Inventory and score those activities in the same manner that they are otherwise scored for MIPS eligible clinicians (81 FR 77185). Although the policy allows for the submission of additional improvement activities if a MIPS APM receives less than the maximum improvement activities performance category score, to date all MIPS APM have qualified for the maximum improvement activities score. Therefore, we assume that no additional submission will be needed.</P>
                    <P>Eligible clinicians who attain Partial QP status may incur additional burden if they elect to participate in MIPS, which is discussed in more detail in the CY 2018 Quality Payment Program final rule (82 FR 53841 through 53844).</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50343"/>
                        <GID>EP17AU20.088</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="50344"/>
                    <P>The policies finalized in the CY 2017 and CY 2018 Quality Payment Program final rules, the CY 2019 and CY 2020 PFS final rules, and continued in this proposed rule create some additional data collection requirements not listed in Table 53. These additional data collections, some of which are currently approved by OMB under the control numbers 0938-1314 (Quality Payment Program, CMS-10621) and 0938-1222 (CAHPS for MIPS, CMS-10450), are as follows:</P>
                    <HD SOURCE="HD3">Additional ICRs Related to MIPS Third-Party Intermediaries (See Section VI.B.5.c)</HD>
                    <P>• Self-nomination of new and returning QCDRs (81 FR 77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59998 through 60000) (OMB 0938-1314).</P>
                    <P>• Self-nomination of new and returning registries (81 FR 77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 through 59998) (OMB 0938-1314).</P>
                    <P>• Open Authorization Credentialing and Token Request Process (New) (OMB 0938-1314) (see section VI.B.5.d).</P>
                    <HD SOURCE="HD3">Additional ICRs Related to the Data Submission and the Quality Performance Category (See Section VI.B.5.e)</HD>
                    <P>• CAHPS for MIPS survey completion by beneficiaries (81 FR 77509, 82 FR 53916 through 53917, and 83 FR 60008 through 60009) (OMB 0938-1222).</P>
                    <P>• Quality Payment Program Identity Management Application Process (82 FR 53914 and 83 FR 60003 through 60004) (OMB 0938-1314).</P>
                    <HD SOURCE="HD3">Additional ICRs Related to the Promoting Interoperability Performance Category (See Section VI.B.5.g)</HD>
                    <P>• Reweighting Applications for Promoting Interoperability and other performance categories (82 FR 53918 and 83 FR 60011 through 60012) (OMB 0938-1314).</P>
                    <HD SOURCE="HD3">Additional ICRs Related To Call for New MIPS Measures and Activities (See Sections VI.B.5.f, VI.B.5.h, VI.B.5.j. and VI.B.5.k)</HD>
                    <P>• Nomination of improvement activities (82 FR 53922 and 83 FR 60017 through 60018) (OMB 0938-1314).</P>
                    <P>• Call for new Promoting Interoperability measures (83 FR 60014 through 60015) (OMB 0938-1314).</P>
                    <P>• Call for MIPS quality measures (83 FR 60010 through 60011) (OMB 0938-1314).</P>
                    <P>• Nomination of MVPs (OMB 0938-1314)</P>
                    <HD SOURCE="HD3">Additional ICRs Related to MIPS (See Section VI.B.5.o)</HD>
                    <P>• Opt out of performance data display on Physician Compare for voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 60022) (OMB 0938-1314).</P>
                    <HD SOURCE="HD3">Additional ICRs Related to APMs (See Sections VI.B.5.m and VI.B.5.n)</HD>
                    <P>• Partial QP Election (81 FR 77512 through 77513, 82 FR 53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314).</P>
                    <P>• Other Payer Advanced APM determinations: Payer Initiated Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB 0938-1314).</P>
                    <P>• Other Payer Advanced APM determinations: Eligible Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-1314).</P>
                    <P>• Submission of Data for All-Payer QP Determinations (83 FR 60021) (OMB 0938-1314).</P>
                    <HD SOURCE="HD3">b. ICRs Regarding the Virtual Group Election (§ 414.1315)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the virtual group election. The virtual group election requirements and burden are currently approved by OMB under control number 0938-1343 (CMS-10652). Consequently, we are not making any virtual group election changes under that control number.</P>
                    <HD SOURCE="HD3">c. ICRs Regarding Third-Party Intermediaries (§ 414.1400)</HD>
                    <P>In section IV.A.3.g. of this rule, we proposed multiple changes to the third party intermediary regulations at § 414.1400. Specifically, we are proposing to: (1) Amend current requirements for approval of third party intermediaries to take into account past performance and provision of inaccurate information regarding MIPS program requirements to eligible clinicians; (2) require attendance by all third party intermediaries for training and support sessions; (3) require that QCDRs and qualified registries must conduct an annual data validation audit and if one or more deficiencies or data errors are identified also conduct targeted audits; (4) incrementally increase requirements for QCDR measure testing and clarify what is meant by full testing; and (5) require third party intermediaries to submit a CAP to address identified deficiencies and data issues as well as actions to prevent recurrence. The collection of information burdens associated with each of these topics are discussed separately below for qualified registries, QCDRs, and survey vendors.</P>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>
                        Under MIPS, the quality, Promoting Interoperability, and improvement activities performance category data may be submitted via relevant third-party intermediaries, such as qualified registries, QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which counts as either one quality performance category measure, or towards an improvement activity, can be submitted via CMS-approved survey vendors. Entities seeking approval to submit data on behalf of clinicians as a qualified registry, QCDR, or survey vendor must complete a self-nominate process annually.
                        <SU>109</SU>
                        <FTREF/>
                         The processes for self-nomination for entities seeking approval as qualified registries and QCDRs are similar with the exception that QCDRs have the option to nominate QCDR measures for approval for the reporting of quality performance category data. Therefore, differences between QCDRs and qualified registry self-nomination are associated with the preparation of QCDR measures for approval.
                    </P>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             As stated in the CY 2019 PFS final rule (83 FR 53998), health IT vendors are not included in the burden estimates for MIPS.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(2) QCDR Self-Nomination Applications</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related solely to QCDRs. For simplicity and due to limitations in data available, the changes in burden associated with QCDRs due to this rule's proposals have been incorporated into the discussion of burden for qualified registries. We assume no additional changes in burden due to other proposals discussed in this section. The requirements and burden for QCDRs are currently approved by OMB under control number 0938-1314 (CMS-10652). Consequently, we are not making any changes under that control number other than those discussed in the context of qualified registries.</P>
                    <HD SOURCE="HD3">(a) Self-Nomination Process and Other Requirements</HD>
                    <P>
                        We refer readers to § 414.1400(a)(4) which states that QCDRs interested in submitting MIPS data to us on behalf of a MIPS eligible clinician, group, or virtual group will need to complete a self-nomination process to be considered for approval to do so. We also refer readers to § 414.1400(b) and the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final 
                        <PRTPAGE P="50345"/>
                        rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59998 through 60000), and the CY 2020 PFS final rule (84 FR 63116 through 63121) for our previously finalized requirements and burden for self-nomination of QCDRs and nomination of QCDR measures. In sections VI.A.3.g.(2)(a) of this rule, we are proposing to codify that beginning with the 2023 payment year as a condition of approval each QCDR must conduct an annual data validation audit that conforms to the requirements in § 414.1400(b)(2)(iv), including specific obligations discussed in detail in those sections, and if one or more deficiencies or data errors are identified the QCDR must also conduct targeted audits that conform to the § 414.1400(b)(2)(v) including specific obligations discussed in detail in those sections. In particular, we propose to codify at § 414.1400(b)(2)(iv)(G), that in a form and manner and by a deadline specified by CMS, the QCDR must report the results of each data validation audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or data error, and how and when each deficiency or data error type was corrected. In addition, we propose to codify at § 414.1400(b)(2)(v)(D), that in a form and manner and by a deadline specified by CMS, the QCDR must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected. We are not revising our burden estimates as a result of the proposal to codify that QCDRs must conduct particular data validation audits and report data validation results because we believe the burdens of the proposed data validation requirements are not greater than existing expectations for which we have already accounted the associated burden as stated in the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999) and previously submitted to OMB for approval under control number 0938-1314 (CMS-10621). With regard to the proposal to require QCDRs to conduct targeted audits if one or more data errors are identified during data validation audits, we are unable to estimate the number of targeted audits which may occur or the time and costs associated with submitting results which could vary substantially depending on the nature of the data error and the amount of data to be audited. We seek comment on the burdens associated with the proposed requirements for data validation audits and targeted audits, including expected frequency of targeted audits and the anticipated scope of effort related to submitting results to assist in estimating the burden associated with this proposal. We also discuss additional impacts of this proposal in section VIII.F.16.d.(4)(d) of the Regulatory Impact Analysis.
                    </P>
                    <P>In sections VI.A.3.g.(1)(b)(iii) of this rule, we are proposing to codify that beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner and at the times specified by CMS. Due to the nature of the information provided during these calls and because the proposed training requirements as applied to qualified registries and QDCRs are similar to existing expectations for these entities, we are not revising our burden estimates as a result of these proposals. However, we refer readers to section VIII.F.16.d.(4)(d) of this proposed rule for discussion of our estimates of overall impact.</P>
                    <P>In section VI.A.3.g.(1)(b)(ii) of this rule, we are proposing that the determination of whether to approve as entity as a third party intermediary for a MIPS performance period may take into account: (1) Whether the entity failed to comply with requirements of third party intermediaries for any prior MIPS payment year for which it was approved as third party intermediary; and (2) whether the entity provided inaccurate information regarding the requirements of this subpart to any eligible clinician. Because this proposal does not require any additional effort for affected entities but instead allows CMS to utilize already available information to make approval decisions, collection of information burden is unaffected for all entities. In addition, we do not anticipate this proposal will result in any QCDRs electing not to self-nominate during the 2021 MIPS performance period, but believe it is possible this may occur. However, we have neither any data nor knowledge of intent from previously approved QCDRs with which to support making any changes to our burden estimates as a result of this proposal. We are soliciting public feedback to help us determine if there are any burden implications.</P>
                    <HD SOURCE="HD3">(b) QCDR Measure Requirements</HD>
                    <P>
                        Previously, we finalized a requirement to require all QCDR measures to be fully developed and tested, with complete testing results at the clinician level, beginning with the CY 2021 performance period in the CY 2020 PFS final rule (84 FR 40816). In the May 8th COVID-19 IFC-2 (85 FR 27594 through 27595), we delayed this requirement such that beginning with the CY 2022 performance period, all QCDR measures must be fully developed and tested, with complete testing results at the clinician level, prior to submitting the QCDR measure at the time of self-nomination. In section VI.A.3.g.(2)(b)(i)(A)(aa) of this rule, we are proposing an incremental approach to require fully tested QCDR measures. Specifically, we propose at § 414.1400(b)(3)(v)(C)(1) that, generally, QCDR measures that were previously approved for the CY 2020 performance period, would be required to, at a minimum, be face valid prior to being self-nominated for the CY 2022 performance period/CY 2024 payment year. To be approved for the 2025 MIPS payment year and future years, a QCDR measure must be face valid for the initial MIPS payment year for which it is approved and fully tested for any subsequent MIPS payment year for which it is approved. In order for the QCDR measure to be considered for approval, testing must be completed at the clinician level by the time the measure is self-nominated. However, to be included in an MVP for the 2024 MIPS payment year and future years, a QCDR measure must be fully tested. QCDR measures that were previously approved for the 2020 performance period, will be required to, at a minimum, be face valid prior to being self-nominated for the CY 2022 performance period, and would be required to be fully tested prior to being self-nominated for any subsequent performance periods in order to be considered for inclusion in the MIPS program. Because these proposals are not modifying the final testing requirements for QCDR measures but are instead proposing modifications to the phasing and timeline for implementation of previously finalized requirements for QCDR measures other than those which will be included in an MVP, we are not making any changes to our currently approved burden estimates; however, we refer readers to section VIII.F.16.d.(4)(d) of this proposed rule for discussion of impacts associated with this proposal. Such burden estimates and requirements are currently approved by OMB under control number 0938-1314 (CMS-10621). We seek comment on our burden estimates and assumptions 
                        <PRTPAGE P="50346"/>
                        associated with these proposals regarding the testing of QCDR measures including those which will be included in an MVP.
                    </P>
                    <HD SOURCE="HD3">(3) Qualified Registry Self-Nomination Process and Other Requirements</HD>
                    <P>The requirements and burden associated with this rule's proposed data submission changes related to qualified registries and QCDRs will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to § 414.1400(a)(4) which states that qualified registries interested in submitting MIPS data to us on behalf of MIPS eligible clinicians, groups, or virtual groups need to complete a self-nomination process to be considered for approval to do so. We also refer readers to § 414.1400 (c) and the CY 2017 Quality Payment Program final rule (81 FR 77507 through 77508), CY 2018 Quality Payment Program final rule (82 FR 53906 through 53908), CY 2019 PFS final rule (83 FR 59997 through 59998), and the CY 2020 PFS final rule (84 FR 63114 through 63116) for our previously finalized requirements and burden for self-nomination of qualified registries.</P>
                    <P>In sections IV.A.3.g.(3)(a) of this rule, we are proposing to codify that beginning with the 2023 payment year as a condition of approval each qualified registry must conduct an annual data validation audit that conforms to the requirements in § 414.1400(b)(2)(iv), including specific obligations discussed in detail in those sections and if one or more deficiencies or data errors are identified the qualified registry must also conduct targeted audits that conform to the § 414.1400(b)(2)(v) including specific obligations discussed in detail in those sections. In particular, we propose to codify at § 414.1400(c)(2)(iii)(G), that in a form and manner and by a deadline specified by CMS, the qualified registry must report data validation results, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or data error, and how and when each deficiency or data error type was corrected. In addition, we propose to codify at § 414.1400(c)(2)(iv)(D), in a form and manner and by a deadline specified by CMS, the qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each error type was corrected. We are not revising our burden estimates as a result of the proposal to codify that qualified registries must conduct particular data validation audits and report data validation results because we believe the burdens of the proposed data validation requirements are not greater than existing expectations for which we have already accounted for the associated burden as stated in the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999) and previously submitted to OMB for approval under control number 0938-1314 (CMS-10621). With regard to the proposal to require qualified registries conduct targeted audits if one or more data errors are identified during data validation audits, we are unable to estimate the number of targeted audits which may occur or the time and costs associated with submitting results which could vary substantially depending on the nature of the data error and the amount of data to be audited. We seek comment on the burdens associated with the proposed requirements for data validation audits and targeted audits, including expected frequency of targeted audits and the anticipated scope of effort related to submitting results to assist in estimating the burden associated with this proposal. We also discuss additional impacts of this proposal in section VIII.F.16.d.(4)(d) of the Regulatory Impact Analysis.</P>
                    <P>In sections VI.A.3.g.(1)(b)(iii) of this rule, we are proposing to codify that beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner and at the times specified by CMS. Due to the nature of the information provided during these calls and because the proposed training requirements as applied to qualified registries and QDCRs are similar to existing expectations for these entities, we are not revising our burden estimates as a result of these proposals. However, we do refer readers to section VIII.F.16.d.(4)(d) of this proposed rule for discussion of our estimates of the overall impact of this proposal for all third party intermediaries.</P>
                    <P>In section VI.A.3.g.(1)(b)(ii) of this rule, we are proposing that the determination of whether to approve an entity as a third party intermediary for a MIPS performance period may take into account: (1) Whether the entity failed to comply with requirements of third party intermediaries for any prior MIPS payment year for which it was approved as third party intermediary; and (2) whether the entity provided inaccurate information regarding the requirements of the subpart to any eligible clinician. Because this proposal does not require any additional effort for affected entities but instead allows CMS to utilize already available information to make approval decisions, collection of information burden is unaffected for all entities. We also do not anticipate this proposal will result in any qualified registries or other third party intermediaries electing not to self-nominate during the 2021 MIPS performance period, but believe it is possible this may occur. However, we have neither any data nor knowledge of intent from previously approved qualified registries or other third party intermediaries with which to support making any changes to our burden estimates as a result of this proposal. We are soliciting public feedback to help us determine if there are any burden implications.</P>
                    <P>
                        In section VI.A.3.g.(4) of this proposed rule, we are proposing to modify the existing requirement at § 1400(f)(1)(i) requiring third party intermediaries to submit to CMS by a date specified by the agency a Corrective Action Plan (CAP) to address the identified deficiencies or data issue, including the actions it will take to prevent the deficiencies or data issues from recurring. While the requirement for third party intermediaries to submit a CAP was finalized in our CY 2017 Quality Payment Program final rule (81 FR 77389), we did not specify the information that must be included to be included in the CAP and neglected to identify the burden associated with the required information. We are correcting that oversight in this proposed rule. In addition, to clarify expectations and create consistency in the content of the CAPs provide by third party intermediaries, we are proposing to revise and elaborate on the obligations for a CAP in this proposed rule. Specifically, we propose to modify § 414.1400(f)(1)(i) such that, unless different or additional information is specified by CMS, the CAP submitted by the third party intermediary must address four issues: (1) The issues that contributed to the non-compliance; (2) the impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program; (3) the corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved will not 
                        <PRTPAGE P="50347"/>
                        recur in the future and (4) the detailed timeline for achieving compliance with the applicable requirements. Specifically, we propose at § 414.1400(f)(1)(i)(A) to require that each third party intermediary be required to articulate the issues that contributed to the non-compliance. The third party intermediary must articulate what factors cause it to fail in its obligation to meet program requirements. We also propose at § 414.1400(f)(1)(i)(B) to require that a third party intermediary subject to a CAP disclose to CMS the impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program. In addition, we propose at § 414.1400(f)(1)(i)(C) that a third party intermediary subject to a CAP must address the corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future. Furthermore, we propose at § 414.1400(f)(1)(i)(D) that each CAP must include the detailed timeline for achieving compliance with the applicable requirements. We have historically received a total of 34 CAPs over the 3-year period of CY 2017-2019 (an average of 11.3 per year). As third party intermediaries become increasingly effective at identifying data issues and discrepancies prior to submitting data to CMS and accounting for the estimated decrease in number of QCDRs and qualified registries self-nominating in the 2020 MIPS performance period compared to the 2019 MIPS performance period (from 350 to 229), we anticipate the annual number of CAPs received to decrease to fewer than 10 per year (83 FR 59997 through 60000 and 84 FR 63114 through 63121). The effort involved in developing a CAP including the detail specified in this proposed rule and submitting it to CMS is likely to be no more than 3 hours for a computer systems analyst at a rate of $92.46/hr. In aggregate we estimate an annual burden of no more than 30 hours (3 hr × 10 CAPs) at a cost of $2,774 (30 hr × $92.46/hr) for third party intermediaries to develop and submit a CAP.
                    </P>
                    <P>In the CY 2020 PFS final rule, we estimated 153 qualified registries would self-nominate (84 FR 63116). Using updated wage rates, the currently approved burden associated with these qualified registries is 459 hours (153 respondents × 3 hr/respondent) at a cost of $42,439 (459 hr × $92.46/hr). Because we are unable to predict how many of the estimated 10 third party intermediaries submitting CAPs will be qualified registries, QCDRs, survey vendors, or health IT vendors; for simplicity we are adding the burden to the currently approved burden for qualified registries for a total of 489 hours (459 hr + 30 hr) at a cost of $45,213 ($42,439 + $2,774).</P>
                    <HD SOURCE="HD3">(4) Survey Vendor Requirements</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to CMS-approved CAHPS for MIPS survey vendors. The requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450). Consequently, we are not making any MIPS survey vendor changes under that control number.</P>
                    <HD SOURCE="HD3">(5) Health IT Vendors</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to health IT vendors and we do not anticipate any changes to the CEHRT process as a result of proposals promulgated in this proposed rule. Consequently, we are not setting out burden or making any changes under the 0938-1314 (CMS-10621) control number.</P>
                    <HD SOURCE="HD3">d. Open Authorization (OAuth) Credentialing and Token Request Process</HD>
                    <P>In the CY 2017 Quality Payment Program final rule (81 FR 77035), we finalized the initial MIPS data submission terminology at § 414.1305 and requirements at § 414.1325, as well as the associated burden estimates. As discussed in the CY 2019 PFS final rule (83 FR 59747 through 59748), it subsequently came to our attention that the way we had previously described data submission did not precisely reflect the experience users have when submitting data to us. To ensure clarity and precision for all users, we amended the terminology at § 414.1305 to more precisely reflect this experience and made conforming amendments to § 414.1325 and other MIPS regulations. Among the newly defined terms was “submission type”, which we defined at § 414.1305 as the mechanism by which a submitter type submits data to CMS, including, as applicable: Direct, log in and upload, log in and attest, Medicare Part B claims and the CMS Web Interface. We stated in the CY 2019 PFS final rule that the direct submission type allows users to transmit data through a computer-to-computer interaction, such as an Application Programming Interface (API).</P>
                    <P>
                        Beginning in the 2021 MIPS performance period, CMS will offer the Open Authorization (OAuth) Credentialing and Token Request Process. This process utilizes an API to allow users to transmit data through a computer-to-computer interaction. As such, it is an alternate means of operationalizing the previously established direct submission type. The process first requires software developers to apply for production OAuth credentials to the submissions API by registering their application so that it can interact with the system providing OAuth capabilities. Next, the developer must request a meeting with the Quality Payment Program development team. During this meeting, the requesting organization will demonstrate their application's use of OAuth to successfully submit data in the Submissions API test environment. The requesting organization will also provide documentation about their terms of service, privacy policy, and related information for review by the Quality Payment Program team. If further clarification is required about any of the documentation or application, the Quality Payment Program team will follow up with the requesting organization. Once approved, the Quality Payment Program development team will issue production OAuth credentials to the requesting organization's point of contact. Detailed instructions for the authentication process and application for organizations to request OAuth credentials are available at 
                        <E T="03">https://cmsgov.github.io/qpp-submissions-docs/.</E>
                    </P>
                    <P>
                        The following burden estimates are associated with the first year of data collection for the OAuth Credentialing and Token Request Process. This process is available to all submitter types to be approved to submit data via the direct submission type. However, we assume the only parties that will elect to undergo the process will be health IT vendors or other third party intermediaries, as we believe these are the most likely parties to be developing applications. The burden associated with this ICR belongs only to the application developer; QPP participants will not be required to do anything additional to submit their data. For third party intermediaries, OAuth Credentialing will allow QPP participants to use their own QPP credentials to login through the third party intermediary's application to submit their data and view performance feedback from QPP. The proposed burden associated with the OAuth 
                        <PRTPAGE P="50348"/>
                        Credentialing and Token Request Process will be submitted to OMB for approval under control number 0938-1314 (CMS-10621). We refer readers to § 414.1400(a)(2) and the CY 2017 Quality Payment Program final rule (81 FR 77363 through 77364) and as further revised in the CY 2019 and CY 2020 PFS final rules at § 414.1400(a)(2) (83 FR 60088 and 84 FR 63052) for our current policy regarding the types of MIPS data third party intermediaries may submit.
                    </P>
                    <P>As stated in the CY 2020 PFS final rule (84 FR 63049) we are aware of stakeholders' desire to have a more cohesive participation experience across all performance categories under MIPS. We are offering this process in support of our current requirements for QCDRs and qualified registries to be able to submit data for all MIPS performance categories and health IT vendors to be able to submit data for at least one MIPS performance category (84 FR 63052 and 84 FR 63076) as well as our desire to further reduce administrative burden for clinicians to participate in MIPS. As we discuss in sections VI.B.5.e.(5), VI.B.5.e.(6), VI.B.5.g, and VI.B.5.i of this proposed rule individual clinicians or groups may submit their quality measures using the direct submission type via the MIPS CQM and QCDR or eCQM collection types as well as their Promoting Interoperability measures and improvement activities through the same direct submission type. Entities that receive approval for their applications through this process will be able to provide QPP participants a more comprehensive and less administratively burdensome experience using the direct submission type.</P>
                    <P>We estimate it would take approximately 1 hour at $92.46/hr for a computer systems analyst (or their equivalent) to provide documentation and any follow-up communication via email. We estimate that for during the 2021 MIPS performance period, 15 submitter types, consisting of third party intermediaries will complete this process to be approved for the CY 2022 submission period. We expect health IT vendors to adopt this method initially, with limited further adoption by QCDRs and Qualified Registries in future years. As shown in Table 54, we estimate it would take 1 hour at $92.46/hr for a computer systems analyst (or their equivalent) to complete the process. We estimate an annual burden of 15 hours (15 vendors × 1 hr) at a cost of $1,387 (15 hr × $92.46/hr) or $92.46 per organization ($1,387/15 vendors).</P>
                    <GPH SPAN="3" DEEP="109">
                        <GID>EP17AU20.089</GID>
                    </GPH>
                    <HD SOURCE="HD3">e. ICRs Regarding Quality Data Submission (§§ 414.1325 and 414.1335)</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77502 through 77503), CY 2018 Quality Payment Program final rule (82 FR 53908 through 53912), CY 2019 PFS final rule (83 FR 60000 through 60003), and the CY 2020 PFS final rule (84 FR 63121 through 63124) for our previously finalized requirements for data submission for the quality performance category.</P>
                    <P>Under our current policies, two groups of clinicians must submit quality data under MIPS: Those who submit as MIPS eligible clinicians and those who opt to submit data voluntarily but are not subject to MIPS payment adjustments. Clinicians are ineligible for MIPS payment adjustments if they are newly enrolled to Medicare; are QPs; are partial QPs who elect to not participate in MIPS; are not one of the clinician types included in the definition for MIPS eligible clinician; or do not exceed the low-volume threshold as an individual or as a group.</P>
                    <HD SOURCE="HD3">(2) Changes and Adjustments to Quality Performance Category Respondents</HD>
                    <P>To determine which QPs should be excluded from MIPS, we used the QP List for the 2019 third snapshot that contains participation in Advanced APMs as of August 31, 2019, that could be connected into our respondent data and are the best estimate of future expected QPs. From this data, we calculated the QP determinations as described in the Qualifying APM Participant (QP) definition at § 414.1305 for the 2021 QP Performance Period. We assumed that all Partial QPs will participate in MIPS data collections. Due to data limitations, we could not identify specific clinicians who have not yet enrolled in APMs, but who may become QPs in the future 2021 QP Performance Period (and therefore will no longer need to submit data to MIPS); hence, our model may underestimate or overestimate the number of respondents.</P>
                    <P>
                        In the CY 2019 PFS final rule, we finalized limiting the Medicare Part B claims collection type to small practices beginning with the 2021 MIPS payment year and allowing clinicians in small practices to report Medicare Part B claims as a group or as individuals (83 FR 59752). In the CY 2020 PFS final rule, we provided a set of assumptions and an approach to account for the clinicians not in small practices for whom the Medicare Part B claims collection type will no longer be available as an option for collecting and reporting quality data (84 FR 63121 through 63122). As in the CY 2020 PFS final rule, we are using 2018 MIPS performance period data to estimate the number of respondents, so we use the same methodology for this proposed rule; however, because of changes in the number of QPs and APM participation, the application of this methodology results in a slightly different adjustment to our estimates of respondents. In the CY 2020 PFS final rule, this approach resulted in a 103,103 decrease in the estimated number of clinicians who will submit quality data via Medicare Part B claims and a 12,931 increase in the number of clinicians who will submit via the QCDR/MIPS CQM collection type (84 FR 63122). For this rule, our assumptions result in a 101,390 decrease (from 195,977 to 94,587 in the estimated number of clinicians who will 
                        <PRTPAGE P="50349"/>
                        submit quality data via Medicare Part B claims and a 12,496 increase (from 92,340 to 104,836 in the number of clinicians who will submit via the MIPS CQM and QCDR collection type.
                    </P>
                    <P>In section IV.A.3.c.(1)(c) of this rule, we are proposing to sunset the CMS Web Interface measures as a collection type/submission type starting with the 2021 performance period. If this proposal is finalized, it will result in groups of 25 or more clinicians that previously submitted quality performance data via the CMS Web Interface being required to use an alternate collection type, which will have to be either the MIPS CQM and QCDR or eCQM collection type. While we know that 111 groups submitted quality performance data via the CMS Web Interface in the 2019 MIPS performance period, we are not able to ascertain what alternative collection type(s) the groups would elect. In order to estimate the number of groups that will select each of these collection types, we first clustered the number of groups which submitted data via the CMS Web Interface collection type during the 2018 MIPS performance period by practice size (between 25 and 49 clinicians, between 50 and 99 clinicians, etc.). Then, for each cluster, we allocated these groups to each of the MIPS CQM and QCDR and eCQM collection types based on the percent of TINs that submitted MIPS data via these two collection types. For example, of the 1,335 TINs with a practice size of 25 to 49 clinicians which submitted data for the 2018 MIPS performance period, 974 (73 percent) submitted data via the MIPS CQM and QCDR collection type and 361 (27 percent) submitted data via the eCQM collection type. We applied these percentages to the 11 TINs with a practice size of 25 to 49 clinicians which submitted data via the CMS Web Interface collection type for the 2018 MIPS performance period to estimate that 8 (11 TINs × 0.73) would elect to submit data via the MIPS CQM and QCDR collection type and the remaining 3 (11 TINs × 0.27) would elect to submit data via the eCQM collection type. In total, we estimate that 50 of the 111 groups that submitted data via the CMS Web Interface collection type for the 2018 MIPS performance period will now submit quality data via the MIPS CQM and QCDR collection type and 61 groups will now submit quality data via the eCQM collection type. Note that the 111 groups is an increase of 7 from our currently approved estimate of 104 groups due to updated data (84 FR 63123) (111 groups − 104 groups). We also performed this analysis to determine the number of clinicians that would be affected and would need to submit quality data via an alternate collection type. In total, of the estimated 39,318 individual clinicians affected by this proposal, we estimate that 11,448 would submit quality data as part of a group via the MIPS CQM and QCDR collection type and 27,870 would submit quality data as part of a group via the eCQM collection type. These estimates are reflected in Tables 55 and 57 and the associated changes in burden are reflected in Tables 61, 63, and 85. In aggregate, as discussed in sections VI.B.5.e.(5), (6), and (9) of this proposed rule, we estimate the proposal to sunset the CMS Web Interface measures as a collection type/submission type will result in a net decrease in quality performance data reporting burden while acknowledging the additional financial impacts on clinicians as discussed in section VIII.F.16.d.(4)(b)(i) of the Regulatory Impact Analysis. We assume that 100 percent of ACO APM Entities will submit quality data to CMS as required under their models. While we do not believe there is additional reporting for ACO APM entities, consistent with assumptions used in the CY 2019 and CY 2020 PFS final rules (83 FR 60000 through 60001 and 84 FR 63122), we include all quality data voluntarily submitted by MIPS APM participants made at the individual or TIN-level in our respondent estimates. As stated in section VI.4.a.(4) of this proposed rule, we assume non-ACO APM Entities will participate through traditional MIPS and submit as an individual or group rather than as an entity. To estimate who will be a MIPS APM participant in the 2021 MIPS performance period, we used the latest QP List for the third snapshot data of the 2019 QP performance period and supplemented with clinicians who are in an APM in 2018 but not in the 2019 snapshot. This file was selected to better reflect the expected increase in the number of MIPS APMs in future years compared to previous APM eligibility files. If a MIPS eligible clinician is determined to not be scored as a MIPS APM, then their reporting assumption is based on their reporting for the CY 2018 MIPS performance period.</P>
                    <P>
                        Our burden estimates for the quality performance category do not include the burden for the quality data that APM Entities submit to fulfill the requirements of their APMs. The burden is excluded as sections 1899(e) and 1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models tested under section 1115A of the Act (or section 3021 of the Affordable Care Act) are not subject to the PRA.
                        <SU>110</SU>
                        <FTREF/>
                         Tables 55, 56 and 57 explain our revised estimates of the number of organizations (including groups, virtual groups, and individual MIPS eligible clinicians) submitting data on behalf of clinicians segregated by collection type.
                    </P>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             Our estimates do reflect the burden on MIPS APM participants of submitting Promoting Interoperability performance category data, which is outside the requirements of their APMs.
                        </P>
                    </FTNT>
                    <P>Table 55 provides our estimated counts of clinicians that will submit quality performance category data as MIPS individual clinicians or groups in the 2021 MIPS performance period based on data from the 2018 MIPS performance period.</P>
                    <P>For the 2021 MIPS performance period, respondents will have the option to submit quality performance category data via Medicare Part B claims, direct, and log in and upload submission types. We estimate the burden for collecting data via collection type: Claims, QCDR and MIPS CQMs, and eCQMs. We believe that, while estimating burden by submission type may be better aligned with the way clinicians participate with the Quality Payment Program, it is more important to reduce confusion and enable greater transparency by maintain consistency with previous rulemaking.</P>
                    <P>As shown in Table 55, using participation data from the 2018 MIPS performance period combined with the estimate of QPs for the 2021 performance period, we estimate a total of 792,061 clinicians will submit quality data as individuals or groups in the 2021 MIPS performance period, an increase of 11,456 clinicians when compared to our estimate of 780,605 clinicians in the CY 2020 PFS final rule (84 FR 63122). We estimate 94,587 clinicians will submit data as individuals for the Medicare Part B claims collection type; 410,518 clinicians will submit data as individuals or as part of groups for the MIPS CQM and QCDR collection type; and 286,956 clinicians will submit data as individuals or as part of groups via eCQM collection types.</P>
                    <P>
                        Table 55 provides estimates of the number of clinicians to collect quality measures data via each collection type, regardless of whether they decide to submit as individual clinicians or as part of groups. Because our burden estimates for quality data submission assume that burden is reduced when clinicians elect to submit as part of a group, we also separately estimate the 
                        <PRTPAGE P="50350"/>
                        expected number of clinicians to submit as individuals or part of groups.
                    </P>
                    <GPH SPAN="3" DEEP="114">
                        <GID>EP17AU20.090</GID>
                    </GPH>
                    <P>In the CY 2018 Quality Payment Program final rule (82 FR 53625 through 53626), beginning with the 2019 MIPS performance period, we allowed MIPS eligible clinicians to submit data for multiple collection types for a single performance category. Therefore, with the exception of clinicians not in small practices who previously submitted quality data via Medicare Part B claims, we captured the burden of any eligible clinician that may have historically collected via multiple collection types, as we assume they will continue to collect via multiple collection types and that our MIPS scoring methodology will take the highest score where the same measure is submitted via multiple collection types. Hence, the estimated numbers of individual clinicians and groups to collect via the various collection types are not mutually exclusive and reflect the occurrence of individual clinicians or groups that collected data via multiple collection types during the 2018 MIPS performance period.</P>
                    <P>Table 56 uses methods similar to those described to estimate the number of clinicians that will submit data as individual clinicians via each collection type in the 2021 MIPS performance period. We estimate that approximately 94,587 clinicians will submit data as individuals using the Medicare Part B claims collection type; approximately 104,836 clinicians will submit data as individuals using MIPS CQM and QCDR collection type; and approximately 41,477 clinicians will submit data as individuals using eCQMs collection type.</P>
                    <GPH SPAN="3" DEEP="114">
                        <GID>EP17AU20.091</GID>
                    </GPH>
                    <P>Consistent with the policy finalized in the CY 2018 Quality Payment Program final rule that for MIPS eligible clinicians who collect measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection types and submit more than the required number of measures (82 FR 53735 through 54736), we will score the clinician on the required measures with the highest assigned measure achievement points and thus, the same clinician may be counted as a respondent for more than one collection type. Therefore, our columns in Table 56 are not mutually exclusive.</P>
                    <P>Table 57 provides our estimated counts of groups or virtual groups that will submit quality data on behalf of clinicians for each collection type in the 2021 MIPS performance period. We assume that groups that submitted quality data as groups in the 2018 MIPS performance period will continue to submit quality data either as groups or virtual groups for the same collection types as they did as a group or TIN within a virtual group for the 2021 MIPS performance period. Specifically, we estimate that 11,071 groups and virtual groups will submit data for the MIPS CQM and QCDR collection type on behalf of 305,682 clinicians; and 4,474 groups and virtual groups will submit for eCQM collection types on behalf of 245,479 eligible clinicians. In section IV.A.3.(b) of this rule, we are proposing the APM Performance Pathway for clinicians in APM Entities. The APM Performance Pathway is available for both ACO and non ACOs. However, due to data limitations and our inability to determine who would use the APM Performance Pathway versus the traditional MIPS submission mechanism, we assume non-ACO APM Entities would participate through traditional MIPS and base our estimates on submissions received in the 2018 MIPS performance period.</P>
                    <GPH SPAN="3" DEEP="119">
                        <PRTPAGE P="50351"/>
                        <GID>EP17AU20.092</GID>
                    </GPH>
                    <P>The burden associated with the submission of quality performance category data have some limitations. We believe it is difficult to quantify the burden accurately because clinicians and groups may have different processes for integrating quality data submission into their practices' workflows. Moreover, the time needed for a clinician to review quality measures and other information, select measures applicable to their patients and the services they furnish, and incorporate the use of quality measures into the practice workflows is expected to vary along with the number of measures that are potentially applicable to a given clinician's practice and by the collection type. For example, clinicians submitting data via the Medicare Part B claims collection type need to integrate the capture of quality data codes for each encounter whereas clinicians submitting via the eCQM collection types may have quality measures automated as part of their EHR implementation.</P>
                    <P>We believe the burden associated with submitting quality measures data will vary depending on the collection type selected by the clinician, group, or third-party. As such, we separately estimated the burden for clinicians, groups, and third parties to submit quality measures data by the collection type used. For the purposes of our burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and eCQM collection types, we also assume that, on average, each clinician or group will submit 6 quality measures. In terms of the quality measures available for clinicians and groups to report for the 2021 MIPS performance period, the total number of quality measures will be 206. The new MIPS quality measures proposed for inclusion in MIPS for the 2021 MIPS performance period and future years are found in Table Group A of Appendix 1; MIPS quality measures with proposed substantive changes can be found in Table Group D of Appendix 1; and MIPS quality measures proposed for removal can be found in Table Group C of Appendix 1. These measures are stratified by collection type in Table 58 as well as counts of new, removed, and substantively changed measures.</P>
                    <GPH SPAN="3" DEEP="162">
                        <GID>EP17AU20.093</GID>
                    </GPH>
                    <P>For the 2021 MIPS performance period, there is a net reduction of 12 quality measures across all collection types compared to the 218 measures finalized for the 2020 MIPS performance period (84 FR 63124). Specifically, as discussed in section IV.A.3.c.(1)(d), we are proposing to add 2 new administrative claims outcome measures, remove 14 quality measures, and make substantive updates to 92 quality measures where the changes will require the removal of an existing benchmark. We do not anticipate that removing these measures will increase or decrease the reporting burden on clinicians and groups as respondents are still required to submit quality data for 6 measures.</P>
                    <HD SOURCE="HD3">(3) Quality Payment Program Identity Management Application Process</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the identity management application process. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any identity management application process changes under that control number.</P>
                    <HD SOURCE="HD3">(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based Collection Type</HD>
                    <P>
                        This rule is not proposing any new or revised collection of information requirements related to the submission of Medicare Part B claims data for the quality performance category. However, we are adjusting our currently approved burden estimates based on more recent data. The following proposed burden 
                        <PRTPAGE P="50352"/>
                        will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
                    </P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77501 through 77504), CY 2018 Quality Payment Program final rule (82 FR 53912), CY 2019 PFS final rule (83 FR 60004 through 60005), and the CY 2020 PFS final rule (84 FR 63124 through 63126) for our previously finalized requirements and burden for quality data submission via the Medicare Part B claims collection type.</P>
                    <P>As noted in Table 55, based on 2018 MIPS performance period data, we assume that 94,587 individual clinicians will collect and submit quality data via the Medicare Part B claims collection type. This rule is proposing to adjust the number of Medicare Part B claims respondents from 94,846 to 94,587 (a decrease of 259) based on more recent data and our methodology of accounting only for clinicians in small practices who submitted such claims data in the 2018 MIPS performance period rather than all clinicians who submitted quality data codes to us for the Medicare Part B claims collection type.</P>
                    <P>As shown in Table 59, consistent with our currently approved per response time figures, we estimate that the burden of quality data submission using Medicare Part B claims will range from 0.15 hours (9 minutes) at a cost of $13.87 (0.15 hr × $92.46/hr) to 7.2 hours at a cost of $665.71 (7.2 hr × $92.46/hr). The burden will involve becoming familiar with MIPS quality measure specifications. We believe that the start-up cost for a clinician's practice to review measure specifications is 7 hours, consisting of 3 hours at $110.74/hr for a medical and health services manager, 1 hour at $212.78/hr for a physician, 1 hour at $46.64/hr for an LPN, 1 hour at $92.46/hr for a computer systems analyst, and 1 hour at $39.06/hr for a billing and posting clerk. We are not revising our currently approved per response time estimates.</P>
                    <P>Considering both data submission and start-up requirements, the estimated time (per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to a maximum of 14.2 hours (7.2 hr + 7 hr). In this regard the total annual time ranges from 676,297 hours (7.15 hr × 94,587 clinicians) to 1,343,135 hours (14.2 hr × 94,587 clinicians). The estimated annual cost (per clinician) ranges from $737.03 [(0.15 hr × $92.46/hr) + (3 hr × $110.74/hr) + (1 hr × $92.46/hr) + (1 hr × $46.64/hr) + (1 hr × $39.06/hr) + (1 hr × $212.78/hr)] to a maximum of $1,388.87 [(7.2 hr × $92.46/hr) + (3 hr × $110.74/hr) + (1 hr × $92.46/hr) + (1 hr × $46.64/hr) + (1 hr × $39.06/hr) + (1 hr × $212.78/hr)]. The total annual cost ranges from a minimum of $69,713,362 (94,587 clinicians × $737.03) to a maximum of $131,369,236 (94,587 clinicians × $1,388.87).</P>
                    <P>Table 59 summarizes the range of total annual burden associated with clinicians submitting quality data via Medicare Part B claims.</P>
                    <GPH SPAN="3" DEEP="389">
                        <GID>EP17AU20.094</GID>
                    </GPH>
                    <PRTPAGE P="50353"/>
                    <P>As shown in Table 60, using the unchanged currently approved per respondent burden estimates which range from $737.03 to $1,388.87, the decrease in number of respondents from 94,846 to 94,587 results in a total adjustment of between −1,852 hours (−259 respondents × 7.15 hr/respondent) at a cost of −$190,891 (−259 respondents × $737.03/respondent) and −3,678 hours (−259 respondents × 14.2 hr/respondent) at a cost of −$359,718 (−259 respondents × $1,388.87/respondent). For purposes of calculating total burden associated with the proposed rule as shown in Table 60, only the maximum burden is used.</P>
                    <GPH SPAN="3" DEEP="164">
                        <GID>EP17AU20.095</GID>
                    </GPH>
                    <HD SOURCE="HD3">(5) Quality Data Submission by Individuals and Groups Using MIPS CQM and QCDR Collection Types</HD>
                    <P>The following proposed requirement and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77504 through 77505), CY 2018 Quality Payment Program final rule (82 FR 53912 through 53914), CY 2019 PFS final rule (83 FR 60005 through 60006), and the CY 2020 PFS final rule (84 FR 63127 through 63128) for our previously finalized requirements and burden for quality data submission via the MIPS CQM and QCDR collection types.</P>
                    <P>As discussed in section IV.A.3.c.(1)(c) of this rule, we are proposing to sunset the CMS Web Interface measures as a collection type and submission type starting with the 2021 performance period. Using the methodology discussed in section VI.B.5.e.(1) of this proposed rule, we estimate 50 groups which previously submitted quality data via the CMS Web Interface collection type will now submit quality data via the MIPS CQM and QCDR collection type.</P>
                    <P>As noted in Tables 55, 56, and 57, and based on 2018 MIPS performance period data, we assume that 410,518 clinicians will submit quality data as individuals or groups using MIPS CQM or QCDR collection types; 104,836 clinicians will submit as individuals and the remaining 305,682 clinicians will submit as members of 11,071 groups and virtual groups. Given that the number of measures required is the same for clinicians and groups, we expect the burden to be the same for each respondent collecting data via MIPS CQM or QCDR, whether the clinician is participating in MIPS as an individual or group.</P>
                    <P>Under the MIPS CQM and QCDR collection types, the individual clinician or group may either submit the quality measures data directly to us, log in and upload a file, or utilize a third-party intermediary to submit the data to us on the clinician's or group's behalf.</P>
                    <P>We estimate that the burden associated with the QCDR collection type is similar to the burden associated with the MIPS CQM collection type; therefore, we discuss the burden for both together below. For MIPS CQM and QCDR collection types, we estimate an additional time for respondents (individual clinicians and groups) to become familiar with MIPS quality measure specifications and, in some cases, specialty measure sets and QCDR measures. Therefore, we believe that the burden for an individual clinician or group to review measure specifications and submit quality data total 9.083 hours at $891.13. This consists of 3 hours at $92.46/hr for a computer systems analyst (or their equivalent) to submit quality data along with 2 hours at $110.74/hr for a medical and health services manager, 1 hour at $92.46/hr for a computer systems analyst, 1 hour at $46.64/hr for a LPN, 1 hour at $39.06/hr for a billing clerk, and 1 hour at $212.78/hr for a physician to review measure specifications. Additionally, clinicians and groups who do not submit data directly will need to authorize or instruct the qualified registry or QCDR to submit quality measures' results and numerator and denominator data on quality measures to us on their behalf. We estimate that the time and effort associated with authorizing or instructing the quality registry or QCDR to submit this data will be approximately 5 minutes (0.083 hours) at $92.46/hr for a computer systems analyst at a cost of $7.70 (0.083 hr × $92.46/hr). Overall we estimate a cost of $897.47/response [(3 hr × $92.46/hr) + (2 hr × $110.74/hr) + (1 hr × $212.78/hr) + (1 hr × $92.46/hr) + (1 hr × $46.64/hr) + (1 hr × $39.06/hr) + (0.083 hr × $92.46/hr)].</P>
                    <P>In aggregate, we estimate an annual burden of 1,052,783 hours [9.083 hr/response × (104,836 clinicians submitting as individuals + 11,071 groups submitting via QCDR or MIPS CQM on behalf of individual clinicians or 115,907 responses)] at a cost of $ 104,023,540 (115,907 responses × $897.47/response). Based on these assumptions, we have estimated in Table 61 the burden for these submissions.</P>
                    <GPH SPAN="3" DEEP="424">
                        <PRTPAGE P="50354"/>
                        <GID>EP17AU20.096</GID>
                    </GPH>
                    <P>As shown in Table 62, using the unchanged currently approved per respondent burden estimate, the increase of 4,689 respondents from 111,218 to 115,907 results in an increase of 42,590 hours (4,689 respondents × 9.083 hr/respondent) and $4,208,256 (4,689 respondents × $897.47/respondent).</P>
                    <GPH SPAN="3" DEEP="156">
                        <GID>EP17AU20.097</GID>
                    </GPH>
                    <PRTPAGE P="50355"/>
                    <HD SOURCE="HD3">(6) Quality Data Submission by Clinicians and Groups: eCQM Collection Type</HD>
                    <P>The following proposed requirement and burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77505 through 77506), CY 2018 Quality Payment Program final rule (82 FR 53914 through 53915), CY 2019 PFS final rule (83 FR 60006 through 60007), and the CY 2020 PFS final rule (84 FR 63128 through 63130) for our previously finalized requirements and burden for quality data submission via the eCQM collection types.</P>
                    <P>In section IV.A.3.c.(1)(c) of this rule, we are proposing to sunset the CMS Web Interface measures as a collection type and submission type starting with the 2021 performance period. Using the methodology discussed in section VI.B.5.e.(1) of this proposed rule, we estimate 61 groups which previously submitted quality data via the CMS Web Interface collection type will now submit quality data via the eCQM collection type.</P>
                    <P>Based on 2018 MIPS performance period data, we assume that 286,956 clinicians will elect to use the eCQM collection type; 41,477 clinicians are expected to submit eCQMs as individuals; and 4,474 groups and virtual groups are expected to submit eCQMs on behalf of the remaining 245,479 clinicians. We expect the burden to be the same for each respondent using the eCQM collection type, whether the clinician is participating in MIPS as an individual or group. For this collection of information request, we estimate 45,951 respondents (41,477 clinicians who are expected to submit eCQMs as individuals + 4,474 groups and virtual groups who are expected to submit eCQMs) an increase of 2,618 respondents (45,951 proposed respondents−43,333 active respondents).</P>
                    <P>Under the eCQM collection type, the individual clinician or group may either submit the quality measures data directly to us from their eCQM, log in and upload a file, or utilize a third-party intermediary to derive data from their CEHRT and submit it to us on the clinician's or group's behalf.</P>
                    <P>To prepare for the eCQM collection type, the clinician or group must review the quality measures on which we will be accepting MIPS data extracted from eCQMs, select the appropriate quality measures, extract the necessary clinical data from their CEHRT, and submit the necessary data to a QCDR/qualified registry or use a health IT vendor to submit the data on behalf of the clinician or group. We assume the burden for collecting quality measures data via eCQM is similar for clinicians and groups who submit their data directly to us from their CEHRT and clinicians and groups who use a health IT vendor to submit the data on their behalf. This includes extracting the necessary clinical data from their CEHRT and submitting the necessary data to a QCDR/qualified registry.</P>
                    <P>We estimate that it will take no more than 2 hours at $92.46/hr for a computer systems analyst to submit the actual data file. The burden will also involve becoming familiar with MIPS quality measure specifications. In this regard, we estimate it will take 6 hours for a clinician or group to review measure specifications. Of that time, we estimate 2 hours at $110.74/hr for a medical and health services manager, 1 hour at $212.78/hr for a physician, 1 hour at $92.46/hr for a computer systems analyst, 1 hour at $46.64/hr for an LPN, and 1 hour at $39.06/hr for a billing clerk. Overall we estimate a cost of $797.34/response [(2 hr × $92.46/hr) + (2 hr × $110.74/hr) + (1 hr × $212.78/hr) + (1 hr × $92.46/hr) + (1 hr × $46.64/hr) + (1 hr × $39.06/hr)].</P>
                    <P>In aggregate we estimate an annual burden of 367,608 hours (8 hr × 45,951 groups and clinicians submitting as individuals) at a cost of $36,638,570 (45,951 responses × $797.34/response). Based on these assumptions, we have estimated in Table 63 the burden for these submissions.</P>
                    <GPH SPAN="3" DEEP="357">
                        <PRTPAGE P="50356"/>
                        <GID>EP17AU20.098</GID>
                    </GPH>
                    <P>As shown in Table 64, using the unchanged currently approved per respondent burden estimate, the increase of 2,618 respondents from 43,333 to 45,951 results in a total difference of 20,944 hours (2,618 respondents × 8 hr/respondent) at a cost of $2,087,436 (2,618 respondents × $797.34/respondent).</P>
                    <GPH SPAN="3" DEEP="146">
                        <GID>EP17AU20.099</GID>
                    </GPH>
                    <HD SOURCE="HD3">(7) Beneficiary Responses to CAHPS for MIPS Survey</HD>
                    <P>
                        In this proposed rule, we are proposing changes to requirements for the CAHPS for MIPS survey which, if finalized, will result in updates to the CAHPS for MIPS survey instrument which is currently approved by OMB under control number 0938-1222 (CMS-10450). The survey instrument is not ready at this time, therefore we will make the updated survey instrument and burden available for public review through a stand-alone non-rule 
                        <E T="04">Federal Register</E>
                         notice that is expected to publish in early CY 2021.
                    </P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77509), CY 2018 Quality Payment Program final rule (82 FR 53916 through 53917), and CY 2019 PFS final rule (83 FR 60009 through 60010 for our previously finalized requirements and burden for beneficiary responses to the CAHPS for MIPS survey.</P>
                    <P>
                        In section IV.A.3.c.(1)(e)(ii), we are proposing to (1) revise and codify at 
                        <PRTPAGE P="50357"/>
                        § 414.1305 the definition of primary care services used in the MIPS assignment methodology to include virtual primary care visits and telehealth visits to determine patient assignment to groups starting in the 2021 CAHPS for MIPS survey; and (2) revise the CAHPS for MIPS Survey cover page to include a reference to care received in telehealth settings. We do not believe any of these proposals will impact the number of groups electing to have the CAHPS for MIPS survey administered on their behalf, the number of beneficiaries who complete the survey, or the time required for a beneficiary to complete the survey. In the future, if additional data becomes available, we may revise our assumptions at that time.
                    </P>
                    <P>Additionally, we are also proposing in IV.A.2.c.(1)(e)(i) to add a survey-based measure on telehealth that assesses patient-reported usage of telehealth services to the performance year 2021 CAHPS for MIPS Survey. Currently, the CAHPS for MIPS survey instrument contains 58 questions and we estimate it requires a beneficiary 12.9 minutes on average to complete it, or approximately 0.2 minutes per question. We assume this proposal will result in 1 additional question being added to the survey which would result in the total time to complete the survey increasing from 12.9 minutes (0.215 hr) to 13.1 minutes (0.2183 hr) per beneficiary, or an increase of 0.2 minutes (0.0033 hr).</P>
                    <P>Based on the number of beneficiaries who completely or partially responded to the survey in the 2019 MIPS performance period, we assume that 29,915 beneficiaries will respond to the survey during the 2021 MIPS performance period. This is a decrease of 9,124 from our currently approved estimate of 39,039 beneficiaries. Using this updated number of respondents and our revised estimate of burden per respondent, we estimate an annual burden of 6,531 hours (29,915 respondents × 0.2183 hr/respondent) at a cost of $167,989 (6,531 hr × $25.72/hr). Table 66 shows the estimated annual burden for beneficiaries to participate in the CAHPS for MIPS Survey.</P>
                    <GPH SPAN="3" DEEP="106">
                        <GID>EP17AU20.100</GID>
                    </GPH>
                    <P>Independent of the change in burden per respondent, the decrease of −9,124 respondents from 39,039 to 29,915 results in a difference of −1,962 hours (−9,124 respondents × 0.215 hr/respondent) at a cost of −$50,454 (−9,124 hrs × $25.72/hr). Accounting for the change in number of respondents, the increase in burden per respondent from 0.215 hours to 0.2183 hours results in a difference of 100 hours (29,915 respondents × 0.0033 hr/respondent) at a cost of $2,565 (100 hrs × $25.72/hr). As shown in Table 66, the aggregate change in burden is −1,862 hours (100 hours−1,962 hours) at a cost of −$47,889 ($2,565−$50,454).</P>
                    <GPH SPAN="3" DEEP="146">
                        <GID>EP17AU20.101</GID>
                    </GPH>
                    <FP>
                        The revised survey and burden will be released to the public via the standard non-rule PRA process which includes the publication of 60- and 30-day 
                        <E T="04">Federal Register</E>
                         notices.
                    </FP>
                    <HD SOURCE="HD3">(8) Group Registration for CAHPS for MIPS Survey</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the group registration for the CAHPS for MIPS Survey. The CAHPS for MIPS survey requirements and burden are currently approved by OMB under control number 0938-1222 (CMS-10450). Consequently, we are not making any changes to burden for CAHPS for MIPS survey group registration under that control number.</P>
                    <HD SOURCE="HD3">(9) Removal of Quality Data Submission by Clinicians and Groups: CMS Web Interface Collection Type and Group Registration for CMS Web Interface ICRs</HD>
                    <P>
                        The following proposed changes will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).
                        <PRTPAGE P="50358"/>
                    </P>
                    <P>As discussed in section IV.A.3.c.(1)(c) we are proposing to sunset the CMS Web Interface measures as a collection type/submission type starting with the 2021 performance period. If this proposal is finalized, it will result in removal of the CMS Web Interface collection type and group registration for CMS Web Interface ICRs as they will no longer be necessary. In the CY 2020 PFS final rule, we estimated the time associated with quality data submissions via the CMS Web Interface to be 6,414 hours (104 responses × 61.67 hr per response) (84 FR 63130). Using more recent BLS wage estimates, we estimate a cost of $593,038 (6,414 hr × $92.46/hr). We had also estimated the time associated with group registration for the CMS Web Interface to be 17.25 hours (69 responses × 0.25 hr per response) (84 FR 63131). Using more recent BLS wage estimates, we estimate a cost of $1,595 (17.25 hr × $92.46/hr). In this regard, this rule proposes a reduction of 6,431 hours (6,414 hr + 17.25 hr) and $594,633 ($593,038 + $1,595) (see Table 85).</P>
                    <HD SOURCE="HD3">f. ICRs Regarding the Call for MIPS Quality Measures</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the call for MIPS quality measures. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any call for MIPS quality measure changes under that control number.</P>
                    <HD SOURCE="HD3">g. ICRs Regarding Promoting Interoperability Data (§§ 414.1375 and 414.1380)</HD>
                    <HD SOURCE="HD3">(1) Background</HD>
                    <P>For the 2021 MIPS performance period, clinicians and groups can submit Promoting Interoperability data through direct, log in and upload, or log in and attest submission types. With the exception of submitters who elect to use the log in and attest submission type for the Promoting Interoperability performance category, which is not available for the quality performance category, we anticipate that individuals and groups will use the same data submission type for the both of these performance categories and that the clinicians, practice managers, and computer systems analysts involved in supporting the quality data submission will also support the Promoting Interoperability data submission process. The following burden estimates show only incremental hours required above and beyond the time already accounted for in the quality data submission process. Although this analysis assesses burden by performance category and submission type, we emphasize that MIPS is a consolidated program and submission analysis and decisions are expected to be made for the program as a whole.</P>
                    <HD SOURCE="HD3">(2) Reweighting Applications for Promoting Interoperability and Other Performance Categories</HD>
                    <P>The requirements and burden associated with this rule's proposed data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53918 through 53919), CY 2019 PFS final rule (83 FR 60011 through 60012), and the CY 2020 PFS final rule (84 FR 63134 through 63135) for our previously finalized requirements and burden for reweighting applications for Promoting Interoperability and other performance categories.</P>
                    <P>As established in the CY 2017 and CY 2018 Quality Payment Program final rules, MIPS eligible clinicians who meet the criteria for a significant hardship or other type of exception may submit an application requesting a zero percent weighting for the Promoting Interoperability, quality, cost, and/or improvement activities performance categories under specific circumstances (81 FR 77240 through 77243, 82 FR 53680 through 53686, and 82 FR 53783 through 53785). Respondents who apply for a reweighting for the quality, cost, and/or improvement activities performance categories have the option of applying for reweighting for the Promoting Interoperability performance category on the same online form. We assume that respondents applying for a reweighting of the Promoting Interoperability performance category due to extreme and uncontrollable circumstances will also request a reweighting of at least one of the other performance categories simultaneously and not submit multiple reweighting applications.</P>
                    <P>Table 67 summarizes the burden for clinicians to apply for reweighting the Promoting Interoperability performance category to zero percent due to a significant hardship exception (including a significant hardship exception for small practices) or as a result of a decertification of an EHR. Based on the number of reweighting applications received by December 31, 2019 for the 2019 MIPS performance period, we assume 51,098 respondents (eligible clinicians or groups) will submit a request to reweight the Promoting Interoperability performance category to zero percent due to a significant hardship (including clinicians in small practices) or EHR decertification and an additional 994 respondents will submit a request to reweight one or more of the quality, cost, Promoting Interoperability, or improvement activity performance categories due to an extreme or uncontrollable circumstance, for a total of 52,092 reweighting applications submitted. This is an increase of 21,472 respondents compared to our currently approved estimate of 30,620 respondents (84 FR 63134). Similar to the data used to estimate the number of respondents in the CY 2020 PFS final rule, our respondent estimate includes a significant number of applications submitted as a result of a data issue CMS was made aware of and is specific to a single third-party intermediary. While we do not anticipate similar data issues to occur in each performance period, we do believe future similar incidents may occur and are electing to use this data without adjustment to reflect this belief. Our respondent estimate is also based on data that does not include applications submitted during the extended period ending April 30, 2020 due to the 2019 Coronavirus Disease (COVID-19) pandemic, as we do not believe it would be an accurate basis for future estimates of application submissions. Of our total respondent estimate of 52,092, we estimate that 35,986 respondents (eligible clinicians or groups) will submit a request for reweighting the Promoting Interoperability performance category to zero percent due to extreme and uncontrollable circumstances, insufficient internet connectivity, lack of control over the availability of CEHRT, or as a result of a decertification of an EHR. An additional 16,106 respondents will submit a request for reweighting the Promoting Interoperability performance category to zero percent as a small practice experiencing a significant hardship.</P>
                    <P>
                        In section IV.A.3.c.(5)(e), we are proposing that, beginning with the 2022 MIPS payment year (2020 performance year), APM Entities may submit an extreme and uncontrollable circumstances exception application for all four performance categories and applicable to all MIPS eligible clinicians in the APM Entity group. As previously discussed in section VI.B.5.a.(4), due to data limitations and our inability to determine who would use the APM Performance Pathway versus the traditional MIPS submission mechanism for the 2021 MIPS performance period, 
                        <PRTPAGE P="50359"/>
                        we assume ACO APM Entities will submit data through the APM Performance Pathway and non-ACO APM Entities would participate through traditional MIPS, thereby submitting as an individual or group rather than as an entity. Therefore, we limited our analysis to ACOs that were eligible for an exception due to extreme and uncontrollable circumstances during the 2019 MIPS performance period and elected not to report quality data. Based on this data, we estimate 7 APM Entities will submit an extreme and uncontrollable circumstances exception application for the 2021 MIPS performance period. Combined with our aforementioned estimate of 52,092 eligible clinicians and groups, the total estimated number of respondents for the 2021 MIPS performance period is 52,099.
                    </P>
                    <P>The application to request a reweighting to zero percent only for the Promoting Interoperability performance category is a short online form that requires identifying the type of hardship experienced or whether decertification of an EHR has occurred and a description of how the circumstances impair the clinician or group's ability to submit Promoting Interoperability data, as well as some proof of circumstances beyond the clinician's control. The application for reweighting of the quality, cost, Promoting Interoperability, and/or improvement activities performance categories due to extreme and uncontrollable circumstances requires the same information with the exception of there being only one option for the type of hardship experienced. We continue to estimate it will take 0.25 hours at $92.46/hr for a computer system analyst to complete and submit the application. As shown in Table 67, we estimate an annual burden of 13,025 hours (52,099 applications × 0.25 hr/application) and $1,204,268 (13,025 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="180">
                        <GID>EP17AU20.102</GID>
                    </GPH>
                    <P>As shown in Table 68, using our unchanged currently approved per respondent burden estimate, the increased number of respondents results in a total adjustment of 5,370 hours (21,479 respondents × 0.25 hr/respondent) and $496,487 (5,370 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="138">
                        <GID>EP17AU20.103</GID>
                    </GPH>
                    <HD SOURCE="HD3">(3) Submitting Promoting Interoperability Data</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements related to the submission of data for the Promoting Interoperability performance category. However, we are adjusting our currently approved burden estimates based on more recent data. The proposed burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77509 through 77511), CY 2018 Quality Payment Program final rule (82 FR 53919 through 53920), CY 2019 PFS final rule (83 FR 60013 through 60014), and the CY 2020 PFS final rule (84 FR 63135 through 63137) for our previously finalized requirements and burden for submission of data for the Promoting Interoperability performance category.</P>
                    <P>
                        In this proposed rule, we are not proposing any changes to our current criteria for automatic reweighting of the 
                        <PRTPAGE P="50360"/>
                        Promoting Interoperability performance category for certain MIPS eligible clinicians or MIPS eligible clinicians who have experienced a significant hardship or decertification of an EHR.
                    </P>
                    <P>In section IV.A.3.c.(4)(b) of this rule, we are proposing to add § 414.1320(g)(1), which would establish a performance period for the Promoting Interoperability performance category of a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year. Because this does not change the number of required Promoting Interoperability measures that must be reported, we are not making any changes to our burden assumptions.</P>
                    <P>In section IV.3.c.(4)(c)(2)(b) we are proposing to add the HIE bi-directional exchange measure for the 2021 performance period and subsequent years as an optional alternative to the two existing measures: The Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. This proposal provides clinicians the option of either reporting the new measure or the two existing measures. Because the new HIE measure is an optional alternative instead of a new requirement and the proposal does not change the number of required Promoting Interoperability measures that must be reported, we are not making any changes to our burden assumptions.</P>
                    <P>A variety of organizations will submit Promoting Interoperability data on behalf of clinicians. Clinicians not participating in a MIPS APM may submit data as individuals or as part of a group. In the CY 2017 Quality Payment Program final rule (81 FR 77258 through 77260, 77262 through 77264) and CY 2019 PFS final rule (83 FR 59822-59823), we established that eligible clinicians in MIPS APMs (including the Shared Savings Program) may report for the Promoting Interoperability performance category as an APM Entity group, individuals, or a group. Because we are not making changes at § 414.1375 to the scoring for APM entities as a result of our proposal in section IV.A.3.(b) of this proposed rule to establish an APM Performance Pathway, our reporting assumptions for clinician in MIPS APMs remains unchanged.</P>
                    <P>As shown in Table 69, based on data from the 2018 MIPS performance period, we estimate that a total of 77,499 respondents consisting of 62,746 individual MIPS eligible clinicians and 14,753 groups and virtual groups will submit Promoting Interoperability data. Since our CY 2020 final rule estimated 74,281 respondents, this represents an increase of 3,218 respondents (77,499 proposed respondents−74,281 active respondents).</P>
                    <P>We assume that MIPS eligible clinicians previously scored under the APM scoring standard, as described in the CY 2020 PFS final rule, will continue to submit Promoting Interoperability data (84 FR 63006) in a similar way through the APM Performance Pathway. As a result, we do not anticipate any change in burden. Each MIPS eligible clinician in an APM Entity reports data for the Promoting Interoperability performance category through either their group TIN or individual reporting. Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 U.S.C. 1315a, respectively) state that the Shared Savings Program and the testing, evaluation, and expansion of Innovation Center models are not subject to the PRA. However, in the CY 2019 PFS final rule, we established that MIPS eligible clinicians who participate in the Shared Savings Program are no longer limited to reporting for the Promoting Interoperability performance category through their ACO participant TIN (83 FR 59822 through 59823). Burden estimates for this proposed rule assume group TIN-level reporting as we believe this is the most reasonable assumption for the Shared Savings Program, which requires that ACOs include full TINs as ACO participants. As we receive updated information which reflects the actual number of Promoting Interoperability data submissions submitted by Shared Savings Program ACO participants, we will update our burden estimates accordingly.</P>
                    <GPH SPAN="3" DEEP="109">
                        <GID>EP17AU20.104</GID>
                    </GPH>
                    <P>We continue to estimate the time required for an individual or group to submit Promoting Interoperability data to be 2.67 hours. As shown in Table 70, the total burden estimate for submitting data on the specified Promoting Interoperability objectives and measures is estimated to be 206,664 hours (77,499 respondents × 2.67 incremental hours for a computer analyst's time above and beyond the physician, medical and health services manager, and computer system's analyst time required to submit quality data) and $19,108,153 (206,664 hr × $92.46/hr)).</P>
                    <GPH SPAN="3" DEEP="165">
                        <PRTPAGE P="50361"/>
                        <GID>EP17AU20.105</GID>
                    </GPH>
                    <P>As shown in Table 71, using our unchanged currently approved per respondent burden estimate, the decrease in number of respondents results in a total adjustment of +8,581 hours (3,218 respondents × 2.67 hr/respondent) at a cost of +$793,430 (8,581 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="142">
                        <GID>EP17AU20.106</GID>
                    </GPH>
                    <HD SOURCE="HD3">h. ICRs Regarding the Nomination of Promoting Interoperability (PI) Measures</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the nomination of Promoting Interoperability measures. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes under that control number.</P>
                    <HD SOURCE="HD3">i. ICRs Regarding Improvement Activities Submission (§§ 414.1305, 414.1355, 414.1360, and 414.1365)</HD>
                    <P>We are adjusting our currently approved burden estimates based on more recent data. The proposed adjusted burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2017 Quality Payment Program final rule (81 FR 77511 through 77512), CY 2018 Quality Payment Program final rule (82 FR 53920 through 53922), CY 2019 PFS final rule (83 FR 60015 through 60017), and the CY 2020 PFS final rule (84 FR 63138 through 63140) for our previously finalized requirements and burden for submission of data for the Improvement Activities performance category.</P>
                    <P>In this proposed rule, we are not proposing any changes to our requirements associated with criteria for attesting to specific improvement activities.</P>
                    <P>As discussed in section IV.A.3.c.(3)(b)(iii) of this rule, we are proposing for the CY 2021 performance period and future years to modify 2 existing improvement activities. We refer readers to Appendix 2 of this proposed rule for further details. Because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform, we do not expect these proposals to affect our currently approved information collection burden estimates.</P>
                    <P>
                        In section IV.A.3.(b).(3)(c) of this rule, we propose how we would assign a score for the Improvement Activities performance category for MIPS APMs. We would assign Improvement Activities scores to APM participants in the APP based on the requirements of participation in APMs. To develop the Improvement Activities score for MIPS APMs, we would compare requirements of the APM with the list of Improvement Activities measures for the applicable year, and score those measures as they would otherwise be scored according to § 414.1355. In the event a MIPS APM participant does not actually perform an activity for which Improvement Activities credit would otherwise be assigned under this proposal, the MIPS APM participant would not receive credit for the associated Improvement Activity. In the event that the assigned score does not represent the maximum improvement activities score, we propose that MIPS eligible clinicians reporting through the APP would have the opportunity to report additional improvement activities that then would be applied towards their scores. Our burden estimates assume there will be no improvement activities burden for MIPS APM participants electing the APP. We will assign the improvement 
                        <PRTPAGE P="50362"/>
                        activities performance category score at the APM Entity level.
                    </P>
                    <P>A variety of organizations and in some cases, individual clinicians, will submit improvement activity performance category data. As finalized in the CY 2017 Quality Payment Program final rule (81 FR 77264), APM Entities only need to report improvement activities data if the CMS-assigned improvement activities score is below the maximum improvement activities score. Similar to our assumption in the CY 2018 Quality Payment Program final rule, our burden estimates assume that the MIPS APM models for the 2021 MIPS performance period will qualify for the maximum improvement activities performance category score and, as such, APM Entities will not submit any additional improvement activities. (82 FR 53921 through 53922).</P>
                    <P>As represented in Table 72, based on 2018 MIPS performance period data, we estimate that a total of 102,474 respondents consisting of 85,760 individual clinicians and 16,714 groups will submit improvement activities during the 2021 MIPS performance period. Since our currently approved burden sets out 103,813 respondents, this represents a decrease of −1,339 respondents (102,474 proposed respondents−103,813 active respondents).</P>
                    <P>As discussed in sections VI.B.5.e.(2) and VI.B.5.g.(3) of this proposed rule regarding our estimate of clinicians and groups submitting data for the quality and Promoting Interoperability performance categories, we have updated our estimates for the number of clinicians and groups that will submit improvement activities data based on projections of the number of eligible clinicians that were not QPs or members of an ACO in the 2018 MIPS performance period but will be in the 2021 MIPS performance period, and will therefore not be required to submit improvement activities data.</P>
                    <GPH SPAN="3" DEEP="179">
                        <GID>EP17AU20.107</GID>
                    </GPH>
                    <P>Consistent with the CY 2020 PFS final rule, we continue to estimate that the per response time required per individual or group is 5 minutes for a computer system analyst to submit by logging in and manually attesting that certain activities were performed in the form and manner specified by CMS with a set of authenticated credentials (84 FR 63140).</P>
                    <P>As shown in Table 73, we estimate an annual burden of 8,540 hours (102,474 responses × 5 minutes/60) and $789,562 (8,540 hr × $92.46/hr)).</P>
                    <GPH SPAN="3" DEEP="142">
                        <GID>EP17AU20.108</GID>
                    </GPH>
                    <P>As shown in Table 74, using our unchanged currently approved per respondent burden estimate, the decrease in the number of respondents results in an adjustment of −111 hours (−1,339 responses × 5 minutes/60) at a cost of −$10,317 (−111 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="130">
                        <PRTPAGE P="50363"/>
                        <GID>EP17AU20.109</GID>
                    </GPH>
                    <HD SOURCE="HD3">j. ICRs Regarding the Nomination of Improvement Activities (§ 414.1360)</HD>
                    <P>The requirements and burden associated with this rule's proposed data submission will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53922), CY 2019 PFS final rule (83 FR 60017 through 60018), and the CY 2020 PFS final rule (84 FR 63141) for our previously finalized requirements and information collection burden for the nomination of improvement activities.</P>
                    <P>In the CY 2018 Quality Payment Program final rule, for the 2018 and future MIPS performance periods, stakeholders were provided an opportunity to propose new activities formally via the Annual Call for Activities nomination form that was posted on the CMS website (82 FR 53657). In section IV.A.3.c.(3)(b)(i)(B)(bb) of this rule, we are proposing to require nominated improvement activities to be linked to existing and related quality and cost measures, as applicable and feasible. Similar to the burden assumptions finalized in the CY 2020 PFS final rule for the nomination of quality measures, we believe this will require approximately 0.6 hours at $110.74/hr for a medical and health services manager and 0.4 hours at $212.78/hr for a physician to research existing measures and provide a rationale for the linkage (84 FR 63132). We previously estimated it would require 1.2 hours for a medical and health services manager or equivalent and 0.8 hours for a physician to nominate an improvement activity (84 FR 63141). Combined with our currently approved burden estimate, we now estimate 1.8 hours at $110.74/hr for a medical and health services manager or equivalent and 1.2 hours at $212.78/hr for a physician to nominate an improvement activity. This represents a change of +0.6 hours (1.8 hr−1.2 hr) for a medical and health services manager or equivalent and +0.4 hours (1.2 hr−0.8 hr) for a physician and an overall increase of 1 hour.</P>
                    <P>In section IV.A.3.c.(3)(b)(i)(A)(bb), we are proposing to make an exception to the established timeframe for nomination of improvement activities, such that during a PHE, stakeholders can nominate improvement activities outside of the established Annual Call for Activities timeframe. Instead of only accepting nominations and modifications submitted February 1st through June 30th each year, we would accept nominations for the duration of the PHE as long as the improvement activity is still relevant. No other aspects of the Annual Call for Activities process would be affected (for example, criteria for nominating improvement activities, considerations for selection of improvement activities, or weighting policies would all still apply). While we expect additional nominations may be received as a result of this proposal, we do not have any data with which to estimate what the additional number may be. As a result, our burden estimate remains unchanged due to this proposal. Additionally, in section IV.A.3.c.(3)(b)(ii)(B), we are proposing, beginning with the CY 2021 performance period and future years, to consider agency-nominated improvement activities. Because these nominations would be submitted by federal agencies, the associated time is exempt from the PRA and therefore not included in our estimates. We also refer readers to section VIII.F.16.d.(4)(c) where we discuss our impact analysis.</P>
                    <P>The 2020 Annual Call for Activities will end on July 1, 2020. Therefore, we continue to use our currently approved assumption that we will receive 31 nominations of new or modified activities which will be evaluated for the Improvement Activities Under Consideration (IAUC) list for possible inclusion in the CY 2022 Improvement Activities Inventory.</P>
                    <P>As shown in Table 75, we estimate an annual information collection burden of 93 hours (31 nominations × 3 hr/nomination) at a cost of $14,095 (31 × [(1.8 hr × $110.74/hr) + (1.2 hr × $212.78/hr)]).</P>
                    <GPH SPAN="3" DEEP="155">
                        <PRTPAGE P="50364"/>
                        <GID>EP17AU20.110</GID>
                    </GPH>
                    <P>As shown in Table 76, using our unchanged estimate of the number of activities nominated, the increase in the burden per nomination results in a change of 31 hours (31 nominations × 1 hr/nomination) at a cost of $4,698 (31 activities × [(0.6 hr × $110.74/hr) + (0.4 hr × $212.78/hr)]).</P>
                    <GPH SPAN="3" DEEP="128">
                        <GID>EP17AU20.111</GID>
                    </GPH>
                    <HD SOURCE="HD3">k. Nomination of MVPs</HD>
                    <P>The following reflects the burden associated with the first year of data collection associated with a new process available for all clinicians/third party intermediaries to nominate MVPs for inclusion in the Quality Payment Program. The proposed requirements and burden associated with the Nomination of MVPs will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>Beginning with the 2022 performance period, we are proposing at that stakeholders should formally submit their MVP candidates utilizing a standardized template, which will be published in the QPP resource library four our consideration for future implementation. Stakeholders should submit all information including a description of how their MVP abides by the MVP development criteria as described in section IV.A.3.a.(2)(a)(i) of this proposed rule, and provide rationales as to why specific measures and activities were chosen to construct the MVP. As MVP candidates are received, they will be reviewed, vetted, and evaluated by CMS and our contractors to determine if the MVP is feasible and ready for inclusion in the upcoming performance period. For the 2021 MIPS performance period, we assume 25 MVP nominations will be received and the estimated time required to submit all required information is 12 hours per nomination. We seek comment on our estimate of the time required to nominate an MVP.</P>
                    <P>Similar to the call for quality measures, nomination of Promoting Interoperability measures, and the nomination of improvement activities, we assume MVP nomination will be performed by both practice administration staff or their equivalents and clinicians. We estimate 7.2 hours at $110.74/hr for a medical and health services manager or equivalent and 4.8 hours at $212.78/hr for a physician to nominate an MVP. As shown in Table 77, we estimate an annual burden of 300 hours (25 nominations × 12 hr/nomination) at a cost of $45,467 (25 × [(7.2 hr × $110.74/hr) + (4.8 hr × $212.78/hr)]).</P>
                    <GPH SPAN="3" DEEP="155">
                        <PRTPAGE P="50365"/>
                        <GID>EP17AU20.112</GID>
                    </GPH>
                    <HD SOURCE="HD3">l. ICRs Regarding the Cost Performance Category (§ 414.1350)</HD>
                    <P>The cost performance category relies on administrative claims data. The Medicare Parts A and B claims submission process (OMB control number 0938-1197; CMS-1500 and CMS-1490S) is used to collect data on cost measures from MIPS eligible clinicians. MIPS eligible clinicians are not required to provide any documentation by CD or hardcopy. Moreover, the provisions of this proposed rule do not result in the need to add or revise or delete any claims data fields. Consequently, we are not setting out burden or making any changes under the 0938-1197 control number.</P>
                    <HD SOURCE="HD3">m. ICRs Regarding Partial QP Elections (§§ 414.1310(b)(ii) and 414.1430)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements related to the Partial QP Elections to participate in MIPS as a MIPS eligible clinician. However, we are adjusting our currently approved burden estimates based on updated projections for the 2021 MIPS performance period. The proposed burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>As shown in Table 78, based on our predictive QP analysis for the 2021 QP performance period, which accounts for historical response rates in performance year 2019, we estimate that 100 APM Entities and 200 eligible clinicians (representing approximately 2,500 Partial QPs) will make the election to participate as a Partial QP in MIPS, a total of 300 elections which is a decrease of 1,722 from the 2,022 elections that are currently approved by OMB under the aforementioned control number. We continue to estimate it will take the APM Entity representative or eligible clinician 15 minutes (0.25 hr) to make this election. In aggregate, we estimate an annual burden of 75 hours (300 respondents × 0.25 hr/election) and $6,935 (75 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="126">
                        <GID>EP17AU20.113</GID>
                    </GPH>
                    <P>As shown in Table 79, using our unchanged currently approved per respondent burden estimate, the decrease in the number of Partial QP elections results in an adjustment of −430.5 hours (−1,722 elections × 0.25 hr) from our currently approved burden of 505.5 hours at a cost of −$39,804 (−430.5 hr × $92.46/hr) (84 FR 63142).</P>
                    <GPH SPAN="3" DEEP="134">
                        <PRTPAGE P="50366"/>
                        <GID>EP17AU20.114</GID>
                    </GPH>
                    <HD SOURCE="HD3">n. ICRs Regarding Other Payer Advanced APM Determinations: Payer-Initiated Process (§ 414.1445) and Eligible Clinician Initiated Process (§ 414.1445)</HD>
                    <P>The following proposed burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <HD SOURCE="HD3">(1) Payer Initiated Process (§ 414.1445)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements related to the Payer-Initiated Process. However, we are adjusting our currently approved burden estimates based on updated projections for the 2021 MIPS performance period. As mentioned above, the adjusted burden will be submitted to OMB for approval.</P>
                    <P>As shown in Table 80, based on the actual number of requests received in the 2019 QP performance period, we estimate that in CY 2021 for the 2022 QP performance period 80 payer-initiated requests for Other Payer Advanced APM determinations will be submitted (10 Medicaid payers, 50 Medicare Advantage Organizations, and 20 remaining other payers), a decrease of 30 from the 110 total requests currently approved by OMB under the aforementioned control number. We continue to estimate it will take 10 hours for a computer system analyst per arrangement submission. We estimate an annual burden of 800 hours (80 submissions × 10 hr/submission) and $73,968 (800 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="137">
                        <GID>EP17AU20.115</GID>
                    </GPH>
                    <P>As shown in Table 81, using our unchanged currently approved per respondent burden estimate, the decrease in the number of payer-initiated requests from 110 to 80 results in an adjustment of −300 hours (−30 requests × 10 hr) from our currently approved burden of 1,100 hours at a cost of −$27,738 (−300 hr × $92.46/hr) (84 FR 63143).</P>
                    <GPH SPAN="3" DEEP="147">
                        <GID>EP17AU20.116</GID>
                    </GPH>
                    <PRTPAGE P="50367"/>
                    <HD SOURCE="HD3">(2) Eligible Clinician Initiated Process (§ 414.1445)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements or burden related to the Eligible-Clinician Initiated Process. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the eligible clinician initiated process under that control number.</P>
                    <HD SOURCE="HD3">(3) Submission of Data for QP Determinations Under the All-Payer Combination Option (§ 414.1440)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements related to the Submission of Data for QP Determinations under the All-Payer Combination Option. The requirements and burden are currently approved by OMB under control number 0938-1314 (CMS-10621). Consequently, we are not making any changes to the QP Determinations under the All-Payer Combination Option under that control number.</P>
                    <HD SOURCE="HD3">o. ICRs Regarding Voluntary Participants Election To Opt-Out of Performance Data Display on Physician Compare (§ 414.1395)</HD>
                    <P>This rule is not proposing any new or revised collection of information requirements related to the election by voluntary participants to opt-out of public reporting on Physician Compare. However, we are adjusting our currently approved burden estimates based on data from the 2018 MIPS performance period. The proposed burden will be submitted to OMB for approval under control number 0938-1314 (CMS-10621).</P>
                    <P>We refer readers to the CY 2018 Quality Payment Program final rule (82 FR 53924 through 53925), CY 2019 PFS final rule (83 FR 60022), and the CY 2020 PFS final rule (84 FR 63145 through 63146) for our previously finalized requirements and burden for voluntary participants to opt-out of public reporting on Physician Compare.</P>
                    <P>We estimate that 10 percent of the total clinicians and groups who will voluntarily participate in MIPS will also elect not to participate in public reporting. This results in a total of 9,904 (0.10 × 99,042 voluntary MIPS participants) clinicians and groups, a decrease of 138 from the currently approved estimate of 10,042. Voluntary MIPS participants are clinicians that are not QPs and are expected to be excluded from MIPS after applying the eligibility requirements set out in the CY 2019 PFS final rule but have elected to submit data to MIPS. As discussed in the RIA section of the CY 2019 PFS final rule, we estimate that 33 percent of clinicians that exceed one (1) of the low-volume criteria, but not all three (3), will elect to opt-in to MIPS, become MIPS eligible, and no longer be considered a voluntary reporter (83 FR 60050).</P>
                    <P>Table 82 shows that for these voluntary participants, we continue to estimate it will take 0.25 hours for a computer system analyst to submit a request to opt-out. In aggregate, we estimate an annual burden of 2,476 hours (9,904 requests × 0.25 hr/request) and $228,931 (2,476 hr × $92.46/hr).</P>
                    <GPH SPAN="3" DEEP="126">
                        <GID>EP17AU20.117</GID>
                    </GPH>
                    <P>As shown in Table 83, using our unchanged currently approved per respondent burden estimate, the decrease of −138 opt outs by voluntary participants results in an adjustment of −34.5 hours (−138 requests × 0.25 hr) from our currently approved burden of 2,510.5 hours at a cost of −$3,190 (−34.5 hr × $92.46/hr) (84 FR 63145).</P>
                    <GPH SPAN="3" DEEP="144">
                        <PRTPAGE P="50368"/>
                        <GID>EP17AU20.118</GID>
                    </GPH>
                    <HD SOURCE="HD3">p. Summary of Annual Quality Payment Program Burden Estimates</HD>
                    <P>Table 85 summarizes this proposed rule's burden estimates for the Quality Payment Program. In the CY 2020 PFS final rule, the total estimated burden was 2,932,649 hours at a cost of $279,550,490 ($279,573,747−$23,257) (84 FR 63146). Accounting for updated wage rates and the subset of all Quality Payment Program ICRs discussed in this rule compared to the CY 2020 PFS final rule, the total estimated burden of continuing policies and information set forth in the CY 2020 PFS final rule into the 2021 MIPS performance period is 2,937,520 hours at a cost of $287,160,638; an increase of 4,871 hours and $7,610,148. To understand the burden implications of the policies proposed in this rule, we provide an estimate of the total burden associated with continuing the policies and information collections set forth in the CY 2020 PFS final rule into the 2021 MIPS performance period. This burden estimate of 3,008,022 hours at a cost of $293,717,313 reflects the availability of more accurate data to account for all potential respondents and submissions across all the performance categories and more accurately reflect the exclusion of QPs from all MIPS performance categories, a difference of 70,502 hours and $7,044,791. This burden estimate is higher than the burden approved for information collection related to the CY 2020 PFS final rule due to updated data and assumptions as well as the addition of the Open Authorization Credentialing and Token Request Process information collection, which is not a result of any new or revised policies proposed in this rule or finalized in any previous final rule, but rather an operational improvement. The difference of −5,488 hours (70,502 hours−66,876 hours + 1,862 hours) and −$488,115 ($7,044,791−$6,604,565 + $47,889) between this estimate and the total burden shown in Table 87 is the reduction in burden associated with impacts of the proposed policy to sunset the CMS Web Interface measures as a collection type/submission type; partially offset by an increase in burden due to a new information collection for nomination of MVPs, the proposed policy to add a survey-based measure on telehealth that assesses patient-reported usage of telehealth services to the CAHPS for MIPS Survey, the proposal to allow APM Entities to submit an extreme and uncontrollable circumstances exception application, and the proposed policy to require nominated improvement activities to be linked to existing and related quality and cost measures, as applicable and feasible. We have included Table 84 to assist in understanding these differences.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="121">
                        <GID>EP17AU20.119</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="559">
                        <PRTPAGE P="50369"/>
                        <GID>EP17AU20.120</GID>
                    </GPH>
                    <P>Table 86 provides the reasons for changes in the estimated burden for information collections in the Quality Payment Program segment of this proposed rule. We have divided the reasons for our change in burden into those related to new policies and those related to adjustments in burden from continued Quality Payment Program Year 4 policies that reflect updated data and revised methods.</P>
                    <GPH SPAN="3" DEEP="617">
                        <PRTPAGE P="50370"/>
                        <GID>EP17AU20.121</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="236">
                        <PRTPAGE P="50371"/>
                        <GID>EP17AU20.122</GID>
                    </GPH>
                    <HD SOURCE="HD2">C. Summary of Annual Burden Estimates for Proposed Requirements</HD>
                    <GPH SPAN="3" DEEP="218">
                        <GID>EP17AU20.123</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD2">D. Submission of Comments</HD>
                    <P>We have submitted a copy of this rule to OMB for its review of the rule's proposed information collection requirements and burden. The requirements are not effective until they have been approved by OMB.</P>
                    <P>
                        To obtain copies of the supporting statement and any related forms for the proposed collections previously discussed, please visit CMS's website at 
                        <E T="03">https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html,</E>
                         or call the Reports Clearance Office at (410) 786-1326.
                    </P>
                    <P>
                        We invite public comments on the proposed information collection requirements and burden. If you wish to comment, please submit your comments electronically as specified in the 
                        <E T="02">DATES</E>
                         and 
                        <E T="02">ADDRESSES</E>
                         sections of this proposed rule and identify the rule (CMS-1734-P) and where applicable the ICR's CFR citation, CMS ID number, and OMB control number.
                    </P>
                    <HD SOURCE="HD1">VII. 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 
                        <E T="02">DATES</E>
                         section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
                        <PRTPAGE P="50372"/>
                    </P>
                    <HD SOURCE="HD1">VIII. Regulatory Impact Analysis</HD>
                    <HD SOURCE="HD2">A. Statement of Need</HD>
                    <P>This proposed rule would make payment and policy changes under the Medicare PFS and implements required statutory changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better Life Experience Act (ABLE), the Protecting Access to Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, the Consolidated Appropriations Act of 2016, the Bipartisan Budget Act of 2018, and sections 2005 6063, and 6111 of the SUPPORT for Patients and Communities Act of 2018. This proposed rule would also make changes to payment policy and other related policies for Medicare Part B.</P>
                    <P>This proposed rule is necessary to make policy changes under Medicare fee-for-service. Therefore, we included a detailed Regulatory Impact Analysis (RIA) to assess all costs and benefits of available regulatory alternatives and explained the selection of these regulatory approaches that we believe adhere to statutory requirements and, to the extent feasible, maximize net benefits.</P>
                    <HD SOURCE="HD2">B. Overall Impact</HD>
                    <P>We examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).</P>
                    <P>
                        Executive Orders 12866 and 13563 direct 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). An RIA must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimated, as discussed in this section, that the PFS provisions included in this proposed rule would redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we prepared an RIA that, to the best of our ability, presents the costs and benefits of the rulemaking. The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details, see the SBA's website at 
                        <E T="03">http://www.sba.gov/content/table-small-business-size-standards</E>
                         (refer to the 620000 series)). Individuals and states are not included in the definition of a small entity.
                    </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>Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this proposed rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities.</P>
                    <P>In addition, section 1102(b) of the Act requires us to prepare an RIA 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 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 of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. The PFS does not reimburse for services provided by rural hospitals; the PFS pays for physicians' services, which can be furnished by physicians and nonphysician practitioners (NPPs) in a variety of settings, including rural hospitals. We did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.</P>
                    <P>Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits on state, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2020, that threshold is approximately $156 million. This proposed rule will impose no mandates on state, local, or tribal governments or on the private sector.</P>
                    <P>Executive Order 13132 establishes certain requirements that an agency must meet when it issues 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. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.</P>
                    <P>Executive Order 13771, entitled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017. This proposed rule, if finalized, is expected to be an E.O. 13771 regulatory action. We estimate the rule generates $1.34 million in annualized costs in 2016 dollars, discounted at 7 percent relative to year 2016 over a perpetual time horizon. Details on the estimated costs of this rule can be found in the preceding and subsequent analyses.</P>
                    <P>
                        We prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this proposed rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we would use to minimize the burden on small entities. As indicated elsewhere in this proposed rule, we proposed a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services, and implementing statutory provisions. We provide information for each of the policy changes in the relevant sections of this proposed rule. 
                        <PRTPAGE P="50373"/>
                        We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this proposed rule. The relevant sections of this proposed rule contain a description of significant alternatives if applicable.
                    </P>
                    <HD SOURCE="HD2">C. Changes in Relative Value Unit (RVU) Impacts</HD>
                    <HD SOURCE="HD3">1. Resource-Based Work, PE, and MP RVUs</HD>
                    <P>Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality.</P>
                    <P>Our estimates of changes in Medicare expenditures for PFS services compared payment rates for CY 2020 with payment rates for CY 2021 using CY 2019 Medicare utilization. The payment impacts in this proposed rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and would depend on the mix of services he or she furnishes. The average percentage change in total revenues will be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule (CLFS).</P>
                    <P>The annual update to the PFS conversion factor (CF) was previously calculated based on a statutory formula; for details about this formula, we refer readers to the CY 2015 PFS final rule with comment period (79 FR 67741 through 67742). Section 101(a) of the MACRA repealed the previous statutory update formula and amended section 1848(d) of the Act to specify the update adjustment factors for CY 2015 and beyond. The update adjustment factor for CY 2021, as required by section 1848(d)(19) of the Act, is 0.00 percent before applying other adjustments.</P>
                    <P>To calculate the CY 2021 CF, we multiplied the product of the current year CF and the update adjustment factor by the budget neutrality adjustment described in the preceding paragraphs. We estimate the CY 2021 PFS CF to be 32.2605 which reflects the budget neutrality adjustment under section 1848(c)(2)(B)(ii)(II) of the Act and the 0.00 percent update adjustment factor specified under section 1848(d)(19) of the Act. We estimate the CY 2021 anesthesia CF to be 19.9631 which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments.</P>
                    <GPH SPAN="3" DEEP="231">
                        <GID>EP17AU20.124</GID>
                    </GPH>
                    <P>Table 90 shows the payment impact on PFS services of the policies contained proposed rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues will be different from those shown in Table 90 (CY 2021 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 90.</P>
                    <P>
                        • 
                        <E T="03">Column A (Specialty):</E>
                         Identifies the specialty for which data are shown.
                    </P>
                    <P>
                        • 
                        <E T="03">Column B (Allowed Charges):</E>
                         The aggregate estimated PFS allowed charges for the specialty based on CY 2019 utilization and CY 2020 rates. That is, allowed charges are the PFS amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty.
                    </P>
                    <P>
                        • 
                        <E T="03">Column C (Impact of Work RVU Changes):</E>
                         This column shows the estimated CY 2021 impact on total allowed charges of the changes in the work RVUs, including the impact of changes due to potentially misvalued codes.
                    </P>
                    <P>
                        • 
                        <E T="03">Column D (Impact of PE RVU Changes):</E>
                         This column shows the estimated CY 2021 impact on total allowed charges of the changes in the PE RVUs.
                    </P>
                    <P>
                        • 
                        <E T="03">Column E (Impact of MP RVU Changes):</E>
                         This column shows the 
                        <PRTPAGE P="50374"/>
                        estimated CY 2021 impact on total allowed charges of the changes in the MP RVUs.
                    </P>
                    <P>
                        • 
                        <E T="03">Column F (Combined Impact):</E>
                         This column shows the estimated CY 2021 combined impact on total allowed charges of all the changes in the previous columns. Column F may not equal the sum of columns C, D, and E due to rounding.
                    </P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="640">
                        <PRTPAGE P="50375"/>
                        <GID>EP17AU20.125</GID>
                    </GPH>
                    <GPH SPAN="3" DEEP="148">
                        <PRTPAGE P="50376"/>
                        <GID>EP17AU20.126</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <HD SOURCE="HD3">2. CY 2021 PFS Impact Discussion</HD>
                    <HD SOURCE="HD3">a. Changes in RVUs</HD>
                    <P>The most widespread specialty impacts of the RVU changes are generally related to the changes to RVUs for specific services resulting from the misvalued code initiative, including RVUs for new and revised codes. The estimated impacts for some specialties, including endocrinology, rheumatology, family practice, and hematology/oncology reflect increases relative to other physician specialties. These increases can largely be attributed to previously finalized policies for increases in valuation for office/outpatient E/M visits which constitute nearly 20 percent of total spending under the PFS. These increases are also due to proposed increases in value for particular services following the recommendations from the American Medical Association (AMA)'s Relative Value Scale Update Committee (RUC) and CMS review, increased payments as a result of finalized updates to supply and equipment pricing, and the continuing implementation of the adjustment to indirect PE allocation for some office-based services. For nephrologists, our proposal to increase the valuations of the ESRD monthly capitation payments that have office/outpatient E/M visits explicitly included in their valuations result in estimated impacts of +5 percent. For clinical social workers and clinical psychologists, our proposals to increase the valuations for certain behavioral health services that are analogous to office/outpatient E/M visits result in estimated impacts of 0 percent.</P>
                    <P>The estimated impacts for several specialties, including radiology, nurse anesthetists, pathology, and cardiac surgery reflect decreases in payments relative to payment to other physician specialties which are largely the result of the redistributive effects of previously finalized changes to the office/outpatient E/M visits taking effect in 2021. These decreases are also due to the revaluation of individual procedures reviewed by the AMA's RUC and CMS, as well as decreased payments as a result of continuing implementation of the previously finalized updates to supply and equipment pricing. The estimated impacts also reflect decreased payments due to continued implementation of previously finalized code-level reductions that are being phased in over several years. For the physical/occupational therapy specialty, estimated impacts of −8 percent reflect proposed increased valuations for therapy evaluation services that are analogous to office/outpatient E/M visits. However, therapy evaluation services do not account for a large portion of allowed charges for these specialties.</P>
                    <P>For emergency medicine practitioners, estimated impacts of −6 percent reflect a 3 percent gain as a result of proposed increased valuations to emergency department visits using specialty society recommendations to maintain relativity with office/outpatient E/M visits. However, the magnitude of the office/outpatient E/M visit valuations are dampening the effect of increased valuations for the emergency department visits. For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the CLFS. As a result, the estimated 5 percent decrease for CY 2021 is only applicable to approximately 17 percent of the Medicare payment to these entities.</P>
                    <P>We often receive comments regarding the changes in RVUs displayed on the specialty impact table (Table 90), including comments received in response to the proposed rates. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes. The percentages in Table 90 are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty.</P>
                    <HD SOURCE="HD3">b. Impact</HD>
                    <P>
                        Column F of Table 90 displays the estimated CY 2021 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under “downloads” on the CY 2021 PFS proposed rule website at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.</E>
                         We selected these procedures for sake of illustration from among the procedures most commonly furnished by a broad spectrum of specialties. The change in both facility rates and the nonfacility rates are shown. For an explanation of facility and nonfacility PE, we refer readers to Addendum A on the CMS website at 
                        <E T="03">http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.</E>
                    </P>
                    <HD SOURCE="HD2">D. Effect of Changes Related to Telehealth Services</HD>
                    <P>
                        As discussed in section II.F. of this proposed rule, we are proposing to add eight new codes, HCPCS code GPC1X and CPT codes 99XXX, 96121, 99483, 99334, 99335, 99347, and 99348, to the list of Medicare telehealth services list for CY 2021. We are also proposing to add the following services provisionally on a category 3 basis: CPT codes 96130, 
                        <PRTPAGE P="50377"/>
                        96131, 96132, 96133, 96136, 96137, 96138, 96139, 99281, 99282, 99283, 99315, 99316, 99336, 99337, 99349, and 99350. Although we expect these changes to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the additions, we estimate there will only be a negligible impact on PFS expenditures from these additions. For example, services already on the list are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall. The restrictions placed on Medicare telehealth services by section 1834(m) of the statute limit increases in utilization; however, we believe there is value in allowing physicians to furnish these additional services via Medicare Telehealth, and for patients to receive broader access to this care through telehealth. Additionally, for services added to the Medicare telehealth list on a Category 3 basis, outside of the circumstances of the PHE, all of the statutory restrictions will also apply to these services. Even with the addition of the category 3 services for an additional year, we would not anticipate any significant uptick in utilization.
                    </P>
                    <HD SOURCE="HD2">E. Effect of Proposed Changes Related to Scopes of Practice</HD>
                    <P>As discussed in section II.G. Scopes of Practice for PFS Services, of this proposed rule, we proposed to allow certain nonphysician practitioners to supervise diagnostic tests, which would authorize NPs, CNSs, PAs, and CNMs to provide the appropriate level of supervision assigned to diagnostic tests, to the extent authorized under State law and scope of practice. As for all services they furnish, in accordance with statute, the NP, CNS or PA necessarily would be working either under physician supervision or in collaboration with a physician. This flexibility may increase the capacity and availability of practitioners who can supervise diagnostic tests, which would alleviate some of the demand on physicians as the only source to perform this particular function. However, we have not located information indicating the degree to which NPP scope of practice includes supervision of auxiliary staff, especially for the subset of services that are diagnostic tests. There is a wide range of diagnostic tests, from a simple strep throat swab to more sophisticated and/or invasive tests such as X-rays and cardiology procedures. We would need to understand the scope of practice for many types of auxiliary staff (some of whom are not licensed) who could potentially provide these tests under the supervision of an NPP, including RNs, LPNs, medical assistants, radiologic technicians, and many others. To the extent practice patterns change, there could be induced utilization that would increase costs, but this might be offset by reduced payment rates because direct payment to NPPs is at a lower rate than payment to physicians.</P>
                    <P>An alternative in the case of this proposal concerning supervision of diagnostic tests is to maintain the status quo. That is, we could maintain the basic rule under § 410.32(b)(1) that allows only physicians as defined under Medicare law to supervise the performance of diagnostic tests. In that case, the pool of practitioners who could supervise diagnostic tests would remain at current levels and certain NPPs would be limited under Medicare from practicing to the full extent allowed by their state license and scope of practice.</P>
                    <P>Also, we are proposing to allow a physical therapist (PT) or occupational therapist (OT)—whether they are an enrolled private practice PT or OT or a therapist working for an institutional provider—who establishes a therapy maintenance program to assign the duties to a PTA or OTA, as clinically appropriate, to perform maintenance therapy services. We added this as a flexibility under the May 8th COVID-19 IFC for the duration of the PHE based on respondents feedback on scope of practice following the President's Executive Order 13890. Our current requirements for maintenance therapy services restrict a PT's/OT's ability to delegate the performance of maintenance therapy services to PTAs and OTAs which is counter to the therapist's ability to use PTAs/OTAs in furnishing rehabilitative outpatient physical or occupational therapy services. Our proposal would allow PTs/OTs to oversee and delegate to a PTA or OTA the performance of physical and occupational therapy services in the same way, whether the therapy services are part of a plan of care geared toward rehabilitative or maintenance therapy. While therapy services furnished by PTs/OTs and their PTAs/OTAs are separately payable when they occur in different time slots (that is, if the PT/PTA or OT/OTA work together at the same time in furnishing a service to the patient, only one service is payable), we do not believe that there would be an increase in utilization since it is of no consequence whether the PTA/OTA is furnishing the service as rehabilitative or maintenance therapy. Additionally, we note that beginning January 1, 2022, payment for services furnished in whole or in part by a PTA/OTA (when the part by the PTA/OTA separate from the part of furnished by the PT/OT exceeds 10 percent of the service) will be paid at a lower rate (85 percent of the PFS fee schedule amount) which could offset any nominal increase in service volume. The alternative option—maintaining the status quo to require the PT/OT to personally furnish all maintenance therapy services, would not address the mandates established in Executive Order 13890. Currently, in SNF and home health settings when payment for therapy is made under Part A, maintenance therapy can be furnished by a PT/OT or delegated to be performed by a PTA/OTA, and our proposal would permit this to occur in all settings when therapy is paid under Part B.</P>
                    <P>In summary, we expect that these proposed policies regarding scope of practice would result in increased administrative and clinical flexibility for the specified professionals, but we cannot determine the specific impact our proposed policies would have on practice business plans and demand for certain types of clinicians. This is especially true due to the wide variation in diagnostic tests as well as variation in state law and facility policies.</P>
                    <HD SOURCE="HD2">F. Effect of Proposed Changes to Bundled Payments Under the PFS for Substance Use Disorders (HCPCS Codes G2086, G2087, and G2088)</HD>
                    <P>As discussed in section II.H. Valuation of Specific Codes, of this proposed rule, we are proposing to expand the bundled payments described by HCPCS codes G2086, G2087, and G2088, finalized in the CY 2020 PFS final rule (84 FR 62673) to be inclusive of all SUDs. As noted in the CY 2020 PFS final rule (84 FR 62673), if a patient's treatment involves MAT, this bundled payment would not include payment for the medication itself. Billing and payment for medications under Medicare Part B or Part D would remain unchanged. We note that payment for the proposed codes would be budget neutral under the PFS and therefore have no cost impact on PFS spending; however, this policy may have impacts on billing practices and services provided.</P>
                    <P>
                        Currently, the codes most frequently used when billing for treatment of SUD include the E/M visit codes, psychotherapy codes, SBIRT codes, and potentially the Behavioral Health Integration codes. HCPCS codes G2086-G2088 offer a bundled payment that would allow a more streamlined approach to billing in cases where all of the services described in the code descriptors are furnished. In our 
                        <PRTPAGE P="50378"/>
                        previous response, we sought to clarify that these codes provide an option for billing, but are not required; therefore, in cases where only select services are being furnished, practitioners may continue to bill for the code that most accurately describes the service that was furnished, which could be, for example, just an E/M visit code.
                    </P>
                    <HD SOURCE="HD2">G. Effect of Proposed Modifications to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)</HD>
                    <P>Section 2005 of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act established a new Medicare Part B benefit for OUD treatment services furnished by OTPs on or after January 1, 2020. As part of CY 2020 PFS rulemaking, we implemented coverage requirements, created new coding to describe bundled episodes of care for the treatment of OUD, and established payment methodologies to determine the payment amounts for the drug and non-drug components of an episode of care.</P>
                    <P>For CY 2021, we are proposing to create two new add-on codes, one add-on code for nasal naloxone and another add-on code for auto-injector naloxone. We are proposing to price nasal naloxone based upon the methodology set forth in section 1847A of the Act, except that the payment amount shall be ASP + 0. We are proposing to price the auto-injector using the lowest pricing available (the lower of ASP + 0, WAC + 0, or NADAC). Under this methodology, the proposed price for nasal naloxone would be $89.63 per 2-pack and the proposed price for the naloxone auto-injector would be $178 per 2-pack. We are proposing to limit Medicare payment to OTPs for naloxone to one add-on code (HCPCS code GOTP1 or GOTP2) every 30 days to the extent that it is medically reasonable and necessary.</P>
                    <P>We estimate the cost impact of the recommended naloxone add-on codes will be approximately $2.28 million in CY 2021. This estimate is based on a maximum impact of approximately $23 million, scaled down using the percentage of beneficiaries on MAT who received naloxone under Medicare Part D in 2018 (9.91 percent). The maximum total annual cost was calculated using the proposed payment rate for the more expensive of the two codes, and we assumed every Medicare beneficiary receiving treatment at an OTP would receive the maximum allowed number of doses ($178 × 12 months) under the proposed frequency limit. However, we note that some patients would receive the less expensive nasal formulation and we believe that many patients would not require doses each month, if no need arises for opioid overdose reversal. This estimate uses the assumption from CY 2020 rulemaking that roughly 10,600 beneficiaries would utilize the OTP benefit in the first year. This estimate also assumes that there is no beneficiary cost-sharing and makes no assumptions for ramp-up.</P>
                    <P>
                        We believe that the benefits associated with establishing payment for naloxone in the OTP setting justify the cost of this proposal. As noted in section II.I. of this proposed rule, Modifications Related to Medicare Coverage for Opioid Use Disorder (OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs), U.S. Surgeon General Jerome M. Adams, M.D., M.P.H. has released a public health advisory stating that, “Research shows that when naloxone and overdose education are available to community members, overdose deaths decrease in those communities. Therefore, increasing the availability and targeted distribution of naloxone is a critical component of our efforts to reduce opioid-related overdose deaths and, when combined with the availability of effective treatment, to ending the opioid epidemic.” 
                        <SU>111</SU>
                        <FTREF/>
                         We are proposing to add naloxone to the definition of OUD treatment services in order to increase access to this important emergency treatment and to allow OTPs to be paid under Medicare for dispensing naloxone to Medicare beneficiaries who are receiving other OUD treatment services from the OTP. Under this proposal, beneficiaries receiving OUD treatment services from the OTP would be able to receive two doses of naloxone from the OTP every 30 days under the OUD treatment services benefit, to the extent it is medically reasonable and necessary as part of their OUD treatment. We believe allowing beneficiaries to access this important emergency treatment at the OTP may help decrease barriers to access because there are no copayments for services furnished by OTPs and beneficiaries would not need to visit a separate provider to access naloxone.
                    </P>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             
                            <E T="03">https://www.hhs.gov/surgeongeneral/priorities/opioids-and-addiction/naloxone-advisory/index.html.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">H. Other Provisions of the Regulation</HD>
                    <HD SOURCE="HD3">1. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-In of Payment Reductions</HD>
                    <P>In section III.A. of this proposed rule, we discuss statutory revisions to the data reporting period and phase-in of payment reductions. In accordance with section 105(a) of the FCAA and section 3718 of the CARES Act, we are proposing to make certain conforming changes to the data reporting and payment requirements in our regulations at 42 CFR part 414, subpart G. Specifically, for clinical diagnostic laboratory tests (CDLTs) that are not advanced diagnostic laboratory tests (ADLTs), we are revising § 414.504(a)(1) to indicate that initially, data reporting begins January 1, 2017 and is required every 3 years beginning January 2022. This revision delays the next data reporting period under the CLFS by 2 years, that is, it will require the next data reporting during the period of January 1, 2022 through March 31, 2022. Subsequently, the next private payor rate-based CLFS update will be effective January 1, 2023 instead of January 1, 2021. In addition, we are proposing to make conforming changes to our requirements for the phase-in of payment reductions to reflect the CARES Act amendments. Specifically, we are proposing to revise § 414.507(d) to indicate that for CY 2021, payment may not be reduced by more than 0.0 percent as compared to the amount established for CY 2020, and for CYs 2022 through 2024, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year.</P>
                    <P>We recognize that private payor rates for CDLTs paid on the CLFS and the volumes paid at each rate for each test, which are used to determine the weighted medians of private payor rates, have changed since the first data collection period (January 1, 2016 through June 30, 2016) and data reporting period (January 1, 2017 through March 31, 2017). In addition, as discussed in section III.A. of this proposed rule, in the CY 2019 PFS final rule (83 FR 59671 through 59676), we amended the definition of applicable laboratory to include hospital outreach laboratories that bill Medicare Part B using the CMS-1450 14x Type of Bill. As such, the conforming regulatory changes to the data reporting period would delay using updated private payor rate data and data reported by hospital outreach laboratories to set revised CLFS payment rates.</P>
                    <P>
                        Due to the unforeseen changes in private payor rates, inclusion of hospital outreach laboratory data, and unpredictable nature of test volumes and their impact on calculating updated weighted medians private payor rates, we are uncertain as to whether the delay in data reporting would result in a measurable budgetary impact. In other 
                        <PRTPAGE P="50379"/>
                        words, in order to comprehend the impact of delayed reporting and subsequent implementation of updated CLFS rates, we would need to calculate weighted medians of private payor rates based on new data and compare the revised rates to the current rates. As such, we believe that we will only know the impact of the delay in data reporting after collecting actual updated applicable information from applicable laboratories, including the collection of private payor rate data from applicable hospital outreach laboratories, and calculate the updated weighted medians of private payor rates.
                    </P>
                    <P>With regard to the conforming changes to our requirements for the phase-in of payment reductions, we note that this revision shifts the 15 percent limitation on payment reductions from CYs 2021 through 2023, to CYs 2022 through 2024. Therefore, we believe this conforming regulatory amendment to the phase-in of payment reductions in § 414.507(d) is budget neutral for scoring purposes.</P>
                    <HD SOURCE="HD3">2. OTP Provider Enrollment Regulation Updates for Institutional Claim Submissions</HD>
                    <P>We stated in section III.B. of this proposed rule that:</P>
                    <P>• Section 424.67(b)(2) requires newly enrolling OTPs to pay an application fee at the time of enrollment under § 424.514.</P>
                    <P>• 300 currently enrolled OTPs would change their enrollment from a Form CMS-855B to a Form CMS-855A.</P>
                    <P>• 10 OTPs that enroll using the Form CMS-855A would later change their enrollment to a Form CMS-855B.</P>
                    <P>These 310 OTPs would be required to pay an application fee because said change to a Form CMS-855A enrollment would constitute a new/initial enrollment.</P>
                    <P>The application fees for each of the past 3 calendar years (CY) were or are $569 (CY 2018), $586, (CY 2019), and $595 (CY 2020). Consistent with § 424.514, the differing fee amounts are predicated on changes/increases in the Consumer Price Index (CPI) for all urban consumers (all items; United State city average, CPI-U) for the 12-month period ending on June 30 of the previous year. Although we cannot predict future changes to the CPI, the fee amounts between 2018 and 2020 increased by an average of $13 per year. We believe this is a reasonable barometer with which to estimate (strictly for purposes of this proposed rule) the fee amount in CY 2021, the year in which we believe all of the above-referenced 310 OTPs would change their enrollments. Accordingly, we project a fee amount of $608 in 2021, resulting in a total application fee cost of $188,480 (310 × $608).</P>
                    <HD SOURCE="HD3">3. Payment for Principal Care Management (PCM) Services in Rural Health Centers (RHCs) and Federally Qualified Health Centers (FQHCs)</HD>
                    <P>After reviewing the PFS, FQHC, and RHC historical spending, including the first quarter of calendar year 2020 spending for the new principal care management codes under the PFS, we estimate the addition of these codes (G2064 and G2065) to G0511 would have a negligible impact on Medicare spending.</P>
                    <HD SOURCE="HD3">4. Changes to the Federally Qualified Health Center Prospective Payment System (FQHC PPS) for CY 2021: Proposed Rebasing and Revising of the FQHC Market Basket</HD>
                    <P>Since the proposed FQHC market basket and multi-factor productivity adjustment are the same under the current 2013-based market basket and the proposed 2017-based market basket (1.9 percent), we estimate no economic impact from rebasing and revising of the FQHC market basket for CY 2021.</P>
                    <HD SOURCE="HD3">5. Comprehensive Screenings for Seniors: Section 2002 of the Substance Use-Disorder Prevention That Promote Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act)</HD>
                    <P>We are proposing to implement section 2002 of the Support Act by adding regulatory language to the existing Initial Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV) regulations to explicitly include elements regarding screening for potential substance use disorders and a review of current opioid prescriptions. We expect the new regulatory elements to add minimal burden since review of medical and social history, risk factor identification, education, counseling, and referrals are already fundamental parts of the IPPE and AWV. Standard documentation in the medical record that these services were furnished would not change based on these new requirements. We note that in section VIII.C.2.a. of this RIA, we discuss the increase in payment for E/M visits in general. Accordingly, the increase in payment for E/M visits applies to the IPPE and AWV and the impact to 2021 expenditures is included in section VIII.C.2.a. of this RIA.</P>
                    <HD SOURCE="HD3">6. Medicaid Promoting Interoperability Program Requirements for Eligible Professionals (EPs)</HD>
                    <P>In the Medicaid Promoting Interoperability Program, to keep electronic clinical quality measure (eCQM) specifications current and minimize complexity, we propose to align the eCQMs available for Medicaid EPs in 2021 with those available for MIPS eligible clinicians for the CY 2021 performance period. We anticipate that this alignment would reduce burden for Medicaid EPs by aligning the requirements for multiple reporting programs, and that the system changes required for EPs to implement this change would not be significant, as many EPs are expected to report eCQMs to meet the quality performance category of MIPS and therefore should be prepared to report on those eCQMs for 2021. Not implementing this alignment could lead to increased burden because EPs might have to report on different eCQMs for the Medicaid Promoting Interoperability Program, if they opt to report on newly added eCQMs for MIPS. We expect that this proposed policy would have only a minimal impact on states, by requiring minor adjustments to state systems for 2021 to maintain current eCQM lists and specifications. Based on a sampling of funding requests, each state typically spends, on average, approximately $670,000 per year to operate its Medicaid Promoting Interoperability Program attestation system for EPs. Only a small fraction of those costs is typically attributable to updating eCQM specifications. We estimate that the costs for updating eCQM specifications under this proposal would be approximately $100,000 per state. State expenditures to make any systems changes that would be required as a result of this proposal would most likely be eligible for 90 percent Federal financial participation.</P>
                    <P>
                        For 2021, we propose to require that Medicaid EPs report on any six eCQMs that are relevant to the EP's scope of practice, including at least one outcome measure, or if no applicable outcome measure is available or relevant, at least one high priority measure, regardless of whether they report via attestation or electronically. This proposal would generally align with the MIPS data submission requirement for eligible clinicians using the eCQM collection type for the quality performance category, which is established in § 414.1335(a)(1). If no outcome or high priority measure is relevant to a Medicaid EP's scope of practice, he or she could report on any six eCQMs that are relevant. This proposal would be a continuation of our policy for 2020 and we believe it will not create new burden for EPs or states.
                        <PRTPAGE P="50380"/>
                    </P>
                    <HD SOURCE="HD3">7. Medicare Shared Savings Program</HD>
                    <P>In section III.G.1.c. of this proposed rule, we propose changes to the Shared Savings Program quality performance standard. The quality performance standard is the minimum performance level ACOs must achieve in order to share in any savings earned, avoid maximum losses under certain payment tracks, and avoid quality-related compliance actions. We are proposing to increase the quality performance standard for all ACOs to achievement of a quality performance score equivalent to the 40th percentile or above across all MIPS Quality performance category scores, excluding entities/providers eligible for facility-based scoring. Please refer to section III.G.1.c. of this proposed rule for a detailed discussion of the data simulation used to inform the impacts for the proposed change to the quality performance standard.</P>
                    <P>Our analysis of quality performance data reported by ACOs for performance year 2018 indicates that the proposed methodological changes in ACO quality scoring will reduce the mean ACO quality score by roughly 10 to 15 percentage points relative to recent historical performance years where ACO quality performance scores have averaged 90 percent or more. Despite an expectation for a decreasing score for most ACOs and an increase in the fraction of ACOs failing to achieve the minimum threshold for qualifying for potential shared savings, the proposal is estimated to marginally increase overall shared savings payments to ACOs because under the proposed approach we would no longer prorate the savings sharing rate for ACOs that do meet or exceed the threshold. Our best estimate is that shared savings payments to ACOs would increase by $38 million for the 2021 performance year because of these proposed changes, representing an increase in shared savings payments of only about 2 percent of projected total gross measured savings for ACOs earning shared savings that year. We also recognize that this impact could differ if the 40th percentile across all MIPS Quality performance category scores improves relative to ACOs' quality performance scores, or alternatively if ACOs, particularly ACOs at risk of failing, respond to the methodology change by boosting their performance. Taking into account such possibilities indicates the impact of the proposed changes to the quality performance standard could range from $15 million in lower total shared savings payments to ACOs to $154 million in additional shared savings payments to ACOs (reflecting the respective extreme scenarios assumed above). However, it is important to note that under all scenarios, the program continues to achieve significant net savings after sharing savings with ACOs.</P>
                    <P>We do not anticipate a material aggregate impact for the other proposed changes related to the Shared Savings Program, specifically the changes related to repayment mechanism requirements (section III.G.3. of this proposed rule) and the assignment methodology (section III.G.2. of this proposed rule); however, the latter proposal may have differing effects on a subset of participating ACOs, for example by changing which competing ACO ultimately achieves the assignment for a small subset of beneficiaries.</P>
                    <HD SOURCE="HD3">8. Modifications to Medicare Shared Savings Program Quality Reporting Requirements for Performance Year 2020</HD>
                    <P>We are proposing to waive the CAHPS for ACOs reporting requirement for performance year 2020 and will assign automatic full credit to all ACOs for the CAHPS for ACOs survey measures. Based on recent ACO performance on CAHPS measures, we estimate moving to a 100 percent score for the CAHPS measures would increase the final quality score for the group of all non-new ACOs by roughly 2 percentage points. This would translate to an estimated increase in total shared savings payments to ACOs of approximately $20 million.</P>
                    <HD SOURCE="HD3">9. Proposal To Remove Selected National Coverage Determinations</HD>
                    <P>We are proposing to remove nine older NCDs that no longer contain clinically pertinent and current information or that involve items or services that are used infrequently by beneficiaries. Generally, proactively removing obsolete or unnecessary NCDs removes barriers to innovation and reduces burden for stakeholders and CMS. The nine NCDs fall into two impact categories. First, eliminating an NCD for items and services that were previously covered means that the item or service will no longer be automatically covered by Medicare. Instead, the coverage determinations for those items and services will be made by Medicare Administrative Contractors (MACs). Second, if the previous national coverage determination barred coverage for an item or service under title XVIII, MACs would now be able to cover the item or service if the MAC determines that such action is appropriate under the statute. We believe that allowing local contractor flexibility in these cases better serves the needs of the Medicare program and its beneficiaries since we believe the future utilization for items and services within these policies will be limited, each affecting less than one percent of the Medicare FFS population.</P>
                    <P>For the six NCDs where we are proposing to go from limited coverage to MAC discretion, claims data from 2019 show that less than one percent of the Medicare population are affected. Specifically, CMS provides limited coverage for specific conditions under NCD 20.5, Extracorporeal Immunoadsorption (ECI) using Protein A Columns, where CMS paid 1,918 Medicare FFS claims for 118 beneficiaries for a total expenditure of $3,757,178.36. Under NCD 100.9, Implantation of Gastroesophageal Reflux Device, CMS received no claims in 2019. For NCD 110.14, Apheresis (Therapeutic Pheresis), CMS paid 84,539 Medicare FFS claims for 10,641 beneficiaries for a total expenditure of $77,486,916.37. CMS provides coverage for FDA approved labeled indications under NCD 110.19, Abarelix, and no claims were submitted in 2019 because the device is no longer marketed. Under NCD 190.1, Histocompatability Testing, CMS paid 4,986 Medicare FFS claims for 2,525 beneficiaries for a total expenditure of $206,085.04. For NCD 190.3, Cytogenetic Studies, CMS paid 163,522 Medicare FFS claims for 145,212 beneficiaries for a total expenditure of $18,997,807.17. If under MAC discretion, these items and services continue to be covered, we estimate there will be de minimis change to 2021 expenditures, compared to 2019. However, we note that MAC discretion may result in the MACs determining that in particular instances of these items and services, a noncoverage decision may be appropriate for the patient, which could result in a decrease in 2021 expenditures, compared to 2019.</P>
                    <P>
                        For the three non-covered NCDs proposed to be eliminated, we would not expect to find historical claims data. CMS broadly noncovers both Electrosleep Therapy (NCD 30.4) and Magnetic Resonance Imaging (NCD 220.2.1) for all indications. CMS noncovers FDG PET (NCD 220.6.16) for three specific conditions. The FDG PET NCD as written is silent on covered conditions, thereby allowing MACs to determine coverage for all other conditions not specifically noncovered. Because these NCDs provide for noncoverage, we do not have accurate claims data to estimate total impact. However, based on the diagnoses and services, we expect future claims to affect less than one percent of Medicare 
                        <PRTPAGE P="50381"/>
                        FFS beneficiaries. Furthermore, removing a national noncoverage NCD may reduce burden for stakeholders and CMS. It may also remove barriers to innovations and increase patient access to technologies that may now be beneficial for some uses.
                    </P>
                    <HD SOURCE="HD3">10. Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan</HD>
                    <P>This provision does not have any cost to stakeholders other than what is reflected in the Collection of Information section of this proposed rule, including cost to Medicare.</P>
                    <HD SOURCE="HD3">11. Medicare Part B Drug Payment for Drugs Approved Through the Pathway Established Under Section 505(b)(2) of the Food, Drug, and Cosmetic Act</HD>
                    <P>We believe that if finalized, our proposal to continue assigning certain section 505(b)(2) drug products to existing multiple source drug codes, as described in section III.L. of this proposed rule, would result in continued savings by preventing excessive payments for some drug products that are labeled and used in a manner that is similar to generic versions of existing products that are paid under multiple source drug codes. Finalizing this proposal would result in the continuation of what we have characterized as longstanding policy. We believe that savings would continue based on differences in Medicare payment allowances between codes that contain only section 505(b)(2) drug products (with labeling and uses that are similar to multiple source drug codes) and multiple source drug codes that include generic drugs with the same active ingredient(s). In these cases, recent payment limits determined under section 1847A of the Act for the 505(b)(2) drugs were roughly 10 times higher than the payments for multiple source drug codes that included the generic drug products. The multiple source drug code payment limits used in the comparisons consisted of a weighted average of generic and branded drug products.</P>
                    <P>We are not able to provide a detailed estimate of the potential continued savings for the following reasons. First, we cannot estimate how many section 505(b)(2) drug products will be approved over the next few years. Second, we cannot estimate how many of these drug products will be paid under Part B. Third, we cannot estimate what share of Part B drug claims relative to similar (and potentially lower priced) multiple source drug codes the section 505(b)(2) drug products will capture. Fourth, we cannot estimate the price or payment difference between the yet to be approved section 505(b)(2) drug products and items priced in multiple source drug codes. We also note that the proposed approach will not prevent the separate payment of all section 505(b)(2) drug products. If an approved section 505(b)(2) drug product does not meet the definition of a multiple source drug as discussed in section III.L. of this proposed rule and is separately payable under Part B, that section 505(b)(2) drug product would be paid separately, for example it would be assigned to a single source drug code.</P>
                    <P>
                        However, we can provide a very rough estimate of the effect on spending that this policy has. Based on 2018 data on the Part B Drug Spending Dashboard (
                        <E T="03">https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Information-on-Prescription-Drugs/MedicarePartB</E>
                        ), a 50 percent uptake of two recently approved section 505(b)(2) drug products relative to the corresponding multiple source drug code, and payment allowance estimates derived from the July 2020 ASP Drug Pricing files (or WAC from pricing compendia if ASP was not yet available), we estimate that payment under separate single source drug codes could result in $15 million to $33 million more spending per code each year for each section 505(b)(2) drug product that is assigned to a separate code. Even if a small number of section 505(b)(2) drug products were paid under separate codes, for example 5 to 10 each year, this could result in $75 million to $330 million in additional spending per year (just for each year's 5 to 10 new section 505(b)(2) drug products). Over 10 years, the combined total for paying for 5 to 10 more additional section 505(b)(2) drug products each year using separate codes could result in over $1 billion in additional Part B spending if this proposal is not finalized and these section 505(b)(2) drug products are treated as single source drugs.
                    </P>
                    <P>We also note that as discussed in section III.L. of this rule, the proposed approach will not prevent the separate payment of all section 505(b)(2) drug products.</P>
                    <HD SOURCE="HD3">12. Updates To Certified Electronic Health Record Technology Due to the 21st Century Cures Act</HD>
                    <P>In section III.M. of this proposed rule, we propose to update the definitions of CEHRT for the Promoting Interoperability Programs and for MIPS. Under this proposal, the technology must be certified under the Certification Program to the current 2015 Edition certification criteria or the certification criteria in the 2015 Edition Cures Update, for the period of 24 months, as described in timelines finalized in the 21st Century Cures Act final rule (85 FR 25670). After that time, when ONC only allows certification under the 2015 Edition Cures Update, the technology must be certified to the 2015 Edition Cures Update. We also propose flexibility such that participants in the Hospital IQR Program may use either the 2015 Edition certification criteria or the 2015 Edition Cures update for CEHRT beginning in the CY 2020 reporting period.</P>
                    <P>If these proposals are finalized, eligible hospitals and clinicians would be required to update their EHR technology to meet the CEHRT definition under the 2015 Edition Cures Update. It is important to note that the regulatory impacts of the ONC 21st Century Cures Act final rule accounts for the quantified and unquantified costs and benefits to hospitals and clinicians associated with acquiring technology certified to the 2015 Edition Cures Update (85 FR 25905 through 25938). Specifically, ONC based their analysis regarding the number of hospitals and health care providers that would be impacted by their regulatory action on the number of hospitals and health care providers that have historically participated in the CMS EHR Incentive Programs (now Promoting Interoperability (PI) Programs (85 FR 25908). Because we expect that the eligibility criteria proposed under this rule will be a subset of those who participated in the EHR Incentive Programs (for example the MIPS program has eligibility criteria for low-volume that the EHR Incentive program did not have), this regulatory impact analysis assumes that the cost to program participants to acquire the upgraded technology has been accounted for under the ONC 21st Century Cures Act. However, we acknowledge ambiguity in attributing impacts across that earlier rule and this proposal, and request comment that would help with identification of effects that are dependent on these new regulatory provisions. (We further note that if the ambiguity is ultimately resolved such that all the costs are attributed to the ONC 21st Century Cure Rule, leaving no costs associated with this proposed rule's certified EHR provisions, then these provisions would also yield no benefits.)</P>
                    <HD SOURCE="HD3">13. Proposal To Establish New Code Categories</HD>
                    <P>
                        In section III.N. of this proposed rule, we are proposing to create 15 new Level 
                        <PRTPAGE P="50382"/>
                        II HCPCS codes to identify the current array of buprenorphine/naloxone products available on the U.S. market. This code series is intended to replace and more specifically identify the series of four existing codes (J0572 through and including J0575). Even though this would result in a greater number of codes than previously available, the net result of this modification is simply a more complete set of codes, updated to reflect the current market, available for health care providers and coders to identify and report on claims. Therefore these changes place no additional burden on coders, health care providers.
                    </P>
                    <HD SOURCE="HD3">14. Medicare Diabetes Prevention Program Expanded Model Emergency Policy</HD>
                    <HD SOURCE="HD3">a. Effects on Beneficiaries</HD>
                    <P>In section III.O. of this proposed rule, we are proposing certain Medicare Diabetes Prevention Program (MDPP) expanded model policies to allow CMS to remove the once per life time benefit for some MDPP beneficiaries, increase the number of virtual sessions, allow MDPP suppliers to start new cohorts, and allow certain MDPP suppliers to deliver time-limited virtual MDPP sessions in the event of extreme and uncontrollable circumstances that would adversely affect access to MDPP services. These proposed changes would apply during the COVID-19 Public Health Emergency (PHE) and any future PHE, in the emergency area during the emergency period, as defined under section 1135 (g) of the Act, when the Secretary has authorized waivers under section 1135 for such emergency area and period.</P>
                    <P>Throughout the rulemaking for the MDPP expanded model, we sought to ensure that the set of MDPP services would be delivered in-person, in a classroom-based setting, within an established interval timeline. At the time, the priority was placed on establishing a structured service that, when delivered within the confines of the rule, would create the least risk of fraud and abuse, increase the likelihood of success, and maintain the integrity of the data collected for evaluation purposes. However, circumstances such as the COVID-19 PHE have led CMS to make changes to the MDPP expanded model, and now to propose an Emergency Policy for MDPP that allows for temporary flexibilities and that prioritizes availability and continuity of services for MDPP suppliers and MDPP beneficiaries impacted by 1135 waiver events.</P>
                    <P>In the March 31st COVID-19 IFC, we sought to ensure that the set of MDPP services that had already started when the COVID-19 PHE began could continue given the guidance from CDC that Medicare age beneficiaries stay home. The priority was to allow for temporary flexibilities that prioritize availability and continuity of services for MDPP suppliers and MDPP beneficiaries impacted by the COVID-19 PHE. Given the extended duration of the COVID-19 PHE, we are proposing to finalize the regulations in the March 31st COVID-19 IFC, amend the MDPP expanded model to revise certain MDPP policies during the COVID-19 PHE and any future 1135 waiver event where such 1135 waiver event may cause a disruption to in-person MDPP services. These proposed temporary flexibilities allow beneficiaries to either continue to have access to set of MDPP services through virtual sessions, pause in-person set of MDPP services and resume with the most recent attendance session of record, or restart MDPP from the beginning in accordance with the March 31st COVID-19 IFC (85 FR 19230). Under the current MDPP regulations, as implemented in the IFC, and for future 1135 events, should MDPP suppliers deliver set of MDPP services virtually and beneficiaries opt to continue with the set of MDPP services virtually during the 1135 waiver event, those beneficiaries are not eligible to restart the set of MDPP services at a later date.</P>
                    <P>Beneficiaries who are eligible to restart the set of MDPP services, as proposed in § 410.79(e)(4)(vi), would be currently enrolled in the first 12 months of the set of MDPP services, as demonstrated by the effective date of the first core session.</P>
                    <HD SOURCE="HD3">b. Effects on the Market</HD>
                    <P>At this point, we cannot make clear estimates of the true costs of the MDPP Emergency Policy costs given the current Medicare enrollment. For an example, as part of the COVID-19 flexibilities, we are using authority under section 1135 of the Act to waive the supplier enrollment application fee for any applications submitted on or after March 1, 2020 in response to COVID-19. This, along with CDC's promotion of the temporary application fee waiver to its DPRP registered organizations, have led to an increase in MDPP supplier enrollment applications and approved suppliers. Currently, more than 250 organizations nationally are enrolled as MDPP suppliers, representing 938 locations across the US and its territories.</P>
                    <P>For the current COVID-19 PHE, we anticipated in the March 31st COVID-19 IFC that of the 1,818 beneficiaries identified through our monitoring data and the CDC's Diabetes Prevention Recognition Program (DPRP) data, 1,358 beneficiaries may be impacted by allowing both the once-per-lifetime benefit and the minimum weight loss requirement to be waived for those beneficiaries in the first 12 months of MDPP. Of those, we assumed that roughly half of the beneficiaries will want to restart their set of MDPP services after the PHE ends, with a $279,748 cost impact of our waiving the once-per-lifetime benefit as part of the COVID-19 flexibilities, assuming that the estimated cost of year 1 of MDPP is $412.</P>
                    <P>
                        For this MDPP Emergency Policy, we propose to update our assumptions, based on subsequent data from the CDC regarding DPRP organizations' plans for managing their existing cohorts during the PHE, which include either continuing with their cohorts virtually, pausing set of MDPP services and restarting them virtually, or restarting at a later date after the emergency event ends. Based on these data, we assume that 20 percent of MDPP suppliers and 20 percent of beneficiaries will want to restart the set of MDPP services at the first core session after the emergency event ends, taking advantage of the once-per-lifetime requirement removal. We assume that future emergencies will be more geographic-specific, resulting from a natural disaster versus the national-level COVID-19 PHE. For future emergencies, we assume that 2,500 beneficiaries will be enrolled in MDPP in the impacted geographic region. We note that this number is currently an overestimate, and over time, it will likely be an underestimate. We also note that these assumptions are incorrect in cases where a geographic region suffers widespread damage, including to electrical and/or telecommunications systems. In this scenario, we assume there would be no virtual or physical access to set of MDPP services for some time, and the supplier will need to either pause or restart classes altogether until such infrastructure systems are back in place. We also assume that beneficiaries who opt to continue with the set of MDPP services virtually are within the first 12 months of the MDPP core service period, and will not be eligible to take advantage of the waived once-per-lifetime limit; and beneficiaries who are in year 2 of the set of MDPP services, as demonstrated by the effective date of the first core session, are not eligible to restart MDPP at the beginning. The cost per impacted geographic area of the removal of the once-per-lifetime limit is estimated to be $209,000. This assumes 
                        <PRTPAGE P="50383"/>
                        that MDPP suppliers are paid an estimated $418 due to beneficiaries reaching the following performance milestones: Beneficiary attended 9 sessions, and reached the 5 percent weight loss during interval 2 of the core maintenance session, and attended the required core maintenance sessions.
                    </P>
                    <GPH SPAN="3" DEEP="158">
                        <GID>EP17AU20.127</GID>
                    </GPH>
                    <HD SOURCE="HD3">15. Changes Due to Updates to the Quality Payment Program</HD>
                    <P>In section IV.A. of this proposed rule, we included our policies for the Quality Payment Program. In this section of the proposed rule, we present the overall and incremental impacts to the number of expected QPs and associated APM Incentive Payments. In MIPS, we estimate the total MIPS eligible population and the payment impacts by practice size for the 2021 MIPS performance period based on various proposed policies to modify the MIPS final score and the performance threshold proposed in section IV.A.3.e.(3) of this rule and additional performance threshold finalized in the CY 2020 PFS final rule (84 FR 63040).</P>
                    <P>The measure submissions for the 2019 MIPS performance period were not available in time to incorporate into this CY 2021 PFS proposed rule regulatory impact analysis. As a result, this analysis uses the 2018 MIPS performance period submissions that were used for the CY 2020 PFS final rule (84 FR 63164), with some updates of supplementary 2019 datasets used to better reflect trends in APM participation and QP status since the 2018 MIPS performance period. Furthermore, due to the application of the extreme and uncontrollable circumstances policy for the 2019 MIPS performance period, not all clinicians submitted measure data for the 2019 performance period. We will evaluate for the final rule as to whether it will be appropriate to use the 2019 performance period data.</P>
                    <HD SOURCE="HD3">a. Estimated APM Incentive Payments to QPs in Advanced APMs and Other Payer Advanced APMs</HD>
                    <P>From 2019 through 2024, through the Medicare Option, eligible clinicians receiving a sufficient portion of Medicare Part B payments for covered professional services or seeing a sufficient number of Medicare patients through Advanced APMs as required to become QPs, for the applicable performance period, will receive a lump-sum APM Incentive Payment equal to 5 percent of their estimated aggregate payment amounts for Medicare covered professional services furnished during the calendar year immediately preceding the payment year. Beginning in payment year 2021, in addition to the Medicare Option, eligible clinicians may become QPs through the All-Payer Combination Option. The All-Payer Combination Option allows eligible clinicians to become QPs by meeting the QP payment amount or patient count threshold through a pair of calculations that assess a combination of both Medicare Part B covered professional services furnished through Advanced APMs and services furnished through Other Payer Advanced APMs.</P>
                    <P>The APM Incentive Payment is separate from and in addition to the payments for covered professional services furnished by an eligible clinician during that year. Eligible clinicians who become QPs for a year are not subject to MIPS reporting requirements and payment adjustments. Eligible clinicians who do not become QPs, but meet a lower threshold to become Partial QPs for the year, may elect to report to MIPS and, if they elect to report, would then be scored under MIPS and receive a MIPS payment adjustment. Partial QPs are not eligible to receive the APM Incentive Payment. For the 2021 QP Performance Period, as set forth in § 414.1430(a)(2), Partial QPs are eligible clinicians in Advanced APMs who have at least 50 percent, but less than 75 percent, of their payments for Part B covered professional services through an APM Entity, or furnish Part B covered professional services to at least 35 percent, but less than 50 percent, of their Medicare beneficiaries through an APM Entity. This MIPS payment adjustment may be positive, negative, or neutral. If an eligible clinician does not attain either QP or Partial QP status, and does not meet any another exemption category, the eligible clinician would be subject to MIPS, would report to MIPS, and would receive the corresponding MIPS payment adjustment.</P>
                    <P>
                        Beginning in payment year 2026, the Conversion Factor (CF) used to calculate payment rates for services furnished by clinicians who achieve QP status for a year would be increased each year by 0.75 percent for the year, while the CF used to calculate payment rates for services furnished by clinicians who do not achieve QP status for the year would be increased by 0.25 percent. In addition, MIPS eligible clinicians would receive positive, neutral, or negative MIPS payment adjustments to payment for their Part B PFS services in a payment year based on performance during a prior performance period. Although the statute establishes overall payment rate and procedure parameters until 2026 and beyond, this impact analysis covers only the fifth payment year (2023 payment year) of the Quality Payment Program.
                        <PRTPAGE P="50384"/>
                    </P>
                    <P>Overall, we estimate that for the 2021 QP Performance Period between 196,000 and 252,000 eligible clinicians will become QPs, therefore be excluded from MIPS, and qualify for the lump sum APM incentive payment in Payment Year 2023 based on 5 percent of their Part B paid amounts for covered professional services in the preceding year. These paid amounts for QPs are estimated to be between approximately $14,012 million and $18,015 million in total for the 2021 performance year. The analysis for this proposed rule used the 2019 third snapshot participation file. We based APM Incentive Payment Amounts on paid amounts with service states of January 1, through September 30, 2019. We multiplied the calculated amounts by 1.5 to approximate payment amounts for the full calendar year. We estimate that the total lump sum APM Incentive Payments will be approximately $700-900 million for the 2023 Quality Payment Program payment year.</P>
                    <P>In section IV.F.10.b. of this proposed rule, we projected the number of eligible clinicians that will be QPs, and thus excluded from MIPS, using several sources of information. First, the projections are anchored in the most recently available public information on Advanced APMs. The projections reflect Advanced APMs that will be operating during the 2021 QP Performance Period, as well as some Advanced APMs anticipated to be operational during the 2021 QP Performance Period. The projections also reflect an estimated number of eligible clinicians that would attain QP status through the All-Payer Combination Option. We note that the Next Generation ACO Model, previously scheduled to conclude December 2020, the Comprehensive Care for Joint Replacement Payment Model (CEHRT Track), currently scheduled to conclude March 31, 2021, and the Radiation Oncology Model as proposed, have been included in our analysis as we anticipate that they will be Advanced APMs in 2021. The following APMs are expected to be Advanced APMs for the 2021 QP Performance Period:</P>
                    <P>• Bundled Payments for Care Improvement Advanced Model;</P>
                    <P>• Comprehensive Care for Joint Replacement Payment Model (CEHRT Track), if extended;</P>
                    <P>• Comprehensive Primary Care Plus (CPC+) Model;</P>
                    <P>• Direct Contracting Model;</P>
                    <P>• Kidney Care Choices Model;</P>
                    <P>• Maryland Total Cost of Care Model (Care Redesign Program; Maryland Primary Care Program);</P>
                    <P>• Medicare Shared Savings Program (Track 2, Track 3, Basic Track Level E, and the ENHANCED Track);</P>
                    <P>• Medicare ACO Track 1+ Model;</P>
                    <P>• Next Generation ACO Model, if extended;</P>
                    <P>• Oncology Care Model (Two-Sided Risk Arrangements);</P>
                    <P>• Primary Care First (PCF) Model;</P>
                    <P>• Radiation Oncology Model (RO), if finalized; and</P>
                    <P>• Vermont All-Payer ACO Model (Vermont Medicare ACO Initiative).</P>
                    <P>
                        We used the Participation Lists and Affiliated Practitioner Lists, as applicable, (
                        <E T="03">see</E>
                         81 FR 77444 through 77445 for information on the APM Participant Lists and QP determinations) for the Predictive QP determination file for 2019 to estimate the number of QPs, total Part B paid amounts for covered professional services, and the aggregate total of APM Incentive Payments for the 2021 QP Performance Period. We examined the extent to which Advanced APM participants would meet the QP Thresholds of having at least 75 percent of their Part B covered professional services or at least 50 percent of their Medicare beneficiaries furnished Part B covered professional services through the APM Entity.
                    </P>
                    <HD SOURCE="HD3">b. Impact for the 2022 MIPS Payment Year</HD>
                    <P>In section IV.A.3.d.(2)(a) of this proposed rule, we proposed to double the total points available for the complex patient bonus to up to 10 points. If this proposal is finalized, we expect the median bonus to increase by 3 points, thus increasing MIPS final scores at the median by 3 points. We do not know the effects of the COVID-19 PHE and its effect on MIPS performance in 2020, so we did not recreate the analysis and payment distributions with the updated bonus for the 2020 MIPS performance period. We expect the higher MIPS final scores would result in smaller payment adjustments for two reasons. First, we expect reductions to the budget neutral pool due to the higher scores. Second, for clinicians above the performance threshold or additional performance threshold, an increased score would mean more clinicians sharing the budget neutral pool and additional $500 million for exceptional performance and potentially lowering the scaling factor that is applied to the MIPS payment adjustment and additional payment adjustment.</P>
                    <HD SOURCE="HD3">c. Estimated Number of Clinicians Eligible for MIPS Eligibility for the 2023 MIPS Payment Year</HD>
                    <HD SOURCE="HD3">(1) Methodology To Assess MIPS Eligibility</HD>
                    <HD SOURCE="HD3">(a) Clinicians Included in the Model Prior To Applying the Low-Volume Threshold Exclusion</HD>
                    <P>
                        To estimate the number of MIPS eligible clinicians for the 2021 MIPS performance period in this proposed rule, our scoring model used a combination of the first determination period from the 2019 MIPS performance period (from October 1, 2017 to September 30, 2018) and data from the end of calendar year 2018 (from October 1, 2018 to December 31, 2018). The first determination period from the 2019 MIPS performance period eligibility file was selected as it includes the several eligibility file changes that affect the Quality Payment Program moving forward. The rationale for including the data from the end of CY 2018 was to create a 15-month window for assigning MIPS eligible clinicians, as finalized in the CY 2019 PFS final rule (83 FR 59727 through 59730). We included 1.6 million clinicians (
                        <E T="03">see</E>
                         Table 92) who had PFS claims from October 1, 2017 to December 31, 2018. We excluded from our analysis individual clinicians who were affected by the automatic extreme and uncontrollable policy finalized for the 2018 MIPS performance period/2020 MIPS payment year in the CY 2019 PFS final rule (83 FR 59876) as we are unable to predict how these clinicians would perform in a year where there was no extreme and uncontrollable event. We also excluded from our analysis submissions from clinicians that are CPC+ practitioners due to data limitations and an inability to model their behavior within the APM Performance Pathway. Finally, submitters with one or more categories identified as being suppressed as a result of bad data were also excluded.
                    </P>
                    <P>Clinicians are ineligible for MIPS (and are excluded from MIPS payment adjustment) if they are newly enrolled to Medicare; are QPs; are partial QPs who elect to not participate in MIPS; are not one of the clinician types included in the definition for MIPS eligible clinician; or do not exceed the low-volume threshold as an individual or as a group. Therefore, we excluded these clinicians when calculating the estimate of clinicians eligible for MIPS.</P>
                    <P>
                        For the estimated MIPS eligible population for the 2023 MIPS payment year, we restricted our analysis to clinicians who are a physician (as defined in section 1861(r) of the Act), a 
                        <PRTPAGE P="50385"/>
                        physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5) of the Act); a certified registered nurse anesthetist (as defined in section 1861(bb)(2) of the Act); a physical therapist, occupational therapist, speech-language pathologist, audiologist, clinical psychologist, and registered dietitian or nutrition professional as finalized in the CY 2019 PFS final rule (83 FR 60076).
                    </P>
                    <P>As noted previously, we excluded QPs from our scoring model since these clinicians are not MIPS eligible clinicians. To determine which clinicians in the initial population of 1.6 million should be excluded as QPs, we used Advanced APM payment and patient percentages from the APM Participant List for the final snapshot date for the 2019 QP performance period, supplemented by the most recent 2018 performance period APM participation data for those clinicians not on the 2019 first snapshot list. From this data, we calculated the QP determinations as described in the Qualifying APM Participant definition at § 414.1305 for the 2021 QP performance period. We assumed that all Partial QPs would elect to participate in MIPS and included them in our scoring model and eligibility counts. The projected number of QPs excluded from our model is 115,936. Due to data limitations, we could not identify specific clinicians who may become QPs in the 2021 Medicare QP Performance Period; hence, our model may underestimate or overestimate the fraction of clinicians and allowed charges for covered professional services that will remain subject to MIPS after the exclusions.</P>
                    <P>We also excluded newly enrolled Medicare clinicians from our model. To identify newly enrolled Medicare clinicians, we used the enrollment date from the 2018 Quality Payment Program performance period data.</P>
                    <HD SOURCE="HD3">(b) Assumptions Related To Applying the Low-Volume Threshold Exclusion</HD>
                    <P>The low-volume threshold policy may be applied at the individual (that is, TIN/NPI) or group (that is, TIN) levels based on how data are submitted or at the APM Entity level if the clinician is part of an APM Entity in a MIPS APM (hereafter, a MIPS APM Entity) that elects to submit to MIPS. A clinician or group that exceeds at least one but not all three low-volume threshold criteria may become MIPS eligible by electing to opt-in and subsequently submitting data to MIPS, thereby getting measured on performance and receiving a MIPS payment adjustment. Our method of modeling opt-in participation is described later in this section.</P>
                    <P>Table 92 presents the estimated MIPS eligibility status and the associated PFS allowed charges of clinicians in the initial population of 1.6 million clinicians in the analysis of the 2021 MIPS performance period after using 2018 MIPS performance period data and applying the proposed policies for the 2021 MIPS performance period.</P>
                    <P>
                        To apply the low-volume threshold, we need to understand whether clinicians participate as a group, virtual group, APM entity, or as individuals. For the purposes of this regulatory impact analysis, we made assumptions as to which clinicians would elect group reporting, virtual group or APM Entity reporting. One extreme and unlikely assumption is that no practices elect group reporting, virtual group reporting, or participate in an APM Entity that elects MIPS reporting and the low-volume threshold is applied at the individual level. Although we believe a scenario in which clinicians would only participate as individuals is unlikely, this assumption is important because it quantifies the minimum number of MIPS eligible clinicians. For this proposed rule model, we estimate approximately 230,000 clinicians 
                        <SU>112</SU>
                        <FTREF/>
                         would be MIPS eligible because they exceed the low volume threshold as individuals and are not otherwise excluded. In Table 92, we identify these clinicians as having “required eligibility.”
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             The count of 230,738 MIPS eligible clinicians for required eligibility includes those who participated in MIPS (212,973 MIPS eligible clinicians), as well as those who did not participate (17,765 MIPS eligible clinicians).
                        </P>
                    </FTNT>
                    <P>For this RIA, we assume the following participation requirements for virtual groups and MIPS APM Entities that elect to participate in MIPS. We assume that TINs that registered as a virtual group for the CY 2018 MIPS performance period will continue to do so for the CY 2021 MIPS performance period. Due to data limitations and our inability to determine who would use the APM Performance Pathway versus the traditional MIPS submission mechanism for the 2021 MIPS performance period, our model assumes ACO APM Entities would elect to submit data to MIPS through the APM Performance Pathway and that participants in non-ACO APM Entities would participate in MIPS as an individual or group rather than as an APM Entity. We included those who are in MIPS APM ACOs in the 2018 performance period as well as the additional clinicians in the final snapshot date of the 2019 QP performance period.</P>
                    <P>Finally, we assume that groups that submitted to MIPS as a group will continue to do so for the CY 2021 MIPS performance period. Using CY 2018 MIPS performance period data, we can identify group reporting through the submission of improvement activities, Promoting Interoperability, or quality performance category data. Using these assumptions, we identified 680,253 MIPS eligible clinicians who are eligible because they had the low-volume threshold applied to an identified group, APM entity, or virtual groups. In Table 92, we identify these clinicians who do not meet the low-volume threshold individually but are assumed to submit to MIPS as a group, virtual group or MIPS APM as having “group eligibility.”</P>
                    <P>To model the opt-in policy finalized in the CY 2019 PFS final rule (83 FR 59735), we assumed that 33 percent of the clinicians who exceed at least one but not all low-volume threshold criteria and submitted data to CY 2018 MIPS performance period would elect to opt-in to MIPS. We selected a random sample of 33 percent of clinicians without accounting for performance. We believe this 33 percent opt-in participation assumption is reasonable because some clinicians may choose not to submit data due to performance, practice size, or resources or alternatively, some may submit data, but elect to be a voluntary reporter and not be subject to a MIPS payment adjustment based on their performance. This 33 percent participation assumption is identified in Table 92 as “Opt-In eligibility”. In this proposed rule analysis, we estimate an additional 20,059 clinicians would be eligible through this “opt-in” policy for a total MIPS eligible clinician population of approximately 930,000. The leads to an associated $72 billion allowed PFS charges estimated to be included in the 2021 MIPS performance period.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="549">
                        <PRTPAGE P="50386"/>
                        <GID>EP17AU20.128</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <P>There are an estimated 368,961 clinicians who are not MIPS eligible, but could be if their practice decides to participate or they elect to opt-in. We describe this group as “Potentially MIPS eligible”. These clinicians would be included as MIPS eligible in the unlikely scenario in which all group practices elect to submit data as a group and all clinicians that could elect to opt-into MIPS do elect to opt-in. This assumption is important because it quantifies the maximum number of MIPS eligible clinicians. When this unlikely scenario is modeled, we estimate the MIPS eligible clinician population could be as high as 1.3 million clinicians.</P>
                    <P>Finally, there are some clinicians who would not be MIPS eligible either because they and their group are below the low-volume threshold on all three criteria (approximately 80,000) or because they are excluded for other reasons (approximately 220,000).</P>
                    <P>
                        Since eligibility among many clinicians is contingent on submission to MIPS as a group, virtual group, APM participation in a MIPS APM Entity that elects to report to MIPS, or election to opt-in, we will not know the number of MIPS eligible clinicians until the 
                        <PRTPAGE P="50387"/>
                        submission period for the 2021 MIPS performance period is closed. For this impact analysis, we used the estimated population of 931,050 MIPS eligible clinicians described above.
                    </P>
                    <HD SOURCE="HD3">d. Estimated Impacts on Payments to MIPS Eligible Clinicians for the 2023 MIPS Payment Year</HD>
                    <HD SOURCE="HD3">(1) Summary of Approach</HD>
                    <P>In sections IV.A.3.c., IV.A.3.d. and IV.A.3.e. of this proposed rule, we present several provisions which impact the measures and activities that impact the performance category scores, final score calculation, and the MIPS payment adjustment. We discuss these changes in more detail in section VIII.H.15.c.(2) of this RIA as we describe our methodology to estimate MIPS payments for the 2023 MIPS payment year. We note that some of the MIPS policies in the CY 2020 PFS final rule were only defined for the 2020 MIPS performance period and 2022 MIPS payment year and did not continue to future years, such as the quality and cost performance category weights. Because we did not have category weights for the 2021 MIPS performance period, we could not calculate a final score for the 2021 MIPS performance period and 2023 MIPS payment year. Therefore, we could not create a baseline for the 2021 performance period that would allow us to fully distinguish between the impact of the previously finalized policies for the 2021 performance period and the proposed policies for the 2021 performance period. Our impact analysis looks at the total effect of the previously finalized and newly proposed MIPS policies on the MIPS final score and payment adjustment for the CY 2021 MIPS performance period/CY 2023 MIPS payment year.</P>
                    <P>The payment impact for a MIPS eligible clinician is based on the clinician's final score, which is a value determined by their performance (as an individual, group, virtual group, or APM Entity) in the four MIPS performance categories: Quality, cost, improvement activities, and Promoting Interoperability. As discussed in section VIII.H.15.c.(2) of this proposed rule, we generally used the most recently available data from the Quality Payment Program which is data submitted for the 2018 MIPS performance period.</P>
                    <P>The estimated payment impacts presented in this proposed rule reflect averages by practice size based on Medicare utilization. The payment impact for a MIPS eligible clinician could vary from the average and would depend on the combination of services that the MIPS eligible clinician furnishes. The average percentage change in total revenues that clinicians earn would be less than the impact displayed here because MIPS eligible clinicians generally furnish services to both Medicare and non-Medicare patients; this program does not impact payment from non-Medicare patients. In addition, MIPS eligible clinicians may receive Medicare revenues for services under other Medicare payment systems, such as the Medicare Federally Qualified Health Center Prospective Payment System, that would not be affected by MIPS payment adjustment factors.</P>
                    <HD SOURCE="HD3">(2) Methodology To Assess Impact</HD>
                    <P>To estimate participation in MIPS for the CY 2021 Quality Payment Program for this proposed rule, we generally used 2018 MIPS performance period data. Our scoring model included the 931,050 estimated MIPS eligible clinicians as described in section VIII.H.15.b.(1)(b) of this RIA.</P>
                    <P>
                        To estimate the impact of MIPS policies on MIPS eligible clinicians, we generally used the 2018 MIPS performance period data, including data submitted for the quality, improvement activities, and Promoting Interoperability performance categories, CAHPS for MIPS and CAHPS for ACOs, the total per capita cost measure, Medicare Spending Per Beneficiary (MSPB) clinician measure and other data sets.
                        <SU>113</SU>
                        <FTREF/>
                         We calculated a hypothetical final score for the 2021 MIPS performance period/2023 MIPS payment year for each MIPS eligible clinician using score estimates described in this section for quality, cost, Promoting Interoperability, and improvement activities performance categories.
                    </P>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             Data submitted to MIPS for the 2017 MIPS performance period data was used for the improvement score for the quality performance category. We also incorporated some additional data sources when available to represent more current data.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(a) Methodology To Estimate the Quality Performance Category Score</HD>
                    <P>We estimated the quality performance category score using a similar methodology described in the CY 2020 PFS final rule (84 FR 63168 through 63169) with the following modifications that reflect the newly proposed policies for the 2021 MIPS performance period. As discussed in section IV.A.3.c.(1)(c) of this proposed rule, we proposed to replace the All-Cause Readmission measure with the Hospital Wide Readmission measure and add the hip-knee complications measure for those for whom it is applicable. We used testing data for these new administrative claims measures.</P>
                    <P>As discussed in section IV.A.3.d.(1)(b) of this proposed rule, we proposed to use a performance period benchmark as opposed to a historical benchmark. Because the performance data for this analysis came primarily from the 2018 MIPS performance period, we elected to continue using the 2018 MIPS performance period benchmarks. We did not believe using performance period benchmarks for 2018 performance period submissions would appropriately simulate the data issues that might occur with historic benchmarks for the 2019 MIPS performance period. The one exception to using the 2018 MIPS performance benchmarks is we identified measures subject to the topped out scoring cap that was finalized (82 FR 53721 through 53727) using the 2020 MIPS performance period benchmark file.</P>
                    <P>As discussed in section IV.A.3.c.(1)(b) of this proposed rule, we proposed the removal of Web Interface as a collection type for the 2021 MIPS performance period. As discussed in section IV.A.3.c.(1) of this proposed rule, we proposed a quality performance category weight of 40 percent for the 2021 MIPS performance period.</P>
                    <P>
                        To estimate a quality performance category score for clinicians in groups who previously used Web Interface as a collection type in 2018, we assumed these groups would use the other two other collection types (MIPS CQMs and eCQMs) available in the 2021 MIPS performance period. To estimate the effect of this change, we used the measures submitted through Web Interface in 2018 and estimated a 2021 quality performance category score by multiplying their computed 2021 quality performance category score using Web Interface by an adjustment factor. The assumption is that the adjustment factor would reflect how clinicians who previously used Web Interface in the 2018 MIPS performance period would perform in the 2021 MIPS performance period in the absence of Web Interface when using the other two collection types available in the 2021 MIPS performance period. The computed adjustment factor accounts for the distribution of clinicians using MIPS CQMs and eCQMs in 2018 and the associated average quality performance category score by practice size categories (25-49 clinicians, 50-99 clinicians, 100-199 clinicians, 200-499 clinicians, 500-999 clinicians, and 1000 or more clinicians). The adjustment factor was calculated in two steps within each practice size category: In 
                        <PRTPAGE P="50388"/>
                        step one, the average quality performance category score for each collection type was weighted by the proportion of MIPS eligible clinicians using each collection type. In step two, the weighted average quality performance category score for the other collection types was divided by the average quality performance score for Web Interface, which yields the adjustment factor for each practice size category.
                    </P>
                    <P>
                        Finally, our model applied the APM Performance Pathway policies proposed in section IV.A.3.b. of this proposed rule for clinicians in APM Entities. The APM Performance Pathway is available for both ACO and non ACOs. However, due to data limitations, our analysis only applied the APM Performance Pathway scoring policies to ACO APM Entities. For ACOs, quality performance under the proposed APM performance pathway was modeled using data from the 2018 Shared Savings Program and Next Generation ACO Model public use files.
                        <SU>114</SU>
                        <FTREF/>
                         We simulated scores for the Hospital Wide Readmission measure proposed in section IV.A.3.c.(1)(c). Data does not exist for APM performance pathway or MIPS quality measures for non-ACO APM Entities, so we assumed these non-ACO APM entities would not participate in the APP. For the purposes of modeling, we assumed that their participating clinicians (or their groups) would participate in regular MIPS, and scored those clinicians using the available MIPS submissions of the clinician or its group. Therefore, because of data limitations our results may overestimate or underestimate the number of APM Entities that elect to participate in MIPS as an APM Entity and how they elect to participate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             The public use files for the 2018 Medicare Shared Savings Program can be accessed here: 
                            <E T="03">https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-data.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">(b) Methodology To Estimate the Cost Performance Category Score</HD>
                    <P>In section IV.A.3.c.(2) of this proposed rule, we proposed a cost performance category weight of 20 percent for the 2021 MIPS performance period. We estimated the cost performance category score using the methodology described in the CY 2020 PFS final rule (84 FR 63169)</P>
                    <HD SOURCE="HD3">(c) Methodology To Estimate the Facility-Based Measurement Scoring</HD>
                    <P>As finalized in the CY2019 PFS final rule (83 FR 59856), we determine the eligible clinician's MIPS cost and quality performance category score in facility-based measurement based on Hospital VBP Program Total Performance Score for eligible clinicians or groups who meet the eligibility criteria, which we designed to identify those who primarily furnish services within a hospital. We estimated the facility-based score using the scoring policies finalized in the CY2018 Quality Payment Program final rule (82 FR 53763) and the methodology described in the CY 2020 PFS final rule (84 FR 63169).</P>
                    <HD SOURCE="HD3">(d) Methodology To Estimate the Promoting Interoperability Performance Category Score</HD>
                    <P>We estimated the Promoting Interoperability performance category score using the methodology described in the CY 2020 PFS final rule (84 FR 63169 through 84 FR 63170)).</P>
                    <P>In section IV.2.c.(4)(c)(ii)(B) we are proposing to add the HIE bi-directional exchange measure for the 2021 performance period and subsequent years as an optional alternative to the two existing measures: The Support Electronic Referral Loops by Sending Health Information measure and the Support Electronic Referral Loops by Receiving and Incorporating Health Information measure. This proposal provides clinicians the option of either reporting the new measure or the two existing measures. Because we lack data on who would adopt these new measures and how they would score, we have used past reporting on existing measures to estimate future PI performance, and do not otherwise model the impact of these HIE measures.</P>
                    <P>In our model, for the APM participants that we modeled as participating in APP (that is, those in ACO entities), we simulated MIPS APM Entity scores by using submitted Promoting Interoperability data by groups or individuals that we identified as being in a MIPS APM to calculate an APM Entity score.</P>
                    <HD SOURCE="HD3">(e) Methodology To Estimate the Improvement Activities Performance Category Score</HD>
                    <P>We modeled the improvement activities performance category score based on CY 2018 MIPS performance period data and APM participation identified in section VIII.H.15.b.(1)(b) of this proposed rule. We continued to apply the methodology described in the CY 2020 PFS final rule (84 FR 63170) to assign an improvement activities performance category score. For the APM participants identified in section IV.A.3.b.(2) of this proposed rule, as there was no APM performance pathway score in the previous final rule, we assigned an improvement activity performance category score of 100 percent.</P>
                    <HD SOURCE="HD3">(f) Methodology To Estimate the Complex Patient Bonus</HD>
                    <P>In section IV.A.3.d.(2)(a) of this proposed rule, we proposed to continue the complex patient bonus for the 2021 MIPS performance period. Consistent with the policy to define complex patients as those with high medical risk or with dual eligibility, our scoring model used the complex patient bonus information calculated for the 2018 performance period data.</P>
                    <HD SOURCE="HD3">(g) Methodology To Estimate the Final Score</HD>
                    <P>As discussed in sections IV.A.3.c.(1)(b), IV.A.3.c.(2)(a), and summarized in section IV.A.3.d.(2)(b) of this proposed rule, our model assigned a final score for each TIN/NPI by multiplying each performance category score by the corresponding performance category weight, adding the products together, multiplying the sum by 100 points, and adding the complex patient bonus. After adding any applicable bonus for complex patients, we reset any final scores that exceeded 100 points equal to 100 points. For MIPS eligible clinicians who were assigned a weight of zero percent for any performance category, we redistributed the weights according to section IV.A.3.d.(2)(b)(iii) of this proposed rule.</P>
                    <HD SOURCE="HD3">(h) Methodology To Estimate the MIPS Payment Adjustment</HD>
                    <P>As described in section IV.A.3.e.(2) of this proposed rule we applied the proposed hierarchy to determine which final score should be used for the payment adjustment for each MIPS eligible clinician when more than one final score is available.</P>
                    <P>
                        We then calculated the parameters of an exchange function in accordance with the statutory requirements related to the linear sliding scale, budget neutrality, minimum and maximum adjustment percentages and additional payment adjustment for exceptional performance (as finalized under § 414.1405), using the performance threshold of 50 points which was proposed in section IV.A.3.e.(3) of this rule and the previously finalized additional performance threshold of 85 points (84 FR 63039 through 63040). In the alternatives considered discussed in section VIII.I.2. of this rule, we include the key statistics if the performance threshold was 60 as finalized in the CY 2020 PFS final rule (84 FR 63037). We used these resulting parameters to estimate the positive or negative MIPS 
                        <PRTPAGE P="50389"/>
                        payment adjustment based on the estimated final score and the paid amount for covered professional services furnished by the MIPS eligible clinician.
                    </P>
                    <HD SOURCE="HD3">(3) Impact of Payments by Practice Size</HD>
                    <P>Using the assumptions provided above, our model estimates that $442 million would be redistributed through budget neutrality and that $500 million would be distributed to MIPS eligible clinicians that meet or exceed the additional performance threshold. The mean final score is 76.75 and the median is 81.32.</P>
                    <P>The model further estimates that the maximum positive payment adjustments are 6.9 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In the alternatives considered discussed in section VIII.I.2. of this rule, we include the details of the model in which the performance threshold was set to 60, which had been finalized in the 2020 PFS final rule. In this alternate model, $520 million would be redistributed through budget neutrality and the maximum positive payment adjustments would be 7.4 percent.</P>
                    <P>Table 93 shows the impact of the payment adjustments by practice size and based on whether clinicians are expected to submit data to MIPS. We estimate that a smaller proportion of clinicians in small practices (1-15 clinicians) who participate in MIPS will receive a positive or neutral payment adjustment compared to larger sized practices. Table 93 also shows that 90.7 percent of MIPS eligible clinicians that participate in MIPS are expected to receive positive or neutral payment adjustments. We want to highlight that we are using 2018 MIPS performance period submissions data to simulate a 2021 MIPS performance period final score, and it is likely that there will be changes that we cannot account for at this time, including services and payments disrupted by the PHE or clinicians changing behavior because of the performance thresholds increased for the 2021 MIPS performance period to avoid a negative payment adjustment.</P>
                    <P>The combined impact of negative and positive adjustments and the additional positive adjustments for exceptional performance as a percent of paid amount among those that do not submit data to MIPS was not the maximum negative payment adjustment of 9 percent possible because some MIPS eligible clinicians that do not submit data to MIPS receive a non-zero score for the cost performance category, which utilizes administrative claims data and does not require separate data submission to MIPS. Among those who we estimate would not submit data to MIPS, 89 percent are in small practices (15,748 out of 17,780 clinicians who do not submit data). To address participation concerns, we have policies targeted towards small practices including technical assistance and special scoring policies to minimize burden and facilitate small practice participation in MIPS or APMs. We also note this participation data is generally based off participation for the 2018 performance period, which is associated with the 2020 MIPS payment year and had a performance threshold of 15 points, and that participation may change for the 2021 performance period when the performance threshold is proposed at 50 points.</P>
                    <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                    <GPH SPAN="3" DEEP="323">
                        <GID>EP17AU20.129</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 4120-01-C</BILCOD>
                    <PRTPAGE P="50390"/>
                    <HD SOURCE="HD3">(4) Additional Impacts From Outside Payment Adjustments</HD>
                    <HD SOURCE="HD3">(a) Burden Overall</HD>
                    <P>In addition to the payment adjustments, we propose several policies that have an impact on burden. In section VI.B.4 of this proposed rule, we outline the costs of data collection that includes both policy updates and adjustments due to the use of updated data sources. For each proposal included in this regulation which impacts our estimate of collection burden, the incremental burden for each is summarized in Table 94. We also provide additional burden discussions that we are not able to quantify.</P>
                    <GPH SPAN="3" DEEP="251">
                        <GID>EP17AU20.130</GID>
                    </GPH>
                    <HD SOURCE="HD3">(b) Additional Impacts to Clinicians</HD>
                    <HD SOURCE="HD3">(i) Web Interface</HD>
                    <P>As discussed in section IV.A.3.c.(1)(b) of this proposed rule, we are proposing to sunset the CMS Web Interface measures as a collection type for groups and virtual groups with 25 or more eligible clinicians starting with the 2021 performance period. We recognize that the sunset of the CMS Web Interface for groups and virtual groups may be burdensome to current groups and virtual groups submitting quality data on CMS Web Interface measures. Such groups and virtual groups would need to select a different collection type/submission type and redesign their systems to be able to interact with the new collection type/submission type. Given that the Medicare Part B claims collection type is limited to small practices, the alternatives for these groups and virtual groups would be either the MIPS CQM, QCDR or eCQM collection types. Given the size of the affected groups and virtual groups, we believe the majority are likely to already be using a QCDR, qualified registry, or EHR as part of their practice workflow. Of the 2,932 TINs comprised of 25 or more clinicians who submitted MIPS data via a collection type other than the CMS Web Interface, 62 percent reported via the MIP CQM and QCDR collection type and 38 percent reported via the eCQM collection type. For groups converting from Web Interface, there will be some non-recurring costs associated with modifying clinical and MIPS data reporting workflows to utilize an alternate collection type. For any remaining groups and virtual groups there will also be registry fees paid to a QCDR or qualified registry or the financial expense of purchasing/licensing and deploying an EHR system. Because we are unable to assess either the existing workflows of each individual group and virtual group or the decisions each group and virtual group will make in response to this proposal, we cannot quantify the resulting economic impact. While there may be an initial increase in burden for current groups and virtual groups utilizing the CMS Web Interface measures having to transition to the utilization of a different collection type/submission type, we recognize that we would also be reducing reporting requirements. Groups and virtual groups would no longer have to completely report on all pre-determined CMS Web Interface measures and would be able to select their own measures (at least 6) to report.</P>
                    <P>
                        Groups and virtual groups account for less than 20 percent of organizations utilizing the CMS Web Interface measures while ACOs participating in the Medicare Shared Savings Program and Next Generation ACO Model account for more than 80 percent. With an 80 percent reduction and a continued decrease interest of groups and virtual groups seeking to report quality data on CMS Web Interface measures, it is not fiscally viable, feasible, or sustainable for MIPS to continue to make available the CMS Web Interface measures as a collection type/submission type. There would be proportionally higher costs associated with the operationalization and maintenance of the CMS Web Interface with a significantly smaller number of groups and virtual groups utilizing the CMS Web Interface. In assessing the utilization of the CMS Web Interface by groups and virtual groups, there has been a substantial decrease in participation each year since the inception of MIPS in the 2017 performance period. From 2017 to 2019, the number of groups eligible to report quality measures via the CMS Web Interface (groups registered to utilize the CMS Web Interface) decreased by approximately 45 percent. Similarly, the number of groups utilizing the CMS 
                        <PRTPAGE P="50391"/>
                        Web Interface as a collection type decreased by approximately 40 percent from 2017 to 2019. In our cost analysis, operating and maintaining the CMS Web Interface for significantly smaller number of groups and virtual groups would not be cost-effective. To operate and maintain the CMS Web Interface measures solely for groups and virtual groups, there would be an increase in cost and needed resources under MIPS associated with the items such as the establishment and maintenance of CMS Web Interface benchmarks, assignment and sampling, technical support, and education and outreach; thus, there would be proportionally higher costs associated with the operationalization and maintenance of the CMS Web Interface with a significantly smaller number of groups and virtual groups utilizing the CMS Web Interface measures as a collection type/submission type.
                    </P>
                    <HD SOURCE="HD3">(ii) Administrative Claims Measure</HD>
                    <P>As discussed in section IV.A.3.c.(1)(c), we are proposing to add two new administrative claims measures beginning in the 2021 MIPS performance period and for future performance periods. We acknowledge there are administrative burdens and related financial costs associated with each administrative claims measure that clinicians, groups, and organizations may choose to monitor. However, because these costs can vary significantly due to organizational size, number of administrative claims measures being reported, volume of clinicians reporting each measure, and the specific methods employed to improve performance, we are unable to provide an estimate of the financial impact each clinician, group, or organization may experience. In summary, we are acknowledging that while there is no data submission requirements per § 414.1325(a)(2)(i) for administrative claim measures, there may be associated costs for clinicians and group practices to monitor new administrative claim measures; however, we are unable to quantify that impact.</P>
                    <HD SOURCE="HD3">(iii) Modifications to the Improvement Activities Inventory</HD>
                    <P>As discussed in section IV.A.3.c.(3)(b)(ii) of this rule, we are proposing for the CY 2021 performance period and future years to modify two existing improvement activities. We refer readers to Appendix 2 of this proposed rule for further details. We do not believe these proposals would impact time or financial burden on stakeholders because MIPS eligible clinicians are still required to submit the same number of activities and the per response time for each activity is uniform. We do not expect this proposal to affect our currently approved information collection burden estimates in terms of neither the number of estimated respondents nor the burden per response. We anticipate that the vast majority of clinicians performing improvement activities, to comply with existing MIPS policies, would continue to perform the same activities under the policies established in this proposed rule because previously finalized improvement activities continue to apply for the current and future years unless otherwise modified per rulemaking (82 FR 54175). Most of the improvement activities in the Inventory remain unchanged for the 2020 MIPS performance period.</P>
                    <HD SOURCE="HD3">(c) Stakeholders Nominating Improvement Activities</HD>
                    <P>In section IV.A.3.c.(3)(b)(i)(A)(aa) of this rule, we are proposing to make an exception to the established timeframe for nomination of improvement activities, such that during a PHE, stakeholders can nominate improvement activities outside of the established Annual Call for Activities timeframe. While we expect additional nominations may be received as a result of this proposal, we do not have any data with which to estimate what the additional number may be but we assume the additional costs associated with nominating new improvement activities are unchanged. Additionally, in section IV.A.2.c.(3)(b)(ii)(B) of this rule, we are proposing, beginning with the CY 2021 performance period and future years, to consider agency-nominated improvement activities. We are unable to estimate the number of improvement activity nominations we will receive, but similar to the per respondent estimate we have provided in section VI.B.5.i. of this proposed rule, we assume it will require 3 hours at $55.75/hr for a GS-13 Step 5 to nominate an improvement activity for a total cost of $167.25 (3 hrs × $55.75/hr) per activity.</P>
                    <HD SOURCE="HD3">(d) Impact on Third Party Intermediaries</HD>
                    <P>In section IV.A.3.g. of this rule, we proposed multiple changes to the third party intermediary regulations at § 414.1400. Specifically, we are proposing to: (1) Amend current requirements for approval of third party intermediaries to take into account past performance and provision of inaccurate information regarding MIPS program requirements to eligible clinicians; (2) require attendance by all third party intermediaries for training and support sessions; (3) require that QCDRs and qualified registries must conduct an annual data validation audit and if one or more deficiencies or data errors are identified also conduct targeted audits; (4) incrementally increase requirements for QCDR measure testing and clarify what is meant by full testing; and (5) require third party intermediaries to submit a CAP to address identified deficiencies and data issues as well as actions to prevent recurrence.</P>
                    <P>With regard to the proposal to amend current requirements for approval of third party intermediaries, we do not anticipate this to require any additional effort for affected entities as the proposal is to allow CMS to utilize already available information to make approval decisions.</P>
                    <P>
                        The proposed requirement for attendance at training and support sessions and the associated burdens on third parties closely aligns to expectations previously established in the CY 2017 Quality Payment Program final rule (81 FR 77367 through 77374) and (81 FR 77384 through 77386). With regard to survey vendors, we previously finalized the CMS-approved survey vendor approval criteria in § 414.1400(e) as discussed in the CY 2018 PFS final rule (83 FR 59907 through 59908). Among the approval criteria, § 414.1400(e)(3) established the requirement that the entity has successfully completed, and has required its subcontractors to successfully complete, vendor training(s) administered by CMS or its contractors. Therefore, we assume no additional impact for survey vendors as a result of this proposal. We do not have data on the number of health IT vendors that missed training and support sessions, but the most recent data cites 684 health IT developers through program year 2016 of the Medicare EHR Incentive Program.
                        <SU>115</SU>
                        <FTREF/>
                         In CY 2019, 16 total training and support sessions were missed by 14 QCDRs and 33 total sessions were missed by 27 qualified registries. Based on historical frequency and duration, we expect future training and support sessions to continue occurring monthly for approximately 2 hours each. For QCDRs and qualified registries, we estimate an impact of 98 hours [(16 sessions by QCDRs + 33 sessions by qualified registries) × 2 hours]. We lack insight into the exact occupation of session attendees, but for estimating purposes we assume a Physician labor rate of $212.78/hr and 
                        <PRTPAGE P="50392"/>
                        estimate a total burden of $20,852 ($212.78/hr × 98 hours).
                    </P>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             
                            <E T="03">https://dashboard.healthit.gov/quickstats/pages/FIG-Vendors-of-EHRs-to-Participating-Professionals.php.</E>
                        </P>
                    </FTNT>
                    <P>We do not anticipate a significant impact to QCDRs and qualified registries resulting from proposal to require QCDRs and qualified registries to conduct an annual data validation audit and if one or more deficiencies or data errors are identified also conduct targeted audits. First, we are not revising our burden estimates because the proposed data validation requirements are similar to existing expectations which we have already accounted for the associated burden as stated in the CY 2017 Quality Payment Program final rule (81 FR 77383 through 77384) and the CY 2019 PFS final rule (83 FR 59998 through 59999). Second, we believe that the proposed requirements for conduct of the data validation audits are aligned with methods and procedures which stakeholders currently utilize.</P>
                    <P>With regard to the proposal to require QCDRs and qualified registries to conduct targeted audits if one or more data errors are identified during data validation audits, we are unable to estimate the number of audits which may occur or the time and costs associated with their conduct which could vary substantially depending on the nature of the data error and the amount of data to be audited. We seek comment on the expected frequency of targeted audits and the anticipated scope of effort.</P>
                    <P>Because the proposal to incrementally increase requirements for QCDR measure testing is not changing the requirements for fully testing measures, but is instead proposing an incremental approach to achieve previously finalized requirements, we do not anticipate any additional impact as a result of the proposal.</P>
                    <P>As discussed in section VI.B.5.c.(2) of this rule, we estimate the total burden impact associated with the proposal to require CAPs to be 30 hours (10 respondents × 3 hr/respondent) at a cost of $2,774 for all respondents (10 respondents × $277.38/respondent).</P>
                    <HD SOURCE="HD3">f. Assumptions &amp; Limitations</HD>
                    <P>
                        We note several limitations to our estimates of clinicians' MIPS eligibility and participation, negative MIPS payment adjustments, and positive payment adjustments for the 2023 MIPS payment year. Due to the PHE, we are aware that there may be changes in health care delivery and billing patterns that will impact results for the 2023 MIPS payment year that we were not able to model with our historic data sources. We based our analyses on the data prepared to support the 2019 performance period initial determination of clinician and special status eligibility (available via the NPI lookup on 
                        <E T="03">qpp.cms.gov</E>
                        ),
                        <SU>116</SU>
                        <FTREF/>
                         APM Participant List for the final snapshot date for the 2019 QP performance period, CY 2018 Quality Payment Program Year 2 data, 2018 ACO Public Use File for MSSP and Next Gen and CAHPS for ACOs. The scoring model results presented in this proposed rule assume that CY 2018 Quality Payment Program data submissions and performance are representative of CY 2021 Quality Payment Program data submissions and performance. The estimated performance for CY 2021 MIPS performance period using CY 2018 Quality Payment Program data may be underestimated because the performance threshold to avoid a negative payment adjustment for the 2018 MIPS performance period/2020 MIPS payment year was significantly lower (15 out of 100 points) than the performance threshold for the 2021 MIPS performance period/2023 MIPS payment year (60 out of 100). We anticipate clinicians may submit more performance categories to meet the higher performance threshold to avoid a negative payment adjustment.
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             The time period for this eligibility file (September 1, 2017 to August 31, 2018) maximizes the overlap with the performance data in our model.
                        </P>
                    </FTNT>
                    <P>In our MIPS eligible clinician assumptions, we assumed that 33 percent of the opt-in eligible clinicians that participated in the CY 2018 Quality Payment Program would elect to opt-in to the MIPS program. It is difficult to predict whether clinicians will elect to opt-in to participate in MIPS with the proposed policies.</P>
                    <P>There are additional limitations to our estimates: (1) To the extent that there are year-to-year changes in the data submission, volume and mix of services provided by MIPS eligible clinicians, the actual impact on total Medicare revenues will be different from those shown in Table 93; and (2) our cost data does not overlap with CY 2018 so we may not be capturing performance for all clinicians. Due to the limitations described, there is considerable uncertainty around our estimates that is difficult to quantify.</P>
                    <HD SOURCE="HD2">I. Alternatives Considered</HD>
                    <P>This proposed rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this proposed rule, we presented the estimated impact on total allowed charges by specialty.</P>
                    <HD SOURCE="HD3">1. Alternatives Considered for the MDPP Expanded Model Emergency Policy</HD>
                    <P>For the MDPP Expanded Model Emergency Policy, no alternatives were considered. If we do not take action it will have an extremely negative impact to MDPP supplier and beneficiaries; which would threaten the success of the entire expanded model; as beneficiaries would become ineligible and not be able to finish the program, MDPP suppliers would not be paid for services rendered, and no new cohorts of set of MDPP services could be started, effectively ending the expanded model test.</P>
                    <HD SOURCE="HD3">2. Alternatives Considered for the Quality Payment Program</HD>
                    <P>For purposes of the payment impact on the Quality Payment Program, we view the performance threshold as a critical factor affecting the distribution of payment adjustments. We ran a separate model with a performance threshold of 60 which was previously finalized in the CY 2020 final rule (84 FR 63037) as an alternative to the proposed performance threshold of 50. For reference, our model of proposed policies has a mean final score of 76.75 and median final score of 81.32. The model with a performance threshold of 60, has a mean final score of 76.75 and a median final score of 81.32. We estimate that $520 million would be redistributed through budget neutrality. There would be a maximum payment adjustment of 7.36 percent after considering the MIPS payment adjustment and the additional MIPS payment adjustment for exceptional performance. In addition, 10.4 percent of MIPS eligible clinicians would receive a negative payment adjustment among those that submit data.</P>
                    <P>
                        In addition, we view the cost performance category weight as a critical factor affecting final scores. We ran two separate models with cost performance category weights of 15 and 30, with corresponding quality performance category weights of 45 and 30, respectively (as an alternative to the proposed cost performance category weight of 20 and quality performance category weight of 40) to estimate the impact of keeping the weights consistent with the CY 2020 PFS final rule and a more aggressive increase in the cost performance category weight. 
                        <PRTPAGE P="50393"/>
                        The model with a cost performance category weight of 15 has a mean score of 82.14 and a median score of 77.31. The model with a cost performance category weight of 30 has a mean score of 75.85 and a median score 80.06. We refer readers to section IV.A.2.c.(2)(a) for additional rationale on the selection of the cost performance category weight.
                    </P>
                    <HD SOURCE="HD3">3. Alternatives Considered for Changes Related to Scopes of Practice</HD>
                    <P>With regard to the proposal concerning supervision of diagnostic tests by certain NPPs, an alternative would be to maintain the status quo. That is, we could maintain the basic rule under § 410.32(b)(1) that allows only physicians as defined under Medicare law to supervise the performance of diagnostic tests. In that case, the pool of practitioners who could supervise diagnostic tests would remain at current levels and certain NPPs would be limited under Medicare from practicing to the full extent allowed by their state license and scope of practice. However, this alternative would fail to address the mandates established in E.O. 13890.</P>
                    <P>With regard to the proposal to allow a PTA/OTA to furnish maintenance therapy services, an alternative would be maintaining the status quo to require the PT/OT to personally furnish all maintenance therapy services. However, this alternative would not address the mandates established in E.O. 13890. It would also be inconsistent with our policy in SNF and home health settings when payment for therapy is made under Part A, maintenance therapy can be furnished by a PT/OT or delegated to be performed by a PTA/OTA.</P>
                    <HD SOURCE="HD2">J. Impact on Beneficiaries</HD>
                    <P>We do not believe our proposals will have a negative impact on beneficiaries given overall PFS budget neutrality.</P>
                    <HD SOURCE="HD3">1. Medicare Diabetes Prevention Program Expanded Model Emergency Policy</HD>
                    <P>This change would have a positive impact on affected MDPP beneficiaries, as it would allow them to maintain eligibility for the program, and request virtual sessions if needed for successful completion of attendance and weight loss milestones. It would also allow them to start set of MDPP services virtually, allowing remote digital technology to capture body weight measurement or self-reported weight measurements from a participant's personal home digital scale. Finally, if continuing with set of MDPP services is not an option for beneficiaries during the PHE, the proposed Emergency Policy allows beneficiaries to restart their set of MDPP services, maximizing beneficiary options and access to MDPP both during the PHE and after it ends.</P>
                    <HD SOURCE="HD3">2. Quality Payment Program</HD>
                    <P>There are several changes in this rule that would have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, would have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. For example, several of the new measures include patient-reported outcomes, which may be used to help patients make more informed decisions about treatment options. Patient-reported outcome measures provide information on a patient's health status from the patient's point of view and may also provide valuable insights on factors such as quality of life, functional status, and overall disease experience, which may not otherwise be available through routine clinical data collection. Patient-reported outcomes are factors frequently of interest to patients when making decisions about treatment.</P>
                    <HD SOURCE="HD2">K. Estimating Regulatory Familiarization Costs</HD>
                    <P>If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on this year's proposed rule will be the number of reviewers of this rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcomed any comments on the approach in estimating the number of entities which will review this rule.</P>
                    <P>We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We sought comments on this assumption.</P>
                    <P>
                        Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $110.74 per hour, including overhead and fringe benefits 
                        <E T="03">https://www.bls.gov/oes/current/oes_nat.htm.</E>
                         Assuming an average reading speed, we estimate that it would take approximately 8.0 hours for the staff to review half of this rule. For each facility that reviews the rule, the estimated cost is $885.92 (8.0 hours × $110.74). Therefore, we estimated that the total cost of reviewing this regulation is $38,477,277.44 ($885.92 × 43,432 reviewers on last year's proposed rule).
                    </P>
                    <HD SOURCE="HD2">L. Accounting Statement</HD>
                    <P>
                        As required by OMB Circular A-4 (available at 
                        <E T="03">http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf</E>
                        ), in Tables 95 and 96 (Accounting Statements), we have prepared an accounting statement. This estimate includes growth in incurred benefits from CY 2020 to CY 2021 based on the FY 2021 President's Budget baseline.
                    </P>
                    <GPH SPAN="3" DEEP="235">
                        <PRTPAGE P="50394"/>
                        <GID>EP17AU20.131</GID>
                    </GPH>
                    <HD SOURCE="HD2">M. Conclusion</HD>
                    <P>The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides an RIA. 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 410</CFR>
                        <P>Diseases, Health facilities, Health professions, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.</P>
                        <CFR>42 CFR Part 414</CFR>
                        <P>Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Diseases, Medicare, Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 415</CFR>
                        <P>Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.</P>
                        <CFR>42 CFR Part 423</CFR>
                        <P>Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Medicare, Penalties, Privacy, 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 425</CFR>
                        <P>Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.</P>
                    </LSTSUB>
                    <P>For the reasons set forth in the preamble, the Centers for Medicare &amp; Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:</P>
                    <PART>
                        <HD SOURCE="HED">PART 410—SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS</HD>
                    </PART>
                    <AMDPAR>1. The authority citation for part 410 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P>42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.</P>
                    </AUTH>
                    <AMDPAR>2. Section 410.15 is amended in paragraph (a)—</AMDPAR>
                    <AMDPAR>a. By adding a definition for “A review of any current opioid prescriptions” in alphabetical order;</AMDPAR>
                    <AMDPAR>b. In the definition of “First annual wellness visit providing personalized prevention plan services” by revising paragraph (xi) and adding paragraphs (xii) and (xiii);</AMDPAR>
                    <AMDPAR>c. In the definition of “Subsequent annual wellness visit providing personalized prevention plan services” by revising paragraph (ix) and adding paragraphs (x) and (xi).</AMDPAR>
                    <P>The additions and revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 410.15 </SECTNO>
                        <SUBJECT> Annual wellness visits providing Personalized Prevention Plan Services: Conditions for and limitations on coverage.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            <E T="03">A review of any current opioid prescriptions</E>
                             means, with respect to the individual determined to have a current prescription for opioids, all of the following:
                        </P>
                        <P>(i) A review of the potential risk factors to the individual for opioid use disorder;</P>
                        <P>(ii) An evaluation of the individual's severity of pain and current treatment plan;</P>
                        <P>(iii) The provision of information on non-opioid treatment options; and</P>
                        <P>(iv) A referral to a specialist, as appropriate.</P>
                        <STARS/>
                        <P>
                            <E T="03">First annual wellness visit providing personalized prevention plan services</E>
                             * * *
                        </P>
                        <P>(xi) Furnishing of a review of any current opioid prescriptions as that term is defined in this section.</P>
                        <P>(xii) Screening for potential substance use disorders including a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.</P>
                        <P>(xiii) Any other element determined appropriate through the national coverage determination process.</P>
                        <STARS/>
                        <P>
                            <E T="03">Subsequent annual wellness visit providing personalized prevention plan services</E>
                             * * *
                        </P>
                        <P>(ix) Furnishing of a review of any current opioid prescriptions as that term is defined in this section.</P>
                        <P>
                            (x) Screening for potential substance use disorders including a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.
                            <PRTPAGE P="50395"/>
                        </P>
                        <P>(xi) Any other element determined appropriate through the national coverage determination process.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>2. Section 410.16 is amended in paragraph (a)—</AMDPAR>
                    <AMDPAR>a. By adding the definition for “A review of any current opioid prescriptions” in alphabetical order;</AMDPAR>
                    <AMDPAR>b. In the definition of “Initial preventive physical examination” by revising paragraphs (6) and (7) and adding paragraphs (8) and (9).</AMDPAR>
                    <P>The addition and revisions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 410.16 </SECTNO>
                        <SUBJECT> Initial preventive physical examination: Conditions for and limitations on coverage.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            <E T="03">A review of any current opioid prescriptions</E>
                             means, with respect to the individual determined to have a current prescription for opioids, all of the following:
                        </P>
                        <P>(i) A review of the potential risk factors to the individual for opioid use disorder;</P>
                        <P>(ii) An evaluation of the individual's severity of pain and current treatment plan;</P>
                        <P>(iii) The provision of information on non-opioid treatment options; and</P>
                        <P>(iv) A referral to a specialist, as appropriate.</P>
                        <STARS/>
                        <P>
                            <E T="03">Initial preventive physical examination</E>
                             * * *
                        </P>
                        <P>(6) A review of any current opioid prescriptions as defined in this section.</P>
                        <P>(7) Screening for potential substance use disorders to include a review of the individual's potential risk factors for substance use disorder and referral for treatment as appropriate.</P>
                        <P>(8) 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>(9) Education, counseling, and referral, including a brief written plan such as a checklist provided to the individual for obtaining an electrocardiogram, as appropriate, and the appropriate screening and other preventive services that are covered as separate Medicare Part B benefits as described in sections 1861(s)(10), (jj), (nn), (oo), (pp), (qq)(1), (rr), (uu), (vv), (xx)(1), (yy), (bbb), and (ddd) of the Act.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>3. Section 410.32 is amended by—</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (b)(1) and (b)(2)(iii)(B),</AMDPAR>
                    <AMDPAR>b. Adding paragraph (b)(2)(ix), and</AMDPAR>
                    <AMDPAR>c. Revising paragraph (b)(3)(ii).</AMDPAR>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 410.32 </SECTNO>
                        <SUBJECT> Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            (1) 
                            <E T="03">Basic rule.</E>
                             Except as indicated in paragraph (b)(2) of this section, all diagnostic x-ray and other 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 or, to the extent that they are authorized to do so under their scope of practice and applicable State law, by a nurse practitioner, clinical nurse specialist, physician assistant or a certified nurse-midwife. Services furnished without the required level of supervision are not reasonable and necessary (see § 411.15(k)(1) of this chapter).
                        </P>
                        <P>(2) * * *</P>
                        <P>(iii) * * *</P>
                        <P>(B) Furnished under the general supervision of a physician or clinical psychologist; or under the general supervision of a nurse practitioner, clinical nurse specialist, physician assistant, or certified nurse-midwife, to the extent they are authorized to perform the tests under their scope of practice and applicable State laws.</P>
                        <STARS/>
                        <P>(ix) Diagnostic tests performed by a physician assistant authorized to perform the tests under their scope of practice and applicable State laws.</P>
                        <P>(3) * * *</P>
                        <P>
                            (ii) 
                            <E T="03">Direct supervision</E>
                             in the office setting means the physician (or other supervising practitioner) must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the procedure. It does not mean that the physician (or other supervising practitioner) must be present in the room when the procedure is performed. Until the later of the end of the calendar year in which the PHE as defined in § 400.200 of this chapter ends or, December 31, 2021, the presence of the physician (or other practitioner) includes virtual presence through audio/video real-time communications technology (excluding audio-only).
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>4. Section 410.33 is amended by adding paragraph (j) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 410.33 </SECTNO>
                        <SUBJECT>Independent diagnostic testing facility.</SUBJECT>
                        <STARS/>
                        <P>
                            (j) 
                            <E T="03">Exception for IDTFs with no beneficiary interaction.</E>
                             An IDTF supplier that has no beneficiary interaction, treatment, or testing at its practice location must not be subject to the requirements at:
                        </P>
                        <P>(1) Paragraph (c) of this section.</P>
                        <P>(2) Paragraph (e)(1)(i) of this section.</P>
                        <P>(i) The requirement that the IDTF maintain documentation that its technicians are licensed and certified in each of the States in which the IDTF operates does not apply to IDTFs that are excepted in this paragraph (j). The requirement that the IDTF maintain documentation that its supervising physicians are licensed and certified in each of the States in which the IDTF operates does apply to IDTFs that are excepted in this paragraph.</P>
                        <P>(ii) [Reserved]</P>
                        <P>(3) Paragraph (e)(1)(ii) of this section.</P>
                        <P>(4) Paragraph (g)(1) of this section.</P>
                        <P>(5) Paragraph (g)(6) of this section.</P>
                        <P>(6) Paragraph (g)(8) of this section.</P>
                        <P>(7) Paragraph (g)(9) of this section.</P>
                        <P>(8) Paragraph (g)(11) of this section.</P>
                        <P>(9) Paragraph (g)(12) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>5. Section 410.67 is amended—</AMDPAR>
                    <AMDPAR>a. By revising paragraph (7) and adding paragraph (8) in the definition of “Opioid use disorder treatment service”;</AMDPAR>
                    <AMDPAR>b. By revising paragraph (d)(2)(i)(A); and</AMDPAR>
                    <AMDPAR>c. By adding paragraph (d)(4)(i)(E).</AMDPAR>
                    <P>The additions and revision read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 410.67 </SECTNO>
                        <SUBJECT> Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>
                            <E T="03">Opioid use disorder treatment service</E>
                             * * *
                        </P>
                        <P>(7) Periodic assessment services required under § 8.12(f)(4) of this title, that are furnished during a face-to-face encounter, including services furnished via two-way interactive audio-video communication technology, as clinically appropriate, and in compliance with all applicable requirements. During the Public Health Emergency, as defined in § 400.200 of this chapter, in cases where a beneficiary does not have access to two-way audio-video communications technology, periodic assessments can be furnished using audio-only telephone calls if all other applicable requirements are met.</P>
                        <P>(8) Opioid antagonist medications that are approved by the Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for the emergency treatment of known or suspected opioid overdose.</P>
                        <STARS/>
                        <PRTPAGE P="50396"/>
                        <P>(d) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) For implantable and injectable medications, the payment is determined using the methodology set forth in section 1847A of the Act, except that the payment amount must be 100 percent of the ASP, if ASP is used; and the payment must be 100 percent of the wholesale acquisition cost (WAC), if WAC is used.</P>
                        <STARS/>
                        <P>(4) * * *</P>
                        <P>(i) * * *</P>
                        <P>(E) Take-home supply of opioid antagonist medications that are approved by the Food and Drug Administration under section 505 of the Federal, Food, Drug and Cosmetic Act for the emergency treatment of known or suspected opioid overdose an adjustment will be made when these medications are dispensed. This adjustment will be limited to once every 30 days to the extent that it is medically reasonable and necessary. The amount of the adjustment will be determined using the methodology in paragraph (d)(2)(i) of this section, except the payment for auto-injector naloxone will be determined using the lowest pricing available (the lower of 100 percent of the ASP, 100 percent of WAC, or the National Average Drug Acquisition Cost).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>6. Section 410.78 is amended by revising paragraph (a)(3) and (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 410.78 </SECTNO>
                        <SUBJECT> Telehealth services.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>
                            (3) 
                            <E T="03">Interactive telecommunications system</E>
                             means multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site physician or practitioner.
                        </P>
                        <STARS/>
                        <P>
                            (f) 
                            <E T="03">Process for adding or deleting services.</E>
                             Except as otherwise provided in this paragraph (f), changes to the list of Medicare telehealth services are made through the annual physician fee schedule rulemaking process. During the Public Health Emergency, as defined in § 400.200 of this chapter, we will use a subregulatory process to modify the services included on the Medicare telehealth list during the Public Health Emergency taking into consideration infection control, patient safety, and other public health concerns resulting from the emergency. CMS maintains the list of services that are Medicare telehealth services under this section, including the current HCPCS codes that describe the services on the CMS website.
                        </P>
                    </SECTION>
                    <AMDPAR>7. Section 410.79 is amended by revising paragraphs (c)(3)(i) and (ii) and (e) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 410.79 </SECTNO>
                        <SUBJECT> Medicare Diabetes Prevention Program expanded model: Conditions of coverage.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) Except as set forth in paragraph (c)(3)(ii) of this section—</P>
                        <P>(A) The MDPP services period ends upon completion of the core services period described in paragraph (c)(2)(i) of this section, unless the MDPP beneficiary qualifies for the first ongoing maintenance session interval, in accordance with paragraph (c)(1)(ii) of this section.</P>
                        <P>(B) If the MDPP beneficiary qualifies for the first ongoing maintenance session interval as described in paragraph (c)(1)(ii) of this section, the MDPP services period ends upon completion of that maintenance session interval, unless the MDPP beneficiary qualifies for a subsequent ongoing maintenance session interval, in accordance with paragraph (c)(1)(iii) of this section, in which case the MDPP service period ends upon completion of the last ongoing maintenance session interval for which the beneficiary qualified.</P>
                        <P>(ii) In the case of an applicable 1135 waiver event as defined in paragraph (e) of this section, the MDPP services period may be suspended and resumed or restarted in accordance with paragraph (e) of this section.</P>
                        <STARS/>
                        <P>
                            (e) 
                            <E T="03">MDPP expanded model Emergency Policy.</E>
                             (1) Notwithstanding paragraphs (a) through (d) of this section, the policies described in this paragraph (e) apply during the Public Health Emergency (PHE) as defined in § 400.200 of this chapter and during any future 1135 waiver event that CMS determines may disrupts in-person MDPP services (an “applicable 1135 waiver event”). For purposes of this paragraph (e), “1135 waiver event” means an emergency period and emergency area, as such terms are defined in section 1135(g) of the Act, for which the Secretary has authorized one of more waivers under section 1135 of the Act.
                        </P>
                        <P>(2)(i) CMS determines that an 1135 waiver event may disrupt in-person MDPP services if MDPP suppliers would likely be unable to conduct classes in-person, or MDPP beneficiaries would likely be unable to attend in-person classes, for reasons related to health, safety, or site availability or suitability. Health and safety reasons may include, but are not limited to, the avoidance of transmission of contagious diseases, compliance with laws and regulations during an 1135 waiver event, or the physical safety of MDPP beneficiaries and MDPP coaches, as defined in § 424.205(a), during an 1135 waiver event.</P>
                        <P>(ii) If CMS determines that an 1135 event may disrupt in-person MDPP services, CMS will communicate such determination for policies described in this paragraph (e), to all impacted MDPP suppliers.</P>
                        <P>(3) The following changes apply under this paragraph (e), when CMS has determined that an 1135 waiver event may disrupt in-person MDPP services:</P>
                        <P>(i) The in-person attendance requirements of paragraphs (c)(1)(ii)(A) and (c)(1)(iii)(A) of this section do not apply.</P>
                        <P>(ii) MDPP suppliers may start new cohorts during the PHE as defined in § 400.200 of this chapter or an applicable 1135 waiver event only if a baseline weight measurement can be obtained as described in paragraph (e)(4)(iii) of this section.</P>
                        <P>(iii) MDPP suppliers can obtain weight measurements for MDPP beneficiaries for the baseline weight and any weight loss based performance achievement goals in the following manner:</P>
                        <P>(A) In-person, when the weight measurement can be obtained safely and in compliance with all applicable laws and regulations;</P>
                        <P>(B) Via digital technology, such as scales that transmit weights securely via wireless or cellular transmission; or</P>
                        <P>(C) Self-reported weight measurements from the at-home digital scale of the MDPP beneficiary. Self-reported weights must be submitted via video, by the MDPP beneficiary to the MDPP supplier. The video must clearly document the weight of the MDPP beneficiary as it appears on his/her digital scale on the date associated with the billable MDPP session.</P>
                        <P>(iv) The virtual session limits described in paragraphs (d)(2), (d)(3)(i) and (ii) of this section do not apply, and MDPP suppliers may provide all MDPP sessions virtually during the PHE as defined in § 400.200 of this chapter or applicable 1135 waiver event so long as the provision of virtual services complies with all of the following requirements:</P>
                        <P>
                            (A) The curriculum furnished during the virtual session must address the 
                            <PRTPAGE P="50397"/>
                            same CDC-approved DPP curriculum topic as the regularly scheduled session;
                        </P>
                        <P>(B) The MDPP supplier furnishes to the MDPP beneficiary a maximum of one virtual make-up session on the same day as a regularly scheduled session;</P>
                        <P>(C) The MDPP supplier furnishes to the MDPP beneficiary a maximum of one virtual make-up session per week;</P>
                        <P>(D) Virtual sessions must be furnished in a manner consistent with the DPRP standards for virtual sessions;</P>
                        <P>(E) An MDPP supplier can offer virtual sessions only upon an individual MDPP beneficiary's request or agreement to receive services virtually;</P>
                        <P>(F) An MDPP supplier can offer to an MDPP beneficiary:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) No more than 16 virtual sessions offered weekly during the core session period, months 1 through 6 of the MDPP services period;
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) No more than 6 virtual sessions offered monthly during the core maintenance session interval periods, months 7 through 12 of the MDPP services period; and
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) No more than 12 virtual sessions offered monthly during the ongoing maintenance session intervals, months 13 through 24.
                        </P>
                        <P>(v) MDPP suppliers may suspend the in-person delivery of the set of MDPP services, when necessary due to the 1135 waiver event, and subsequently resume services either upon the effective end date of the 1135 waiver event or upon an effective date specified by CMS. Upon resumption of the set of MDPP services, the MDPP services must be furnished in compliance with the requirements in accordance with the following paragraphs (the once per lifetime requirement as described in paragraph (c)(1)(i)(B) of this section does not apply):</P>
                        <P>(A) Beneficiaries who were receiving MDPP services as of March 1, 2020 may elect to restart the set of MDPP services at the beginning or resume with the most recent attendance session of record.</P>
                        <P>(B) Beneficiaries who begin the set of MDPP services on or after January 1, 2021 and who are in the first 12 months of the set of MDPP services as of the start of an applicable 1135 waiver event, and whose sessions are suspended due to the applicable 1135 waiver event, may elect to restart the set of MDPP services at the beginning, or may resume with the most recent attendance session of record.</P>
                        <P>(C) Beneficiaries who began the set of MDPP services on or after January 1, 2021 and who are in the second year of the set of MDPP services as of the start of an applicable 1135 waiver event are eligible to restart the ongoing maintenance session interval in which they were participating at the start of the applicable 1135 waiver event or may resume with the most recent attendance session of record;</P>
                        <P>(D) Beneficiaries who elected to continue with MDPP services virtually, as described in paragraph (c)(iii) of this section, are not eligible to restart or resume the set of MDPP services at a later date.</P>
                        <P>(E) Beneficiaries who elect to suspend the set of MDPP services at the start of an applicable 1135 waiver event may choose to restart the set of MDPP services at the beginning, or may resume with the most recent attendance session of record, only one time per 1135 waiver event.</P>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES</HD>
                    </PART>
                    <AMDPAR>8. The authority citation for part 414 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).</P>
                    </AUTH>
                    <AMDPAR>9. Section 414.502 is amended by revising the definitions of “Data collection period” and “Data reporting period” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.502 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Data collection period</E>
                             is the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data reporting period, except that for the data reporting period of January 1, 2022 through March 31, 2022, the data collection period is January 1, 2019 through June 30, 2019.
                        </P>
                        <P>
                            <E T="03">Data reporting period</E>
                             is the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to CMS and that follows the preceding data collection period, except that for the data collection period of January 1, 2019 through June 30, 2019, the data reporting period is January 1, 2022 through March 31, 2022.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>10. Section 414.504 is amended by revising paragraph (a)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.504 </SECTNO>
                        <SUBJECT>Data reporting requirements.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(1) For CDLTs that are not ADLTs, initially January 1, 2017 and every 3 years beginning January 1, 2022.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>11. Section 414.507 is amended by revising paragraphs (d) introductory text and (d)(4) and adding paragraph (d)(7) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.507 </SECTNO>
                        <SUBJECT>Payment for clinical diagnostic laboratory tests.</SUBJECT>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Phase-in of payment reductions.</E>
                             For years 2018 through 2024, the payment rates established under this section for each CDLT that is not a new ADLT or new CDLT, may not be reduced by more than the following amounts for—
                        </P>
                        <STARS/>
                        <P>(4) 2021—0.0 percent of the payment rate established in 2020.</P>
                        <STARS/>
                        <P>(7) 2024—15 percent of the payment rate established in 2023.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>12. Section 414.902 is amended by revising the definition of “Multiple source drug” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.902 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Multiple source drug</E>
                             means a drug described by section 1847A(c)(6)(C) of the Act, including drug products approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that are described in § 414.904(k).
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>13. Section 414.904 is amended by adding paragraph (k) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.904 </SECTNO>
                        <SUBJECT>Average sales price as the basis for payment.</SUBJECT>
                        <STARS/>
                        <P>
                            (k) 
                            <E T="03">Assigning drug products approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to a multiple source drug code.</E>
                             (1) Drug products approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act are assigned to multiple source drug billing and payment codes based on—
                        </P>
                        <P>(i) The existence of a multiple source drug billing code described by section 1847A(c)(6)(C) of the Act.</P>
                        <P>(ii) A determination of whether an existing multiple source drug code's descriptor describes the drug product approved through the pathway established under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act based on factors including—</P>
                        <P>(A) The active ingredient(s), drug name, and the drug description.</P>
                        <P>(B) Information in drug labeling.</P>
                        <P>(C) Prescribing and clinical use of the drug.</P>
                        <P>(2) [Reserved]</P>
                    </SECTION>
                    <AMDPAR>14. Section 414.1305 is amended—</AMDPAR>
                    <AMDPAR>a. By revising the definition of “Attestation”;</AMDPAR>
                    <AMDPAR>
                        b. In the definition of “Certified Electronic Health Record Technology 
                        <PRTPAGE P="50398"/>
                        (CEHRT)” by revising paragraphs (1)(ii)(D) and (2)(ii) introductory text;
                    </AMDPAR>
                    <AMDPAR>c. By revising the definition of “Collection type”;</AMDPAR>
                    <AMDPAR>d. By removing the definition of “Full TIN APM;</AMDPAR>
                    <AMDPAR>e. By revising the definitions of “Low volume threshold”, “Meaningful EHR user for MIPS”, and “MIPS APM”;</AMDPAR>
                    <AMDPAR>f. By adding definitions for “Physician Compare” and “Primary care services” in alphabetical order; and</AMDPAR>
                    <AMDPAR>g. By revising the definitions of “Submission type” and “Submitter type”.</AMDPAR>
                    <P>The revisions and addition read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 414.1305 </SECTNO>
                        <SUBJECT>Definitions.</SUBJECT>
                        <STARS/>
                        <P>
                            <E T="03">Attestation</E>
                             means a secure mechanism, specified by CMS, with respect to a particular performance period, whereby a MIPS eligible clinician or group may submit the required data for the Promoting Interoperability or the improvement activities performance categories of MIPS in a manner specified by CMS.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Certified Electronic Health Record Technology (CEHRT)</E>
                             * * *
                        </P>
                        <P>(1) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(D) The certification criteria that are necessary to report on applicable objectives and measures specified for the MIPS Promoting Interoperability performance category, including the applicable measure calculation certification criterion at 45 CFR 170.314(g)(1) or (2) or 45 CFR 170.315(g)(1) or (2) for all certification criteria that support an objective with a percentage-based measure.</P>
                        <STARS/>
                        <P>(2) * * *</P>
                        <P>(ii) Necessary to report on applicable objectives and measures specified for the MIPS Promoting Interoperability performance category including the following:</P>
                        <STARS/>
                        <P>
                            <E T="03">Collection type</E>
                             means a set of quality measures with comparable specifications and data completeness criteria, as applicable, including, but not limited to: electronic clinical quality measures (eCQMs); MIPS Clinical Quality Measures (MIPS CQMs); QCDR measures; Medicare Part B claims measures; for the 2019 through 2022 MIPS payment years, CMS Web Interface measures; the CAHPS for MIPS survey; and administrative claims measures.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">Low-volume threshold</E>
                             means:
                        </P>
                        <P>(1) For the 2019 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has Medicare Part B allowed charges less than or equal to $30,000 or provides care for 100 or fewer Medicare Part B-enrolled individuals.</P>
                        <P>(2) For the 2020 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the low-volume threshold determination period described in paragraph (4) of this definition, has allowed charges for covered professional services less than or equal to $90,000 or furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals.</P>
                        <P>(3) For the 2021 and 2022 MIPS payment years, the low-volume threshold that applies to an individual eligible clinician, group, or APM Entity group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part B-enrolled individuals.</P>
                        <P>(4) For the 2019 and 2020 MIPS payment years, the low-volume threshold determination period is a 24-month assessment period consisting of:</P>
                        <P>(i) An initial 12-month segment that spans from the last 4 months of the calendar year 2 years prior to the performance period through the first 8 months of the calendar year preceding to the performance period; and</P>
                        <P>(ii) A second 12-month segment that spans from the last 4 months of the calendar year 1 year prior to the performance period through the first 8 months of the calendar year performance period. An individual eligible clinician, group, or APM Entity group that is identified as not exceeding the low-volume threshold during the initial 12-month segment will continue to be excluded under § 414.1310(b)(1)(iii) for the applicable year regardless of the results of the second 12-month segment analysis. For the 2019 MIPS payment year, each segment of the low-volume threshold determination period includes a 60-day claims run out. For the 2020 MIPS payment year, each segment of the low-volume threshold determination period includes a 30-day claims run out.</P>
                        <P>(5) Beginning with the 2023 MIPS payment year, the low-volume threshold that applies to an individual eligible clinician, or group that, during the MIPS determination period, has allowed charges for covered professional services less than or equal to $90,000, furnishes covered professional services to 200 or fewer Medicare Part B-enrolled individuals, or furnishes 200 or fewer covered professional services to Medicare Part B-enrolled individuals.</P>
                        <P>
                            <E T="03">Meaningful EHR user for MIPS means</E>
                             a MIPS eligible clinician who possesses CEHRT, uses the functionality of CEHRT, and reports on applicable objectives and measures specified for the Promoting Interoperability performance category for a performance period in the form and manner specified by CMS, supports information exchange and the prevention of health information blocking, and engages in activities related to supporting providers with the performance of CEHRT.
                        </P>
                        <STARS/>
                        <P>
                            <E T="03">MIPS APM</E>
                             means:
                        </P>
                        <P>(1) For the 2019 through 2022 MIPS payment years, an APM that meets the criteria specified under § 414.1370(b).</P>
                        <P>(2) Beginning with the 2023 MIPS payment year, an APM that meets the criteria as set forth in § 414.1367(b).</P>
                        <STARS/>
                        <P>
                            <E T="03">Physician Compare</E>
                             means the Physician Compare internet website of the Centers for Medicare &amp; Medicaid Services (or a successor website).
                        </P>
                        <P>
                            <E T="03">Primary care services</E>
                             for purposes of CAHPS for MIPS survey beneficiary assignment means the set of services identified by the following:
                        </P>
                        <P>(1) CPT codes:</P>
                        <P>(i) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient); 99304 through 99318 (codes for professional services furnished in a nursing facility, excluding professional services furnished in a SNF for claims identified by place of service (POS) modifier 31); 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit); 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by POS modifier 12); 99487, 99489, and 99490 (codes for chronic care management); and 99495 and 99496 (codes for transitional care management services); and</P>
                        <P>
                            (ii) Beginning with the 2023 MIPS payment year, 99421, 99422, and 99423 (codes for online digital evaluation and management services (e-visit)); 99441, 99442, and 99443 (codes for telephone evaluation and management services); and 96160 and 96161 (codes for administration of health risk assessment).
                            <PRTPAGE P="50399"/>
                        </P>
                        <P>(2) HCPCS codes:</P>
                        <P>(i) G0402 (code for the Welcome to Medicare visit); and G0438 and G0439 (codes for the annual wellness visits); and</P>
                        <P>(ii) Beginning with the 2023 MIPS payment year, G2010 (code for remote evaluation of patient video/images); and G2012 (code for virtual check-in).</P>
                        <STARS/>
                        <P>
                            <E T="03">Submission type</E>
                             means the mechanism by which the submitter type submits data to CMS, including, but not limited to:
                        </P>
                        <P>(1) Direct;</P>
                        <P>(2) Log in and upload;</P>
                        <P>(3) Log in and attest;</P>
                        <P>(4) Medicare Part B claims; and</P>
                        <P>(5) For the 2019 through 2022 MIPS payment years, the CMS Web Interface.</P>
                        <P>
                            <E T="03">Submitter type</E>
                             means the MIPS eligible clinician, group, Virtual Group, APM Entity, or third party intermediary acting on behalf of a MIPS eligible clinician, group, Virtual Group, or APM Entity, as applicable, that submits data on measures and activities under MIPS.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>15. Section 414.1310 is amended by revising paragraphs (b)(1)(iii) and (e)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1310 </SECTNO>
                        <SUBJECT>Applicability.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iii) Does not exceed the low volume threshold.</P>
                        <P>(A) Beginning with the 2021 MIPS payment year, if an individual eligible clinician or group exceeds at least one, but not all, of the low-volume threshold criteria and elects to participate in MIPS as a MIPS eligible clinician, the individual eligible clinician or group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For such solo practitioners and groups that elect to participate in MIPS as a virtual group (except for APM Entity groups in MIPS APMs), the virtual group election under § 414.1315 constitutes an election under this paragraph and results in the solo practitioners and groups being treated as MIPS eligible clinicians for the applicable MIPS payment year.</P>
                        <P>(B) For the 2021 and 2022 MIPS payment years, if an APM Entity group in a MIPS APM exceeds at least one, but not all, of the low-volume threshold criteria and elects to participate in MIPS as a MIPS eligible clinician, the APM Entity group is treated as a MIPS eligible clinician for the applicable MIPS payment year. For such APM Entity groups in MIPS APMs, only the APM Entity group election can result in the APM Entity group being treated as MIPS eligible clinicians for the applicable MIPS payment year.</P>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(1) Except as provided under §§ 414.1317(b) and 414.1370(f)(2), each MIPS eligible clinician in the group will receive a MIPS payment adjustment factor (or additional MIPS payment adjustment factor) based on the group's combined performance assessment.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>16. Section 414.1317 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1317 </SECTNO>
                        <SUBJECT>APM Entity groups.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">APM entity group determination.</E>
                             The APM Entity group will be determined according to the requirements set forth in § 414.1425(b)(1).
                        </P>
                        <P>(1) In addition to the dates set forth in § 414.1425(b)(1), for purposes of MIPS, the APM Entity group includes an eligible clinician who is on a Participation List on December 31 of the MIPS performance period.</P>
                        <P>(2) For purposes of MIPS scoring, the APM Entity group will be comprised only of those eligible clinicians within the APM Entity group who are determined to be MIPS eligible at the individual or group level.</P>
                        <P>(3) For purposes of calculating the APM Entity group score, MIPS scores submitted by virtual groups will not be included.</P>
                        <P>
                            (b) 
                            <E T="03">APM Entity group scoring.</E>
                             The MIPS final score calculated for the APM Entity is applied to each MIPS eligible clinician in the APM Entity group. The MIPS payment adjustment is applied at the TIN/NPI level for each of the MIPS eligible clinicians in the APM Entity group.
                        </P>
                        <P>
                            (1) 
                            <E T="03">Determination of performance category score for each MIPS eligible clinician in an APM Entity.</E>
                             For APM Entities, where a performance category is not reported by the APM Entity, CMS uses one score for each MIPS eligible clinician in an APM Entity group to derive a single average APM Entity score for the performance category. The applicable score for each MIPS eligible clinician is the higher of either:
                        </P>
                        <P>(i) A group score based on the measure data for the performance category reported by a TIN for the MIPS eligible clinician according to MIPS submission and reporting requirements for groups.</P>
                        <P>(ii) An individual score based on the measure data for the performance category reported by the MIPS eligible clinician according to MIPS submission and reporting requirements for individuals.</P>
                        <P>(iii) In the event that a MIPS eligible clinician in an APM Entity receives an exception from the reporting requirements, such eligible clinician will be assigned a null score when CMS calculates the APM Entity's performance category score.</P>
                        <P>
                            (2) 
                            <E T="03">Improvement scoring for APM Entity groups.</E>
                             For an APM Entity for which CMS calculated a total performance category score for one or more participants in the APM Entity for the preceding MIPS performance period, CMS calculates an improvement score for each performance category for which a previous year's total performance category score is available as specified in § 414.1380(b).
                        </P>
                        <P>
                            (3) 
                            <E T="03">Extreme and uncontrollable circumstances.</E>
                             Beginning with the 2022 MIPS payment year, an APM Entity may submit to CMS an application described at § 414.1380(c)(2)(i)(A)(
                            <E T="03">6</E>
                            ) and § 414.1380(c)(2)(i)(C)(2) requesting reweighting of all four MIPS performance categories and for all MIPS eligible clinicians in the APM Entity group, based on extreme and uncontrollable circumstances.
                        </P>
                        <P>(i) An APM Entity must demonstrate in its application to CMS that greater than 75 percent of its participant MIPS eligible clinicians would be eligible for reweighting the Promoting Interoperability performance category for the applicable performance period.</P>
                        <P>(ii) If CMS approves the request for reweighting based on an APM Entity's application, and if MIPS data are submitted for the APM Entity for the applicable performance period, all four of the MIPS performance categories will be reweighted for the APM Entity group notwithstanding the data submission.</P>
                    </SECTION>
                    <AMDPAR>17. Section 414.1320 is amended by revising paragraphs (d) introductory text and (d)(1) and adding paragraph (g) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1320 </SECTNO>
                        <SUBJECT>MIPS performance period.</SUBJECT>
                        <STARS/>
                        <P>(d) Beginning with the 2023 MIPS payment year, the performance period for:</P>
                        <P>(1) The quality and cost performance categories is the full calendar year (January 1 through December 31) that occurs 2 years prior to the applicable MIPS payment year, except as otherwise specified for administrative claims-based measures in the MIPS final list of quality measures described in § 414.1330(a)(1).</P>
                        <STARS/>
                        <P>
                            (g) For purposes of the 2024 MIPS payment year and each subsequent MIPS payment year, the performance period for:
                            <PRTPAGE P="50400"/>
                        </P>
                        <P>(1) The Promoting Interoperability performance category is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable MIPS payment year, up to and including the full calendar year.</P>
                        <P>(2) [Reserved]</P>
                    </SECTION>
                    <AMDPAR>18. Section 414.1325 is amended by revising paragraph (c)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1325 </SECTNO>
                        <SUBJECT>Data submission requirements.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(1) For the quality performance category, the direct; login and upload; Medicare Part B claims (beginning with the 2021 MIPS payment year, for small practices only); and for the 2019 through 2022 MIPS payment years, CMS Web Interface (for groups consisting of 25 or more eligible clinicians or a third party intermediary submitting on behalf of a group) submission types.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>19. Section 414.1330 is amended by adding paragraphs (b)(4) and (5) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1330</SECTNO>
                        <SUBJECT>Quality performance category.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(4) 40 percent of a MIPS eligible clinician's final score for the MIPS payment year 2023.</P>
                        <P>(5) 30 percent of a MIPS eligible clinician's final score for the MIPS payment year 2024 and future years.</P>
                    </SECTION>
                    <AMDPAR>20. Section 414.1350 is amended by adding paragraphs (d)(4) and (5) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1350 </SECTNO>
                        <SUBJECT>Cost performance category.</SUBJECT>
                        <STARS/>
                        <P>(d) * * *</P>
                        <P>(4) 20 percent of the MIPS final score for MIPS payment year 2023.</P>
                        <P>(5) 30 percent of the MIPS final score for MIPS payment year 2024 and each subsequent MIPS payment year.</P>
                    </SECTION>
                    <AMDPAR>21. Section 414.1367 is added to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1367 </SECTNO>
                        <SUBJECT>APM performance pathway.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General.</E>
                             Beginning with the 2023 MIPS payment year, the APM Performance Pathway is a MIPS scoring methodology available to MIPS eligible clinicians identified on the Participation List or Affiliated Practitioner List of an APM Entity participating in a MIPS APM.
                        </P>
                        <P>
                            (b) 
                            <E T="03">Criteria for MIPS APMs.</E>
                             MIPS APMs are those in which:
                        </P>
                        <P>(1) APM Entities participate in the APM under an agreement with CMS or through a law or regulation; and</P>
                        <P>(2) The APM bases payment on quality measures and cost/utilization.</P>
                        <P>
                            (c) 
                            <E T="03">MIPS performance category scoring in the APM Performance Pathway.</E>
                        </P>
                        <P>
                            (1) 
                            <E T="03">Quality.</E>
                             Except as provided in paragraphs (c)(1)(i) and (ii) of this section, the quality performance category score is calculated for a MIPS eligible clinician, group, or APM Entity group in accordance with § 414.1380(b)(1) based on the APM Performance Pathway quality measure set established by CMS through rulemaking for a MIPS payment year.
                        </P>
                        <P>(i) Each submitted measure that does not have a benchmark or meet the case minimum requirement is excluded from the MIPS eligible clinician, group, or APM Entity group's total measure achievement points and total available measure achievement points.</P>
                        <P>(ii) Any measure that is identified as topped out is not subject to the scoring cap described at § 414.1380(b)(1)(iv).</P>
                        <P>
                            (2) 
                            <E T="03">Cost.</E>
                             The cost performance category weight is zero percent for MIPS eligible clinicians who are scored through the APM Performance Pathway.
                        </P>
                        <P>
                            (3) 
                            <E T="03">Improvement activities.</E>
                             The improvement activities performance category score is calculated for a MIPS eligible clinician, group, or APM Entity group in accordance with § 414.1380(b)(3) based on the activities required by the MIPS APM that are included in the MIPS final inventory of improvement activities described in § 414.1355(a) (excluding any such activities that the MIPS eligible clinician, group, or APM Entity group does not perform. MIPS eligible clinicians, groups, or APM Entities may report additional improvement activities in accordance with § 414.1360.
                        </P>
                        <P>
                            (4) 
                            <E T="03">Promoting interoperability.</E>
                             The promoting interoperability performance category will be scored for the MIPS eligible clinician, group, or APM Entity as described in § 414.1375.
                        </P>
                        <P>
                            (d) 
                            <E T="03">APM Performance Pathway performance category weights</E>
                            —(1) 
                            <E T="03">Performance category weights.</E>
                             Subject to paragraph (d)(2) of this section, the performance category weights used to calculate the final score for a MIPS eligible clinician, group, or APM Entity reporting through the APM performance Pathway are:
                        </P>
                        <P>(i) Quality: 50 percent.</P>
                        <P>(ii) Cost: 0 percent.</P>
                        <P>(iii) Improvement Activities: 20 percent.</P>
                        <P>(iv) Promoting Interoperability: 30 percent.</P>
                        <P>
                            (2) 
                            <E T="03">Reweighting MIPS performance categories.</E>
                             If CMS determines, in accordance with § 414.1380(c)(2), that a different scoring weight should be assigned to the quality or promoting interoperability performance category, CMS will redistribute the performance category weights as follows:
                        </P>
                        <P>(i) If CMS reweights the quality performance category to 0 percent: Promoting Interoperability performance category is reweighted to 75 percent, and Improvement Activities performance category is reweighted to 25 percent.</P>
                        <P>(ii) If CMS reweights the Promoting Interoperability performance category to 0 percent: Quality performance category is reweighted to 75 percent, and Improvement Activities performance category is reweighted to 25 percent.</P>
                        <P>
                            (e) 
                            <E T="03">Final score.</E>
                             The final score is calculated for a MIPS eligible clinician, group, or APM Entity in accordance with § 414.1380(c).
                        </P>
                    </SECTION>
                    <AMDPAR>22. Section 414.1370 is amended by revising paragraph (a) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1370 </SECTNO>
                        <SUBJECT>APM scoring standard under MIPS.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General.</E>
                             For the 2019 through 2022 MIPS payment years, the APM scoring standard is the MIPS scoring methodology applicable for MIPS eligible clinicians identified on the Participation List for the performance period of an APM Entity participating in a MIPS APM.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>23. Section 414.1380 is amended—</AMDPAR>
                    <AMDPAR>a. By revising paragraph (b)(1)(i) introductory text;</AMDPAR>
                    <AMDPAR>
                        b. In paragraph (b)(1)(i)(A)(
                        <E T="03">1</E>
                        ) by removing “for the 2019 through 2022 MIPS payment years” and adding in its place “for the 2019 through 2023 MIPS payment years”;
                    </AMDPAR>
                    <AMDPAR>c. By revising paragraphs (b)(1)(iii) and (b)(1)(iv)(B);</AMDPAR>
                    <AMDPAR>
                        d. In paragraph (b)(1)(v)(A)(
                        <E T="03">1</E>
                        )(
                        <E T="03">ii</E>
                        ) by removing “For the 2019 through 2022 MIPS payment years” and adding in its place “For the 2019 through 2023 MIPS payments years”;
                    </AMDPAR>
                    <AMDPAR>
                        e. In paragraph (b)(1)(v)(B)(
                        <E T="03">1</E>
                        )(
                        <E T="03">i</E>
                        ) by removing “For the 2019 through 2022 MIPS payment years” and adding in its place “For the 2019 through 2023 MIPS payment years”;
                    </AMDPAR>
                    <AMDPAR>
                        f. In paragraph (b)(1)(vi)(C)(
                        <E T="03">4</E>
                        ) by removing “For the 2020 through 2022 MIPS payment years” and adding in its place “For the 2020 through 2023 MIPS payment years”;
                    </AMDPAR>
                    <AMDPAR>g. By revising paragraph (b)(1)(vii)(A);</AMDPAR>
                    <AMDPAR>h. By removing paragraph (b)(1)(viii);</AMDPAR>
                    <AMDPAR>
                        i. By revising paragraphs (c)(2)(i)(A)(
                        <E T="03">4</E>
                        ) and (
                        <E T="03">5</E>
                        );
                    </AMDPAR>
                    <AMDPAR>j. By adding paragraphs (c)(2)(ii)(E) and (F);</AMDPAR>
                    <AMDPAR>k. By revising paragraph (c)(3) introductory text and (c)(3)(iii); and</AMDPAR>
                    <AMDPAR>l. By adding paragraph (c)(3)(iv).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <PRTPAGE P="50401"/>
                        <SECTNO>§ 414.1380 </SECTNO>
                        <SUBJECT>Scoring.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) Measure achievement points. For the 2019 through 2023 MIPS payment years, MIPS eligible clinicians receive between 3 and 10 measure achievement points (including partial points) for each measure required under § 414.1335 on which data is submitted in accordance with § 414.1325 that has a benchmark at paragraph (b)(1)(ii) of this section, meets the case minimum requirement at paragraph (b)(1)(iii) of this section, and meets the data completeness requirement at § 414.1340 and for each administrative claims-based measure that has a benchmark at paragraph (b)(1)(ii) of this section and meets the case minimum requirement at paragraph (b)(1)(iii) of this section. The number of measure achievement points received for each such measure is determined based on the applicable benchmark decile category and the percentile distribution. MIPS eligible clinicians receive zero measure achievement points for each measure required under § 414.1335 on which no data is submitted in accordance with § 414.1325. MIPS eligible clinicians that submit data in accordance with § 414.1325 on a greater number of measures than required under § 414.1335 are scored only on the required measures with the greatest number of measure achievement points. Beginning with the 2021 MIPS payment year, MIPS eligible clinicians that submit data in accordance with § 414.1325 on a single measure via multiple collection types are scored only on the data submission with the greatest number of measure achievement points.</P>
                        <STARS/>
                        <P>
                            (iii) 
                            <E T="03">Minimum case requirements.</E>
                             Except as otherwise specified for administrative claims-based measures in the MIPS final list of quality measures described in § 414.1330(a)(1), the minimum case requirement is 20 cases.
                        </P>
                        <P>(iv) * * *</P>
                        <P>
                            (B) Except as provided in paragraph (b)(1)(iv)(B)(
                            <E T="03">1</E>
                            ) of this section, beginning with the 2021 MIPS payment year, each measure (except for measures in the CMS Web Interface) for which the benchmark for the applicable collection type is identified as topped out for 2 or more consecutive years receives no more than 7 measure achievement points in the second consecutive year it is identified as topped out, and beyond.
                        </P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) For the 2023 MIPS payment year, a measure is topped out if it is identified as such in the baseline period benchmarks for the 2020 MIPS performance period and in the performance period benchmarks for the 2021 MIPS performance period.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) [Reserved]
                        </P>
                        <STARS/>
                        <P>(vii) * * *</P>
                        <P>(A) For each submitted measure that is impacted by significant changes that CMS determines may result in patient harm or misleading results, performance is based on data for 9 consecutive months of the applicable CY performance period. If such data are not available, the measure is excluded from a MIPS eligible clinician's total measure achievement points and total available measure achievement points. For purposes of this paragraph (b)(1)(vii)(A), “significant changes” means changes to codes (including, but not limited to, ICD-10, CPT, and HCPCS codes), clinical guidelines, or measure specifications. CMS will publish on the CMS website a list of all measures scored under this paragraph (b)(1)(vii)(A) as soon as technically feasible, but by no later than the beginning of the data submission period at § 414.1325(e)(1).</P>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) * * *</P>
                        <P>(A) * * *</P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) For the Promoting Interoperability performance category for the 2021, 2022 and 2023 MIPS payment years, the MIPS eligible clinician is a physical therapist, occupational therapist, clinical psychologist, qualified audiologist, qualified speech-language pathologist, or a registered dietitian or nutrition professional. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) For the Promoting Interoperability performance category for the 2019, 2020, 2021, 2022, and 2023 MIPS payment years, the MIPS eligible clinician is a nurse practitioner, physician assistant, clinical nurse specialist, or certified registered nurse anesthetist. In the event that a MIPS eligible clinician submits data for the Promoting Interoperability performance category, the scoring weight specified in paragraph (c)(1) of this section will be applied and its weight will not be redistributed.
                        </P>
                        <STARS/>
                        <P>(ii) * * *</P>
                        <P>(E) For the 2023 MIPS payment year:</P>
                        <GPH SPAN="3" DEEP="231">
                            <PRTPAGE P="50402"/>
                            <GID>EP17AU20.132</GID>
                        </GPH>
                        <P>(F) For the 2024 MIPS payment year:</P>
                        <GPH SPAN="3" DEEP="220">
                            <GID>EP17AU20.133</GID>
                        </GPH>
                        <STARS/>
                        <P>
                            (3) 
                            <E T="03">Complex patient bonus.</E>
                             For the 2020, 2021, 2022, and 2023 MIPS payment years, provided that a MIPS eligible clinician, group, virtual group or APM entity submits data for at least one MIPS performance category for the applicable performance period for the MIPS payment year, a complex patient bonus will be added to the final score for the MIPS payment year, as follows:
                        </P>
                        <STARS/>
                        <P>(iii) The complex patient bonus cannot exceed 5.0 except as provided in paragraph (c)(3)(iv) of this section.</P>
                        <P>(iv) For the 2022 MIPS payment year, the complex patient bonus is calculated pursuant to paragraphs (c)(3)(i) and (ii), and the resulting numerical value is then multiplied by 2.0. The complex patient bonus cannot exceed 10.0.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>24. Section 414.1400 is amended—</AMDPAR>
                    <AMDPAR>a. By revising paragraphs (a)(2)(i) and (ii) and (a)(4);</AMDPAR>
                    <AMDPAR>b. By revising the paragraph (b) subject heading and paragraph (b)(2) introductory text;</AMDPAR>
                    <AMDPAR>c. By adding paragraphs (b)(2)(iv) and (v);</AMDPAR>
                    <AMDPAR>
                        d. By adding paragraphs (b)(3)(v)(C)(
                        <E T="03">1</E>
                        ) and (
                        <E T="03">2</E>
                        );
                    </AMDPAR>
                    <AMDPAR>e. By revising paragraphs (b)(3)(v)(E) and (b)(3)(vi);</AMDPAR>
                    <AMDPAR>f. By removing paragraphs (b)(3)(vii)(H) and (L);</AMDPAR>
                    <AMDPAR>g. By redesignating paragraphs (b)(3)(vii)(I), (J), (K), (M), and (N) as paragraphs (b)(3)(vii)(H), (I), (J), (K), and (L), respectively;</AMDPAR>
                    <AMDPAR>h. By revising the paragraph (c) subject heading;</AMDPAR>
                    <AMDPAR>i. By adding paragraphs (c)(2)(iii) and (iv); and</AMDPAR>
                    <AMDPAR>j. By revising paragraph (f)(1)(i).</AMDPAR>
                    <P>The additions and revisions read as follows:</P>
                    <SECTION>
                        <PRTPAGE P="50403"/>
                        <SECTNO>§ 414.1400 </SECTNO>
                        <SUBJECT>Third party intermediaries.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) Except as provided under paragraph (a)(2)(ii) of this section, QCDRs, qualified registries, and Health IT vendors must be able to submit data for all of the following MIPS performance categories:</P>
                        <P>(A) Quality, except:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) The CAHPS for MIPS survey; and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For qualified registries and Health IT vendors, QCDR measures;
                        </P>
                        <P>(B) Improvement activities; and</P>
                        <P>
                            (C) Promoting Interoperability, if the eligible clinician, group, or virtual group is using CEHRT; however, a third party intermediary may be excepted from this requirement if its MIPS eligible clinicians, groups or virtual groups fall under the reweighting policies at § 414.1380(c)(2)(i)(A)(
                            <E T="03">4</E>
                            ) or (
                            <E T="03">5</E>
                            ) or § 414.1380(c)(2)(i)(C)(
                            <E T="03">1</E>
                            ) through (
                            <E T="03">7</E>
                            ) or § 414.1380(c)(2)(i)(C)(
                            <E T="03">9</E>
                            ).
                        </P>
                        <P>(ii) Health IT vendors that do not support MIPS Value Pathways must be able to submit data for at least one of the MIPS performance categories described in paragraphs (a)(2)(i)(A) through (C) of this section.</P>
                        <STARS/>
                        <P>(4) Third party intermediary approval criteria—</P>
                        <P>(i) To be approved as a third party intermediary, an entity must agree to meet the applicable requirements of this section, including, but not limited to, the following:</P>
                        <P>(A) A third party intermediary's principle place of business and retention of any data must be based in the U.S.</P>
                        <P>(B) If the data is derived from CEHRT, a QCDR, qualified registry, or health IT vendor must be able to indicate its data source.</P>
                        <P>(C) All data must be submitted in the form and manner specified by CMS.</P>
                        <P>(D) If the clinician chooses to opt-in in accordance with § 414.1310, the third party intermediary must be able to transmit that decision to CMS.</P>
                        <P>(E) The third party intermediary must provide services throughout the entire performance period and applicable data submission period.</P>
                        <P>(F) Prior to discontinuing services to any MIPS eligible clinician, group, or virtual group during a performance period, the third party intermediary must support the transition of such MIPS eligible clinician, group, or virtual group to an alternate third party intermediary, submitter type, or, for any measure on which data has been collected, collection type according to a CMS approved a transition plan.</P>
                        <P>(ii) The determination of whether to approve an entity as a third party intermediary for a MIPS payment year may take into account:</P>
                        <P>(A) Whether the entity failed to comply with the requirements of this section for any prior MIPS payment year for which it was approved as third party intermediary; and</P>
                        <P>(B) Whether the entity provided inaccurate information regarding the requirements of this subpart to any eligible clinician.</P>
                        <P>(iii) Beginning with the 2023 MIPS payment year, third party intermediaries must attend and complete training and support sessions in the form and manner, and at the times, specified by CMS.</P>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">QCDRs.</E>
                        </P>
                        <STARS/>
                        <P>
                            (2) 
                            <E T="03">QCDR conditions for approval.</E>
                             In addition to the other requirements in this section, the criteria for an entity to be approved as a QCDR include the following:
                        </P>
                        <STARS/>
                        <P>(iv) Beginning with the 2023 payment year, the QCDR must conduct annual data validation audits in accordance with this paragraph (b)(2)(iv).</P>
                        <P>(A) The QCDR must conduct data validation for the payment year prior to submitting any data for that payment year to CMS for purposes of the MIPS program.</P>
                        <P>(B) The QCDR must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories.</P>
                        <P>(C) The QCDR must conduct data validation on data for each submitter type for which it will submit data, including if applicable MIPS eligible clinicians, groups, virtual groups, voluntary participants, and opt-in participants.</P>
                        <P>(D) The QCDR must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed.</P>
                        <P>(E) The QCDR shall conduct each data validation audit using a sampling methodology that meets the following requirements:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Uses a sample size of at least 3 percent of the TIN/NPIs for which the QCDR will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the QCDR must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the QCDR may use a sample size of 50 TIN/NPIs.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients.
                        </P>
                        <P>(F) Each QCDR data validation audit must include the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Verification of the eligibility status of each eligible clinician, group, virtual group, opt-in participant, and voluntary participant.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Verification of the accuracy of TINs and NPIs.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Calculation of reporting and performance rates.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Verification that only the MIPS quality measures and QCDR measures, as applicable, that are relevant to the performance period will be used for MIPS submission.
                        </P>
                        <P>(G) In a form and manner and by a deadline specified by CMS, the QCDR must report the results of each data validation audit, including the overall data deficiencies or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or error, and, how and when each deficiency or data error type was corrected.</P>
                        <P>(v) Beginning with the 2023 MIPS payment year, the QCDR must conduct targeted audits in accordance with this this paragraph (b)(2)(v).</P>
                        <P>(A) If a data validation audit under § 414.1400(b)(2)(iv) identifies one or more deficiency or data error, the QCDR must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year.</P>
                        <P>(B) The QCDR must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year.</P>
                        <P>(C) The QCDR must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (b)(2)(iv)(E) of this section. The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified.</P>
                        <P>(D) In a form and manner and by a deadline specified by CMS, the QCDR must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, and how and when each deficiency or data error type was corrected.</P>
                        <P>
                            (3) * * *
                            <PRTPAGE P="50404"/>
                        </P>
                        <P>(v) * * *</P>
                        <P>(C) * * *</P>
                        <P>
                            (
                            <E T="03">1)</E>
                             To be approved for the 2024 MIPS payment year, a QCDR measure must be face valid. To be approved for the 2025 MIPS payment year and future years, a QCDR measure must be face valid for the initial MIPS payment year for which it is approved and fully tested for any subsequent MIPS payment year for which it is approved.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) To be included in an MIPS Value Pathway for the 2024 MIPS payment year and future years, a QCDR measure must be fully tested.
                        </P>
                        <STARS/>
                        <P>(E) Beginning with the 2022 MIPS payment year, CMS may provisionally approve the individual QCDR measures for 1 year with the condition that QCDRs address certain areas of duplication with other approved QCDR measures or MIPS quality measures in order to be considered for the program in subsequent years. If such areas of duplication are not addressed, CMS may reject the duplicative QCDR measure.</P>
                        <P>(vi) Beginning with the 2023 MIPS payment year, QCDR measures may be approved for 2 years, at CMS discretion by attaining approval status by meeting QCDR measure considerations and requirements. Upon annual review, CMS may revoke a QCDR measure's second year approval, if the QCDR measure is found to be: Topped out; duplicative of a more robust measure; reflects an outdated clinical guideline; or if the QCDR self-nominating the QCDR measure is no longer in good standing.</P>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Qualified registries.</E>
                        </P>
                        <P>(2) * * *</P>
                        <P>(iii) Beginning with the 2023 payment year, the qualified registry must conduct annual data validation audits in accordance with this paragraph (c)(2)(iii).</P>
                        <P>(A) The qualified registry must conduct their data validation audits prior to submitting any data to CMS for purposes of the MIPS program.</P>
                        <P>(B) The qualified registry must conduct data validation on data for each performance category for which it will submit data, including if applicable the Quality, Improvement Activities, and Promoting Interoperability performance categories.</P>
                        <P>(C) The qualified registry must conduct data validation on data for each submitter type for which it will submit data, including if applicable MIPS eligible clinicians, groups, virtual groups, voluntary participants, and opt-in participants.</P>
                        <P>(D) The qualified registry must use clinical documentation (provided by the clinicians they are submitting data for) to validate that the action or outcome measured actually occurred or was performed.</P>
                        <P>(E) The qualified registry shall conduct each data validation audit using a sampling methodology that meets the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Uses a sample size of at least 3 percent of the TIN/NPIs for which the qualified registry will submit data to CMS, except that if a 3 percent sample size would result in fewer than 10 TIN/NPIs, the qualified registry must use a sample size of at least 10 TIN/NPIs, and if a 3 percent sample size would result in more than 50 TIN/NPIs, the qualified registry may use a sample size of 50 TIN/NPIs.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Uses a sample that includes at least 25 percent of the patients of each TIN/NPI in the sample, except that the sample for each TIN/NPI must include a minimum of 5 patients and does not need to include more than 50 patients.
                        </P>
                        <P>(F) Each qualified registry data validation audit must include the following:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) Verification of the eligibility status of each eligible clinician, group, virtual group, opt-in participant, and voluntary participant.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) Verification of the accuracy of TINs and NPIs.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) Calculation of reporting and performance rates.
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) Verification that only MIPS quality measures and qualified registry measures that are relevant to the performance period will be utilized for MIPS submission.
                        </P>
                        <P>(G) In a form and manner and by a deadline specified by CMS, the qualified registry must report data validation results, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by any deficiency or data error, how and when each deficiency or data error type was corrected.</P>
                        <P>(iv) Beginning with the 2023 MIPS payment year, the qualified registry must conduct targeted audits in accordance with this paragraph (c)(2)(iv).</P>
                        <P>(A) If a data validation audit under § 414.1400(c)(2)(iii) identifies one or more deficiency or data error, the qualified registry must conduct a targeted audit into the impact and root cause of each such deficiency or data error for that MIPS payment year.</P>
                        <P>(B) The qualified registry must conduct any required targeted audits for the MIPS payment year and correct any deficiencies or data errors identified through such audit prior to the submission of data for that MIPS payment year.</P>
                        <P>
                            (C) The qualified registry must conduct the targeted audit using the sampling methodology that meets the requirements described in paragraph (c)(2)(iii)(E)(
                            <E T="03">1</E>
                            ) and (
                            <E T="03">2</E>
                            ) of this section. The sample for the targeted audit must not include data from the sample used for the data validation audit in which the deficiency or data error was identified.
                        </P>
                        <P>(D) In a form and manner and by a deadline specified by CMS, the qualified registry must report the results of each targeted audit, including the overall deficiency or data error rate, the types of deficiencies or data errors discovered, the percentage of clinicians impacted by each deficiency or data error, how and when each deficiency or data error type was corrected.</P>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) Require the third party intermediary to submit a corrective action plan (CAP) by a date specified by CMS. The CAP must address the following issues, unless different or additional information is specified by CMS:</P>
                        <P>(A) The issues that contributed to the non-compliance.</P>
                        <P>(B) The impact to individual clinicians, groups, or virtual groups, regardless of whether they are participating in the program because they are MIPS eligible, voluntary participating, or opting in to participating in the MIPS program.</P>
                        <P>(C) The corrective actions to be implemented by the third party intermediary to ensure that the non-compliance has been resolved and will not recur in the future.</P>
                        <P>(D) The detailed timeline for achieving compliance with the applicable requirements.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>25. Section 414.1405 is amended by revising paragraph (b)(8) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1405 </SECTNO>
                        <SUBJECT>Payment.</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(8) The performance threshold for the 2023 MIPS payment year is 50 points.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>26. Section 414.1435 is amended by revising paragraph (c)(1) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1435 </SECTNO>
                        <SUBJECT>Qualifying APM Participant determination: Medicare option.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) * * *
                            <PRTPAGE P="50405"/>
                        </P>
                        <P>(1) Attributed beneficiaries are determined from each Advanced APM Entity's attributed beneficiary lists generated by each Advanced APM's specific attribution methodology except as set forth below.</P>
                        <P>(i) Beneficiaries who have been prospectively attributed to an APM Entity for a QP Performance Period will be excluded from the attribution-eligible beneficiary count for any other APM Entity that is participating in an APM where that beneficiary would be ineligible to be added to the APM Entity's attributed beneficiary list.</P>
                        <P>(ii) [Reserved]</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>27. Section 414.1450 is amended by revising paragraphs (b)(1) and (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1450 </SECTNO>
                        <SUBJECT>APM incentive payment.</SUBJECT>
                        <STARS/>
                        <P>
                            (b) 
                            <E T="03">* * *</E>
                        </P>
                        <P>(1) The amount of the APM Incentive Payment is equal to 5 percent of the estimated aggregate payments for covered professional services as defined in section 1848(k)(3)(A) of the Act furnished during the calendar year immediately preceding the payment year. CMS uses the paid amounts on claims for covered professional services to calculate the estimated aggregate payments on which CMS will calculate the APM Incentive Payment.</P>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">APM Incentive Payment recipient.</E>
                             CMS will pay the APM Incentive Payment amount for a payment year to the TIN or TINs associated with the QP identified at a specific step in the following hierarchy. If no TIN or TINs with which the QP has an association can be identified at a step, CMS will move to the next and successive steps listed below until CMS identifies a TIN or TINs with which the QP is associated, and to which CMS will make the APM Incentive Payment.
                        </P>
                        <P>(1) Any TIN associated with the QP that, during the QP Performance Period, is associated with an APM Entity through which the eligible clinician achieved QP status;</P>
                        <P>(2) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity through which the eligible clinician achieved QP status;</P>
                        <P>(3) Any TIN associated with the QP that, during the APM Incentive Payment base period, is associated with an APM Entity participating in an Advanced APM through which the eligible clinician had achieved QP status;</P>
                        <P>(4) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated in an APM Entity in an Advanced APM;</P>
                        <P>(5) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in any track of the APM through which the eligible clinician achieved QP status;</P>
                        <P>(6) Any TIN associated with the QP that, during the APM Incentive Payment base period, participated with an APM Entity in an APM other than an Advanced APM;</P>
                        <P>(7) Any TIN associated with the QP that submitted a claim for covered professional services furnished by the QP during the APM Incentive Payment base period, even if such TIN has no relationship to any APM Entity or APM; then</P>
                        <P>(8) If we have not identified any TIN associated with the QP to which we can make the APM Incentive Payment, we will attempt to contact the QP via a public notice to request their Medicare payment information. The QPs identified in the public notice, or any other eligible clinicians who believe that they are entitled to an APM Incentive Payment must then notify CMS of their claim as directed in the public notice by November 1 of the payment year, or 60 days after CMS announces that initial payments for the year have been made, whichever is later. After that time, any claims by a QP to an APM Incentive Payment will be forfeited for such payment year.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>28. Section 414.1455 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 414.1455 </SECTNO>
                        <SUBJECT>Limitation on review.</SUBJECT>
                        <P>(a) There is no right to administrative or judicial review under sections 1869, 1878, or otherwise, of the Act of the following:</P>
                        <P>(1) The determination that an eligible clinician is a QP or Partial QP under § 414.1425.</P>
                        <P>(2) The determination of the amount of the APM Incentive Payment under § 414.1450, including any estimation as part of such determination.</P>
                        <P>
                            (b) 
                            <E T="03">Targeted review.</E>
                             (1) An eligible clinician or APM Entity may request targeted review of a QP or Partial QP determination only if they believe in good faith that, due to a CMS clerical error, an eligible clinician was omitted from a Participation List.
                        </P>
                        <P>(2) If CMS determines that there was such a clerical error, if the QP determination for the eligible clinician would have been made at the APM Entity level under § 414.1425(b)(1), CMS will assign to the eligible clinician the most favorable QP status that was determined at the APM Entity level on any snapshot dates for the relevant QP Performance Period on which the eligible clinician participated in the APM Entity.</P>
                        <P>(3) The process for targeted review is as follows:</P>
                        <P>(i) An eligible clinician or APM Entity may submit a request for targeted review.</P>
                        <P>(ii) All requests for targeted review must be submitted during the targeted review request submission period, which is a 60-day period that begins with the publication of MIPS performance feedback as described at § 414.1385(a)(2). The targeted review request submission period may be extended as specified by CMS.</P>
                        <P>(iii) All requests for targeted review must be submitted in accordance with the form and manner specified by CMS.</P>
                        <P>(iv) A request for targeted review may be denied if the request is duplicative of another request for a targeted review; the request is not submitted during the targeted review request submission period; or the request is outside the scope of targeted review specified in this section. If the targeted review request is denied, CMS will make no changes to the QP status of the eligible clinician for whom targeted review was requested.</P>
                        <P>(iv) CMS will respond to each timely submitted request for targeted review.</P>
                        <P>(v) A request for targeted review may include additional information in support of the request at the time it is submitted. CMS may also request additional information from the requestor. If CMS requests additional information relating to the eligible clinician or the APM Entity group that is the subject of a request for targeted review, responsive information must be provided and received by CMS within 30 days of the request. If CMS does not receive a timely response to a request for additional information, CMS may make a final decision on the targeted review request based on the information available.</P>
                        <P>(vi) If targeted review requests reveal a pattern of CMS error with impacts that extend beyond the scope of eligible clinicians or APM Entities that submitted such targeted review requests, CMS may adjust the QP status of other affected eligible clinicians as provided in paragraph (b)(2) of this section.</P>
                        <P>(vi) Decisions on a targeted review request are final, and not subject to any further administrative or judicial review in accordance with paragraph (a) of this section.</P>
                    </SECTION>
                    <PART>
                        <PRTPAGE P="50406"/>
                        <HD SOURCE="HED">PART 415—SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN CERTAIN SETTINGS</HD>
                    </PART>
                    <AMDPAR>29. The authority citation for part 415 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 42 U.S.C. 1302 and 1395hh.</P>
                    </AUTH>
                    <AMDPAR>30. Section 415.184 is revised to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 415.184 </SECTNO>
                        <SUBJECT>Psychiatric services.</SUBJECT>
                        <P>Physician fee schedule payment is made for psychiatric services furnished under an approved GME program if the requirements of §§ 415.170 and 415.172 are met, including documentation, except that the requirement for the presence of the teaching physician during the service in which a resident is involved may be met by observation of the service by use of a one-way mirror, video equipment, or similar device. During the Public Health Emergency, as defined in § 400.200 of this chapter, for the COVID-19 pandemic, the requirement for the presence of the teaching physician during the service in which a resident is involved may be met by audio/video real-time communications technology.</P>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT</HD>
                    </PART>
                    <AMDPAR>31. The authority citation for part 423 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 1302, 1395w-01 through 1395w-152, and 1395hh.</P>
                    </AUTH>
                    <AMDPAR>32. Section 423.160 is amended by adding paragraph (a)(5) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 423.160 </SECTNO>
                        <SUBJECT>Standards for electronic prescribing.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(5) On or after January 1, 2022, prescribers must, except in circumstances in which the Secretary waives the requirement, conduct all prescribing for all Schedule II, III, IV, and V controlled substances electronically using the applicable standards in paragraph (b) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 424—CONDITIONS FOR MEDICARE PAYMENT</HD>
                    </PART>
                    <AMDPAR>33. The authority citation for part 424 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P> 42 U.S.C. 1302 and 1395hh.</P>
                    </AUTH>
                    <AMDPAR>34. Section 424.67 is amended by—</AMDPAR>
                    <AMDPAR>a. Revising paragraphs (b)(1) introductory text, (b)(1)(ii), (b)(2) and (3), and (b)(5) introductory text;</AMDPAR>
                    <AMDPAR>b. Redesignating paragraphs (c) through (f) as paragraphs (d) through (g), respectively;</AMDPAR>
                    <AMDPAR>c. Adding new paragraph (c); and</AMDPAR>
                    <AMDPAR>d. Revising newly redesignated paragraph (e)(2)(i).</AMDPAR>
                    <P>The revisions and additions read as follows:</P>
                    <SECTION>
                        <SECTNO>§ 424.67 </SECTNO>
                        <SUBJECT>Enrollment requirements for opioid treatment programs (OTP).</SUBJECT>
                        <STARS/>
                        <P>(b) * * *</P>
                        <P>(1) Fully complete and submit, as applicable, the Form CMS-855A or Form CMS-855B application (or their successor applications) and any applicable supplement or attachment thereto to its applicable Medicare contractor. This includes, but is not limited to, the following:</P>
                        <STARS/>
                        <P>(ii) Certifying via the Form CMS-855A or Form CMS-855B (as applicable) and/or the applicable supplement or attachment thereto that the OTP meets and will continue to meet the specific requirements and standards for enrollment described in paragraphs (b) and (e) of this section.</P>
                        <P>(2) Comply with the application fee requirements in § 424.514. (This includes OTPs enrolling under the circumstances described in paragraph (c)(2) of this section.)</P>
                        <P>(3)(i) Except as stated in paragraph (b)(3)(ii) of this section, successfully complete the assigned categorical risk level screening required under, as applicable, § 424.518(b) and (c).</P>
                        <P>(ii) For currently enrolled OTPs that are changing their OTP enrollment from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, successfully complete the limited level of categorical screening under § 424.518(a) if the OTP has already completed, as applicable, the moderate or high level of categorical screening under § 424.518(b) or (c), respectively.</P>
                        <STARS/>
                        <P>(5) Report on the Form CMS-855A or Form CMS-855B (as applicable) and/or any applicable supplement all OTP staff who meet the definition of “managing employee” in § 424.502. Such individuals include, but are not limited to, the following:</P>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Clarification of required enrollment forms.</E>
                             (1) An OTP may only be enrolled as an OTP via the Form CMS-855A or Form CMS-855B but not both.
                        </P>
                        <P>(2) If a currently enrolled OTP is changing its OTP enrollment from a Form CMS-855B enrollment to a Form CMS-855A enrollment, or vice versa, the effective date of billing that was established for the OTP's prior enrollment under §§ 424.520(d) and 424.521(a) of this chapter is applied to the OTP's new enrollment.</P>
                        <STARS/>
                        <P>(e) * * *</P>
                        <P>(2) * * *</P>
                        <P>(i) The provider does not have a current, valid certification by SAMHSA as required under paragraph (b)(4)(i) of this section or fails to meet any other applicable requirement or standard in this section, including, but not limited to, the OTP standards in paragraphs (b)(6) and (e)(1) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>35. Section 424.210 is amended by revising paragraph (a) and adding paragraph (b)(9) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 424.210 </SECTNO>
                        <SUBJECT> Beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Definitions.</E>
                             In addition to the definitions specified at § 410.79(b) and § 424.205(a) of this chapter, the following definitions apply to this section:
                        </P>
                        <P>
                            <E T="03">1135 waiver event</E>
                             means an emergency period and emergency area, as such terms are defined in section 1135(g) of the Act, for which the Secretary has authorized waivers under section 1135 of the Act.
                        </P>
                        <P>
                            <E T="03">COVID-19 Public Health Emergency</E>
                             means the emergency period and emergency area, as such terms are defined in section 1135(g) of the Social Security Act, related to the COVID-19 pandemic and declared by the Secretary on January 27, 2020.
                        </P>
                        <P>
                            <E T="03">Engagement incentive period</E>
                             means the period of time during which an MDPP supplier may furnish in-kind beneficiary engagement incentives to a given MDPP beneficiary to whom the MDPP supplier is furnishing MDPP services. This period begins when an MDPP supplier furnishes any MDPP service to an MDPP eligible beneficiary, and ends when one of the following occurs, whichever occurs first:
                        </P>
                        <P>(i) The MDPP beneficiary's MDPP services period ends as described in § 410.79(c)(3) of this chapter.</P>
                        <P>(ii) The MDPP supplier knows that the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier.</P>
                        <P>
                            (iii) The MDPP supplier has not had direct contact, either in person by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period, unless the lack of direct contact is due to the suspension or cancellation of MDPP services under 
                            <PRTPAGE P="50407"/>
                            § 410.79(e) of this chapter and the MDPP services are eventually resumed or restarted in accordance with § 410.79(e) of this chapter.
                        </P>
                        <P>(b) * * *</P>
                        <P>(9) If the item or service is furnished during the COVID-19 Public Health Emergency or an 1135 waiver event that CMS has determined may disrupt in-person MDPP services, and the item or service is furnished to an MDPP beneficiary who is receiving MDPP services virtually, the MDPP beneficiary must be capable of using the item or service during the COVID-19 Public Health Emergency or the section 1135 waiver event, as applicable.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>36. Section 424.518 is amended by redesignating paragraphs (a)(1)(xii) through (xvi) as paragraphs (a)(1)(xiii) through (xvii) and adding a new paragraph (a)(1)(xii) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 424.518 </SECTNO>
                        <SUBJECT>Screening levels for Medicare providers and suppliers.</SUBJECT>
                        <STARS/>
                        <P>(a) * * *</P>
                        <P>(1) * * *</P>
                        <P>(xii) Opioid treatment programs (if § 424.67(b)(3)(ii) applies).</P>
                        <STARS/>
                    </SECTION>
                    <PART>
                        <HD SOURCE="HED">PART 425—MEDICARE SHARED SAVINGS PROGRAM</HD>
                    </PART>
                    <AMDPAR>37. The authority citation for part 425 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority: </HD>
                        <P> 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.</P>
                    </AUTH>
                    <AMDPAR>38. Section 425.100 is amended by revising paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.100 </SECTNO>
                        <SUBJECT>General.</SUBJECT>
                        <STARS/>
                        <P>(b) An ACO is eligible to receive payments for shared savings under subpart G of this part if all of the following conditions are met:</P>
                        <P>(1) The ACO meets or exceeds the applicable minimum savings rate established under § 425.604, § 425.605, § 425.606, § 425.609 or § 425.610.</P>
                        <P>(2) The ACO meets the minimum quality performance standards established under § 425.500 (for performance years or a performance period beginning on or before January 1, 2020), or under the quality performance standard established under § 425.512 (for performance years beginning on or after January 1, 2021).</P>
                        <P>(3) The ACO otherwise maintains its eligibility to participate in the Shared Savings Program under this part.</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 425.112 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>39. Section 425.112 is amended in paragraph (b)(2)(i) by removing the reference “§ 425.500” and adding in its place the references “§§ 425.500 or 425.510, as applicable”.</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.200 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>40. Section 425.200 is amended in paragraph (d) by removing the reference “§ 425.500(c)” and adding in its place the references “§§ 425.500(c) or 425.510, as applicable”.</AMDPAR>
                    <AMDPAR>41. Section 425.204 is amended by revising paragraphs (f)(3)(i) through (iv), (f)(4)(iv), and (f)(5) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.204 </SECTNO>
                        <SUBJECT>Content of the application.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(3) * * *</P>
                        <P>(i) An ACO participating in Track 2 must demonstrate the adequacy of its repayment mechanism prior to any change in the terms and type of the repayment mechanism, and at such other times as requested by CMS.</P>
                        <P>(ii) An ACO entering an agreement period in Levels C, D, or E of the BASIC track or the ENHANCED track must demonstrate the adequacy of its repayment mechanism prior to the start of its agreement period, prior to any change in the terms and type of the repayment mechanism, and at such other times as requested by CMS.</P>
                        <P>(iii) An ACO entering an agreement period in Level A or Level B of the BASIC track must demonstrate the adequacy of its repayment mechanism prior to the start of any performance year in which it either elects to participate in, or is automatically transitioned to a two-sided model, Level C, Level D, or Level E, of the BASIC track, prior to any change in the terms and type of the repayment mechanism, and at such other times as requested by CMS.</P>
                        <P>(iv) An ACO that has submitted a request to renew its participation agreement must submit as part of the renewal request documentation demonstrating the adequacy of the repayment mechanism that could be used to repay any shared losses incurred for performance years in the next agreement period. The repayment mechanism applicable to the new agreement period may be the same repayment mechanism currently used by the ACO, provided that the ACO submits documentation establishing that the duration of the existing repayment mechanism has been revised to comply with paragraph (f)(6)(ii) of this section and the amount of the repayment mechanism complies with paragraph (f)(4) of this section.</P>
                        <P>(4) * * *</P>
                        <P>(iv)(A) In the case of an ACO that has submitted a request to renew its participation agreement for an agreement period starting on or after January 1, 2022 and that wishes to use its existing repayment mechanism to establish its ability to repay any shared losses incurred for performance years in the new agreement period, the amount of the repayment mechanism must be equal to at least the amount calculated by CMS in accordance with paragraph (f)(4)(ii) of this section.</P>
                        <P>(B) Under the following circumstances, an ACO that renewed its participation agreement for an agreement period beginning on July 1, 2019, or January 1, 2020, may elect to decrease the amount of its repayment mechanism.</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) The ACO elected to continue to use its existing repayment mechanism for the agreement period beginning on July 1, 2019, or January 1, 2020, and the amount of that repayment mechanism was greater than the repayment mechanism amount estimated at the time of renewal application according to paragraph (f)(4)(ii) of this section.
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) The repayment mechanism amount for performance year 2021, as recalculated pursuant to paragraph (f)(4)(iii) of this section, is less than the existing repayment mechanism amount.
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) CMS will notify the ACO in writing if the ACO may elect to decrease the amount of its repayment mechanism pursuant to this paragraph (f)(4)(iv)(B). The ACO must submit such election, together with revised repayment mechanism documentation, in a form and manner and by a deadline specified by CMS. CMS will review the revised repayment mechanism documentation and may reject the election if the repayment mechanism documentation does not comply with the requirements of this paragraph (f).
                        </P>
                        <P>(5) After the repayment mechanism has been used to repay any portion of shared losses owed to CMS, the ACO must replenish the amount of funds available through the repayment mechanism within 90 days. The resulting amount available through the repayment mechanism must be at least the amount specified by CMS in accordance with paragraph (f)(4) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>42. Section 425.224 is amended by revising paragraph (b)(1)(ii)(A) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.224 </SECTNO>
                        <SUBJECT>Application procedures for renewing ACOs and re-entering ACOs.</SUBJECT>
                        <STARS/>
                        <P>
                            (b) * * *
                            <PRTPAGE P="50408"/>
                        </P>
                        <P>(1) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(A) Whether the ACO demonstrated a pattern of failure to meet the quality performance standards or met any of the criteria for termination under §§ 425.316(c)(1)(ii) or 425.316(c)(2)(ii).</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 425.302 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>43. Section 425.302 is amended in paragraph (a)(1) by removing the reference “§ 425.500” and adding in its place the references “§§ 425.500 or 425.510, as applicable”.</AMDPAR>
                    <AMDPAR>44. Section 425.316 is amended by revising paragraph (c) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.316 </SECTNO>
                        <SUBJECT>Monitoring of ACOs.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Monitoring ACO compliance with quality performance standards.</E>
                             To identify ACOs that are not meeting the quality performance standards, CMS will review an ACO's submission of quality measurement data under §§ 425.500 or 425.512. CMS may request additional documentation from an ACO, ACO participants, or ACO providers/suppliers, as appropriate. If an ACO does not meet quality performance standards or fails to report on one or more quality measures, CMS will take the following actions:
                        </P>
                        <P>
                            (1) 
                            <E T="03">For performance years (or a performance period) beginning on or before January 1, 2020.</E>
                             (i) The ACO may be given a warning for the first time it fails to meet the minimum attainment level on at least 70 percent of the measures, as determined under § 425.502, in one or more domains and may be subject to a CAP. CMS may forgo the issuance of the warning letter depending on the nature and severity of the noncompliance and instead subject the ACO to actions set forth at § 425.216 or immediately terminate the ACO's participation agreement under § 425.218.
                        </P>
                        <P>(ii) The ACO's compliance with the quality performance standards will be re-evaluated the following year. If the ACO continues to fail to meet quality performance standard in the following year, the agreement will be terminated.</P>
                        <P>(iii) An ACO will not qualify to share in savings in any year it fails to report accurately, completely, and timely on the quality performance measures.</P>
                        <P>
                            (2) 
                            <E T="03">For performance years beginning on or after January 1, 2021.</E>
                             (i) If the ACO fails to meet the quality performance standard, CMS may take one or more of the actions prior to termination specified in § 425.216. Depending on the nature and severity of the noncompliance, CMS may forgo pre-termination actions and may immediately terminate the ACO's participation agreement under § 425.218.
                        </P>
                        <P>(ii) CMS will terminate an ACO's participation agreement under any of the following circumstances:</P>
                        <P>(A) The ACO fails to meet the quality performance standard for 2 consecutive performance years within an agreement period.</P>
                        <P>(B) The ACO fails to meet the quality performance standard for any 3 performance years within an agreement period, regardless of whether the years are in consecutive order.</P>
                        <P>(C) A renewing ACO or re-entering ACO fails to meet the quality performance standard for the last performance year of the ACO's previous agreement period and this occurrence was either the second consecutive performance year of failed quality performance or the third nonconsecutive performance year of failed quality performance during the previous agreement period.</P>
                        <P>(D) A renewing ACO or re-entering ACO fails to meet the quality performance standard for 2 consecutive performance years across 2 agreement periods, specifically the last performance year of the ACO's previous agreement period and the first performance year of the ACO's new agreement period.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>45. Section 425.400 is amended by revising paragraph (c)(1)(iv) introductory text and adding paragraph (c)(1)(v) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.400 </SECTNO>
                        <SUBJECT>General.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(1) * * *</P>
                        <P>(iv) For performance years (or a performance period) during 2019, and performance year 2020 as follows:</P>
                        <STARS/>
                        <P>(v) For the performance year starting on January 1, 2021, and subsequent performance years as follows:</P>
                        <P>(A) CPT codes:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) 96160 and 96161 (codes for administration of health risk assessment).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) 99201 through 99215 (codes for office or other outpatient visit for the evaluation and management of a patient).
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) 99304 through 99318 (codes for professional services furnished in a nursing facility; professional services or services reported on an FQHC or RHC claim identified by these codes are excluded when furnished in a SNF).
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) 99319 through 99340 (codes for patient domiciliary, rest home, or custodial care visit).
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) 99341 through 99350 (codes for evaluation and management services furnished in a patient's home for claims identified by place of service modifier 12).
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) 99354 and 99355 (add-on codes, for prolonged evaluation and management or psychotherapy services beyond the typical service time of the primary procedure; when the base code is also a primary care service code under this paragraph (c)(1)(v)).
                        </P>
                        <P>
                            (
                            <E T="03">7</E>
                            ) 99421, 99422, and 99423 (codes for online digital evaluation and management).
                        </P>
                        <P>
                            (
                            <E T="03">8</E>
                            ) 99483 (code for assessment of and care planning for patients with cognitive impairment).
                        </P>
                        <P>
                            (
                            <E T="03">9</E>
                            ) 99484, 99492, 99493 and 99494 (codes for behavioral health integration services).
                        </P>
                        <P>
                            (
                            <E T="03">10</E>
                            ) 99487, 99489, 99490 and 99491 (codes for chronic care management).
                        </P>
                        <P>
                            (
                            <E T="03">11</E>
                            ) 99495 and 99496 (codes for transitional care management services).
                        </P>
                        <P>
                            (
                            <E T="03">12</E>
                            ) 99497 and 99498 (codes for advance care planning; services identified by these codes furnished in an inpatient setting are excluded).
                        </P>
                        <P>(B) HCPCS codes:</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) G0402 (code for the Welcome to Medicare visit).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) G0438 and G0439 (codes for the annual wellness visits).
                        </P>
                        <P>
                            (
                            <E T="03">3</E>
                            ) G0442 (code for alcohol misuse screening service).
                        </P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) G0443 (code for alcohol misuse counseling service).
                        </P>
                        <P>
                            (
                            <E T="03">5</E>
                            ) G0444 (code for annual depression screening service).
                        </P>
                        <P>
                            (
                            <E T="03">6</E>
                            ) G0463 (code for services furnished in ETA hospitals).
                        </P>
                        <P>
                            (
                            <E T="03">7</E>
                            ) G0506 (code for chronic care management).
                        </P>
                        <P>
                            (
                            <E T="03">8</E>
                            ) G2058 (code for non-complex chronic care management).
                        </P>
                        <P>
                            (
                            <E T="03">9</E>
                            ) G2064 and G2065 (codes for principal care management services).
                        </P>
                        <P>
                            (
                            <E T="03">10</E>
                            ) GCOL1 (code for psychiatric collaborative care model).
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>46. Section 425.500 is amended by revising the section heading and paragraph (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.500 </SECTNO>
                        <SUBJECT>Measures to assess the quality of care furnished by an ACO for performance years (or a performance period) beginning on or before January 1, 2020.</SUBJECT>
                        <STARS/>
                        <P>
                            (d) 
                            <E T="03">Patient experience of care survey.</E>
                             (1) For performance years (or a performance period) beginning in 2014 through 2019, ACOs must select a CMS-certified vendor to administer the survey and report the results accordingly.
                        </P>
                        <P>
                            (2) For performance year 2020, CMS waives the CAHPS for ACOs reporting 
                            <PRTPAGE P="50409"/>
                            requirement and will assign all ACOs automatic credit for the CAHPS for ACOs survey measures.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>47. Section 425.502 is amended by revising the section heading to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.502 </SECTNO>
                        <SUBJECT>Calculating the ACO quality performance score for performance years (or a performance period) beginning on or before January 1, 2020.</SUBJECT>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>48. Section 425.508 is amended by revising the paragraph (a) subject heading and adding paragraph (b) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.508 </SECTNO>
                        <SUBJECT>Incorporating quality reporting requirements related to the Quality Payment Program.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">For performance years (or a performance period) beginning in 2017-2020.</E>
                             * * *
                        </P>
                        <P>
                            (b) 
                            <E T="03">For performance years beginning on or after January 1, 2021.</E>
                             ACOs must submit the quality data via the Alternative Payment Model Performance Pathway (APP) established under § 414.1367 of this chapter, to satisfactorily report on behalf of the eligible clinicians who bill under the TIN of an ACO participant for purposes of the MIPS Quality performance category of the Quality Payment Program.
                        </P>
                    </SECTION>
                    <AMDPAR>49. Section 425.510 is added to subpart F to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.510 </SECTNO>
                        <SUBJECT>Application of the Alternative Payment Model Performance Pathway (APP) to Shared Savings Program ACOs for performance years beginning on or after January 1, 2021.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">General.</E>
                             (1) CMS establishes quality performance measures to assess the quality of care furnished by the ACO. If the ACO demonstrates to CMS that it has satisfied the quality performance requirements in this subpart, and the ACO meets all other applicable requirements, the ACO is eligible to receive shared savings.
                        </P>
                        <P>(2) CMS seeks to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both.</P>
                        <P>
                            (b) 
                            <E T="03">Quality reporting.</E>
                             ACOs must report quality data via the APP established under § 414.1367 of this chapter, according to the method of submission established by CMS.
                        </P>
                        <P>
                            (c) 
                            <E T="03">Audit and validation of data.</E>
                             CMS retains the right to audit and validate quality data reported by an ACO under paragraph (b) of this section according to § 414.1390 of this chapter.
                        </P>
                    </SECTION>
                    <AMDPAR>50. Section 425.512 is added to subpart F to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.512 </SECTNO>
                        <SUBJECT>Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021.</SUBJECT>
                        <P>
                            (a) 
                            <E T="03">Establishing a quality performance standard.</E>
                             (1) The quality performance standard is the overall standard the ACO must meet in order to be eligible to receive shared savings for a performance year. An ACO will not qualify to share in savings in any year it fails to meet the quality performance standard.
                        </P>
                        <P>(2) For all ACOs, CMS designates the quality performance standard as the ACO reporting quality data via the APP established under § 414.1367 of this chapter, according to the method of submission established by CMS and achieving a quality performance score that is equivalent to or higher than the 40th percentile across all MIPS Quality performance category scores.</P>
                        <P>(3) If an ACO does not report any of the three measures it is actively required to report and does not field a CAHPS for MIPS survey via the APP the ACO would not meet the quality performance standard.</P>
                        <P>
                            (b) 
                            <E T="03">Extreme and uncontrollable circumstances.</E>
                             For performance year 2021 and subsequent performance years, including the applicable quality data reporting period for the performance year, CMS uses an alternative approach to calculating the quality score for ACOs affected by extreme and uncontrollable circumstances instead of the methodology specified in paragraph (a) of this section as follows:
                        </P>
                        <P>(1) CMS determines the ACO was affected by an extreme and uncontrollable circumstance based on either of the following:</P>
                        <P>(i) Twenty percent or more of the ACO's assigned beneficiaries reside in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance.</P>
                        <P>(A) Assignment is determined under subpart E of this part.</P>
                        <P>(B) In making this determination, CMS uses the quarter four list of assigned beneficiaries.</P>
                        <P>(ii) The ACO's legal entity is located in an area identified under the Quality Payment Program as being affected by an extreme and uncontrollable circumstance. An ACO's legal entity location is based on the address on file for the ACO in CMS' ACO application and management system.</P>
                        <P>(2) If CMS determines the ACO meets the requirements of paragraph (b)(1) of this section, CMS calculates the ACO's quality score as follows:</P>
                        <P>(i) The ACO's minimum quality performance score is set to the equivalent of the 40th percentile MIPS Quality performance category score for the relevant performance year.</P>
                        <P>(ii) If the ACO reports quality data via the APP framework and meets data completeness and case minimum requirements, CMS will use the higher of the ACO's quality performance score or the equivalent of the 40th percentile MIPS Quality performance category score.</P>
                        <P>(3) CMS applies determinations made under the Quality Payment Program with respect to—</P>
                        <P>(i) Whether an extreme and uncontrollable circumstance has occurred; and</P>
                        <P>(ii) The affected areas.</P>
                        <P>(4) CMS has sole discretion to determine the time period during which an extreme and uncontrollable circumstance occurred, the percentage of the ACO's assigned beneficiaries residing in the affected areas, and the location of the ACO legal entity.</P>
                    </SECTION>
                    <AMDPAR>51. Section 425.600 is amended by revising paragraph (f)(4)(i) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.600 </SECTNO>
                        <SUBJECT>Selection of risk model.</SUBJECT>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(4) * * *</P>
                        <P>(i) The quality performance standard as described in § 425.502(a), for performance years (or a performance period) beginning on or before January 1, 2020.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>52. Section 425.601 is amended by revising paragraphs (a)(9) and (f)(5)(iv) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.601 </SECTNO>
                        <SUBJECT>Establishing, adjusting, and updating the benchmark for agreement periods beginning on July 1, 2019, and in subsequent years.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(9) For the second and each subsequent performance year during the term of the agreement period, the ACO's benchmark is adjusted for the following, as applicable: for the addition and removal of ACO participants or ACO providers/suppliers in accordance with § 425.118(b), for a change to the ACO's beneficiary assignment methodology selection under § 425.226(a)(1), and for a change to the beneficiary assignment methodology specified in subpart E of this part. To adjust the benchmark, CMS does the following:</P>
                        <P>(i) Takes into account the expenditures of beneficiaries who would have been assigned to the ACO in any of the 3 most recent years prior to the start of the agreement period.</P>
                        <P>
                            (ii) Redetermines the regional adjustment amount under paragraph 
                            <PRTPAGE P="50410"/>
                            (a)(8) of this section, according to the ACO's assigned beneficiaries for BY3.
                        </P>
                        <STARS/>
                        <P>(f) * * *</P>
                        <P>(5) * * *</P>
                        <P>(iv) If during the term of the agreement period CMS adjusts the ACO's benchmark, as specified in paragraph (a)(9) of this section, CMS redetermines whether the ACO is considered to have lower spending or higher spending compared to the ACO's regional service area for purposes of determining the percentage in paragraphs (f)(1) and (2) of this section used in calculating the adjustment under either paragraph (a)(8) or (e) of this section.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>53. Section 425.602 is amended by revising paragraph (a)(8) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.602 </SECTNO>
                        <SUBJECT>Establishing, adjusting, and updating the benchmark for an ACO's first agreement period beginning on or before January 1, 2018.</SUBJECT>
                        <P>(a) * * *</P>
                        <P>(8) The ACO's benchmark is adjusted for the addition and removal of ACO participants or ACO providers/suppliers in accordance with § 425.118(b) and for a change to the beneficiary assignment methodology specified in subpart E of this part, as applicable, to take into account the expenditures for beneficiaries who would have been assigned to the ACO in any of the 3 most recent years prior to the start of the agreement period.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>
                        54. Section 425.603 is amended by revising paragraphs (c)(8) and (c)(9)(ii)(B)(
                        <E T="03">4</E>
                        )(
                        <E T="03">iv</E>
                        ) to read as follows:
                    </AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.603 </SECTNO>
                        <SUBJECT>Resetting, adjusting, and updating the benchmark for a subsequent agreement period beginning on or before January 1, 2019.</SUBJECT>
                        <STARS/>
                        <P>(c) * * *</P>
                        <P>(8) The ACO's benchmark is adjusted for the following, as applicable: For the addition and removal of ACO participants or ACO providers/suppliers in accordance with § 425.118(b), and for a change to the beneficiary assignment methodology specified in subpart E of this part. To adjust the benchmark, CMS does the following:</P>
                        <P>(i) Takes into account the expenditures for beneficiaries who would have been assigned to the ACO in any of the 3 most recent years prior to the start of the agreement period.</P>
                        <P>(ii) Redetermines the regional adjustment amount under paragraph (c)(9) of this section, according to the ACO's assigned beneficiaries for BY3.</P>
                        <P>(9) * * *</P>
                        <P>(ii) * * *</P>
                        <P>(B) * * *</P>
                        <P>
                            (
                            <E T="03">4</E>
                            ) * * *
                        </P>
                        <P>
                            (
                            <E T="03">iv</E>
                            ) If CMS adjusts the ACO's benchmark, as specified in paragraph (c)(8) of this section, CMS redetermines whether the ACO is considered to have lower spending or higher spending compared to the ACO's regional service area for purposes of determining the percentage used in calculating the adjustment in paragraphs (c)(9)(ii)(B)(
                            <E T="03">1</E>
                            ) and (
                            <E T="03">2</E>
                            ) of this section.
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>55. Section 425.604 is amended by revising paragraphs (c) and (d) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.604 </SECTNO>
                        <SUBJECT>Calculation of savings under the one-sided model.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Qualification for shared savings payment.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. In order to qualify for shared savings, an ACO must meet or exceed its minimum savings rate determined under paragraph (b) of this section, meet the minimum quality performance standards established under § 425.502, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.
                        </P>
                        <P>(2) For the performance year beginning on January 1, 2021. To qualify for shared savings, an ACO must meet or exceed its minimum savings rate determined under paragraph (b) of this section, meet the quality performance standard established under § 425.512, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.</P>
                        <P>
                            (d) 
                            <E T="03">Final sharing rate.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the one-sided model will receive a shared savings payment of up to 50 percent of all savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (e)(2) of this section).
                        </P>
                        <P>(2) For the performance year beginning on January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under Track 1 will receive a shared savings payment of 50 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (e)(2) of this section).</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>56. Section 425.605 is amended by revising paragraphs (c), (d)(1)(i)(A), (d)(1)(ii)(A), (d)(1)(iii)(A), (d)(1)(iv)(A), and (d)(1)(v)(A) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.605 </SECTNO>
                        <SUBJECT>Calculation of shared savings and losses under the BASIC track.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Qualification for shared savings payment.</E>
                             (1) For performance years beginning on or before January 1, 2020. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the minimum quality performance standards established under § 425.502, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.
                        </P>
                        <P>(2) For performance years beginning on or after January 1, 2021. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the quality performance standard established under § 425.512, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.</P>
                        <P>(d) * * *</P>
                        <P>(1) * * *</P>
                        <P>(i) * * *</P>
                        <P>
                            (A) 
                            <E T="03">Final sharing rate.</E>
                             (
                            <E T="03">1</E>
                            ) For performance years beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level A, receives a shared savings payment of up to 40 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (d)(1)(i)(B) of this section).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level A, receives a shared savings payment of 40 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (d)(1)(i)(B) of this section).
                        </P>
                        <STARS/>
                        <P>(ii) * * *</P>
                        <P>
                            (A) 
                            <E T="03">Final sharing rate.</E>
                             (
                            <E T="03">1</E>
                            ) For performance years beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level B, receives a shared savings payment of up to 40 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance 
                            <PRTPAGE P="50411"/>
                            payment limit described in paragraph (d)(1)(ii)(B) of this section).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level B, receives a shared savings payment of 40 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (d)(1)(ii)(B) of this section).
                        </P>
                        <STARS/>
                        <P>(iii) * * *</P>
                        <P>
                            (A) 
                            <E T="03">Final sharing rate.</E>
                             (
                            <E T="03">1</E>
                            ) For performance years beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level C, receives a shared savings payment of up to 50 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (d)(1)(iii)(B) of this section).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level C, receives a shared savings payment of 50 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (d)(1)(iii)(B) of this section).
                        </P>
                        <STARS/>
                        <P>(iv) * * *</P>
                        <P>
                            (A) 
                            <E T="03">Final sharing rate.</E>
                             (
                            <E T="03">1</E>
                            ) For performance years beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level D, receives a shared savings payment of up to 50 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (d)(1)(iv)(B) of this section).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level D, receives a shared savings payment of 50 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (d)(1)(iv)(B) of this section).
                        </P>
                        <STARS/>
                        <P>(v) * * *</P>
                        <P>
                            (A) 
                            <E T="03">Final sharing rate.</E>
                             (
                            <E T="03">1</E>
                            ) For performance years beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level E, receives a shared savings payment of up to 50 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (d)(1)(v)(B) of this section).
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the BASIC track, Level E, receives a shared savings payment of 50 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (d)(1)(v)(B) of this section).
                        </P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>57. Section 425.606 is amended by revising paragraphs (c), (d), and (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.606 </SECTNO>
                        <SUBJECT>Calculation of shared savings and losses under Track 2.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Qualification for shared savings payment.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the minimum quality performance standards established under § 425.502, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.
                        </P>
                        <P>(2) For the performance year beginning on January 1, 2021. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the quality performance standard established under § 425.512, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.</P>
                        <P>
                            (d) 
                            <E T="03">Final sharing rate.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under Track 2 will receive a shared savings payment of up to 60 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (e)(2) of this section).
                        </P>
                        <P>(2) For the performance year beginning on January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under Track 2 will receive a shared savings payment of 60 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (e)(2) of this section).</P>
                        <STARS/>
                        <P>
                            (f) 
                            <E T="03">Shared loss rate.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. For an ACO that is required to share losses with the Medicare program for expenditures over the updated benchmark, the amount of shared losses is determined based on the inverse of its final sharing rate described in paragraph (d)(1) of this section (that is, 1 minus the final shared savings rate determined under paragraph (d)(1) of this section). The shared loss rate—
                        </P>
                        <P>(i) May not exceed 60 percent; and</P>
                        <P>(ii) May not be less than 40 percent.</P>
                        <P>(2) For the performance year beginning on January 1, 2021. For an ACO that is required to share losses with the Medicare program for expenditures over the updated benchmark, the amount of shared losses is determined as follows:</P>
                        <P>(i) If the ACO meets the quality performance standard established in § 425.512, CMS determines the shared loss rate as follows:</P>
                        <P>(A) Calculate the quotient of the MIPS quality performance category points earned divided by the total MIPS quality performance category points available.</P>
                        <P>(B) Calculate the product of the quotient determined in paragraph (f)(2)(i)(A) of this section and 60 percent.</P>
                        <P>(C) Calculate the shared loss rate as 1 minus the product determined in paragraph (f)(2)(i)(B) of this section. The shared loss rate—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) May not exceed 60 percent; and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) May not be less than 40 percent.
                        </P>
                        <P>(ii) If the ACO fails to meet the quality performance standard established in § 425.512, the shared loss rate is 60 percent.</P>
                        <STARS/>
                    </SECTION>
                    <AMDPAR>58. Section 425.610 is amended by revising paragraphs (c), (d), and (f) to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 425.610 </SECTNO>
                        <SUBJECT>Calculation of shared savings and losses under the ENHANCED track.</SUBJECT>
                        <STARS/>
                        <P>
                            (c) 
                            <E T="03">Qualification for shared savings payment.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the minimum quality performance standards established under § 425.502, and otherwise maintain its eligibility to participate in 
                            <PRTPAGE P="50412"/>
                            the Shared Savings Program under this part.
                        </P>
                        <P>(2) For performance years beginning on or after January 1, 2021. To qualify for shared savings, an ACO must meet the minimum savings rate requirement established under paragraph (b) of this section, meet the quality performance standard established under § 425.512, and otherwise maintain its eligibility to participate in the Shared Savings Program under this part.</P>
                        <P>
                            (d) 
                            <E T="03">Final sharing rate.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. An ACO that meets all the requirements for receiving shared savings payments under the ENHANCED track will receive a shared savings payment of up to 75 percent of all the savings under the updated benchmark, as determined on the basis of its quality performance under § 425.502 (up to the performance payment limit described in paragraph (e)(2) of this section).
                        </P>
                        <P>(2) For performance years beginning on or after January 1, 2021. An ACO that meets all the requirements for receiving shared savings payments under the ENHANCED track will receive a shared savings payment of 75 percent of all the savings under the updated benchmark (up to the performance payment limit described in paragraph (e)(2) of this section).</P>
                        <STARS/>
                        <P>
                            (f) 
                            <E T="03">Shared loss rate.</E>
                             (1) For performance years (or a performance period) beginning on or before January 1, 2020. For an ACO that is required to share losses with the Medicare program for expenditures over the updated benchmark, the amount of shared losses is determined based on the inverse of its final sharing rate described in paragraph (d)(1) of this section (that is, 1 minus the final shared savings rate determined under paragraph (d)(1) of this section). The shared loss rate—
                        </P>
                        <P>(i) May not exceed 75 percent; and</P>
                        <P>(ii) May not be less than 40 percent.</P>
                        <P>(2) For performance years beginning on or after January 1, 2021. For an ACO that is required to share losses with the Medicare program for expenditures over the updated benchmark, the amount of shared losses is determined as follows:</P>
                        <P>(i) If the ACO meets the quality performance standard established in § 425.512, CMS determines the shared loss rate as follows:</P>
                        <P>(A) Calculate the quotient of the MIPS quality performance category points earned divided by the total MIPS quality performance category points available.</P>
                        <P>(B) Calculate the product of the quotient determined in paragraph (f)(2)(i)(A) of this section, and 75 percent.</P>
                        <P>(C) Calculate the shared loss rate as 1 minus the product determined in paragraph (f)(2)(i)(B) of this section. The shared loss rate—</P>
                        <P>
                            (
                            <E T="03">1</E>
                            ) May not exceed 75 percent; and
                        </P>
                        <P>
                            (
                            <E T="03">2</E>
                            ) May not be less than 40 percent.
                        </P>
                        <P>(ii) If the ACO fails to meet the quality performance standard established in § 425.512, the shared loss rate is 75 percent.</P>
                        <STARS/>
                    </SECTION>
                    <SECTION>
                        <SECTNO>§ 425.800 </SECTNO>
                        <SUBJECT>[Amended]</SUBJECT>
                    </SECTION>
                    <AMDPAR>59. Section 425.800 is amended—</AMDPAR>
                    <AMDPAR>a. In paragraph (a)(1) by removing the references “§ 425.500 and § 425.502” and adding in its place the references “§§ 425.500, 425.502, 425.510 and 425.512”;</AMDPAR>
                    <AMDPAR>b. In paragraph (a)(2) by removing the reference “§ 425.502” and adding in its place the references “§§ 425.502 or 425.512, as applicable”; and</AMDPAR>
                    <AMDPAR>c. In paragraph (a)(6) by removing the reference “§ 425.502” and adding in its place the references “§§ 425.502 or 425.512, as applicable”.</AMDPAR>
                    <SIG>
                        <DATED>Dated: July 16, 2020.</DATED>
                        <NAME>Seema Verma</NAME>
                        <TITLE>Administrator, Centers for Medicare &amp; Medicaid Services.</TITLE>
                        <DATED>Dated: July 31, 2020.</DATED>
                        <NAME>Alex M. Azar II,</NAME>
                        <TITLE>Secretary, Department of Health and Human Services.</TITLE>
                    </SIG>
                    <NOTE>
                        <HD SOURCE="HED">Note:</HD>
                        <P>The following appendices will not appear in the Code of Federal Regulations.</P>
                    </NOTE>
                    <HD SOURCE="HD1">Appendix 1: MIPS Quality Measures</HD>
                    <EXTRACT>
                        <P>
                            <E T="04">NOTE:</E>
                             Except as otherwise noted in this proposed rule, previously finalized measures and specialty measure sets will continue to apply for the 2023 MIPS payment year and future years. In addition, electronic Clinical Quality Measures (eCQMs) that are National Quality Forum (NQF) endorsed are shown in Table A as follows: NQF #/eCQM NQF #.
                        </P>
                        <BILCOD>BILLING CODE 4120-01-P</BILCOD>
                        <GPH SPAN="3" DEEP="520">
                            <PRTPAGE P="50413"/>
                            <GID>EP17AU20.134</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="640">
                            <PRTPAGE P="50414"/>
                            <GID>EP17AU20.135</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="161">
                            <PRTPAGE P="50415"/>
                            <GID>EP17AU20.136</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="578">
                            <PRTPAGE P="50416"/>
                            <GID>EP17AU20.137</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="414">
                            <PRTPAGE P="50417"/>
                            <GID>EP17AU20.138</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="534">
                            <PRTPAGE P="50418"/>
                            <GID>EP17AU20.139</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="222">
                            <PRTPAGE P="50419"/>
                            <GID>EP17AU20.140</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="620">
                            <PRTPAGE P="50420"/>
                            <GID>EP17AU20.141</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="388">
                            <PRTPAGE P="50421"/>
                            <GID>EP17AU20.142</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="575">
                            <PRTPAGE P="50422"/>
                            <GID>EP17AU20.143</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="583">
                            <PRTPAGE P="50423"/>
                            <GID>EP17AU20.144</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="566">
                            <PRTPAGE P="50424"/>
                            <GID>EP17AU20.145</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="620">
                            <PRTPAGE P="50425"/>
                            <GID>EP17AU20.146</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="415">
                            <PRTPAGE P="50426"/>
                            <GID>EP17AU20.147</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="303">
                            <PRTPAGE P="50427"/>
                            <GID>EP17AU20.148</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="373">
                            <PRTPAGE P="50428"/>
                            <GID>EP17AU20.149</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="171">
                            <GID>EP17AU20.150</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="593">
                            <PRTPAGE P="50429"/>
                            <GID>EP17AU20.151</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="605">
                            <PRTPAGE P="50430"/>
                            <GID>EP17AU20.152</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="442">
                            <PRTPAGE P="50431"/>
                            <GID>EP17AU20.153</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="485">
                            <PRTPAGE P="50432"/>
                            <GID>EP17AU20.154</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="589">
                            <PRTPAGE P="50433"/>
                            <GID>EP17AU20.155</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="589">
                            <PRTPAGE P="50434"/>
                            <GID>EP17AU20.156</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="208">
                            <PRTPAGE P="50435"/>
                            <GID>EP17AU20.157</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="270">
                            <GID>EP17AU20.158</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="619">
                            <PRTPAGE P="50436"/>
                            <GID>EP17AU20.159</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="429">
                            <PRTPAGE P="50437"/>
                            <GID>EP17AU20.160</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="274">
                            <PRTPAGE P="50438"/>
                            <GID>EP17AU20.161</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="537">
                            <PRTPAGE P="50439"/>
                            <GID>EP17AU20.162</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="534">
                            <PRTPAGE P="50440"/>
                            <GID>EP17AU20.163</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="163">
                            <PRTPAGE P="50441"/>
                            <GID>EP17AU20.164</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="594">
                            <PRTPAGE P="50442"/>
                            <GID>EP17AU20.165</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="373">
                            <PRTPAGE P="50443"/>
                            <GID>EP17AU20.166</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="186">
                            <GID>EP17AU20.167</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="197">
                            <PRTPAGE P="50444"/>
                            <GID>EP17AU20.168</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="611">
                            <PRTPAGE P="50445"/>
                            <GID>EP17AU20.169</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="555">
                            <PRTPAGE P="50446"/>
                            <GID>EP17AU20.170</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="564">
                            <PRTPAGE P="50447"/>
                            <GID>EP17AU20.171</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="298">
                            <PRTPAGE P="50448"/>
                            <GID>EP17AU20.172</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="584">
                            <PRTPAGE P="50449"/>
                            <GID>EP17AU20.173</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="593">
                            <PRTPAGE P="50450"/>
                            <GID>EP17AU20.174</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="610">
                            <PRTPAGE P="50451"/>
                            <GID>EP17AU20.175</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="627">
                            <PRTPAGE P="50452"/>
                            <GID>EP17AU20.176</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="618">
                            <PRTPAGE P="50453"/>
                            <GID>EP17AU20.177</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="465">
                            <PRTPAGE P="50454"/>
                            <GID>EP17AU20.178</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="618">
                            <PRTPAGE P="50455"/>
                            <GID>EP17AU20.179</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="568">
                            <PRTPAGE P="50456"/>
                            <GID>EP17AU20.180</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="524">
                            <PRTPAGE P="50457"/>
                            <GID>EP17AU20.181</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="561">
                            <PRTPAGE P="50458"/>
                            <GID>EP17AU20.182</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="263">
                            <PRTPAGE P="50459"/>
                            <GID>EP17AU20.183</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="463">
                            <PRTPAGE P="50460"/>
                            <GID>EP17AU20.184</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="549">
                            <PRTPAGE P="50461"/>
                            <GID>EP17AU20.185</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="590">
                            <PRTPAGE P="50462"/>
                            <GID>EP17AU20.186</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="584">
                            <PRTPAGE P="50463"/>
                            <GID>EP17AU20.187</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="450">
                            <PRTPAGE P="50464"/>
                            <GID>EP17AU20.188</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="317">
                            <PRTPAGE P="50465"/>
                            <GID>EP17AU20.189</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="603">
                            <PRTPAGE P="50466"/>
                            <GID>EP17AU20.190</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="636">
                            <PRTPAGE P="50467"/>
                            <GID>EP17AU20.191</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="141">
                            <PRTPAGE P="50468"/>
                            <GID>EP17AU20.192</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="626">
                            <PRTPAGE P="50469"/>
                            <GID>EP17AU20.193</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="618">
                            <PRTPAGE P="50470"/>
                            <GID>EP17AU20.194</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="388">
                            <PRTPAGE P="50471"/>
                            <GID>EP17AU20.195</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="378">
                            <PRTPAGE P="50472"/>
                            <GID>EP17AU20.196</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="570">
                            <PRTPAGE P="50473"/>
                            <GID>EP17AU20.197</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="210">
                            <PRTPAGE P="50474"/>
                            <GID>EP17AU20.198</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="640">
                            <PRTPAGE P="50475"/>
                            <GID>EP17AU20.199</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="117">
                            <PRTPAGE P="50476"/>
                            <GID>EP17AU20.200</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="569">
                            <PRTPAGE P="50477"/>
                            <GID>EP17AU20.201</GID>
                        </GPH>
                        <GPH SPAN="3" DEEP="606">
                            <PRTPAGE P="50478"/>
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                    </EXTRACT>
                </SUPLINF>
                <FRDOC>[FR Doc. 2020-17127 Filed 8-4-20; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 4120-01-C</BILCOD>
            </PRORULE>
        </PRORULES>
    </NEWPART>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="50667"/>
            <PARTNO>Part III</PARTNO>
            <AGENCY TYPE="P">Federal Trade Commission</AGENCY>
            <CFR>16 CFR Part 315</CFR>
            <TITLE>Contact Lens Rule; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="50668"/>
                    <AGENCY TYPE="S">FEDERAL TRADE COMMISSION</AGENCY>
                    <CFR>16 CFR Part 315</CFR>
                    <RIN>RIN 3084-AB36</RIN>
                    <SUBJECT>Contact Lens Rule</SUBJECT>
                    <AGY>
                        <HD SOURCE="HED">AGENCY:</HD>
                        <P>Federal Trade Commission (“FTC” or “Commission”).</P>
                    </AGY>
                    <ACT>
                        <HD SOURCE="HED">ACTION:</HD>
                        <P>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>The FTC is publishing a final rule to implement amendments to the Contact Lens Rule. These amendments require that prescribing eye care practitioners obtain a confirmation of prescription release from patients after releasing a contact lens prescription and maintain each such acknowledgment for a period of not less than three years. The Commission is permitting prescribers to comply with automatic prescription release via electronic delivery in certain circumstances. Further, these amendments specify a time period for prescribers to respond to requests for prescriptions; clarify and institute additional requirements for automated telephone verification messages; more precisely delineate what constitutes unlawful alteration of a prescription; and require that sellers provide a method for, and notice of the method for, patient prescription presentation.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>This rule is effective October 16, 2020.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            Relevant portions of the record of this proceeding, including this document, are available at 
                            <E T="03">https://www.ftc.gov.</E>
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Alysa Bernstein (202-326-3289), 
                            <E T="03">abernstein@ftc.gov,</E>
                             Paul Spelman (202-326-2487), 
                            <E T="03">pspelman@ftc.gov,</E>
                             or Andrew Wone (202-326-2934), 
                            <E T="03">awone@ftc.gov,</E>
                             Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <HD SOURCE="HD1">Table of Contents</HD>
                    <EXTRACT>
                        <FP SOURCE="FP-2">I. Background</FP>
                        <FP SOURCE="FP1-2">A. Overview of the Contact Lens Rule</FP>
                        <FP SOURCE="FP1-2">B. History of the Rule</FP>
                        <FP SOURCE="FP1-2">C. Initial Request for Comments in 2015</FP>
                        <FP SOURCE="FP1-2">D. Notice of Proposed Rulemaking in 2016</FP>
                        <FP SOURCE="FP1-2">E. Supplemental Notice of Proposed Rulemaking</FP>
                        <FP SOURCE="FP-2">II. Final Rule Pertaining to Confirmation of Prescription Release</FP>
                        <FP SOURCE="FP1-2">A. Proposed Modifications in the SNPRM</FP>
                        <FP SOURCE="FP1-2">B. Basis for SNPRM Confirmation of Prescription Release Proposal</FP>
                        <FP SOURCE="FP1-2">C. Comments on the Confirmation of Prescription Release Proposal and the Basis for Such Proposal</FP>
                        <FP SOURCE="FP1-2">1. Comments About the Need for the Confirmation of Prescription Release and Whether Prescribers Are Complying With the Rule's Automatic Prescription Release Requirement</FP>
                        <FP SOURCE="FP1-2">a. Survey Evidence as Proof of Non-Compliance</FP>
                        <FP SOURCE="FP1-2">b. Lack of Consumer Complaints as Evidence of Compliance</FP>
                        <FP SOURCE="FP1-2">c. Number of Verifications as Evidence of Non-Compliance With the Automatic Prescription Release Requirement</FP>
                        <FP SOURCE="FP1-2">2. Comments About the Need To Improve the Commission's Ability To Monitor Compliance and Enforce the Rule</FP>
                        <FP SOURCE="FP1-2">3. Comments About Whether the Structure of the Contact Lens Market Creates a Need for Verifiable Enforcement of Automatic Prescription Release</FP>
                        <FP SOURCE="FP1-2">4. Comments About the Text of the Proposed Confirmation of Prescription and the Option To Include the Confirmation as Part of a Patient's Prescription or Sales Receipt</FP>
                        <FP SOURCE="FP1-2">5. Comments About Option (D) and Using Electronic Delivery for Confirmation of Prescription Release</FP>
                        <FP SOURCE="FP1-2">a. Use of Patient Portals and Patient Consent</FP>
                        <FP SOURCE="FP1-2">b. Requirement To Maintain Records of Patient Consent</FP>
                        <FP SOURCE="FP1-2">6. Comments About Alternatives to the Confirmation of Prescription Release</FP>
                        <FP SOURCE="FP1-2">a. Signage</FP>
                        <FP SOURCE="FP1-2">b. Educational Programs as an Alternative to Confirmation of Prescription Release</FP>
                        <FP SOURCE="FP1-2">7. Comments About the Burden and Benefits of the Confirmation of Prescription Release Proposal</FP>
                        <FP SOURCE="FP1-2">8. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Contact Lenses</FP>
                        <FP SOURCE="FP1-2">D. Additional Discussion and Commission Determination Regarding the Confirmation of Prescription Release Proposal</FP>
                        <FP SOURCE="FP-2">III. Additional Requirements for Sellers Using Verification Calls Containing Automated Messages</FP>
                        <FP SOURCE="FP1-2">A. The Congressional Record Does Not Support Prohibiting Automated Telephone Messages</FP>
                        <FP SOURCE="FP1-2">B. Comments About, and Adoption of, Requirements Proposed in the SNPRM To Improve Quality of Automated Telephone Messages</FP>
                        <FP SOURCE="FP1-2">C. The Commission's Proposal Requiring Sellers To Record Automated Telephone Messages</FP>
                        <FP SOURCE="FP1-2">D. The Final Rule Does Not Adopt Commenters' Additional Recommendations Regarding Automated Telephone Messages</FP>
                        <FP SOURCE="FP-2">IV. Prescribers' Selection of Communication Mechanism</FP>
                        <FP SOURCE="FP-2">V. Miscellaneous Passive Verification Issues</FP>
                        <FP SOURCE="FP1-2">A. Active Verification Is Not Required</FP>
                        <FP SOURCE="FP1-2">B. Concerns About Patient Manipulation</FP>
                        <FP SOURCE="FP1-2">C. Eight-Business-Hour Time Frame Is Appropriate</FP>
                        <FP SOURCE="FP-2">VI. Seller Alteration of Contact Lens Prescriptions and Private Label Concerns</FP>
                        <FP SOURCE="FP1-2">A. The Final Rule Includes a Requirement for Sellers To Accept Prescription Presentation</FP>
                        <FP SOURCE="FP1-2">B. Alteration Includes a Seller Providing a Prescriber With a Verification Request for a Non-Prescribed Manufacturer or Brand, but Includes an Exception for Verifying a Manufacturer or Brand That a Consumer Indicates Is on Her Prescription</FP>
                        <FP SOURCE="FP1-2">1. The Final Rule Modifications Regarding Alteration Are Beneficial and Address Abuses of the Verification System</FP>
                        <FP SOURCE="FP1-2">2. Comments Related to the Exception to Alteration When a Seller Provides the Manufacturer or Brand of Lenses That a Consumer Provides in Response to a Seller's Request for That Information</FP>
                        <FP SOURCE="FP1-2">3. Comments Regarding and Commission Guidance on Acceptable Methods for Obtaining the Brand or Manufacturer Listed on Consumers' Prescriptions</FP>
                        <FP SOURCE="FP1-2">4. The Commission Is Not Imposing a Recordkeeping Requirement for Sellers Related to the Exception</FP>
                        <FP SOURCE="FP1-2">C. Private Label Issues</FP>
                        <FP SOURCE="FP1-2">1. The Commission Adopts a Technical Amendment and Clarifies That the Only Permissible Substitution Involves Private Label Lenses</FP>
                        <FP SOURCE="FP1-2">2. The Commission Is Not Imposing Additional Requirements on Prescriptions for Private Label Lenses</FP>
                        <FP SOURCE="FP-2">VII. “Directly or by Facsimile” Language Includes Use of Online Patient Portals to Present Prescriptions</FP>
                        <FP SOURCE="FP-2">VIII. Requests for an Additional Copy of a Prescription</FP>
                        <FP SOURCE="FP1-2">A. Benefits of an Additional Copy and the Time Period To Respond to a Request</FP>
                        <FP SOURCE="FP1-2">B. Requirement To Maintain Records</FP>
                        <FP SOURCE="FP-2">IX. Excessive Quantity</FP>
                        <FP SOURCE="FP-2">X. Expiration of Contact Lens Prescriptions</FP>
                        <FP SOURCE="FP1-2">A. Length of Contact Lens Prescriptions</FP>
                        <FP SOURCE="FP1-2">B. Sales Using Expired Contact Lens Prescriptions</FP>
                        <FP SOURCE="FP-2">XI. Paperwork Reduction Act</FP>
                        <FP SOURCE="FP1-2">A. Confirmation of Prescription Release and Affirmative Consent to Digital Delivery of a Prescription</FP>
                        <FP SOURCE="FP1-2">1. SNPRM Burden Estimate for the Confirmation of Prescription Release</FP>
                        <FP SOURCE="FP1-2">2. Comments Regarding the SNPRM Estimate for the Confirmation of Prescription Release Requirement</FP>
                        <FP SOURCE="FP1-2">3. Estimated Additional Burden Hours for the Confirmation of Prescription Release Requirement</FP>
                        <FP SOURCE="FP1-2">4. Estimated Total Labor Cost Burden for the Confirmation of Prescription Release Modification</FP>
                        <FP SOURCE="FP1-2">5. Capital and Other Non-Labor Costs for the Confirmation of Prescription Release Requirement</FP>
                        <FP SOURCE="FP1-2">B. Recording of Automated Telephone Messages</FP>
                        <FP SOURCE="FP1-2">C. Total Burden for the Modifications to the Rule</FP>
                        <FP SOURCE="FP-2">XII. Regulatory Flexibility Act</FP>
                        <FP SOURCE="FP1-2">A. Need for and Objectives of the Rule Amendments</FP>
                        <FP SOURCE="FP1-2">1. Amendments Affecting Prescribers</FP>
                        <FP SOURCE="FP1-2">2. Amendments Affecting Sellers</FP>
                        <FP SOURCE="FP1-2">B. Significant Issues Raised by Public Comments in Response to the IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration, and the Agency's Response, Including Any Changes Made in the Final Rule Amendments</FP>
                        <FP SOURCE="FP1-2">
                            1. Amendments Affecting Prescribers
                            <PRTPAGE P="50669"/>
                        </FP>
                        <FP SOURCE="FP1-2">2. Amendments Affecting Sellers</FP>
                        <FP SOURCE="FP1-2">C. Description and Estimate of the Number of Small Entities to Which the Amendments Will Apply or Explanation Why No Estimate Is Available</FP>
                        <FP SOURCE="FP1-2">D. Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Amendments, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record</FP>
                        <FP SOURCE="FP1-2">1. Amendments Affecting Prescribers</FP>
                        <FP SOURCE="FP1-2">2. Amendments Affecting Sellers</FP>
                        <FP SOURCE="FP1-2">E. Steps Taken To Minimize the Significant Impact, if Any, of the Amendments, Including Why Any Significant Alternatives Were Not Adopted</FP>
                        <FP SOURCE="FP1-2">1. Steps and Alternatives for Amendments Affecting Prescribers</FP>
                        <FP SOURCE="FP1-2">2. Steps and Alternatives for Amendments Affecting Sellers</FP>
                        <FP SOURCE="FP-2">XIII. Congressional Review Act</FP>
                    </EXTRACT>
                    <HD SOURCE="HD1">I. Background</HD>
                    <HD SOURCE="HD2">A. Overview of the Contact Lens Rule</HD>
                    <P>
                        In 2003, Congress enacted the Fairness to Contact Lens Consumers Act (“FCLCA” or “Act”),
                        <SU>1</SU>
                        <FTREF/>
                         and pursuant to the Act, the Commission promulgated the Contact Lens Rule on July 2, 2004.
                        <SU>2</SU>
                        <FTREF/>
                         The Rule went into effect on August 2, 2004.
                    </P>
                    <FTNT>
                        <P>
                            <SU>1</SU>
                             15 U.S.C. 7601-7610 (Pub. L. 108-164).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>2</SU>
                             Contact Lens Rule, 16 CFR part 315 (2015).
                        </P>
                    </FTNT>
                    <P>
                        The Contact Lens Rule (“Rule”) promotes competition in retail sales of contact lenses by facilitating consumers' ability to comparison shop for contact lenses. When an eye care practitioner (“prescriber”) 
                        <SU>3</SU>
                        <FTREF/>
                         completes a contact lens fitting, the Rule requires that the prescriber automatically provide the patient with a portable copy of the patient's prescription, whether or not the patient requests it.
                        <SU>4</SU>
                        <FTREF/>
                         The Rule also requires that the prescriber verify or provide such prescriptions to authorized third parties. At the same time, the Rule requires that sellers only sell contact lenses in accordance with valid prescriptions written by licensed prescribers that were either (a) presented to the seller by the patient or a designated agent of the patient or (b) verified by direct communication with the prescriber.
                        <SU>5</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>3</SU>
                             Under the Rule, prescriber is defined as an ophthalmologist, optometrist, or other person permitted under State law to issue prescriptions for contact lenses in compliance with any applicable requirements established by the Food and Drug Administration. `Other person,' in this context, includes dispensing opticians who are permitted under State law to issue prescriptions and who are authorized or permitted under State law to perform contact lens fitting services. 16 CFR 315.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>4</SU>
                             The Commission also notes that apart from requiring that the contact lens fitting be complete, the FCLCA and Rule do not include any other requirements or exceptions that would permit a prescriber to withhold a patient's contact lens prescription following a fitting. 16 CFR 315.3(a)(1). Therefore, prescribers must automatically provide patients with copies of their prescriptions following their fitting, regardless of whether patients indicate an intention to purchase contact lenses—no matter the quantity (and even an annual supply)—from their prescribers.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>5</SU>
                             16 CFR 315.5(a).
                        </P>
                    </FTNT>
                    <P>
                        The Rule further sets out the information that must be included in a seller's verification request, and directs that a prescription is only verified under the Rule if: (1) The prescriber confirms the prescription is accurate; (2) the prescriber informs the seller that the prescription is inaccurate and provides an accurate prescription in its stead; or (3) the prescriber fails to communicate with the seller within eight business hours after receiving a compliant verification request.
                        <SU>6</SU>
                        <FTREF/>
                         The Rule states that if the prescriber informs the seller within eight business hours of receiving the verification request that the prescription is inaccurate, expired, or invalid, the seller shall not fill the prescription. The Rule requires that the prescriber specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber must correct it.
                        <SU>7</SU>
                        <FTREF/>
                         Sellers may not alter a prescription, but for private label contact lenses, may substitute identical contact lenses that the same company manufactures and sells under a different name.
                        <SU>8</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>6</SU>
                             16 CFR 315.5(b)-(c).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>7</SU>
                             16 CFR 315.5(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>8</SU>
                             16 CFR 315.5(e).
                        </P>
                    </FTNT>
                    <P>
                        The Contact Lens Rule sets a minimum expiration date of one year after the issue date of a prescription with an exception based on a patient's ocular health.
                        <SU>9</SU>
                        <FTREF/>
                         The Rule also incorporates the Act's preemption of state and local laws and regulations that establish a prescription expiration date of less than one year or that restrict prescription release or require active verification.
                        <SU>10</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>9</SU>
                             16 CFR 315.6.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>10</SU>
                             16 CFR 315.11(a). The Rule also preempts any other state or local laws or regulations that are inconsistent with the Act or the relevant section of the Rule, to the extent of the inconsistency. 16 CFR 315.11(b).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. History of the Rule</HD>
                    <P>
                        The FTC has more than three decades of regulatory and research experience regarding the optical goods industry; this history continues to inform the basis and purpose of the Contact Lens Rule and this rule review. In addition to the Rule, the Commission enforces the Ophthalmic Practice Rules (known as the “Eyeglass Rule”), initially promulgated in 1978.
                        <SU>11</SU>
                        <FTREF/>
                         Prior to the Eyeglass Rule, surveys of optometrists found that a majority of prescribers imposed some restriction on the availability of the patient's prescription, usually by either refusing to release prescriptions or charging an additional fee to do so.
                        <SU>12</SU>
                        <FTREF/>
                         Prescribers also used waivers and liability disclaimers to discourage comparison shopping, mislead consumers, and frighten them into purchasing ophthalmic goods from the prescriber.
                        <SU>13</SU>
                        <FTREF/>
                         The Commission determined that these actions reduced consumers' ability to obtain the lowest prices and hindered competition in the optical marketplace.
                        <SU>14</SU>
                        <FTREF/>
                         To address these problems, the Eyeglass Rule required prescribers—generally, optometrists and ophthalmologists—to provide each of their patients, immediately after completion of an eye examination, a free copy of the patient's eyeglass prescription.
                        <SU>15</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>11</SU>
                             Final Trade Regulation Rule, Advertising of Ophthalmic Goods and Services, 43 FR 23992 (June 2, 1978) [hereinafter Eyeglass I]. The Rule was revised in 1992, with the revisions codified at 16 CFR part 456. Ophthalmic Practice Rules, 57 FR 18822 (May 1, 1992).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>12</SU>
                             43 FR at 23998. 
                            <E T="03">See also</E>
                             FTC, “Staff Report on Advertising of Ophthalmic Goods and Services and Proposed Trade Regulation Rule” 240-48 (1977) [hereinafter 1977 Staff Report] (detailing myriad accounts of prescribers refusing to release eyeglass prescriptions to their patients), 
                            <E T="03">https://www.ftc.gov/system/files/documents/reports/staff-report-advertising-ophthalmic-goods-services-proposed-trade-regulation-rule-16-cfr-part-456/r611003-staff_report_on_advertising_of_ophthalmic_goods_and_services_and_proposed_trade_regulation.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>13</SU>
                             43 FR at 23998; 
                            <E T="03">Am. Optometric Ass'n</E>
                             v. 
                            <E T="03">FTC,</E>
                             626 F.2d 896, 916 (D.C. Cir. 1980) (noting considerable “evidence of abuse” by prescribers); 
                            <E T="03">see also</E>
                             1977 Staff Report, 
                            <E T="03">supra</E>
                             note 12, at 277.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>14</SU>
                             FTC, “The Strength of Competition in the Sale of Rx Contact Lenses: An FTC Study” 45-46 (2005), 
                            <E T="03">https://www.ftc.gov/sites/default/files/documents/reports/strength-competition-sale-rx-contact-lenses-ftc-study/050214contactlensrpt.pdf</E>
                             [hereinafter 2005 Contact Lens Report].
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>15</SU>
                             16 CFR 456.2 (separation of examination and dispensing). The FTC also has studied the effects of state-imposed restrictions in the optical goods industry. 
                            <E T="03">See</E>
                             FTC, “The Effects of Restrictions on Advertising and Commercial Practice in the Professions: The Case of Optometry” (1980), 
                            <E T="03">https://www.ftc.gov/sites/default/files/documents/reports/effects-restrictions-advertising-and-commercial-practice-professions-case-optometry/198009optometry.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Eyeglass Rule, however, did not encompass contact lens prescriptions. While a majority of states enacted their own statutes requiring some form of contact lens prescription release,
                        <SU>16</SU>
                        <FTREF/>
                         many prescribers continued to withhold prescriptions for contact lenses.
                        <SU>17</SU>
                        <FTREF/>
                         This, 
                        <PRTPAGE P="50670"/>
                        and other prescriber practices (such as requiring liability waivers, refusing to verify prescriptions when consumers tried to buy lenses from third-party sellers, and encouraging manufacturers not to distribute contact lenses to third-party sellers), made it challenging for consumers to obtain lenses from anyone other than their prescribers.
                        <SU>18</SU>
                        <FTREF/>
                         According to Congress, these obstacles were rooted in an “inherent conflict of interest” in that “[u]nlike medical doctors who are prohibited from selling the drugs they prescribe, eye doctors and optometrists . . . are able to fill the contact lens prescriptions they write.” 
                        <SU>19</SU>
                        <FTREF/>
                         Third-party sellers are thus forced to compete for the sale of lenses with the individual who is writing the prescription.
                        <SU>20</SU>
                        <FTREF/>
                         To address this inherent conflict of interest and achieve freedom of choice and the benefits of competition for contact lens consumers, Congress passed the Fairness to Contact Lens Consumers Act in 2003,
                        <SU>21</SU>
                        <FTREF/>
                         and, in 2004, the Commission issued the Contact Lens Rule,
                        <SU>22</SU>
                        <FTREF/>
                         implementing the Act.
                    </P>
                    <FTNT>
                        <P>
                            <SU>16</SU>
                             By 2003, more than two-thirds of states had laws requiring some form of contact lens prescription release. H.R. Rep. No. 108-318, 108th Cong., 1st Sess. 4 (2003), at 8 (2003).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>17</SU>
                             
                            <E T="03">See id.</E>
                             at 4 (noting that “[t]he practice of optometrists withholding the prescription [for contact lenses] has limited the consumer's ability to shop for the best price and has impacted competition”); Fairness to Contact Lens Consumers Act: Hearing Before the Subcomm. on Commerce, 
                            <PRTPAGE/>
                            Trade, and Consumer Protection of the H. Comm. on Energy and Commerce, 108th Cong. 1 (2003) [hereinafter FCLCA Subcomm. Hearing] (statement of Ami Gadhia, Consumers Union) (noting that multiple surveys of consumers in Texas had found considerable numbers were unable to obtain their contact lens prescription from their prescribers).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>18</SU>
                             H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, 
                            <E T="03">supra</E>
                             note 17 (statements of Howard Beales, Jonathan Coon, Ami Gadhia, Robert Hubbard, Maria Martinez, Rep. W. J. Tauzin; Peggy Venable). 
                            <E T="03">See also In re Disposable Contact Lens Antitrust Litig.,</E>
                             No. 94-MDL 1030-J-20A (M.D. Fla.), in which the Attorneys General of 31 states alleged that eye-care professionals engaged in an organized effort to prevent or hinder consumers from obtaining their contact lens prescriptions. The complaints alleged two conspiracies: (1) That the practitioners and their trade associations conspired to prevent the release of contact lens prescriptions to consumers, and (2) that manufacturers, practitioners, and trade associations, including the American Optometric Association, conspired to eliminate sales of contact lenses by pharmacies, mail order, and other alternative sellers. 
                            <E T="03">Id.</E>
                             According to the Attorneys General, the conspiracy severely restricted the supply of contact lenses available to alternative sellers, which hampered the growth of such sellers, decreased the supply of lenses to consumers, and increased the price of lenses. 
                            <E T="03">Id.</E>
                             The parties reached settlements, the last of which the court approved in November 2001. As part of the settlements, manufacturers agreed to sell contact lenses to alternative distribution channels.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>19</SU>
                             H.R. Rep. No. 108-318, at 5. 
                            <E T="03">See also</E>
                             Letter from Senators Richard Blumenthal and Orrin G. Hatch of the United States Senate Regarding the Contact Lens Rule Rulemaking Proceeding and the Proposed Rule Set Forth in the Notice of Proposed Rulemaking (Aug. 11, 2017) (recognizing the “inherent conflict of interest” and noting that the FCLCA was made necessary by “the unique nature of the contact lens marketplace”), 
                            <E T="03">https://www.ftc.gov/system/files/filings/initiatives/677/public_comment_from_senators_blumenthal_and_hatch_re_contact_lens_rulemaking.pdf [hereinafter Blumenthal Letter]</E>
                            .
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>20</SU>
                             H.R. Rep. No. 108-318, at 4; FCLCA Subcomm. Hearing, 
                            <E T="03">supra</E>
                             note 17 (statements of Rep. W.J. Tauzin) (noting there is a “classic conflict of interest that robs the consumers of the ability to shop competitively for the best price,” and stating that the FCLCA takes the “necessary steps to remedy this stranglehold on contact lens competition”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>21</SU>
                             15 U.S.C. 7601-7610. The FCLCA passed with a vote of 406 in favor and 12 opposed in the House, and unanimous consent in the Senate.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>22</SU>
                             Contact Lens Rule, 69 FR 40482 (July 2, 2004) (codified at 16 CFR pt. 315). Pursuant to its congressional mandate, the FTC also issued a study of competition in the contact lens industry in 2005. 
                            <E T="03">See</E>
                             2005 Contact Lens Report, 
                            <E T="03">supra</E>
                             note 14.
                        </P>
                    </FTNT>
                    <P>
                        As specified in the Act, the Rule imposes requirements on both sellers and prescribers of contact lenses. Because the use of contact lenses involves significant health issues 
                        <SU>23</SU>
                        <FTREF/>
                         and Congress recognized that consumers may be harmed by contact lenses purchased with an expired, inaccurate, or otherwise invalid prescription,
                        <SU>24</SU>
                        <FTREF/>
                         the Act requires that contact lenses be sold only to patients with valid prescriptions, which they receive after contact lens fittings by a prescriber. The Act and the Rule only allow sales of contact lenses when a patient presents a seller with a copy of the prescription or the seller has verified the patient's prescription with the prescriber.
                        <SU>25</SU>
                        <FTREF/>
                         Sellers also are prohibited from altering a contact lens prescription.
                        <SU>26</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>23</SU>
                             
                            <E T="03">See, e.g.,</E>
                             FTC, “Possible Barriers to E-Commerce: Contact Lenses, A Report from the Staff of the Federal Trade Commission” 8-9 (2004), 
                            <E T="03">https://www.ftc.gov/sites/default/files/documents/advocacy_documents/possible-anticompetitive-barriers-e-commerce-contact-lenses-report-staff-ftc/040329clreportfinal.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>24</SU>
                             Contact Lens Rule, 69 FR 40482.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>25</SU>
                             16 CFR 315.5(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>26</SU>
                             16 CFR 315.5(e).
                        </P>
                    </FTNT>
                    <P>
                        The Act and the Rule further impose obligations on prescribers. First and foremost, prescribers are required to release a copy of the prescription to the patient promptly upon completion of the contact lens fitting, “[w]hether or not requested by the patient.” 
                        <SU>27</SU>
                        <FTREF/>
                         Prescribers also are prohibited from requiring: (1) The purchase of contact lenses as a condition of either prescription release or verification, (2) a separate payment for prescription release or verification, and (3) that the patient sign a waiver as a condition of prescription release or verification.
                        <SU>28</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>27</SU>
                             15 U.S.C. 7601(a)(1); 16 CFR 315.3(a)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>28</SU>
                             15 U.S.C. 7601(b)(1)-(3); 16 CFR 315.3(b)(1)-(3).
                        </P>
                    </FTNT>
                    <P>
                        Additionally, prescribers are required to provide or verify a contact lens prescription when “directed by any person designated to act on behalf of the patient.” 
                        <SU>29</SU>
                        <FTREF/>
                         Such verification occurs when the seller provides the prescriber with a consumer's prescription information and: (1) The prescriber confirms that the prescription is accurate, by phone, facsimile, or electronic mail; (2) the prescriber informs the seller that the prescription is inaccurate and provides the correct prescription; or (3) the prescriber does not communicate with the seller within eight business hours of the seller's request for verification (“passive verification”).
                        <SU>30</SU>
                        <FTREF/>
                         The eight-business-hour passive verification lessens the demands on prescribers in the event a seller forwards a query about an accurate and complete prescription from a properly identified patient. It also prevents prescribers from blocking verification—and impeding consumer access to contact lenses that may be lower-priced, or sold by sellers who offer other benefits or convenience—simply by refusing to respond to verification requests.
                    </P>
                    <FTNT>
                        <P>
                            <SU>29</SU>
                             15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>30</SU>
                             15 U.S.C. 7603(d)(1)-(3); 16 CFR 315.5.
                        </P>
                    </FTNT>
                    <P>
                        One outcome of passive verification, however, is that, if a prescriber does not respond to a verification request containing inaccurate information or for an invalid prescription within eight business hours, the prescription is deemed verified; thus, passive verification allows for the possibility that patients can be sold lenses for which they do not have a valid prescription. Congress, when considering the FCLCA, was aware that a passive-verification regime could, in some instances, allow sellers to sell and ship contact lenses based on an invalid or inaccurate prescription, and that this could potentially lead to health risks.
                        <SU>31</SU>
                        <FTREF/>
                         Congress opted for a passive-verification regime despite this concern in order “to ensure that consumers are not caught in the competitive tug-of-war between doctors and third party sellers for the sale of contact lenses.” 
                        <SU>32</SU>
                        <FTREF/>
                         It was also envisioned that prescribers would remain diligent in ensuring that patients did not receive lenses for which they had not been prescribed, since it is in both prescribers' self-interest and the health and safety interests of their patients to prevent this from occurring.
                        <SU>33</SU>
                        <FTREF/>
                         In this manner, the passive-verification system was perceived, to a certain extent, to be self-enforcing, as prescribers would have both a financial interest and an ethical duty to police invalid, incorrect, or expired prescriptions.
                        <SU>34</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>31</SU>
                             
                            <E T="03">See, e.g.,</E>
                             FCLCA Subcomm. Hearing, 
                            <E T="03">supra</E>
                             note 17 (statements of Howard Beales, Federal Trade Commission); 
                            <E T="03">id.</E>
                             (statements of J. Pat Cummings, American Optometric Association) (“And the problem with passive verification is that people will get contact lenses without a prescription.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>32</SU>
                             H.R. Rep. No. 108-318, at 5.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>33</SU>
                             Contact Lens Rule, 69 FR at 40498.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>34</SU>
                             FCLCA Subcomm. Hearing, 
                            <E T="03">supra</E>
                             note 17 (statements of Howard Beales, Federal Trade 
                            <PRTPAGE/>
                            Commission) (stating that passive verification is in many respects self-enforcing). 
                            <E T="03">See also id.</E>
                             (statements of Jonathan Coon, 1-800 CONTACTS) (explaining to the Committee that from their experience with an existing passive verification-system in California, doctors have motivation to block invalid-prescription sales. “So they tell us if there is any problem with the prescription, if it's expired, it's invalid, whatever the problem is with the prescription. If they can tell us, you can believe they tell us absolutely every time.”).
                        </P>
                    </FTNT>
                    <PRTPAGE P="50671"/>
                    <HD SOURCE="HD2">C. Initial Request for Comments in 2015</HD>
                    <P>
                        As part of its periodic review of its rules and guides, on September 3, 2015, the Commission solicited comments on the Contact Lens Rule, seeking input on: The economic impact of, and continuing need for, the Rule; the benefits of the Rule to consumers purchasing contact lenses; the burdens the Rule places on entities subject to its requirements; the impact the Rule has had on the flow of information to consumers; the degree of industry compliance with the Rule; the need for any modifications to increase its benefits or reduce its burdens or to account for changes in relevant technology; and any overlap or conflict with the Rule and other federal, state, or local laws or regulations.
                        <SU>35</SU>
                        <FTREF/>
                         The comment period for this initial request closed on October 26, 2015. The Commission received approximately 660 comments from individuals and entities representing a wide range of viewpoints, including prescribing eye-care practitioners (ophthalmologists and optometrists), opticians and other eye-wear industry members, sellers of contact lenses (both online and brick-and-mortar), contact lens manufacturers, and consumers.
                        <SU>36</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>35</SU>
                             Contact Lens Rule Request for Comment (“RFC”), 80 FR 53272 (Sept. 3, 2015).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>36</SU>
                             Comment figures are approximations because identical comments are sometimes submitted more than once. RFC comments are available at 
                            <E T="03">https://www.ftc.gov/policy/public-comments/2015/09/initiative-621.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. Notice of Proposed Rulemaking in 2016</HD>
                    <P>
                        After a review of comments, surveys, other submitted information, and its own enforcement experience, the Commission determined that the overall weight of the evidence demonstrated a need to improve compliance with the Rule's automatic prescription-release requirement, as well as a need to create a mechanism for monitoring and enforcing the Rule.
                        <SU>37</SU>
                        <FTREF/>
                         To achieve this, the Commission issued a Notice of Proposed Rulemaking (“NPRM”) on December 7, 2016 that proposed to add a signed-acknowledgment requirement.
                        <SU>38</SU>
                        <FTREF/>
                         The signed-acknowledgment requirement was to be triggered once the prescriber presented the prescription to the patient, and the acknowledgment form could be in either paper or electronic format. As proposed, the acknowledgment form was to be entitled “Patient Receipt of Contact Lens Prescription” (“Signed Acknowledgment”), and state, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand that I am free to purchase contact lenses from the seller of my choice.” Prescribers would be required to maintain copies of the acknowledgment forms in paper or electronically for not less than three years.
                    </P>
                    <FTNT>
                        <P>
                            <SU>37</SU>
                             Notice of Proposed Rulemaking, 81 FR 88526 (Dec. 7, 2016) [hereinafter NPRM].
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>38</SU>
                             
                            <E T="03">Id.</E>
                             The NPRM also proposed a technical amendment, to remove the words “private label” from § 315.5(e) to conform the language of the Rule to that of the FCLCA.
                        </P>
                    </FTNT>
                    <P>The NPRM sought comment on this proposal as well as the following issues: The provision of additional copies of prescriptions, the amount of time for a prescriber to respond to such a request, the use of patient portals to release prescriptions, and potential modifications to address concerns about automated telephone verification calls. The sixty-day comment period for the Commission's NPRM closed on January 30, 2017.</P>
                    <P>
                        In response to its NPRM, the Commission received over 4,000 additional comments, many from prescribers concerned about the impact of the proposed signed-acknowledgment requirement.
                        <SU>39</SU>
                        <FTREF/>
                         After considering these and other comments, the Commission determined that certain issues deserved additional discussion and examination. To obtain additional input and more fully consider commenter concerns, the Commission solicited additional comments 
                        <SU>40</SU>
                        <FTREF/>
                         and held a public workshop on the Contact Lens Rule and the Evolving Contact Lens Marketplace on March 7, 2018. The workshop included six panels, covering issues relating to the overall contact lens marketplace, health and safety, competition, purchasing and verification, the proposed Signed Acknowledgment and consumer choice, and the future of contact lens prescribing and selling.
                        <SU>41</SU>
                        <FTREF/>
                         In response to the Commission's request and workshop, the Commission received approximately 3,400 additional comments from a wide range of commenters, including numerous consumers and prescribers, as well as industry associations, state attorneys general, contact lens manufacturers, and contact lens sellers.
                        <SU>42</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>39</SU>
                             NPRM comments available at 
                            <E T="03">https://www.ftc.gov/policy/public-comments/2016/10/initiative-677.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>40</SU>
                             Public Workshop Examining Contact Lens Marketplace and Analyzing Proposed Changes to the Contact Lens Rule, 82 FR 57889 (Dec. 8, 2017).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>41</SU>
                             Workshop transcripts available at 
                            <E T="03">https://www.ftc.gov/news-events/events-calendar/2018/03/contact-lens-rule-evolving-contact-lens-marketplace.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>42</SU>
                             Workshop comments available at 
                            <E T="03">https://www.ftc.gov/policy/public-comments/2018/01/initiative-733.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">E. Supplemental Notice of Proposed Rulemaking</HD>
                    <P>
                        After reviewing the comments submitted in response to the public workshop and Notice of Proposed Rulemaking, the Commission issued a Supplemental Notice of Proposed Rulemaking (“SNPRM”) on May 28, 2019 that modified its previous proposal for a Signed Acknowledgment by instituting a more flexible Confirmation of Prescription Release provision.
                        <SU>43</SU>
                        <FTREF/>
                         In addition, the SNPRM put forth new proposals to modify the Rule by: (a) Adding a definition of the term “provide to the patient a copy,” to allow the prescriber to provide the patient with a digital copy of the patient's prescription in lieu of a paper copy; (b) providing forty business hours as the time period for which a prescriber must provide a prescription upon request to a person designated to act on behalf of the patient; (c) creating new message delivery and recordkeeping requirements for sellers using automated telephone verification messages; (d) amending and clarifying the prohibition on seller alteration of prescriptions; and (e) requiring that sellers provide a method that would allow patients to present their prescriptions to the seller.
                    </P>
                    <FTNT>
                        <P>
                            <SU>43</SU>
                             Supplemental Notice of Proposed Rulemaking, 84 FR 24664 (May 28, 2019) [hereinafter SNPRM].
                        </P>
                    </FTNT>
                    <P>
                        The Commission requested comment on its SNPRM proposal; the sixty-day comment period closed on July 29, 2019. In response to its SNPRM, the Commission received approximately 200 unique comments (and approximately 900 comments total) from a variety of stakeholders, including prescribers and prescriber-trade organizations, contact lens manufacturers, contact lens sellers, legislators, state attorneys general, economic think tanks and academics, consumer-interest organizations, and individual consumers themselves.
                        <SU>44</SU>
                        <FTREF/>
                         The majority of commenters opined on the Confirmation of Prescription Release proposal, and many also commented on the Commission's new proposals regarding prescription verification and alteration. This Statement of Basis and Purpose for the Final Rule summarizes 
                        <PRTPAGE P="50672"/>
                        the relevant comments received in response to the proposals set forth in the NPRM and SNPRM and explains the Commission's analyses and decisions to amend or not amend the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>44</SU>
                             SNPRM comments available at 
                            <E T="03">https://www.regulations.gov/docket?D=FTC-2019-0041.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">II. Final Rule Pertaining to Confirmation of Prescription Release</HD>
                    <P>The following sections discuss the Confirmation of Prescription Release proposal in the SNPRM, the comments to the SNPRM in support of and opposition to the Confirmation of Prescription Release proposal, the Commission's analysis and conclusions, and the amendments to the Final Rule instituting a Confirmation of Prescription Release. Because many of the comments focused on the Commission's basis for its SNPRM proposal, and whether that basis is supported by evidence in the record, the Commission also reiterates the basis set forth in the SNPRM and discusses related comments and subsequent determinations in this Statement of Basis and Purpose for the final amended Contact Lens Rule.</P>
                    <P>
                        The Commission's authority to modify the Rule and implement a Confirmation of Prescription Release requirement derives from the FCLCA, which directed the FTC to prescribe implementing rules, and authorized the Commission to investigate and enforce the Act in the same manner, by the same means, and with the same jurisdictional powers and duties as a trade regulation rule under the Federal Trade Commission Act.
                        <SU>45</SU>
                        <FTREF/>
                         Congress clearly intended that prescriptions be provided to all consumers at the completion of the contact lens fitting process.
                        <SU>46</SU>
                        <FTREF/>
                         Survey evidence, the record of these proceedings, and the Commission's own experience with the Rule indicate that is not occurring at anywhere near the rate Congress intended. Consequently, the Commission believes that imposing a Confirmation of Prescription Receipt requirement is critical to effectuate congressional intent to the fullest extent.
                        <SU>47</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>45</SU>
                             15 U.S.C. 7601-7610 (Pub. L. 108-164).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>46</SU>
                             15 U.S.C. 7601; 
                            <E T="03">see also</E>
                             H.R. Rep. No. 108-318, at 4 (2003) (“The practice of optometrists withholding the prescription has limited the consumer's ability to shop for the best price and has [adversely] impacted competition.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>47</SU>
                             
                            <E T="03">See</E>
                             H.R. Rep. No. 108-318, at 6 (2003) (“The goal of this legislation is to allow consumer access to their contact lens prescriptions. . . .”).
                        </P>
                    </FTNT>
                    <P>
                        In a comment to the NPRM, the American Optometric Association (“AOA”) contended that the Commission does not have the authority to add requirements to the Rule that are not found in the text of the FCLCA.
                        <SU>48</SU>
                        <FTREF/>
                         According to the AOA, because the FCLCA is a statute that “carefully enumerates specific substantive requirements but not others”—as opposed to a general grant of authority—the agency charged with administering the FCLCA “should not add additional requirements that Congress did not enact.” 
                        <SU>49</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>48</SU>
                             American Optometric Association (NPRM Comment #3830).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>49</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not agree with this interpretation. As noted above, the FCLCA contains an express delegation of authority to the FTC to craft rules to carry out the Act.
                        <SU>50</SU>
                        <FTREF/>
                         Pursuant to this delegation, the FTC has broad rulemaking authority to implement requirements for the purpose of preventing unfair or deceptive acts or practices in or affecting commerce, including failure to provide patients with copies of their prescriptions.
                        <SU>51</SU>
                        <FTREF/>
                         The proposed modification requiring that patients sign a Confirmation of Prescription Release is consistent with the statute and falls well within the Commission's statutory jurisdiction under the FCLCA.
                        <SU>52</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>50</SU>
                             15 U.S.C. 7607.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>51</SU>
                             
                            <E T="03">See id.</E>
                             (directing the FTC to “prescribe rules pursuant to section 57a of this title to carry out [the FCLCA]”); 15 U.S.C. 57a(a)(1)(B) (authorizing the FTC to prescribe “rules which define with specificity acts or practices which are unfair or deceptive acts or practices in or affecting commerce,” including rules that contain “requirements prescribed for the purpose of preventing such acts or practices”); 15 U.S.C. 7601(a) (mandating that when a prescriber completes a contact lens fitting, the prescriber “whether or not requested by the patient, shall provide to the patient a copy of the contact lens prescription”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>52</SU>
                             15 U.S.C. 7601(a), 7607. AOA's stance that a statute's enumeration of some requirements but not others necessarily signifies that Congress deliberately excluded the non-included requirements is also incorrect in the rulemaking context. It is well established that the canon of statutory interpretation 
                            <E T="03">expressio unius est exclusion alterius</E>
                             (“the expression of one is the exclusion of others”) does not have force in the administrative setting, where Congress is presumed to have left to reasonable agency discretion questions that it has not directly resolved. 
                            <E T="03">See Adirondack Med. Ctr.</E>
                             v. 
                            <E T="03">Sebelius,</E>
                             740 F.3d 692, 697 (D.C. Cir. 2014); 
                            <E T="03">St. Marks Place Hous. Co.</E>
                             v. 
                            <E T="03">U.S. Dep't of Hous. &amp; Urban Dev.,</E>
                             610 F.3d 75 (D.C. Cir. 2010); 
                            <E T="03">AFL-CIO</E>
                             v. 
                            <E T="03">Chao,</E>
                             409 F. 3d 377 (D.C. Cir. 2005); 
                            <E T="03">Mobile Comm'cns Corp. of Am.</E>
                             v. 
                            <E T="03">FCC,</E>
                             77 F.3d 1399, 1404-05 (D.C. Cir. 1996); 
                            <E T="03">see also Farrell</E>
                             v. 
                            <E T="03">Pompeo,</E>
                             No. 17-490, 2019 U.S. Dist. LEXIS 205831, *25-27 (D.C. Cir. Nov. 27, 2019).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Proposed Modifications in the SNPRM</HD>
                    <P>
                        The SNPRM proposed to amend the NPRM's signed-acknowledgment proposal by replacing that requirement with a shorter and more flexible Confirmation of Prescription Release provision. Rather than requiring, as proposed in the NPRM, that prescribers request that each contact lens patient sign a form with mandatory language acknowledging receipt of the prescription and an understanding of the right to purchase lenses elsewhere,
                        <SU>53</SU>
                        <FTREF/>
                         in the SNPRM the Commission proposed requiring prescribers instead to do one of the following:
                    </P>
                    <FTNT>
                        <P>
                            <SU>53</SU>
                             NPRM, 81 FR at 88559 (The form would have stated: “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I understand I am free to purchase contact lenses from the seller of my choice.”).
                        </P>
                    </FTNT>
                    <P>(A) Request that the patient acknowledge receipt of the contact lens prescription by signing a separate statement confirming receipt of the contact lens prescription;</P>
                    <P>(B) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription;</P>
                    <P>(C) Request that the patient sign a prescriber-retained copy of the sales receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or</P>
                    <P>
                        (D) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message), retain evidence that such prescription was sent, received, or made accessible, downloadable, and printable.
                        <SU>54</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>54</SU>
                             SNPRM, 84 FR at 24667.
                        </P>
                    </FTNT>
                    <P>
                        The Commission's proposal provided sample language for confirmation options (A), (B), and (C),
                        <SU>55</SU>
                        <FTREF/>
                         but also allowed prescribers to craft their own wording of the signed confirmation for these options if they so desired. Unlike the NPRM's signed-acknowledgment proposal, which applied to all prescribers, the SNPRM's Confirmation of Prescription Release proposal only applied to prescribers with a financial interest in the sale of contact lenses.
                        <SU>56</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>55</SU>
                             The Commission said it had no wish to burden prescribers with the task of formulating adequate confirmation language if they would prefer to use a sentence from the language the Commission previously proposed: “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting.” The Commission said use of such language would satisfy the proposed requirement. SNPRM, 84 FR at 24683.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>56</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Basis for SNPRM Confirmation of Prescription Release Proposal</HD>
                    <P>
                        The Commission explained in the SNPRM that it based its Confirmation of Prescription Release proposal on a variety of evidence, including: Multiple consumer surveys consistently showing prescriber non-compliance with, and lack of consumer awareness of, the Rule's prescription-release requirement; numerous accounts of prescribers' failure to release prescriptions; the 
                        <PRTPAGE P="50673"/>
                        persistently high number of verifications, many of which would be unnecessary were consumers in possession of their prescriptions; the regulatory structure of the contact lens market, which requires a consumer to obtain lenses pursuant to a prescription while permitting prescribers to sell what they prescribe; and the lack of credible empirical evidence rebutting or contradicting the evidence that prescribers are not automatically releasing prescriptions, and that consumers are not fully aware of their rights.
                        <SU>57</SU>
                        <FTREF/>
                         The Commission also noted that the potential benefit of increasing the number of patients in possession of their prescriptions is substantial for consumers, sellers, and prescribers: Namely, increased flexibility and choice for consumers; a reduced verification burden for prescribers and sellers; and a reduced likelihood of errors associated with incorrect, invalid, and expired prescriptions and, consequently, improved patient safety.
                        <SU>58</SU>
                        <FTREF/>
                         The Commission further explained that it faces serious challenges enforcing the Rule and monitoring compliance because it often comes down to the word of the patient against the word of the prescriber, which might require the Commission to issue administrative subpoenas and conduct investigational hearings—which could be resource-intensive for the Commission and costly, time-consuming, and disruptive for prescribers—in order to investigate each potential violation.
                        <SU>59</SU>
                        <FTREF/>
                         The Commission thus concluded that some form of retained documentation is necessary to improve its ability to enforce and monitor prescriber compliance with the prescription-release requirements.
                        <SU>60</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>57</SU>
                             
                            <E T="03">Id.</E>
                             at 24680-81.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>58</SU>
                             
                            <E T="03">Id.</E>
                             at 24681.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>59</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>60</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission also determined that signage—an alternative suggested by NPRM commenters—was not an appropriate or effective means of ensuring that patients receive their prescriptions as required by law.
                        <SU>61</SU>
                        <FTREF/>
                         Lastly, the Commission determined that despite commenter concerns, the burden to obtain signatures and retain records would be relatively minimal and outweighed by the benefits.
                        <SU>62</SU>
                        <FTREF/>
                         The Commission, however, was receptive to an NPRM commenter recommendation to modify the signed-acknowledgment proposal in order to further reduce the burden and allow for greater flexibility,
                        <SU>63</SU>
                        <FTREF/>
                         and thus the SNPRM's Confirmation of Prescription Release proposal included three new options for prescribers to obtain or establish proof of prescription release and exempted prescribers who lacked a financial interest in the sale of contact lenses.
                        <SU>64</SU>
                        <FTREF/>
                         According to the Commission, the Confirmation of Prescription Release proposal retained most of the benefits of the NPRM's signed-acknowledgment proposal, but would be less disruptive and burdensome for prescribers.
                        <SU>65</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>61</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>62</SU>
                             
                            <E T="03">Id.</E>
                             at 24681-82.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>63</SU>
                             The recommendation was submitted by the National Association of Optometrists and Opticians in its comments to the Contact Lens Workshop and the NPRM, 
                            <E T="03">see id.</E>
                             at 24680 (citing National Association of Optometrists and Opticians (WS Comment #3208)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>64</SU>
                             SNPRM, 84 FR at 24683.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>65</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Comments on the Confirmation of Prescription Release Proposal and the Basis for Such Proposal</HD>
                    <P>
                        Commenter response to the Commission's proposal in the SNPRM was varied. Some commenters applauded the proposed amendments as improvements to the prior signed-acknowledgment proposal, and as a balanced response to competing interests of consumers, sellers, and prescribers.
                        <SU>66</SU>
                        <FTREF/>
                         Some, for instance, praised the confirmation proposal as an attempt to increase consumer access to prescriptions while making it easier and more efficient for prescribers to adhere to the patient-acknowledgment requirement by allowing flexible methods for obtaining the patient's signature.
                        <SU>67</SU>
                        <FTREF/>
                         Other commenters, however, asserted that the proposal watered down prescriber obligations and would thus be less effective than the NPRM's signed-acknowledgment proposal in ensuring that consumers receive their prescriptions and are aware of their rights.
                        <SU>68</SU>
                        <FTREF/>
                         And several commenters, primarily contact lens prescribers, stated that despite the increased flexibility, the Confirmation of Prescription Release proposal still created too much of a burden for prescribers, and they criticized the Commission's approach and the evidence relied upon.
                        <SU>69</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>66</SU>
                             R Street Institute (SNPRM Comment #15) (“The Commission's proposal is both reasonable and not overly burdensome.”); Grimm (SNPRM Comment #36) (“There is no doubt that the modified Contact Lens Rule should be embraced by prescribers, sellers, and consumers as an improvement to consumer products trade rules.”); Americans for Tax Reform (SNPRM Comment #72) (“These changes strike the correct balance between promoting the free market and protecting important consumer rights.”); Lens.com (SNPRM Comment #85) (“We believe you have struck the correct balance . . . .”); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89) (“What the FTC is proposing is a common sense, minimally-burdensome rule that optometrists, ophthalmologists, and consumers alike can and should support.”); Taxpayers Protection Alliance (SNPRM Comment #118) (“Although we are often critical of government overreach and work hard to make government smaller, we believe that the FTC's proposed Contact Lens Rule is a government rule that works for taxpayers and consumers and creates an open transparent contact lens market in the US where taxpayers have real choice and there is real competition in the marketplace.”); Attorneys General of 27 States (SNPRM Comment #139) (“We believe the proposed modifications in the SNPRM are reasonable modifications that balance the interests of consumers, eye care professionals, and the eye care industry.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>67</SU>
                             Anonymous (SNPRM Comment #63); Rawson (SNPRM Comment #68) (“This proposed rule allows prescribers the ability to model the rule to best fit their practice, but still give the consumers the protection and the knowledge they need.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>68</SU>
                             Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>69</SU>
                             American Optometric Association (SNPRM Comment #96); Reeder (SNPRM Comment #55) (even signature on prescription or patient receipt is burdensome); Kegler (SNPRM Comment #99) (proposal will still place financial and administrative burdens on prescribers).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. Comments About the Need for the Confirmation of Prescription Release and Whether Prescribers Are Complying With the Rule's Automatic Prescription Release Requirement</HD>
                    <HD SOURCE="HD3">a. Survey Evidence as Proof of Non-Compliance</HD>
                    <P>
                        Many of the SNPRM comments focused on the need for a Signed Acknowledgment or Confirmation of Prescription Release, and on whether evidence in the record supports the Commission's determination that prescribers are not complying with the Rule's prescription-release requirement. Several commenters, such as 1-800 CONTACTS, Consumer Action, and the Attorneys General of Twenty-Seven States, contended (as they did in comments responding to either the NPRM, the Contact Lens Workshop, or both) 
                        <SU>70</SU>
                        <FTREF/>
                         that prescriber noncompliance remains a problem, and that millions of Americans are not receiving their prescriptions after a contact lens fitting.
                        <SU>71</SU>
                        <FTREF/>
                         The Attorneys General of Twenty-Seven States, for instance, commented that consumers in their states continue to report that prescribers are failing to automatically provide patient prescriptions in writing.
                        <SU>72</SU>
                        <FTREF/>
                         Likewise, the online seller 1-800 CONTACTS submitted a new survey of consumers, conducted for it by the 
                        <PRTPAGE P="50674"/>
                        polling firm Dynata (formerly known as Survey Sampling International), showing that prescriber compliance has not markedly improved, despite the attention focused on automatic-prescription-release obligations since the FTC initiated its rule review in 2015.
                        <SU>73</SU>
                        <FTREF/>
                         According to the new survey, nearly 49% of contact lens patients report that their prescribers did not automatically give them their prescription after their eye examination.
                        <SU>74</SU>
                        <FTREF/>
                         Of those who did not receive their prescription automatically, a little more than half received it after requesting it, while 43% never received their prescription.
                        <SU>75</SU>
                        <FTREF/>
                         Extrapolating this data to the general population of 45 million U.S. contact lens users 
                        <SU>76</SU>
                        <FTREF/>
                         would mean there are approximately 22 million annual violations of the Contact Lens Rule, and that each year more than 9.4 million contact lens users do not receive their prescriptions.
                        <SU>77</SU>
                        <FTREF/>
                         The 2019 consumer survey data is consistent with several prior surveys of contact lens users conducted in 2014, 2015, 2016, and 2017 on behalf of 1-800 CONTACTS and the consumer rights organization Consumer Action,
                        <SU>78</SU>
                        <FTREF/>
                         as well as a survey of eyeglass wearers (who, per the FTC's Eyeglass Rule, are also to automatically receive their prescriptions following a refractive eye exam) conducted on behalf of Warby Parker in 2015.
                        <SU>79</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>70</SU>
                             
                            <E T="03">See</E>
                             1-800 CONTACTS (NPRM Comment #3898); 1-800 CONTACTS (WS Comment #3207); Consumer Action (NPRM Comment #3721); Comments of the Attorneys General of 20 States (NPRM Comment #3804).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>71</SU>
                             1-800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>72</SU>
                             Attorneys General of 27 States (SNPRM Comment #139).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>73</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>74</SU>
                             1-800 CONTACTS (SNPRM Comment #135, Ex. B). The poll was of 1011 contact lens users between the ages of 18-49, and the relevant questions asked were “At your last eye exam, did the eye care provider provide you with a copy of your contact lens prescription?” and “In order to obtain a copy of your prescription, did you have to ask your eye care provider for it?” Approximately 41% said they received it automatically, 49% said they did not, and 10% did not recall or were unsure.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>75</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>76</SU>
                             Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, 
                            <E T="03">https://www.cdc.gov/contactlenses/fast-facts.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>77</SU>
                             This is based on the estimate—long used to calculate the financial burden of the Rule for Paperwork Reduction Act purposes—that consumers obtain one contact lens prescription per year. 
                            <E T="03">See, e.g.,</E>
                             SNPRM, 84 FR at 24692; Paperwork Reduction Act Proposed Collection; Comment Request, 81 FR at 31940; Paperwork Reduction Act Proposed Collection; Comment Request, 78 FR at 9392.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>78</SU>
                             SNPRM, 84 FR at 24671-72.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>79</SU>
                             NPRM, 81 FR at 88531.
                        </P>
                    </FTNT>
                    <P>
                        Some commenters also pointed to previously-submitted evidence indicating that many U.S. contact lens users are still unaware of their right to automatically receive their prescriptions and take them elsewhere for filling.
                        <SU>80</SU>
                        <FTREF/>
                         While commenters to the SNPRM did not submit updated polling data on consumer awareness, several cited previously-submitted data indicating that between 46-60% of consumers are unaware that under federal law a prescriber is required to provide the patient with a copy of their prescription after they complete their contact lens exam.
                        <SU>81</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>80</SU>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); 1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>81</SU>
                             Consumer Action (SNPRM Comment #101) (“Our survey showed a fundamental lack of understanding by consumers about their automatic right to receive a copy of their prescription”); 1-800 CONTACTS (SNPRM Comment #135); 
                            <E T="03">see</E>
                             SNPRM 84 FR at 24672 (discussing polls of consumer knowledge of their rights).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter, the National Hispanic Medical Association (“NHMA”), noted that polls show that Hispanic patients are disproportionately impacted by prescribers' failure to release prescriptions, and are less likely to understand their rights under the FCLCA.
                        <SU>82</SU>
                        <FTREF/>
                         According to the NHMA, “Our community continually has been victimized and denied their prescriptions by prescribers and doctors at a higher rate than most other Americans. We strongly believe that more must be done to ensure patients are informed of their rights and given copies of their prescriptions.” 
                        <SU>83</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>82</SU>
                             National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>83</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        A number of SNPRM commenters, however, were critical of the polling data provided to, and relied upon by, the Commission. The American Academy of Ophthalmology (“AAO”) asserted that data showing prescriber non-compliance consisted of “industry-sponsored surveys” and was therefore unreliable.
                        <SU>84</SU>
                        <FTREF/>
                         AAO added that it is “unaware of issues” with prescribers failing to release prescriptions, and stated its members “know that ophthalmology has a strong record of compliance.” 
                        <SU>85</SU>
                        <FTREF/>
                         Likewise, the American Society of Cataract and Refractive Surgery (“ASCRS”) asserted that there is no independent third-party evidence suggesting physicians are not providing prescriptions to patients, and that the Commission is basing compliance on “survey polls sponsored by stakeholders with financial interest in the sale of contact lenses.” 
                        <SU>86</SU>
                        <FTREF/>
                         According to the ASCRS, before amending the Rule, the Commission should obtain data from a disinterested organization.
                        <SU>87</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>84</SU>
                             American Academy of Ophthalmology (SNPRM Comment #136).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>85</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>86</SU>
                             American Society of Cataract and Refractive Surgery (SNPRM Comment #127).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>87</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The AOA was highly critical of polling data supplied by 1-800 CONTACTS, and stated that since the online seller, in its advertising, encouraged consumers to “skip the trip to the optometrist” and instead renew prescriptions online (via telemedicine), the online seller has a demonstrated bias against optometrists that taints the material it submits.
                        <SU>88</SU>
                        <FTREF/>
                         The AOA further stated that some consumer survey findings may be misleading because it is “very typical” for consumers to request their prescriptions before their contact lens fitting is complete, and thus before prescribers are obligated—under the Rule and the FCLCA—to release them to consumers.
                        <SU>89</SU>
                        <FTREF/>
                         Therefore, some consumers might indicate on a survey that they were required to ask for their prescriptions when, in fact, they asked before they were entitled to receive them. As support for this contention, AOA stated that it surveyed some of its members and found that 91.7% “indicated that there are times when a patient will ask for his/her prescription prior to the finalization of the contact lens fitting.” 
                        <SU>90</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>88</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>89</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>90</SU>
                             
                            <E T="03">Id.</E>
                             The AOA reported this result in its comment, and it stated that its survey was of 629 prescribers, but did not provide the FTC with the underlying survey data, information about the manner in which the survey was conducted, how the 629 prescribers were selected, or the specific questions that were asked.
                        </P>
                    </FTNT>
                    <P>
                        The Commission recognizes that some consumers may think they had to ask for their prescriptions when, in fact, they would have received them when their fittings were complete. However, the AOA did not suggest, nor provide any data or information, as to how often this may occur, and thus how much it might skew the results of consumer surveys. As a result, the Commission is unable to estimate what portion of the 49% who stated they did not automatically receive their prescription—in the most recent survey—gave that response because they misunderstood when they were entitled to receive their prescription.
                        <SU>91</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>91</SU>
                             The Commission also notes that eyeglass patients are entitled to their prescriptions immediately following their exam (since they do not have to wait for a fitting), and thus would rarely ask for their prescriptions before they are entitled to them, and yet two 2015 surveys of eyeglass wearers—one on behalf of Warby Parker, the other for 1-800 CONTACTS—found that 47% and 66%, respectively, of eyeglass patients who visited an optometrist reported that they were not automatically provided a prescription at the end of their exam. NPRM, 81 FR at 88531 (citing Warby Parker (Comment #813 on the Ophthalmic Practice Rule), available at 
                            <E T="03">https://www.ftc.gov/policy/public-comments/initiative-624</E>
                            ); 1-800 CONTACTS (RFC Comment #568, Ex. B). This would seem to indicate that most consumer reports that they did not receive their prescriptions are not 
                            <PRTPAGE/>
                            based on a misunderstanding of when they are supposed to receive them.
                        </P>
                    </FTNT>
                    <PRTPAGE P="50675"/>
                    <P>
                        Moreover, even if the Commission were to disregard evidence of consumers who obtained their prescriptions only after asking for them, five consumer surveys from 2015 to 2019 (six if the Warby Parker eyeglass wearers' survey is included) indicate that between 21%-36% of consumers—approximately 9.5 to 16.2 million contact lens users each year—did not receive their prescriptions at all after getting fitted for their lenses.
                        <SU>92</SU>
                        <FTREF/>
                         This level of non-compliance on its own supports the Commission's recommendation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>92</SU>
                             This approximation is based on the current estimate that there are 45 million contact lens users in the United States. Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, 
                            <E T="03">https://www.cdc.gov/contactlenses/fast-facts.html.</E>
                             The results from the individual surveys are as follows: (1) June 2019 survey by Dynata on behalf of 1-800 CONTACTS of 1011 contact lens users found that 21% said they never received their prescriptions (1-800 CONTACTS (SNPRM Comment #135)); (2) January 2017 survey by Caravan ORC International on behalf of Consumer Action of 2018 adults found that 31% of contact lens users said that at their last eye exam, their doctor did not provide them with a paper copy of their prescription (Consumer Action (NPRM Comment #3721)); (3) December 2016 survey of 1000 contact lens users by Survey Sampling International (“SSI”) on behalf of 1-800 CONTACTS found that 24% of consumer respondents said they did not receive their prescription (1-800 CONTACTS (NPRM Comment #3898)); (4) October 2015 SSI survey of 500 contact lens users and 303 eyeglass users on behalf of 1-800 CONTACTS found that 36% of contact lens users and 39% of eyeglass wearers said they did not receive their prescription (1-800 CONTACTS (RFC Comment #568, Ex. B)); (5) May 2015 SSI survey of 2000 contact lens wearers found that 34% said they did not receive their prescription (1-800 CONTACTS (RFC Comment #568, Ex. C)); and (6)November 2014 SSI survey of 2000 contact lens wearers found that 34% said they did not receive their prescription (1-800 CONTACTS (RFC Comment #568, Ex. C)). As noted in the SNPRM, the manner in which a few of the questions were phrased in the 2014 and 2015 surveys raised some Commission concerns, since some questions were leading, lacked an “I don't know” response option, and used a term—“hard copy”—which not all consumers may understand. The more recent surveys represented an improvement because they included an option for respondents to acknowledge that they do not recall whether they received their prescriptions, and used the term “paper copy” rather than “hard copy.” SNPRM, 84 FR at 24672.
                        </P>
                    </FTNT>
                    <P>
                        As for commenter criticism that consumer surveys were submitted by interested parties, the Commission reiterates what it stated in the SNPRM: while cognizant of the interests of submitting parties, the Commission, whenever possible, examines the underlying survey data and methodology to gauge a survey's usefulness and considers factors such as how many people are queried, how the questions are phrased, and whether the surveys are conducted in-house or by independent and established third-party polling firms.
                        <SU>93</SU>
                        <FTREF/>
                         The Commission also recognizes that all surveys may have methodological limitations, and, in this instance, does not treat any one survey as controlling. The Commission, however, also recognizes that multiple surveys conducted by different sources at different times with similar results bolster the credibility of each individual survey, as does the fact that in this matter, one survey, submitted by Consumer Action and conducted by the third-party polling firm Caravan ORC International, is not from a party with a direct financial stake in the contact lens industry.
                        <SU>94</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>93</SU>
                             SNPRM, 84 FR at 24672.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>94</SU>
                             The AOA had previously noted, in response to the NPRM, that Consumer Action has received corporate financial support from, among others, 1-800 CONTACTS. 
                            <E T="03">Id.</E>
                             Consumer Action, however, is a long-established non-profit consumer advocacy organization without a financial interest in the outcome of this Rule review.
                        </P>
                    </FTNT>
                    <P>
                        The Commission also notes that despite multiple opportunities and requests for comment since 2015, the Commission has yet to find or receive any reliable consumer-survey data rebutting or contradicting the submitted survey findings, or establishing that consumers consistently receive their prescriptions. The only empirical evidence of prescriber compliance in the record is a survey of fifty-seven “high volume” prescribers submitted by AOA in response to the NPRM, which found that 93% responded “yes” when asked, “Do you follow Federal law and provide patients with a copy of their contact lens prescription upon completion of a contact lens fitting?” 
                        <SU>95</SU>
                        <FTREF/>
                         For the reasons stated in the SNPRM,
                        <SU>96</SU>
                        <FTREF/>
                         the Commission does not accord this survey significant weight, and finds that it does not counter the multiple consumer surveys conducted over a number of years showing prescriber non-compliance. The Commission accords the empirical data from multiple consumer surveys significant weight in establishing that a substantial percentage of prescribers are not complying with the automatic-prescription-release provision of the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>95</SU>
                             SNPRM, 84 FR at 24672; American Optometric Association (WS Comment #3303, Ex. B). This survey appears to have been conducted by the AOA itself rather than an outside polling firm. It is not clear from the AOA's submission how the fifty-seven optometrists were selected for the survey, what it means to be a “high volume” optometrist, or why high-volume optometrists were chosen.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>96</SU>
                             SNPRM, 84 FR at 24673 (noting concerns about the small sample size, lack of detail as to how prescriber respondents were recruited, and that the way the question is phrased allows prescribers to truthfully answer that they provide patients with a copy of their prescription even if they do not do so for 
                            <E T="03">every</E>
                             patient, and even if they only do so when the patient requests one).
                        </P>
                    </FTNT>
                    <P>
                        Apart from the empirical data discussed above, none of the commenters submitted new evidence relating to prescriber compliance. Many individual prescribers, however, continue to comment that they always comply with the requirement, as do all the prescribers they know, and therefore they believe that the Commission is looking to solve a non-existent problem.
                        <SU>97</SU>
                        <FTREF/>
                         Some prescribers also reiterated that, in their experience, consumers are well aware that they can buy lenses elsewhere so there is no need to educate them further about their rights.
                        <SU>98</SU>
                        <FTREF/>
                         And a few prescribers opined that the requirement was a “waste of time” because, in their experience, consumers would rather not have a copy of their prescription and know that they can request a copy whenever they want.
                        <SU>99</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>97</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Abert (SNPRM Comment #20); Hyndman (SNPRM Comment #21) (“every OD I know follows” the FCLCA requirements); Fair (SNPRM Comment #26) (“I have ALWAYS and will continue to comply fully with the prescription release requirements of the 2003 Fairness to Contact Lens Consumers Act.”); Hughes (SNPRM Comment #113) (most optometrists comply); Ridder (SNPRM Comment #720) (every patient gets their prescription whether they order or ask for it or not).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>98</SU>
                             Abert (SNPRM Comment #20); Jones (SNPRM Comment #48).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>99</SU>
                             Sikes (SNPRM Comment #114); Morey (SNPRM Comment #142).
                        </P>
                    </FTNT>
                    <P>
                        The Commission has considered these comments but does not believe they establish that prescribers, on the whole, are complying with the automatic-release requirement, or that consumers are fully aware of their prescription-portability rights. Any prescriber may indeed comply with the Rule but cannot speak for other eye care providers in the United States, nor for contact lens consumers.
                        <SU>100</SU>
                        <FTREF/>
                         In addition, several previous comments from prescribers and prescriber organizations who assert that they comply with the Rule actually revealed that many prescribers do not fully understand or comply with the Rule's requirement that prescriptions be provided “whether or not requested by the patient.” 
                        <SU>101</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>100</SU>
                             By one estimate, there are approximately 43,000 optometrists and 16,700 ophthalmologists in the U.S. FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel I: Overview of the Contact Lens Marketplace Tr. at 6 (Mar. 7, 2018), 
                            <E T="03">https://www.ftc.gov/system/files/documents/public_events/1285493/panel_i_overview_of_the_contact_lens_marketplace.pdf</E>
                             [hereinafter CLR Panel I Tr.].
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>101</SU>
                             
                            <E T="03">See</E>
                             SNPRM, 84 FR at 24673-74, discussing how a number of prescribers commented that they always 
                            <E T="03">offer</E>
                             prescriptions to consumers, or provide them 
                            <E T="03">on request.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not accord any weight to the comments that consumers do not want their prescriptions. As 
                        <PRTPAGE P="50676"/>
                        evidenced by the numerous NPRM comments from consumers urging the Commission to take action to ensure they are given their prescriptions, it cannot be doubted that many consumers have a compelling desire to have them.
                        <SU>102</SU>
                        <FTREF/>
                         And more importantly, Congress made the determination that prescribers must provide patients with their prescriptions automatically, “whether or not requested by the patient.” 
                        <SU>103</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>102</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Boue (NPRM Comment #1806); Collins (NPRM Comment #1811); Hamilton (NPRM Comment #1835); Acton (NPRM Comment #2070); Dunbar (NPRM Comment #2652); Capuano (NPRM Comment #2722); Muckley (NPRM Comment #2768); Taravella (NPRM Comment #2892); Martinez (NPRM Comment #2894); Ballou (NPRM Comment #3331). 
                            <E T="03">See also</E>
                             SNPRM, 84 FR at 24671 (recounting comments from dozens of consumers complaining that they were denied their prescriptions).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>103</SU>
                             FCLCA, 15 U.S.C. 7601(a)(1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Lack of Consumer Complaints as Evidence of Compliance</HD>
                    <P>
                        Some commenters reiterated the argument—raised and discussed in some detail in the SNPRM 
                        <SU>104</SU>
                        <FTREF/>
                        —that the lack of consumer complaints to the FTC about prescriber non-compliance is evidence that prescribers are releasing prescriptions as required.
                        <SU>105</SU>
                        <FTREF/>
                         In the SNPRM, the Commission explained that it did not equate the lack of complaints with compliance because based on its experience, the vast majority of injured or impacted consumers do not register complaints with the government and, for various reasons, even fewer are likely to file a formal complaint about a prescriber's failure to release their prescription.
                        <SU>106</SU>
                        <FTREF/>
                         The Commission also noted that more than fifty consumers submitted comments to the NPRM recounting personal stories of prescribers withholding their prescriptions, yet none of these commenters had previously registered complaints with the FTC.
                        <SU>107</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>104</SU>
                             SNPRM, 84 FR at 24674-75.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>105</SU>
                             Letter from Sens. Jack Reed and Sheldon Whitehouse (SNPRM Comment #6); Mass Mail Campaign (SNPRM Comment #25); Hanian (SNPRM Comment #27); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Levinson (SNPRM Comment #73); Cinalli (SNPRM Comment #93).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>106</SU>
                             SNPRM, 84 FR at 24674-75.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>107</SU>
                             
                            <E T="03">Id.</E>
                             at 24675.
                        </P>
                    </FTNT>
                    <P>
                        In response, the AOA commented that if complaints to the FTC are not a good bellwether of prescriber compliance because consumers are unlikely to file formal complaints, the FTC should simplify and improve its complaint-reporting system.
                        <SU>108</SU>
                        <FTREF/>
                         The AOA deemed it unfair for the Commission to rely on consumer survey data as evidence of prescribers' failure to release prescriptions, but not rely on the absence of consumer complaints as evidence that prescribers are automatically providing prescriptions.
                        <SU>109</SU>
                        <FTREF/>
                         The AOA stated the Commission should make an effort to make consumer complaint data—or lack thereof—more representative by providing a dedicated FCLCA complaint line for contact-lens-related issues.
                        <SU>110</SU>
                        <FTREF/>
                         At the same time, however, the AOA stated that since “it is very typical” for patients to ask for their prescription before their contact lens fitting is complete, consumer complaints cannot necessarily be viewed as accurate indications of non-compliance.
                        <SU>111</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>108</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>109</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>110</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>111</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not find these arguments persuasive. As noted in the SNPRM, the Commission has gleaned, through its extensive experience with consumer complaints and deceptive practices, that the vast majority of injured or impacted consumers do not file complaints with the government.
                        <SU>112</SU>
                        <FTREF/>
                         And with the exception of the Telemarketing Sales Rule (often referred to as “Do Not Call”), consumer complaints about FTC rule violations are rarer still, perhaps because they require that consumers know what an FTC rule specifies and how it has been violated.
                        <SU>113</SU>
                        <FTREF/>
                         While the Commission continues to regard consumer complaints as valuable and informative, they often represent the tip of the iceberg.
                    </P>
                    <FTNT>
                        <P>
                            <SU>112</SU>
                             SNPRM, 84 FR at 24675. Consumer reticence to complain, particularly to a government entity, is well documented. As one example, an FTC survey revealed that in 2017 there were an estimated 61.8 million incidents of fraud in the United States with approximately 40 million individual victims and average losses of $100 or more, yet the FTC received just 1.2 million complaints of fraud from consumers, approximately 1.9% of all incidents. Keith B. Anderson, FTC, “Mass Market Consumer Fraud in the United States, A 2017 Update,” 24, 56 (Oct. 2019); FTC, “Consumer Sentinel Network Data Book 2017,” Number of Reports by Type, 
                            <E T="03">https://www.ftc.gov/site-information/open-government/data-sets#csn.</E>
                             It is likely these figures actually overstate the percentage of frauds reported to the FTC, since the FTC's fraud surveys are limited to specific types of fraud, while there is no such limitation on complaints of fraud from consumers. 
                            <E T="03">See also</E>
                             Keith B. Anderson, FTC, “Consumer Fraud in the United States: An FTC Survey” 80 (2004), 
                            <E T="03">http://www.ftc.gov/reports/consumer-fraud-united-states-ftc-survey,</E>
                             (indicating that only 8.4% of U.S. fraud victims complained to an official source, with only 1.4% complaining to the FTC); Marc A. Grainer et al., “Consumer Problems and Complaints: a National View,” 6 Advances in Consumer Res. 494 (1979) (noting that “only a small, vocal minority of consumers complain about the problems they experience,” and even fewer (less than 10% of complaints) complain to the government), 
                            <E T="03">http://acrwebsite.org/volumes/9603/volumes/v06/NA-06;</E>
                             John Goodman &amp; Steve Newman, “Understand Customer Behavior and Complaints,” Quality Progress, Jan. 2003, at 51 (finding that for problems that resulted in a relatively minor inconvenience or a small loss of money, only 3% of consumers complained), 
                            <E T="03">http://web.ist.utl.pt/~ist11038/CD_Casquilho/PRINT/qp0103goodman.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>113</SU>
                             
                            <E T="03">See generally,</E>
                             FTC, “Consumer Sentinel Network Data Book 2017,” Number of Reports by Type, 
                            <E T="03">https://www.ftc.gov/site-information/open-government/data-sets#csn.</E>
                             FTC, “Consumer Sentinel Network Data Book for January-December 2016” (2017), 
                            <E T="03">https://www.ftc.gov/system/files/documents/reports/consumer-sentinel-network-data-book-january-december-2016/csn_cy-2016_data_book.pdf.</E>
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, for reasons discussed in detail in the NPRM, the Commission does not believe its complaint-reporting system bears principal responsibility for the shortage of complaints about prescriber violations of the Contact Lens Rule.
                        <SU>114</SU>
                        <FTREF/>
                         While the FTC does not have a dedicated complaint system solely for FCLCA violations, as sought by the AOA, the FTC Complaint Assistant is configured to capture and report all contact lens-related complaints, whether they originate from consumers, prescribers, sellers, or others.
                        <SU>115</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>114</SU>
                             NPRM, 81 FR at 88554-55.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>115</SU>
                             The Commission also notes that if, as the AOA asserts, some consumers would complain that they did not receive their prescriptions before they were, in fact, entitled to them, creating a dedicated system for FCLCA complaints would not make the number of complaints any more or less reflective of prescriber compliance.
                        </P>
                    </FTNT>
                    <P>
                        More to the point, multiple surveys have established that a high percentage of contact lens wearers (46-60%, according to submitted data) do not realize they are entitled to receive their prescription,
                        <SU>116</SU>
                        <FTREF/>
                         and thus would not be aware that an incident about which they should complain had occurred. Many other consumers might be unaware of where to direct a complaint when they do not receive a prescription. Even consumers who are aware that they have a right to their prescription, and know they can file a complaint with the FTC, may be unlikely to file one if they ultimately receive their prescription 
                        <E T="03">after they have asked their provider for it.</E>
                         From the consumers' perspective, they have resolved their problem and may perceive little benefit to themselves from filing a complaint with the government, even if the method for filing one was more streamlined or convenient. Consumers may also not want to risk antagonizing their providers or subjecting them to legal penalties. Thus, for evaluating Contact Lens Rule compliance, the Commission has considered the low rate of consumer complaints filed with the FTC's Complaint Assistant, but remains convinced this is less probative of the 
                        <PRTPAGE P="50677"/>
                        scope of the problem than other evidence.
                        <SU>117</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>116</SU>
                             SNPRM, 84 FR at 24675.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>117</SU>
                             Consumer surveys may also be more reliable since consumers questioned at random are less likely to have a personal interest in stating that they did not receive their prescription.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">c. Number of Verifications as Evidence of Non-Compliance With the Automatic Prescription Release Requirement</HD>
                    <P>
                        In the SNPRM, the Commission noted that it would accord the number of verifications less weight than it had in the NPRM as evidence of prescriber non-compliance out of a recognition that some consumers—even if in possession of their prescription—may find it easier to type in their specifications than present a prescription to the seller, and because some online contact lens sellers do not have a mechanism for consumers to present their prescriptions.
                        <SU>118</SU>
                        <FTREF/>
                         In its comment to the SNPRM, the AOA contended that the high number of verifications should not be accorded 
                        <E T="03">any</E>
                         weight at all for those reasons. As additional support for this contention, the AOA cited internal prescriber complaint data showing that the percentage of prescriber complaints about “problematic verification calls” has increased from roughly 6% to 17% in the past four years; it attributed much of this increase to the emergence of an online seller that does not permit patient prescription presentation.
                        <SU>119</SU>
                        <FTREF/>
                         According to the AOA, the increase in complaints about verification, and the high percentage of such complaints about the online seller, demonstrate that a “high volume of verification calls are occurring based on a prescription that was never written,” and therefore the number of verification calls is “simply not an appropriate measure for assessing contact lens prescription requirements and should be afforded no weight.” 
                        <SU>120</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>118</SU>
                             SNPRM, 84 FR at 24674.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>119</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>120</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission is aware of the issues raised by the AOA, but still believes that the high number of verifications is an indication that many consumers are not receiving their prescriptions from their prescribers. While a few new online sellers do not permit prescription presentation, these sellers' share of the overall contact lens sales is still quite small, even if their share of prescriber complaints, according to the AOA, is disproportionately large.
                        <SU>121</SU>
                        <FTREF/>
                         Sellers with far greater sales, such as 1-800 CONTACTS and Walmart, actively encourage consumers to present their prescriptions, and 1-800 CONTACTS has even at times offered consumers discounts for doing so, because it is faster and less expensive than verification.
                        <SU>122</SU>
                        <FTREF/>
                         Yet despite that encouragement, roughly 73% of overall sales by third-party sellers continues to occur via verification.
                        <SU>123</SU>
                        <FTREF/>
                         Therefore, while the Commission will accord the high number of verifications less weight than it did in the NPRM, the Commission cannot dismiss its significance altogether as an indicator that consumers are not always provided their prescriptions, and will consider it as one of several factors in weighing the evidence of non-compliance in the record. The Commission also notes that even if the high number of verifications were disregarded altogether, the Commission's overall assessment of prescriber compliance, and the need for Rule modifications, would not change.
                    </P>
                    <FTNT>
                        <P>
                            <SU>121</SU>
                             1-800 CONTACTS accounts for approximately 10% of overall retail contact lens sales in the United States, and as much as 60-65% of online sales. The next closest online competitor has less than a quarter of the sales of 1-800 CONTACTS. 
                            <E T="03">See</E>
                             Fed. Trade Comm'n, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel IV: Examining the Verification Process Tr. at 17 (Mar. 7, 2018), 
                            <E T="03">https://www.ftc.gov/system/files/documents/public_events/1285493/panel_iv_examining_the_verification_process.pdf</E>
                             [hereinafter CLR Panel IV Tr.] (statement of Cindy Williams, 1-800 CONTACTS General Counsel). Walmart accounts for between 6-10% of all U.S. contact lens sales. Complaint Counsel's Post-Trial Brief and Exhibits, 
                            <E T="03">In the Matter of 1-800 CONTACTS,</E>
                             5, (June 22, 2017), 
                            <E T="03">https://www.ftc.gov/system/files/documents/cases/d09372ccfindingsoffact.pdf;</E>
                             Respondent 1-800 CONTACTS Proposed Findings of Fact and Conclusions of Law, 
                            <E T="03">In the Matter of 1-800 CONTACTS,</E>
                             59 (June 22, 2017), 
                            <E T="03">https://www.ftc.gov/system/files/documents/cases/d09372respfindingsoffact.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>122</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (“Because of the cost and time it takes to verify a prescription when the script is not available, typically an online seller encourages such uploading and this process aids in consumer satisfaction and quicker, more accurate service.”); 1-800 CONTACTS (SNPRM Comment #135) (1-800 CONTACTS encourages its customers to upload their prescriptions). 
                            <E T="03">See also</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 6-7 (statement of Jennifer Sommer of Walmart); 
                            <E T="03">id.</E>
                             at 6-7, 22 (statement of Cindy Williams of 1-800 CONTACTS).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>123</SU>
                             Paperwork Reduction Act Proposed Collection, Comment Request, 84 FR at 32171. 
                            <E T="03">See also</E>
                             1-800 CONTACTS (NPRM Comment #3898) (stating that 70% of online orders require verification).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Comments About the Need To Improve the Commission's Ability To Monitor Compliance and Enforce the Rule</HD>
                    <P>
                        Several commenters focused on the need to create an auditable record that would enable the Commission to monitor compliance and better enforce the automatic-release provision.
                        <SU>124</SU>
                        <FTREF/>
                         One commenter, the Coalition for Contact Lens Consumer Choice, stated the Confirmation of Prescription Release proposal gives prescribers more leeway to design a system of confirmation of prescription release, but “the important thing is that prescribers are still required to have patients affirmatively acknowledge release. . . . This is critical to increase enforcement of the law and to ensure that bad actors are identified quickly without inconveniencing those who are obeying the law.” 
                        <SU>125</SU>
                        <FTREF/>
                         The commenter Citizen Outreach agreed, stating that the only way to ensure compliance with automatic release is by requiring consumers to sign a confirmation, and suggested that failing to require a consumer's signed confirmation would be a loophole “large enough for `bad actors' to drive a truckload of contact lenses through.” 
                        <SU>126</SU>
                        <FTREF/>
                         Likewise, the Attorneys General of Twenty-Seven States commented that the proposed Confirmation of Prescription Release modifications “strengthen the Commission's ability to verify compliance with the CLR [which] ensures more contact lens consumers have the necessary information to make informed decisions, spurring competition and consumer choice.” 
                        <SU>127</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>124</SU>
                             Bosley (SNPRM Comment #58); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>125</SU>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>126</SU>
                             Citizen Outreach (SNPRM Comment #78).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>127</SU>
                             Attorneys General of 27 States (SNPRM Comment #139).
                        </P>
                    </FTNT>
                    <P>
                        Other commenters, however, felt that the FTC already has sufficient mechanisms to enforce the Contact Lens Rule, and should bring enforcement actions against so-called “outliers” who are violating the Rule, rather than imposing new requirements on all contact lens prescribers.
                        <SU>128</SU>
                        <FTREF/>
                         Some suggested that the Confirmation of Prescription Release requirements should be imposed only on those found to be violating the prescription-release requirement.
                        <SU>129</SU>
                        <FTREF/>
                         “By refocusing these ideas as penalties, rather than mandates,” according to AAO, “the FTC can ensure that they are not inflicting burdens on prescribers that have a record of compliance with the prescription release requirement in the 
                        <PRTPAGE P="50678"/>
                        CLR.” 
                        <SU>130</SU>
                        <FTREF/>
                         AOA believes that the FTC already has sufficient authority and investigative tools at its disposal, and suggested the Commission could use its ability to issue administrative subpoenas to investigate prescribers who might be violating the Rule.
                        <SU>131</SU>
                        <FTREF/>
                         One prescriber also commented that he was skeptical that prescribers who currently disregard the prescription-release requirement would comply with the confirmation requirement,
                        <SU>132</SU>
                        <FTREF/>
                         a concern previously raised and discussed in the SNPRM.
                        <SU>133</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>128</SU>
                             Mass Mail Campaign (SNPRM Comment #25); Ohio Optometric Association (SNPRM Comment #47); Hardy (SNPRM Comment #60) (“Is it a fair idea to punish 100% of optometrists and ophthalmologists for the actions of a fraction of 1%”); American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136) (practices will have to comply with the new burdens even if they have complied with prescription-release for over a decade).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>129</SU>
                             American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>130</SU>
                             American Academy of Ophthalmology (SNPRM Comment #136). The AAO suggested that the acknowledgment and record-keeping provisions should be imposed on prescribers who have had multiple complaints, and whose non-compliance was verified after allowing prescribers an avenue to respond and defend themselves.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>131</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>132</SU>
                             Steinemann (SNPRM Comment #138).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>133</SU>
                             SNPRM, 84 FR at 24676, 24681.
                        </P>
                    </FTNT>
                    <P>
                        Some commenters also criticized the FTC for, in their words, trying to acquire new authority to target small and mid-sized businesses, and stated this ran counter to the current trend for Congress and other federal agencies to “recognize the need to alleviate the administrative burden that federal programs place on physician practices.” 
                        <SU>134</SU>
                        <FTREF/>
                         And several commenters asserted that the Commission should not focus on enforcing requirements against prescribers while contact lens sellers, in their view, are violating Rule provisions in far greater numbers.
                        <SU>135</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>134</SU>
                             American Society of Cataract and Refractive Surgery (SNPRM Comment #127). 
                            <E T="03">See also</E>
                             Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>135</SU>
                             McManus (SNPRM Comment #18); Ulrich (SNPRM Comment #19) (FTC is punishing the wrong actors); Gilberg (SNPRM Comment #46); American Optometric Association (SNPRM Comment #96); American Academy of Ophthalmology (SNPRM Comment #136).
                        </P>
                    </FTNT>
                    <P>After considering these comments, the Commission continues to believe that some form of retained documentation is necessary to improve the Commission's enforcement and monitoring ability. As previously noted, the Commission currently faces challenges in enforcing the Rule. Prescribers, whether intentionally or not, currently can fail to release prescriptions yet risk little because consumers are unlikely to file a complaint if they ask for and subsequently receive a prescription. When a consumer does complain to the FTC, typically the only evidence is the word of the consumer against that of the prescriber, making it difficult for the Commission to establish with a degree of certainty whether a violation has occurred. This fact has played a significant role in the lack of Rule enforcement against prescribers over the last fifteen years, and may be a contributing factor to the high number of contact lens patients who do not currently receive their prescriptions automatically as required by law.</P>
                    <P>
                        While the AOA suggests that the Commission can use its current authority to issue administrative subpoenas and conduct investigative hearings to explore possible Rule violations, an examination of a prescriber's Confirmation of Prescription Release records allows a much more efficient means of determining whether a prescriber is complying with the Rule, and is much less disruptive and burdensome for the prescriber.
                        <SU>136</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>136</SU>
                             Serving administrative subpoenas on a wide-scale basis to prescribers who might not be releasing prescriptions, and requiring that a prescriber identify all of her contact lens customers for the last several months so they could be interviewed, would likely be criticized as excessive and heavy-handed.
                        </P>
                    </FTNT>
                    <P>As for the assertion that prescribers who do not currently comply with prescription release are unlikely to comply with the confirmation requirement, the difference is that in the latter instance, there would be a way to check compliance. If the Commission has concerns about a prescriber's compliance, it can request patient confirmations or proof of digital delivery, or a sample of such, which should resolve most questions as to whether the prescriber provided prescriptions in accordance with the law. In this way, it would benefit prescribers because they would have a relatively quick and inexpensive way to show the FTC they complied with their automatic-release obligations.</P>
                    <P>
                        Further, the Commission is not attempting to expand its authority to target small businesses. The Commission already possesses the authority under the FCLCA to enforce the Rule for all contact lens prescribers, large and small. The Commission's Final Rule institutes a more effective mechanism for enforcing and evaluating the authority it already has. And while the Commission recognizes the need to avoid unnecessary government regulations, the Rule itself is, as one commenter put it, “deregulatory” in nature since its purpose is to restore free market competition, not to rein it in.
                        <SU>137</SU>
                        <FTREF/>
                         If the Rule, as currently applied and enforced, is failing to meet this congressionally mandated goal in some respects, it is the duty of the Commission to find a more effective manner to realize that purpose.
                    </P>
                    <FTNT>
                        <P>
                            <SU>137</SU>
                             National Taxpayers Union (SNPRM Comment #149).
                        </P>
                    </FTNT>
                    <P>
                        With regard to the argument that it is unjust to focus on enforcing the automatic-release provision while not enforcing regulations that apply to sellers, the Commission does not agree with this premise. The Commission is aware of complaints about seller misconduct and is implementing several changes in this Final Rule to improve seller compliance. The Commission has also brought enforcement actions against sellers for violating the Rule and expects it will bring others in the future.
                        <SU>138</SU>
                        <FTREF/>
                         Moreover, seller non-compliance does not excuse prescriber non-compliance, nor does it provide a justification for the Commission to reject taking action to improve compliance with a different requirement in the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>138</SU>
                             
                            <E T="03">See, e.g., U.S.</E>
                             v. 
                            <E T="03">Duskin,</E>
                             No. 1:18-cv-07359 (N.D. Cal. Dec. 6, 2018) (consent) 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Kim,</E>
                             No. 1:11-cv-05723 (E.D.N.Y. Feb 7, 2012) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Royal Tronics, Inc,</E>
                             No. 0:11-cv-62491 (S.D. Fla. Jan. 27, 2012) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Thy Xuan Ho,</E>
                             No. 1:11-cv-03419 (D. Minn. Dec. 27, 2011) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Gothic Lens, LLC,</E>
                             No. 1:11-cv-00159 (N.D. Ga. Feb. 3, 2011) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Jokeshop,</E>
                             LLC, No. 1:11-cv-11221 (D. Mass. Nov. 29, 2011) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Contact Lens Heaven, Inc.,</E>
                             No. 0:08-cv-61713 (S.D. Fla. Dec. 3, 2008) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Chapin N. Wright, II,</E>
                             No. 1:08-cv-11793 (D. Mass. Oct. 31, 2008) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">BeWild, Inc.,</E>
                             No. 2:07-cv-04896 (E.D.N.Y. Dec. 3, 2007) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Pretty Eyes, LLC,</E>
                             No. 1:07-cv-02462 (D. Colo. Nov. 28, 2007) (consent); 
                            <E T="03">U.S.</E>
                             v. 
                            <E T="03">Walsh Optical, Inc.,</E>
                             No. 2:06-cv-03591 (D.N.J. Aug. 30, 2006) (consent); 
                            <E T="03">see also</E>
                             FTC Sends Warning Letters to Sellers of Cosmetic Contacts: All Contact Lens Purchases Require a Prescription from a Medical Professional, 
                            <E T="03">https://www.ftc.gov/news-events/press-releases/2019/10/ftc-sends-warning-letters-sellers-cosmetic-contacts-all-contact;</E>
                             FTC Issues Warning Letters Regarding the Agency's Contact Lens Rule, 
                            <E T="03">https://www.ftc.gov/news-events/press-releases/2016/04/ftc-issues-warning-letters-regarding-agencys-contact-lens-rule.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Comments About Whether the Structure of the Contact Lens Market Creates a Need for Verifiable Enforcement of Automatic Prescription Release</HD>
                    <P>
                        Many SNPRM commenters focused on the structure of the contact lens market and whether a system in which prescribers sell the items they prescribe creates an inherent conflict that requires additional corrective action by the Commission.
                        <SU>139</SU>
                        <FTREF/>
                         U.S. Senator Ron Wyden, for example, commented that 
                        <PRTPAGE P="50679"/>
                        Congress passed the FCLCA “to address a distorted contact lens marketplace that had seen freedom of choice eroded as prescribers largely sold the contact lenses they prescribed,” 
                        <SU>140</SU>
                        <FTREF/>
                         and another commenter wrote, “The system here in the U.S. for buying contact lenses is stacked against consumers because the people who issue you your prescription are also allowed to sell you contact lenses at the very same time. Consumers who don't know their rights are getting `trapped in the exam chair' so to speak, unaware that they can buy lenses elsewhere for lower prices.” 
                        <SU>141</SU>
                        <FTREF/>
                         According to the Information Technology &amp; Innovation Foundation, which describes itself as a nonpartisan research and educational institute, “the profession has both a powerful economic interest (profits) and a powerful tool (the prescription) to make it more difficult for consumers to buy their lenses from lower-cost providers.” 
                        <SU>142</SU>
                        <FTREF/>
                         In fact, a number of commenters support the Commission's proposal because, while regulatory in nature, it is designed to promote free market competition and protect consumers' ability to purchase from the seller of their choice.
                        <SU>143</SU>
                        <FTREF/>
                         One commenter wrote that the only solution to what she termed “the inherent structural problem that continues to cause friction between providers and patients” is to prohibit prescribers from selling contact lenses.
                        <SU>144</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>139</SU>
                             Citizen Outreach (SNPRM Comment #78) (prescribers' ability to sell what they prescribe ensures a “captive market”); Lens.com (SNPRM Comment #85) (“the current system is rigged against consumers and companies who compete with prescribers”); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Taxpayers Protection Alliance (SNPRM Comment #118); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>140</SU>
                             Letter from Sen. Ron Wyden (SNPRM Comment #5); 
                            <E T="03">see also</E>
                             Taxpayers Protection Alliance (SNPRM Comment #118) (“Congress passed the bipartisan Fairness to Contact Lens Consumers Act to protect contact lens wearers. The result was less market distortion and more competition, leading to more choices and lower prices for consumers.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>141</SU>
                             National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>142</SU>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>143</SU>
                             
                            <E T="03">See</E>
                             Americans for Tax Reform (SNPRM Comment #72) (“These changes strike the correct balance between promoting the free market and protecting important consumer rights.”); Citizen Outreach (SNPRM Comment #78); Taxpayers Protection Alliance (SNPRM Comment #118) (“Although we are often critical of government overreach and work hard to make government smaller, we believe that the FTC's proposed Contact Lens Rule is a government rule that works for taxpayers and consumers.”); National Taxpayers Union (SNPRM Comment #149) (“From the perspective of free-market, limited government advocates, the Contact Lens Rule has been one of the most balanced and successful examples of `deregulatory rulemaking' in the FTC's history.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>144</SU>
                             Carafas (SNPRM Comment #39).
                        </P>
                    </FTNT>
                    <P>
                        The AOA, on the other hand, disputes the premise that the contact lens market is unique, and argues that the fact that prescribers sell what they prescribe does not create an impetus for corrective regulation.
                        <SU>145</SU>
                        <FTREF/>
                         According to the AOA, health care professionals in certain other areas—such as ambulatory surgery centers, orthopedic centers, and dental service providers, among others—also sell what they prescribe or recommend for treatment. Furthermore, according to the AOA, helping patients “obtain treatment while in their doctor's office builds strong doctor-patient relationships and promotes patient-centered care.” 
                        <SU>146</SU>
                        <FTREF/>
                         The AOA therefore concludes that “the Commission seems to have used the inaccurate belief that contact lens prescribers' role in the market is entirely unique as a justification for implementing new regulations on physicians,” and thus, “the entire argument for supporting prescriber rule changes must be reevaluated.” 
                        <SU>147</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>145</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>146</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>147</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Several commenters also felt that the contact lens market is functioning properly, as evidenced by the relatively large number of contact lens sellers, and by lens prices that appear competitive, and thus there is no need for FTC intervention to modify the Rule.
                        <SU>148</SU>
                        <FTREF/>
                         As support for this position, the AOA submitted a price-comparison analysis that it stated showed that the average price difference for contact lenses between online sellers and office prescribers was just thirty-two cents.
                        <SU>149</SU>
                        <FTREF/>
                         According to the AOA, this demonstrates that the market is highly competitive, and thus the FCLCA and Rule are working as intended and, consequently, there is no need for Rule modification and a Confirmation of Prescription Release.
                        <SU>150</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>148</SU>
                             Warner (SNPRM Comment #9); Ohio Optometric Association (SNPRM Comment #47); Cutter (SNPRM Comment #81); American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>149</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>150</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not share this assessment. While there are now a number of different types of sellers, and the market has become more competitive than it was before the Rule,
                        <SU>151</SU>
                        <FTREF/>
                         prescribers still possess a significantly higher share of contact lens sales than online sellers, mass merchandisers, or retail chains,
                        <SU>152</SU>
                        <FTREF/>
                         even though prescriber prices, on the whole, are consistently higher.
                        <SU>153</SU>
                        <FTREF/>
                         The AOA's assessment appears to be based on lens price per-packet, rather than per-day or per-year.
                        <SU>154</SU>
                        <FTREF/>
                         The Commission does not believe per-packet pricing is a fair method of comparison, because it compares some lenses that are effectively sold in a multi-month supply with lenses that are only sold as a single month's supply. The Commission conducted a re-analysis of the AOA's data by aggregating to a consistent time-frame in order to compare what consumers might actually spend to wear lenses on a regular basis. This re-analysis—using the data supplied by AOA—determined that the average annual prices of contacts were from $9 to $40 more expensive if purchased from a private practice than from the leading online seller.
                        <SU>155</SU>
                        <FTREF/>
                         The price difference for an annual supply of lenses was even starker between a private practitioner and a leading mass merchandiser, with private practitioners averaging between $62 and $92 more for an annual supply.
                        <SU>156</SU>
                        <FTREF/>
                         Likewise, at the Commission's Contact Lens Workshop, an eye care consultant presented a price survey for sixteen leading contact lens brands and concluded that an annual supply of lenses purchased online 
                        <PRTPAGE P="50680"/>
                        averaged $17.56 less than at an independent prescribers' office, and lenses purchased from a shopper's club averaged $42.44 less.
                        <SU>157</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>151</SU>
                             CLR Panel I Tr., 
                            <E T="03">supra</E>
                             note 100, at 3-5 (remarks of Steve Kodey and accompanying slides, U.S. Optical Market Overview).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>152</SU>
                             Approximately 39% of all contact lenses sales revenue in the U.S. occurs at independent eye care professionals, compared to 18% at conventional chains, 25% at mass merchants and wholesale clubs, and 16% online. Vision Council, U.S. Optical Market Eyewear Overview 4 (2018), 
                            <E T="03">https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf.</E>
                             It is also worth noting that while the contact lens retail market has evolved since 2004, it may well have changed 
                            <E T="03">less</E>
                             dramatically than many other retail industries have since the internet revolution began diverting sales from brick and mortar to online merchants.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>153</SU>
                             
                            <E T="03">See</E>
                             CLR Panel I Tr., 
                            <E T="03">supra</E>
                             note 100, at 9 (remarks of Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales Channel); 
                            <E T="03">see also</E>
                             Opinion of the Commission, 
                            <E T="03">In the Matter of 1-800 CONTACTS,</E>
                             4 (“Among brick-and-mortar retailers, independent ECPs typically have the highest prices for contact lenses . . . .”), 
                            <E T="03">https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>154</SU>
                             The Commission has not been able to precisely replicate the thirty-two-cent-difference figure stated by AOA. But by comparing average packet prices in the data supplied, the difference between private practices and online sellers is 35 cents. For the reasons stated, however, the Commission does not believe this figure is an appropriate comparison measure.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>155</SU>
                             The average depends on whether a consumer purchased an annual supply all at once (in which case they received a discount from the online retailer) or in individual package increments. The Commission also notes that prices at the “Leading Online Retailer,” which, based on sales and market share, could be 1-800 CONTACTS, might not represent the average online price for contact lenses, and prices at 1-800 CONTACTS, by its own admission, are typically higher than those of both other online sellers and retail club stores. Brief of 1-800 CONTACTS, 
                            <E T="03">1-800 CONTACTS</E>
                             v. 
                            <E T="03">Federal Trade Commission</E>
                             (2d Cir. June 12, 2019); 
                            <E T="03">see also</E>
                             Opinion of the Commission, 
                            <E T="03">In the Matter of 1-800 CONTACTS,</E>
                             4, 
                            <E T="03">https://www.ftc.gov/system/files/documents/cases/docket_no_9372_opinion_of_the_commission_redacted_public_version.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>156</SU>
                             The data derives from the ABB Optical Group, Soft Lens Retail Price Monitor (First Quarter 2019).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>157</SU>
                             CLR Panel I Tr., 
                            <E T="03">supra</E>
                             note 100, at 9 (remarks of Wallace Lovejoy and accompanying slides, Contact Lens Price Ranges By Sales Channel).
                        </P>
                    </FTNT>
                    <P>
                        There can be valid reasons for differences in prices among sellers (some sellers may offer more convenience, options, or better customer service), and the Commission does not view price differences between private eye care practitioners and third-party sellers, in and of itself, as dispositive evidence that the market is not functioning in a competitive manner. But the Commission disagrees that the submitted pricing data is proof that the market 
                        <E T="03">is</E>
                         functioning in a perfectly competitive manner, and is proof that prescribers are providing patients with their prescriptions.
                    </P>
                    <P>
                        The Commission is also aware that there are other health care professionals who may sell what they prescribe or recommend for treatment, and has not based its proposal solely on a belief that contact lens prescribers' role and market is unique. Rather, the Commission has considered the structure of the market as a contributing factor in an overall evaluation of the need for improved Rule compliance and enforcement. It must be acknowledged—as it was by Congress when it enacted the FCLCA and directed the FTC to implement the Rule—that it is not in prescribers' self-interest for their patients to take prescriptions elsewhere to buy lenses.
                        <SU>158</SU>
                        <FTREF/>
                         And while it is true that some health care professionals in other fields sell products that they prescribe or recommend for treatment, the sheer volume of contact lens prescribers' revenue and profit derived from the sale of contact lenses—16-32% of revenue, by some accounts 
                        <SU>159</SU>
                        <FTREF/>
                        —creates a powerful incentive to keep those sales in house.
                    </P>
                    <FTNT>
                        <P>
                            <SU>158</SU>
                             
                            <E T="03">See</E>
                             H.R. Rep. No. 108-318, at 4-5 (stating that “[t]he practice of optometrists withholding the prescription has limited the consumer's ability to shop for the best price and has impacted competition” and that obstacles to free market competition are rooted in an “inherent conflict of interest” in that “[u]nlike medical doctors who are prohibited from selling the drugs they prescribe, eye doctors and optometrists . . . are able to fill the contact lens prescriptions they write”); 
                            <E T="03">see also</E>
                             149 Cong. Rec. H11564-65 (daily ed. Nov. 19, 2003) (statement of Rep. Stark) (“Eye doctors cite health concerns, but the fact is they have a strong financial incentive to restrict consumer access to the contact lens market.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>159</SU>
                             Harris Williams &amp; Co., Vision Industry Update, at 4 (Mar. 2017); Harris Williams &amp; Co., Vision Industry Overview, at 3 (Jan. 2015). Contact Lens Spectrum has estimated the percentage of gross practice revenue from contact lenses to be 30%, and the net practice revenue at 26%, but the estimate does not specify how much of that was derived from sales of lenses versus professional fees for contact lens fittings and examinations. Contact Lens Spectrum, at 19 (Jan. 2019), 
                            <E T="03">https://bt.editionsbyfry.com/publication/frame.php?i=552776&amp;p=&amp;pn=&amp;ver=html5. See also</E>
                             Ken Kriviac, How to Hubble-Proof Your Contact Lens Practice, Review of Optometric Business (Jan. 17, 2018) (optometrist stating that 17% of his practice's total revenue is generated from the sale of contact lens related materials, with another 8% from related professional fees), 
                            <E T="03">https://reviewob.com/can-hubble-proof-contact-lens-practice/.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. Comments About the Text of the Proposed Confirmation of Prescription Release, and the Options To Include the Confirmation as Part of a Patient's Prescription or Sales Receipt</HD>
                    <P>
                        As noted previously, unlike the two-sentence signed-acknowledgment proposal from the NPRM,
                        <SU>160</SU>
                        <FTREF/>
                         the SNPRM's Confirmation of Prescription Release proposal did not mandate specific text for the patient's signed confirmation. Instead, the SNPRM, for convenience, provided optional sample language that prescribers could use but left it up to individual prescribers to draft their own confirmation language if they so preferred.
                        <SU>161</SU>
                        <FTREF/>
                         The Commission proposed this flexibility in response to commenter concerns that the language of the NPRM's signed-acknowledgment interfered with the prescriber-patient relationship by imparting the impression that prescribers had done something wrong. By permitting prescribers to draft their own confirmation language or use the provided, shortened sample language, the Commission aimed to allow prescribers to use wording that they believe would be less likely to reflect negatively on the prescribers' conduct.
                        <SU>162</SU>
                        <FTREF/>
                         The Commission also proposed to allow prescribers to include the confirmation as part of a patient's prescription or sales receipt.
                        <SU>163</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>160</SU>
                             NPRM, 81 FR at 88559.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>161</SU>
                             SNPRM, 84 FR at 24683. The sample language provided by the Commission consisted of the following: “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting.”
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>162</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>163</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        One commenter, the National Association of Optometrists and Opticians (“NAOO”), praised the new options and flexibility, stating it would “assist the industry in, and lighten the burdens of, compliance.” 
                        <SU>164</SU>
                        <FTREF/>
                         The NAOO also approved of the FTC sample confirmation language, calling it a “concise statement of the point of the Rule,” and predicting it would be used by most of its members.
                        <SU>165</SU>
                        <FTREF/>
                         The NAOO did suggest, however, that to avoid potential confusion from a confirmation statement containing additional acknowledgments or unnecessary information, the Rule should clarify that the patient's confirmation statement should not contain any message or acknowledgment other than that relating to confirmation of prescription release.
                        <SU>166</SU>
                        <FTREF/>
                         The NAOO also suggested that in instances where a consumer refused to sign the confirmation, the Commission should allow the prescriber to note the refusal and the reason for it as evidence of compliance.
                        <SU>167</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>164</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>165</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>166</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>167</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Other commenters felt that even with the new confirmation-language flexibility, requiring patients to confirm receipt of their prescriptions would imply that prescribers had been improperly withholding them.
                        <SU>168</SU>
                        <FTREF/>
                         One prescriber commented, “Why would I need to get a signature of my patient to confirm they received a prescription unless I was doing something wrong that required proof.” 
                        <SU>169</SU>
                        <FTREF/>
                         Others felt that the requirement still unfairly forced them to aid their competition by reminding consumers that they could take their prescriptions to other sellers to have them filled.
                        <SU>170</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>168</SU>
                             Abert (SNPRM Comment #20) (“The additional time required for this unneeded paperwork would disrupt the patient-doctor relationship by communicating to the patients that they should be wary of their physician, and assume that their doctor is a violator of Federal law.”); Ohio Optometric Association (SNPRM Comment #47) (“The proposal, even in its latest form, will . . . cast public doubt on the integrity of the optometrists and ophthalmologists . . . .”); Cutter (SNPRM Comment #81); Ritzel (SNPRM Comment #157) (“The idea of me having to have a patient sign a form certifying that I actually gave them a copy of their contact lens prescription—because “Big Brother” is watching—is insulting to myself as a person, and to my profession.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>169</SU>
                             Cutter (SNPRM Comment #81).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>170</SU>
                             Sanders (SNPRM Comment #61) (“It's akin to having Target have a big sign next to their own that states, `You can get everything here at Walmart as well!' ”); Poulter (SNPRM Comment #131) (“It is no more necessary for providers to inform patients of their right to purchase elsewhere than it is for a dentist to let a patient know he can purchase a crown from another party, then return to the dentist to have it placed.”).
                        </P>
                    </FTNT>
                    <P>
                        In contrast, some commenters felt that allowing prescribers to draft their own language, and removing the second sentence of the acknowledgment (the requirement that patients confirm the statement: “I understand I am free to purchase contact lenses from the seller of my choice”), greatly reduced the effectiveness of the new proposal.
                        <SU>171</SU>
                        <FTREF/>
                         The online seller 1-800 CONTACTS, in particular, asserted that removal of the second sentence significantly reduced the educational benefit of the 
                        <PRTPAGE P="50681"/>
                        requirement since consumers who were unaware they had a right to their prescription would not be so informed. 1-800 CONTACTS also stated that eliminating the second sentence made it less likely prescribers would release prescriptions directly after the fitting is complete, and prescribers would instead wait until patients had purchased lenses before giving them their prescriptions and obtaining Confirmations of Prescription Release.
                        <SU>172</SU>
                        <FTREF/>
                         1-800 CONTACTS also said there is no reason the second sentence would “sow consumer doubt or harm prescribers' reputations” unless the prescriber had previously been withholding prescriptions.
                        <SU>173</SU>
                        <FTREF/>
                         The online seller therefore proposed that instead of leaving the wording up to prescribers, the confirmation requirement should again specify the wording required and include the second sentence from the acknowledgment proposal—albeit with a minor adjustment—so as to state, “I understand that I am free to purchase contact lenses from my eye care professional or the seller of my choice.” 
                        <SU>174</SU>
                        <FTREF/>
                         Inclusion of the option to purchase from the “eye care professional” might alleviate some concern that the notice was instructing consumers to buy from someone other than their prescriber.
                    </P>
                    <FTNT>
                        <P>
                            <SU>171</SU>
                             Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>172</SU>
                             1-800 CONTACTS (SNPRM Comment #135) (According to a survey conducted by an independent polling firm on behalf of 1-800 CONTACTS, 38% of consumers who are given their prescription receive it at the same time or only after they have already purchased lenses from the prescriber).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>173</SU>
                             
                            <E T="03">Id.</E>
                             (“Because the Confirmation does not require that prescribers provide consumers with any notice of their rights, but merely requires that consumers acknowledge receipt by signature, it is far less likely to either educate consumers or discourage prescribers from pressuring consumers into buying lenses.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>174</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <P>
                        The consumer advocacy organization Consumer Reports also opposed permitting prescribers to devise their own language of confirmation, and opposed allowing prescribers to make the confirmation part of a prescription copy or sales receipt (Confirmation of Prescription Release options (B) and (C)).
                        <SU>175</SU>
                        <FTREF/>
                         Instead, Consumer Reports stated that the confirmation should remain a stand-alone document, and suggested requiring the statement, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting. I should give a copy of my prescription to the contact lens seller I choose.” 
                        <SU>176</SU>
                        <FTREF/>
                         According to Consumers Reports, there are “clear advantages to standardized wording,” and by instructing consumers to present their prescription to sellers, this would further promote the Commission's goal of reducing verifications.
                        <SU>177</SU>
                        <FTREF/>
                         Consumer Reports opined that a statement of confirmation added to the prescriber's copy of the prescription, or added to an examination receipt, might not be noticed by the patient.
                        <SU>178</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>175</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>176</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>177</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>178</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Some commenters also opined that when prescribers satisfy the confirmation by releasing the prescription electronically (option (D)), prescribers should still provide consumers with a statement advising them that they have a right to their prescription and have the option to buy lenses elsewhere.
                        <SU>179</SU>
                        <FTREF/>
                         And many commenters raised concerns about whether to allow option (D) altogether, as discussed in more detail below.
                    </P>
                    <FTNT>
                        <P>
                            <SU>179</SU>
                             
                            <E T="03">Id.;</E>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <P>With respect to allowing options (B) and (C), and permitting prescribers to craft their own wording, the Commission acknowledges that the confirmation proposal may provide less of an immediate educational benefit than the NPRM's proposed Signed Acknowledgment. By permitting prescribers to include the confirmation on the prescription itself, or on a sales receipt, it is indeed possible that some consumers will fail to understand its purpose, or what it is they are signing. And by not requiring that the confirmation include a sentence specifically informing consumers of their right to have prescriptions filled elsewhere, and not requiring a notice to this effect with digital delivery, some consumers may remain unaware of prescription portability.</P>
                    <P>
                        The Commission, however, continues to believe that the benefit from providing prescribers with greater flexibility, reducing the possible paperwork burden, and limiting potential interference with the prescriber-patient relationship, justifies the trade-off. As noted in the SNPRM, the Confirmation of Prescription Release will maintain much of the effectiveness and enforceability of the Signed Acknowledgment, while reducing the impact on prescribers.
                        <SU>180</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>180</SU>
                             SNPRM, 84 FR at 24683.
                        </P>
                    </FTNT>
                    <P>
                        The Commission also does not believe that requiring patients to sign a confirmation will provoke doubts about the integrity of their prescribers. While patients might draw the conclusion that some prescribers have not always automatically released prescriptions, there is little reason for patients to conclude that their individual prescriber had failed to do so, especially if their prescriber has always provided them with their prescription. It seems more likely that patients may simply conclude that the law has changed. Furthermore, as noted in the SNPRM, consumers are accustomed to signing acknowledgments or receipts. Many pharmacists require patients to acknowledge that they do not have questions upon receiving a prescription; physicians' offices require visitors to sign in; and patients are accustomed to signing HIPAA acknowledgment forms signifying they received a provider's Notice of Privacy Practices.
                        <SU>181</SU>
                        <FTREF/>
                         The Commission is not aware of any evidence that such requirements sow distrust on the part of the person signing the receipt. The Commission believes this will hold true for the Confirmation of Prescription Release, particularly since prescribers can devise their own language of confirmation. The Commission also believes that while it may be advisable for providers to avoid potential patient confusion by not including any other acknowledgments or information on the confirmation document, it is not necessary to expressly prohibit this in the Rule at this time. Such a prohibition might limit the flexibility of the new proposal, and could make it more difficult for providers to avail themselves of options (B) and (C) by including patient confirmation as part of a sales receipt or prescription copy. Moreover, as noted in the SNPRM, while prescribers are free to provide their own language, it would remain a violation for the receipt to include additional information proscribed by the Rule, such as liability waivers or agreements to purchase lenses from the prescriber.
                        <SU>182</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>181</SU>
                             
                            <E T="03">Id.</E>
                             at 24682.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>182</SU>
                             
                            <E T="03">Id.</E>
                             at 24683.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Comments About Option (D) and Using Electronic Delivery for Confirmation of Prescription Release</HD>
                    <P>
                        In the SNPRM, the Commission proposed modifying the Rule to allow prescribers to satisfy the automatic prescription release requirement by providing a digital copy in lieu of a paper copy when the patient gives verifiable affirmative consent.
                        <SU>183</SU>
                        <FTREF/>
                         The Commission noted that using online patient portals and other electronic methods to complete the automatic prescription release offered potential benefits for sellers, prescribers, and patients.
                        <SU>184</SU>
                        <FTREF/>
                         Patients would be able to 
                        <PRTPAGE P="50682"/>
                        access their prescriptions and have electronic copies to send to sellers. With the prescription, a seller would no longer need to submit a verification request, which would benefit prescribers by reducing the volume of requests. However, there were also some concerns about portals, including that patients may not be aware of the portal or have difficulty accessing it.
                        <SU>185</SU>
                        <FTREF/>
                         Because the Commission did not have sufficient information to determine whether solely posting a contact lens prescription on a patient portal would be sufficient to satisfy the Rule's obligation for prescribers to provide a copy of the prescription after completing the contact lens fitting, the Commission sought comments on its proposed Rule modification.
                        <SU>186</SU>
                        <FTREF/>
                         The Commission also asked for comments on whether prescribers should be required to maintain any records documenting a patient's verifiable consent to receive a prescription electronically.
                        <SU>187</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>183</SU>
                             
                            <E T="03">Id.</E>
                             at 24669.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>184</SU>
                             
                            <E T="03">Id.</E>
                             at 24668.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>185</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>186</SU>
                             
                            <E T="03">Id.</E>
                             at 24669.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>187</SU>
                             
                            <E T="03">Id.</E>
                             at 24690.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Use of Patient Portals and Patient Consent</HD>
                    <P>
                        Many commenters expressed support for allowing prescribers to use electronic methods, such as a patient portal, to provide prescriptions to patients who consent.
                        <SU>188</SU>
                        <FTREF/>
                         Among the potential benefits, commenters noted the reduction in verification calls or requests for additional copies, easier access to and use of a prescription, lower costs, and flexibility for patients and prescribers.
                        <SU>189</SU>
                        <FTREF/>
                         Currently, many prescribers already use a portal or other electronic methods to communicate with and, in some instances, provide prescriptions to their patients,
                        <SU>190</SU>
                        <FTREF/>
                         and use of electronic methods is expected to increase in the future.
                        <SU>191</SU>
                        <FTREF/>
                         For example, one survey found that approximately 64.2% of eye care professionals communicated with patients by text message, of which 26.4% used it to respond to personal questions about the patient's eye health.
                        <SU>192</SU>
                        <FTREF/>
                         Because a significant percentage of eye care providers already use electronic communications and portals, the Commission believes that the required, automatic prescription release could be completed effectively through a digital copy when a patient provides verifiable affirmative consent. Verifiable affirmative consent means that a patient must have provided his or her consent to the prescriber in a way that can be later confirmed. A signed consent form, an email from the patient to the prescriber, or an audio recording from a telephone conversation with a patient would be examples of verifiable affirmative consent. Notification through, for example, a posted office sign or a general written notice of office policies or practices would not constitute affirmative consent because patients have not indicated to the prescriber whether or not they consent.
                    </P>
                    <FTNT>
                        <P>
                            <SU>188</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Liao (SNPRM Comment #2); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); Alcon Vision, LLC (SNPRM Comment #117); National Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130) (noting that electronic delivery of a prescription is “a common-sense, low burden method of giving patients better access to their prescriptions”); 1-800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139); National Hispanic Medical Association (SNPRM Comment #146); Backus (WS Comment #1650).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>189</SU>
                             Americans for Tax Reform (SNPRM Comment #72); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130); Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>190</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96); National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that practice management systems and electronic health records are easily available at reasonable prices); Sikes (SNPRM Comment #114); Klepfisz (SNPRM Comment #140); Eklund (WS Comment #502); Holland (WS Comment #513); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>191</SU>
                             FTC, The Contact Lens Rule and the Evolving Contact Lens Marketplace, Panel V: Prescription Release &amp; Consumer Choice Tr. at 18-21 (Mar. 7, 2018), 
                            <E T="03">https://www.ftc.gov/system/files/documents/public_events/1285493/panel_v_prescription_release_and_consumer_choice.pdf</E>
                             [hereinafter CLR Panel V Tr.].
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>192</SU>
                             Jobson Research, ECP Digital Solutions Study (2019) (also finding that of those surveyed, approximately 74.4% contacted their patients by email, of which 45.5% used it to respond to personal questions about the patient's eye health). As noted in the SNPRM, another survey showed that approximately 30% of patients were offered access to a portal during their last eye exam and that 29% chose to use the portal. SNPRM, 84 FR at 24668 n.50.
                        </P>
                    </FTNT>
                    <P>
                        Several commenters supported the use of electronic methods, but had a variety of concerns or proposed changes. Some thought patients might prefer a paper copy instead of an electronic copy of their prescription, including people who are older, reluctant to use technology or worried about online privacy or identity theft, unable to navigate a cumbersome portal, without internet or smartphone access, or not proficient in English.
                        <SU>193</SU>
                        <FTREF/>
                         The Commission shares these concerns and the Final Rule thus maintains the ability for patients who prefer a paper copy for any reason to obtain such a copy. Even if a prescriber offers electronic delivery, a patient could decline to provide consent. Likewise, prescribers who are concerned about the security or costs of electronic methods can continue providing paper copies.
                        <SU>194</SU>
                        <FTREF/>
                         The Final Rule neither compels prescribers to offer prescription release by an electronic method nor requires that patients accept their prescription by electronic method when offered by the prescriber.
                    </P>
                    <FTNT>
                        <P>
                            <SU>193</SU>
                             R Street (SNPRM Comment #15); Americans for Tax Reform (SNPRM Comment #72); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96); National Hispanic Medical Association (SNPRM Comment #146); National Taxpayers Union (SNPRM Comment #149).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>194</SU>
                             American Optometric Association (SNPRM Comment #96); American Society of Cataract and Refractive Surgery (SNPRM Comment #127).
                        </P>
                    </FTNT>
                    <P>
                        One seller urged the Commission to require that the prescribers, when seeking affirmative consent, identify to patients the specific method of electronic delivery that would be used.
                        <SU>195</SU>
                        <FTREF/>
                         The Commission believes that requiring prescribers to identify the specific method or methods 
                        <SU>196</SU>
                        <FTREF/>
                         would allow patients to make a more informed decision and increase awareness of how the prescription would be provided if they were to consent. It is also possible that a patient prefers one method of electronic communication, but not others.
                        <SU>197</SU>
                        <FTREF/>
                         Therefore, the Commission is amending the definition of “Provide to the patient a copy” to require that prescribers who choose to offer an electronic method, identify the specific method or methods to be used and, if a patient consents, have evidence of verifiable affirmative consent to the identified method or methods.
                    </P>
                    <FTNT>
                        <P>
                            <SU>195</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>196</SU>
                             A request for consent that states that the prescription would be delivered electronically, but does not state the method, such as email, text, or portal, would not be adequate. If more than one method is offered, prescribers must specifically identify each one.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>197</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <P>
                        Regarding patient portals specifically, some commenters expressed concerns that: (1) Patients would be unaware that their prescription is on a portal; (2) there could be a delay in posting prescriptions to the portal; or (3) prescribers might intentionally make portals difficult to use, post prescriptions without telling their patients, or confuse patients into thinking that they must buy lenses from 
                        <PRTPAGE P="50683"/>
                        them.
                        <SU>198</SU>
                        <FTREF/>
                         They urged the Commission to require that prescribers notify patients when a prescription is available on the portal, provide instructions on how to access the portal, or confirm that the prescription has been received.
                        <SU>199</SU>
                        <FTREF/>
                         The Commission believes that the Final Rule provides adequate safeguards for patients who have opted to receive their prescription on a portal. As noted in the SNPRM, the use of a portal or other electronic method does not change the timing of when a prescriber must provide a copy of the contact lens prescription.
                        <SU>200</SU>
                        <FTREF/>
                         A prescriber must provide the prescription immediately after the completion of the contact lens fitting, or in the case of a renewal, when a prescriber determines that no change to the existing prescription is required.
                        <SU>201</SU>
                        <FTREF/>
                         Furthermore, prescribers can only use a portal to satisfy their obligation under § 315.3(a)(1) when they have affirmative consent to the specific method or methods of electronic delivery. Therefore, patients should be aware that their prescription will be provided electronically using the method to which they consented. The Rule also requires that patients be able to access, download, and print the prescriptions from the portal.
                        <SU>202</SU>
                        <FTREF/>
                         If patients were to have any problems with using the portal, they could revoke their consent and request a paper copy.
                        <SU>203</SU>
                        <FTREF/>
                         Notwithstanding these safeguards, the Commission encourages prescribers to provide instructions to patients who may encounter difficulties accessing their portal. The Commission believes that the Rule, with the modification to require that prescribers identify the specific electronic method to be used, balances the interests of prescribers and patients by offering a flexible method that could reduce the burden on prescribers and allow patients greater access to their prescriptions.
                        <SU>204</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>198</SU>
                             R Street (SNPRM Comment #15); Lens.com (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National Hispanic Medical Association (SNPRM Comment #146); Senator Mike Lee (SNPRM Comment #159).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>199</SU>
                             R Street (SNPRM Comment #15); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135); Senator Mike Lee (SNPRM Comment #159).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>200</SU>
                             SNPRM, 84 FR at 24669 n.54.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>201</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>202</SU>
                             The Commission does not have any evidence that prescribers are intentionally making portals difficult for their patients to use. However, such conduct, if it were to occur, could violate the Rule because patients would not be able to access their prescription.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>203</SU>
                             Patients could also request an additional copy under 16 CFR 315.3(a)(3).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>204</SU>
                             Consumer Action appears to encourage the Commission to provide further guidance on portal design in the Rule. SNPRM Comment #101. Given the potential for future developments in technology and the differences among prescribers' practices and current software, the Commission declines to mandate requirements on portal design. 
                            <E T="03">See</E>
                             CLR Panel V Tr., 
                            <E T="03">supra</E>
                             note 191, at 18-21 (discussing the variety of electronic-health-records programs available from “hundreds” of ECH vendors, with each program based on different standards and providing varying degrees of functionality and compatibility).
                        </P>
                    </FTNT>
                    <P>
                        Furthermore, some commenters want a paper copy to be provided in addition to the electronic copy,
                        <SU>205</SU>
                        <FTREF/>
                         but the Commission declines to adopt this suggestion because requiring both copies would undercut a benefit of using electronic methods and be unnecessary for patients who have expressed a preference for an electronic copy. Finally, a commenter states that telemedicine prescribers should not be required to provide paper prescriptions.
                        <SU>206</SU>
                        <FTREF/>
                         Although patients who opt for telemedicine might be more comfortable with technology and receiving health care online,
                        <SU>207</SU>
                        <FTREF/>
                         some patients may still prefer their prescription on paper. Since telemedicine providers should have been providing a paper copy under the current Rule, continuation of this practice, when a patient does not consent to electronic delivery, should not be impractical or overly burdensome.
                    </P>
                    <FTNT>
                        <P>
                            <SU>205</SU>
                             Americans for Tax Reform (SNPRM Comment #72); Lens.com (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>206</SU>
                             Simple Contacts (SNPRM Comment #87).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>207</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">b. Requirement To Maintain Records of Patient Consent</HD>
                    <P>
                        In the SNPRM, the Commission proposed requiring that prescribers obtain affirmative consent in order to provide a prescription electronically, but did not require that prescribers maintain evidence of consent. In response, several commenters have urged the Commission to require that prescribers maintain records pertaining to patients' affirmative consent.
                        <SU>208</SU>
                        <FTREF/>
                         According to some of these commenters, a record of consent would allow more effective compliance monitoring, while the burden of storing such a record would be minimal.
                        <SU>209</SU>
                        <FTREF/>
                         By contrast, the AOA states that prescribers should not be required to maintain records of consent because the AOA believes it would be burdensome 
                        <SU>210</SU>
                        <FTREF/>
                         and “provides no obvious benefit to the patient” since “the likelihood of harm from a patient receiving a contact lens prescription electronically is low to nonexistent.” 
                        <SU>211</SU>
                        <FTREF/>
                         However, other commenters countered that there is a potential for harm since patients who do not consent might not realize that they received their prescription electronically, or might be unable to access it.
                        <SU>212</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>208</SU>
                             Consumer Action (SNPRM Comment #101); Information Technology &amp; Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>209</SU>
                             Consumer Action (SNPRM Comment #101) (stating that the cost of storing digital records is not burdensome); Information Technology &amp; Innovation Foundation (SNPRM Comment #103) (stating that the cost of storing a consent form would be virtually zero).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>210</SU>
                             
                            <E T="03">See also</E>
                             American Society of Cataract and Refractive Surgery (SNPRM Comment #127) (discussing the administrative burden related to maintaining records of consent). Other commenters contend that the burden of storing these records would be minimal. Information Technology &amp; Innovation Foundation (SNPRM Comment #103).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>211</SU>
                             American Optometric Association (SNPRM Comment #96). The AOA also asserts that “[p]atients do not have to consent to the electronic delivery of other prescriptions.” However, there may be differences between contact lens prescriptions and some other types of medical prescriptions. In many instances, other types of prescriptions being delivered electronically are not being sent to a patient, but rather to a pharmacy that then fills the prescription. When a prescription is sent to a pharmacy, the patient would likely have selected or have knowledge of the receiving pharmacy. In 2013, 57% of prescriptions nationally were sent electronically from physicians to pharmacies, with the rate in some states over 80%. U.S. Dep't of Health &amp; Human Servs., The Office of the National Coordinator for Health Information Technology, “E-Prescribing Trends in the United States” 8 (2014) (stating also that 96% of all community pharmacies in the U.S. accept e-prescriptions).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>212</SU>
                             R Street (SNPRM Comment #15); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); National Hispanic Medical Association (SNPRM Comment #146); National Taxpayers Union (SNPRM Comment #149).
                        </P>
                    </FTNT>
                    <P>
                        The Commission finds persuasive the arguments in favor of requiring a record of patient consent to electronic delivery. The burden of retaining a record of patient consent should be minimal, since prescribers who opt for electronic delivery of prescriptions will, in all likelihood, obtain and/or store such consent electronically. Even if they do not, it should not take any longer to obtain and store patient consent to electronic delivery than it would to obtain and store a patient's Confirmation of Prescription Release via options (A), (B) or (C). Furthermore, a prescriber is not required to offer patients a digital prescription. Rather, it is at his or her option. Moreover, consent to receipt of a digital copy would aid in enforcing the Rule since, 
                        <PRTPAGE P="50684"/>
                        without a record of consent, there would be no way for the Commission to confirm that patients who were given their prescriptions electronically agreed to such electronic delivery, and had the ability to access their prescriptions in this manner. The Final Rule will thus require that prescribers keep records or evidence of a patient's affirmative consent to a digital copy for at least three years. Although some commenters have sought longer retention periods,
                        <SU>213</SU>
                        <FTREF/>
                         three years is a time period consistent with other recordkeeping obligations in the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>213</SU>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103) (requesting five years); 1-800 CONTACTS (SNPRM Comment #135) (requesting that the record be kept as long as the affirmative consent is active). State laws could require that prescribers maintain these records for longer than three years.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">6. Comments About Alternatives to the Confirmation of Prescription Release</HD>
                    <P>
                        In addition to the suggestions—discussed previously—that the Commission increase its enforcement of the current Rule, or impose new requirements only as a penalty for specific providers found in non-compliance,
                        <SU>214</SU>
                        <FTREF/>
                         some commenters proposed alternative means of ensuring that consumers receive their prescriptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>214</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">a. Signage</HD>
                    <P>
                        Several commenters reiterated the idea—raised and discussed in some detail in the SNPRM 
                        <SU>215</SU>
                        <FTREF/>
                        —that instead of requiring a patient acknowledgment or confirmation, the Commission ought simply to require that prescribers post signs informing consumers of their right to their prescriptions.
                        <SU>216</SU>
                        <FTREF/>
                         In its SNPRM, the Commission acknowledged that signage offers some of the benefits of a patient confirmation, but concluded that it had significant drawbacks: In the particular environment of a prescriber's office, far fewer consumers would learn of their rights from a sign than from being asked to sign a receipt; signage would serve as less of a reminder to prescribers and their staff to release prescriptions; signage would do nothing to aid the Commission in monitoring and enforcing the prescription-release requirement; and relying on patients to notice a sign and ask for their prescriptions put the onus on consumers to enforce the Rule, and would effectively amend the FCLCA's automatic-release provision to release-upon-request, a statutory revision only Congress can make.
                        <SU>217</SU>
                        <FTREF/>
                         The Commission also noted that relying on consumers to ask for their prescriptions is problematic since consumers might not see the sign, or might be uncomfortable asking their prescribers for their prescriptions.
                        <SU>218</SU>
                        <FTREF/>
                         Based on those reasons, the Commission declined to propose signage as an alternative to a Confirmation of Prescription Release.
                        <SU>219</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>215</SU>
                             SNPRM, 84 FR at 24679.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>216</SU>
                             Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49); Cutter (SNPRM Comment #81); American Optometric Association (SNPRM Comment #96); Gilbert (SNPRM Comment #119); Patel (SNPRM Comment #123); Letter from N.D. State Sen. Judy Lee (SNPRM Comment #161).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>217</SU>
                             SNPRM, 84 FR at 24682-83.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>218</SU>
                             
                            <E T="03">Id.</E>
                             at 24682.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>219</SU>
                             
                            <E T="03">Id.</E>
                             at 24682-83.
                        </P>
                    </FTNT>
                    <P>
                        Some SNPRM commenters agreed with the Commission's position, stating that “requiring prescribers to post signs doesn't work,” 
                        <SU>220</SU>
                        <FTREF/>
                         and asserting that in California, where a state law requires contact lens prescribers to post signs detailing patient rights, some optometrists fail to comply, or post the signs in locations consumers are unlikely to see them.
                        <SU>221</SU>
                        <FTREF/>
                         In contrast, other commenters contended that the Commission should reconsider the signage alternative, reiterating that it would be less burdensome and intrusive for prescribers and could address the FTC's educational objectives without costly regulation.
                        <SU>222</SU>
                        <FTREF/>
                         The AOA also took issue with the fact that the Commission cited HHS's implementation of a signed-acknowledgment for a prescriber's HIPAA obligation instead of opting for signage.
                        <SU>223</SU>
                        <FTREF/>
                         According to the AOA, anything HHS concluded when it constructed the HIPAA signed-acknowledgment is no longer relevant since HHS is now considering eliminating the requirement and switching to signage in order to reduce the burden on health care practitioners.
                        <SU>224</SU>
                        <FTREF/>
                         Furthermore, according to the AOA, “the physician community is united in its belief” that the HIPAA signed-acknowledgment should be eliminated, and this shows that such acknowledgment requirements constitute poor policy, and signage is a better option.
                        <SU>225</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>220</SU>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>221</SU>
                             Americans for Tax Reform (SNPRM Comment #72). As noted in the SNPRM, the Commission does not have empirical data about prescriber compliance with the state signage requirement, 16 CCR 1566, which has been in effect in California since 1994. However, an analysis of consumer survey evidence provided by Survey Sampling International indicates that regardless of signage, Californians do not automatically receive their prescriptions in substantially greater numbers than residents of states without a signage requirement. SNPRM, 84 FR at 24679.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>222</SU>
                             Kochik (SNPRM Comment #8) (stating that the real issue is that patients are unaware of the law, and so the solution is signage); Letter from 20 U.S. Senators (SNPRM Comment #38); Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>223</SU>
                             American Optometric Association (SNPRM Comment #96). The obligation in question is the HIPAA requirement that health care providers provide patients with a Notice of Privacy Practices (“NPP”) and obtain a patient's signature acknowledging receipt of same. Notice of Privacy Practices for Protected Health Information, 14 CFR 164.520(c)(2)(ii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>224</SU>
                             American Optometric Association (SNPRM Comment #96) (quoting Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, 83 FR 64302, 64302-03 (2018), 
                            <E T="03">https://www.govinfo.gov/content/pkg/FR-2018-12-14/pdf/2018-27162.pdf#page=1.</E>
                            )
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>225</SU>
                             American Optometric Association (SNPRM Comment #96). It is worth noting that a review of the comments submitted in response to the recent HHS proposal to eliminate HIPAA's signed-acknowledgment requirement reveals that while many health care providers do consider it an unnecessary use of staff time and resources, other health care providers support the acknowledgment requirement, and several noted that the burden of obtaining a patient's signed acknowledgment is relatively minimal. 
                            <E T="03">See, e.g.,</E>
                             Jackson Health System (Comment in Response to Request For Information, Office for Civil Rights, Department of Health and Human Services [hereinafter “HHS RFI Comment”] #467) (does not support modifying the requirement because signed NPP acknowledgment forms are “useful” to prove that the NPP was provided to the patient); Dr. Mitchell Strauss (HHS RFI Comment #851) (“The signature is the only way of confirming for posterity that the NPP was discussed. If this step is no longer required, it will be far too easy for practices to stop making the effort for acknowledgement of the NPP.”); Multnomah and Clackmas Counties (HHS RFI Comment #926) (foresees adverse consequences—potential complaints and misunderstandings—if signed acknowledgment requirement is removed); San Francisco Department of Public Health (HHS RFI Comment #1241) (“Having a written record assures patients and covered entities that patients are informed about privacy practices.”); American College of Osteopathic Family Physicians (HHS RFI Comment #1262) (strongly believes that there must be some level of accountability and responsibility for ensuring patients understand their privacy rights); Massachusetts Department of Mental Health (HHS RFI Comment #1003) (“The burden is negligible.”); Missouri Hospital Association (HHS RFI Comment #1175) (“MHA's members do not find the requirement cumbersome.”); Cigna (HHS RFI Comment #1132) (“Obtaining acknowledgment of receipt is not an operational burden [and] the burden to maintain document of acknowledgment or declination is minimal.”). HHS RFI Comments are available at 
                            <E T="03">https://www.regulations.gov/docketBrowser?rpp=25&amp;po=0&amp;D=HHS-OCR-2018-0028.</E>
                        </P>
                    </FTNT>
                    <P>
                        While it is true that HHS is presently evaluating whether to eliminate the HIPAA Notice of Privacy Practices signed-acknowledgment requirement, the Commission's Confirmation of Prescription Release proposal, and the decision not to allow signage as an alternative, does not rely on the HIPAA signed-acknowledgment requirement as precedent. In the SNPRM, the Commission merely referenced aspects of HIPAA's signed-acknowledgment requirement and HHS's evaluation of the regulatory burden as informative when considering whether to require some form of patient confirmation of 
                        <PRTPAGE P="50685"/>
                        prescription release.
                        <SU>226</SU>
                        <FTREF/>
                         Any other reliance on the HIPAA signed-acknowledgment requirement is generally inappropriate since that signed-acknowledgment requirement differs from the Commission's confirmation proposal in important respects. The primary intent of the HIPAA signed-acknowledgment was to provide patients an opportunity to review the provider's Notice of Privacy Practices, discuss concerns related to their private health information, and request additional confidentiality.
                        <SU>227</SU>
                        <FTREF/>
                         It was not to remedy a lack of compliance by doctors with HIPAA requirements. Unlike this Rule review, the HHS record does not contain empirical evidence showing that doctors are not fulfilling their obligations to provide Notices of Privacy Practices to patients, and only a handful of commenters to HHS's recent Request for Information even suggested that this could occur should the HIPAA signed acknowledgment be removed.
                        <SU>228</SU>
                        <FTREF/>
                         This contrasts sharply with the circumstances of the Commission's proposed Confirmation of Prescription Release, which is intended to remedy a documented compliance gap resulting, at least to some extent, from inherent incentives that may discourage prescribers from providing patients with their prescriptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>226</SU>
                             SNPRM, 84 FR at 24682.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>227</SU>
                             Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, Office for Civil Rights, Department of Health and Human Services, 83 FR at 64308.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>228</SU>
                             
                            <E T="03">See generally</E>
                             Comments in Response to Request for Information on Modifying HIPAA Rules to Improve Coordinated Care, Office for Civil Rights, Department of Health and Human Services, 
                            <E T="03">https://www.regulations.gov/docketBrowser?rpp=25&amp;po=0&amp;D=HHS-OCR-2018-0028.</E>
                        </P>
                    </FTNT>
                    <P>The Commission continues to believe that for purposes of automatic prescription release, signage would be significantly less effective than the proposed Confirmation of Prescription Release. None of the comments to the SNPRM presented any data or evidence that would counter the Commission's prior conclusion. The AOA's argument that the HIPAA signed-acknowledgment experience should not be looked to as a model does not alter the Commission's determination that there is a compelling need for a verifiable method of ensuring that contact lens patients receive their prescriptions.</P>
                    <HD SOURCE="HD3">b. Educational Programs as an Alternative to Confirmation of Prescription Release</HD>
                    <P>
                        Some commenters opined that instead of having consumers confirm that they received their prescription, the best manner to inform consumers about their prescription rights was through an educational program.
                        <SU>229</SU>
                        <FTREF/>
                         According to one contact lens manufacturer, the FTC and sellers should continue to “communicate to patients through social media, websites, advertising, and other channels so that patients become even more aware that they can leave their final fitting with a copy of their right prescription.” 
                        <SU>230</SU>
                        <FTREF/>
                         Others suggested that the Commission could partner with the Centers for Disease Control and the Food and Drug Administration (“FDA”) to produce public service announcements informing patients of their rights.
                        <SU>231</SU>
                        <FTREF/>
                         Another commenter suggested that instead of a signed confirmation, patients' rights to their prescriptions could be “spelled out in the entry forms a patient signs when they check in.” 
                        <SU>232</SU>
                        <FTREF/>
                         Similarly, the AOA suggested that a “patient bill of rights for contact lens wearers” could be provided to patients that would include FDA information on considerations for buying lenses.
                        <SU>233</SU>
                        <FTREF/>
                         One commenter, the NAOO, said that even with a Confirmation of Prescription Release, the Commission should focus on educating the public about its rights to automatic release of a prescription.
                        <SU>234</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>229</SU>
                             Abert (SNPRM Comment #20); Tran (SNPRM Comment #94); CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>230</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>231</SU>
                             American Optometric Association (SNPRM Comment #96); Tran (SNPRM Comment #94).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>232</SU>
                             Cutter (SNPRM Comment #81).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>233</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>234</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <P>
                        The Commission agrees that educating the public can aid in increasing the likelihood that contact lens users will receive their prescriptions after a fitting.
                        <SU>235</SU>
                        <FTREF/>
                         Consumer education in itself, however, whether provided via information entry forms, a patients' bill of rights, advertising, or public service announcements, would not have a significant impact on prescriber compliance with automatic prescription release, and would not increase the Commission's ability to monitor and enforce the Rule. The proposed education alternatives would also place a burden on consumers to enforce their own rights, an approach the Commission has rejected repeatedly in the past when considering whether to amend the Contact Lens Rule and Eyeglass Rule to release-upon-request.
                        <SU>236</SU>
                        <FTREF/>
                         Therefore, while the Commission believes education about the Rule and its automatic-prescription-release provision is important, the Commission does not believe education should be the sole means of improving Rule compliance.
                    </P>
                    <FTNT>
                        <P>
                            <SU>235</SU>
                             The Commission educates consumers on their rights under the Contact Lens Rule through a variety of sources, including blog posts, Facebook, Twitter, and on the FTC's website. 
                            <E T="03">See, e.g., https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>236</SU>
                             
                            <E T="03">See</E>
                             Eyeglass I, 43 FR at 23998 (stating that relying upon release-upon-request is problematic because many consumers are unaware of their right to a prescription, and because the right should be “immunized from an evidentiary squabble over whether the consumer actually did or did not request the prescription”); Final Trade Regulation Rule, Ophthalmic Practice Rules 54 FR 10285, 10286-87 (Mar. 13, 1989) [hereinafter Eyeglass II] (rejecting a proposal to change the Rule to release-upon-request and finding a “continuing need” for automatic release). 
                            <E T="03">See also</E>
                             Contact Lens Rule, 69 FR at 40492 (discussing a commenter proposal to allow prescribers to not release the prescription or release it for “informational purposes only” if the patient has purchased a full year's supply of contact lenses at the time of the examination, and rejecting it because “such an exception would be contrary to the Act's express requirement that consumers receive a copy of their prescription at the completion of a contact lens fitting”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">7. Comments About the Burden and Benefits of the Confirmation of Prescription Release Proposal</HD>
                    <P>
                        Many commenters stated that even with the proposed modifications to increase flexibility, the Confirmation of Prescription Release requirement is still overly burdensome for prescribers.
                        <SU>237</SU>
                        <FTREF/>
                         According to commenters, eye care practitioners are already overburdened by regulatory requirements, and the confirmation requirement would divert resources from patient care, increase health care costs, and might even drive some prescribers to cease prescribing contact lenses or close their practices.
                        <SU>238</SU>
                        <FTREF/>
                         More specifically, the AAO stated that many of the options for obtaining patient confirmation would require practices to change procedures and alter administrative forms.
                        <SU>239</SU>
                        <FTREF/>
                         Others noted 
                        <PRTPAGE P="50686"/>
                        that the requirement to dispense paper copies of the confirmation to patients runs counter to the trend towards electronic records, particularly for those who have already invested in an electronic recordkeeping system.
                        <SU>240</SU>
                        <FTREF/>
                         One commenter opined that patients ought to bear more responsibility for their own health care.
                        <SU>241</SU>
                        <FTREF/>
                         Others noted that the proposal was “going against the tide” by adding a new regulation at a time when some government agencies are looking to reduce regulations.
                        <SU>242</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>237</SU>
                             Warner (SNPRM Comment #9); Mass Mail Campaign (SNPRM Comment #25) (saying the requirement imposed “massive new costs and far-reaching new requirements on all contact lens prescribing”); Yokum (SNPRM Comment #53); Staup (SNPRM Comment #104); American Society of Cataract and Refractive Surgery (SNPRM Comment #127); Letter from Sen. Lisa Murkowski (SNPRM Comment #49).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>238</SU>
                             Goldstein (SNPRM Comment #14) (“The economic burdens of administrative compliance with these new regulations would except in rare cases encourage me not to fit or prescribe contact lenses.”); Pierce (SNPRM Comment #17) (will ultimately lead to higher health care costs, might have to raise fees); Mass Mail Campaign (SNPRM Comment #25); Shum (SNPRM Comment #80) (“Adding more paperwork and scanning work—and making it required on everyone—doesn't sound like it would be a big deal, but to a small practice it's huge.”); Cinalli (SNPRM Comment #93) (new regulation will close many practices); Klepfisz (SNPRM Comment #140) (burden has the potential to put some prescribers out of business).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>239</SU>
                             American Academy of Ophthalmology (SNPRM Comment #136).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>240</SU>
                             Lowe (SNPRM Comment #40); Reeder (SNPRM Comment #55) (signature upon receipt of prescription is “burdensome and counter to other initiatives to reduce paper held by offices”); Boyer (SNPRM Comment #59) (“We try very hard to reduce paper waste . . . . [This] will undo our efficiency and distract our staff from our daily caseload, resulting in increased costs and reduced care.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>241</SU>
                             Steiner (SNPRM Comment #7).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>242</SU>
                             American Optometric Association (SNPRM Comment #96); American Society of Cataract and Refractive Surgery (SNPRM Comment #127).
                        </P>
                    </FTNT>
                    <P>
                        Some commenters believed the Commission was underestimating the burden to obtain confirmations and preserve the records, and provided their own estimates, including that it would cost $10,000 per year,
                        <SU>243</SU>
                        <FTREF/>
                         or would require 10 minutes per patient for a total of “850 man-hours per year,” 
                        <SU>244</SU>
                        <FTREF/>
                         the equivalent of about 21 additional weeks of work. The AOA, which had previously estimated the cost of the signed-acknowledgment requirement to be as high as $18,795 per optometrist,
                        <SU>245</SU>
                        <FTREF/>
                         did not submit a new burden estimate for the Confirmation of Prescription Release proposal, but reiterated its belief that the Rule's burden falls disproportionately on prescribers, and expressed concern that the estimated financial burden for the Rule in the 2019 SNPRM is higher than the financial burden estimate cited for the NPRM's signed-acknowledgment proposal.
                        <SU>246</SU>
                        <FTREF/>
                         Some commenters also stated that the use of option (D), electronic delivery, would not significantly reduce their burden, since it would require them to update their systems or invest in expensive technology.
                        <SU>247</SU>
                        <FTREF/>
                         According to the AOA, many prescribers would not be able to opt for electronic delivery because of limitations in electronic health records systems, privacy and data-security concerns, and state regulations that might not permit prescription posting to portals.
                        <SU>248</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>243</SU>
                             Pierce (SNPRM Comment #17).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>244</SU>
                             Steinemann (SNPRM Comment #65).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>245</SU>
                             American Optometric Association (NPRM Comment #3830). This estimate was cited again by some commenters to the SNPRM. Koerber (SNPRM Comment #41); American Society of Cataract and Refractive Surgery (SNPRM Comment #127). In the SNPRM, the Commission explained that it could not accord this estimate significant weight because it was based not on the cost of the Commission's proposed Signed Acknowledgment but on the overall cost of government regulations (including those already in place), and because the survey had various methodological limitations. SNPRM, 84 FR at 24677.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>246</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>247</SU>
                             American Society of Cataract and Refractive Surgery (SNPRM Comment #127).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>248</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <P>
                        Other commenters disputed that the burden would be significant, and stated that the confirmation requirement would not add significant costs or time.
                        <SU>249</SU>
                        <FTREF/>
                         According to the Information Technology &amp; Innovation Foundation, prescriber claims that the proposal would require significant additional staff training are overstated.
                        <SU>250</SU>
                        <FTREF/>
                         Another commenter, a prescriber, stated, “In our office, we already have patients sign a contact lens agreement before the contact lens evaluation process. I don't see a problem adding a document at the end of the process and having the patient sign an acknowledgment of rx receipt.” 
                        <SU>251</SU>
                        <FTREF/>
                         One commenter contended that while there would be some burden on eye care providers, it represented just a “tiny fraction” of the industry's overall revenue, and would be far outweighed by the benefits.
                        <SU>252</SU>
                        <FTREF/>
                         Others asserted that allowing prescribers to provide patients with digital copies would save both prescribers and patients time and money.
                        <SU>253</SU>
                        <FTREF/>
                         Some commenters suggested that the Commission was actually over-estimating the burden imposed by the confirmation requirement.
                        <SU>254</SU>
                        <FTREF/>
                         1-800 CONTACTS, for example, submitted a new analysis from Stanford University Professor Laurence Baker, which called the assumptions used in the Commission's burden analysis very “conservative,” and estimated that a reduction in verifications by just 15% would be sufficient to offset all of the costs of the confirmation requirement.
                        <SU>255</SU>
                        <FTREF/>
                         The NAOO also felt the burden would be “minimal,” and opined that with more patients in possession of their prescriptions, there would be fewer orders relying on the verification process, and thus fewer verifications for prescribers to have to take the time to respond to.
                        <SU>256</SU>
                        <FTREF/>
                         NAOO also opined that with more practitioners moving to practice management systems and electronic health records, digital delivery of contact lens prescriptions is a “very feasible” option for many prescribers, which would reduce the burden of the confirmation requirement.
                        <SU>257</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>249</SU>
                             Tobias (SNPRM Comment #45); Rawson (SNPRM Comment #68); (Citizen Outreach (SNPRM Comment #78); Consumer Action (SNPRM Comment #101); Information Technology and Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>250</SU>
                             Information Technology and Innovation Foundation (SNPRM Comment #103) (“A few minutes of instruction, coupled with reading a one- or two-page memo should more than suffice.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>251</SU>
                             Gilberg (SNPRM Comment #46).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>252</SU>
                             Taxpayer Protection Alliance (SNPRM Comment #118) (overall burden of the new requirement would be minimal and outweighed by the substantial benefit of having significantly more patients in possession of their prescription).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>253</SU>
                             Grimm (SNPRM Comment #36) (proposal to allow new methods for providing prescriptions will help relieve paperwork burden); Coalition for Contact Lens Consumer Choice (SNPRM Comment #78); Liao (SNPRM Comment #2) (portal proposal will make automatic release more efficient).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>254</SU>
                             National Taxpayers Union (SNPRM Comment #149); 1-800 CONTACTS (SNPRM Comment #135, Ex. A).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>255</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>256</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>257</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Some commenters also felt that the Commission should not give much weight to burden concerns raised by prescribers due to their history of not complying with their prescription-release obligations.
                        <SU>258</SU>
                        <FTREF/>
                         The National Hispanic Medical Association, for example, stated that the focus on the burden for prescribers was “upsetting when one remembers just how many patients are being robbed of their right to lower prices and more convenient shipping and being denied a copy of something that they worked hard to pay for, namely, their own prescription.” 
                        <SU>259</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>258</SU>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>259</SU>
                             National Hispanic Medical Association (SNPRM Comment #146).
                        </P>
                    </FTNT>
                    <P>
                        The Commission has considered the burden the Confirmation of Prescription Release requirement would place on prescribers. As stated in the SNPRM, the evidentiary record does not establish that the burden will be substantial.
                        <SU>260</SU>
                        <FTREF/>
                         Nothing received or revealed since the SNPRM alters that assessment. In fact, numerous health care providers—commenting on their experience with HIPAA—said that the burden of requiring that a patient sign a confirmation-type receipt is “minimal,” 
                        <SU>261</SU>
                        <FTREF/>
                         “negligible,” 
                        <SU>262</SU>
                        <FTREF/>
                         or “not significant.” 
                        <SU>263</SU>
                        <FTREF/>
                         And while AOA is 
                        <PRTPAGE P="50687"/>
                        correct that the SNPRM's estimated financial burden for the Confirmation of Prescription Release was higher than that estimated for the Signed Acknowledgment, that was primarily due to an increase in the average hourly wages for prescribers and staff.
                        <SU>264</SU>
                        <FTREF/>
                         In terms of 
                        <E T="03">time</E>
                         required for prescribers and their staff to comply, the SNPRM burden from the confirmation proposal was 13% less than that of the NPRM's signed-acknowledgment proposal.
                        <SU>265</SU>
                        <FTREF/>
                         The estimated burden of this modified Final Rule is also higher than the Signed Acknowledgment proposal, but a large part of the increase is due to higher wages and a substantial rise in the number of estimated contact lens wearers since publication of the NPRM.
                        <SU>266</SU>
                        <FTREF/>
                         Furthermore, while the Final Rule's estimated financial burden for the Confirmation of Prescription Release requirement of $20,428,750, is not insignificant, it amounts to approximately just $342 in increased administrative costs per eye care provider.
                        <SU>267</SU>
                        <FTREF/>
                         In addition, while not every prescriber will be able to use option (D) to deliver a prescription electronically, the Commission is confident that this option will still reduce the burden for many, especially as more prescribers move toward electronic recordkeeping.
                    </P>
                    <FTNT>
                        <P>
                            <SU>260</SU>
                             SNPRM, 84 FR at 24681.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>261</SU>
                             Multnomah and Clackamas Counties (HHS RFI Comment #926); Cigna (HHS RFI Comment #1132).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>262</SU>
                             Massachusetts Department of Mental Health (HHS RFI Comment #1003).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>263</SU>
                             San Francisco Department of Public Health (HHS RFI Comment #1238). 
                            <E T="03">See also</E>
                             Jackson Health System (HHS RFI Comment #467) (“The acknowledgment procedure takes less than one 
                            <PRTPAGE/>
                            minute.”); UnityPoint Health (HHS RFI Comment #1122) (costs are relatively low, average of 60 seconds to explain NPP and obtain patient's signature); UC Health (HHS RFI Comment #1155) (time spent to explain and obtain each signed acknowledgment is 40 seconds per patient); Missouri Hospital Association (HHS RFI Comment #1175); American Alliance of Orthopaedic Executives (HHS RFI Comment #1183). Other commenters to the HHS proposal disagreed, stating that the NPP signed acknowledgment requirement was an unnecessary burden, although much of their criticism was directed at the NPP itself rather than the acknowledgment. 
                            <E T="03">See, e.g.,</E>
                             American Physical Therapy Association (HHS RFI Comment #601) (“Providers currently undertake reasonable efforts to obtain the patient's signature, and in most instances the patients ignore the language when signing the document.”); Highmark Health (HHS RFI Comment #1124) (“The effort to comply with this requirement is disproportionately onerous vis-à-vis the general lack of attention individuals afford the NPP.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>264</SU>
                             SNPRM, 84 FR at 24693-94.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>265</SU>
                             SNPRM, 84 FR at 24693-94.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>266</SU>
                             
                            <E T="03">See</E>
                             Section XI, 
                            <E T="03">infra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>267</SU>
                             This is based on an estimate from Wallace Lovejoy, a consultant for the National Association of Optometrists and Opticians, that there are approximately 43,000 optometrists and 16,700 ophthalmologists in the U.S. CLR Panel I Tr., 
                            <E T="03">supra</E>
                             note 100, at 6. Estimates vary as to the total number of eye care providers and contact lens prescribers in the United States, making it difficult to precisely calculate the burden on a per-provider or per-prescriber basis. The investment firm Harris Williams &amp; Co., for instance, put the estimate at 46,000 optometrists and 18,000 ophthalmologists. Harris Williams &amp; Co., Vision Industry Update, at 2 (Mar. 2017) 
                            <E T="03">https://www.harriswilliams.com/system/files/industry_update/vision_industry_update_hcls_0.pdf.</E>
                             Meanwhile, the U.S. Bureau of Labor Statistics estimates there are 42,100 optometrists in the U.S., but does not provide an estimate for the number of ophthalmologists. 
                            <E T="03">https://www.bls.gov/ooh/healthcare/optometrists.htm#tab-1.</E>
                             It must be noted, however, that not all optometrists and ophthalmologists prescribe contact lenses.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">8. Comments About the Exemption for Prescribers Who Do Not Have a Direct or Indirect Financial Interest in the Sale of Contact Lenses</HD>
                    <P>
                        In the SNPRM, the Commission proposed an exemption from the Confirmation of Prescription Release requirement for prescribers who do not have a direct or indirect financial interest in the sale of contact lenses, including, but not limited to, though an association, affiliation, or co-location with a contact lens seller.
                        <SU>268</SU>
                        <FTREF/>
                         The purpose of the proposed exemption was to reduce the burden on prescribers who do not sell lenses, and therefore, have no incentive to withhold prescriptions. The failure of the prescriber to provide the prescription under such circumstances would provide no benefit to the prescriber while likely alienating the patient. In fact, there is a strong incentive to provide patients with their prescriptions, since that is the only way they would be able to obtain contact lenses.
                    </P>
                    <FTNT>
                        <P>
                            <SU>268</SU>
                             SNPRM, 84 FR at 24698.
                        </P>
                    </FTNT>
                    <P>
                        At least one commenter voiced support for the exemption,
                        <SU>269</SU>
                        <FTREF/>
                         but some were critical of the proposal.
                        <SU>270</SU>
                        <FTREF/>
                         Some commenters suggested removing it in order to “future proof” the prescription-release process in light of new and evolving business models—and intermingled financial interests—between prescribers and contact lens sellers.
                        <SU>271</SU>
                        <FTREF/>
                         According to one commenter, the exception for those without a financial interest is “intentionally vague and leaves the barn door open for interpretation and abuse.” 
                        <SU>272</SU>
                        <FTREF/>
                         The AOA also objected to the underlying premise that prescribers might consider their own interests above those of their patients.
                        <SU>273</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>269</SU>
                             Consumer Reports (SNPRM Comment #133) (“Although getting and keeping a record of the patient confirmation will not pose any significant burden, by definition these prescribers would seem not to pose any risk of conflict of interest in releasing the prescription; indeed, they would have an inherent interest in releasing it.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>270</SU>
                             Contact Lens Institute (SNPRM Comment #79); Zerbinopoulos (SNPRM Comment #147); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>271</SU>
                             
                            <E T="03">See</E>
                             Contact Lens Institute (SNPRM Comment #79); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151); Alcon (SNPRM Comment #117).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>272</SU>
                             Zerbinopoulos (SNPRM Comment #147).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>273</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <P>The Commission recognizes these concerns, but believes there is a significant benefit in more narrowly targeting only those with an incentive to withhold prescriptions, thereby further reducing the overall burden and avoiding unnecessarily impacting prescribers who are unlikely to violate the Rule. Moreover, the Commission believes that determination of whether a financial interest exists is feasible, and that prescribers are unlikely to arrange their financial interests and business structures solely to circumvent the Confirmation of Prescription Release requirement. The Commission also believes it has the investigative tools to examine whether there is a financial interest, should the need arise. And if the Commission determines upon later review that such financial manipulation is occurring to circumvent the Rule, the Commission can revisit whether to remove the exemption.</P>
                    <HD SOURCE="HD2">D. Additional Discussion and Commission Determination Regarding the Confirmation of Prescription Release Proposal</HD>
                    <P>The Commission has carefully reviewed and analyzed the entire record developed with respect to the Confirmation of Prescription Release proposal. This record includes more than 8,000 comments submitted in response to its 2015 Request for Comment, 2016 NPRM, 2018 Contact Lens Workshop, and 2019 SNPRM, as well the original history and legislative record relating to enactment of the FCLCA and the Rule in 2004.</P>
                    <P>
                        The evidentiary record as set forth in the NPRM and the SNPRM, as well as the Commission's enforcement and oversight experience, supports the view that compliance with the Rule's automatic-prescription-release requirement is sub-optimal, and as a result, a substantial number of consumers—several million contact lens users every year—are not receiving their contact lens prescriptions as required by law. Many consumers are unaware they even have a right to receive them. Implementing a Confirmation of Prescription Release requirement will result in an increase in the number of patients in possession of their prescriptions; improved flexibility and choice for consumers; a reduced verification burden for prescribers and sellers; a reduced likelihood of medical errors associated with incorrect, invalid, and expired prescriptions; and a reduction in the number of attempts to verify with the wrong prescriber.
                        <SU>274</SU>
                        <FTREF/>
                         The ultimate result will be improved competition in the market, more efficient contact lens sales, improved patient safety, and lower prices for consumers. Furthermore, the 
                        <PRTPAGE P="50688"/>
                        requirement will increase the Commission's ability to enforce and assess its Rule, and will accomplish this in a reasonable manner that takes into consideration the needs and burdens of prescribers and sellers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>274</SU>
                             SNPRM, 84 FR at 24681.
                        </P>
                    </FTNT>
                    <P>In response to commenters' concerns, the Commission has made three modifications to the proposal put forth in the SNPRM. The Commission concurs with the suggestion that requiring prescribers to identify the specific method or methods they would use for electronic delivery of prescriptions will increase awareness and allow patients to make a more informed decision. The Commission will therefore define “Provide to the patient a copy” in the Final Rule to require that prescribers who choose to offer an electronic method of delivery identify the specific method or methods used. The Commission also believes that evidence of consumer consent to electronic delivery of a prescription will aid in enforcing the Rule, and thus in its Final Rule, the Commission is requiring that prescribers keep records or evidence of a patient's affirmative consent to a digital copy for at least three years. Lastly, for instances where a consumer refuses to sign the confirmation, in the Final Rule, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance. The Commission believes that the burden from these three changes will be minimal.</P>
                    <HD SOURCE="HD1">III. Additional Requirements for Sellers Using Verification Calls Containing Automated Messages</HD>
                    <P>
                        In response to the Commission's NPRM, a number of commenters criticized the use of verification calls containing automated messages (“automated telephone messages”), which they often refer to as “robocalls,” 
                        <SU>275</SU>
                        <FTREF/>
                         with some requesting an outright ban of these calls.
                        <SU>276</SU>
                        <FTREF/>
                         The Act and the Rule dictate that sellers that do not have a contact lens prescription presented to them directly or by facsimile verify the prescription by “direct communication.” 
                        <SU>277</SU>
                        <FTREF/>
                         That term, in the Act and Rule, is defined as “completed communication by telephone, facsimile, or electronic mail.” 
                        <SU>278</SU>
                        <FTREF/>
                         The Commission has stated that the Act expressly permits telephone communication for verification and believes that it would be contrary to congressional intent to prohibit use of automated telephone calls for the purpose of prescription verification.
                        <SU>279</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>275</SU>
                             
                            <E T="03">See</E>
                             SNPRM, 16 FR at 24684 and n.270.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>276</SU>
                             
                            <E T="03">See</E>
                             SNPRM, 16 FR at 24685 and n.281.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>277</SU>
                             15 U.S.C. 7603(a); 16 CFR 315.5(a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>278</SU>
                             Specifically, the Act defines direct communication to “include” a completed communication via one of these three methods, 15 U.S.C. 7603(g), whereas the Rule defines “direct communication” to “mean” a completed communication via one of these three methods, 16 CFR 315.2, a distinction discussed below.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>279</SU>
                             SNPRM, 16 FR at 24684.
                        </P>
                    </FTNT>
                    <P>
                        In response to the SNPRM, commenters continued to express criticism of automated telephone messages 
                        <SU>280</SU>
                        <FTREF/>
                         with some continuing to urge the Commission to ban them.
                        <SU>281</SU>
                        <FTREF/>
                         The AOA indicated that issues surrounding automated telephone messages have increased in the past five years and that poor quality automated telephone messages are jeopardizing eye health and resulting in consumers wearing non-prescribed contact lenses. It reports an increase in the use of calls that are difficult to understand, do not include all of the necessary information to confirm the prescription, and create barriers for prescribers to communicate corrections.
                        <SU>282</SU>
                        <FTREF/>
                         Johnson &amp; Johnson Vision Care and individual prescribers believe that automated telephone messages can ultimately lead to patients receiving incorrect lenses and suffering adverse health outcomes.
                        <SU>283</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>280</SU>
                             Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); Contact Lens Institute (SNPRM Comment #79); American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>281</SU>
                             Gilberg (SNPRM Comment #46); Armitage (SNPRM Comment #66); Contact Lens Institute (SNPRM Comment #79); Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>282</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>283</SU>
                             Reeder (SNPRM Comment #55) (automated calls and passive verification can result in approval for patients who have never been seen and can lead to injury); Armitage (SNPRM Comment #66) (no way to safely and accurately ensure that a patient's prescription is correctly verified with a robocall-based system); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151). 
                            <E T="03">See also</E>
                             Alcon Vision, LLC (SNPRM Comment #117) (noting health and safety risks associated with robocalls).
                        </P>
                    </FTNT>
                    <P>
                        Other commenters, however, indicated that automated telephone messages were not problematic and should not be prohibited.
                        <SU>284</SU>
                        <FTREF/>
                         Consumer Action stated that “automated call systems appear to be working in a majority of cases” and that prescribers should design more responsive systems for handling such requests.
                        <SU>285</SU>
                        <FTREF/>
                         The NAOO commented that from its members' perspective, there are “no issues with the use of automated calls, which tend to be infrequent to any particular prescriber's office” and that such calls are an efficient method of verification.
                        <SU>286</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>284</SU>
                             Consumer Action (SNPRM Comment #101); National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>285</SU>
                             Consumer Action (SNPRM Comment #101).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>286</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129); 
                            <E T="03">see also</E>
                             1-800 CONTACTS (SNPRM Comment #135) (its records indicate that “on average, prescribers are asked to verify just one order from 1-800 a week”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. The Congressional Record Does Not Support Prohibiting Automated Telephone Messages</HD>
                    <P>
                        Commenters in favor of a ban on such calls argue that the Commission lacks evidence that Congress intended to include automated calls in the definition of “direct communication” 
                        <SU>287</SU>
                        <FTREF/>
                         and should eliminate the use of this antiquated technology in favor of methods that provide written documentation and the possibility of greater oversight in the verification process.
                        <SU>288</SU>
                        <FTREF/>
                         In support of a ban, commenters stated that the Act does not mention the use of automated telephone messages and that the Commission's interpretation of such calls as a valid form of “direct communication” may be counter to testimony provided during hearings that occurred prior to the Act's implementation.
                        <SU>289</SU>
                        <FTREF/>
                         These commenters stated that “congressional members and the then CEO of a major online contact lens seller made statements critical of automated telephone verification, stating explicitly that fax or another verifiable method were the preferred prescription verification methods for contact lens prescriptions.” 
                        <SU>290</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>287</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>288</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151). CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 9 (request of Steinemann for written requests only and not “robocalls”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>289</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>290</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <P>
                        A closer analysis of the congressional testimony reveals a question to the CEO of the contact lens seller about earlier testimony by the AOA mentioning problems with both automated calls and continuous faxes.
                        <SU>291</SU>
                        <FTREF/>
                         The CEO's 
                        <PRTPAGE P="50689"/>
                        response merely recognized that there had been criticism of automated calls, and stated that at that time the company preferred fax verifications because they were written.
                        <SU>292</SU>
                        <FTREF/>
                         There is no other mention of issues with automated calls by congressional members or the CEO during that hearing.
                        <SU>293</SU>
                        <FTREF/>
                         Instead, such testimony arguably shows that Congress had been made aware of the criticisms of automated calls and, if it had wished to do so, could have banned their use explicitly. Yet, Congress specifically included telephone as a valid form of direct communication. The hearing also evidences a recognition that telephone communications, unlike faxes, would not be written. As a result, reference to this testimony does not change the Commission's view that automated telephone messages are a permissible form of direct communication.
                    </P>
                    <FTNT>
                        <P>
                            <SU>291</SU>
                             
                            <E T="03">See</E>
                             “Fairness to Contact Lens Consumers Act: Hearing Before the Subcommittee on Commerce, Trade, and Consumer Protection of the House Committee on Energy and Commerce,” 108th Cong. 1 (Sept. 12, 2003) (Rep. Shimkus: “Mr. Coon [CEO of 1-800 CONTACTS], there have been some questions [raised in earlier hearing testimony from the AOA] about the techniques companies like yours use to verify orders for contact lens 
                            <PRTPAGE/>
                            prescriptions, and problems such as automated calls and continuous faxes inhibiting optometrists from verifying prescriptions. Could you just go through your procedures for me?”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>292</SU>
                             
                            <E T="03">Id.</E>
                             (In response to Rep. Shimkus's request to go through the company's procedures, Rep. Burr: Mr. Coon, how does 1-800 currently request doctor verification? Mr. Coon: Well, the best system that we have found works the best, which we do in a majority of our orders—and there has been criticism of phone automated systems and other things. The system that works the best is in writing by fax. We know that there is a confirmation that it was received. And that's the system that we would recommend.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>293</SU>
                             The Commission is also unaware of any other on-the-record discussions about automated calls during congressional consideration of the FCLCA.
                        </P>
                    </FTNT>
                    <P>
                        The Health Care Alliance for Patient Safety referred to automated telephone messages as antiquated technology,
                        <SU>294</SU>
                        <FTREF/>
                         and stated that the Commission should ban such calls in favor of methods that provide verifiable written communication, including fax, emails, and electronic portals.
                        <SU>295</SU>
                        <FTREF/>
                         Such documentation, according to the Alliance, will allow for greater oversight and a safer environment allowing prescription verification through clearer, more concise and accurate communication between the prescriber and the seller.
                        <SU>296</SU>
                        <FTREF/>
                         As previously stated, Congress expressly permitted use of the telephone knowing that this method did not produce writings like the other delineated verification methods, facsimile and email, and thus, the Commission declines to prohibit the use of this medium for verification.
                    </P>
                    <FTNT>
                        <P>
                            <SU>294</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>295</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); CooperVision, Inc. (SNPRM Comment #130). The Commission declines to include portals as a method by which sellers can verify prescriptions. In considering the proposal, the Commission considered that the Act defines direct communication to include telephone, fax, or email. As stated in the 2004 SBP, Congress's use of the term “includes” contemplates that additional methods of communication could develop that could be used in the verification process. 69 FR 40490. However, there is no evidence that prescribers and sellers are using, or are likely to use, portals in the verification process.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>296</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128). The Contact Lens Institute criticized the Commission for failing to address the fact that the information conveyed in a telephonic communication needs to be reduced to a writing by the prescriber's office so it can be compared to patient records, a process that must in virtually all cases be conducted separately from the call itself. SNPRM Comment #79. It follows, according to CLI, that written requests are more efficient and effective communication tools for both sellers and prescribers.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Comments About, and Adoption of, Requirements Proposed in the SNPRM To Improve Quality of Automated Telephone Messages</HD>
                    <P>
                        In the SNPRM, the Commission recognized that additional requirements for automated verification calls were necessary to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales.
                        <SU>297</SU>
                        <FTREF/>
                         As a result, the Commission proposed, via an amendment to § 315.5, requirements for sellers to improve verification calls that use, in whole or in part, an automated message. For these calls, sellers must: (1) Record the entire call; (2) commence the call by identifying it as a request for prescription verification; (3) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; and (4) give the prescriber the option to repeat the information.
                        <SU>298</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>297</SU>
                             SNPRM, 16 FR at 24685.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>298</SU>
                             SNPRM, 16 FR at 24685.
                        </P>
                    </FTNT>
                    <P>
                        Commenters were largely in favor of the Commission's proposals to: (1) Commence the call by identifying it as a request for prescription verification; (2) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; 
                        <SU>299</SU>
                        <FTREF/>
                         and (3) give the prescriber the option to repeat this information.
                        <SU>300</SU>
                        <FTREF/>
                         Seller 1-800 CONTACTS indicated that its verification messages already comply with these proposed requirements, and the NAOO indicated that its members have not identified any significant burdens in complying with these requirements.
                        <SU>301</SU>
                        <FTREF/>
                         CooperVision indicated that these proposals, along with some of the Commission's other proposals, helped address some of the more troubling issues with automated messages.
                        <SU>302</SU>
                        <FTREF/>
                         On the other hand, the Contact Lens Institute, comprised of the major contact lens manufacturers, indicated that the Commission's proposed measures demonstrate the impossibility of assuring that automated messages provide effective communication of required information and a reliable basis for passive verification.
                        <SU>303</SU>
                        <FTREF/>
                         For instance, it stated that the Commission's requirements to commence the call by identifying it as a request for prescription verification and to give prescribers an option to repeat assumes that prescribers will have live staff available 24 hours a day and will not need to rely on recording devices.
                        <SU>304</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>299</SU>
                             The Commission notes that these criteria have always been part of the Rule, but it has determined that they should be expressly set forth in the Rule. 
                            <E T="03">See</E>
                             81 FR 88540 (“A request delivered by an automated telephone system does not comply with the Rule if it is not delivered in a volume and cadence that a reasonable person can understand.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>300</SU>
                             American Optometric Association (SNPRM Comment #96) (stating support for these requirements, but expressing concern they are coming too late); National Association of Optometrists &amp; Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151) (expressing approval for these provisions should the Commission not prohibit these calls altogether).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>301</SU>
                             National Association of Optometrists &amp; Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>302</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>303</SU>
                             Contact Lens Institute (SNPRM Comment #79). Members of the Contact Lens Institute are Alcon Vision, Bausch + Lomb, CooperVision and Johnson &amp; Johnson Vision Care. The Commission notes that the opinions expressed in the CLI's comment do not always conform with the opinions of the manufacturers as expressed in their individually filed comments.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>304</SU>
                             It also described the Commission's requirement to deliver the message in a “slow and deliberate manner” and at a “reasonable volume” as so vague as to be potentially unenforceable. Contact Lens Institute (SNPRM Comment #79. The Commission disagrees with this assessment, finding that these conditions are met if, upon listening to a call, the required information is comprehensible to a reasonable person.
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not find these criticisms compelling. The Commission recommended these proposals with an awareness that sometimes prescribers' offices take these calls live and, at other times, the calls are left on recording devices. An option to repeat the information is helpful if a person answers live. If not, the prescriber has the ability to replay the message from the recording device. Similarly, commencing the call by identifying it as a request for prescription verification should help ensure that the prescriber's office is ready to take the relevant information down, both when answering live and when playing the message from a recording device. As a 
                        <PRTPAGE P="50690"/>
                        result, the Commission is implementing these amendments in its Final Rule.
                    </P>
                    <HD SOURCE="HD2">C. The Commission's Proposal Requiring Sellers To Record Automated Telephone Messages</HD>
                    <P>
                        In the SNPRM, the Commission also requested comments on its proposed amendment to § 315.5 to require sellers who verify prescriptions through automated telephone verification messages to record the entire call.
                        <SU>305</SU>
                        <FTREF/>
                         Some commenters opposed the proposal,
                        <SU>306</SU>
                        <FTREF/>
                         while others supported it.
                        <SU>307</SU>
                        <FTREF/>
                         1-800 CONTACTS opposed the recording requirement, stating that it would impose a costly burden on sellers, is unnecessary because the Commission lacks evidence of a systematic problem with automated calls, and would not facilitate enforcement or improve compliance.
                        <SU>308</SU>
                        <FTREF/>
                         This seller also commented that the requirement combined with state wiretapping laws may cause sellers to switch to other, perhaps less-reliable verification methods.
                        <SU>309</SU>
                        <FTREF/>
                         In favor of the proposal, the AOA indicated that the cost of compliance is justified given the widespread issues with robocalls that currently exist.
                        <SU>310</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>305</SU>
                             SNPRM, 84 FR at 24685.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>306</SU>
                             Contact Lens Institute (SNPRM Comment #79); 1-800 CONTACTS (SNPRM Comment #135); Consumer Reports (Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>307</SU>
                             The Health Care Alliance for Patient Safety (SNPRM Comment #128), CooperVision, Inc. (SNPRM Comment #130), and Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151), supported the recording requirement if the Commission did not ban automated telephone messages altogether. 
                            <E T="03">See also</E>
                             American Optometric Association (SNPRM Comment #96); National Association of Optometrists &amp; Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>308</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>309</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>310</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <P>
                        In support of its position that the recording requirement is unnecessary, 1-800 CONTACTS pointed to the Commission's statement in the SNPRM that it does not have empirical data showing the frequency of verification calls that contain incomplete or incomprehensible automated messages.
                        <SU>311</SU>
                        <FTREF/>
                         The seller further commented that the number of sellers that use this particular technology is likely limited and the Commission can much more easily acquire the evidence necessary to investigate complaints and bring an enforcement action in appropriate circumstances.
                        <SU>312</SU>
                        <FTREF/>
                         It stated that “the same cost-benefit approach that justifies additional recordkeeping for prescription release, counsels against additional superfluous and costly regulation and in favor of targeted enforcement.” 
                        <SU>313</SU>
                        <FTREF/>
                         Consumer Reports noted that it was not aware of noncompliance similar to that of prescribers' failure to release prescriptions.
                        <SU>314</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>311</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>312</SU>
                             1-800 CONTACTS stated that the Commission lacked evidence about whether problems occur with automated calls of more than a limited number of sellers, and if it is a limited number of sellers, the Commission should consider education and enforcement efforts instead of rule changes. For instance, the Commission could obtain the recording itself from prescribers who assert that they have received an invalid or incomprehensible verification call. 
                            <E T="03">Id.</E>
                             Although the Commission could obtain such recordings from prescribers, the information would not be complete. Without the ability to obtain recordings from the seller, the Commission would be unable to assess if the call the seller relied on was compliant, was non-compliant (violating the Rule) but an anomaly, or was part of a widespread use of problematic calls. Moreover, as to its point about the limited number of sellers making these calls, new contact lens sellers are routinely entering the market and the Commission needs to ensure it can enforce against them if it receives complaints.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>313</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>314</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <P>
                        The Commission lacks empirical data on this issue, as noted in the SNPRM.
                        <SU>315</SU>
                        <FTREF/>
                         However, it is undisputed that automated telephone messages are a commonly used method of verification. Moreover, these calls impose a cost on prescribers, and there are potential health risks to patients from incomplete and incomprehensible automated telephone requests.
                        <SU>316</SU>
                        <FTREF/>
                         In fact, many commenters have indicated problems with the quality of automated telephone messages.
                        <SU>317</SU>
                        <FTREF/>
                         The AOA commented in response to the SNPRM that, in its survey of 629 doctors of optometry, 85% reported that automated calls for prescription verifications have increased in the past five years, and 88% indicated that the quality of such calls has decreased in the past five years.
                        <SU>318</SU>
                        <FTREF/>
                         These commenters have exposed an issue for enforcement: Without a call recording,
                        <SU>319</SU>
                        <FTREF/>
                         the Commission cannot reliably assess whether that call was compliant and further whether the seller has a pattern of placing non-compliant calls (and selling after such calls).
                    </P>
                    <FTNT>
                        <P>
                            <SU>315</SU>
                             SNPRM, 84 FR at 24685.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>316</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>317</SU>
                             NPRM, 81 FR at 88538 nn.152, 154, 155; SNPRM, 84 FR at 24684 n.270. 
                            <E T="03">See also</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 8 (statement of David Cockrell that the office can't understand many of the robocalls); 
                            <E T="03">id.</E>
                             at 8 (statement of Tim Steinemann that many robocalls are unintelligible or cut off).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>318</SU>
                             American Optometric Association (SNPRM Comment #96). However, because the AOA did not provide the survey itself or the data from the survey, the Commission does not rely on it as more than anecdotal evidence.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>319</SU>
                             The Commission has received numerous comments from prescribers indicating that they have received non-compliant messages, some of which were left on their answering machines, yet has received very few actual recordings of these messages from prescribers.
                        </P>
                    </FTNT>
                    <P>
                        1-800 CONTACTS commented that it is an unnecessary burden for sellers to record and retain copies of thousands of identical verification calls, the costs of which would exceed the benefits.
                        <SU>320</SU>
                        <FTREF/>
                         Consumer Reports shared this sentiment and suggested that it would be more reasonable for the Commission to require sellers to retain a sample recording of the standard script, leaving blanks for prescription and patient details.
                        <SU>321</SU>
                        <FTREF/>
                         The Commission believes that seeing a script of information relayed or a sample recording has limited utility. A script or a sample recording would not reveal whether the required information was transmitted for any particular automated telephone message or if, for instance, required information was transmitted before a representative or machine answered, after an answering machine cut off, when a prescriber's office put the call on hold, or over hold music, in which case the call could not be lawfully used as a basis for the sale.
                        <SU>322</SU>
                        <FTREF/>
                         Further, a script or sample recording would not permit the Commission to assess whether each call was delivered in a “slow and deliberate manner” and at a “reasonably understandable volume.” Without knowing this information, the Commission would be unable to determine conclusively whether any particular verification request was valid. Therefore, the Commission is not adopting this recommendation.
                    </P>
                    <FTNT>
                        <P>
                            <SU>320</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>321</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>322</SU>
                             One commenter requested a requirement for online sellers to maintain files of recordings of 
                            <E T="03">each verification attempt</E>
                             made by automated message for a period of no less than three years. Health Care Alliance for Patient Safety (SNPRM Comment #128). The Commission is only requiring sellers to maintain recordings of automated telephone calls that are the basis for the sale, and to maintain these recordings for three years. There is no need under the Rule for sellers to maintain recordings of unsuccessful verification attempts.
                        </P>
                    </FTNT>
                    <P>
                        1-800 CONTACTS asserted that the requirement to record verification calls would not only impose additional regulatory burdens on sellers, but also expose sellers to legal risk.
                        <SU>323</SU>
                        <FTREF/>
                         The seller argued that by recording telephone communications, sellers might risk violating two-party consent laws in the states that require all parties on the call to consent to recordings.
                        <SU>324</SU>
                        <FTREF/>
                         After 
                        <PRTPAGE P="50691"/>
                        reviewing the relevant statutes and applicable case law, the Commission does not believe sellers risk conducting illegal calls by recording them.
                        <SU>325</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>323</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>324</SU>
                             Twelve states have such a requirement: California, Connecticut, Delaware, Florida, Illinois, Maryland, Massachusetts, Montana, Nevada, New Hampshire, Pennsylvania, and Washington. 
                            <E T="03">See</E>
                             Cal. Penal Code § 632(a), (c) (West 2019); Conn. Gen. Stat. § 52-570d(a) (West 2019); Del. Code Ann. tit. 11, § 2402(a), (c)(4) (West 2019); Fla. Stat. Ann. § 934.03(1), (3)(d) (West 2019); 720 Ill. Comp. Stat. Ann. 5/14-2(a) (West 2019); Md. Code. Ann., Cts. 
                            <PRTPAGE/>
                            &amp; Jud. Proc. § 10-402(a), (c)(3) (West 2019); Mass. Gen. Laws Ann. ch. 272, § 99(C) (West 2019); Mont. Code Ann. § 45-8-213(1)(c), (2)(a)(iii) (West 2019); Nev. Rev. Stat. Ann. § 200.620 (West 2019); N.H. Rev. Stat. Ann. § 570-A:2 (2019); 18 Pa. Stat. and Cons. Stat. Ann. § 5703, 5704(4) (West 2019); Wash. Rev. Code Ann. § 9.73.030(1), (3) (West 2019). It is also possible that Michigan has a two-party consent law, although interpretations of the law differ, and the issue has not been firmly resolved. 
                            <E T="03">See</E>
                             Mich. Comp. Laws Ann. § 750.539c (“Any person . . . who willfully uses any device to eavesdrop . . . without the consent of all parties thereto . . . is guilty of a felony). 
                            <E T="03">Compare AFT Mich.</E>
                             v. 
                            <E T="03">Project Veritas,</E>
                             378 F. Supp. 3d 614, 620 (E.D. Mich. 2019) (finding statute prohibits participants from recording private discourse of any other person involved in the conversation unless all persons consent); 
                            <E T="03">with Sullivan</E>
                             v. 
                            <E T="03">Gray,</E>
                             324 N.W.2d 58, 60 (Mich. Ct. App. 1982) (finding statute does not require two-party consent because it only prohibits eavesdropping, which is defined as recording the “private discourse 
                            <E T="03">of others.”</E>
                             (emphasis added)).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>325</SU>
                             Of course, the Commission cannot predict precisely how different jurisdictions will apply state laws. However, the Commission is unaware of a party ever being held liable for violating two-party consent requirements in a situation where the call contained a disclosure message at its onset. The Commission further notes that jurisdictions take different approaches to deciding which state law applies for interstate or multi-state phone calls. 
                            <E T="03">See, e.g., Ditech Fin. LLC</E>
                             v. 
                            <E T="03">Buckles,</E>
                             401 P.3d 215 (Nev. 2017). Therefore, when recording calls with prescribers located in other states, sellers should abide by the more stringent law that applies or obtain the consent of all parties to the communication. As the Commission stated in the SNPRM, 84 FR at 24685 n.288, sellers are responsible for determining compliance with state law taping requirements.
                        </P>
                    </FTNT>
                    <P>
                        For instance, though the California penal code prohibits eavesdropping on or recording confidential communications without two-party consent, the code excludes from the definition of “confidential communication” any circumstances “in which the parties to the communication may reasonably expect that the communication may be overheard or recorded.” 
                        <SU>326</SU>
                        <FTREF/>
                         The California Supreme Court has stressed that § 632 of the California penal code does not preclude parties from ever recording conversations, but rather prohibits parties from doing so “secretly” or “surreptitiously,” declaring that a business would not violate the state's wiretapping laws if it advised parties to a communication of its intent to record the call at the outset of the conversation.
                        <SU>327</SU>
                        <FTREF/>
                         Similarly, in Massachusetts, a person cannot willfully intercept any wire or oral communication, with “interception” defined in the statute as secretly hearing, secretly recording, or aiding another to do so without the parties' consent.
                        <SU>328</SU>
                        <FTREF/>
                         The Massachusetts Supreme Court has ruled that a system that expressly notifies the parties that the call will be recorded does not commit an interception because the system does not record the conversation in secrecy.
                        <SU>329</SU>
                        <FTREF/>
                         Thus, in California and Massachusetts, sellers who provide a standard notification at the beginning of the call, which has become customary in many business communications, are unlikely to risk violating state wiretapping laws.
                    </P>
                    <FTNT>
                        <P>
                            <SU>326</SU>
                             Cal. Penal Code § 632(a), (c).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>327</SU>
                             
                            <E T="03">Kearney</E>
                             v. 
                            <E T="03">Salomon Smith Barney, Inc.,</E>
                             137 P.3d 914, 930 (Cal. 2006); 
                            <E T="03">see also Hataishi</E>
                             v. 
                            <E T="03">First Am. Home Buyers Prot. Corp.,</E>
                             168 Cal. Rptr. 3d 262, 271 (Cal. Ct. App. 2014) (stating California consumers are accustomed to receiving notice of a business's intention to record a call); 
                            <E T="03">CS Wang &amp; Assoc.</E>
                             v. 
                            <E T="03">Wells Fargo Bank, N.A.,</E>
                             305 F. Supp. 3d 864, 885 (N.D. Ill. 2018) (Under the California Invasion of Privacy Act, “the baseline assumption in situations where the recorded party does not initiate the call, does not have a prior relationship with the caller, 
                            <E T="03">and does not receive a warning at the outset of the call,</E>
                             is that it is reasonable for a party to expect that its conversation is not being recorded.”) (emphasis added).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>328</SU>
                             
                            <E T="03">See</E>
                             Mass. Gen. Laws Ann. ch. 272, § 99(B)(4), (C)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>329</SU>
                             
                            <E T="03">See Commonwealth</E>
                             v. 
                            <E T="03">Boyarsky,</E>
                             897 N.E.2d 574, 579 (Mass. 2008) (finding “there was no interception because there was no secret recording, and the inquiry is at an end”); 
                            <E T="03">see also Marquis</E>
                             v. 
                            <E T="03">Google, Inc.,</E>
                             No. SUCV2011-02808-BLS1, 2014 WL 4180400, at *12 (Mass. Super. Ct. July 27, 2014) (“The core of the statute is . . . the prevention of the 
                            <E T="03">secret</E>
                             interception of wire communications . . . . In consequence, if a recording is `not made secretly,' it does `not constitute an `interception” and there has been no violation of the statute.”).
                        </P>
                    </FTNT>
                    <P>
                        Moreover, after reviewing the plain language of other state statutes requiring two-party consent and case law, the Commission concludes that if sellers express their intentions to record the conversation at the outset of each call, sellers located in or contacting prescribers in two-party consent states will not risk violating a state's respective wiretapping law. Announcements at the outset of the calls would prevent sellers from committing violations because prescribers can either provide or withhold consent. For instance, under Florida's and Maryland's statutes,
                        <SU>330</SU>
                        <FTREF/>
                         as long as a party has received notice of an intent to record, the notified party can expressly or impliedly consent by remaining on the line.
                        <SU>331</SU>
                        <FTREF/>
                         1-800 CONTACTS notes that a prescriber could effectively reject a valid method of verification—verification by telephone—by declining to give consent.
                        <SU>332</SU>
                        <FTREF/>
                         In the event that a prescriber declines to consent to a recorded call containing an automated telephone verification message, sellers may make verification requests via email, live call, or fax. Sellers may also elect to leave automated telephone messages after hours on prescribers' answering machines. Such calls would not implicate wiretapping laws since the prescriber is not on the line.
                        <SU>333</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>330</SU>
                             Fla. Stat. Ann. § 934.03(2)(d); Md. Code. Ann., Cts. &amp; Jud. Proc. § 10-402(a), (c)(3).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>331</SU>
                             
                            <E T="03">See Levin</E>
                             v. 
                            <E T="03">Red Rock Fin. Servs., LLC,</E>
                             No. 70006, 2017 WL 519414, at *1 (Nev. Ct. App. Jan. 30, 2017) (agreeing that summary judgment applying Nevada and Florida law had been properly granted because appellant “necessarily heard the pre-recorded announcement during every phone call . . . and consequently gave implied consent to be recorded during each call 
                            <E T="03">by continuing with the call”</E>
                            ) (emphasis added); 
                            <E T="03">Briddell</E>
                             v. 
                            <E T="03">State,</E>
                             No. 1220, 2016 WL 4698158, at *3-4 (Md. Ct. Spec. App. Sept. 7, 2016) (finding plaintiff “was not forced to communicate . . . nor continue with the phone conversation after being notified that it would be recorded and monitored” and consented to recording “by continuing to speak 
                            <E T="03">after</E>
                             the [warning] messaged [had] played.”) (emphasis added). 
                            <E T="03">See also</E>
                             Wash. Rev. Code Ann. § 9.73.030(3) (“[C]onsent shall be considered obtained whenever one party has announced to all other parties engaged in the communication or conversation, in any reasonably effective manner, that such communication or conversation is about to be recorded or transmitted.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>332</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>333</SU>
                             Some prescribers commenting on the Rule have expressed concern that verification calls placed during non-business hours violate the Rule. 
                            <E T="03">See</E>
                             NPRM, 81 FR at 88544 and n.232. Sellers who leave compliant verification messages after hours do not violate the Rule as long as they wait the required eight business hours before selling lenses (assuming there is no communication from the prescriber invalidating or approving the message before that time period concludes).
                        </P>
                    </FTNT>
                    <P>
                        Commenters also opined on whether the Commission should extend its recording requirement to verification calls that do not involve automated messages, 
                        <E T="03">i.e.,</E>
                         live calls. 1-800 CONTACTS suggested that the requirement to record calls including automated messages should apply equally to live calls because sellers might otherwise have an incentive to outsource live verification calls to inexpensive call centers that can “game the system” by making it difficult for prescribers to understand or respond to live verification requests.
                        <SU>334</SU>
                        <FTREF/>
                         On the other hand, the NAOO, without explanation, supported the Commission's recording requirement for automated calls as long as the Commission does not expand the requirement to apply to live calls.
                        <SU>335</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>334</SU>
                             1-800 CONTACTS (SNPRM Comment #135). The seller also pointed to the Commission's statement in the SNPRM that it does not know that a phone call with an automated message is necessarily less reliable than one with a live person. 
                            <E T="03">Id.</E>
                             (citing SNPRM, 84 FR at 24685).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>335</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <P>
                        For several reasons, the Commission declines to compel sellers to record live calls. Foremost, during live calls, a prescriber can ask a seller to repeat the message or to clarify unintelligible information, and can look up a patient's file in real time to verify the 
                        <PRTPAGE P="50692"/>
                        prescription.
                        <SU>336</SU>
                        <FTREF/>
                         In this setting, a seller is likely to limit any bad conduct. While bad actors could speak incoherently, exclude key information, or refuse to repeat the message when asked, the Commission has not received or seen evidence of such behavior, and the record does not reflect any other widespread issue involving the quality of live calls. Finally, the Commission considered mass merchandisers that verify prescriptions largely or exclusively by calling prescribers to obtain verification via a live call when a customer purchases lenses at the store. Because these sellers use their phone lines for a multitude of purposes unrelated to prescription verification, such as taking consumer orders or checking inventory for a consumer, it would be difficult to implement a recording system in compliance with this Rule. However, should the Commission receive complaints that show an issue with sellers' conduct on live calls, the Commission will reassess the need to require sellers to record live verification calls.
                    </P>
                    <FTNT>
                        <P>
                            <SU>336</SU>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 15 (statement of David Cockrell referring to how live calls provide opportunity for two-way conversation).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">D. The Final Rule Does Not Adopt Commenters' Additional Recommendations Regarding Automated Telephone Messages</HD>
                    <P>
                        A number of additional recommendations were suggested by commenters regarding calls that contain, in full or in part, automated messages.
                        <SU>337</SU>
                        <FTREF/>
                         The Health Care Alliance for Patient Safety and Johnson &amp; Johnson Vision Care requested that the FTC review and approve a transcript of sellers' automated telephone messages before sellers are permitted to use calls containing such messages.
                        <SU>338</SU>
                        <FTREF/>
                         The Contact Lens Institute urged the Commission to require sellers to follow a “specific script that includes standardized terms, a standardized order of presenting the required information, and a standardized pace,” 
                        <SU>339</SU>
                        <FTREF/>
                         and to require sellers to document that they only use means of transmission that have been tested and shown to result in receipt of clear and unambiguous information at the receiving end of the call.
                        <SU>340</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>337</SU>
                             The Contact Lens Institute (SNPRM Comment #79), Health Care Alliance for Patient Safety (SNPRM Comment #128), and Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151) proposed these additional requirements in the event that the Commission declined to prohibit use of verification via automated telephone messages.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>338</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>339</SU>
                             Contact Lens Institute (SNPRM Comment #79). Alcon Vision made a similar recommendation. 
                            <E T="03">See</E>
                             SNPRM Comment #117.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>340</SU>
                             Contact Lens Institute (SNPRM Comment #79).
                        </P>
                    </FTNT>
                    <P>
                        The Commission is not implementing these recommendations. The information that sellers need to include to make a valid verification request is clearly delineated in § 315.5(b), (d)(2), and (d)(4) of the Final Rule.
                        <SU>341</SU>
                        <FTREF/>
                         The Commission does not believe that reviewing and approving a transcript would be an effective use of its resources because it is the call itself that ultimately determines whether there is a valid verification request. Further, while there is some utility in providing a script so prescribers receive the information in a predictable manner, the Commission is not convinced that there is only one effective way for a seller to comply with the Rule, or that this requirement is necessary.
                        <SU>342</SU>
                        <FTREF/>
                         The Rule already indicates what information needs to be included in the message, and the additional requirements the Commission is implementing should make it easier for prescribers to obtain the information. Should seller verification messages be deficient in providing all the required information, prescribers should notify the seller. Moreover, assuming a seller is complying with the Rule by recording calls that contain these messages, the Commission can ascertain whether the call included all the required information (and whether the seller ultimately sold lenses pursuant to an invalid verification call). A review of the recording will provide better information on compliance than would knowing that the seller used a transcript—including an FTC-approved transcript—or a means of transmission that the seller has tested and documented as effective.
                    </P>
                    <FTNT>
                        <P>
                            <SU>341</SU>
                             Commission review of a script would not reveal whether the seller was complying with Section 315.5(d)(3) and (4) of the Final Rule (the requirements as to cadence, volume, and the ability to repeat the information).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>342</SU>
                             Similarly, 1-800 CONTACTS requested a requirement that a pre-recorded message be limited to providing only the information required under the Rule and not include extraneous information that could make the call confusing or more burdensome. SNPRM Comment #135. Although the Commission cautions sellers against including extraneous information, it has not seen evidence of a widespread use of calls including such information and thus is not implementing this recommendation.
                        </P>
                    </FTNT>
                    <P>
                        The Health Care Alliance for Patient Safety and Johnson &amp; Johnson Vision Care also requested a requirement that online sellers confirm that automated calls are answered by a person at the prescriber's office, as opposed to a recording device, before initiating an automated message.
                        <SU>343</SU>
                        <FTREF/>
                         In essence, they are asking for a requirement that all verification calls be placed during a prescriber's business hours, presumably the time when prescribers' phone lines are staffed.
                        <SU>344</SU>
                        <FTREF/>
                         These commenters also requested that the Commission require online sellers who use automated telephone messages to provide, for prescriber's use, a centralized call-back number and have the call-back number staffed by a person from the seller.
                        <SU>345</SU>
                        <FTREF/>
                         In the same vein, CooperVision commented that the Commission should require sellers to provide the means for the prescriber to disrupt a verification call that uses, in whole or in part, an automated message, in order to connect with a person at the seller to provide correct information.
                        <SU>346</SU>
                        <FTREF/>
                         Without this requirement, according to CooperVision, eye care professionals are limited in their ability to correct information that is important for the patient's eye health or that could prevent improper substitution of lenses.
                        <SU>347</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>343</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>344</SU>
                             It is not clear that this option would be desired by prescribers, some of whom have indicated that they do not have time during business hours to respond to these requests or that such calls tie up their phone lines. 
                            <E T="03">See</E>
                             NPRM, 81 FR 88539 n.158.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>345</SU>
                             
                            <E T="03">Id.; see also</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 10 (statement of David Cockrell that the office needs to be able to contact the seller immediately and it “can't even leave a message”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>346</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>347</SU>
                             CooperVision also stated confusion as to whether the Commission's requirement for sellers to provide an option to repeat the verification information included a requirement for sellers to provide the means for the prescriber to immediately disrupt an automatic call in order to connect with a live person. SNPRM Comment #130. It does not.
                        </P>
                    </FTNT>
                    <P>
                        The Rule does not require sellers' communication via telephone, email, or fax to occur during business hours. The Rule requires, instead, that sellers wait eight business hours after a valid verification call to sell the lenses. Moreover, the Rule already requires the seller to provide the name of a contact person at the seller's company, including facsimile and telephone numbers.
                        <SU>348</SU>
                        <FTREF/>
                         Should a prescriber inform the seller within eight business hours that the prescription was inaccurate, expired, or otherwise invalid, the seller cannot lawfully sell those contact lenses. If a prescriber informs a seller that the verification request itself was non-compliant, the seller is on notice that it may need to provide another verification request prior to selling the lenses. The prescriber need not relay that information to a person at the seller, whether during the verification 
                        <PRTPAGE P="50693"/>
                        call or at other times.
                        <SU>349</SU>
                        <FTREF/>
                         Instead, it is sufficient notice for a prescriber to leave a voicemail, or send a facsimile, that provides the seller with enough information so as to identify the consumer or order being called about (a consumer name, reference number, or even the prescriber's name with the date of the verification call could be adequate), and that the prescription is inaccurate, expired, or otherwise invalid.
                        <SU>350</SU>
                        <FTREF/>
                         In addition, requiring sellers to reach a person (and not a machine) at the prescriber's office, or to provide a call-back number that is answered by a person (and not a machine), would mean either that sellers would need to have agents available at all times, or else only contact prescribers during business hours for both the seller and prescriber, which may be difficult if they are located in different time zones. Requiring that sellers have someone available at all times to respond to prescriber inquiries would also be costly for sellers, with no readily apparent countervailing benefit. For these reasons, the Commission declines to implement a requirement that sellers ensure that automated telephone messages are answered by a person at the prescriber's office, as opposed to a recording device, or that prescribers be able to reach a live person at the seller.
                        <SU>351</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>348</SU>
                             16 CFR 315.5(b)(6).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>349</SU>
                             If a seller does not maintain a person to answer the phone number it provides, it must provide an opportunity for the prescriber to leave a message. A seller that does not check its voicemail runs the risk of selling lenses after a prescriber has timely invalidated or corrected the prescription, thereby violating the Rule.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>350</SU>
                             Final Rule § 315.5(e) requires the prescriber to specify the basis for the inaccuracy or invalidity of the prescription, and if the prescription is inaccurate, the prescriber shall correct it. Final Rule 16 CFR 315.5(e). Even if the prescriber violates the Rule by failing to specify the basis for the inaccuracy or invalidity, or by failing to correct the prescription, the seller is still prohibited from selling if a prescriber informs the seller that the prescription is inaccurate, expired, or otherwise invalid within the eight-business-hour time period.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>351</SU>
                             The Commission notes that some sellers have agents who stay on the line to ensure that, before commencing the automated message, an individual at the prescriber's office has answered the phone, or that the answering machine has picked up before leaving the message. Such a practice helps ensure that the beginning of the message is not cutoff or played over hold music.
                        </P>
                    </FTNT>
                    <P>
                        The Health Care Alliance for Patient Safety and Johnson &amp; Johnson Vision Care further requested a requirement that online sellers verify that they are making verification calls to the office of a legitimate eye care professional. The Commission is aware of allegations of sellers making verification calls to numbers clearly not affiliated with eye care prescribers. The Rule requires a seller to sell contact lenses in accordance with a contact lens prescription for the patient that, if not presented to the seller, is verified by direct communication.
                        <SU>352</SU>
                        <FTREF/>
                         Of course, for prescription verification to be meaningful, that verification must go to the consumer's eye care prescriber. Although the seller does not know whether the prescriber contact information provided by the consumer is that of the consumer's own eye care prescriber, to ensure that its verification request complies with the Rule, it is incumbent upon the seller to ascertain whether the number provided by the consumer is for 
                        <E T="03">an eye care prescriber.</E>
                         If it is apparent from the consumer's entry itself,
                        <SU>353</SU>
                        <FTREF/>
                         or from the seller's research on the internet or otherwise, that the number provided is not affiliated with a prescriber, or if it cannot be determined whether it is, the seller should either reach out to the consumer to obtain better contact information or cancel the order. Calls to numbers clearly not associated with eye care prescribers are not compliant verification requests, and any sales made pursuant to such requests violate the Rule. The Commission intends for this notice to provide sufficient guidance for sellers and does not see a need to amend the Rule to address this issue.
                    </P>
                    <FTNT>
                        <P>
                            <SU>352</SU>
                             16 CFR 315.5(a).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>353</SU>
                             For instance, sellers should not verify a prescription when the consumer identifies the prescriber as “Santa Claus.” Similarly, sellers should not place verification calls to phone numbers that consumers list as the prescriber phone number when that phone number is the same number a consumer lists as her own contact number.
                        </P>
                    </FTNT>
                    <P>
                        The Commission is implementing the recommendations outlined in the SNPRM for automated telephone messages in the Final Rule, without modification. CooperVision requested guidance on how the Commission intends to interpret and enforce these provisions.
                        <SU>354</SU>
                        <FTREF/>
                         This notice should provide sellers with information to assist them in complying with the new rule requirements. The Commission also plans to publish education on these Final Rule requirements. As to enforcement, should the Commission receive complaints about the quality of automated calls, it can request that the seller produce the recording of the call in question.
                    </P>
                    <FTNT>
                        <P>
                            <SU>354</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">IV. Prescribers' Selection of Communication Mechanism</HD>
                    <P>
                        In the NPRM, the Commission pointed out that the Act does not permit prescribers to limit the communication mechanism sellers may use to submit requests for verifying prescriptions, and that sellers are able to use any or all of the three delineated methods, telephone, facsimile, or electronic mail.
                        <SU>355</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>355</SU>
                             NPRM, 81 FR at 88542.
                        </P>
                    </FTNT>
                    <P>
                        In response, prescribers continued to request that they be able to select the method of communication used to submit verification requests from among telephone, facsimile, or electronic mail.
                        <SU>356</SU>
                        <FTREF/>
                         Johnson &amp; Johnson Vision Care commented that it wished to work with the Commission and Congress to improve prescriber-seller communications, such as by allowing a prescriber to select her preferred method for verification requests.
                        <SU>357</SU>
                        <FTREF/>
                         The AOA commented that the Commission took a step in the right direction when it suggested that sellers evaluate whether honoring prescriber preferences with regard to communication method would increase the speed and efficiency of the verification process.
                        <SU>358</SU>
                        <FTREF/>
                         It nevertheless urged the Commission to provide more instruction to sellers, and to outline the verification-related complaints that the Commission has received, so prescribers and sellers can work together to ensure patients receive the contact lenses that were prescribed.
                        <SU>359</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>356</SU>
                             O'Daniel (NPRM Comment #179); Krattli (NPRM Comment #1976).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>357</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (NPRM Comment #4327). The manufacturer also requested that sellers be required to provide an option, as part of a verification message, for the prescriber's office to elect an alternate means to receive the request, and an alternate time frame after which the window to respond to verification requests must be completed. Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>358</SU>
                             American Optometric Association (NPRM Comment #3830).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>359</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission reiterates its suggestion that sellers and prescribers work together to ensure that patients receive their prescribed lenses. As stated in the NPRM, the Commission requests sellers to consider whether the speed and efficiency of the verification process would be increased by accommodating prescribers' requests to contact them with verification requests via a certain method.
                        <SU>360</SU>
                        <FTREF/>
                         However, because the Act defines “direct communication” to include three different communication mechanisms that sellers may use—telephone, facsimile, or electronic mail—the Act does not permit prescribers to limit the communication mechanisms sellers may 
                        <PRTPAGE P="50694"/>
                        use to submit verification requests.
                        <SU>361</SU>
                        <FTREF/>
                         The Commission is therefore not making any changes to the Rule in this area.
                    </P>
                    <FTNT>
                        <P>
                            <SU>360</SU>
                             NPRM, 81 FR at 88542. Similarly, the seller should consider whether to accommodate prescribers' requests to contact them during specified time-periods (
                            <E T="03">i.e.,</E>
                             business hours, or after business hours).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>361</SU>
                             
                            <E T="03">See</E>
                             15 U.S.C. 7603(g). The Commission came to the same conclusion in its initial rulemaking. 69 FR at 40497. The Commission recognizes that in practice, sellers' options may be limited. For instance, should a prescriber's office not have facsimile, a seller would be unable to complete a verification request via fax.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">V. Miscellaneous Passive Verification Issues</HD>
                    <HD SOURCE="HD2">A. Active Verification Is Not Required</HD>
                    <P>
                        In the NPRM, the Commission declined to propose replacing passive verification with active verification, despite concerns from many commenters.
                        <SU>362</SU>
                        <FTREF/>
                         Commenters expressed concern that the passive verification system could easily be manipulated, for example, by a patient who provides false or incorrect prescriber information to a seller, or by a seller who sends the same verification request over and over again in the hope that the prescriber will fail to reply and deny one of them.
                        <SU>363</SU>
                        <FTREF/>
                         However, because Congress decided to include a passive verification system in the Act, and the issues commenters raised were identical to those raised during the initial 2004 rulemaking, the Commission chose not to revisit the decision to include passive verification.
                        <SU>364</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>362</SU>
                             NPRM, 81 FR at 88543.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>363</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>364</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Following the NPRM, many commenters reiterated the same concerns with respect to passive verification, including that sellers could abuse the system or that consumers might obtain lenses without a prescription or receive incorrect lenses, and they advocated for a switch to active verification.
                        <SU>365</SU>
                        <FTREF/>
                         Because these concerns are similar to those raised during the initial rulemaking in 2004 and because Congress mandated passive verification in the FCLCA, the Commission again declines to modify the Rule to require active verification.
                        <SU>366</SU>
                        <FTREF/>
                         However, the Commission has made several changes to the Rule aimed at improving the quality of automated verification calls, which will allow prescribers to more effectively prevent the sale of contact lenses when the prescription is inaccurate, expired, or otherwise invalid.
                        <SU>367</SU>
                        <FTREF/>
                         The Commission has also improved patients' access to their prescriptions by implementing requirements enabling patients to obtain electronic copies and additional copies of their prescriptions, and to present their prescriptions directly to sellers, which should reduce the need for passive verification requests.
                        <SU>368</SU>
                        <FTREF/>
                         The Commission recognizes that some sellers may engage in verification practices that violate the Rule's requirements 
                        <SU>369</SU>
                        <FTREF/>
                         and, for that reason, will continue to monitor the marketplace and investigate potential violations when appropriate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>365</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Golden (WS Comment #1353); Weidel (WS Comment #2333); Gray (WS Comment #2730); Audia (NPRM Comment #698); Bazan (NPRM Comment #706); Dewart (NPRM Comment #897); Nixon (NPRM Comment #1510); Weissman (NPRM Comment #1676); Goshe (NPRM Comment #2597); Fritsch (NPRM Comment #2683); Garr (NPRM Comment #2858); Phan (NPRM Comment #3350). Some commenters continued to support passive verification. 
                            <E T="03">See</E>
                             1-800 CONTACTS (WS Comment #3207); National Association of Optometrist and Opticians (WS Comment #3208) (“No changes are needed to the passive verification system.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>366</SU>
                             The Commission also notes that nothing in the Rule prevents active verification by a seller. If it prefers, a seller can choose to actively verify a prescription. CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 5 (statement of Jennifer Sommer) (stating that Walmart often actively verifies prescriptions by calling the prescriber's office).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>367</SU>
                             
                            <E T="03">See</E>
                             Section III, 
                            <E T="03">supra;</E>
                             16 CFR 315.5(c)(2), (d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>368</SU>
                             
                            <E T="03">See</E>
                             Section II.C.5, 
                            <E T="03">supra,</E>
                             and Sections VII and VIII, 
                            <E T="03">infra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>369</SU>
                             16 CFR 315.5(a)-(d).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Concerns About Patient Manipulation</HD>
                    <P>
                        In the NPRM, the Commission declined to propose any changes to the Rule to address concerns that patients were manipulating the passive verification system by deliberately providing inaccurate prescriber information to the seller.
                        <SU>370</SU>
                        <FTREF/>
                         The Commission noted that if prescribers received a verification request for an individual who was not their patient, they have the ability to respond that such request is invalid, which would prevent the sale under § 315.5 of the Rule. Some commenters provided anecdotal evidence of instances where consumers have intentionally provided inaccurate information, but the Commission did not have any empirical evidence showing the frequency of this problem.
                        <SU>371</SU>
                        <FTREF/>
                         Moreover, Congress was aware that passive verification was not a foolproof method to prevent verification of invalid prescriptions, but nonetheless mandated passive verification to balance the interests of consumer health and prescription portability.
                    </P>
                    <FTNT>
                        <P>
                            <SU>370</SU>
                             NPRM, 81 FR at 88543.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>371</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        In response to the NPRM, commenters continued to express concerns with patients being able to obtain contact lenses without a valid prescription, especially with only eight business hours to respond to a verification request, and with the potential health consequences.
                        <SU>372</SU>
                        <FTREF/>
                         To address concerns with patient manipulation of passive verification, commenters advocated using an active verification system, requiring that a prescription be presented, changing the method used to send verification requests, or increasing the amount of time for a prescriber to respond.
                        <SU>373</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>372</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151); Lem (WS Comment #470); Dillehay (WS Comment #822); Baird (WS Comment #1918); Hemler (WS Comment #2312); Patel (WS Comment #2691); Gray (WS Comment #2730); Bottjer (WS Comment #3378); Tuttle (NPRM Comment #161); Gilberg (NPRM Comment #198); Moy (NPRM Comment #382); Engler (NPRM Comment #453); Francis (NPRM Comment #588); Stott (NPRM Comment #687); Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); Schlater (NPRM Comment #3504); Bengoa (NPRM Comment #3600); Jackson (NPRM Comment #3736).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>373</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Northsight Vision Care Center (WS Comment #1196); Golden (WS Comment #1353); Begeny-Mahan (WS Comment #1702) (requesting that the eight-business-hour period be changed to forty-eight hours); Kirkconnell (WS Comment #1754) (requesting two business days to respond and stating that requests should be faxed); American Society of Cataract and Refractive Surgery (WS Comment #3142) (advocating for extending the eight-business-hour time-period for passive verification to five business days); Bazan (NPRM Comment #706); Garr (NPRM Comment #2858); Greitzer (NPRM Comment #3388).
                        </P>
                    </FTNT>
                    <P>
                        The Commission recognizes prescribers' concerns about the potential health effects on patients who wear non-prescribed lenses. However, as noted in the NPRM, Congress chose the passive verification framework as a way to balance consumer health and prescription portability.
                        <SU>374</SU>
                        <FTREF/>
                         Congress also allowed verifications by direct communication, which it defined as including telephone, facsimile, and electronic mail.
                        <SU>375</SU>
                        <FTREF/>
                         Congress was aware that passive verification was not a perfect method to prevent patients from deliberately providing incorrect information.
                        <SU>376</SU>
                        <FTREF/>
                         The Commission does not have any evidence, aside from anecdotal reports, showing the extent to which patients are intentionally providing incorrect information to a seller in order to obtain contact lenses. Thus, the Commission does not believe that significant modifications to the Rule to address the concern about consumers submitting inaccurate prescriber information are warranted.
                    </P>
                    <FTNT>
                        <P>
                            <SU>374</SU>
                             NPRM, 81 FR at 88543.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>375</SU>
                             15 U.S.C. 7603.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>376</SU>
                             NPRM, 81 FR at 88543.
                        </P>
                    </FTNT>
                    <P>
                        However, in its Final Rule, the Commission has implemented several changes to improve verification calls that use an automated telephone system, which will make it easier for prescribers to deny requests based on inaccurate prescriber information. These changes 
                        <PRTPAGE P="50695"/>
                        include identifying at the start of the call that it is a prescription verification request, delivering the information in a slow and deliberate manner and at a reasonably understandable volume, and giving the prescriber the option to repeat the call.
                        <SU>377</SU>
                        <FTREF/>
                         Prescribers will be better able to identify the relevant patient information and inform sellers during the eight-business-hour period that the request is invalid.
                        <SU>378</SU>
                        <FTREF/>
                         The Commission will also continue to monitor the marketplace, investigate any sellers encouraging patients to provide false information, and continue its consumer education efforts communicating the importance of having a prescription when purchasing contact lenses.
                        <SU>379</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>377</SU>
                             
                            <E T="03">See</E>
                             Section III.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>378</SU>
                             16 CFR 315.5(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>379</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Federal Trade Commission, 
                            <E T="03">Halloween know-how: Cosmetic contacts require an Rx, https://www.consumer.ftc.gov/blog/2019/10/halloween-know-how-cosmetic-contacts-require-rx;</E>
                             Federal Trade Commission, 
                            <E T="03">Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses</E>
                             (“All contact lenses—even ones just meant to change your appearance—require a prescription.”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Eight-Business-Hour Time Frame Is Appropriate</HD>
                    <P>
                        In the NPRM, the Commission considered commenters' concerns that the eight-business-hour time frame was too short and that verification calls were being placed outside of business hours or when the prescriber's office was closed.
                        <SU>380</SU>
                        <FTREF/>
                         The Commission declined to lengthen or otherwise modify the eight-business-hour time frame during which a prescriber must respond to a verification request.
                        <SU>381</SU>
                        <FTREF/>
                         The Commission did not find sufficient evidence quantifying how the eight-business-hour time frame imposed a significant burden or showing that a significant number of prescribers were unable to respond to the verification requests within the allotted time. The Commission further noted that there have been no compelling changes to the marketplace since the Rule was implemented in 2004 that would justify extending the period beyond eight business hours.
                    </P>
                    <FTNT>
                        <P>
                            <SU>380</SU>
                             NPRM, 81 FR at 88544-5. Other concerns about passive verification, unrelated to the length of time a prescriber has to respond to a verification request, are addressed in Sections III, IV, and V.A and B.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>381</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        In response to the NPRM, some commenters indicated that eight business hours constituted a sufficient period for a prescriber to respond to a verification request.
                        <SU>382</SU>
                        <FTREF/>
                         However, other commenters continued to express concerns with the limited time frame,
                        <SU>383</SU>
                        <FTREF/>
                         particularly due to the potential negative health consequences for patients wearing non-prescribed lenses, should a prescriber fail to deny an invalid verification request in time.
                        <SU>384</SU>
                        <FTREF/>
                         Many prescribers wrote that eight business hours was just not a sufficient amount of time to respond due to, for example, busy offices, limited staff, high volume of requests, and regular office closures on business days.
                        <SU>385</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>382</SU>
                             Coalition for Contact Lens Consumer Choice (WS Comment #3239); Consumer Action (NPRM Comment #3721); Consumers Union (NPRM Comment 3969) (stating that eight business hours “was generally sufficient and has proven workable,” but suggesting that the period could be changed to twenty-four hours with weekends and holidays excluded); 
                            <E T="03">see also</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 16 (statement of Cindy Williams) (stating that eight hours is sufficient time to respond).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>383</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Becker (WS Comment #571); Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment #1702) (requesting that the eight-business-hour period be changed to forty-eight hours); Kirkconnell (WS Comment #1754) (requesting two business days to respond and stating that requests should be faxed); American Society of Cataract and Refractive Surgery (WS Comment #3142) (advocating for extending the eight-business-hour time-period for passive verification to five business days); Hanen-Smith (NPRM Comment #154); Cade (NPRM Comment #2163) (suggesting that sellers should exclude a weekday from the eight-business-hour calculation if they become aware that the prescriber's office is closed); American Academy of Opthalmology (NPRM Comment #3657) (proposing lengthening the response period to two business days); Coalition for Patient Vision Care Safety (NPRM Comment #3883); Contact Lens Association of Ophthalmologists (NPRM Comment #4259) (asking that the period be extended to two days).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>384</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Rhee (WS Comment #3468); Meyers (NPRM Comment #173); Gilberg (NPRM Comment #198); Engler (NPRM Comment #453); Kempf (NPRM Comment #915); McPherson (NPRM Comment #3397); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); Tesinsky (NPRM Comment #4012).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>385</SU>
                             Boyer (SNPRM Comment #59); Becker (WS Comment #571) (recommending two business days); Contact Lens Association of Ophthalmologists, Inc. (WS Comment #770); Begeny-Mahan (WS Comment 1702) (stating that the eight-hour period is a problem because the office is closed on Wednesdays); Huynh (WS Comment #1940); Dhaliwal (WS Comment #2684); American Society of Cataract and Refractive Surgery (WS Comment #3142); Morales (WS Comment #3404); Yu-Davis (WS Comment #3410), Rhee (WS Comment #3468); Meyers (NPRM Comment #173); Pierce (NPRM Comment #187) (estimating that the office spends approximately twelve minutes responding to a verification request); Kempf (NPRM Comment #915) (stating that the office is closed on Wednesdays and incorrect prescriptions received late on Tuesday will be filled); Goodman (NPRM Comment #1340) (stating that the prescriber is unable to respond to requests within the eight-hour period because the office is closed on Mondays); Speiser (NPRM Comment #2233) (stating that eight hours are not enough time because the doctor spends time at the hospital and is not in the office every day); Weingeist (NPRM Comment #2496) (stating that the practice is small and the requests are burdensome); American Society of Cataract and Refractive Surgery (NPRM Comment #3820); McPherson (NPRM Comment #3397) (stating that the office is very busy with patients and verification requests can be forgotten).
                        </P>
                    </FTNT>
                    <P>
                        The Commission considered these comments and, for the reasons stated in the NPRM, declines to change the eight-business-hour period, including by lengthening the period or changing how the period is calculated. Congress mandated the verification system and that a prescriber respond within “8 business hours, or a similar time as defined by the Federal Trade Commission.” 
                        <SU>386</SU>
                        <FTREF/>
                         In determining this time period, Congress balanced the harm to consumers if they were unduly delayed in receiving their contact lenses against the harm from receiving contact lenses based on an invalid prescription.
                        <SU>387</SU>
                        <FTREF/>
                         The Commission does not find any compelling changes to the marketplace since the Rule's promulgation in 2004 that support extending the eight business hour period.
                        <SU>388</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>386</SU>
                             NPRM, 81 FR at 88544. Some prescribers or sellers may be confused about when the eight-business-hour period starts following a verification request and the applicable time zone. 
                            <E T="03">See, e.g.,</E>
                             Goodman (WS Comment #599); Palmer (WS Comment #2215); Wang (WS Comment #3448); Gilberg (NPRM Comment #198); Huff (NPRM Comment #1964); Osterholzer (NPRM Comment #2085) (stating that the office is not open during the same hours as the seller and in a different time zone). Under the Rule, when a request is received after 5 p.m., the eight-business- hour period would not start until 9 a.m. the next weekday that is not a federal holiday, or if applicable, on Saturday at the beginning of the prescriber's actual business hours. A business hour is determined based on the time zone of the prescriber. 16 CFR 315.2, 315.5.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>387</SU>
                             NPRM, 81 FR at 88544.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>388</SU>
                             The Commission recognizes a need for clarification with respect to whether a seller can ship lenses to a consumer after receiving notification from a prescriber that the submitted prescription is inaccurate, invalid, or expired but when such notification occurs after the eight-business-hour period has passed. In its initial rulemaking, the Commission declined to expressly prohibit sellers from shipping lenses in such an instance, but noted that nothing in the Rule prohibits a prescriber from submitting late notifications to the seller or the seller from acting upon them, and that it would likely be in the best interest of their mutual consumer for them to do so. Contact Lens Rule, 69 FR 40050. However, the Commission is aware that the marketplace for contact lens sales now includes subscription models, in which sellers provide a quantity of lenses to consumers, not in a single-delivery supply, but rather in periodic installments (usually every month, although sometimes quarterly or semi-annually). In such a circumstance, the seller would have plenty of time to halt a subsequent installment shipment after being informed that the consumer's prescription was invalid, inaccurate, or expired. Therefore, the Commission clarifies that while the Rule does not prohibit an initial shipment to a consumer in instances where the seller received such notification after the eight-business-hour period has passed, any subsequent shipments based on the initial verification request would violate the Rule. A seller who has been notified that the patient does not have a valid prescription cannot ignore such notification and continue to sell and ship lenses every month simply because the notification came in after the eight-business-hour deadline.
                        </P>
                    </FTNT>
                    <PRTPAGE P="50696"/>
                    <HD SOURCE="HD1">VI. Seller Alteration of Contact Lens Prescriptions and Private Label Concerns</HD>
                    <P>
                        The current Rule states that a “seller may not alter a contact lens prescription.” The only exception applies to private label contact lenses and allows the seller, when a patient has a prescription for private label contact lenses, to substitute identical contact lenses that the same company manufactures and sells under a different name.
                        <SU>389</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>389</SU>
                             16 CFR 315.5(e).
                        </P>
                    </FTNT>
                    <P>
                        In the SNPRM, the Commission expressed its concern about the emergence of sellers' business models that rely exclusively on passive verification as a means to substitute their own brand of contact lenses for the prescribed lens.
                        <SU>390</SU>
                        <FTREF/>
                         As noted in the SNPRM, many prescribers detailed harm that resulted from wearing unprescribed lenses, such as headaches, corneal neovascularization, corneal ulcers, and other irreversible and vision-threatening diagnoses.
                        <SU>391</SU>
                        <FTREF/>
                         As a result, the Commission proposed two modifications to the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>390</SU>
                             SNPRM, 84 FR at 24687-88.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>391</SU>
                             
                            <E T="03">Id.</E>
                             at 24686.
                        </P>
                    </FTNT>
                    <P>
                        The first modification proposed in the SNPRM, adding a paragraph (g) to § 315.5, would require sellers to provide a clear and prominent method for the patient to present the seller with a copy of the patient's prescription. Such method might include, without limitation, electronic mail, text message, file upload, or facsimile. The Commission stated that this proposal would address prescriber and manufacturer concerns by increasing the number of patients who present online sellers with their prescriptions rather than relying on verification.
                        <SU>392</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>392</SU>
                             
                            <E T="03">Id.</E>
                             at 24688.
                        </P>
                    </FTNT>
                    <P>
                        The second modification proposed in the SNPRM targeted concerns about prescription verification more directly. The proposed modification of § 315.5(f) would define alteration to include a seller's providing, as part of a verification request, a prescriber with a manufacturer or brand other than that specified on a patient's prescription. The proposal included an exception, however, for sellers when they provide a manufacturer or brand that a patient provided to the seller, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription. In other words, to avail themselves of the exception, sellers must ask consumers to provide the manufacturer or brand listed on their prescription. The SNPRM further provided that a seller would not be able to avail itself of the exception by relying on a prepopulated or preselected box, or on consumers' online searches for a particular manufacturer or brand, as an indication that they were prescribed that manufacturer or brand.
                        <SU>393</SU>
                        <FTREF/>
                         A seller not covered under the exception discussed above who made a verification request containing a manufacturer or brand other than, and not identical to, the one written on the consumer's prescription by their prescriber, would violate the Rule, even if a prescriber subsequently invalidated the request and the lenses were never sold.
                        <SU>394</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>393</SU>
                             
                            <E T="03">Id.</E>
                             at 24689.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>394</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. The Final Rule Includes a Requirement for Sellers To Accept Prescription Presentation</HD>
                    <P>
                        Commenters who discussed the Commission's proposal to require sellers to provide a clear and prominent method to present prescriptions were unanimous in their support, although some suggested revisions that they believed would make it more effective.
                        <SU>395</SU>
                        <FTREF/>
                         A number of commenters asserted that this amendment would help decrease the number of verification requests 
                        <SU>396</SU>
                        <FTREF/>
                         and eliminate errors stemming from incorrect verification requests.
                        <SU>397</SU>
                        <FTREF/>
                         In addition, the NAOO pointed out that such presentation benefits the consumer and the seller by reducing the time needed to fill the order and providing additional assurance of the prescription's validity.
                        <SU>398</SU>
                        <FTREF/>
                         1-800 CONTACTS also supported—and says that it already complies with—the prescription presentation proposal.
                        <SU>399</SU>
                        <FTREF/>
                         Simple Contacts commented that the proposed requirement is fair, and opined that “any seller who does not support prescription presentation has not made a good faith attempt to accurately verify all patient prescriptions.” 
                        <SU>400</SU>
                        <FTREF/>
                         Simple Contacts, however, expressed skepticism that the amendment would significantly reduce the number of alterations by sellers abusing the passive verification system.
                        <SU>401</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>395</SU>
                             Simple Contacts (SNPRM Comment #87); American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>396</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>397</SU>
                             Health Care Alliance for Patient Safety (SNPRM Comment #128); National Association of Optometrists and Opticians (SNPRM Comment #129); 1-800 CONTACTS (SNPRM Comment #135); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>398</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>399</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>400</SU>
                             Simple Contacts (SNPRM Comment #87). 
                            <E T="03">See also</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (“Contact lens sellers that do not provide a method to upload the prescription may be trying to avoid getting the patient's specific brand information, so that they can switch the patient into a different proprietary brand.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>401</SU>
                             Simple Contacts (SNPRM Comment #87). The Health Care Alliance for Patient Safety stated that “it is unclear whether the proposed amendment would have any effect on the incidence of alteration[s]” since the Commission is not also prohibiting calls containing automated verification messages. SNPRM Comment #128.
                        </P>
                    </FTNT>
                    <P>Because the Commission did not receive any comments opposing this proposal, the Commission is incorporating the requirement in its Final Rule. The Commission believes the proposal will help reduce the number of verifications, reduce errors associated with incorrect verification attempts, and make it more difficult for ill-intentioned sellers to abuse the passive verification framework and take advantage of consumers who might not realize that the seller intends to verify a different lens than the one written on their prescription.</P>
                    <P>
                        In the Final Rule, the Commission has changed the “clear and prominent” requirement to pertain to a disclosure of the method of prescription presentation (
                        <E T="03">e.g.,</E>
                         a disclosure that the method is available to provide the prescription). In so doing, the Commission makes clear that sellers cannot provide a method of prescription presentation without also providing a clear and prominent disclosure thereof.
                        <SU>402</SU>
                        <FTREF/>
                         The Commission has retained the requirement that the method (
                        <E T="03">e.g.,</E>
                         email address, phone number to receive text messages, or upload link) be prominent.
                        <SU>403</SU>
                        <FTREF/>
                         The Commission has also determined that it is unnecessary to include prescribers in this section of the Rule since it pertains to the ordering process between a seller and a consumer.
                        <SU>404</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>402</SU>
                             For telephone orders, sellers would comply by making a prominent method available and giving clear and prominent notice of the method.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>403</SU>
                             The Commission finds its proposed SNPRM requirement that the method be clear unnecessary given the new language requiring the disclosure of the method to be clear and prominent.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>404</SU>
                             The Rule anticipates prescription presentation by prescribers to sellers. Section 315.5(a)(1) indicates that one way sellers can sell contact lenses is if they receive a prescription from a prescriber directly or by facsimile. 16 CFR 315.5(a)(1).
                        </P>
                    </FTNT>
                    <P>
                        Commenters suggested three additional requirements for the prescription presentation proposal. First, the NAOO suggested the 
                        <PRTPAGE P="50697"/>
                        Commission require that the method to present prescriptions be in close proximity to the option to provide the parameters of the contact lens for verification, so as to increase the likelihood that consumers would understand they have a choice between providing a prescription or having one verified with their prescriber.
                        <SU>405</SU>
                        <FTREF/>
                         As drafted, the language did not specify at what point in the process a seller must make the method for prescription presentation available. The Commission believes that the NAOO's suggestion of close proximity would be helpful, but notes that if the method, and a disclosure thereof, are provided in close proximity but 
                        <E T="03">after</E>
                         the collection of all information required for verification is provided, the prescription presentation benefit may be diminished. In other words, if a consumer enters all the information required for verification (contact lens brand, powers, prescriber name and phone number) before learning about prescription presentation, and having an opportunity to present the prescription, the consumer may choose not to also provide the prescription. As a result, the Commission is amending the language of § 315.5(g) in the Final Rule to require that the method and the disclosure of the method for the patient to present the seller with a copy of the patient's prescription must be 
                        <E T="03">prior to</E>
                         requesting a prescriber's contact information, which is necessary to verify a contact lens prescription.
                        <SU>406</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>405</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>406</SU>
                             In the case of orders placed by telephone, the Rule requires sellers to provide clear and prominent disclosure of the method for prescription presentation (
                            <E T="03">e.g.,</E>
                             a seller's email address) prior to requesting a prescriber's contact information.
                        </P>
                    </FTNT>
                    <P>
                        Two commenters opined on whether consumers should be able to choose the method for providing their prescriptions. Consumer Reports stated its belief that, when offering prescription presentation, sellers should be required to provide consumers all four methods listed in the proposed Rule—electronic mail, text message, file upload, and facsimile—in lieu of giving sellers the option to choose from those methods.
                        <SU>407</SU>
                        <FTREF/>
                         It indicated that requiring all four would not burden the seller, and there may be reasons that patients prefer one option over the others.
                        <SU>408</SU>
                        <FTREF/>
                         On the other hand, the NAOO supported the Commission's proposal to let the seller decide the method.
                        <SU>409</SU>
                        <FTREF/>
                         The Commission has decided to require sellers to offer prescription presentation by the same medium through which the order is placed, or by electronic mail, text message, or file upload.
                        <SU>410</SU>
                        <FTREF/>
                         When orders are placed via telephone, sellers are required to offer prescription presentation via electronic mail, text message, or file upload. Because faxes are not commonly used by consumers, sellers can offer fax presentation as the sole option only when the orders are placed by fax. This framework gives consumers and prescribers an opportunity to present prescriptions, while limiting the burden on sellers, some of whom are small.
                        <SU>411</SU>
                        <FTREF/>
                         The Commission believes that these changes from the SNPRM proposal are not significant, are consistent with the stated purpose of the proposal as outlined in the SNPRM,
                        <SU>412</SU>
                        <FTREF/>
                         and will help ensure the maximum benefit from the Rule change.
                    </P>
                    <FTNT>
                        <P>
                            <SU>407</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>408</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>409</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>410</SU>
                             A seller who chooses to offer all methods will likely benefit by having more consumers provide prescriptions than if it offered only one or even two methods. Benefits to sellers from having prescriptions on file include avoiding the costs involved in verification, and having the ability to provide contact lenses more quickly than relying on verification.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>411</SU>
                             For all orders, sellers can meet the requirement by accepting prescriptions via email. There should not be a significant burden on business to obtain and maintain an email address and process and store prescriptions received through email.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>412</SU>
                             SNPRM, 84 FR at 24688-89.
                        </P>
                    </FTNT>
                    <P>
                        Consumer Reports also recommended that sellers be required not just to accept prescription presentation, but also to specifically request and encourage patients to provide prescriptions.
                        <SU>413</SU>
                        <FTREF/>
                         The Commission declines to adopt this suggestion. The Commission's Final Rule requires sellers to accept prescriptions. The Final Rule also requires that sellers clearly and prominently disclose how consumers can provide them with prescriptions. Sellers that more overtly request or encourage the submission of prescriptions (
                        <E T="03">e.g.,</E>
                         through price cuts and faster delivery times) will likely further increase the number of prescriptions presented, allowing both sellers and consumers to reap the benefits. However, the Commission has determined that beyond providing a method for consumers to present their prescriptions and notice of such method prior to requesting their prescriber's contact information, sellers should have discretion whether to promote or incentivize that practice.
                    </P>
                    <FTNT>
                        <P>
                            <SU>413</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Alteration Includes a Seller Providing a Prescriber With a Verification Request for a Non-Prescribed Manufacturer or Brand, but Includes an Exception for Verifying a Manufacturer or Brand That a Consumer Indicates Is on Her Prescription</HD>
                    <P>
                        In the SNPRM, the Commission proposed a modification of § 315.5(f) to define alteration to include a seller's providing, as part of a verification request, a prescriber with a manufacturer or brand other than that specified on a patient's prescription. The proposal included an exception, however, for sellers when they provide in a verification request a manufacturer or brand that a patient provided to the seller, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription.
                        <SU>414</SU>
                        <FTREF/>
                         As discussed below, in the Final Rule, the Commission has determined to adopt this definition of alteration along with a modified version of the accompanying exception.
                    </P>
                    <FTNT>
                        <P>
                            <SU>414</SU>
                             SNPRM, 84 FR at 24698.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. The Final Rule Modifications Regarding Alteration Are Beneficial and Address Abuses of the Verification System</HD>
                    <P>
                        1-800 CONTACTS expressed its belief that the proposed alteration modification was unnecessary and requested that the Commission carefully evaluate any new regulations that could interfere with the convenience and competitive pricing of legitimate sellers.
                        <SU>415</SU>
                        <FTREF/>
                         Although the seller recognized the presence of single-brand sellers in the market, and the problems some cause, 1-800 CONTACTS stated that the addition of quality standards for verification calls, along with targeted enforcement against sellers with a business model based solely on noncompliant verification methods, would reduce the ability of these sellers to profit from abusing the passive verification system.
                        <SU>416</SU>
                        <FTREF/>
                         Specifically, it felt that “enforcement against one such business [ ] would likely be sufficient to chill or completely eliminate replication of this business model.” 
                        <SU>417</SU>
                        <FTREF/>
                         The Commission agrees that the requirement to provide a method for prescription presentation, and a disclosure thereof, should reduce the number of verification requests, and that the addition of quality standards for verification calls should reduce the incidence of non-compliant verification calls and increase the ability of prescribers to deny invalid requests or 
                        <PRTPAGE P="50698"/>
                        correct inaccurate ones. However, based on comments from prescribers as well as its own investigations and experience, the Commission believes those amendments on their own are inadequate to curb the practice of substitution to non-prescribed brands through abuse of the verification system. The Commission has previously stated that, under the existing Rule, a verification request is not valid and does not commence the eight-business-hour verification period if a seller knows or should know that the verification request includes a different brand and manufacturer than that prescribed.
                        <SU>418</SU>
                        <FTREF/>
                         Any sales after such requests violate the Rule, even if a prescriber has not responded. In these instances, the seller is not selling in accordance with a prescription. Despite clearly articulating this position, the FTC continues to receive reports about the proliferation of passive verification abuses. Furthermore, sellers may argue that they are technically compliant with the Rule because they submitted verification requests and prescribers had an opportunity to respond to the requests. They may also argue that they did not have knowledge that a consumer did not have a prescription for that manufacturer or brand of lens.
                    </P>
                    <FTNT>
                        <P>
                            <SU>415</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>416</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>417</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>418</SU>
                             SNPRM, 84 FR at 24687-88.
                        </P>
                    </FTNT>
                    <P>
                        Additionally, this is not an issue of one bad actor. As noted in the SNPRM, the Commission has seen the emergence of businesses that rely exclusively, or almost exclusively, on passive verification as a means to substitute their own brand of contact lenses.
                        <SU>419</SU>
                        <FTREF/>
                         Simple Contacts' comment notes that, within the last two years, several new companies have entered the U.S. market and that their abuse of the verification system appears willful.
                        <SU>420</SU>
                        <FTREF/>
                         The AOA similarly noted an increase of direct-to-consumer brands and named three new market entrants that reportedly replace their own brand of lenses for the prescribed brand.
                        <SU>421</SU>
                        <FTREF/>
                         The Commission therefore sees benefits to defining alteration to include a seller's providing a prescriber, as part of a verification request, with a manufacturer or brand other than that specified on a patient's prescription.
                    </P>
                    <FTNT>
                        <P>
                            <SU>419</SU>
                             SNPRM, 84 FR at 24687.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>420</SU>
                             Simple Contacts (SNRPM Comment #87).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>421</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Comments Related to the Exception to Alteration When a Seller Provides the Manufacturer or Brand of Lenses That a Consumer Provides in Response to a Seller's Request for That Information</HD>
                    <P>
                        The SNPRM proposed that sellers receive an exception from alteration when they provide, in a verification request, a manufacturer or brand that a patient provided to them, either on the order form or orally in response to a request for the manufacturer or brand listed on the prescription.
                        <SU>422</SU>
                        <FTREF/>
                         If the seller seeks to verify a manufacturer or brand other than that indicated by the consumer, even if a prescriber ultimately denies the request, the seller has committed a violation. The implementation of the alteration definition, including the exception, should serve as an effective deterrent against sellers that try to game the verification system to sell non-prescribed contact lenses.
                    </P>
                    <FTNT>
                        <P>
                            <SU>422</SU>
                             SNPRM, 84 FR at 24686.
                        </P>
                    </FTNT>
                    <P>
                        In response to the SNPRM, commenters expressed concerns that some sellers might take advantage of the exception by inducing, suggesting, advertising, or otherwise causing consumers to provide a name other than that on their prescription so as to allow the seller to seek verification of a brand that had not been prescribed for the consumer.
                        <SU>423</SU>
                        <FTREF/>
                         The NAOO was specifically concerned that “less scrupulous sellers” would attempt to take advantage of this exception, and noted that currently some sellers only request the power of the lenses from the customer and then ask prescribers to verify a prescription with a private label brand.
                        <SU>424</SU>
                        <FTREF/>
                         Commenters proffered different recommendations as to how to address this issue. CooperVision requested that the Commission state in a guidance document that sellers cannot induce, suggest, advertise, or otherwise cause patients to provide the wrong name, and to provide examples of improper statements.
                        <SU>425</SU>
                        <FTREF/>
                         Johnson &amp; Johnson Vision Care suggested that, should the Commission retain the exception, it should add the following clarifying language to the preamble section of the Rule: “This exception is intended to provide explicit direction for sellers as to when they are responsible for instances of prescription alteration. Under no circumstances may a seller, wishing to avail themselves of this exception, direct, encourage, motivate, or suggest, either implicitly or explicitly, that a patient enter any manufacturer or brand other than that listed on the patient's prescription.” 
                        <SU>426</SU>
                        <FTREF/>
                         The NAOO recommended that the Rule itself be further amended to provide more specific direction as to what the seller must, may, and cannot do when asking patients for the information the FCLCA requires in a verification request. Specifically, it recommended adding a requirement that to avail itself of the exception, a seller must have had no reason to believe that the name provided by the consumer was not the manufacturer or brand listed on that consumer's prescription.
                        <SU>427</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>423</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129); CooperVision, Inc. (SNPRM Comment #130); Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>424</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>425</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>426</SU>
                             Johnson &amp; Johnson Vision Care recognized that the exception could serve as guidance for sellers to determine whether they are responsible for an illegal prescription alteration. However, it believes the exception should not be added to the Rule because a patient may not be able to correctly enter their information given the nuances of a contact lens prescription and the meaning of the different elements therein. Ultimately, Johnson &amp; Johnson Vision Care is concerned that the exception may contribute to passive verification of an inaccurate prescription, and thus, illegal substitution. SNPRM Comment #151. The Commission does not believe that this concern is relevant to the exception, which relates to a consumer only providing her manufacturer or brand.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>427</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129).
                        </P>
                    </FTNT>
                    <P>
                        The Commission agrees that sellers must not induce, suggest, advertise, or otherwise lead consumers to provide a manufacturer or brand different from that listed on their prescriptions. The Commission believes, however, that the recommended change is unnecessary because, should a seller attempt to induce or trick the consumer into providing the seller with a manufacturer or brand different from that listed on the consumer's prescription, it would not be able to avail itself of the exception. Any such conduct by the seller would call into question whether the consumer had 
                        <E T="03">provided</E>
                         the seller with the manufacturer or brand listed 
                        <E T="03">on her prescription</E>
                         in response to a clear request for such information, as required by the Rule.
                    </P>
                    <P>
                        Commenters expressed concern that the exception for patient prescription entry would allow consumers to override their prescriptions by providing a manufacturer or brand of contact lenses other than that prescribed to them by their prescriber.
                        <SU>428</SU>
                        <FTREF/>
                         Similarly, one commenter stated that sellers should ensure that consumers understand that they need to request the lens specified on their prescription and, if consumers want a different lens, 
                        <PRTPAGE P="50699"/>
                        sellers shall state prominently that consumers must discuss the request with, and make the change through, their prescribers.
                        <SU>429</SU>
                        <FTREF/>
                         The concern that this amendment gives consumers permission to override their prescriptions, including choosing a new brand, is unfounded. The exception in no way gives consumers the ability to override prescribers' prescriptions, and it does not change the prescriber's ability to inform a seller that the prescription submitted for verification is inaccurate, expired, or otherwise invalid.
                        <SU>430</SU>
                        <FTREF/>
                         In fact, by requiring sellers to ask consumers their manufacturer or brand to meet the exception, the proposal is encouraging just the opposite—inviting consumers to choose the brand prescribed for them. And, once the seller receives a communication from the prescriber that the prescription is invalid, it cannot sell the lenses without violating the Rule. The Commission therefore does not see a need to require sellers to inform consumers that if they want a different lens, they must go to their prescribers. Asking consumers for the manufacturer or brand listed on their prescriptions, and clarifying that sellers may not induce, suggest, or otherwise cause consumers to select or provide a manufacturer or brand other than that prescribed, should be adequate to curtail much of the illegal alterations occurring through abuse of the verification system. Moreover, the Commission has issued consumer notices that indicate that if consumers wish to switch their brand of lens, they need to contact their prescribers.
                        <SU>431</SU>
                        <FTREF/>
                         The Commission will continue its educational efforts in this area.
                    </P>
                    <FTNT>
                        <P>
                            <SU>428</SU>
                             American Optometric Association (SNPRM Comment #96); Health Care Alliance for Patient Safety (SNPRM Comment #128).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>429</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>430</SU>
                             Final Rule 16 CFR 315.5(e). Despite this prohibition, substitution to another brand of lenses was always a risk with passive verification, but it was a risk Congress considered before instituting the verification framework set forth in the Act. 
                            <E T="03">See, e.g.,</E>
                             FCLCA Subcomm. Hearing, 
                            <E T="03">supra</E>
                             note 17 (statements of Howard Beales, Federal Trade Commission); 
                            <E T="03">id.</E>
                             (statements of J. Pat Cummings, American Optometric Association) (“And the problem with passive verification is that people will get contact lenses without a prescription.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>431</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Federal Trade Commission, 
                            <E T="03">Prescription Glasses and Contact Lenses, https://www.consumer.ftc.gov/articles/0116-prescription-glasses-and-contact-lenses</E>
                             (last visited Nov. 19, 2019).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Comments Regarding and Commission Guidance on Acceptable Methods for Obtaining the Brand or Manufacturer Listed on Consumers' Prescriptions</HD>
                    <P>
                        1-800 CONTACTS expressed concern that the Commission's amendment might interfere with its ability to improve the user experience. It indicated that it sells hundreds of brands of lenses and offers consumers a variety of methods to identify their brand, including drop-down menus, a search box, and filters that display lenses by brand, modality, and other parameters and that some consumers do not enter their brand information on an order form.
                        <SU>432</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>432</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <P>
                        Simple Contacts asked for greater specificity on the acceptable mechanisms for soliciting the contact lens brand or manufacturer, as a way to prevent bad actors from finding mechanisms to circumvent the intent of the Rule. Simple Contacts recommended limiting such mechanisms to five: Providing verbal confirmation of the brand or manufacturer; providing a copy of a prior prescription indicating the brand or manufacturer; typing a selection into a free entry text or search field; selecting a brand or manufacturer from a list or database containing the majority of commercially available brands (
                        <E T="03">e.g.,</E>
                         a drop-down menu), or providing a photo of a contact lens box.
                        <SU>433</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>433</SU>
                             Simple Contacts (SNPRM Comment #87). The NAOO also stated that a seller should be able to rely on a customer-provided photograph of packaging of contact lenses for a current prescription. SNPRM Comment #129.
                        </P>
                    </FTNT>
                    <P>
                        Johnson &amp; Johnson Vision Care opined that should the Commission proceed with the exception, a seller should not be able to avail itself of the exception by relying on a prepopulated or preselected box, or on consumers' online searches for a particular brand or manufacturer, as a representation by consumers that they do, in fact, have a prescription for that brand or manufacturer. In contrast to the view expressed by 1-800 CONTACTS and Simple Contacts, Johnson &amp; Johnson Vision Care requested the Commission prohibit drop-down menus and similar tools as methods by which a seller could avail itself of the exception.
                        <SU>434</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>434</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (SNPRM Comment #151).
                        </P>
                    </FTNT>
                    <P>The Commission agrees that greater specificity surrounding acceptable methods would benefit sellers trying to comply with the Rule, but recognizes the myriad of ways consumers can interact with sellers to purchase lenses. Specifically, the Commission agrees that the requirement to provide the manufacturer or brand if not orally, then on an order form, imposes unnecessary limits for a consumer to select her manufacturer or brand. As a result, it is removing the term “order form” from the Final Rule. However, while sensitive to sellers' needs to create the best and most convenient consumer experience, the Commission believes requiring that they ask for the name of the manufacturer or brand listed on consumers' prescriptions can still be done while providing a positive purchasing experience for their customers.</P>
                    <P>
                        At a minimum, in order for sellers to consider the consumer's indication of manufacturer or brand as adequate to qualify for the exception, the manufacturer or brand must be: (1) Provided in response to a seller's request for the manufacturer or brand listed on the consumer's prescription, and (2) an affirmative statement or selection by the consumer, not a preselected or prefilled entry (collectively “the minimum criteria”). As to the first minimum criterion, a seller cannot assume that a consumer who searches on the internet for a specific manufacturer or brand of lens has a prescription for that manufacturer or brand of lens. Similarly, a consumer's selection next to a request for the manufacturer or brand the consumer wears or wishes to purchase would be insufficient because a consumer may be wearing or attempting to order a non-prescribed lens. In contrast, a seller can reasonably rely on a consumer's entry of a manufacturer or brand in response to a request for the “manufacturer or brand listed on your prescription.” The second minimum criterion for sellers to qualify for the exception is that they must elicit from the consumer an affirmative statement or selection of the manufacturer or brand. A seller that relies on a preselected, prechecked box stating “I agree I have a prescription for this brand,” or something similar, would not qualify for the exception to alteration. For telephone orders, the consumer must state the name of the manufacturer or brand in response to a seller's request for the manufacturer or brand listed on her prescription.
                        <SU>435</SU>
                        <FTREF/>
                         A seller can rely on a consumer-provided photograph of a contact lens box or a copy of a prior prescription so long as the seller meets the two minimum criteria listed above and obtains additional information from the consumer or prescriber that the consumer has a current prescription for that brand.
                        <SU>436</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>435</SU>
                             A seller receiving an affirmative response to its request “Do you have a prescription for this brand?” would be unable to meet the exception.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>436</SU>
                             The information from the prescriber or consumer would provide the seller with a basis for the verification other than the expired prescription. 
                            <E T="03">See</E>
                             Section X.B., 
                            <E T="03">supra</E>
                             and NPRM, 81 FR at 88546-67 (a seller may not use an expired prescription as the basis for a verification request).
                        </P>
                    </FTNT>
                    <P>
                        The Commission is not limiting the permissible methods for obtaining 
                        <PRTPAGE P="50700"/>
                        manufacturer or brand to meet the exception to only those discussed above. The Commission instead is leaving sellers the option of deriving other ways to elicit the prescribed manufacturer or brand, within the guidelines discussed in this section. The Commission also declines to add a preamble further explaining the ways for sellers to meet the exception, but instead relies on this notice as guidance.
                    </P>
                    <P>
                        1-800 CONTACTS opined that the Commission should not refer to “brand” in the amendment to the Rule as that language does not appear elsewhere in the Rule. It points out that the Rule defines a prescription as including a “material or manufacturer or both” and that the Commission's inclusion of the reference to brand imposes an additional limit on consumer choice that the Act does not require. 1-800 CONTACTS requested instead that the exception to the Rule be applicable to “providing the prescriber with the name of a manufacturer or material other than that specified by the patient's prescriber . . . .” The reference to brand in the definition of alteration and in the exception would indeed be the only references to brand in the Rule. However, in practice, it appears many, if not most, prescriptions list the manufacturer's brand, not the manufacturer or material, and the brand is viewed as shorthand for the entire device.
                        <SU>437</SU>
                        <FTREF/>
                         Furthermore, very few consumers know the manufacturer or material of contact lens that they wear, and typically refer to their lenses by brand name. Amending the exception in the way 1-800 CONTACTS recommended would be unworkable since many consumers would be unable to provide the manufacturer or material in response to a seller's request, and might even have to ask their prescribers. Should prescribers' practices change from listing a brand on a prescription to listing a manufacturer or material, the Commission will reevaluate its decision.
                    </P>
                    <FTNT>
                        <P>
                            <SU>437</SU>
                             SNPRM, 84 FR at 24686 n.299. 
                            <E T="03">See also</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (noting as an example that many, if not most, prescriptions for My Day lenses manufactured by CooperVision get written as “My Day,” not as “CooperVision” or “CooperVision My Day”).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">4. The Commission Is Not Imposing a Recordkeeping Requirement for Sellers Related to the Exception</HD>
                    <P>
                        Lastly, CooperVision strongly recommended that the Commission reconsider its decision not to require sellers to keep records related to the exception and noted that the Rule relies heavily on requiring written evidence. CooperVision claimed that the lack of a recordkeeping requirement would leave a gap that could be exploited, and would make it difficult for the Commission to pursue enforcement against sellers who violate the Rule.
                        <SU>438</SU>
                        <FTREF/>
                         The Commission disagrees with this assessment. Since the exception to alteration would be a defense for a seller, the seller would have the burden of proof to show it met the exception. Should the Commission believe that the seller has altered a contact lens prescription and submitted a verification request for a manufacturer or brand other than that indicated by a consumer, the seller would need evidence that it meets the exception. Sellers who determine not to maintain records do so at their own peril.
                    </P>
                    <FTNT>
                        <P>
                            <SU>438</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Private Label Issues</HD>
                    <P>
                        Although most contact lenses in the United States are sold under national brand names (such as Acuvue Oasys, or Dailies Aquacomfort Plus), some manufacturers distribute their lenses to prescribers and retail sellers under private labels (such as Costco's Kirkland Signature contact lens brand or LensCrafters 1-Day Premium contact lenses). Private label contact lenses can be unique to one seller, or the private label brand may be available at multiple unaffiliated sellers.
                        <SU>439</SU>
                        <FTREF/>
                         Despite the label, however, the lenses inside the packaging are exactly the same as lenses sold under a national brand.
                        <SU>440</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>439</SU>
                             2005 Contact Lens Report, 
                            <E T="03">supra</E>
                             note 14, at 14-15.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>440</SU>
                             For example, Costco's Kirkland Signature Premium Daily Disposable lenses are the same as CooperVision MyDay disposable lenses.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">1. The Commission Adopts a Technical Amendment and Clarifies That the Only Permissible Substitution Involves Private Label Lenses</HD>
                    <P>
                        In § 315.2, the Rule defines private label lenses as “contact lenses that are sold under the label of a seller where the contact lenses are identical to lenses made by the same manufacturer but sold under the labels of other sellers.” 
                        <SU>441</SU>
                        <FTREF/>
                         The Rule also provides that a prescription for private label contact lenses must include, in addition to other required information, the name of the manufacturer, trade name of the private label brand, and if applicable, the trade name of equivalent brand name.
                        <SU>442</SU>
                        <FTREF/>
                         The Rule's definition for a private label lens prescription tracks the language of the Act.
                        <SU>443</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>441</SU>
                             16 CFR 315.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>442</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>443</SU>
                             
                            <E T="03">See</E>
                             15 U.S.C. 7610(3)(H).
                        </P>
                    </FTNT>
                    <P>
                        With respect to how sellers treat and substitute private label lenses, however, the Commission recognized in the NPRM that the construction of § 315.5(e) of the Rule does not presently conform to the language or intent of the Act.
                        <SU>444</SU>
                        <FTREF/>
                         The clear language of the Act allows sellers to substitute national brand name lenses for private label lenses, and vice versa, so long as it is “the same contact lens manufactured by the same company and sold under multiple labels to individual providers.” 
                        <SU>445</SU>
                        <FTREF/>
                         The Rule, meanwhile, states that a seller may “substitute for private label contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.” 
                        <SU>446</SU>
                        <FTREF/>
                         The different language of the Act thus allows sellers to substitute brand names for identical private labels, and private labels for identical brand names, while the Rule, as currently drafted, could be read to proscribe the latter.
                    </P>
                    <FTNT>
                        <P>
                            <SU>444</SU>
                             NPRM, 81 FR at 88552.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>445</SU>
                             15 U.S.C. 7603(f). Although the Commission imagines it would be quite rare, it believes a seller should be permitted under the Rule to substitute one private label lens for another private label lens so long as the lenses are identical.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>446</SU>
                             16 CFR 315.5(e).
                        </P>
                    </FTNT>
                    <P>
                        To conform the Rule to the Act, the Commission proposed in the NPRM to strike the words “private label” from § 315.5(e), so it would state that a seller may “substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.” 
                        <SU>447</SU>
                        <FTREF/>
                         The Rule's definitions of a “contact lens prescription” and of a “private label contact lens” would remain unchanged. The Commission made this proposal after becoming aware that, in addition to prescribers, some other sellers (such as Costco) now market and sell private label contact lenses that are identical to, and are made by the same manufacturer as, brand name contact lenses. As a result, when a patient presents a contact lens prescription for brand name contact lenses to certain sellers, those sellers may wish to sell, as a substitute, their own private label lenses to the patient.
                    </P>
                    <FTNT>
                        <P>
                            <SU>447</SU>
                             NPRM, 81 FR at 88552.
                        </P>
                    </FTNT>
                    <P>
                        While the Commission's proposal was intended to clarify the Rule and align it with the Act's intent, some commenters opposed the change because they believed it could be interpreted as allowing substitution beyond that of private label lenses.
                        <SU>448</SU>
                        <FTREF/>
                         According to Johnson &amp; Johnson Vision Care, the 
                        <PRTPAGE P="50701"/>
                        “private label” modifier is necessary to provide guidance that the only instance in which a seller can lawfully substitute lenses for those written on a prescription is for identical private label lenses, and that removing the words “private label” from the command section of the Rule (leaving it only in the definitions section), will render the term meaningless.
                        <SU>449</SU>
                        <FTREF/>
                         The removal of this term is especially problematic, according to the manufacturer, because illegal substitution is a problem in the marketplace, and it could ultimately cause undue, avoidable harm to patient eye health and vision safety.
                        <SU>450</SU>
                        <FTREF/>
                         Should the Commission choose to proceed with its removal of the term “private label” from § 315.5(e), Johnson &amp; Johnson Vision Care requested that the Commission explicitly clarify that such removal does not allow for substitution beyond the scope of private label lenses or identical contact lenses that the same company manufactures and sells under different labels. It further suggested that the most appropriate and effective place to clarify how the Commission interprets this Rule provision would be in the preamble of the Rule, rather than the regulatory language itself.
                        <SU>451</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>448</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (NPRM Comment #4327); 
                            <E T="03">see also</E>
                             Tesinsky (NPRM Comment #4012) (fearing change may be interpreted as the “ability to substitute a different contact by the same manufacturer (for example substituting Acuvue Oasys for Acuvue Vita), rather than just a private label substitute”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>449</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (NPRM Comment #4327); 
                            <E T="03">see also</E>
                             American Optometric Association (NPRM Comment #3830) (opposing Commission's proposal and finding the term “private label” provides necessary clarity to ensure inappropriate substitutions do not occur).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>450</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (NPRM Comment #4327).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>451</SU>
                             Johnson &amp; Johnson Vision Care, Inc. also supported its position that the clarification should be made in the preamble by reference to the fact that there were not specific reports of sellers encountering issues with the original Rule language. NPRM Comment #4327.
                        </P>
                    </FTNT>
                    <P>
                        Costco, in contrast, supported the Commission's proposed change, because it would make clear that sellers can substitute their own private label contact lenses for prescribed lenses that are identical to lenses made by the same manufacturer and sold under the manufacturer's brand.
                        <SU>452</SU>
                        <FTREF/>
                         Although Costco believes that the existing Rule allows it, when presented with a valid prescription for the manufacturer's brand, to substitute Kirkland Signature lenses, it believed that modifications to the language of § 315.5(e) would clarify and eliminate any doubt about the lawfulness of this practice. Costco also opined that without such a change, the legality of such substitution might be in question, and, as a result, some sellers, particularly those without an established relationship with prescribers, would likely be unwilling to invest in a private label lens line.
                        <SU>453</SU>
                        <FTREF/>
                         Consumers Union also supported the change, indicating that it increases the choices available to consumers, including potentially more affordable options, without in any way undermining patient safety.
                        <SU>454</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>452</SU>
                             Costco Wholesale Corporation (NPRM Comment #4281).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>453</SU>
                             
                            <E T="03">Id.</E>
                             Costco also commented that bringing a private label lens to market can significantly benefit consumers in terms of introducing lower prices. NPRM Comment #4281.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>454</SU>
                             Consumers Union (NPRM Comment #3969).
                        </P>
                    </FTNT>
                    <P>
                        The Commission did not intend for the removal of the words “private label” in the Rule to make substitution more widely permissible beyond that of a seller being able to provide a private label lens when the 
                        <E T="03">identical</E>
                         lens (made by the same manufacturer but sold under a different label) is written on the prescription. However, in order to allay concerns, the Commission has retained the term “private label,” but reordered the provision to clarify that permissible substitution only involves private label contact lenses. Thus, the Final Rule allows private label and brand name lenses, when they are identical lenses made by the same manufacturer listed on the prescription, to be substituted for each other.
                        <SU>455</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>455</SU>
                             Section 315.5(f) of the Final Rule reads: “Notwithstanding the preceding sentences, for private label contact lenses, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.” The Commission revised the provision to refer to the “preceding sentences” to make it clear that the phrase beginning with “[n]otwithstanding” does not apply to anything other than § 315.5(f).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. The Commission Is Not Imposing Additional Requirements on Prescriptions for Private Label Lenses</HD>
                    <P>
                        As mentioned above, the Act and the Rule require prescriptions for private label contact lenses to include “the name of the manufacturer, trade name of the private label brand, and if applicable, trade name of equivalent brand name.” 
                        <SU>456</SU>
                        <FTREF/>
                         LD Vision Group (
                        <E T="03">LensDiscounters.com</E>
                        ), in response to the NPRM, provided the Commission with instances of alleged rule violations involving private label prescriptions improperly written or written without equivalents.
                        <SU>457</SU>
                        <FTREF/>
                         It also requested that the Commission reconsider LD Vision Group's previous recommendations to: (1) Require prescribers to annotate private label lens prescriptions with the brand-name equivalent and if the name-brand equivalent is unavailable, the private-label prescription must be medically necessary for that particular patient; (2) require manufacturers of contact lenses to make brand information available to all sellers, consumers, and the FTC; or (3) require manufacturers and sellers to make brand equivalency information available and easily accessible for private labels on their brand label packaging and online.
                    </P>
                    <FTNT>
                        <P>
                            <SU>456</SU>
                             15 U.S.C. 7610; 16 CFR 315.2 (in definition of contact lens prescription).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>457</SU>
                             This commenter also disagreed with what it stated was the “Commission's diminishment of private label concerns.” LD Vision Group, Inc. (NPRM Comment #3958).
                        </P>
                    </FTNT>
                    <P>
                        Although the Commission appreciates the additional information provided by LD Vision Group, the information has not altered the fact, as stated in the SNPRM, that the Act does not impose a requirement of medical necessity in order for a prescriber to prescribe a private label lens for which no name-brand equivalent exists.
                        <SU>458</SU>
                        <FTREF/>
                         The Act also does not expressly contemplate the imposition of disclosure requirements on manufacturers. Therefore, the Commission is not implementing the recommendations of LD Vision Group.
                    </P>
                    <FTNT>
                        <P>
                            <SU>458</SU>
                             SNPRM, 81 FR 88551. In the SNPRM, the Commission also referenced the initial rulemaking, where sellers recommended that prescribers be required, when prescribing private label contact lenses, to identify on the prescription the name of a brand that a consumer could purchase from a seller other than the prescribing office. 69 FR 40503. The Act does not limit, in any way, the brand that a prescriber must select, and the current record does not have sufficient evidence indicating that this is a problem. 
                            <E T="03">Id.</E>
                             Therefore, LD Vision Group's proposal to limit prescribers from prescribing private label brands without a brand-equivalent is not adopted.
                        </P>
                    </FTNT>
                    <P>
                        The Act and the Rule expressly require that, for private label contact lens prescriptions, prescribers include “trade name of equivalent brand name.” 
                        <SU>459</SU>
                        <FTREF/>
                         Prescribers violate the Rule if they provide a script that omits this information because the script does not meet the definition of a contact lens prescription. With that in mind and given the additional information provided by LD Vision Group, the Commission will consider whether enforcement action is appropriate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>459</SU>
                             15 U.S.C. 7610, 16 CFR 315.2 (contact lens prescription defined to include, in the case of a private label contact lens, the name of the manufacturer, trade name of the private label brand, and, if applicable, trade name of equivalent brand name).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VII. “Directly or by Facsimile” Language Includes Use of Online Patient Portals to Present Prescriptions</HD>
                    <P>
                        Section 315.5(a)(1) of the Rule provides that a seller may sell contact lenses in accordance with a prescription that is presented to the seller “directly or by facsimile.” In the NPRM, the Commission initially determined that the provision “directly or by facsimile” includes the use of online patient portals by patients and prescribers to present contact lens prescriptions to 
                        <PRTPAGE P="50702"/>
                        sellers.
                        <SU>460</SU>
                        <FTREF/>
                         The Commission noted that use of a patient portal “necessarily involves `an exact copy of the prescription within the scope of acceptable direct presentation mechanisms.' ” 
                        <SU>461</SU>
                        <FTREF/>
                         The Commission observed in the NPRM that technology had evolved since the Rule's implementation in 2004 and that patient portals offered several potential benefits, including reducing: The chance of an inaccurate or expired prescription being presented to a seller; the costs for prescribers, patients, and sellers by making it easier and more efficient for patients to share and present prescriptions; and the number of verification requests to prescribers.
                        <SU>462</SU>
                        <FTREF/>
                         The Commission sought comments on whether the use of online portals complies with the Rule and requested information about whether the Commission should consider any other issues related to the presentation of prescriptions to sellers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>460</SU>
                             NPRM, 81 FR at 88537-38.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>461</SU>
                             
                            <E T="03">Id.</E>
                             at 88538.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>462</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Although the Commission received many comments indicating that patients are able to receive their prescriptions electronically, including through patient portals, and interact with their prescribers electronically,
                        <SU>463</SU>
                        <FTREF/>
                         few comments addressed the use of portals to present prescriptions directly to sellers. Commenters agreed that such technology could offer benefits, including reducing the number of requests for verification and additional copies, and giving patients greater access to their prescriptions.
                        <SU>464</SU>
                        <FTREF/>
                         However, it is unclear how often, if at all, prescribers send prescriptions to sellers through a portal. Use of portals to transmit prescriptions to sellers could face barriers, including technology issues between the parties caused by using different software and platforms, and privacy restrictions preventing sellers from accessing patients' portal accounts.
                        <SU>465</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>463</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Eklund (WS Comment #502); Reed (WS Comment #749); Gitchell (WS Comment #759); Andrews (WS Comment #1014); Carvell (WS Comment #1021); Cecil (WS Comment #1892); Kuryan (WS Comment #3472); Hopkins (NPRM Comment #184); Wilson (NPRM Comment #1310); Grove (NPRM Comment #1702); MacDonald (NPRM Comment #2118); Andrus (NPRM Comment #3345); American Academy of Ophthalmology (NPRM Comment #3657) (“For practices that utilize electronic medical record systems, patients can request a copy of their prescription and [be] issued one electronically.”); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>464</SU>
                             National Association of Optometrists and Opticians (NPRM Comment #3851) (noting that the option to provide a prescription through a portal should be available because technology will continue to advance); 1-800 CONTACTS (NPRM Comment #3898); Costco Wholesale Corp. (NPRM Comment #4281) (supporting the FTC's determination regarding presentation of prescriptions directly or by facsimile for the reasons cited in the NPRM); NPRM, 81 FR at 88538 (identifying the potential benefits of using a portal to present a prescription to a seller). Other commenters have expressed the potential benefits of portals or electronic health records generally. 
                            <E T="03">See, e.g.,</E>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103); Opticians Association of Americas (WS Comment #482); Marshall (WS Comment #518) (suggesting the benefit of electronic medical records in allowing easier access to the prescription); McCarty (WS Comment #1898); CooperVision, Inc. (WS Comment #3077); Coalition for Contact Lens Consumer Choice (WS Comment #3239) (stating that new technologies like electronic health records have benefits for consumers).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>465</SU>
                             Hill (WS Comment #1361); McCarty (WS Comment #1898); Shum (WS Comment #543) (stating that “[t]he use of patient portals to send Rx would be unreliable due to inconsistent EHR [(electronic health records)] software and that some doctors do not have EHR”); National Hispanic Medical Association (SNPRM Comment #146) (stating that creating a portal to share prescription information could be a burden on prescribers and patients); 1-800 CONTACTS (NPRM Comment #3898) (stating that “to the extent prescribers use portals to provide sellers with prescriptions, their portal should have the ability to send the prescription to the seller directly by email, text, or facsimile, and a seller should not be required to develop direct communication links to the portal”); CLR Panel V Tr., 
                            <E T="03">supra</E>
                             note 191, at 19-20.
                        </P>
                    </FTNT>
                    <P>
                        The Act and Rule clearly envision and support the use of electronic means to provide prescriptions. Section 7601(a)(2) of the Act requires prescribers to “provide or verify the contact lens prescription by electronic or other means” to patients' agents.
                        <SU>466</SU>
                        <FTREF/>
                         As discussed in the NPRM, it would be inconsistent for the Rule to permit prescribers to provide prescriptions electronically to patients, but not allow prescribers to provide a prescription electronically to a seller.
                        <SU>467</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>466</SU>
                             15 U.S.C. 7601(a)(2); 16 CFR 315.3(a)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>467</SU>
                             NPRM, 81 FR at 88538.
                        </P>
                    </FTNT>
                    <P>
                        Use of electronic medical records has increased in the health field generally,
                        <SU>468</SU>
                        <FTREF/>
                         and many prescribers already use electronic methods to communicate with patients, including through patient portals.
                        <SU>469</SU>
                        <FTREF/>
                         Given the potential benefits, prescribers and patients should have the option to present a prescription to sellers through a patient portal when this method is available. Therefore, the Commission affirms its initial determination that the “directly or by facsimile” language includes the use of online patient portals by patients and prescribers to present contact lens prescriptions to sellers.
                    </P>
                    <FTNT>
                        <P>
                            <SU>468</SU>
                             One survey from 2017 found that 52% of individuals were offered online access to their medical records by a health provider or insurer, an increase from 42% in 2014. Of those patients who were offered online access, more than half actually viewed their online medical records at least once in the past year. U.S. Dep't of Health &amp; Human Servs., The Office of the National Coordinator for Health Information Technology, “Individuals' Use of Online Medical Records &amp; Technology for Health Needs” 1-2 (2018). Furthermore, in 2013, 57% of prescriptions nationally were sent electronically from physicians to pharmacies, with the rate in some states over 80%. U.S. Dep't of Health &amp; Human Servs., The Office of the National Coordinator for Health Information Technology, “E-Prescribing Trends in the United States” 8 (2014).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>469</SU>
                             American Optometric Association (SNPRM Comment #96) (stating that approximately 47.5% of optometrists used electronic health records with a patient portal in their practice); National Association of Optometrists and Opticians (SNPRM Comment #129) (“Practice management systems and electronic health records (EHRs) with the capacity to allow patient portals, email, and text communication are easily available at reasonable prices to optometrists . . . .”); National Hispanic Medical Association (SNPRM Comment #146); 1-800 CONTACTS (NPRM Comment #3898). 
                            <E T="03">But see</E>
                             CLR Panel V Tr., 
                            <E T="03">supra</E>
                             note 191, at 17 (comment by a panelist that only 8% of his office's patients used the portal).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">VIII. Requests for an Additional Copy of a Prescription</HD>
                    <P>
                        In the SNPRM, the Commission proposed requiring that prescribers who receive requests for additional copies of prescriptions from patients or their agents respond within forty business hours.
                        <SU>470</SU>
                        <FTREF/>
                         The Commission believed that the forty-business-hour requirement was necessary to ensure that patients or their agents could receive additional copies of their prescription in a timely manner while recognizing that a shorter time period was unnecessary because patients would have already received a copy of their prescription after the contact lens fittings were completed and sellers could always submit a verification request.
                        <SU>471</SU>
                        <FTREF/>
                         Additionally, prescribers would be required to note in the patient's file the name of the requester and the date and time the prescription was provided. The Commission sought comment on whether prescribers should be required to respond within a certain time period, whether forty business hours was the appropriate time period, and what records, if any, prescribers should be required to keep to document the request and response.
                        <SU>472</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>470</SU>
                             SNPRM, 84 FR at 24684.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>471</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>472</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Benefits of an Additional Copy and the Time Period To Respond to a Request</HD>
                    <P>
                        The AOA contends that Congress did not intend for sellers to be given authorization to serve as the patient's agent.
                        <SU>473</SU>
                        <FTREF/>
                         Rather, the AOA “assume[s] that Congress implemented this provision to account for cases in which a family member or caregiver needed authorization to obtain a patient's 
                        <PRTPAGE P="50703"/>
                        prescription.” 
                        <SU>474</SU>
                        <FTREF/>
                         As noted in the NPRM, the Commission relied on the plain language of the Act and Rule to determine that sellers could serve as agents for patients,
                        <SU>475</SU>
                        <FTREF/>
                         and the AOA does not point to any contrary evidence.
                        <SU>476</SU>
                        <FTREF/>
                         Additionally, the AOA believes that no deadline to respond to requests for additional copies is necessary because prescribers take their responsibilities to their patients seriously.
                        <SU>477</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>473</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>474</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>475</SU>
                             NPRM, 81 FR at 88536. In addition to sellers, the SNPRM noted that patients themselves could request an additional copy of the prescription. Although a commenter requested that the Commission modify the Rule to clarify that patients can request their own additional copy (National Association of Optometrists and Opticians (SNPRM Comment #129)), the Commission believes that the Rule's language is sufficient and declines to make such change. SNPRM, 84 FR at 24684 n.259.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>476</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>477</SU>
                             
                            <E T="03">Id.</E>
                             The AOA also urged the Commission not to rely on 1-800 CONTACTS data indicating that only 46% of its requests for an additional copy of a prescription received a response because 1-800 CONTACTS may not have the patients' consent to act as an agent. Although the Commission considered the 1-800 CONTACTS data, the Commission did not rely solely on this information when issuing its proposed Rule. SNPRM, 84 FR at 24669.
                        </P>
                    </FTNT>
                    <P>
                        Other commenters supported the Commission's proposal regarding requests for additional copies.
                        <SU>478</SU>
                        <FTREF/>
                         Commenters noted that a deadline to respond would: (1) Make the process more predictable for patients and sellers, especially when involving a prescriber who has not responded to such requests in the past; 
                        <SU>479</SU>
                        <FTREF/>
                         (2) potentially reduce the number of verification requests, which would benefit prescribers, sellers, and patients; and (3) improve the accuracy of information provided to sellers ensuring that patients receive the correct lenses.
                        <SU>480</SU>
                        <FTREF/>
                         In addition to anecdotal accounts of prescribers not responding to requests for additional copies, 1-800 CONTACTS commented that, in 2019 to date, it had received a response to approximately 52% of its requests for an additional copy with 82% of the responses being received within forty-eight hours of the request.
                        <SU>481</SU>
                        <FTREF/>
                         This 2019 data is similar to 1-800 CONTACTS' 2016 data, which showed that 46% of the requests received a response and 90% of those responses were received within two days.
                        <SU>482</SU>
                        <FTREF/>
                         In response, the AOA questions 1-800 CONTACTS' 2016 data because patients, who gave consent through a prechecked box, may not have intended for 1-800 CONTACTS to act as their agent in requesting the prescription.
                        <SU>483</SU>
                        <FTREF/>
                         The AOA posits that prescriber concern over patients' consent “may have impacted responses to [1-800 CONTACTS'] requests,” but offers no evidence to support this argument.
                        <SU>484</SU>
                        <FTREF/>
                         Likewise, the AOA did not provide any data showing the extent to which prescribers have responded to requests for additional copies. Given the potential benefits and the aforementioned data, the Commission does not believe it is sufficient to rely simply on the expectation that all prescribers would fulfill their responsibilities to their patients. Rather, the Commission believes that the Rule should be amended to add a deadline to respond to a request for an additional copy.
                    </P>
                    <FTNT>
                        <P>
                            <SU>478</SU>
                             Citizen Outreach (SNPRM Comment #78); 
                            <E T="03">Lens.com</E>
                             (SNPRM Comment #85); Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); Consumer Action (SNPRM Comment #101); Information Technology and Innovation Foundation (SNPRM Comment #103); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135); American Academy of Ophthalmology (SNPRM Comment #136); Attorneys General of 27 States (SNPRM Comment #139).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>479</SU>
                             Although not always the case, some sellers expressed difficulties with obtaining responses from prescribers. 
                            <E T="03">See</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that at least one NAOO member reported receiving timely responses while other members found that it was “difficult, if not impossible, to get any form of a timely response”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>480</SU>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133); 1-800 CONTACTS (SNPRM Comment #135); Attorneys General of 27 States (SNPRM Comment #139); Contact Lens Association of Ophthalmologists (NPRM Comment #4259).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>481</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>482</SU>
                             1-800 CONTACTS (NPRM Comment #3898).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>483</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>484</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Although some commenters agreed that the Commission's proposed deadline of forty business hours was a reasonable length of time,
                        <SU>485</SU>
                        <FTREF/>
                         other commenters urged the Commission to use a shorter period, such as one business day 
                        <SU>486</SU>
                        <FTREF/>
                         or twenty-four business hours,
                        <SU>487</SU>
                        <FTREF/>
                         because (1) patients would want a quicker response, (2) the longer time period could undercut a benefit of using a prescription—reducing the number of verification requests, and (3) prescribers could be confused between forty business hours for an additional copy request and eight business hours for a verification request.
                        <SU>488</SU>
                        <FTREF/>
                         Additionally, the work involved for a prescriber's office to respond to a request would not increase with a shorter deadline.
                        <SU>489</SU>
                        <FTREF/>
                         Although patients would benefit from a shorter response period, the Commission recognizes the additional stress on prescribers of having less time to respond, even if the work involved to complete a response remains the same. Because patients should have already received a copy of their prescription after the fitting,
                        <SU>490</SU>
                        <FTREF/>
                         sellers can submit a verification request to complete the sale more quickly,
                        <SU>491</SU>
                        <FTREF/>
                         and prescribers have an obligation to respond to a request for an additional copy, unlike a verification request, the Commission declines to make any further changes and will adopt the proposed forty-business-hour period.
                    </P>
                    <FTNT>
                        <P>
                            <SU>485</SU>
                             Coalition for Contact Lens Consumer Choice (SNPRM Comment #89); American Optometric Association (SNPRM Comment #96) (noting that if a deadline were added, forty business hours would be reasonable); Information Technology and Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM Comment #135); American Academy of Ophthalmology (SNPRM Comment #136).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>486</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>487</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (supporting a shorter time limit, in part, because the burden of complying could be lower due to portal, text, or email use).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>488</SU>
                             National Association of Optometrists and Opticians (SNPRM Comment #129); Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>489</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>490</SU>
                             16 CFR 315.3(a)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>491</SU>
                             16 CFR 315.5(a)(2).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Requirement To Maintain Records</HD>
                    <P>
                        Finally, as to what records, if any, a prescriber should be required to maintain regarding the request for an additional copy, the AOA believes that sellers, not prescribers, should shoulder this burden because sellers are “leveraging the patient agent provision to obtain patient prescriptions.” 
                        <SU>492</SU>
                        <FTREF/>
                         Records of the request and the response would allow the Commission to monitor compliance.
                        <SU>493</SU>
                        <FTREF/>
                         However, the Commission does not believe requiring the requestor to maintain such information would be appropriate because the obligation under the Rule to respond to prescription requests rests with prescribers and they would be in the best position to maintain records.
                        <SU>494</SU>
                        <FTREF/>
                         Importantly, the Rule allows “any person designated to act on behalf of the patient[,]” including the patients themselves, family members, or caregivers, to request a copy of a prescription, not just sellers.
                        <SU>495</SU>
                        <FTREF/>
                         A shift of the recordkeeping burden to any 
                        <PRTPAGE P="50704"/>
                        designated agent making a request would not allow for effective monitoring because the Commission might need to obtain records from a wide variety of agents in order to determine whether a particular prescriber is complying with the Rule. Thus, the Commission declines to change the recordkeeping requirement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>492</SU>
                             American Optometric Association (SNPRM Comment #96).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>493</SU>
                             The proposed Rule would mandate that prescribers make notations of the required information in their records, but would not require that they keep specific documentation. SNPRM, 84 FR at 24698. However, prescribers could choose to keep documentation of the request and response if they preferred.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>494</SU>
                             
                            <E T="03">See also</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (“We believe it will be straight-forward and simple for the prescriber to keep a record of receiving the request for a copy and noting how and when the prescriber responded.”).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>495</SU>
                             SNPRM, 84 FR at 24684 n.259, 24698.
                        </P>
                    </FTNT>
                    <P>In conclusion, the Commission adopts the changes proposed in the SNPRM to require that prescribers respond to requests for an additional copy of a prescription within forty business hours and note in the patient's record the name of the requestor and the date and time that the prescription was provided in response.</P>
                    <HD SOURCE="HD1">IX. Excessive Quantity</HD>
                    <P>
                        In the NPRM, the Commission declined to make any changes regarding the number of lenses that a consumer can purchase with a prescription.
                        <SU>496</SU>
                        <FTREF/>
                         Several commenters had expressed concerns that consumers were able to obtain more than a year's supply of contact lenses, often by purchasing more than a year's worth at one time or by refilling their prescription just before the expiration date.
                        <SU>497</SU>
                        <FTREF/>
                         However, the Commission determined that there was insufficient evidence on the record to support a limit on the maximum quantity of lenses that consumers can purchase prior to the prescription's expiration.
                        <SU>498</SU>
                        <FTREF/>
                         Although there was some evidence that patients purchased contact lenses just before their prescriptions expired, this evidence did not show that the quantity of lenses being purchased was excessive or that consumers were skipping eye exams.
                        <SU>499</SU>
                        <FTREF/>
                         Furthermore, the Commission believed that a maximum quantity limit would be difficult to administer and could have a more significant negative effect on consumers who, instead of following the recommended replacement schedule, opt to wear their lenses longer until they see a prescriber.
                        <SU>500</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>496</SU>
                             NPRM, 81 FR at 88549.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>497</SU>
                             
                            <E T="03">Id.</E>
                             at 88547-48.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>498</SU>
                             
                            <E T="03">Id.</E>
                             at 88548-49. The Commission also declined to modify the Rule to state that contact lens prescriptions are valid for an unlimited quantity of lenses regardless of any prescriber-imposed limitation. The Commission found no evidence that prescribers were using quantity limits to undercut the prescription length and recognized that some state laws or regulations mandated that quantity information be included on a prescription, or that a prescriber may choose to do so. NPRM, 81 FR at 88549-50. However, prescribers cannot use quantity limits as a way to frustrate the Rule's prescription expiration requirements. 
                            <E T="03">Id.</E>
                             at 88550.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>499</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>500</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        In response to the NPRM, some commenters supported the Commission's decision not to impose quantity limits 
                        <SU>501</SU>
                        <FTREF/>
                         while others expressed concerns about the purchase of excessive quantities and advocated for limits.
                        <SU>502</SU>
                        <FTREF/>
                         The commenters who support quantity limits are concerned that patients who purchase excessive quantities of lenses face increased health risks because they do not see their prescriber as often.
                        <SU>503</SU>
                        <FTREF/>
                         Contrary to the Commission's position in the NPRM, they believe that there is evidence in the record that consumers are purchasing an excessive number of lenses close to the end of their prescription and that a quantity limit can be implemented.
                        <SU>504</SU>
                        <FTREF/>
                         These commenters point to survey evidence by Johnson &amp; Johnson Vision Care showing that consumers, in response to reminders that their prescriptions would be expiring soon, ordered more lenses.
                        <SU>505</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>501</SU>
                             Coalition for Contact Lens Consumer Choice (NPRM Comment #3718); Consumer Action (NPRM Comment #3721); 1-800 CONTACTS (NPRM Comment #3898).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>502</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Contact Lens Institute (SNPRM Comment #79); Goodman (WS Comment 599); Hanen (WS Comment #712); Dillehay (WS Comment #822); Rosenblatt (WS Comment #841); Hooven (WS Comment #1366); Henry (WS Comment #2194); Robson (WS Comment #2210); Wiechmann (WS Comment #2823); Health Alliance for Patient Safety (WS Comment #3206); Alcon Laboratories, Inc. (WS Comment #3339); Ellenbecker (WS Comment #3353); Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002); Silva (NPRM Comment #3072); CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883); 
                            <E T="03">see</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 19 (statement of David Cockrell).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>503</SU>
                             Jeun (NPRM Comment #1774); Daza (NPRM Comment #2002); CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>504</SU>
                             CooperVision, Inc. (NPRM Comment #3841); Coalition for Patient Vision Care Safety (NPRM Comment #3883).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>505</SU>
                             CooperVision, Inc. (NPRM Comment #3841) (stating that evidence of the high number of patients being contacted in the last days of their prescription “provides a powerful inference that sales in many situations are excessive”); Coalition for Patient Vision Care Safety (NPRM Comment #3883).
                        </P>
                    </FTNT>
                    <P>
                        However, the concern is not whether consumers are purchasing lenses near the end of their prescription, but whether they are purchasing excessive quantities. As noted in the NPRM, the Johnson &amp; Johnson Vision Care survey did not ask about the quantity of lenses purchased by consumers.
                        <SU>506</SU>
                        <FTREF/>
                         The Commission had previously found that consumers typically do not purchase a year's supply of lenses at one time.
                        <SU>507</SU>
                        <FTREF/>
                         Additionally, 1-800 CONTACTS stated that it was aware of survey evidence it believed showed that six months is the average size of an order made during the last thirty days of a prescription, which is similar to, based on 1-800 CONTACTS internal data, the average quantity ordered throughout the duration of the prescription.
                        <SU>508</SU>
                        <FTREF/>
                         Thus, the Commission does not have sufficient basis to conclude, despite anecdotal reports and alleged practices by some sellers, that consumers are purchasing lenses in excessive quantities near the end of their prescription.
                        <SU>509</SU>
                        <FTREF/>
                         Neither does the Commission have sufficient evidence showing that consumers are going to eye care providers less frequently because they previously purchased large quantities of contact lenses. In fact, evidence suggests that a majority of consumers are seeing their eye care provider regularly. One survey found that contact lens wearers have an eye exam every thirteen months on average while another survey showed that about 56% of respondents received an eye exam every twelve months or less, with an overall average of approximately sixteen months.
                        <SU>510</SU>
                        <FTREF/>
                         These surveys appear consistent with a prior survey by the Coalition for Patient Vision Care Safety, which found that 87% of contact lens wearers had an eye exam last year.
                        <SU>511</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>506</SU>
                             NPRM, 81 FR at 88549-50; 
                            <E T="03">see also</E>
                             Johnson &amp; Johnson Vision Care, Inc. (RFC Comment #582) (asking consumers whether a seller notified them that their prescription was expiring and whether they have ever ordered lenses within a month of their prescription's expiration).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>507</SU>
                             NPRM, 81 FR at 88549.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>508</SU>
                             1-800 CONTACTS (NPRM Comment #3898) (stating that for a monthly contact lens the standard package size is six months, which is the minimum quantity available).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>509</SU>
                             NPRM, 81 FR at 88549.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>510</SU>
                             1-800 CONTACTS (NPRM Comment #3898).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>511</SU>
                             NPRM, 81 FR at 88549 n.308.
                        </P>
                    </FTNT>
                    <P>
                        Some commenters also believe that a quantity limitation would not be difficult to implement when the seller has the prescription because sales could be limited to the amount of lenses necessary for the remaining period of the prescription or based on typical usage.
                        <SU>512</SU>
                        <FTREF/>
                         However, it would be impractical for sellers to determine whether the quantity of lenses being purchased is necessary or typical because such amounts may not be the same for all consumers. Additionally, as noted in the NPRM, there are legitimate reasons why a consumer may want to purchase a supply of lenses that exceeds the remaining period of the 
                        <PRTPAGE P="50705"/>
                        prescription, including having enough lenses until the next scheduled appointment, having replacements for lost or torn lenses, or replacing lenses more frequently.
                        <SU>513</SU>
                        <FTREF/>
                         Additionally, quantity limitations could encourage some consumers to stretch out their lens supply by wearing them longer than recommended, which is a well-documented health issue that outweighs the potential harm of patients purchasing a quantity of lenses that exceeds what is strictly anticipated by the remaining length of the prescription.
                        <SU>514</SU>
                        <FTREF/>
                         Although it is possible that patients could purchase large quantities of lenses by presenting their prescription to multiple sellers, the Commission does not have evidence about the extent of such practice.
                        <SU>515</SU>
                        <FTREF/>
                         Finally, when verification is used, a prescriber can determine whether the quantity ordered is excessive, and, if it is, inform the seller within the eight-business-hour period that the request is inaccurate and specify the appropriate amount of lenses.
                        <SU>516</SU>
                        <FTREF/>
                         In conclusion, the Commission declines to modify the Rule to limit the quantity of lenses that consumers can purchase.
                    </P>
                    <FTNT>
                        <P>
                            <SU>512</SU>
                             Contact Lens Institute (SNPRM Comment #79) (stating that the “health and safety of patients requires limits on the sale of quantities of contact lenses beyond those reasonably required for patient use during the remaining term of a prescription” and urging that a verification request for a prescription that is close to expiration be treated as an alteration because it seeks to dispense excessive quantities of lenses); Coalition for Patient Vision Care Safety (NPRM Comment #3883) (stating that “when the seller has the prescription, no sale should exceed a supply of lenses necessary to last the remaining period of the prescription”); CooperVision, Inc. (NPRM Comment #3841).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>513</SU>
                             NPRM, 81 FR at 88549; 1-800 CONTACTS (NPRM Comment #3898).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>514</SU>
                             NPRM, 81 FR at 88549. 
                            <E T="03">See also</E>
                             1-800 CONTACTS (NPRM Comment #3898) (citing survey data showing that 65% of participants tended to wear their last pair of contact lenses longer than when they have a supply of lenses).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>515</SU>
                             NPRM, 81 FR at 88550.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>516</SU>
                             16 CFR 315.5(d); Contact Lens Rule, 69 FR at 40501; NPRM, 81 FR at 88550 n.313.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">X. Expiration of Contact Lens Prescriptions</HD>
                    <P>
                        Section 315.6(a) of the Rule requires that a prescription expire on the date specified by the law of the state in which the prescription was written, if that date is one year or more after the issue date of the prescription.
                        <SU>517</SU>
                        <FTREF/>
                         The Rule also provides that a prescription shall not expire less than one year after the issue date of the prescription, unless the prescriber specifies a shorter period that is “based on the medical judgment of the prescriber with respect to the ocular health of the patient” and documents the reasoning for the shorter expiration period in the patient's medical record.
                        <SU>518</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>517</SU>
                             16 CFR 315.6(a)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>518</SU>
                             16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
                        </P>
                    </FTNT>
                    <P>
                        The NPRM addressed comments requesting that the Commission set a longer minimum length for prescriptions, prohibit expirations on certain prescriptions, or leave prescription length to the sole discretion of the provider.
                        <SU>519</SU>
                        <FTREF/>
                         However, because the Rule's provisions closely track the Act, which sets a minimum expiration date “to prevent prescribers from selecting a short expiration date . . . that unduly limits the ability of consumers to purchases contact lenses” and because the Commission concluded that, in drafting the Act, Congress intended to defer to state law except where such law establishes a period of less than one year, the Commission stated that the current framework is appropriate and declined to make changes.
                        <SU>520</SU>
                        <FTREF/>
                         The NPRM also addressed prescriber reports of patients obtaining contact lenses through sellers, especially online sellers, with expired contact lens prescriptions.
                        <SU>521</SU>
                        <FTREF/>
                         Commenters requested a Rule change or greater enforcement of the Rule to deal with this problem.
                        <SU>522</SU>
                        <FTREF/>
                         However, finding that the Rule sufficiently prohibited the use of expired prescriptions, the Commission declines to amend the Rule.
                        <SU>523</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>519</SU>
                             NPRM, 81 FR at 88546.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>520</SU>
                             
                            <E T="03">Id.; see also</E>
                             15 U.S.C. 7604.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>521</SU>
                             NPRM, 81 FR at 88546-47.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>522</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>523</SU>
                             
                            <E T="03">Id.</E>
                             at 88547.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Length of Contact Lens Prescriptions</HD>
                    <P>
                        Following the NPRM's discussion of expiration length, the Commission received additional comments that favored making prescriptions valid for more than one year.
                        <SU>524</SU>
                        <FTREF/>
                         Some commenters advocated for such change because they believed that prescriptions rarely change 
                        <SU>525</SU>
                        <FTREF/>
                         or that consumers would save money if they needed to obtain exams less often.
                        <SU>526</SU>
                        <FTREF/>
                         Other commenters expressed concern that shorter prescription expirations may have the undesirable result of encouraging consumers to wear contacts for longer than recommended 
                        <SU>527</SU>
                        <FTREF/>
                         or that there should not be a standard minimum expiration in the Rule due to variations in patient needs.
                        <SU>528</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>524</SU>
                             Radcliffe (WS Comment #2); Williams (WS Comment #1036); Yenovkian (WS Comment #1362); Yuen (NPRM Comment #1854); Susswein (NPRM Comment #3759).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>525</SU>
                             Radcliffe (WS Comment #2); Williams (WS Comment #1036).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>526</SU>
                             Williams (WS Comment #1036); Yuen (NPRM Comment #1854).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>527</SU>
                             Berenguer (WS Comment #111).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>528</SU>
                             Moss (WS Comment #837).
                        </P>
                    </FTNT>
                    <P>
                        However, some manufacturer and prescriber organizations favored maintaining the Rule's current expiration provisions. Johnson &amp; Johnson Vision Care stated that the current Rule “ensures that patients continue to receive the vital professional oversight to decrease avoidable risks and increases patient access to the latest technologies to best meet their vision care needs.” 
                        <SU>529</SU>
                        <FTREF/>
                         Likewise, the AOA and the Contact Lens Institute supported the Commission maintaining the Rule's current prescription length provisions.
                        <SU>530</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>529</SU>
                             Johnson &amp; Johnson Vision Care, Inc. (NPRM Comment #4327). Peter Menziuso, President of JJVCI, also echoed this sentiment at the workshop, stating that the company feels strongly about maintaining the one-year expiration to assure patients are seeing their prescriber regularly and prioritizing health. 
                            <E T="03">See</E>
                             CLR Panel IV Tr., 
                            <E T="03">supra</E>
                             note 121, at 16.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>530</SU>
                             Contact Lens Institute (SNPRM Comment #79); American Optometric Association (NPRM Comment #3830).
                        </P>
                    </FTNT>
                    <P>
                        After reviewing the comments, the Commission again declines to modify or remove the Rule's prescription length provisions. The current Rule closely tracks the Act, which Congress mandated, and already contains provisions that allow for prescriptions longer than one year, dependent upon state law, and shorter than one year, when those are appropriate based on the medical judgment of the prescriber, ensuring flexibility.
                        <SU>531</SU>
                        <FTREF/>
                         The Commission does not find the record adequately supports lengthening the Rule's prescription expiration provisions. Therefore, the Commission declines to alter the Rule's provisions relating to prescription length.
                    </P>
                    <FTNT>
                        <P>
                            <SU>531</SU>
                             16 CFR 315.6(a)(2)-(3); 16 CFR 315.6(b)(1).
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Sales Using Expired Contact Lens Prescriptions</HD>
                    <P>
                        After the NPRM, commenters again raised the issue of sellers selling contact lenses past the prescription expiration dates,
                        <SU>532</SU>
                        <FTREF/>
                         and some argued that additional regulation is needed.
                        <SU>533</SU>
                        <FTREF/>
                         The Rule already makes clear that expired prescriptions are invalid and prohibits 
                        <PRTPAGE P="50706"/>
                        sales with such prescriptions.
                        <SU>534</SU>
                        <FTREF/>
                         If a consumer presents the seller with an expired prescription, the seller cannot use it as the basis for the sale. Not only is the seller unable to base a sale on that expired prescription, but as the Commission clarified in the NPRM, a seller may not use an expired prescription as the basis for a verification request.
                        <SU>535</SU>
                        <FTREF/>
                         If, however, a seller is presented with a prescription that lacks an expiration date,
                        <SU>536</SU>
                        <FTREF/>
                         and that seller does not have knowledge as to whether the prescription is expired, the seller must verify the prescription with the prescriber prior to dispensing lenses. In this instance, the seller may rely on the prescriber to inform the seller if the prescription is expired.
                        <SU>537</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>532</SU>
                             
                            <E T="03">See, e.g.,</E>
                             Hanian (SNPRM Comment #27); Pirozzolo (SNPRM Comment #33); Wilkes (SNPRM Comment #86); AOA (SNPRM Comment #96); Parikh (SNPRM Comment #152); Fuller (WS Comment #531); McBride (WS Comment #630); Swindell (WS Comment #682); Hamilton (WS Comment #781); Caywood (WS Comment #788); Matus (WS Comment #1534); Malaski (WS Comment #3160); DiGirolamo (NPRM Comment #23); Endry (NPRM Comment #29); Ross (NPRM Comment #48); Hanen-Smith (NPRM Comment #154); Weisz (NPRM Comment #963); Helwig (NPRM Comment #2349); Simpson (NPRM Comment #2896); Holle (NPRM Comment #3214); Gordon (NPRM Comment #3544); Reinstein (NPRM Comment #3560); Sheffer (NPRM Comment #3577).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>533</SU>
                             Kepley (SNPRM Comment #76); Radford (NPRM Comment #59); Rodriguez (NPRM Comment #3896) (“I was disappointed to learn that the FTC will not, under its existing authority, seek to more-fully address the many unscrupulous business practices of online contact lens sellers that have been putting the health and safety of patients at risk for more than a decade. Expired contact lens prescriptions are regularly processed and filled by these online business.”); Huang (NPRM Comment #2203); Avila (NPRM Comment #52); Hanen-Smith (NPRM Comment #154); Letter from Senator Heidi Heitkamp to Acting Chairwoman Maureen Ohlhausen (Jan. 5, 2018); Letter from Congressman Jeff Denham et al. to Chairman Joseph Simons (July 27, 2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>534</SU>
                             16 CFR 315.5(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>535</SU>
                             NPRM, 81 FR at 88546-47.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>536</SU>
                             16 CFR 315.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>537</SU>
                             NPRM, 81 FR at 88547.
                        </P>
                    </FTNT>
                    <P>
                        CooperVision requested that the Commission require that sellers, when not in possession of an unexpired prescription, ask consumers if their prescriptions have expired.
                        <SU>538</SU>
                        <FTREF/>
                         In the NPRM, the Commission addressed a similar request by AOA to require sellers to include the expiration and issue dates, both required elements of a prescription, in verification requests.
                        <SU>539</SU>
                        <FTREF/>
                         According to the AOA, this requirement would incentivize sellers to make sure patients know their prescription expiration date. However, as explained in the NPRM, the seller would not necessarily have the expiration or issue dates, and neither would the patient.
                        <SU>540</SU>
                        <FTREF/>
                         A better source for this information is the prescriber, who has the ability to invalidate a prescription request because it is expired.
                        <SU>541</SU>
                        <FTREF/>
                         For this reason, the Commission will not implement CooperVision's proposal. Additionally, a number of prescriber organizations expressed concerns that consumers are able to buy lenses on expired prescriptions because of passive verification.
                        <SU>542</SU>
                        <FTREF/>
                         Further, to lessen the chances of the sale of lenses after the expiration of a prescription, some commenters requested that the Commission require that prescriptions be presented at the time of the sale of lenses.
                        <SU>543</SU>
                        <FTREF/>
                         As stated in Section V, Congress mandated passive verification, and requiring prescription presentation would be inconsistent with Congress's intent. The Final Rule also includes several changes to automated verification calls that will improve passive verification by allowing prescribers to better identify requests based on expired prescriptions.
                        <SU>544</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>538</SU>
                             CooperVision, Inc. (SNPRM Comment #130).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>539</SU>
                             NPRM, 81 FR at 88547 (citing AOA Comment #644).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>540</SU>
                             NPRM, 81 FR at 88547.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>541</SU>
                             As explained in the Alteration section, Section VI, 
                            <E T="03">supra,</E>
                             if a seller wishes to avail itself of the exception to alteration, it may use an expired prescription as an indication of manufacturer or brand if the minimum criteria discussed in that Section are met, and the seller obtains additional information, from the consumer or the prescriber, that the consumer has a current prescription for that brand. In so doing, the seller obtains a basis for the verification request other than the expired prescription.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>542</SU>
                             Contact Lens Institute (SNPRM Comment #79) (“Indeed, CLI remains concerned about the contribution of passive verification via robocalls to filling expired or invalid prescriptions . . .”); American Society of Cataract and Refractive Surgery (SNPRM Comment #127) (“Significant concerns with patient safety, as the current eight-hour validation window allows inaccurate, falsified, and expired contact lens prescriptions to be filled. Subsequently, patients' ocular health is put at risk because of a restricted validation period.”); American Society of Cataract and Refractive Surgery (NPRM Comment #3820) (“Many of our members practice in solo or small practices that often do not have the resources to respond to verification requests within the eight-hour time frame. This rule allows a seller to fill a prescription that is inaccurate, expired, or falsified simply because the prescriber has been unable to respond within eight hours. As a result, patients suffer serious eye injuries by wearing ill-fitted contacts.”); Massachusetts Society of Eye Physicians and Surgeons (NPRM Comment #4270).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>543</SU>
                             Sanders (SNPRM Comment #61); Wisniewski (NPRM Comment #1769); Hanian (NPRM Comment #153).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>544</SU>
                             
                            <E T="03">See</E>
                             Section III, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        Finally, commenters again requested that the Commission bring enforcement actions against sellers that sell lenses after the expiration of the prescription.
                        <SU>545</SU>
                        <FTREF/>
                         As stated in the NPRM, if the Commission receives credible evidence that sellers are selling contact lenses when they have actual knowledge that the prescriptions are expired (either because they were presented with a copy of an expired prescription or received a response from a prescriber within the time frame specified in the Rule telling the seller that the prescription is expired), the Commission will take appropriate steps to investigate the allegations.
                        <SU>546</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>545</SU>
                             Cooper Vision, Inc. (SNPRM Comment #130); Stout (WS Comment #450); Stolicker (NPRM Comment #10); Osetek (NPRM Comment #22); Bass (NPRM Comment #55); Coalition for Patient Vision Care Safety (NPRM Comment #3883); Letter from Congressman David Roe to Chairman Joseph Simons (Nov. 29, 2018).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>546</SU>
                             NPRM, 81 FR at 88547.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">XI. Paperwork Reduction Act</HD>
                    <P>
                        The existing Rule contains recordkeeping and disclosure requirements that constitute “collection[s] of information” as defined by 5 CFR 1320.3(c) under Office of Management and Budget (“OMB”) regulations that implement the Paperwork Reduction Act (“PRA”), 44 U.S.C. 3501 
                        <E T="03">et seq.</E>
                        <SU>547</SU>
                        <FTREF/>
                         On May 28, 2019, the Commission issued a SNPRM proposing amendments that would contain new information collection requirements subject to OMB review and approval. Specifically, the SNPRM estimated an additional recordkeeping burden for prescribers resulting from the proposed Rule modifications to 597,917 hours (85,417 hours regarding signatures + 512,500 hours regarding their retention) and the associated estimated annual labor cost burden of $13,244,727.
                        <SU>548</SU>
                        <FTREF/>
                         On the same date, the Commission also submitted a request to OMB seeking approval for the new information collections associated with the proposed rulemaking. On September 20, 2019, the OMB directed the Commission to examine public comments relating to the proposed rulemaking and describe any public comments received regarding the collection, as well as why the Commission did or did not incorporate the commenter's recommendation.
                        <SU>549</SU>
                        <FTREF/>
                         Below, the Commission describes and discusses the amendments to the Final Rule, the public comments received relating to the collection of information burden associated with the SNPRM, and the Commission's ultimate determination of the burden generated by the final amendments.
                    </P>
                    <FTNT>
                        <P>
                            <SU>547</SU>
                             On October 2, 2019, the Commission requested permission from OMB to continue these pre-existing information collections, which were estimated to be 2,104,050 annual hours of burden (which were derived by adding 1,045,650 disclosure hours for contact lens prescribers to 1,058,400 recordkeeping hours for contact lens sellers). See 84 FR 51162 (Sept. 27, 2019); Agency Information Collection Activities; Submission for OMB. On December 9, 2019, OMB approved the Rule's existing information collection requirements through December 31, 2022. OMB Control No. 3804-0127. See 84 FR 51162 (Sept. 27, 2019); Agency Information Collection Activities; Submission for OMB Review; Comment Request.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>548</SU>
                             
                            <E T="03">See</E>
                             84 FR at 24693-94 (May 28, 2019); Supplemental notice of proposed rulemaking; request for public comment.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>549</SU>
                             OMB Control No. 3804-0127, ICR Reference No. 201910-3084-001, Notice of Office of Management and Budget Action (Sept. 10, 2019).
                        </P>
                    </FTNT>
                    <P>
                        The Commission has made a number of modifications to the Rule that contain recordkeeping requirements that are collections of information as defined by 5 CFR 1320.3(c). First, the Rule has been modified to require that prescribers either: (A) Obtain from patients, and maintain for a period of not less than three years, a signed confirmation of prescription release on a separate stand-alone document; (B) obtain from patients, and maintain for a period of not less than three years, a patient's signature on a confirmation of prescription release included on a copy of a patient's prescription; (C) obtain from patients, and maintain for a period of not less than three years, a patient's signature on a confirmation of 
                        <PRTPAGE P="50707"/>
                        prescription release included on a copy of a patient's contact lens fitting sales receipt; or (D) provide each patient with a copy of the prescription via online portal, electronic mail, or text message, and for three years retain evidence that such prescription was sent, received, or, if provided via an online-patient portal, made accessible, downloadable, and printable by the patient.
                        <SU>550</SU>
                        <FTREF/>
                         For prescribers who choose to offer an electronic method of prescription delivery, the Final Rule requires that such prescribers identify the specific method or methods to be used, and maintain records or evidence of affirmative consent by patients to such digital delivery for three years.
                        <SU>551</SU>
                        <FTREF/>
                         For instances where a consumer refuses to sign the confirmation or accept digital delivery of their prescription, the Final Rule directs the prescriber to note the refusal and preserve this record as evidence of compliance.
                        <SU>552</SU>
                        <FTREF/>
                         None of these new requirements, however, would apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses.
                        <SU>553</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>550</SU>
                             16 CFR 315.3(c)(1).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>551</SU>
                             16 CFR 315.2.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>552</SU>
                             16 CFR 315.3(c)(1)(iii).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>553</SU>
                             16 CFR 315.3(c)(3).
                        </P>
                    </FTNT>
                    <P>
                        Additional modifications to the Rule that constitute collections of information as defined by 5 CFR 1320.3(c) require that sellers who use calls containing automated verification messages: (1) Record the entire call; (2) commence the call by identifying it as a request for prescription verification; (3) provide the information required by § 315.5(b) in a slow and deliberate manner and at a reasonably understandable volume; and (4) give the prescriber the option to repeat the information.
                        <SU>554</SU>
                        <FTREF/>
                         The call recordings must be preserved for at least three years.
                        <SU>555</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>554</SU>
                             16 CFR 315.5(d).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>555</SU>
                             16 CFR 315.5(h)(4).
                        </P>
                    </FTNT>
                    <P>The Commission hereby provides PRA burden estimates, analysis, and discussion for the requirements to collect patient signatures as confirmation of prescription release and as consent to electronic prescription delivery; and the requirement to record automated verification messages; and associated recordkeeping obligations.</P>
                    <HD SOURCE="HD2">A. Confirmation of Prescription Release and Affirmative Consent to Digital Delivery of a Prescription</HD>
                    <HD SOURCE="HD3">1. SNPRM Burden Estimate for the Confirmation of Prescription Release</HD>
                    <P>
                        In its SNPRM, the Commission put forth estimates for the additional burden on individual prescribers' offices to generate and present to patients the confirmations of prescription release, and to collect and maintain the confirmations of prescription release for a period of not less than three years.
                        <SU>556</SU>
                        <FTREF/>
                         As set out in the PRA section's introductory paragraph above, the Commission previously calculated this burden to be 597,917 hours (85,417 hours for prescribers to collect patient signatures and 512,500 hours for prescribers' office staff to store them).
                        <SU>557</SU>
                        <FTREF/>
                         Based on average hourly wage rates, the Commission calculated the aggregate labor cost burden (totaling prescribers and prescribers' office staff) at $13,244,727.
                        <SU>558</SU>
                        <FTREF/>
                         The Commission noted, however, that arguably, the overall burden of the Rule—including verification costs previously approved by the Office of Management and Budget 
                        <SU>559</SU>
                        <FTREF/>
                        —could be lower (or not increase) given the proposed modification's potential offsetting effects of more patients being in possession of their prescriptions and consequently fewer verifications.
                        <SU>560</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>556</SU>
                             SNPRM, 84 FR at 24692.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>557</SU>
                             
                            <E T="03">Id.</E>
                             at 24693.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>558</SU>
                             
                            <E T="03">Id.</E>
                             at 24694. This estimate was based on a mean hourly wage of $57.26 for optometrists and $16.30 for office clerks. Economic News Release, U.S. Dep't of Labor, Bureau of Labor Statistics, Table 1. National employment and wage data from the Occupational Employment Statistics survey by occupation, May 2017.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>559</SU>
                             
                            <E T="03">See</E>
                             note 549, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>560</SU>
                             SNPRM, 84 FR at 24693-94.
                        </P>
                    </FTNT>
                    <P>
                        The Commission requested comment on the accuracy of the FTC's burden estimates, including whether the methodology and assumptions used are valid (such as whether prescribers or office staff are more likely to collect patient signatures and retain associated recordkeeping), and a quantification of the reduction in verifications resulting from the confirmation of prescription proposal.
                        <SU>561</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>561</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Comments Regarding the SNPRM Estimate for the Confirmation of Prescription Release Requirement</HD>
                    <P>
                        In response to the Commission's SNPRM proposal, several commenters reiterated that obtaining and storing the Confirmations of Prescription Release would create “onerous” administrative and financial burdens, but most commenters did not supply financial estimates for this burden.
                        <SU>562</SU>
                        <FTREF/>
                         The AOA, which had previously estimated the cost of the NPRM's signed-acknowledgment proposal to be as high as $18,795 per optometrist,
                        <SU>563</SU>
                        <FTREF/>
                         did not submit a new burden estimate for the Confirmation of Prescription Release proposal, but did opine that the increased flexibility of the new proposal would not reduce the overall burden on prescribers.
                        <SU>564</SU>
                        <FTREF/>
                         One commenter estimated that it would cost his practice $10,000 per year in “paperwork, storage, and time spent by secretaries handling paperwork,” but did not provide details about his practice (the number of patients and prescribers, for instance) or how the estimate was derived, and what the cost amounted to on a per-patient or per-prescription basis.
                        <SU>565</SU>
                        <FTREF/>
                         Another commenter, Dr. Thomas Steinemann, wrote, “I dispute the FTC contention that each documentation will only take `one minute.' Additional documentation can actually take several minutes when there are discrepancies in verification.” 
                        <SU>566</SU>
                        <FTREF/>
                         Dr. Steinemann commented that according to his office manager, the “additional steps of verification and documentation” would add 10 minutes of administrative time per patient.
                        <SU>567</SU>
                        <FTREF/>
                         The comment, however, does not articulate how the Confirmation of Prescription Release requirement can create discrepancies in verification, or what “additional steps of verification” Dr. Steinemann or his office manager are referring to. The Confirmation of Prescription Release requirement does not directly impact the requirement that prescribers verify prescriptions upon request, other than to potentially make such requests less common if more patients have possession of their prescriptions and can present them to sellers when ordering.
                    </P>
                    <FTNT>
                        <P>
                            <SU>562</SU>
                             
                            <E T="03">See</E>
                             Section II.C.7, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>563</SU>
                             American Optometric Association (NPRM Comment #3830). As noted in note 247, 
                            <E T="03">supra,</E>
                             the Commission explained in the SNPRM that it could not accord this estimate significant weight because it was based not on the cost of the proposed Signed Acknowledgment but on the overall cost of government regulations (including those already in place), and because the survey had numerous methodological limitations. SNPRM, 84 FR at 24677.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>564</SU>
                             American Optometric Association (SNPRM Comment #96). A few SNPRM commenters reiterated the AOA's $18,000 estimate (which the Commission previously determined it could not rely on, for reasons explained in the SNPRM), 84 FR at 24677, but did not provide additional information or empirical support for this figure. Koerber (SNPRM Comment #110); American Society of Cataract and Refractive Surgery (SNPRM Comment #127).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>565</SU>
                             Pierce (SNPRM Comment #17).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>566</SU>
                             Steinemann (SNPRM Comment #65); Steinemann (SNPRM Comment #138).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>567</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        In contrast to those critical of the burden and the Commission's SNPRM PRA analysis, other commenters contended that the burden of the new requirement would be minimal or offset by a reduced burden in other respects of the Rule.
                        <SU>568</SU>
                        <FTREF/>
                         One commenter, the ITIF, asserted that evidence that the new 
                        <PRTPAGE P="50708"/>
                        requirement would increase prescriber costs “appears to be significantly overstated,” and noted that storing confirmation signatures in paper takes up “very little room and cost,” and, if stored electronically, storage costs are “essentially zero.” 
                        <SU>569</SU>
                        <FTREF/>
                         The ITIF also stated allowing prescribers to deliver prescriptions digitally would reduce the “already small” burden on prescribers of the confirmation of release requirement, and at the same time reduce the number of verification calls from third party lens sellers, thus further reducing the overall burden on both sellers and prescribers.
                        <SU>570</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>568</SU>
                             
                            <E T="03">See</E>
                             Section II.C.7, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>569</SU>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>570</SU>
                             
                            <E T="03">Id. See also</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that with more practitioners moving to practice management systems and electronic health records, digital delivery of contact lens prescriptions is a “very feasible” option for many prescribers, which will further reduce the burden of the confirmation requirement).
                        </P>
                    </FTNT>
                    <P>
                        Another commenter, the National Taxpayers Union (“NTU”), felt the SNPRM burden-estimates were “plausible,” and noted that the FTC's estimates were based on underlying assumptions that may be overly cautious, and thus lead to overcounting.
                        <SU>571</SU>
                        <FTREF/>
                         In particular, the NTU noted that the Commission, in calculating the SNPRM's PRA burden: (1) Assumed that only optometrists would obtain patient signatures, when, in fact, support staff—who are paid less per hour—are permitted to do so; (2) provided sample confirmation language so prescribers wouldn't have to formulate their own; (3) assumed that every provider would spend a minute per confirmation even though states already impose recordkeeping requirements, and electronic storage might take seconds; and (4) did not account for potentially offsetting reductions in burden hours for eye care providers due to reduced time and effort spent responding to verification requests (since more patients would have possession of their prescriptions and be able to present them to third-party contact lens sellers).
                        <SU>572</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>571</SU>
                             National Taxpayers Union (SNPRM Comment #149).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>572</SU>
                             
                            <E T="03">Id. See also</E>
                             National Association of Optometrists and Opticians (SNPRM Comment #129) (stating that with more patients in possession of their prescriptions, there would be fewer orders relying on the verification process).
                        </P>
                    </FTNT>
                    <P>
                        Likewise, 1-800 CONTACTS submitted a new analysis from Stanford Health Research Professor Laurence Baker that called the Commission's burden analysis “conservative,” and estimated that a reduction in verification requests by 13-15% would be sufficient to offset all of the costs of the confirmation requirement.
                        <SU>573</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>573</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <P>
                        None of the SNPRM commenters offered detailed suggestions for reducing the burden resulting from the Confirmation of Prescription Release proposal, other than to suggest that the Commission withdraw its proposal completely or choose a substantially different alternative, such as signage or public education.
                        <SU>574</SU>
                        <FTREF/>
                         For reasons discussed in Section II.C.6., 
                        <E T="03">supra,</E>
                         the Commission does not believe such alternatives would effectively serve the purpose of the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>574</SU>
                             
                            <E T="03">See</E>
                             Section II.C.6, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">3. Estimated Additional Burden Hours for the Confirmation of Prescription Release Requirement</HD>
                    <P>
                        Commission staff estimates the PRA burden of the Confirmation of Prescription Release requirement based on comments received and its long-standing knowledge and experience with the eye care industry.
                        <SU>575</SU>
                        <FTREF/>
                         Staff continues to believe there will be an additional burden on individual prescribers' offices to satisfy the confirmations of prescription release requirements, but that this burden will be relatively small in the context of the overall market for contact lenses and examinations.
                        <SU>576</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>575</SU>
                             
                            <E T="03">See</E>
                             Section I.B., 
                            <E T="03">supra,</E>
                             discussing the Commission's three decades of experience with the optical goods industry.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>576</SU>
                             One survey estimated that the U.S. contact lens market totaled approximately $5,012,800,000 (not counting examination revenue) in 2017. “Vision Markets See Continued Growth in 2017, VisionWatch Says,” Vision Monday, March 20, 2018, 
                            <E T="03">http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also</E>
                             note 609 and accompanying text, 
                            <E T="03">infra.</E>
                        </P>
                    </FTNT>
                    <P>
                        The number of contact lens wearers in the United States is currently estimated to be approximately 45 million.
                        <SU>577</SU>
                        <FTREF/>
                         Therefore, assuming an annual contact lens exam for each contact lens wearer, the Confirmation of Prescription Release requirement would require that 45 million people either read and sign a Confirmation of Prescription Release or agree to receive their prescription electronically.
                    </P>
                    <FTNT>
                        <P>
                            <SU>577</SU>
                             Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, 
                            <E T="03">https://www.cdc.gov/contactlenses/fast-facts.html.</E>
                             This is an updated figure that represents an increase of four million wearers since the NPRM and SNPRM estimates were prepared.
                        </P>
                    </FTNT>
                    <P>Nothing in the comments to the SNPRM alters the Commission's belief that generating and presenting the Confirmation of Prescription Release will not require significant time or effort. The comments describing the burden as crippling and onerous do not contain empirical facts or data regarding the amount of time and cost of the Commission's proposal, and some estimates appear overstated.</P>
                    <P>The Commission continues to believe that creating the Confirmation of Prescription Release should not be difficult to implement since the requirement is flexible in that it allows any one of several different modalities and delivery methods, including adding the confirmation to existing documentation that prescribers routinely provide (sales receipts) or are already required to provide (prescriptions) to patients. The requirement is also flexible in that it does not prescribe other details such as the precise content or language of the patient confirmation, but merely requires that, if provided to the patient pursuant to options specified in § 315.3(c)(1)(i)(A), (B), and (C), the confirmation from the patient must be in writing. At the same time, it is not required that prescribers spend time formulating their own content for the confirmation, since the Rule provides draft language that prescribers are free to use, should they so desire. Furthermore, the confirmation requirement is flexible enough to cover situations where a contact lens fitting is completed remotely, since a prescriber can readily satisfy the confirmation and prescription-release requirements by various methods, including email, text, or uploading the prescription to a patient portal, so long as the patient consents to such delivery.</P>
                    <P>
                        The four options for a prescriber to confirm a prescription release to a patient are set out in § 315.3(c)(1)(i)(A), (B), (C), and (D). The requirement in options (A), (B), and (C) to provide the patient with a Confirmation of Prescription Release statement are not disclosures constituting an information collection under the PRA because the FTC, in § 315.3(c)(1)(ii), has supplied the prescriber with draft language the prescriber can use to satisfy this requirement.
                        <SU>578</SU>
                        <FTREF/>
                         As noted above, however, the requirement in (A), (B), and (C) to collect a patient's signature on the Confirmation of Prescription Release and preserve it constitutes an information collection as defined by OMB regulations that implement the PRA. Nonetheless, the Commission believes it will require minimal time for a patient to read the confirmation and provide a signature. The Commission estimated in the SNPRM that it would 
                        <PRTPAGE P="50709"/>
                        take patients ten seconds to read the one-sentence Confirmation of Prescription Release and provide a signature,
                        <SU>579</SU>
                        <FTREF/>
                         and the Commission believes that ten seconds remains an appropriate estimate.
                    </P>
                    <FTNT>
                        <P>
                            <SU>578</SU>
                             “The public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public is not included within” the definition of “collection of information.” 5 CFR 1320.3(c)(2).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>579</SU>
                             SNPRM, 84 FR at 24693. This estimate was based on responses to a consumer survey regarding how long it would take consumers to read the Signed Acknowledgment, and a prior PRA estimate for consumers to complete a similar signed acknowledgment.
                        </P>
                    </FTNT>
                    <P>
                        The fourth option, § 315.3(c)(1)(i)(D), does not, in and of itself, constitute an information collection under the PRA, since no new information that would not otherwise be provided under the Rule is provided to or requested from the patient.
                        <SU>580</SU>
                        <FTREF/>
                         Excluding that option from consideration, and assuming the remaining three options are exercised with equal frequency, 75% of approximately 45 million annual prescription releases will entail reading and signing a confirmation statement. Thus, assuming ten seconds for each release, prescribers and their office staff would devote 93,750 hours, cumulatively (75% × 45 million prescriptions yearly × 10 seconds each) to obtaining patient signatures as confirmations of prescription release.
                        <SU>581</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>580</SU>
                             In order to utilize § 315.3(c)(1)(i)(D), however, a prescriber must obtain and maintain records or evidence of affirmative consent by patients to electronic delivery of their prescriptions. 16 CFR 315.2. The burden to do so is included in the recordkeeping burden calculation of this PRA Section.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>581</SU>
                             Section 315.3(c)(1)(iii) also requires that in the event that a patient declines to sign a confirmation requested under paragraphs (c)(1)(i)(A), (B), or (C), the prescriber must note the patient's refusal on the document and sign it. However, the Commission has no reason to believe that such notation should take any longer than for the patient to read and sign the document, so the Commission will maintain its calculation as if all confirmations requested under (c)(1)(i)(A), (B), or (C) require the same amount of time.
                        </P>
                    </FTNT>
                    <P>
                        Maintaining those signed confirmations for a period of not less than three years should also not impose substantial new burdens on individual prescribers and office staff. The majority of states already require that optometrists keep records of eye examinations for at least three years,
                        <SU>582</SU>
                        <FTREF/>
                         and thus many prescribers who opt to include the confirmation of prescription release on the prescription itself would be preserving that document, regardless. Similarly, most prescribers already retain customer sales receipts for financial accounting and recordkeeping purposes, and thus prescribers who opt to include the confirmation of prescription release on the sales receipt also could be retaining that document, regardless. Moreover, storing a one-page document per patient per year should not require more than a few seconds, and an inconsequential, or 
                        <E T="03">de minimis,</E>
                         amount of record space. Some prescribers might also present the Confirmation of Prescription Release in electronic form, enabling patients to sign a computer screen or tablet directly and have their confirmation immediately stored as an electronic document. For other prescribers, the new recordkeeping requirement would likely require that office staff either preserve the confirmation in paper format, or electronically scan the signed confirmation and save it as an electronic document. For prescribers who preserve the confirmation electronically by scanning it, Commission staff estimates that saving such a document would consume approximately one minute of staff time. Commission staff does not possess detailed information on the percentage of prescribers' offices that currently use and maintain paper forms, electronic forms, or that scan paper files and maintain them electronically. Thus, for purposes of this PRA analysis, Commission staff will assume that 
                        <E T="03">all</E>
                         prescriber offices who opt for § 315.3(c)(1)(i) (A), (B), or (C) require a full minute per confirmation for recordkeeping arising from the modifications. Excluding from PRA consideration the fourth option, § 315.3(c)(1)(i)(D), as there is no signature to obtain or retain, and assuming that prescribers elect the other options three-fourths or 75% of the time, the recordkeeping burden for all prescribers to scan and save such confirmations would amount to 562,500 hours (75% × 45 million prescriptions yearly × one minute for scanning and storing) per year.
                    </P>
                    <FTNT>
                        <P>
                            <SU>582</SU>
                             
                            <E T="03">See, e.g.,</E>
                             246 Mass. Code Regs. § 3.02 (requiring optometrists to maintain patient records for at least seven years); Wash. Admin. Code § 246-851-290 (requiring optometrists to maintain records of eye exams and prescriptions for at least five years); Iowa Admin. Code r. 645-182.2(2) (requiring optometrists to maintain patient records for at least five years); Fla. Admin. Code r. 64B13-3.003(6) (requiring optometrists to maintain patient records for at least five years).
                        </P>
                    </FTNT>
                    <P>
                        As noted previously, the fourth option for satisfying the Confirmation of Prescription Release requirement does not necessitate that prescribers obtain or maintain a record of the patient's signature confirming receipt of her prescription. However, as explained in § 315.2, under the Rule's now-modified definition of 
                        <E T="03">Provide to the patient a copy,</E>
                         in order to avail themselves of the fourth option, prescribers must obtain and maintain records or evidence of the patients' affirmative consent to electronic delivery for three years. In order to remain as cautious as possible in estimating the burden, the Commission will use the assumption that consumers sign such consents for electronic delivery pursuant to § 315.3(c)(1)(i)(D) for one quarter of the 45 million prescriptions released per year,
                        <SU>583</SU>
                        <FTREF/>
                         and that this task would take the same amount of time as to obtain and maintain a signature of the patient's Confirmation of Prescription Release. Thus, the Commission will allot 218,750 hours 
                        <SU>584</SU>
                        <FTREF/>
                         for the time required for prescribers to obtain affirmative consents and maintain records of same.
                    </P>
                    <FTNT>
                        <P>
                            <SU>583</SU>
                             11,250,000 (45 million prescriptions × 25%).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>584</SU>
                             31,250 hours (11,250,000 prescriptions yearly × 10 seconds) for obtaining the signature plus 187,500 hours (11,250,000 affirmative consents × one minute) for storing such records.
                        </P>
                    </FTNT>
                    <P>Therefore, the estimated incremental PRA recordkeeping burden for prescribers and their staff resulting from the Confirmation of Prescription Release modifications to the Rule amounts to 906,250 total hours ((93,750 and 31,250 hours, respectively, to obtain signatures confirming release and consenting to electronic delivery) plus (562,500 and 218,750 hours, respectively, to maintain such records for three years)).</P>
                    <P>
                        As some commenters noted, the overall burden of the Rule—particularly verification costs previously approved by the Office of Management and Budget 
                        <SU>585</SU>
                        <FTREF/>
                        —could lessen (or not increase by as much as the incremental burden from the proposed Rule modifications), given potentially offsetting effects presented by the Commission's Rule modifications.
                        <SU>586</SU>
                        <FTREF/>
                         With more patients in possession of their prescriptions (due to increased prescription release), and a greater ability to present them to sellers (due to the modification requiring sellers to provide a method for patients to present prescriptions) fewer time-consuming verifications would be necessary.
                        <SU>587</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>585</SU>
                             
                            <E T="03">See</E>
                             note 549, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>586</SU>
                             
                            <E T="03">See</E>
                             Information Technology &amp; Innovation Foundation (SNPRM Comment #103); 1-800 CONTACTS (SNPRM Comment #135); National Taxpayers Union (SNPRM Comment #149).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>587</SU>
                             
                            <E T="03">Id.</E>
                        </P>
                    </FTNT>
                    <P>
                        Based on new projections from 1-800 CONTACTS 
                        <SU>588</SU>
                        <FTREF/>
                         and a previous analysis by the Commission,
                        <SU>589</SU>
                        <FTREF/>
                         a decrease of between 13%-23% in verifications could be sufficient to offset the entire cost of the Confirmation of Prescription Release requirement. In the SNPRM, however, the Commission noted that these estimates rely on a number of assumptions, not all of which are confirmed as accurate.
                        <SU>590</SU>
                        <FTREF/>
                         Furthermore, 
                        <PRTPAGE P="50710"/>
                        neither 1-800 CONTACTS, nor any other commenter, provided empirical data or projections as to how much the number of verifications will decline due to the Rule modifications. The Commission continues to lack this data, and thus cannot predict whether the verification decrease—should it occur—would be sufficient to offset any or all of the burden. Therefore, the Commission will not make an adjustment for offsetting effects and benefits at this time.
                    </P>
                    <FTNT>
                        <P>
                            <SU>588</SU>
                             1-800 CONTACTS (SNPRM Comment #135) (estimating that a reduction of 13%-15% in verifications would offset the estimated costs of the proposal).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>589</SU>
                             SNPRM, 84 FR at 24693-94.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>590</SU>
                             
                            <E T="03">Id.</E>
                             at 24678. The calculation also does not take into account any of the benefit to consumers from 
                            <PRTPAGE/>
                            having their prescriptions and being able to choose from among competing sellers; the savings consumers might achieve by purchasing lower-priced lenses; the improvements to health and safety due to a reduction in errors associated with invalid prescriptions currently verified through passive verification; and the Commission's ability to assess and verify compliance with the Rule.
                        </P>
                    </FTNT>
                    <P>For this specific reason, and the various cautious assumptions described above, the Commission's estimate of 906,250 total hours for prescribers and their staff resulting from the Confirmation of Prescription Release requirement may well overstate the burden of the modification. Furthermore, the actual burden should be even lower because none of the Confirmation of Prescription Release requirements apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses. The Commission requested but did not receive comment on the percentage of prescribers who might be exempt, and does not currently possess sufficient information to determine what percentage of prescribers do not have a financial interest in the sale of contact lenses. The Commission thus has not reduced the estimated PRA burden accordingly at this time.</P>
                    <HD SOURCE="HD3">4. Estimated Total Labor Cost Burden for the Confirmation of Prescription Release Modification</HD>
                    <P>
                        Commission staff derives labor costs by applying appropriate hourly-cost figures to the burden hours described above. The task to obtain patient confirmations and consent to electronic delivery could theoretically be performed by medical professionals (
                        <E T="03">e.g.,</E>
                         optometrists, ophthalmologists) or their support staff (
                        <E T="03">e.g.,</E>
                         dispensing opticians, medical technicians, office clerks). In the SNPRM, the Commission requested comment as to whether prescribers or office staff are more likely to collect patient signatures and retain associated recordkeeping, but did not receive significant guidance on this. Therefore, staff will continue to assume that optometrists will perform the task of collecting patient signatures, and staff will perform the labor pertaining to printing, scanning, and storing of documents, even though this may lead to some overcounting of the burden.
                    </P>
                    <P>
                        According to the Bureau of Labor Statistics, salaried optometrists earn an average wage of $57.68 per hour, and general office clerks earn an average wage of $16.92 per hour.
                        <SU>591</SU>
                        <FTREF/>
                         Using the aforementioned estimate of 125,000 total prescriber labor hours for obtaining patient signatures, the resultant aggregate labor costs to obtain patient signatures is $7,210,000 (125,000 hours × $57.68).
                    </P>
                    <FTNT>
                        <P>
                            <SU>591</SU>
                             Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment Statistics—May 2018, 
                            <E T="03">https://www.bls.gov/news.release/ocwage.t01.htm.</E>
                        </P>
                    </FTNT>
                    <P>As previously noted, Commission staff assumes that office clerks will typically perform the labor pertaining to the printing, scanning and storing of prescription release confirmations. Applying a mean hourly wage for office clerks of $16.92 per hour to the aforementioned estimate of 781,250 hours, cumulative labor costs for those tasks would total $13,218,750.</P>
                    <P>
                        Therefore, combining the aggregate labor costs for both prescribers and office staff to obtain signed patient confirmations and consent to electronic delivery and preserve the associated records, the Commission estimates the total labor burden of the Confirmation of Prescription Release modification to be $20,428,750. This represents an increase from the SNPRM's estimated burden for the Confirmation of Prescription Release proposal due to a relatively large increase in the number of contact lens wearers now estimated by the Centers for Disease Control,
                        <SU>592</SU>
                        <FTREF/>
                         increases in the estimated wages of optometrists and office staff by the Bureau of Labor Statistics,
                        <SU>593</SU>
                        <FTREF/>
                         and the additional Rule modification requiring prescribers to collect and preserve patients' affirmative consent to electronic delivery of their prescriptions.
                    </P>
                    <FTNT>
                        <P>
                            <SU>592</SU>
                             Centers for Disease Control, Healthy Contact Lens Wear and Care, Fast Facts, 
                            <E T="03">https://www.cdc.gov/contactlenses/fast-facts.html.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>593</SU>
                             Press Release, Bureau of Labor Statistics, United States Department of Labor, Occupational Employment Statistics—May 2018, 
                            <E T="03">https://www.bls.gov/news.release/ocwage.t01.htm.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">5. Capital and Other Non-Labor Costs for the Confirmation of Prescription Release Requirement</HD>
                    <P>
                        The proposed recordkeeping requirements detailed above regarding prescribers impose negligible capital or other non-labor costs, as prescribers likely have already the necessary equipment and supplies (
                        <E T="03">e.g.,</E>
                         prescription pads, patients' medical charts, scanning devices, recordkeeping storage) to perform those requirements.
                    </P>
                    <HD SOURCE="HD2">B. Recording of Automated Telephone Messages</HD>
                    <P>
                        As noted above, the Commission has further modified the Rule to require that sellers who use automated verification messages record the calls and preserve the recordings for three years. In the SNPRM, the Commission staff did not put forth a specific burden estimate for this requirement, but rather sought comments to help inform such estimated burden, to the extent applicable.
                        <SU>594</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>594</SU>
                             SNPRM, 84 FR at 24694.
                        </P>
                    </FTNT>
                    <P>
                        The Commission received a few comments stating that the requirement presented a burden for sellers.
                        <SU>595</SU>
                        <FTREF/>
                         1-800 CONTACTS, for instance, commented that the requirement to store the recorded calls would impose a costly new burden while providing relatively few associated benefits.
                        <SU>596</SU>
                        <FTREF/>
                         Consumer Reports essentially reiterated this view.
                        <SU>597</SU>
                        <FTREF/>
                         None of the commenters, however, provided data or cost figures that would help inform the Commission's estimated burden.
                    </P>
                    <FTNT>
                        <P>
                            <SU>595</SU>
                             
                            <E T="03">See</E>
                             Sections III.B., C. and D, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>596</SU>
                             1-800 CONTACTS (SNPRM Comment #135).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>597</SU>
                             Consumer Reports (SNPRM Comment #133).
                        </P>
                    </FTNT>
                    <P>
                        The Commission does not believe that requiring sellers who use automated telephone messages for verification to record the calls and preserve the recordings will create a substantial burden. The requirement will not require additional labor time for sellers, since the verification calls will be for the same duration that they are now (the length of time required to submit the information required for verification under § 315.5 (b)). However, the new requirement will likely require capital and other non-labor costs to record the calls and store them electronically. But sellers who utilize automated telephone messages for verification are already availing themselves of sophisticated communication technology, and thus should not find it daunting to implement technology to record such calls. Meanwhile the growth of digital recording technology, and the capital investment required for recording equipment and record storage, is rapidly declining and has been for some time.
                        <SU>598</SU>
                        <FTREF/>
                         A phone service provider used by at least one online contact lens seller, for example, advertises that it charges a quarter of one cent ($.0025) for each minute recorded, plus a storage fee of $.0005-per-month for each minute of 
                        <PRTPAGE P="50711"/>
                        recorded storage over 10,000.
                        <SU>599</SU>
                        <FTREF/>
                         In other words, assuming each verification call requires three minutes of recording, the first 3333 verification calls recorded and stored would cost $25 (three-fourths of one cent per call),
                        <SU>600</SU>
                        <FTREF/>
                         and each additional verification call would cost approximately six cents apiece to record and store for three years.
                        <SU>601</SU>
                        <FTREF/>
                         Other phone service providers surveyed advertise call-recording options such as $4.99 per gigabyte (about 5000 minutes) of recorded calls (about 4/10th of a cent per verification call),
                        <SU>602</SU>
                        <FTREF/>
                         and 1000 minutes of call recording for $14.95 (approximately 4.5 cents per verification call).
                        <SU>603</SU>
                        <FTREF/>
                         Some services also advertise unlimited call-recording plans ranging anywhere from $20-70 a month, depending on how many lines, and how much storage is required.
                        <SU>604</SU>
                        <FTREF/>
                         The costs of these services would vary depending on what other options are selected, how long storage is required, and the size of the order, among other things, and the Commission does not vouch for the sufficiency of any of these services. Rather, the Commission mentions these advertised promotions to demonstrate that the cost of recording calls does not appear to be burdensome. Moreover, the Commission believes, as stated in Section III, 
                        <E T="03">supra,</E>
                         that any incremental costs to sellers for recording calls is outweighed by the benefit to consumers and prescribers from curtailing invalid verification calls. For purposes of calculating the PRA burden, however, the Commission will estimate that each three-minute verification call costs five cents to record.
                    </P>
                    <FTNT>
                        <P>
                            <SU>598</SU>
                             
                            <E T="03">See</E>
                             Final Rule, Telemarketing Sales Rule, 68 FR 4622 (Jan. 29, 2003) (discussing the cost for recording calls, and determining it was not a significant obstacle for telemarketers).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>599</SU>
                             Twilio Support, 
                            <E T="03">https://support.twilio.com/hc/en-us/articles/223132527-How-much-does-it-cost-to-record-a-call-.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>600</SU>
                             (10,000 minutes × $.0025) ÷ 3333 three-minute calls = $.0075 per call.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>601</SU>
                             
                            <E T="03">Id.</E>
                             For each additional three-minute verification call, it would cost three-quarters of a cent to record and .15 of a cent per month to store the recording (5.4 cents for 36 months), for a total of 6.15 cents per call.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>602</SU>
                             
                            <E T="03">https://getvoip.com/blog/2017/11/16/call-recording/</E>
                            ; 
                            <E T="03">see also https://jive.com/features/call-recording</E>
                             (estimating that one gigabyte typically stores about 5,000 minutes of recorded calls).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>603</SU>
                             
                            <E T="03">https://www.phone.com/pricing-all/.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>604</SU>
                             
                            <E T="03">https://www.avoxi.com/blog/best-call-recording-service/.</E>
                        </P>
                    </FTNT>
                    <P>
                        According to recent survey data, approximately 36% of contact lens purchases are from a source other than the prescriber.
                        <SU>605</SU>
                        <FTREF/>
                         Assuming that each of the 45 million contact lens wearers in the U.S. makes one purchase per year, this would mean that approximately 16,200,000 contact lens purchases (45 million × 36%) are made annually from sellers other than the prescriber. Based on prior discussions with industry, approximately 73% of sales by non-prescriber sellers require verification, meaning that approximately 11,826,000 purchases would require verification calls, faxes, or emails (16,200,000 × 73%). The Commission does not possess information as to the percentage of verifications completed by telephone versus fax or email. Thus for purposes of this analysis, the Commission will assume that all verifications are performed via telephone. Furthermore, the Commission does not have information as to the percentage of telephone verifications that are automated as opposed to live calls, and thus will assume that all telephone verifications are automated calls and subject to the new call-recording requirement.
                    </P>
                    <FTNT>
                        <P>
                            <SU>605</SU>
                             Jason J. Nichols &amp; Deborah Fisher, “2018 Annual Report,” Contact Lens Spectrum, Jan. 1, 2019, 
                            <E T="03">https://www.clspectrum.com/issues/2019/january-2019</E>
                            ; VisionWatch, Contact Lenses, September 2019.
                        </P>
                    </FTNT>
                    <P>
                        Based on the aforementioned assumptions, the Commission estimates that the requirement to record automated telephone messages will require recording 11,826,000 calls 
                        <SU>606</SU>
                        <FTREF/>
                         at an annual cost to third-party sellers, in the aggregate, of $591,300 (11,826,000 × $.05).
                    </P>
                    <FTNT>
                        <P>
                            <SU>606</SU>
                             In some instances, sellers may have to call more than once to verify an order. In those instances, however, only the recording of the successful verification would need be preserved.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">C. Total Burden for the Modifications to the Rule</HD>
                    <P>
                        Combining the marginal cost of the Rule modifications for both sellers and prescribers, the Commission estimates that the amendments will impose an additional burden of $21,020,050 ($20,428,750 for prescribers + $591,300 for third-party sellers). Adding these estimated costs to the OMB's already approved existing cost burden ($84,548,448) results in a total PRA burden from the Rule of $105,568,498. While not insubstantial, this represents just two percent of the overall $5,012,800,000 contact lens market in the United States.
                        <SU>607</SU>
                        <FTREF/>
                         Moreover, as noted previously, the estimated burden is calculated using several cautious assumptions that may overstate the actual cost; in all likelihood, the actual burden will be significantly less.
                    </P>
                    <FTNT>
                        <P>
                            <SU>607</SU>
                             “Vision Markets See Continued Growth in 2017, VisionWatch Says,” Vision Monday, March 20, 2018, 
                            <E T="03">http://www.visionmonday.com/business/research-and-stats/article/vision-markets-see-continued-growth-in-2017-visionwatch-says/. See also,</E>
                             Steve Kodey, US Optical Market Eyewear Overview, 4, 
                            <E T="03">https://www.ftc.gov/sites/default/files/filefield_paths/steve_kodey_ppt_presentation.pdf.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">XII. Regulatory Flexibility Act</HD>
                    <P>
                        The Regulatory Flexibility Act (“RFA”) 
                        <SU>608</SU>
                        <FTREF/>
                         requires that the Commission provide an Initial Regulatory Flexibility Analysis (“IRFA”) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (“FRFA”) with the Final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.
                        <SU>609</SU>
                        <FTREF/>
                         The purpose of the regulatory flexibility analysis is to ensure that the agency considers the impact on small entities and examines regulatory alternatives that could achieve the regulatory purpose while minimizing burdens on small entities.
                    </P>
                    <FTNT>
                        <P>
                            <SU>608</SU>
                             5 U.S.C. 601-612.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>609</SU>
                             5 U.S.C. 603-605.
                        </P>
                    </FTNT>
                    <P>
                        Although the Commission believed that the amendments it proposed would not have a significant economic impact on small entities, it included an IRFA in the SNPRM and solicited public comment.
                        <SU>610</SU>
                        <FTREF/>
                         In this section, the Commission discusses the SNPRM comments that addressed the IRFA,
                        <SU>611</SU>
                        <FTREF/>
                         as appropriate, below. The Final Rule is similar to the rule proposed in the SNPRM. The Commission continues to believe that the amendments it is adopting will not have a significant economic impact upon small entities, but has nonetheless deemed it appropriate as a matter of discretion to provide this FRFA.
                    </P>
                    <FTNT>
                        <P>
                            <SU>610</SU>
                             SNPRM, 84 FR at 24694. The Commission's NPRM also included an IRFA. NPRM, 81 FR at 88588.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>611</SU>
                             Unlike many other commenters who addressed the IRFA indirectly, the AOA commented on the RFA by name stating its belief that the Commission “has not fully considered the regulatory burden under which physicians are already operating” and cited to the Office of Advocacy of the U.S. Small Business Administration's FY 2018 Report on the Regulatory Flexibility Act. According to the AOA, that report stated that “[s]mall businesses have told advocacy stories that exemplify how federal regulations drain small businesses' resources, energy, and in some cases even their desire to stay in business.” The AOA indicated that it “has heard the same concerns voiced by doctors of optometry who after years of service in patient care find that the regulatory framework is so intrusive to the doctor patient relationship, [
                            <E T="03">sic</E>
                            ] that some consider leaving the profession.” SNPRM Comment #96.
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">A. Need for and Objectives of the Rule Amendments</HD>
                    <P>
                        The Commission's Final Rule incorporates changes affecting prescribers and sellers. These changes were, in large part, previously addressed in the Commission's NPRM and SNPRM, including in the Regulatory Flexibility Act sections. As explained in the earlier IRFAs, the need for and objective of these changes is to clarify 
                        <PRTPAGE P="50712"/>
                        and update the Rule in accordance with marketplace practices.
                    </P>
                    <HD SOURCE="HD3">1. Amendments Affecting Prescribers</HD>
                    <P>
                        The following changes affect prescribers, many of whom are small businesses: (1) Should the prescriber so choose, allow for electronic delivery of prescriptions as a means for automatic prescription release when agreed to by the patient (and in such cases, prescribers must retain evidence for not less than three years that the prescription was sent, received, or made accessible, downloadable, and printable). The prescriber must identify to the patient the specific method of electronic delivery and obtain the patient's consent to that method, and maintain the evidence of consent for a period of not less than three years; (2) Request the patient sign a confirmation of receipt of a contact lens prescription (and if a patient declines to sign, must note the patient's refusal on the document and sign it); 
                        <SU>612</SU>
                        <FTREF/>
                         and (3) Respond to authorized seller requests for copies of a prescription within forty business hours, and require the prescriber to make a notation in the patient's record when responding to such requests.
                    </P>
                    <FTNT>
                        <P>
                            <SU>612</SU>
                             This requirement does not apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses.
                        </P>
                    </FTNT>
                    <P>
                        As explained in detail in this Final Rule notice, the Commission has determined that a Confirmation of Prescription Release is necessary for several reasons, including: (1) Multiple consumer surveys consistently show prescriber non-compliance with, and lack of consumer awareness of, the Rule's prescription-release requirement; (2) numerous personal accounts of prescribers' failure to release prescriptions; (3) the persistently high number of verifications, many of which would be unnecessary were consumers in possession of their prescriptions; (4) the regulatory structure of the contact lens market, which requires a consumer to obtain lenses pursuant to a prescription while permitting prescribers to sell what they prescribe, thus creating an incentive for prescribers to withhold prescriptions; and (5) the lack of credible empirical evidence rebutting or contradicting the evidence that prescribers are not automatically releasing prescriptions, and that consumers are not fully aware of their rights.
                        <SU>613</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>613</SU>
                             
                            <E T="03">See</E>
                             Section II, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission further determined that allowing prescribers to satisfy the automatic prescription release requirement by using an online patient portal or other electronic method in lieu of a paper copy, when the patient gives verifiable affirmative consent, offered benefits for sellers, prescribers, and patients. Patients would be able to access their prescriptions and have electronic copies to send to sellers. With the prescription, a seller would no longer need to submit a verification request, which would also benefit prescribers by reducing the volume of requests.
                        <SU>614</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>614</SU>
                             For a more detailed analysis of the reasons the Commission allowed prescribers to satisfy the automatic release requirement electronically in the Final Rule, 
                            <E T="03">see</E>
                             Section II.C.5., 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission is also instituting a forty-business-hour requirement for prescribers to provide additional copies of prescriptions upon request from a patient's agent to ensure that patients or their agents can receive additional copies of their prescription in a timely manner.
                        <SU>615</SU>
                        <FTREF/>
                         Additionally, prescribers would be required to note in the patient's file the name of the requester and the date and time the prescription was provided so that the Commission is able to determine, if necessary, whether a prescriber has complied with the Rule.
                    </P>
                    <FTNT>
                        <P>
                            <SU>615</SU>
                             
                            <E T="03">See</E>
                             Section VIII, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Amendments Affecting Sellers</HD>
                    <P>The amendments affecting sellers require them: (1) When using automated telephone messages to verify prescriptions, to record the entire call (and maintain such recordings for a period of not less than three years), commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, deliver the required information in a slow and deliberate manner and at a reasonably understandable volume, and make the required information repeatable at the prescriber's option; (2) to provide consumers with a method that allows consumers to submit their prescriptions to sellers; and (3) to verify only the contact lens brand or manufacturer that appears on the consumer's prescription, unless the consumer has provided an unprescribed contact lens manufacturer or brand in response to a specific request from the seller.</P>
                    <P>The Commission implemented the additional requirements for automated verification calls to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales. The Commission imposed the amendments in response to concerns about the quality of automated telephone messages, and instated the recording requirement because without such a record, the Commission cannot reliably assess whether a call was compliant, and further, whether the seller has a pattern of placing non-compliant calls (and unlawfully selling after such calls).</P>
                    <P>The Commission also imposed a requirement for sellers to accept prescription presentation to reduce the number of verifications, reduce errors associated with incorrect verification attempts, and make it more difficult for ill-intentioned sellers to abuse the passive verification framework and take advantage of consumers who might not realize that the seller intends to verify a different lens than the one written on their prescription.</P>
                    <P>
                        The Commission modified the definition of alteration, and included an exception for sellers that verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions in order to address the emergence of several businesses that rely exclusively, or almost exclusively, on passive verification as a means to substitute their own brand of contact lenses for those originally prescribed by the patient's prescriber. The Commission continues to receive reports about the proliferation of passive verification abuses. The implementation of the alteration definition, including the exception, should serve as an effective deterrent against sellers that try to game the verification system to sell non-prescribed contact lenses.
                        <SU>616</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>616</SU>
                             The reasons for this Final Rule amendment are more fully discussed in Section VI, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD2">B. Significant Issues Raised by Public Comments in Response to the IRFA, Including Any Comments Filed by the Chief Counsel for Advocacy of the Small Business Administration, and the Agency's Response, Including Any Changes Made in the Final Rule Amendments</HD>
                    <P>The Commission did not receive any comments from the Small Business Administration on this Rule Review. The Commission did receive comments from various interested parties in response to the SNPRM, and it discusses them below.</P>
                    <HD SOURCE="HD3">1. Amendments Affecting Prescribers</HD>
                    <P>
                        As discussed in detail in this notice, the Commission, in the SNPRM, determined that the Rule needs to contain some form of patient confirmation requirement, but the Commission made changes to its prior 
                        <PRTPAGE P="50713"/>
                        signed-acknowledgment proposal (put forth in the NPRM) in an effort to reduce the burden associated with, and address other criticisms surrounding, the proposal. These changes included: (1) Adding an option for prescribers to satisfy the confirmation requirement by releasing the prescription electronically under certain conditions; (2) excluding from the requirement eye care prescribers who have no direct or indirect financial interest in the sale of contact lenses; and (3) allowing prescribers to craft their own wording of the signed confirmation, while providing sample confirmation language that prescribers can use at their discretion.
                        <SU>617</SU>
                        <FTREF/>
                         In response to the SNPRM proposal, the Commission received a number of comments, mostly from prescribers, criticizing, and detailing the burden of, and other issues associated with complying with, the Commission's Confirmation of Prescription Release requirement.
                        <SU>618</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>617</SU>
                             In the Final Rule, for instances where a patient refuses to sign the confirmation, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>618</SU>
                             
                            <E T="03">See</E>
                             Section II, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        Other SNPRM commenters provided new views or concerns about the NPRM's proposal to require that prescribers respond to requests from patients or their agent for an additional copy of a prescription within forty business hours. Some commenters felt that the Commission should not impose a time period for prescribers to respond to requests from patients or their agents for an additional copy of a prescription. Other commenters recommended that the Commission require prescribers to respond to such requests within a shorter period of time. The Commission has determined that a defined time period is necessary, and that its SNPRM proposal of forty business hours should be sufficient to ensure prescribers comply within a reasonable amount of time, while at the same time limit the additional burden on them to do so.
                        <SU>619</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>619</SU>
                             These commenters' concerns and the Commission's response to such concerns are addressed more fully in Section VIII, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD3">2. Amendments Affecting Sellers</HD>
                    <P>
                        In response to the SNPRM's proposal to require that each verification call: commence by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule; deliver the required information in a slow and deliberate manner and at a reasonably understandable volume; and make the required information repeatable at the prescriber's option, the Commission did not receive any comments suggesting that this resulted in a burden. Some commenters did raise objections, however, to the Commission's recording requirement, as discussed in detail in Section III.C., 
                        <E T="03">supra.</E>
                         For the reasons discussed in that Section and reiterated in A.2. of this Section, the Commission determined to retain the recording requirement.
                    </P>
                    <P>
                        The Commission did not receive any comments opposing the SNPRM's proposal requiring that sellers provide a method of, and a disclosure of the method of, prescription presentation. The Commission did receive a comment, however, suggesting that the Commission require that the method to present prescriptions be in close proximity to the option to provide the parameters of the contact lens for verification. Although the Commission did not impose that requirement, it took that comment into account in determining that, to maximize the potential benefit from the amendment, the seller must provide and disclose the method for the patient to present the seller with a copy of the patient's prescription prior to requesting a prescriber's contact lens prescription. In addition, the Commission, in response to comments addressing the issue, provided more guidance on the methods that sellers need to use (
                        <E T="03">i.e.,</E>
                         the method by which the order is taken or email, text or file upload).
                    </P>
                    <P>
                        The Commission also received comments on the SNPRM's proposed modification defining alteration, and providing an exception to alteration for sellers that verify only the brand or manufacturer that consumers indicate is on their prescription. Some commenters felt the modification was unnecessary, and that other Rule changes were adequate to curb the practices of substitution to non-prescribed brands through use of the verification system. As addressed in Section VI.B., 
                        <E T="03">supra,</E>
                         the Commission has determined that there are benefits to retaining this modification. In response to comments, however, the Commission provided additional guidance on the acceptable methods for obtaining brand and manufacturer information.
                    </P>
                    <HD SOURCE="HD2">C. Description and Estimate of the Number of Small Entities to Which the Amendments Will Apply or Explanation Why No Estimate Is Available</HD>
                    <P>
                        Prescribers of contact lenses are affected by the amendments concerning the option for electronic delivery of prescriptions as a means for automatic prescription release, Confirmation of Prescription Release, and the imposition of a forty-business-hour time frame for responding to authorized requests for additional copies of prescriptions. There are approximately 43,000 optometrists and 16,700 ophthalmologists in the United States,
                        <SU>620</SU>
                        <FTREF/>
                         though not all optometrists and ophthalmologists would be affected by the amendments since some do not prescribe contact lenses. Some prescribers who prescribe contact lenses also would not be affected by the Confirmation of Prescription Release requirement if they do not have a direct or indirect interest in the sale of contact lenses. Of the contact lens prescribers who are affected by the modifications, the Commission—based on its knowledge of the eye-care industry—believes that many fall into the category of small entities (
                        <E T="03">e.g.,</E>
                         offices of optometrists with less than $7.5 million in average annual receipts).
                        <SU>621</SU>
                        <FTREF/>
                         Determining a precise estimate of the number of small entities covered by the Rule's prescription-release requirements is not readily feasible, however, because most prescribers' offices are private entities that do not release the underlying revenue information necessary to make this determination.
                        <SU>622</SU>
                        <FTREF/>
                         The Commission sought comment in its SNPRM regarding the estimated number or nature of such small business entities, if any, for which the proposed amendments would have a significant impact, and did not receive commenter guidance in return.
                    </P>
                    <FTNT>
                        <P>
                            <SU>620</SU>
                             
                            <E T="03">See</E>
                             note 269, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>621</SU>
                             
                            <E T="03">See</E>
                             U.S. Small Business Admin., “Table of Small Business Size Standards Matched to North American Industry Classification System Codes,” (eff. Feb. 26, 2016), 
                            <E T="03">https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.</E>
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>622</SU>
                             5 U.S.C. 601(6).
                        </P>
                    </FTNT>
                    <P>
                        Non-prescriber sellers of contact lenses are affected by the amendments concerning the additional requirements for using an automated telephone verification message, requirements to accept prescription presentation, and requirements to verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions.
                        <SU>623</SU>
                        <FTREF/>
                         Based on its knowledge of the industry, staff believes that the number of these entities that likely qualify as small businesses (less than $22 million in average annual receipts) is not likely to be substantial.
                        <SU>624</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>623</SU>
                             Most prescribers who sell lenses do so after fitting the patient with the prescribed lens, and thus do not rely on prescription verification. The amendments affecting sellers pertain to verification or prescription presentation and do not pertain to these sales. As a result, the Commission does not consider prescribers in its estimated burden for the proposals affecting sellers.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>624</SU>
                             
                            <E T="03">See</E>
                             U.S. Small Business Admin., “Table of Small Business Size Standards Matched to North American Industry Classification System Codes” (Aug. 19, 2019), 
                            <E T="03">
                                https://www.ecfr.gov/cgi-bin/text-
                                <PRTPAGE/>
                                idx?SID=b919ec8f32159d9edaaa36a7eaf6b695amp;mc=true&amp;node=pt13.1.121&amp;rgn=div5#se13.1.121_1201.
                            </E>
                        </P>
                    </FTNT>
                    <PRTPAGE P="50714"/>
                    <HD SOURCE="HD2">D. Description of the Projected Reporting, Recordkeeping and Other Compliance Requirements of the Amendments, Including an Estimate of the Classes of Small Entities That Will Be Subject to the Requirement and the Type of Professional Skills Necessary for Preparation of the Report or Record</HD>
                    <HD SOURCE="HD3">1. Amendments Affecting Prescribers</HD>
                    <P>The Confirmation of Prescription Release amendment requires that prescribers with a direct or indirect interest in the sale of contact lenses request that patients sign, and maintain for a period of not less than three years, either (A) a statement confirming receipt of the contact lens prescription; (B) a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription; or (C) a prescriber-retained copy of the receipt for the examination that contains a statement confirming receipt of the contact lens prescription.</P>
                    <P>As an alternative to (A), (B), and (C), under certain conditions, prescribers can provide a contact lens prescription digitally. In order to avail themselves of this option, prescribers must maintain, for a period of not less than three years, evidence that the prescriptions were sent, received, or made accessible, downloadable and printable. In addition, the prescriber must identify to the patient the specific method or methods of electronic delivery to be used, such as text message, electronic mail, or an online patient portal, obtain the patient's verifiable affirmative consent to receive a digital copy through the identified method or methods, and maintain records or evidence of a patient's affirmative consent for a period of not less than three years.</P>
                    <P>The small entities potentially covered by these amendments will include all such entities subject to the Rule. The professional skills necessary for compliance with the Rule as modified will include office and administrative support supervisors to create the language and format of the confirmation, and clerical personnel to collect signatures from patients and maintain records, or in the case of digital prescriptions, retain evidence that the prescription was sent, received, or made accessible, downloadable and printable and retain evidence of a patient's affirmative consent. Compliance may include some minimal training time as well. The Commission has provided language that prescribers can use for the Confirmation of Prescription Release which, should a prescriber elect to use such language, negates the burden of formulating appropriate language. The Commission believes the overall burden imposed on small businesses by these requirements is relatively small, for the reasons described previously in Section II.C.7. of this notice. That section also addresses in detail the comments received, which discuss the burden from this amendment.</P>
                    <P>The amendment relating to providing a designated agent with an additional copy of a prescription requires that the prescriber respond within forty business hours of receipt of the request, and note in the patient's record the name of the requester and the date and time that the prescription was provided to the requester. The professional skills necessary for compliance with this amendment will include office and administrative support staff to respond to the request within forty business hours. Previously, office and administrative support staff were already required to respond to such requests, just not within a specific time frame. The forty-business-hour time period, in and of itself, should not impose a significant new burden. The office and administrative support staff will also need to make the required notations in the patient's records. As noted, the required notation would be limited to the name of the requester and the date and time the prescription was provided to the requester. Although the Rule does not require that prescribers retain the notations, the Commission expects prescribers would make and retain such notations in the ordinary course of their business and thus believes the proposal would not create much, if any, additional burden.</P>
                    <HD SOURCE="HD3">2. Amendments Affecting Sellers</HD>
                    <P>To the extent, if any, that non-prescriber sellers are small entities, the amendments relating to changes in verifications made through automated telephone messages require sellers to record the entire call, commence the call by identifying it as a request for prescription verification made in accordance with the Rule, deliver the information in a slow and deliberate manner and at a reasonably understandable volume, and make the information repeatable at the prescriber's option. Sellers must retain the complete call recording of such automated telephone messages for at least three years.</P>
                    <P>
                        The Commission believes that most small sellers who are covered by the Rule, if any, are unlikely to have undergone or to undergo the expense associated with creating and maintaining an automated telephone system for verification requests.
                        <SU>625</SU>
                        <FTREF/>
                         Instead, the Commission believes that small sellers typically comply with the Rule by receiving copies of prescriptions from patients, or making verification requests to prescribers via fax, email, or telephone calls using “live” agents. If a small seller already has an automated system for verification, the Commission does not believe the costs to accommodate the changes would be more than minimal, if any. For a seller who was following the FTC's prior guidance that automated messages be delivered at a volume and cadence that a reasonable person can understand,
                        <SU>626</SU>
                        <FTREF/>
                         it already complies with the new proposal that all such messages be at a “reasonably understandable volume” and delivered in a “slow and deliberate manner.” Similarly, if not already in compliance, a seller might need to modify its model verification recording to identify at the start that a call is being made in accordance with the Contact Lens Rule and to make the required information repeatable at the prescriber's option.
                    </P>
                    <FTNT>
                        <P>
                            <SU>625</SU>
                             1-800 CONTACTS also believes this to be the case. 
                            <E T="03">See</E>
                             1-800 CONTACTS (SNPRM Comment #135) (stating that the number of sellers that use this particular technology is likely limited).
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>626</SU>
                             Prior guidance from the FTC directed sellers to deliver verification messages at a volume and cadence that a reasonable person can understand. 
                            <E T="03">See</E>
                             note 301, 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>
                        The Commission also has little reason to believe that the new requirement that sellers who use automated messages record such calls and retain them for no less than three years creates a substantial burden for small sellers. The Commission's SNPRM invited comment on the frequency with which small sellers use automated telephone messages for verification and the costs associated with the proposals pertaining to these messages, including whether existing verification systems include the capability to record and the capacity for storage, and the costs associated with recording the calls and maintaining the recordings for no less than three years. The Commission received little guidance in response. 1-800 CONTACTS, a large contact lens seller, stated the proposal to record and store these calls imposes a “costly” burden, but did not detail the costs associated with recording and maintaining the calls. The Commission's own research surrounding such costs for recording phone calls does not support this contention.
                        <SU>627</SU>
                        <FTREF/>
                         And as noted above, the 
                        <PRTPAGE P="50715"/>
                        number of sellers that employ this technology is limited, and the Commission does not believe that small sellers use or are likely to use automated messages for verification calls.
                    </P>
                    <FTNT>
                        <P>
                            <SU>627</SU>
                             
                            <E T="03">See</E>
                             PRA discussion of the cost of recording calls, Section XI.B., 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <P>The new requirement that sellers provide a method, and a clear and prominent disclosure of the method, for the consumer to present the seller with a copy of the patient's prescription also does not impose a large burden on small sellers. A small seller would need to update its website or other consumer interface to inform consumers about the ability to provide the seller with a prescription, or alternatively, if an order occurs via telephone or in person, to verbally inform the consumer about the ability to provide the seller with a prescription. The professional skill or time necessary for this task would include personnel with the skills required to update the website or other consumer interface, and the time it takes to make the updates, or if the information is relayed over the phone or in person, the additional time for an employee or agent of the seller to inform a consumer that he or she is able to provide a prescription, and of the method by which a consumer can do so. These proposals may also require training time for staff. The seller would also need to provide a mechanism for a consumer to provide the prescription to the seller. Because a small seller almost certainly already has the capacity to accept prescriptions via an existing electronic system or email account, the Commission believes there is little additional burden of complying with this part of the proposal.</P>
                    <P>The small seller would also need to maintain prescriptions it receives via patient presentation. The Commission has not received any comments that alter its understanding that such retention does not create more than a minimal burden. Further, by retaining a patient's prescription, a seller is relieved of the burden to verify that prescription or maintain records of verification. As a result, the burden from obtaining and retaining prescriptions likely offsets the burden from making verification requests and storing records of such requests.</P>
                    <P>Both the FCLCA and the Rule prohibit illegal alteration of a prescription. The modification of the Rule's definition of alteration would clarify what constitutes alteration, and permit sellers to avail themselves of an exception by verifying only the contact lens brand or manufacturer that consumers indicate is on their prescriptions when asked by the seller. As a result, all non-prescriber sellers that qualify as small businesses would need to request and obtain manufacturer or brand information via website or other consumer interface, telephone, or in person to qualify for the exception. The professional skill or time necessary for this task would include personnel with the skills required to update the website or other consumer interface and the time it takes to make the updates, or if the information is relayed over the phone or in person, the additional time for an employee or agent of the seller to obtain the information. Such employees would also need to be trained on this requirement.</P>
                    <P>Although there is no associated document retention requirement set forth in the Rule, the Commission is aware that without the evidence that the manufacturer or brand provided on the verification request was the one provided by the customer, the seller would not be able to avail itself of the exception to illegal alteration. As a result, the Commission has considered the associated document retention as a new burden. However, since many contact lens sales by non-prescriber sellers occur online, the burden of such record retention may be minimized by the ability to keep electronic sales records. For sales that occur via telephone or in person, the seller would be required to maintain records of the request made by, and the information supplied by, the consumer. The Commission believes that sellers retain phone-order records in the ordinary course of business and any additional recordkeeping sellers may do to qualify for the exception is likely to be minimal.</P>
                    <HD SOURCE="HD2">E. Steps Taken To Minimize the Significant Impact, if Any, of the Amendments, Including Why Any Significant Alternatives Were Not Adopted</HD>
                    <HD SOURCE="HD3">1. Steps and Alternatives for Amendments Affecting Prescribers</HD>
                    <P>
                        The Commission considered a number of alternatives to the requirement for prescribers to request the patient sign a confirmation of receipt of a contact lens prescription, including signage and educating consumers about their rights to a contact lens prescription. The Commission determined that signage would be significantly less effective than a Confirmation of Prescription Release requirement. It also determined that consumer education in itself, whether provided via information entry forms, a patients' bill of rights, advertising, or public service announcements, would not have a significant impact on prescriber compliance with automatic prescription release, and would not increase the Commission's ability to monitor and enforce the Rule.
                        <SU>628</SU>
                        <FTREF/>
                         In response to commenter concerns about its proposal as outlined in the NPRM and SNPRM, the Commission took steps to minimize the impact of the Confirmation of Prescription Release. First, the Commission included an option for prescribers to satisfy the confirmation by releasing the prescription electronically. While not every prescriber will be able to use this option to deliver a prescription electronically, the Commission is confident that this option will still reduce the burden for many, especially as more prescribers move toward electronic recordkeeping. Second, the Commission excluded from the requirement eye care prescribers who have no direct or indirect financial interest in the sale of contact lenses. By more narrowly targeting the requirement to only those with an incentive to withhold prescriptions, the Commission further reduced the overall burden and avoided unnecessarily impacting prescribers who are unlikely to violate the Rule. Third, the Commission reduced the burden by allowing a significant degree of flexibility in how prescribers comply with the confirmation requirement. The Final Rule allows prescribers to craft their own wording for statements confirming receipt of contact lens prescriptions (on a stand-alone statement, on a prescriber-retained copy of a prescription, or on a prescriber-retained copy of an examination receipt), while providing sample language for prescribers to use, should they not wish to formulate their own confirmation. This change reduces the possible paperwork burden and limits potential interference with the prescriber-patient relationship.
                        <SU>629</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>628</SU>
                             These alternatives and the reasons the Commission found them to be insufficient alternatives to Confirmation of Prescription Release are more fully described in Section II.C.6., 
                            <E T="03">supra,</E>
                             of this notice.
                        </P>
                    </FTNT>
                    <FTNT>
                        <P>
                            <SU>629</SU>
                             In the Final Rule, for instances where a patient refuses to sign the confirmation, the Commission directs the prescriber to note the refusal and preserve this record as evidence of compliance.
                        </P>
                    </FTNT>
                    <P>
                        In considering the amendment requiring prescribers to respond to requests for copies of a prescription within a defined period (forty business hours), the Commission considered, but rejected, the option to simply rely on the expectation that all prescribers would fulfill their responsibilities to their patients. It is the Commission's understanding that prescribers do not always comply, or comply expediently, and therefore believes the time-limit requirement is necessary. In order to minimize the burden on prescribers, however, the Commission rejected 
                        <PRTPAGE P="50716"/>
                        commenter requests to make the time limit significantly shorter, such as eight business hours. As for the new requirement that prescribers make a notation in the patient's record when responding to such requests, the Commission declined to shift the recordkeeping burden to the designated agent making a request because, to determine whether a particular prescriber is complying with the Rule, the Commission would need to obtain records from a wide variety of agents.
                    </P>
                    <HD SOURCE="HD3">2. Steps and Alternatives for Amendments Affecting Sellers</HD>
                    <P>
                        The Commission did not consider specific alternatives to the Final Rule's requirement that sellers, when using automated telephone messages to verify prescriptions, commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, deliver the required information in a slow and deliberate manner and at a reasonably understandable volume, and make the required information repeatable at the prescriber's option.
                        <SU>630</SU>
                        <FTREF/>
                         The Commission included these amendments in the Final Rule to relieve the burden on prescribers and reduce potential health risks to patients from incomplete or incomprehensible automated telephone messages. Specifically, the Commission noted that prescribers must be able to understand automated messages so they can, if necessary, respond to sellers to prevent improper sales. Commenters presented additional suggestions to improve call quality, but did not suggest alternatives to commencing the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule, and to make the required information repeatable at the prescriber's option, nor did they express opposition to such requirements.
                    </P>
                    <FTNT>
                        <P>
                            <SU>630</SU>
                             The requirements that the seller deliver the required information in a slow and deliberate manner and at a reasonably understandable volume have been part of the FTC's prior guidance that the information be delivered at a volume and cadence that a reasonable person can understand.
                        </P>
                    </FTNT>
                    <P>The Commission considered whether to require sellers to retain a sample recording of the standard script leaving blanks for prescription and patient details instead of recording all calls using automated telephone messages. However, the Commission determined that a script or a sample recording would not reveal whether the required information was transmitted effectively or if, for instance, it was transmitted before a representative or machine answered, after an answering machine cut off, when a prescriber's office put the call on hold, or over hold music, in which case the call could not be used as a basis for the sale. In addition, a script or sample recording would not permit the Commission to assess whether a particular call was delivered in a “slow and deliberate manner” and at a “reasonable understandable volume.” Without knowing this information, the Commission would be unable to determine conclusively whether any particular verification request was valid. Therefore, the Commission did not adopt this recommendation.</P>
                    <P>With respect to the requirement that sellers accept prescription presentation, the Commission did not receive any comments opposing this proposal, and thus did not consider alternatives. In response to commenter concerns, however, the Commission determined not to permit sellers to select any method of communication, but opted instead to maximize the benefits from the amendment by requiring the seller to present the prescription through the same medium by which the order is placed, or electronic mail, text message, or file upload.</P>
                    <P>For verification requests, the Commission expressly defined alteration as occurring when sellers provide prescribers with the name of a manufacturer or brand other than that specified on a patient's prescription. However, the Commission provided an exception such that it would not amount to alteration in instances when sellers verify only the contact lens brand or manufacturer that consumers indicate is on their prescriptions after a seller requests that information. As possible alternatives to these changes, the Commission considered whether it could instead rely on the new requirements that sellers (a) provide a method for prescription presentation and (b) meet quality standards for verification calls, but the Commission determined that those requirements alone are inadequate to curb the practice of unlawful substitution to non-prescribed brands through abuse of the verification system. Although the Commission has previously stated that a verification request is not valid and does not commence the eight-business-hour verification period if a seller knows or should know that the verification request includes a different brand and manufacturer than that prescribed, the FTC continues to receive reports about the proliferation of passive verification abuses, and sellers “gaming the system” to substitute a different brand or manufacturer. Furthermore, without the changes to the definition of alteration, sellers may argue that they are technically compliant with the Rule because they submitted verification requests and prescribers had an opportunity to respond to the requests, and may also argue that they did not have knowledge that a consumer did not have a prescription for that manufacturer or brand of lens. The Final Rule amendment will give them a basis of knowledge by requesting that a consumer state the brand or manufacturer of her brand of lens. Additionally, the Commission determined that without the express definition of alteration and the exception thereto, enforcement would not, in and of itself, be adequate to protect consumers, because alteration via abuse of the verification system does not occur with only one bad actor, and because of an increase in companies that appear to alter prescriptions in this way.</P>
                    <P>Seller 1-800 CONTACTS also commented that the amendment should not refer to “brand” as that language does not appear elsewhere in the Rule. It pointed out that the Rule defines a prescription as including a “material or manufacturer or both” and that the Commission's inclusion of the reference to brand imposes an additional limit on consumer choice that is not required by the Act. 1-800 CONTACTS requested that the exception to the Rule be applicable to “providing the prescriber with the name of a manufacturer or material other than that specified by the patient's prescriber . . . .” The reference to brand in the definition of alteration and in the exception are the only references to brand in the Rule. However, because many, if not most, prescriptions list the manufacturer's brand, not the manufacturer or material, and very few consumers know the manufacturer or material of contact lens that they wear (typically referring to their lenses by brand name), the Commission declines to follow 1-800 CONTACTS' recommendation because many consumers would be unable to respond to a seller's request.</P>
                    <P>
                        1-800 CONTACTS expressed concern that the Commission's amendment might interfere with its ability to improve the user experience. It indicated that it sells hundreds of brands of lenses and offers consumers a variety of methods to identify their brand, including drop-down menus, a search box, and filters that display lenses by brand, modality, and other parameters and that some consumers do not enter their brand information on an order form. In response, the Commission, in the Final Rule, removed the language from its earlier proposal that sellers must obtain the information 
                        <PRTPAGE P="50717"/>
                        on “an order form.” In comparison, other commenters requested greater specificity or even prohibitions on the acceptable mechanisms for sellers to request and consumers to select their brand. In response, the Commission clarified that, at a minimum, in order for sellers to consider the consumer's indication of manufacturer or brand as adequate to qualify for the exception, the manufacturer or brand must be: (1) Provided in response to a seller's request for the manufacturer or brand listed on the consumer's prescription; and (2) an affirmative statement or selection by the consumer, not a preselected or prefilled entry.
                        <SU>631</SU>
                        <FTREF/>
                    </P>
                    <FTNT>
                        <P>
                            <SU>631</SU>
                             
                            <E T="03">See</E>
                             Section VI.B., 
                            <E T="03">supra.</E>
                        </P>
                    </FTNT>
                    <HD SOURCE="HD1">XIII. Congressional Review Act</HD>
                    <P>
                        Pursuant to the Congressional Review Act (5 U.S.C. 801 
                        <E T="03">et seq.</E>
                        ), the Office of Information and Regulatory Affairs designated these rule amendments as not a “major rule,” as defined by 5 U.S.C. 804(2).
                    </P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 16 CFR Part 315</HD>
                        <P>Advertising, Medical devices, Ophthalmic goods and services, Trade practices.</P>
                    </LSTSUB>
                    <P>For the reasons discussed in the preamble, the Federal Trade Commission amends title 16 of the Code of Federal Regulations, part 315, as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 315—CONTACT LENS RULE</HD>
                    </PART>
                    <REGTEXT TITLE="16" PART="315">
                        <AMDPAR>1. The authority for part 315 is revised to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority: </HD>
                            <P>15 U.S.C. 7601-7610.</P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="16" PART="315">
                        <AMDPAR>2. Amend § 315.2 by adding in alphabetical order the definitions of “Provide to the patient a copy”, “Reasonably understandable volume” and “Slow and deliberate manner” to read as follows:</AMDPAR>
                        <SECTION>
                            <SECTNO>§ 315.2 </SECTNO>
                            <SUBJECT>Definitions.</SUBJECT>
                            <STARS/>
                            <P>
                                <E T="03">Provide to the patient a copy</E>
                                 means giving a patient a copy of his or her contact lens prescription:
                            </P>
                            <P>(1) On paper; or</P>
                            <P>(2) In a digital format that can be accessed, downloaded, and printed by the patient. For a copy provided in a digital format, the prescriber shall identify to the patient the specific method or methods of electronic delivery to be used, such as text message, electronic mail, or an online patient portal, and obtain the patient's verifiable affirmative consent to receive a digital copy through the identified method or methods; and maintain records or evidence of a patient's affirmative consent for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives.</P>
                            <P>
                                <E T="03">Reasonably understandable volume</E>
                                 means at an audible level that renders the message intelligible to the receiving audience.
                            </P>
                            <P>
                                <E T="03">Slow and deliberate manner</E>
                                 means at a rate that renders the message intelligible to the receiving audience.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="16" PART="315">
                        <AMDPAR>3. Amend § 315.3 by: </AMDPAR>
                        <AMDPAR>a. Revising paragraphs (a)(1) and (2); </AMDPAR>
                        <AMDPAR>b. Adding paragraph (a)(3); </AMDPAR>
                        <AMDPAR>c. Revising paragraphs (b)(1) through (3); and </AMDPAR>
                        <AMDPAR>d. Adding paragraph (c).</AMDPAR>
                        <P>The additions and revisions read as follows:</P>
                        <SECTION>
                            <SECTNO>§ 315.3 </SECTNO>
                            <SUBJECT>Availability of contact lens prescriptions to patients.</SUBJECT>
                            <P>
                                (a) 
                                <E T="03">In general.</E>
                                 When a prescriber completes a contact lens fitting, the prescriber:
                            </P>
                            <P>(1) Whether or not requested by the patient, shall provide to the patient a copy of the contact lens prescription;</P>
                            <P>(2) Shall, as directed by any person designated to act on behalf of the patient, verify the contact lens prescription by electronic or other means; and</P>
                            <P>(3) Shall, upon request, provide any person designated to act on behalf of the patient with a copy of the patient's contact lens prescription by electronic or other means within forty (40) business hours of receipt of the request. A prescriber shall note in the patient's record the name of the requester and the date and time that the prescription was provided to the requester.</P>
                            <P>
                                (b) 
                                <E T="03">Limitations.</E>
                                 A prescriber may not:
                            </P>
                            <P>(1) Require the purchase of contact lenses from the prescriber or from another person as a condition of providing a copy of a prescription under paragraph (a)(1) or (a)(3) of this section or as a condition of verification of a prescription under paragraph (a)(2) of this section;</P>
                            <P>(2) Require payment in addition to, or as part of, the fee for an eye examination, fitting, and evaluation as a condition of providing a copy of a prescription under paragraph (a)(1) or (a)(3) of this section or as a condition of verification of a prescription under paragraph (a)(2) of this section; or</P>
                            <P>(3) Require the patient to sign a waiver or release as a condition of releasing or verifying a prescription under paragraph (a)(1), (a)(2), or (a)(3) of this section.</P>
                            <P>
                                (c) 
                                <E T="03">Confirmation of prescription release.</E>
                                 (1)(i) Upon completion of a contact lens fitting, the prescriber shall do one of the following:
                            </P>
                            <P>(A) Request that the patient acknowledge receipt of the contact lens prescription by signing a statement confirming receipt of the contact lens prescription;</P>
                            <P>(B) Request that the patient sign a prescriber-retained copy of a contact lens prescription that contains a statement confirming receipt of the contact lens prescription;</P>
                            <P>(C) Request that the patient sign a prescriber-retained copy of the receipt for the examination that contains a statement confirming receipt of the contact lens prescription; or </P>
                            <P>(D) If a digital copy of the prescription was provided to the patient (via methods including an online portal, electronic mail, or text message) in compliance with paragraph (a)(1) of this section, retain evidence that the prescription was sent, received, or made accessible, downloadable, and printable.</P>
                            <P>(ii) If the prescriber elects to confirm prescription release via paragraphs (c)(1)(i)(A), (B), or (C) of this section, the prescriber may, but is not required to, use the statement, “My eye care professional provided me with a copy of my contact lens prescription at the completion of my contact lens fitting” to satisfy the requirement.</P>
                            <P>(iii) In the event the patient declines to sign a confirmation requested under paragraph (c)(1)(i)(A), (B), or (C) of this section, the prescriber shall note the patient's refusal on the document and sign it.</P>
                            <P>(2) A prescriber shall maintain the records or evidence required under paragraph (c)(1) of this section for a period of not less than three years. Such records or evidence shall be available for inspection by the Federal Trade Commission, its employees, and its representatives.</P>
                            <P>(3) Paragraphs (c)(1) and (c)(2) of this section shall not apply to prescribers who do not have a direct or indirect financial interest in the sale of contact lenses, including, but not limited to, through an association, affiliation, or co-location with a contact lens seller.</P>
                        </SECTION>
                    </REGTEXT>
                    <REGTEXT TITLE="16" PART="315">
                        <AMDPAR>4. Amend § 315.5 by: </AMDPAR>
                        <AMDPAR>a. Redesignating paragraphs (d), (e), (f), and (g) as paragraphs (e), (f), (h), and (i), respectively; </AMDPAR>
                        <AMDPAR>b. Adding new paragraph (d); </AMDPAR>
                        <AMDPAR>c. Revising newly redesignated paragraph (f); </AMDPAR>
                        <AMDPAR>d. Adding new paragraph (g); </AMDPAR>
                        <AMDPAR>e. Adding new paragraph (h)(2)(iii); </AMDPAR>
                        <AMDPAR>f. Revising newly redesignated paragraph (i).</AMDPAR>
                        <P>The additions and revisions read as follows:</P>
                        <SECTION>
                            <PRTPAGE P="50718"/>
                            <SECTNO>§ 315.5 </SECTNO>
                            <SUBJECT>Prescriber verification.</SUBJECT>
                            <STARS/>
                            <P>
                                (d) 
                                <E T="03">Automated telephone verification messages.</E>
                                 If a seller verifies prescriptions through calls that use, in whole or in part, an automated message, the seller must:
                            </P>
                            <P>(1) Record the entire call;</P>
                            <P>(2) Commence the call by identifying it as a request for prescription verification made in accordance with the Contact Lens Rule;</P>
                            <P>(3) Deliver the information required by paragraph (b) of this section in a slow and deliberate manner and at a reasonably understandable volume; and</P>
                            <P>(4) Make the information required by paragraph (b) of this section repeatable at the prescriber's option.</P>
                            <STARS/>
                            <P>
                                (f) 
                                <E T="03">No alteration of prescription.</E>
                                 A seller may not alter a contact lens prescription. In the context of prescription verification, alteration includes, but is not limited to, providing the prescriber with the name of a manufacturer or brand other than that specified by the patient's prescription, unless such name is provided because the patient entered or orally provided it when asked for the manufacturer or brand listed on the patient's prescription. Notwithstanding the preceding sentences, for private label contact lenses, a seller may substitute for contact lenses specified on a prescription identical contact lenses that the same company manufactures and sells under different labels.
                            </P>
                            <P>
                                (g) 
                                <E T="03">Seller requirement to accept prescription presentation:</E>
                                 A seller shall provide a prominent method, and a clear and prominent disclosure of that method, for the patient to present the seller with a copy of the patient's prescription. Such method and the disclosure shall be provided prior to requesting a prescriber's contact information for verification of the prescription; provided, however, in the case of an order placed by telephone, a seller shall comply by providing a disclosure of the method prior to requesting a prescriber's contact information for verification of the prescription. The method to present the prescription shall be provided through (i) the same medium by which the order is placed, or (ii) electronic mail, text message, or file upload.
                            </P>
                            <P>(h) * * *</P>
                            <P>(2) * * *</P>
                            <P>(iii) If the communication occurs via telephone and uses an automated message, the complete recording required pursuant to paragraph (d)(1) of this section.</P>
                            <STARS/>
                            <P>
                                (i) 
                                <E T="03">Recordkeeping requirement—Saturday business hours.</E>
                                 A seller that exercises its option to include a prescriber's regular Saturday business hours in the time period for a request for a copy of the prescription specified in § 315.3(a)(3) or for verification specified in paragraph (c)(3) of this section shall maintain a record of the prescriber's regular Saturday business hours and the basis for the seller's actual knowledge thereof. Such records shall be maintained for a period of not less than three years, and these records must be available for inspection by the Federal Trade Commission, its employees, and its representatives.
                            </P>
                        </SECTION>
                    </REGTEXT>
                    <SIG>
                        <P>By direction of the Commission.</P>
                        <NAME>April J. Tabor,</NAME>
                        <TITLE>Secretary.</TITLE>
                    </SIG>
                </SUPLINF>
                <FRDOC>[FR Doc. 2020-14206 Filed 8-14-20; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 6750-01-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
    <VOL>85</VOL>
    <NO>159</NO>
    <DATE>Monday, August 17, 2020</DATE>
    <UNITNAME>Rules and Regulations</UNITNAME>
    <NEWPART>
        <PTITLE>
            <PRTPAGE P="50719"/>
            <PARTNO>Part IV</PARTNO>
            <AGENCY TYPE="P"> Department of Commerce</AGENCY>
            <SUBAGY> National Oceanic and Atmospheric Administration</SUBAGY>
            <HRULE/>
            <CFR>50 CFR Part 217</CFR>
            <TITLE>Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Alaska Liquefied Natural Gas (LNG) Project in Cook Inlet; Final Rule</TITLE>
        </PTITLE>
        <RULES>
            <RULE>
                <PREAMB>
                    <PRTPAGE P="50720"/>
                    <AGENCY TYPE="S">DEPARTMENT OF COMMERCE</AGENCY>
                    <SUBAGY>National Oceanic and Atmospheric Administration</SUBAGY>
                    <CFR>50 CFR Part 217</CFR>
                    <DEPDOC>[Docket No. 200709-0185]</DEPDOC>
                    <RIN>RIN 0648-BH44</RIN>
                    <SUBJECT>Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Alaska Liquefied Natural Gas (LNG) Project in Cook Inlet</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>Final rule.</P>
                    </ACT>
                    <SUM>
                        <HD SOURCE="HED">SUMMARY:</HD>
                        <P>Upon application from the Alaska Gasline Development Corporation (AGDC), NMFS is issuing regulations under the Marine Mammal Protection Act (MMPA) for the taking of marine mammals incidental to the Alaska Liquefied Natural Gas (LNG) project in Cook Inlet, Alaska, over the course of five years (2020-2025). These regulations allow NMFS to issue a Letter of Authorization (LOA) for the incidental take of marine mammals during the specified construction activities carried out during the rule's period of effectiveness, set forth the permissible methods of taking, set forth other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, and set forth requirements pertaining to the monitoring and reporting of the incidental take.</P>
                    </SUM>
                    <EFFDATE>
                        <HD SOURCE="HED">DATES:</HD>
                        <P>Effective January 1, 2021 through December 31, 2025.</P>
                    </EFFDATE>
                    <ADD>
                        <HD SOURCE="HED">ADDRESSES:</HD>
                        <P>
                            To obtain an electronic copy of the AGDC's LOA application or other referenced documents, visit the internet at: 
                            <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.</E>
                             In case of problems accessing these documents, please call the contact listed below (see 
                            <E T="02">FOR FURTHER INFORMATION CONTACT</E>
                            ).
                        </P>
                    </ADD>
                    <FURINF>
                        <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                        <P>
                            Shane Guan, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at: 
                            <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.</E>
                             In case of problems accessing these documents, please call the contact listed above.
                        </P>
                    </FURINF>
                </PREAMB>
                <SUPLINF>
                    <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                    <P/>
                    <HD SOURCE="HD1">Purpose and Need for Regulatory Action</HD>
                    <P>
                        This final rule establishes a framework under the authority of the MMPA (16 U.S.C. 1361 
                        <E T="03">et seq.</E>
                        ) to allow for the authorization of take of marine mammals incidental to the AGDC's construction activities of an LNG facility in Cook Inlet, Alaska.
                    </P>
                    <P>We received an application from AGDC requesting five-year regulations and authorization to take multiple species of marine mammals. Take would occur by Level A and Level B harassment incidental to impact and vibratory pile driving and pipe laying. Please see “Background” below for definitions of harassment.</P>
                    <HD SOURCE="HD2">Legal Authority for the Proposed Action</HD>
                    <P>Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to five years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Mitigation section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I, provide the legal basis for issuing this final rule containing five-year regulations, and for any subsequent letters of authorization (LOAs). As directed by this legal authority, this final rule contains mitigation, monitoring, and reporting requirements.</P>
                    <HD SOURCE="HD2">Summary of Major Provisions Within the Final Rule</HD>
                    <P>Following is a summary of the major provisions of this final rule regarding AGDC's construction activities. These measures include:</P>
                    <P>• Required time/area closure for beluga whale during summer months in the western portion of the Cook Inlet;</P>
                    <P>• Required monitoring of the construction areas to detect the presence of marine mammals before beginning construction activities;</P>
                    <P>• Shutdown of construction activities under certain circumstances to avoid injury of marine mammals; and</P>
                    <P>• Soft start for impact pile driving to allow marine mammals the opportunity to leave the area prior to beginning impact pile driving at full power.</P>
                    <HD SOURCE="HD1">Background</HD>
                    <P>
                        The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 
                        <E T="03">et seq.</E>
                        ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed incidental take authorization may be provided to the public for review.
                    </P>
                    <P>Authorization for incidental takings must be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.</P>
                    <P>NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.</P>
                    <P>
                        The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal. Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, 
                        <PRTPAGE P="50721"/>
                        including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
                    </P>
                    <HD SOURCE="HD1">National Environmental Policy Act</HD>
                    <P>
                        To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 
                        <E T="03">et seq.</E>
                        ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (
                        <E T="03">i.e.,</E>
                         the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment.
                    </P>
                    <P>Accordingly, NMFS has adopted the Federal Energy Regulatory Commission's (FERC's) Final Environmental Impact Statement (FEIS). Our independent evaluation of the FEIS found that it includes the requisite information analyzing the effects on the human environment of issuing the Letter of Authorization (LOA). NMFS is a cooperating agency on the FERC's FEIS.</P>
                    <P>
                        The FERC's EIS is available at 
                        <E T="03">https://www.ferc.gov/industries/gas/enviro/eis/2020/03-06-20-FEIS.asp.</E>
                    </P>
                    <HD SOURCE="HD1">Summary of Request</HD>
                    <P>On April 18, 2017, NMFS received a request from AGDC for a LOA to take marine mammals incidental to constructing LNG facilities in Cook Inlet. The application was deemed adequate and complete on March 14, 2018. AGDC's request is for takes of a small number of five species of marine mammals by Level B harassment. On April 11, 2018, NMFS published a Notice of Receipt announcing the receipt of AGDC's LOA application (83 FR 15556). Further analysis by NMFS concludes that potential effects to marine mammals from AGDC's activity could result in Level A harassment. Neither AGDC nor NMFS expects serious injury or mortality to result from this activity. However, since AGDC's LNG facility construction activities are expected to last for five years, an LOA is appropriate. On June 28, 2019, NMFS published a proposed rule (84 FR 30991; June 28, 2019) and proposed regulations to govern takes of marine mammals incidental to AGDC's LNG facility construction and requested comments on the proposed regulations. After the public comment period, NMFS further worked with AGDC to address the public comments, which included the addition of monitoring and mitigation measures. On February 17, 2020, AGDC submitted a revised LOA application that includes these additional monitoring and mitigation measures.</P>
                    <HD SOURCE="HD1">Description of Proposed Activity</HD>
                    <HD SOURCE="HD2">Overview</HD>
                    <P>AGDC proposes to construct facilities to transport and offload LNG in Cook Inlet, AK, for export. The Project activities include:</P>
                    <P>• Construction of the proposed Marine Terminal in Cook Inlet, including construction of a temporary Marine Terminal Material Offloading Facility (Marine Terminal MOF) and a permanent Product Loading Facility (PLF);</P>
                    <P>• Construction of the Mainline (main pipeline) across Cook Inlet, including the potential construction of a temporary Mainline Material Offloading Facility (Mainline MOF) on the west side of Cook Inlet; and</P>
                    <P>Components of proposed construction activities in Cook Inlet that have the potential to expose marine mammals to received acoustic levels that could result in take include:</P>
                    <P>• Vibratory and impact pile driving associated with Marine Terminal MOF and PLF construction; and</P>
                    <P>• Anchor handling associated with pipe laying across the Cook Inlet.</P>
                    <P>There is no change in the AGDC's proposed LNG facilities construction from what was described in the proposed rule (84 FR 30991; June 28, 2019).</P>
                    <HD SOURCE="HD2">Dates and Duration</HD>
                    <P>AGDC plans to start the Alaska LNG facilities construction on April 1, 2021, and complete it by the end of October 31, 2025. Construction activities would be divided into phases, with all construction occurring between April 1 and October 31 each year from 2021 to 2025. During the construction season, crews will be working 12 hours per day, 6 days per week.</P>
                    <HD SOURCE="HD2">Specific Geographic Region</HD>
                    <P>The Alaska LNG facilities, which include a Marine Terminal and the Mainline crossing, will be constructed in Cook Inlet. The Marine Terminal would be constructed adjacent to the proposed onshore LNG Plant near Nikiski, Alaska.</P>
                    <P>In addition, a Mainline Material Offloading Facility (Mainline MOF) may be constructed on the west side of Cook Inlet to support installation of the Cook Inlet shoreline crossing and onshore construction between the Beluga Landing shoreline crossing and the Yentna River. The Mainline MOF would be located near the existing Beluga Landing.</P>
                    <P>A map of the Alaska LNG facilities action area is provided in Figure 1 below and is also available in Figures 2 to 4 in the LOA application.</P>
                    <BILCOD>BILLING CODE 3510-22-P</BILCOD>
                    <GPH SPAN="3" DEEP="611">
                        <PRTPAGE P="50722"/>
                        <GID>ER17AU20.447</GID>
                    </GPH>
                    <BILCOD>BILLING CODE 3510-22-C</BILCOD>
                    <HD SOURCE="HD2">Detailed Description of Specific Activity</HD>
                    <P>
                        The construction of the Alaska LNG facilities includes the construction of a product loading facility, marine terminal material offloading facility, a mainline material offloading facility, and the Mainline crossing of Cook Inlet. For all construction activities, each season extends from April 1 through October 31, during which construction crews would be working 12 hours per day, six days per week.
                        <PRTPAGE P="50723"/>
                    </P>
                    <P>The following provides a detailed description of the Alaska LNG facilities to be constructed.</P>
                    <HD SOURCE="HD3">Product Loading Facility (PLF)</HD>
                    <P>The proposed PLF would be a permanent facility used to load LNG carriers (LNGCs) for export. It consists of two loading platforms, two berths, a Marine Operations Platform, and an access trestle that supports the piping that delivers LNG from shore to LNGCs and includes all the equipment to dock LNGCs. Analyzed elements of the PLF are shown in Figures 3 and 4 of the LOA application, and are described as follows.</P>
                    <P>• PLF Loading Platforms—Two loading platforms, one located at either end of the north-south portion of the trestle, would support the loading arm package, a gangway, supporting piping, cabling, and equipment. The platforms would be supported above the seafloor on steel-jacketed structures called quadropods;</P>
                    <P>• PLF Berths—Two berths would be located in natural water depths greater than—53 feet (ft) mean lower low water (MLLW) and would be approximately 1,600 feet apart at opposite ends of the north-south portion of the trestle. Each berth would have four concrete pre-cast breasting dolphins and six concrete pre-cast mooring dolphins. The mooring and breasting dolphins would be used to secure vessels alongside the berth for cargo loading operations. The mooring and breasting dolphins would be supported over the seabed on quadropods. A catwalk, supported on two-pile bents, would connect the mooring dolphins to the loading platforms;</P>
                    <P>• Marine Operations Platform—A Marine Operations Platform would be located along the east-west portion of the access trestle (Figure 4 of the LOA application) and would support the proposed Marine Terminal Building, an electrical substation, piping, cabling, and other equipment used to monitor the loading operations. The platform would be supported above the seafloor on four-pile bents; and</P>
                    <P>• Access Trestle—This structure is T-shaped with a long east-west oriented section and a shorter north-south oriented section and carries pipe rack, roadway, and walkway. The pipe rack contains LNG loading system pipelines, a fire water pipeline, utility lines, power and instrument cables, and lighting. The east-west portion of the trestle extends from shore, seaward, for a distance of approximately 3,650 feet and would be supported on three-pile and four-pile bents at 120-foot intervals. The north-south oriented portion of the access trestle is approximately 1,560 feet long, and is supported on five-pile quadropods.</P>
                    <P>The PLF would be constructed using both overhead and marine construction methods. As planned, the PLF would be constructed over the course of four ice-free seasons (Seasons 2-5); however, Season 2 activities associated with PLF construction include only installation of onshore portions of the PLF and are not included in the analysis. Activities in Seasons 3 through 5 are described below.</P>
                    <P>In Season 3, the marine construction activities would be mobilized and the cantilever bridge would be commissioned. A total of 35 bents and quadropod structures would be installed for part of the east-west and north-south access trestles and berth loading platforms.</P>
                    <P>In Season 4, the remainder of the bents for the east-west access trestle would be installed. Additionally, bents supporting the Marine Operations Platform and north-south trestle would be installed. A total of 26 bent and quadropod structures would be installed.</P>
                    <P>In Season 5, installation of the mooring quadropods would be completed, and the bents supporting the catwalk between the loadout platforms and the mooring dolphins would be installed. A total of 18 bent and quadropod structures would be installed.</P>
                    <P>PLF bents and quadropods are expected to be installed with impact hammers. The anticipated production rate for installation of the bents is one bent per six construction days, and for quadropods it is one quadropod per eight work days. Pile driving is expected to occur during only two of the six days for bents and two of the eight days for quadropods. It is also assumed the impact hammer would only be operated approximately 25 percent of time during the two days of pile driving.</P>
                    <HD SOURCE="HD3">Marine Terminal Material Offloading Facility (Marine Terminal MOF)</HD>
                    <P>The proposed Marine Terminal MOF, to be located near the PLF in Nikiski, would consist of three berths and a quay that would be used during construction of the Liquefaction Facility to enable direct deliveries of equipment modules, bulk materials, construction equipment, and other cargo to minimize the transport of large and heavy loads over road infrastructure.</P>
                    <P>The Marine Terminal MOF quay would be approximately 1,050 feet long and 600 feet wide, which would provide sufficient space for cargo discharge operations and accommodate 200,000 square feet of staging area. It would have a general dock elevation of +32 feet MLLW.</P>
                    <P>The quay would have an outer wall consisting of combi-wall (combination of sheet piles and pipe piles) tied back to a sheet pile anchor wall, and 11 sheet pile coffer cells, backfilled with granular materials.</P>
                    <P>Berths at the Marine Terminal MOF would include:</P>
                    <P>• One Lift-on/Lift-off (Lo-Lo) berth with a maintained depth alongside of −32 feet MLLW;</P>
                    <P>• One Roll-on/Roll-off (Ro-Ro) berth with a maintained depth alongside of −32 feet MLLW; and</P>
                    <P>• One grounded barge bed with a ground pad elevation of +10 feet MLLW.</P>
                    <P>The Temporary MOF has been designed as a temporary facility and would be removed early in operations when it is no longer needed to support construction of the Liquefaction Facility.</P>
                    <P>The Temporary MOF would be constructed over the course of two construction seasons (Seasons 1 and 2).</P>
                    <P>The combi-wall and the first six of eleven coffer cells would be installed in Season 1. An equal amount of sheet pile anchor wall would be associated with the combi-wall, but this is not considered in the analysis as the anchor wall would be driven into fill and would not generate substantial underwater sound. Six 24-inch template pipe piles would be installed with a vibratory hammer before the sheet pile is installed for each coffer cell and then removed when coffer cell installation is complete. The remaining five coffer cells and fill would be installed in Season 2, along with the quadropods for the dolphins for the Ro-Ro berth.</P>
                    <P>The Marine Terminal MOF would be constructed using both land-based (from shore and subsequently from constructed portions of the Marine Terminal MOF) and marine construction methods. The anticipated production rate for installation of combi-wall and coffer cells is 25 linear feet per day per crew, with two crews operating, and vibratory hammers operating 40 percent of each 12-hour construction day. The anticipated production rate for quadropod installation is the same as described in Section 1, above.</P>
                    <P>
                        Dredging would be conducted over two ice free seasons. Dredging at the Marine Terminal MOF during the first season of marine construction may be conducted with either an excavator or clamshell (both mechanical dredges). Various bucket sizes may be used. Sediment removed would be placed in split hull or scow/hopper barges tended 
                        <PRTPAGE P="50724"/>
                        by tugs that would transport the material to the location of dredge material placement.
                    </P>
                    <P>Dredging at the Marine Terminal MOF during the second season may be conducted with either a hydraulic (cutter head) dredger or a mechanical dredger. For a hydraulic dredger, the dredged material would be pumped from the dredge area to the disposal location or pumped into split-hull barges for transport to the placement location. If split-hull barges are used rather than direct piping of material, a manifold system may be set up to load multiple barges simultaneously. For a mechanical dredger, two or more sets of equipment would likely be required to achieve total dredging production to meet the Project schedule. Personnel transfer, support equipment, and supply would be similar to the first season. However, due to the low activity level and source levels from dredging, we do not consider there would be take of marine mammals. Therefore, dredging is not further analyzed in this document.</P>
                    <HD SOURCE="HD3">Mainline Material Offloading Facility (Mainline MOF)</HD>
                    <P>A Mainline MOF may be required on the west side of Cook Inlet to support installation of the Cook Inlet shoreline crossing, and onshore construction between the South of Beluga Landing shoreline crossing and the Yentna River. The Mainline MOF would be located near, but at a reasonable distance, from the existing Beluga Landing. Use of the existing landing is not considered to be feasible.</P>
                    <P>The Mainline MOF would consist of a quay, space for tugs, and berths including:</P>
                    <P>• Lo-Lo Berth for unloading pipes and construction materials;</P>
                    <P>• Ro-Ro Berth and ramp dedicated to Ro-Ro operations; and</P>
                    <P>• Fuel berth dedicated to unloading fuel.</P>
                    <P>The quay would be 450 feet long (along the shoreline) and 310 feet wide (extending into the Cook Inlet). A Ro-Ro ramp (approximately 80 feet by 120 feet) would be constructed adjacent to the quay. Both the quay and the Ro-Ro ramp would consist of anchored sheet pile walls backed by granular fill. The sources for the granular material would be onshore. Surfacing on the quay would be crushed rock. Some fill material for the quay and Ro-Ro ramp are expected to be generated by excavation of the access road. Any additional needed fill materials and crushed rock for surfacing would be barged in.</P>
                    <P>The quay and the Ro-Ro ramp are located within the 0-foot contour, so berths would be practically dry at low tide. No dredging is planned; vessels would access the berths and ground themselves during high tide cycles. The proposed top level of the Mainline MOF is +36 feet MLLW, which is about 11 feet above Mean Higher High Water (MHHW).</P>
                    <P>Approximately 1,270 feet of sheet pile would be installed for construction of the quay and Ro-Ro ramp, and a corresponding length of sheet pile would be installed as anchor wall; however, only 670 feet of sheet pile would be installed in the waters of Cook Inlet. The remainder would be installed as anchor wall in fill material, or in the intertidal area when the tide is out, and would not result in underwater sound.</P>
                    <P>The Mainline MOF would be constructed in a single construction season (Season 1). A break-down of activities per season is provided below. Crews are expected to work 12 hours per day, six days per week. The sheet pile would be installed using marine equipment, with the first 50 percent of embedment conducted using a vibratory hammer and the remaining 50 percent conducted using an impact hammer. Hammers would be expected to be operated either 25 percent of a 12-hour construction day (impact hammer) or 40 percent of a 12-hour construction day (vibratory hammer).</P>
                    <HD SOURCE="HD3">Mainline Crossing of Cook Inlet</HD>
                    <P>The proposed Mainline, a 42-inch-diameter, natural gas pipeline, would cross the Cook Inlet shoreline on the west side of the inlet (north landfall) south of Beluga Landing at pipeline milepost (MP) 766.3, traverse Cook Inlet in a generally southward direction for approximately 26.7 miles, and cross the east Cook Inlet shoreline near Suneva Lake at MP 793.1 (south landfall). The pipe would be trenched into the seafloor and buried from the shoreline out to a water depth of approximately 35-45 feet MLLW on both sides of the inlet, approximately 8,800 feet from the north landfall and 6,600 feet from the south landfall. Burial depth (depth of top of pipe below the seafloor) in these areas would be 3-6 feet. Seaward of these sections, the concrete coated pipeline would be placed on the seafloor. Additional footprint would be impacted by the use of anchors to hold the pipelay vessel in place while installing the pipeline on the seafloor.</P>
                    <P>Geophysical surveys would be conducted just prior to pipeline construction. A detailed bathymetric profile (longitudinal and cross) would be conducted. Types of geophysical equipment expected to be used for the surveys could include:</P>
                    <P>• Single-beam echosounder planned for use during this program operate at frequencies greater than 200 kilohertz (kHz);</P>
                    <P>• Multi-beam echo sounders planned for this program operate at frequencies greater than 200 kHz;</P>
                    <P>• Side-scan sonar system planned for use during this program operate at a frequency of 400 and 900 kHz; and</P>
                    <P>• Magnetometer. These instruments do not emit sound.</P>
                    <P>Operation of geophysical equipment such as echosounders and side-scan sonars at frequencies greater than 200 kHz are not considered to result in takes of marine mammals due to the extremely high frequencies emitted that are above the range of marine mammals' hearing thresholds. Magnetometers do not emit underwater sound. Therefore, geophysical surveys are not evaluated further in this document.</P>
                    <P>The pipeline would be trenched and buried in the nearshore portions of the route across the Cook Inlet.</P>
                    <P>
                        The nearshore portion of the trench is expected to be constructed using amphibious or barge-based excavators. This portion of the trench would extend from the shoreline out to a transition water depth where a dredge vessel can be employed. On the west side of the inlet (Beluga Landing) this is expected to be from the shore out 655 feet, and on the east side (Suneva Lake) from the shoreline out 645 feet. The trench basis is to excavate a mustow slope trench that would not retain sediments (
                        <E T="03">i.e.,</E>
                         a self-cleaning trench). A backhoe dredge may also be required to work in this portion of the crossing.
                    </P>
                    <P>From the transition water depth to water depths of the -35 feet or -45 feet MLLW, a trailing suction hopper dredger would be used to excavate a trench for the pipeline. Alternative burial techniques, such as plowing, backhoe dredging, or clamshell dredging, would be considered if conditions become problematic for the dredger. After installation of the nearshore pipelines, a jet sled or mechanical burial sled could be used to achieve post dredge burial depths.</P>
                    <P>Pipeline joints would be welded together onshore in 1,000-foot-long strings and laid on the ground surface in an orientation that approximates the offshore alignment. A pipe pull barge would be anchored offshore near the seaward end of the trench, and would then be used to pull the pipe strings from their onshore position, out into the trench.</P>
                    <P>
                        Following pipeline installation, the trench is expected to backfill naturally through the movement of seafloor sediments. If manual backfilling is 
                        <PRTPAGE P="50725"/>
                        required, the backfill would be placed by reversing the flow of the trailing suction hopper dredger used offshore (see below) or mechanically with the use of excavators.
                    </P>
                    <P>
                        Seaward of the trenched sections, the pipeline would be laid on the seafloor across Cook Inlet using conventional pipelay vessel methods. The pipelay vessel would likely employ 12 anchors to keep it positioned during pipe laying and provide resistance as it is winched ahead 80 feet each time an additional 80-foot section of pipe is added/welded on the pipe string. Dynamic positioning may be used in addition to the conventional mooring system. Mid-line buoys may be used on the anchor chains when crossing other subsea infrastructure (
                        <E T="03">i.e.,</E>
                         pipelines and cables). A pipe laying rate of 2,000 to 2,500 feet per 24-hour period is expected. It is anticipated that three anchor handling attendant tugs would be used to repeatedly reposition the anchors, thereby maintaining proper position and permitting forward movement. The primary underwater sound sources of concern would be from the anchor handling tugs (AHTs) during the anchor handling for the pipelay vessel.
                    </P>
                    <P>The pipeline crossing of Cook Inlet would be installed in two consecutive construction seasons (Seasons 3 and 4). Work from the pipelay vessel and pull barge would be conducted 24 hours per day, seven days per week, until the work planned for that season is completed. Anchor handling durations were estimated differently for the two construction seasons. Anchor handling is expected to be conducted 25 percent of the time that the pull barge is on site in Season 3. The estimate for anchor handling duration in Season 4 was based on the proposed route length, the total numbers of individual anchors moves, and the estimated time required to retrieve and reset each anchor (approximately 30 minutes per anchor to retrieve and reset). A break-down of activities per season is provided below.</P>
                    <P>Activities in Season 3 in include:</P>
                    <P>• Conduct onshore enabling works including establishing winch/laydown and welding area, and excavation of a trench through onshore sections of the shore approach (open cut the shoreline).</P>
                    <P>• Excavate trench in very nearshore waters using land and amphibious excavation equipment.</P>
                    <P>• Conduct pre-lay excavation of the pipe trench out to depths of -35 to -45 feet MLLW using various subsea excavation methods.</P>
                    <P>• Install the pipe in the nearshore trenches using a pull barge.</P>
                    <P>Anchor handling would occur for approximately six (5.75 days) 24-hour periods in Season 3.</P>
                    <P>Activities in Season 4 include:</P>
                    <P>• Lay unburied offshore section of Mainline across Cook Inlet using conventional pipelay vessel. The Applicant estimates that anchor handling would occur over 13 24-hour periods in Season 4.</P>
                    <P>• Tie-in the offshore section to the buried nearshore sections on both sides of the Cook Inlet.</P>
                    <P>• Flood, hydrotest, and dry the Mainline pipeline with Cook Inlet.</P>
                    <P>A summary of pile driving activities for the entire Alaska LNG facilities construction, breaking down by seasons and project elements, is provided in Table 1.</P>
                    <GPOTABLE COLS="8" OPTS="L2,i1" CDEF="s50,r25,r25,r25,12,12,12,12">
                        <TTITLE>Table 1—In-Water Pile Driving Associated With Alaska LNG Facilities Construction</TTITLE>
                        <BOXHD>
                            <CHED H="1">Element</CHED>
                            <CHED H="1">
                                Driving
                                <LI>method</LI>
                            </CHED>
                            <CHED H="1">Pile type &amp; size</CHED>
                            <CHED H="1">Pile number or length</CHED>
                            <CHED H="1">
                                Number
                                <LI>strikes/hr</LI>
                                <LI>(impact only)</LI>
                            </CHED>
                            <CHED H="1">
                                Hours pile
                                <LI>driving/day</LI>
                            </CHED>
                            <CHED H="1">Number days</CHED>
                            <CHED H="1">
                                Total piling
                                <LI>hours</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="22">Season 1:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF combi wall</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>35</ENT>
                            <ENT>NA</ENT>
                            <ENT>11</ENT>
                            <ENT>11</ENT>
                            <ENT>120</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF combi wall</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>1075 ft</ENT>
                            <ENT>NA</ENT>
                            <ENT>11</ENT>
                            <ENT>11</ENT>
                            <ENT>120</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF cell</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>18-in steel pipe</ENT>
                            <ENT>36</ENT>
                            <ENT>NA</ENT>
                            <ENT>11</ENT>
                            <ENT>28</ENT>
                            <ENT>288</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF cell</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>2454 ft</ENT>
                            <ENT>NA</ENT>
                            <ENT>9.5</ENT>
                            <ENT>28</ENT>
                            <ENT>264</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Season 2:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF cell</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>18-in steel pipe</ENT>
                            <ENT>30</ENT>
                            <ENT>NA</ENT>
                            <ENT>10</ENT>
                            <ENT>27</ENT>
                            <ENT>264</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF cell</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>2447 ft</ENT>
                            <ENT>NA</ENT>
                            <ENT>10</ENT>
                            <ENT>27</ENT>
                            <ENT>264</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF Ro-Ro dolphin quads</ENT>
                            <ENT>Impact</ENT>
                            <ENT>24-in steel pipe</ENT>
                            <ENT>7</ENT>
                            <ENT>1560</ENT>
                            <ENT>7</ENT>
                            <ENT>7</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Marine Terminal MOF Ro-Ro dolphin quads</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>28</ENT>
                            <ENT>1560</ENT>
                            <ENT>7</ENT>
                            <ENT>7</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mainline MOF</ENT>
                            <ENT>Vibratory</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>670 ft</ENT>
                            <ENT>NA</ENT>
                            <ENT>10.5</ENT>
                            <ENT>7</ENT>
                            <ENT>72</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mainline MOF</ENT>
                            <ENT>Impact</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>670 ft</ENT>
                            <ENT>1560</ENT>
                            <ENT>7</ENT>
                            <ENT>7</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Season 3:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Berth 1</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>20</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>8</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Berth 2</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>20</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>8</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">N-S access trestle</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>40</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>16</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">E-W access trestle</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>33</ENT>
                            <ENT>1560</ENT>
                            <ENT>6.6</ENT>
                            <ENT>22</ENT>
                            <ENT>144</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">E-W access trestle</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>40</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>20</ENT>
                            <ENT>120</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Season 4:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Breasting dolphin berths 1 &amp; 2</ENT>
                            <ENT>Impact</ENT>
                            <ENT>Steel pipe 48-in</ENT>
                            <ENT>8</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>4</ENT>
                            <ENT>24</ENT>
                        </ROW>
                        <ROW>
                            <PRTPAGE P="50726"/>
                            <ENT I="03">Breasting dolphin berths 1 &amp; 2</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>32</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>12</ENT>
                            <ENT>72</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mooring dolphin</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>2</ENT>
                            <ENT>1560</ENT>
                            <ENT>12</ENT>
                            <ENT>2</ENT>
                            <ENT>24</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mooring dolphin</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>8</ENT>
                            <ENT>1560</ENT>
                            <ENT>12</ENT>
                            <ENT>2</ENT>
                            <ENT>24</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">N-S access trestle</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>30</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>12</ENT>
                            <ENT>72</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">E-W access trestle</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>28</ENT>
                            <ENT>1560</ENT>
                            <ENT>7</ENT>
                            <ENT>14</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Operation platform</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>12</ENT>
                            <ENT>1560</ENT>
                            <ENT>8</ENT>
                            <ENT>6</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Season 5:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mooring dolphin</ENT>
                            <ENT>Impact</ENT>
                            <ENT>48-in steel pipe</ENT>
                            <ENT>10</ENT>
                            <ENT>1560</ENT>
                            <ENT>8</ENT>
                            <ENT>6</ENT>
                            <ENT>48</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Mooring dolphin</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>40</ENT>
                            <ENT>1560</ENT>
                            <ENT>7</ENT>
                            <ENT>14</ENT>
                            <ENT>96</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Catwalk</ENT>
                            <ENT>Impact</ENT>
                            <ENT>60-in steel pipe</ENT>
                            <ENT>8</ENT>
                            <ENT>1560</ENT>
                            <ENT>6</ENT>
                            <ENT>16</ENT>
                            <ENT>96</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>A summary of anchor handling activities associated to mooring, trenching, and pipe laying are provided in Table 2.</P>
                    <GPOTABLE COLS="4" OPTS="L2,i1" CDEF="xs60,r50,12,12">
                        <TTITLE>Table 2—Duration of Anchor Handling Associated With Alaska LNG Facilities Project</TTITLE>
                        <BOXHD>
                            <CHED H="1">Season</CHED>
                            <CHED H="1">Activity</CHED>
                            <CHED H="1">Hours/day</CHED>
                            <CHED H="1">Days</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>Mooring</ENT>
                            <ENT>6.00</ENT>
                            <ENT>9</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>Pipe trenching</ENT>
                            <ENT>6.00</ENT>
                            <ENT>14</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>Pipeline days at a rate of 2,500 feet per day</ENT>
                            <ENT>6.00</ENT>
                            <ENT>53</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Comments and Responses</HD>
                    <P>
                        NMFS published a Proposed Rule in the 
                        <E T="04">Federal Register</E>
                         on June 28, 2019 (84 FR 30991). During the 30-day public comment period on the Proposed Rule, NMFS received comments from the Marine Mammal Commission (Commission), Center for Biological Diversity (CBD), Cook Inletkeeper, Friends of Animals (FoA), Environmental Investigation Agency (EIA), Defenders of Wildlife (DoF), and an anonymous person. All relevant comments and responses are provided below.
                    </P>
                    <P>
                        <E T="03">Comment 1:</E>
                         The Commission, CBD, Cook Inletkeeper, DoW, and EIA state that they are concerned about the potential cumulative impacts of human activities on the endangered Cook Inlet beluga whale population. The Commission in particular recommends that NMFS defer issuance of a final rule to AGDC or any other applicant proposing to conduct sound-producing activities in Cook Inlet until it has a reasonable basis for determining that authorizing any additional incidental harassment takes of Cook Inlet beluga whales would not contribute to or exacerbate the stock's decline. CBD, Cook Inletkeeper, FoA, and the anonymous person request that NMFS deny AGDC's request for an MMPA incidental take authorization.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         In accordance with our implementing regulations at 50 CFR 216.104(c), we use the best available scientific evidence to determine whether the taking by the specified activity within the specified geographic region will have a negligible impact on the species or stock and will not have an unmitigable adverse impact on the availability of such species or stock for subsistence uses. Based on the scientific evidence available, which includes the inclusion of updated density estimates for Cook Inlet beluga whales as well as consideration of the revised abundance estimates (NMFS 2020), NMFS determined that the impacts of the AGDC LNG facility construction activities, which are primarily acoustic in nature, would meet these standards.
                    </P>
                    <P>
                        In addition, NMFS worked with AGDC and developed a suite of rigorous monitoring and mitigation measures to reduce impacts to Cook Inlet beluga whales and other marine mammals to the lowest level practicable. Some of the major measures that were put in place after the Proposed Rule was published include: (1) Time/area restriction to minimize underwater noise input in the Susitna River delta during summer months (to reduce impacts to belugas during important foraging behaviors) by prohibiting in-water pile driving in west Cook Inlet; (2) requiring AGDC to implement shutdown measures for beluga whales to prevent Level B harassment, shutdown measures for humpback whales and killer whales to prevent Level A harassment, and a 1,000-m exclusion zone for harbor porpoises and harbor seals to reduce Level A harassment; and (3) requiring AGDC to test the effectiveness of air bubble curtains around in-water pile driving. If the results of passive acoustic monitoring show that the air bubble curtain can reduce the source level by 2-dB or greater for a specific type of pile, AGDC will be required to deploy the air bubble curtain system for the driving of such piles. These additional mitigation measures are expected to further reduce both the number and severity of marine mammal takes, particular the Cook Inlet beluga whale, in the AGDC LNG facility construction area. NMFS included these additional mitigation measures after working with AGDC and determined that they are 
                        <PRTPAGE P="50727"/>
                        practicable to further reduce potential impacts to Cook Inlet beluga whales.
                    </P>
                    <P>Our analysis indicates that issuance of these regulations will not contribute to or worsen the observed decline of the Cook Inlet beluga whale population. Additionally, the ESA Biological Opinion determined that the issuance of regulations is not likely to jeopardize the continued existence of the Cook Inlet beluga whales or destroy or adversely modify Cook Inlet beluga whale critical habitat. The Biological Opinion also outlined Terms and Conditions and Reasonable and Prudent Measures to reduce impacts, which have been incorporated into the rule. Therefore, based on the analysis of potential effects, the parameters of the activity, and the rigorous mitigation and monitoring program, NMFS determined that the activity would have a negligible impact on the population.</P>
                    <P>Moreover, the LNG facility construction activity would take only small numbers of marine mammals relative to their population sizes. As described in the proposed rule notice, NMFS used a method that incorporates density of marine mammals overlaid with the anticipated ensonified area to calculate an estimated number of takes for belugas, which was estimated to be less than 10% of the stock abundance. The refined analysis using a 1 km by 1 km grid of Cook Inlet beluga whale density later showed that the estimated take would be even smaller (see detailed discussion in Estimated Take section below), at less than 5% of the population for any given year, which NMFS considers small. Based on all of this information, NMFS determined that the number of beluga whales likely to be taken is small.</P>
                    <P>
                        <E T="03">Comment 2:</E>
                         The Commission recommends that NMFS ensure that AGDC's draft environmental impact statement (EIS) addresses the cumulative impacts of AGDC's proposed activities and all other sound-producing activities on beluga whales, as well as other marine mammals. CBD, Cook Inletkeeper, and EIA also comment that NMFS did not provide adequate analysis for how it arrived at its take estimates and negligible impact finding, and that NMFS did not look into the ongoing and cumulative impacts of the proposed activities combined with other foreseeable activities in Cook Inlet.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Both the statute and the agency's implementing regulations call for analysis of the effects of the applicant's activities on the affected species and stocks, not analysis of other unrelated activities and their impacts on the species and stocks. That does not mean, however, that effects on the species and stocks caused by other non-AGDC activities are ignored. The preamble for NMFS' implementing regulations under section 101(a)(5) (54 FR 40338; September 29, 1989) explains in response to comments that the impacts from other past and ongoing anthropogenic activities are to be incorporated into the negligible impact analysis via their impacts on the environmental baseline. Consistent with that direction, NMFS has factored into its negligible impact analyses the impacts of other past and ongoing anthropogenic activities via their impacts on the baseline (
                        <E T="03">e.g.,</E>
                         as reflected in the density/distribution and status of the species, population size and growth rate, and other relevant stressors). See the Analysis and Negligible Impact Determination section of this rule.
                    </P>
                    <P>Regarding the analysis supporting the take estimates and the negligible impact finding, for the assessments of potential impacts to Cook Inlet beluga whales and other marine mammals in the vicinity of AGDC's LNG facilities construction area, NMFS evaluated the noise sources as well as other stressors produced by the construction activities. We analyzed the noise source types, source levels, and the duration of noise-producing activities, as well as the expanses of ensonified areas in different seasons, to estimate the number of marine mammals that would be exposed to noise levels that could result in takes—both in the forms of Level A harassment and Level B harassment. In addition, NMFS analyzed the likely impacts of those takes on individual marine mammals and the impact on their habitat, including marine mammal prey species and the Cook Inlet beluga whale critical habitat, to support the determination that the authorized takes will result in a negligible impact to the affected species and stocks. These analyses were detailed in the Potential Effects of Specified Activities on Marine Mammals and Their Habitat and Estimated Takes by Incidental Harassment sections in the proposed rule (84 FR 39931; June 18, 2019).</P>
                    <P>Our 1989 final rule for the MMPA implementing regulations also addressed public comments regarding cumulative effects from future, unrelated activities. There we stated that such effects are not considered in making findings under section 101(a)(5) concerning negligible impact. We indicated that NMFS would consider cumulative effects that are reasonably foreseeable when preparing a NEPA analysis and also that reasonably foreseeable cumulative effects would be considered under section 7 of the ESA for ESA-listed species. Accordingly, detailed analysis of the cumulative impacts of the proposed activities combined with other foreseeable activities (including sound-producing activities) in Cook Inlet is provided in FERC's FEIS and, further, the reasonably foreseeable cumulative effects on listed species are considered in NMFS biological opinion.</P>
                    <P>
                        <E T="03">Comment 3:</E>
                         The Commission also recommends that NMFS establish annual limits on the total number and types of takes that are authorized for all sound-producing activities in Cook Inlet before issuing the final rule. FoA states that the proposed project would have more than a negligible impact when analyzed in combination with other authorizations.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As mentioned above, under the MMPA NMFS is required to make our required determinations for the specified activity and, therefore, establishing limits on the total number of takes authorized across multiple actions is inappropriate. Further, setting limits on the number and types of takes across all projects is also unnecessary in the context of the consideration of AGDC's activity. There are few incidental takes of Cook Inlet beluga whales currently authorized under the MMPA in Cook Inlet, and the projects for which takes are authorized are separated spatially and temporally. NMFS considered the effects of potential overlap in projects and the effects of sources other than those authorized for incidental take on Cook Inlet beluga whales in the Cumulative Effects section of the FERC's Final EIS. The analysis concludes that the issuance of an authorization to AGDC for the proposed LNG facility construction in Cook Inlet would not have significant impacts to Cook Inlet beluga whale and other marine mammals in the study area, provided that prescribed monitoring and mitigation measures are implemented.
                    </P>
                    <P>
                        <E T="03">Comment 4:</E>
                         The Commission recommends that NMFS require AGDC to submit a stakeholder engagement plan that includes stakeholders contacted (or to be contacted), a summary of input received, a schedule for ongoing community engagement, and measures that would be implemented to mitigate any potential conflicts with subsistence hunting.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS worked with AGDC to ensure that AGDC engages with stakeholders throughout the project area, including Cook Inlet, including submission of a Stakeholder Engagement Plan (Plan). AGDC provided the Plan to NMFS in April 2020, which includes a list of 
                        <PRTPAGE P="50728"/>
                        stakeholders to be further contacted, and implementation of the Plan through communication. The Plan provides a detailed analysis of subsistence use of marine mammals in the Cook Inlet area, which indicates that Cook Inlet does not have as strong of a subsistence hunting community. Nevertheless, AGDC stated in the Plan that it will actively involve subsistence communities in the process, hearing concerns, and responding to issues. No concerns were raised by subsistence users through this process. Through the Stakeholder Engagement Plan, AGDC would implement measures to keep subsistence users in the Cook Inlet region informed of its project activities.
                    </P>
                    <P>
                        <E T="03">Comment 5:</E>
                         The Commission states that the estimated mean density of beluga whales of 0.000158 animals/km
                        <SU>2</SU>
                         near the temporary MOF appears to be an underestimate when compared to densities used by other recent applicants to estimate takes associated with activities in similar areas of Cook Inlet. The Commission further states that density estimates for beluga whales in Cook Inlet are typically derived from a habitat model developed by Goetz 
                        <E T="03">et al.</E>
                         (2012), which generated density for each 1-square-km cell of Cook Inlet. The Commission recommends that NMFS ensure consistency in density estimates used by applicants for beluga whales in Cook Inlet and update relevant habitat density models as new information becomes available.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Density estimates for beluga in Cook Inlet in the Proposed Rule did use a habitat based model developed by Goetz 
                        <E T="03">et al.</E>
                         (2012). The analysis separated the data into upper, middle, and lower Cook Inlet; and the Goetz model is provided in GIS so that a specific density can be selected for a specific location. AGDC used the highest density estimate for each project location, which in all cases was the Goetz model for the specific area.
                    </P>
                    <P>
                        After the Proposed Rule was published, AGDC conducted additional analyses using Goetz 
                        <E T="03">et al.</E>
                         (2012) modeled aerial survey data collected by NMFS between 1993 and 2008 and developed beluga whale summer densities for each 1-square-kilometer cell of Cook Inlet. To develop a density estimate associated with Project components, the GIS files of the predicted ensonified area for both Level A and Level B harassment associated with each location and pile type, size, and hammer was overlain with the GIS file of the 1-square-kilometer beluga density cells. The cells falling within each ensonified area were provided in an output spreadsheet, and an average cell density for each Project component was calculated. This level of detailed analysis shows that average beluga whale density near the temporary MOF is 0.00005 animal/km
                        <SU>2</SU>
                        .
                    </P>
                    <P>Regarding the Commission's recommendation that NMFS ensure consistency across authorization, while we agree that the best available science should consistently be used to support density estimates for all projects, we disagree that this means the identical density estimate must necessarily be used for all projects. Density estimates themselves may appropriately vary to best inform activities conducted at varied temporal and spatial scales.</P>
                    <P>
                        <E T="03">Comment 6:</E>
                         For harbor seal take estimates, the Commission recommends that NMFS use the haul-out correction factor of 2.33 from Boveng 
                        <E T="03">et al.</E>
                         (2012) to revise the yearly abundance estimates and resulting density estimates and recalculate the number of takes accordingly. The Commission also recommends that NMFS use the gray whale and harbor porpoise densities specified in Table 9 of the Hilcorp Final Rule (84 FR 37481; July 31, 2019) and recalculate the numbers of takes accordingly. The Commission further recommends that NMFS (1) consult with researchers at the Alaska Fisheries Science Center that specialize in both cetacean and pinniped density derivation to ensure it is compiling, enumerating, and analyzing the aerial sightings data and estimating the various marine mammal densities correctly and (2) use marine mammal densities consistently for all future incidental take authorizations in Cook Inlet.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS consulted with researchers at the Alaska Fisheries Science Center and revised the yearly abundance estimates and resulting density estimates and recalculated the number of takes of harbor seals and harbor porpoises as suggested by the Commission (pers. comm.; J. London; April 16, 2020). The revised abundance and density estimates are used in take calculation described in the Estimated Take section.
                    </P>
                    <P>The gray whale was not originally included in the AGDC LOA application, as it was added by NMFS in the Proposed Rule. Further analysis (see Description of Marine Mammals in the Area of Specified Activities section) led us to conclude that takes of gray whale are highly unlikely in upper Cook Inlet where AGDC's construction activity is located. Therefore, this species is not included in the analysis for the final rule.</P>
                    <P>NMFS addressed the comment about density estimation consistency in our response to the previous comment.</P>
                    <P>
                        <E T="03">Comment 7:</E>
                         The Commission states that animal modeling that considers various operational and animal scenarios is the best way to determine the appropriate accumulation time to assess acoustic impacts. The Commission recommends that NMFS continue to make a priority to address the modeling issue to resolve in the near future and consider incorporating animal modeling into its user spreadsheet for acoustic impact assessment.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS has formed a working group to explore and develop such a model-based approach as discussed in the comment.
                    </P>
                    <P>
                        <E T="03">Comment 8:</E>
                         The Commission, CBD, and Cook Inletkeeper point out that AGDC's method for estimating days of pile driving activities, which sums fractions of days in which activities occur to generate the total number of days for each proposed activity, is inconsistent with NMFS' policy for enumerating takes for construction activities in general and underestimated the numbers of days of pile driving activity and Level A and Level B takes. The Commission recommends that NMFS revise the numbers of Level A and Level B harassment takes for all marine mammal species to reflect the actual number of days that impact and vibratory pile driving will occur, regardless of the duration of those activities on a given day.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS worked with AGDC to better characterize the activity and quantify the days of pile driving. Given that the precise number of piles to be installed or removed is generally unknown, the actual number of pile driving days is used in the revised take calculation to calculate potential takes, as recommended.
                    </P>
                    <P>
                        <E T="03">Comment 9:</E>
                         The Commission recommends that NMFS refrain from authorizing Level A harassment takes for species in which the proposed activities are not likely to result in Level A harassment takes during vibratory pile and sheet pile driving, which includes harbor porpoises, Dall's porpoises, Steller sea lions, and California sea lions.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS worked with AGDC and evaluated the potential impact to marine mammal species in the project area and reassessed the likelihood of the species' presence. Based on the reassessment, NMFS determined that it is highly unlikely that AGDC's proposed construction activities would result in Level A harassment of Dall's porpoise, Steller sea lion, or California sea lion in the project area, due to extra-limital distribution of these species. However, presence of harbor porpoise has been 
                        <PRTPAGE P="50729"/>
                        confirmed near the AGDC's project location. In addition, the relatively large Level A harassment zone for high-frequency cetaceans and the difficulty of detection harbor porpoise in the field make it challenging to implement shutdown measures in a timely fashion. Therefore, we consider the possibility that harbor porpoise could be taken by Level A harassment if AGDC PSOs fail to detect an animal before it enters an exclusion zone and remains for the amount of time necessary to incur PTS. The possibility of harbor porpoise Level A harassment is also confirmed by our calculations (see Estimated Take section). Accordingly, a small number of Level A harassment takes of harbor porpoise have been analyzed and authorized.
                    </P>
                    <P>
                        <E T="03">Comment 10:</E>
                         The Commission recommends that NMFS (1) require AGDC to provide a detailed hydroacoustic monitoring plan, (2) provide the plan to the Commission for review, and (3) include in the final rule, the requirement to conduct hydroacoustic monitoring during impact and vibratory pile driving of each pile type to verify and adjust the extents of the Level A and B harassment zones, as necessary.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS required AGDC to provide a detailed hydroacoustic monitoring plan for its pile driving activities associated with the LNG facility construction in Cook Inlet and received the plan in February 2020. NMFS has provided the plan to the Commission for review and addressed all comments and questions from the Commission. NMFS also required AGDC to conduct hydroacoustic monitoring at the beginning of in-water pile driving of each pile type to verify and adjust the extents of the Level A and Level B harassment zones, as necessary.
                    </P>
                    <P>
                        <E T="03">Comment 11:</E>
                         The Commission states that the proposed number of Level A and B harassment takes also are not allocated appropriately based on the extents of the Level A and B harassment zones. As an example, the Commission points out that in Year 5, the Level A harassment zone for high-frequency cetaceans during impact installation of 48- and 60-in pile is 4,524 m, which is 97 percent of the Level B harassment zone of 4,642 m. However, NMFS proposed to authorize 10 Level A harassment takes and 20 Level B harassment takes of harbor porpoises for that year. The Commission recommends that NMFS reallocate the proposed Level A and B harassment take for low-frequency and high-frequency for Years 2, 3, 4, and 5 to ensure that the authorized limits reflect the relative extents of each harassment zone.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS worked with AGDC and recalculated the takes based on animal density, ensonified area, and pile driving days. The estimated takes conservatively reflect the relative extents of each harassment zone. However, it is important to note that while NMFS agrees that comparison of the areas of the Level B and Level A harassment zones is a useful qualitative consideration, we do not agree with the Commission's premise that takes must necessarily be allocated proportionally to the areas of the Level B and Level A harassment zones, as these two “zones” do not represent the same thing. The Level B harassment zone is based on a threshold utilizing a metric of instantaneous exposure and the general underlying assumption is that if an animal enters this zone, even momentarily, it will be exposed above the received level threshold for Level B harassment and thereby taken. Alternately, the thresholds for incurring PTS are not solely based on an instantaneous exposure to some level of sound, they are based on an accrual of energy that results from a combination of the animal's proximity to the source and the time spent there. The isopleth produced by NMFS' User Spreadsheet (which delineates the Level A harassment zone) includes an assumption about the amount of time that an animal would need to remain within the distance identified and, therefore, does not support the assumption that any animal that enters the zone, even briefly, is taken by Level A harassment. Animals that only come within the outer edges of the Level A zone would need to remain there near the full duration of time indicated for the full day of pile driving operation to incur PTS (typically 30 minutes to multiple hours), while animals coming further within the zone would need to remain for progressively shorter amounts of time as they get closer to the source to risk incurring PTS.
                    </P>
                    <P>
                        <E T="03">Comment 12:</E>
                         The Commission states that AGDC would not be able to monitor the entire Level B harassment zones due to the extent of these zones and recommends that NMFS specify how AGDC should enumerate the numbers of marine mammals taken particularly when observers are only monitoring a portion of the Level A and B harassment zones.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS has worked with AGDC on the effectiveness of marine mammal monitoring for extended distances and concluded that if the protected species observers (PSOs) are placed in locations with appropriate height and equipment, they are able to detect beluga whales out to 1.5 km from the site on clear days. However, during less ideal visibility conditions when only a portion of the Level B harassment zone is visible, AGDC are required to enumerate the numbers of marine mammal taken based on take number within the area that is within the visual observation corrected by the proportion of area beyond visual observation.
                    </P>
                    <P>
                        <E T="03">Comment 13:</E>
                         The Commission recommends that NMFS require AGDC to keep a tally of the numbers of marine mammals taken, alert NMFS when the authorized limit is close to being met, and follow any guidance provided.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         AGDC is required to keep a tally of the number of marine mammals taken and alert NMFS when the authorized limit is close to being met based on prescribed monitoring measured in the final rule. In addition, AGDC is required to keep a tally of all marine mammal sightings during the pile driving activities.
                    </P>
                    <P>
                        <E T="03">Comment 14:</E>
                         The CBD and Cook Inletkeeper state that NMFS did not adequately consider the impacts to Cook Inlet beluga whale critical habitat.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The Cook Inlet beluga whale critical habitat is adequately addressed in the Negligible Impact Analysis and Determination section. We noted that AGDC's LNG facilities construction activities could potentially impact Cook Inlet beluga whale critical habitat. Satellite-tagging studies and aerial survey indicate that seasonal shifts exist in Cook Inlet beluga whale distribution, with the whales spending a great percentage of time in coastal areas during the summer and early fall (June through October or November), and dispersing to larger ranges that extend to the middle of the inlet in winter and spring (November or December through May). However, fine scale modeling based on NMFS long-term aerial survey data indicate that the AGDC's proposed LNG facilities construction does not overlap with beluga whale high density areas during the summer and fall (Goetz 
                        <E T="03">et al.,</E>
                         2012).
                    </P>
                    <P>
                        Further, NMFS also addressed potential effects on beluga whale prey species. Studies have shown that fish reacted to sounds when the sound level increased to about 20 dB above the detection level of about 120 dB (Ona, 1988); however, the physical injury and mortality to fish only occurred in the immediate vicinity of impact pile driving (Caltrans, 2015). Therefore, it is highly unlikely that in-water impact pile driving would cause noticeable level fish injury or mortality. During the Alaska LNG facilities construction, only a small fraction of the available habitat would be ensonified at any given time. Disturbance to fish species would be 
                        <PRTPAGE P="50730"/>
                        short-term, and fish would return to their pre-disturbance behavior once the pile driving activity ceases.
                    </P>
                    <P>Furthermore, potential impacts to Cook Inlet beluga whale critical habitat were also addressed in the FERC's FEIS, of which NMFS is a cooperating agency. In addition, the ESA Biological Opinion determined that the issuance of regulations is not likely to jeopardize the continued existence of the Cook Inlet beluga whales or destroy or adversely modify Cook Inlet beluga whale critical habitat. NMFS adequately considered impacts in critical habitat in the analyses supporting its determination.</P>
                    <P>
                        <E T="03">Comment 15:</E>
                         Citing a study by Mooney 
                        <E T="03">et al.</E>
                         (2018), the CBD and Cook Inletkeeper claim that NMFS thresholds of 120 dB re 1µPa (rms) for continuous and 160 dB re 1µPa (rms) for impulsive or intermittent sources to determine Level B harassment are insufficiently conservative to protect Cook Inlet beluga whale because beluga whales are highly sensitive to noise.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The study CBD and Cook Inletkeeper cited addresses the variation of hearing sensitivity in a wild beluga whale population Bristol Bay, AK. The study used auditory evoked potential (AEP) to obtain audiograms of 26 wild beluga whales during capture-release events. The results showed that most beluga whales from the study showed sensitive hearing with low thresholds (&lt;80 dB re 1 1µPa) from 16 to 100 kHz, a frequency range that is much higher than noises generated from in-water pile driving, vessels, and pipe laying. Although not reported in their AEP study, audiograms provided in the paper show a rapid decrease in beluga whale hearing sensitivity as the frequencies get lower, like most odontocetes. Behavioral audiograms of beluga whales show that hearing sensitivity in the frequency below 1 kHz is above 100 dB re 1 1µPa, and elevates to above 120 dB 1µPa at about 100 Hz (White 
                        <E T="03">et al.,</E>
                         1978).
                    </P>
                    <P>In addition, CBD and Cook Inletkeeper are confused between the animals' detection thresholds and threshold of noise induced behavioral disturbances. Being able to detect the sound does not indicate that the animal would respond to the sound, much less be taken by Level B harassment, as defined under the MMPA. Studies show that animals usually respond to received noise at levels much higher than their hearing thresholds.</P>
                    <P>
                        <E T="03">Comment 16:</E>
                         CBD states that impacts of pile driving on beluga whales have been underestimated. CBD further states that pile driving [noise] could mask “strong bottlenose dolphin vocalizations” 10-15 km from the source (David, 2006).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS has carefully reviewed the best available scientific information in assessing impacts to marine mammals and recognizes that these activities have the potential to impact marine mammals through threshold shifts, behavioral effects, stress responses, and auditory masking. However, NMFS has determined that the nature of such potentially localized exposure means that the likelihood of any impacts to fitness and population level disturbance from the authorized take, including from detrimental energetic effects or reproductive impacts, is low. NMFS has also prescribed a robust suite of mitigation measures, such as shutdown measures to avoid beluga Level B harassment, which is expected to further reduce both the number and severity of beluga whale takes.
                    </P>
                    <P>NMFS considers it highly unlikely that dolphin vocalizations could be masked by pile driving noise. As discussed in detail in the Potential Effects of Specified Activities on Marine Mammals and Their Habitat section of the proposed rule, auditory masking occurs at the frequency band that the animals utilize. Since noise generated from vibratory pile driving is mostly concentrated at low frequency ranges below 2 kHz, it is expected to have minimal effects masking high frequency echolocation (clicks) and communication (whistles) sounds by odontocetes, including bottlenose dolphins. The analysis by David (2006) on masking is flawed as it did not adequately consider the frequency spectra of pile driving noise as it relates to auditory frequency response of the dolphin.</P>
                    <P>
                        <E T="03">Comment 17:</E>
                         CBD and Cook Inletkeeper claims that NMFS relied on avoidance [behavior] to make its negligible determination.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         CBD's claim is inaccurate. NMFS did not rely on marine mammal avoidance behavior to make our negligible determination. To the contrary, NMFS considered avoidance as a form of Level B harassment. As stated clearly in the Proposed Rule (84 FR 39901; June 28, 2019), “marine mammals' exposure to certain sounds could lead to behavioral disturbance (Richardson 
                        <E T="03">et al.,</E>
                         1995), such as changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where noise sources are located; and/or flight responses (
                        <E T="03">e.g.,</E>
                         pinnipeds flushing into water from haul-outs or rookeries).”
                    </P>
                    <P>
                        <E T="03">Comment 18:</E>
                         CBD and Cook Inletkeeper state that NMFS failed to account for numerous harmful activities such as dredging, pipeline trenching, vessels transiting, and geophysical surveys that could result in takes of marine mammals.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         As stated in the Proposed Rule (84 FR 39901; June 28, 2019), dredging activity would occur during the construction of the Marine Terminal MOF using either a hydraulic (cutter head) dredger or a mechanical dredger, and pipeline trenching would occur in the Cook Inlet during pipeline laying operations. These activities typically have low noise levels (120-dB isopleths are typically within 150 m) and slow, predictable movement, which support the unlikelihood of resulting take. For example, URS (2007) measured underwater sound level was 141 dB re 1 μPa rms at 12 m associated with U.S. Army Corps of Engineers (USACE) dredging activities at the Port of Alaska (formerly Port of Anchorage). The resulting 120-dB isopleths was 134.6 m. In addition, these activities are typically associated with slow moving barge/vessel and the noise output are intermittent. Nevertheless, NMFS considers how other activities associated with pipeline trenching, such as anchor handling that generates much louder noise, could cause takes of marine mammals. Effects from these activities have been analyzed and takes were estimated.
                    </P>
                    <P>Although noises generated from the vessel can be louder than dredging noise, similar to dredging, the movement is relatively predictable, and habituation to vessel traffic has been documented for some marine mammals in more industrialized areas. Therefore, we do not consider animals exposed to transiting vessels likely to respond in a manner that would rise to the level of a take as defined under the MMPA.</P>
                    <P>The equipment AGDC proposed to use for its geophysical surveys are all high-frequency sources with frequencies above 200 kHz, as described in the Proposed Rule. These frequencies are beyond the detection thresholds of marine mammals. Therefore, NMFS does not expect operating these sources would have takes of marine mammals.</P>
                    <P>
                        <E T="03">Comment 19:</E>
                         CBD, Cook Inletkeeper, and FoA claim that the small numbers determination is flawed and that NMFS underestimated Cook Inlet beluga takes.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with CBD, Cook Inletkeeper, and FoA's 
                        <PRTPAGE P="50731"/>
                        assessment. As described in details in the Proposed Rule (84 FR 39901; June 28, 2019), density estimates for Cook Inlet beluga were based on a habitat-based model developed by Goetz 
                        <E T="03">et al.</E>
                         (2012). Take estimates were calculated using the beluga whale densities in different areas of the Cook Inlet that overlap with the construction activities, taking into consideration ensonified areas and the duration of each activity. After the Proposed Rule was published, AGDC conducted additional analysis, which NMFS concurred was appropriate, using Goetz 
                        <E T="03">et al.</E>
                         (2012) modeled aerial survey data collected by NMFS between 1993 and 2008 and developed beluga whale densities for each 1-square-kilometer cell of Cook Inlet. The calculation shows that the maximum annual take of Cook Inlet beluga whale, adjusted for group number is 13 animals. This translates to less than 5% of the Cook Inlet beluga whale stock's population.
                    </P>
                    <P>
                        Regarding the small numbers determination, NMFS disagrees that it is flawed. NMFS refers the reader to the 
                        <E T="04">Federal Register</E>
                         Notice announcing NMFS' issuance of five IHAs authorizing take incidental to seismic surveys in the Atlantic (83 FR 63268; December 7, 2018), in which the agency describes in detail its method and rationale for determining whether take of marine mammals constitutes small numbers. As described in that notice, and in the associated sections of this notice, the small numbers determination and negligible impact analysis are conducted separately using entirely different approaches, although they necessarily consider some of the same biological information. Also, contrary to the commenter's assertion, NMFS has indicated that the determination of whether take of marine mammals is of small numbers is appropriately considered on an annual basis and the commenter has offered no justification for why this might not be appropriate.
                    </P>
                    <P>
                        <E T="03">Comment 20:</E>
                         CBD and Cook Inletkeeper state that the proposed rule failed to ensure the least practicable adverse impact. Specifically, CBD and Cook Inletkeeper claimed that NMFS did not address the following issues: Limit on cumulative beluga whale takings in Cook Inlet; time-area restrictions; larger exclusion zones; air curtains or other noise reduction technologies; and sound source verification.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with CBD and Inletkeeper's assertion. As described in the Proposed Rule (84 FR 39901; June 28, 2019), NMFS worked with AGDC and proposed a wide range of monitoring and mitigation to achieve the least practicable adverse impact. These measures included, but were not limited to: (1) Limiting in-water pile driving activities to daylight hours only; (2) implementing shutdown measures for beluga whales to prevent Level A harassment of this species; (3) implementing soft start for all impact pile driving; and (4) monitoring both Level A and Level B harassment zones to ensure takes does not exceed the number or species that would not be authorized. NMFS has described why these measures, along with monitoring and mitigation measures described in the proposed rule, will ensure the least practicable adverse impacts to AGDC's LNG facility construction project. After the Proposed Rule was published, NMFS further worked with AGDC to identify additional practicable measures and included the following additional mitigation and monitoring measures: (1) Prohibiting in-water pile driving near beluga whale summer feeding ground between June 1 and September 7 in west Cook Inlet; (2) implementing larger exclusion zones for shutdown measures to prevent/reduce Level B harassment of Cook Inlet beluga whales; (3) implementing shutdown measure to prevent Level A harassment of all mid-frequency cetaceans; (4) implement shutdown measures to reduce Level A takes of all other marine mammals; (5) requiring AGDC to conduct passive acoustic monitoring to assess the range of ensonified zones; (6) requiring AGDC to assess the effectiveness of air bubble curtains by conducting sound source verification; and (7) requiring AGDC to deploy air bubble curtains to reduce pile driving noise level if the air bubble curtains are found to be able to achieve a noise reduction of 2 dB or more. These additional monitoring and mitigation measures address four out of the five concerns raised by CBD and Cook Inletkeeper. Regarding CBD and Cook Inletkeeper's comments on limiting cumulative beluga whale takes in Cook Inlet, NMFS addressed this in Response to Comments 2 and 3 above. Additionally, for the issuance of the LOA, our analysis showed that at a maximum, 14 Cook Inlet beluga whales could be exposed to noise levels that result to Level B harassment in a given year without any mitigation measures in place. This number equates to 5% of the Cook Inlet beluga whale population. Implementation of required monitoring and mitigation are likely to further reduce the severity and number of takes of Cook Inlet beluga whale.
                    </P>
                    <P>
                        <E T="03">Comment 21:</E>
                         CBD and Cook Inletkeeper claims that NMFS finding of no unmitigable impacts on subsistence harvest is arbitrary because the proposed action may have an adverse impact on the availability of beluga whales, harbor seals, Steller sea lions, and sea otters for Native Alaskan subsistence harvest.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with CBD and Cook Inletkeeper's assertion. First, there is no subsistence harvest of Cook Inlet beluga whales because of its low population in more than a decade. The criteria established for when subsistence hunt of Cook Inlet beluga could resume included the need for a ten-year average abundance estimate to exceed 350 animals, as well as a requirement for an increasing population trajectory; therefore, there are no active subsistence uses of beluga whales that the activity could interfere with. Further, as described in this notice, the Level B harassment take of beluga whales allowed through these regulations would be of small numbers and of a low degree not expected to effect the fitness, reproduction, or survival of any individuals, and therefore would not impede the recovery of the population or otherwise affect the ten-year abundance average. In regard to other marine mammal species, NMFS conducted a thorough analysis on substance use of these species. Jones and Kostick (2016) reported that 2 percent of households in Nikiski, the closest village to AGDC's proposed project area, used harbor seals and 1 percent reported using unknown seal species (both gifted from another region). No marine mammals were actively hunted by Alaska Native residents in Nikiski. There is limited use of marine mammals thought to be from the small number of Alaska Natives living in Nikiski (Jones and Kostick, 2016). In other locations, the hunt of marine mammals is conducted opportunistically and at such a low level that totals approximately 50 harbor seals and fewer than 10 Steller sea lions in a typical year. Therefore, AGDC's program is not expected to have an impact on the subsistence use of marine mammals.
                    </P>
                    <P>Nevertheless, NMFS required AGDC to develop a stakeholder engagement plan and communicate with subsistence users in the region to inform its proposed activities.</P>
                    <P>
                        <E T="03">Comment 22:</E>
                         CBD and Cook Inletkeeper claim the draft Environmental Impact Statement (EIS) is flawed based on the assertion that (1) the purpose and need are too narrowly defined; (2) NMFS failed to consider a reasonable range of alternatives related to mitigation measures; and (3) the discussion of environmental and cumulative impacts of the proposed 
                        <PRTPAGE P="50732"/>
                        project is inadequate as it does not discuss the planned oil and gas lease sales, the Hilcorp seismic survey and exploratory drilling, and Pebble Mine.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with CBD and Cook Inletkeeper's assertions. First, NMFS worked with the Federal Energy Regulatory Commission (FERC) and clarified NMFS' responsibility in the “Purpose and Scope of This EIS” section of the final EIS. Specifically, the EIS states that NMFS, in accordance with 40 CFR 1506.3 and 1505.2, intends to adopt this EIS and issue a separate record of decision (ROD) associated with its decision to grant or deny AGDC's request for regulations and a Letter of Authorization (LOA) pursuant to Section 101(a)(5)(A) of the MMPA for construction activities in Cook Inlet.
                    </P>
                    <P>In regard to the range of alternatives being considered, NMFS worked with FERC and required a suite of monitoring and mitigation measures that are the most protective to ensure the least practicable adverse impact. While a range of alternatives concerning the scope of the project were presented in the EIS, many of these project-related alternatives were eliminated either due to no environmental advantage or impracticable for the project and were eliminated.</P>
                    <P>Finally, we note that the projects that CBD and Cook Inletkeeper note (planned oil and gas lease sales, the Hilcorp seismic survey and exploratory drilling, and Pebble Mine) are all discussed in the Cumulative Impacts of the final EIS (pages 4-1188 and 4-1189 of the FEIS). The first two projects are also shown in a map on page 4-1168 of the FEIS, while the site of Pebble Mine is outside the vicinity of AGDC's proposed project area in Cook Inlet.</P>
                    <P>
                        <E T="03">Comment 23:</E>
                         CBD and Cook Inletkeeper states that NMFS should not issue take authorization under the Endangered Species Act (ESA).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS disagree with CBD and Cook Inletkeeper's opinion. As stated in Response to Comment 1, NMFS is required to issue a marine mammal incidental take authorization for a specified activity within the specified geographic region if NMFS is able to determine that the activity will have a negligible impact on the species or stock and will not have an unmitigable adverse impact on the availability of such species or stock for subsistence uses. Based on the scientific evidence available, NMFS determined that the impacts of the AGDC LNG facility construction activities meet these standards.
                    </P>
                    <P>Regarding ESA compliance for the NMFS authorization (under the MMPA) of ESA-listed species such the Cook Inlet beluga whale and Western North Pacific, Hawaii, and Mexico DPS of humpback whales, NMFS' Permit and Conservation Division requested initiation of section 7 consultation with the Alaska Region for the promulgation of 5-year regulations and the subsequent issuance of annual LOAs. The Alaska Region issued a Biological Opinion concluding that NMFS' action is not likely to adversely affect the listed species named above or adversely modify their critical habitat.</P>
                    <P>
                        <E T="03">Comment 24:</E>
                         FoA states that the proposed project would create noise pollution that is likely to cause hearing damage to Cook Inlet beluga whales.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with FoA's assertion. While FoA did not define what constitute to “noise pollution,” NMFS provided an in-depth analysis on noise generated from AGDC's proposed LNG facility construction. Based on the analysis, NMFS finds it extremely unlikely that a beluga whale would experience hearing damage (permanent threshold shift) from the proposed AGDC construction activity. The analysis is supported by scientific information presented in NMFS' 
                        <E T="03">Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (V.2.0)</E>
                         (NMFS, 2016; 2018) and based on density estimate of Cook Inlet beluga whales in the project area, ensonified area and noise exposure duration from construction activities. Our analysis showed that anticipated takes of Cook Inlet beluga whales are expected to be limited to short-term Level B harassment. Beluga whales present in the vicinity of the action area and taken by Level B harassment would most likely show overt brief disturbance (startle reaction) and avoidance of the area from elevated noise levels during pile driving.
                    </P>
                    <P>
                        <E T="03">Comment 25:</E>
                         FoA states that the proposed project is susceptible to catastrophic events, such as oil spill, which is reasonably likely to negatively impact the species.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         Oil spills are not considered because take of marine mammals due to oil spills are not anticipated or authorized. AGDC is required to comply with all regulations related to pileline laying and vessel transiting and is responsible for ensuring its compliance with those regulations. An oil spill, or a violation of other federal regulations, is not authorized under this rule.
                    </P>
                    <P>
                        <E T="03">Comment 26:</E>
                         FoA claims that NMFS' issuance of the LOA would violate the NEPA, and that NMFS should prepare a Programmatic EIS (PEIS).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS originally declared its intent to prepare a PEIS for oil and gas activities in Cook Inlet, Alaska (79 FR 61616; October 14, 2014). However, in a 2017 
                        <E T="04">Federal Register</E>
                         notice (82 FR 41939; September 5, 2017), NMFS indicated that due to a reduced number of Incidental Take Authorization (ITA) requests in the region, combined with funding constraints at that time, we were postponing any potential preparation of a PEIS for oil and gas activities in Cook Inlet. As stated in the 2017 
                        <E T="04">Federal Register</E>
                         notice, should the number of ITA requests, or anticipated requests, noticeably increase, NMFS will re-evaluate whether preparation of a PEIS is necessary. Currently, the number of ITA requests for activities that may affect marine mammals in Cook Inlet is at such a level that preparation of a PEIS is not yet necessary. Nonetheless, under NEPA, NMFS is required to consider cumulative effects of other potential activities in the same geographic area, and these are discussed in greater detail in FERC's Alaska LNG Project Final Environmental Impact Statement (FERC, 2020), which NMFS adopted.
                    </P>
                    <P>
                        <E T="03">Comment 27:</E>
                         DoW requests NMFS defer the comment period for the Proposed Rule until later in the EIS process, when additional relevant information could be available for NMFS and public review, or reopen a public comment period before finalizing the rulemaking on its own determination that additional relevant information has become available.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         When evaluating the AGDC's petition to take marine mammal incidental to its proposed construction of LNG facilities in Cook Inlet, Alaska, NMFS has conducted thorough review of the scope of the proposed activities and the level of potential impacts to marine mammals. In doing so, NMFS consulted internally with its experts who have the best scientific information on the species and their habitat. A Proposed Rule is published for public comment only when NMFS is convinced that it has all relevant information to conduct the impact analyses to support preliminary findings pursuant to the statutory standards. While the NEPA analysis will be finalized at a later time, since NMFS is a cooperating agency on the FERC's EIS, NMFS reviewed all the public comments from the EIS as well to inform its final decision. Therefore, in this case, NMFS does not believe there was a need to defer the public comment period, or reopen a public comment period before finalize the rulemaking.
                    </P>
                    <P>
                        <E T="03">Comment 28:</E>
                         DoW states that NMFS' proposed rule did not consider 
                        <PRTPAGE P="50733"/>
                        operational noise associated with the proposed LNG facilities. Citing FERC's DEIS, DoW states that the highest noise levels would occur when there are two LNG carrier ships docked at the facility. DoW states that NMFS should include this additional noise in its analysis.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         The action being considered here is the issuance of a Letter of Authorization under a rulemaking for the incidental take of small numbers of marine mammals that could result from AGDC's proposed construction of LNG facilities in Cook Inlet. Our action does not include the operation of LNG carrier ships in the future. Therefore, potential impacts to marine mammals beyond what were analyzed for AGDC's proposed LNG facilities construction activities were not analyzed, and any takes caused by those activities are not authorized.
                    </P>
                    <P>
                        <E T="03">Comment 29:</E>
                         DoW claims that twelve hours of noise exposure every day from April through October and the take of 7% Cook Inlet beluga whales should not be considered a negligible impact.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not agree with DoW's conclusion and nor are the assumptions upon which it is based accurate. First, while some of the pile driving activities may occur twelve hours per day, construction activities are expected to be conducted six days a week from April through October. In addition, not all construction activities generate intense underwater noise, and most of the in-water pile driving activities would not last for 12 hours per day. Furthermore, as marine mammals move around Cook Inlet, animals would only be exposed to in-water construction noise when they are present in the area. Finally, the negligible impact determination considers relevant biological and contextual factors, 
                        <E T="03">i.e.,</E>
                         the anticipated impacts to the individuals and the stock, of the take authorized, as described in details in the Proposed Rule (84 FR 39901; June 28, 2019).
                    </P>
                    <P>
                        <E T="03">Comment 30:</E>
                         The EIA expressed concern about potential renewal of the proposed incidental take authorization (IHA).
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         NMFS does not propose to issue nor renew an IHA to AGDC for the proposed LNG facility construction in Cook Inlet. EIA may be confused with NMFS proposed issuance of an LOA under a 5-year regulation. The regulations are valid for five years from the date of issuance with a maximum of a five-year Letter of Authorization requested under these regulations. If AGDC wanted to pursue marine mammal take authorization beyond the effective period of these regulations, they would need to apply anew for an IHA or LOA.
                    </P>
                    <P>
                        <E T="03">Comment 31:</E>
                         EIA is concerned that it was not able to comment on the updated version of the LOA application until July 24, 2019, and that the only application available was a previous version dated February 20, 2019. EIA further states that it was difficult to evaluate the project's impact, because the activities described in both documents are roughly similar for each season and estimates rely on the same research for each density estimate, but NMFS estimated a total of 14 beluga takes from Level B harassments from 2020-2025, while AGDC estimated 10 belugas but in different seasons.
                    </P>
                    <P>
                        <E T="03">Response:</E>
                         While reviewers were mistakenly not provided the most up-to-date version of the application, the scope of the project and analytical methods were accurately described and remained the same in later versions. In AGDC's LOA application, it estimated a total of 10 Cook Inlet beluga whale noise exposure by Level B harassment over the 5-year period of the activity but requested for an annual take of 32 animals. In NMFS' analysis, which is using the same methods, we proposed an annual take of 20 beluga whales based on exposure analysis that is adjusted to account for group size.
                    </P>
                    <HD SOURCE="HD1">Changes Between Proposed Rule and Final Rule</HD>
                    <P>Several changes were made after the publication of the proposed rule on June 28, 2019 (84 FR 39931). Those changes resulted from updated marine mammal density and population information, more detailed analyses on potential impacts using refined data sets, and additional mitigation and monitoring measures to minimize impacts. The changes between proposed and final rules are summarized below.</P>
                    <P>Authorized takes of marine mammal species were reduced from 10 species to 5 species. In the proposed rule, NMFS proposed to authorize takes of humpback whale, fin whale, gray whale, beluga whale, killer whale, harbor porpoise, Dall's porpoise, harbor seal, California sea lion, and Steller sea lion. In the final rule, takes of fin whale, gray whale, Dall's porpoise, California sea lion, and Steller sea lion are not authorized because data show that they are not likely to be present and exposed to the construction activities (see Description of Marine Mammals in the Area of Specified Activities section below).</P>
                    <P>Take numbers of marine mammals were updated based on the newest information on population estimates and refined density modeling. Marine mammal density data in the proposed rule were based on NMFS aerial survey in Cook Inlet from 2000 to 2016. In the final rule, additional density from the 2018 aerial survey were also included. In addition, Cook Inlet beluga whale density was further updated based on the latest population estimated that became available in January 2020 (NMFS, 2020), and the take estimate for this species was reanalyzed using a more refined density grid than what was used for the proposed rule. The take number for harbor seals was adjusted based on comments from the Commission and consultation with NMFS National Marine Mammal Laboratory.</P>
                    <P>The final rule also included additional monitoring and mitigation measures to further reduce potential impacts to marine mammals. Many of these measures are based on consideration of public comments. These additional monitoring and mitigation measures include:</P>
                    <P>• Implementing time/area restriction to minimize potential noise exposure to Cook Inlet beluga whales in the Susitna River Delta;</P>
                    <P>• Implementing larger exclusion zones for all in-water construction activities to prevent or reduce Level A harassment for all marine mammals and to prevent Level B harassment for Cook Inlet beluga whales;</P>
                    <P>• Requiring sound source verification (SSV) measurement for in-water pile driving to better understand underwater noise generated from pile driving activities; and</P>
                    <P>• Deploying air bubble curtains to attenuate noise from in-water pile driving if SSV results show a 2-dB reduction of noise from air bubble curtains.</P>
                    <HD SOURCE="HD1">Description of Marine Mammals in the Area of Specified Activities</HD>
                    <P>
                        Sections 4 and 5 of the IHA application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; 
                        <E T="03">www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments</E>
                        ) and more general information about these species (
                        <E T="03">e.g.,</E>
                         physical and behavioral descriptions) may be found on NMFS' website (
                        <E T="03">www.fisheries.noaa.gov/find-species</E>
                        ).
                    </P>
                    <P>
                        Five species that were analyzed in the Proposed Rule (84 FR 39901; June 28, 2019) but since were removed in the 
                        <PRTPAGE P="50734"/>
                        final analysis due to their extralimital presence in the proposed area, based on in depth analysis of NMFS marine mammal aerial survey data (summarized in Shelden 
                        <E T="03">et al.,</E>
                         2017; 2019). These species are: Fin whale (Balaenoptera physalus), gray whale (
                        <E T="03">Eschrichtius robustus</E>
                        ), Dall's porpoise (
                        <E T="03">Phocoenoides dali</E>
                        ), California sea lion (
                        <E T="03">Zalophus californianus</E>
                        ), and Steller sea lion (
                        <E T="03">Eumetopias jubatus</E>
                        ). As take of these species is not anticipated as a result of the proposed activities, these species are not analyzed further in this document.
                    </P>
                    <P>Table 3 summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2019). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no mortality is anticipated or authorized here, PBR is included here as a gross indicator of the status of the species and other threats.</P>
                    <GPOTABLE COLS="7" OPTS="L2,p7,7/8,i1" CDEF="s50,r50,r50,xls30,r40,8,8">
                        <TTITLE>Table 3—Marine Mammals With Potential Presence Within the Project Area</TTITLE>
                        <BOXHD>
                            <CHED H="1">Common name</CHED>
                            <CHED H="1">Scientific name</CHED>
                            <CHED H="1">Stock</CHED>
                            <CHED H="1">
                                ESA/MMPA status;
                                <LI>
                                    strategic (Y/N) 
                                    <SU>1</SU>
                                </LI>
                            </CHED>
                            <CHED H="1">
                                Stock abundance
                                <LI>
                                    (CV, N
                                    <E T="0732">min</E>
                                    , most recent
                                </LI>
                                <LI>
                                    abundance survey) 
                                    <SU>2</SU>
                                </LI>
                            </CHED>
                            <CHED H="1">PBR</CHED>
                            <CHED H="1">
                                Annual
                                <LI>
                                    M/SI 
                                    <SU>3</SU>
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW EXPSTB="06" RUL="s">
                            <ENT I="21">
                                <E T="02">Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales)</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="22">Family Balaenopteridae:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Humpback whale</ENT>
                            <ENT>
                                <E T="03">Megaptera novaneagliae</E>
                            </ENT>
                            <ENT>Western North Pacific</ENT>
                            <ENT>E/D; Y</ENT>
                            <ENT>1,107 (0.300, 865)</ENT>
                            <ENT>3.0</ENT>
                            <ENT>2.6</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Family Delphinidae:</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Killer whale</ENT>
                            <ENT>
                                <E T="03">Orcinus orca</E>
                            </ENT>
                            <ENT>Eastern North Pacific Alaska Resident</ENT>
                            <ENT>-; N</ENT>
                            <ENT>2,347 (NA, 2,347)</ENT>
                            <ENT>24</ENT>
                            <ENT>1</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">
                                Beluga whale 
                                <SU>4</SU>
                            </ENT>
                            <ENT>
                                <E T="03">Delphinapterus leucas</E>
                            </ENT>
                            <ENT>Cook Inlet</ENT>
                            <ENT>E/D; Y</ENT>
                            <ENT>279 (0.06, NA)</ENT>
                            <ENT>unk</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22">Family Phocoenidae (porpoises):</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="03">Harbor porpoise</ENT>
                            <ENT>
                                <E T="03">Phocoena phocoena</E>
                            </ENT>
                            <ENT>Gulf of Alaska</ENT>
                            <ENT>-; N</ENT>
                            <ENT>31,046 (2.14, NA)</ENT>
                            <ENT>unk</ENT>
                            <ENT>72</ENT>
                        </ROW>
                        <ROW EXPSTB="06" RUL="s">
                            <ENT I="21">
                                <E T="02">Order Carnivora—Superfamily Pinnipedia</E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="22">Family Phocidae (earless seals):</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="03">Harbor seal</ENT>
                            <ENT>
                                <E T="03">Phoca vitulina</E>
                            </ENT>
                            <ENT>Cook Inlet/Shelikof Strait</ENT>
                            <ENT>-; N</ENT>
                            <ENT>28,411 (NA, 26,907)</ENT>
                            <ENT>807</ENT>
                            <ENT>107</ENT>
                        </ROW>
                        <TNOTE>
                            <SU>1</SU>
                             Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock.
                        </TNOTE>
                        <TNOTE>
                            <SU>2</SU>
                             NMFS marine mammal stock assessment reports online at: 
                            <E T="03">https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region#reports.</E>
                             CV is coefficient of variation; N
                            <E T="0732">min</E>
                             is the minimum estimate of stock abundance.
                        </TNOTE>
                        <TNOTE>
                            <SU>3</SU>
                             These values, found in NMFS' SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (
                            <E T="03">e.g.,</E>
                             commercial fisheries, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value or range. A CV associated with estimated mortality due to commercial fisheries is presented in some cases.
                        </TNOTE>
                        <TNOTE>
                            <SU>4</SU>
                             Cook Inlet beluga whale population estimates are updated based on Sheldon 
                            <E T="03">et al.</E>
                             (2019).
                        </TNOTE>
                    </GPOTABLE>
                    <P>Marine mammal species that could potentially occur in the proposed construction areas are included in Table 3. Detailed discussion of these species is provided in the LOA application and summary information is provided below.</P>
                    <P>In addition, sea otters may be found in Cook Inlet. However, sea otters are managed by the U.S. Fish and Wildlife Service and are not considered further in this document.</P>
                    <HD SOURCE="HD2">Humpback Whale</HD>
                    <P>The humpback whale is distributed worldwide in all ocean basins. In winter, most humpback whales occur in the subtropical and tropical waters of the Northern and Southern Hemispheres. Humpback whales in the high latitudes of the North Pacific Ocean are seasonal migrants that feed on euphausiids and small schooling fishes (Nemoto, 1957, 1959; Clapham and Mead, 1999). The humpback whale population was considerably reduced as a result of intensive commercial exploitation during the 20th century.</P>
                    <P>
                        The historical summer feeding range of humpback whales in the North Pacific encompassed coastal and inland waters around the Pacific Rim from Point Conception, California, north to the Gulf of Alaska and the Bering Sea, and west along the Aleutian Islands to the Kamchatka Peninsula and into the Sea of Okhotsk and north of the Bering Strait (Zenkovich, 1954; Nemoto, 1957; Tomlin, 1967; Johnson and Wolman, 1984). Historically, the Asian wintering area extended from the South China Sea east through the Philippines, Ryukyu Retto, Ogasawara Gunto, Mariana Islands, and Marmust Islands (Rice, 1998). Humpback whales are currently found throughout this historical range. Most of the current winter range of humpback whales in the North Pacific is relatively well known, with aggregations of whales in Japan, the Philippines, Hawaii, Mexico, and Central America. The winter range includes the main islands of the Hawaiian archipelago, with the greatest concentration along the west side of Maui. In Mexico, the winter breeding range includes waters around the southern part of the Baja California peninsula, the central portions of the Pacific coast of mainland Mexico, and the Revillagigedo Islands off the mainland coast. The winter range also extends from southern Mexico into Central America, including Guatemala, El Salvador, Nicaragua, and Costa Rica (Calambokidis 
                        <E T="03">et al.,</E>
                         2008).
                    </P>
                    <P>
                        Although there is considerable distributional overlap in the humpback whale stocks that use Alaskan waters, the whales seasonally found in lower Cook Inlet are probably of the Central North Pacific stock (Barlow 
                        <E T="03">et al.,</E>
                         2011; Allen and Angliss 2015).
                    </P>
                    <P>
                        Humpback whale use of Cook Inlet has been observed to be confined to Lower Cook Inlet; the whales have been regularly seen near Kachemak Bay during the summer months (Rugh 
                        <E T="03">et al.,</E>
                         2005). There are anecdotal observations of humpback whales as far north as Anchor Point, with recent summer observations extending to Cape Starichkof (Owl Ridge, 2014). Humpback whales will move about their 
                        <PRTPAGE P="50735"/>
                        range. It is possible for a small number of humpback whales to be observed near the Marine Terminal construction area, but they are unlikely to venture north into the proposed Upper Cook Inlet pipeline crossings.
                    </P>
                    <HD SOURCE="HD2">Killer Whale</HD>
                    <P>Killer whales are widely distributed, although they occur in higher densities in colder and more productive waters (Allen and Angliss, 2015). Two different stocks of killer whales inhabit the Cook Inlet region: The Alaska Resident Stock and the Gulf of Alaska, Aleutian Islands, Bering Sea Transient Stock (Allen and Angliss, 2015).</P>
                    <P>
                        Killer whales are occasionally observed in Lower Cook Inlet, especially near Homer and Port Graham (Shelden 
                        <E T="03">et al.,</E>
                         2003; Rugh 
                        <E T="03">et al.,</E>
                         2005). A concentration of sightings near Homer and inside Kachemak Bay may represent high use, or high observer-effort given most records are from a whale-watching venture based in Homer. The few whales that have been photographically identified in Lower Cook Inlet belong to resident groups more commonly found in nearby Kenai Fjords and Prince William Sound (Shelden 
                        <E T="03">et al.,</E>
                         2003). Prior to the 1980s, killer whale sightings in Upper Cook Inlet were very rare (Rugh 
                        <E T="03">et al.,</E>
                         2005). During aerial surveys conducted between 1993 and 2004, killer whales were observed on only three flights, all in the Kachemak and English Bay area (Rugh 
                        <E T="03">et al.,</E>
                         2005). However, anecdotal reports of killer whales feeding on belugas in Upper Cook Inlet began increasing in the 1990s, possibly in response to declines in sea lions and harbor seals elsewhere (Shelden 
                        <E T="03">et al.,</E>
                         2003). Observations of killer whales in beluga summering grounds have been implicated as a possible contributor to decline of Cook Inlet belugas in the 1990s, although the number of confirmed mortalities from killer whales is small (Shelden 
                        <E T="03">et al.,</E>
                         2003). Recent industry monitoring programs only reported a few killer whale sightings (Kendall 
                        <E T="03">et al.,</E>
                         2015). The sporadic movements and small numbers of this species suggest that there is a rare possibility of encountering this whale during Marine Terminal construction and Mainline pipe laying. There is, however, a greater possibility of transiting vessels associated with the Project encountering killer whales during transit through Lower Cook Inlet.
                    </P>
                    <HD SOURCE="HD2">Beluga Whale</HD>
                    <P>
                        The Cook Inlet beluga whale distinct population segment (DPS) is a small, geographically isolated, and genetically distanced population separated from other beluga populations by the Alaska Peninsula (O'Corry-Crowe 
                        <E T="03">et al.,</E>
                         1997). The Cook Inlet beluga DPS was originally estimated at 1,300 whales in 1979 (Calkins, 1989) and has been the focus of management concerns since experiencing a dramatic decline between 1994 and 1998, when the stock declined 47 percent, attributed to overharvesting by subsistence hunting (Mahoney and Shelden, 2000). Prior to subsistence hunting restrictions, harvest was estimated to annually remove 10 to 15 percent of the population (Mahoney and Shelden, 2000). Only five belugas have been harvested since 1999, yet the population has continued to decline. NMFS listed the population as “depleted” in 2000 because of the decline, and as “endangered” under the ESA in 2008 when the population failed to recover following a moratorium on subsistence harvest.
                    </P>
                    <P>In April 2011, NMFS designated critical habitat for Cook Inlet beluga whales (76 FR 20180; April 11, 2011) in two specific areas of Cook Inlet:</P>
                    <P>
                        • 
                        <E T="03">Area 1:</E>
                         All marine waters of Cook Inlet north of a line from the mouth of Threemile Creek (61°08.5′ N, 151°04.4′ W) connecting to Point Possession (61°02.1′ N, 150°24.3′ W), including waters of the Susitna River south of 61°20.0′ N, the Little Susitna River south of 61°18.0′ N, and the Chickaloon River north of 60°53.0′ N; and
                    </P>
                    <P>
                        • 
                        <E T="03">Area 2:</E>
                         All marine waters of Cook Inlet south of a line from the mouth of Threemile Creek (61°08.5′ N, 151°04.4′ W) to Point Possession (61°02.1′ N, 150°24.3′ W) and north of 60°15.0′ N, including waters within 2 nautical miles seaward of mean-high high water (MHHW) along the western shoreline of Cook Inlet between 60°15.0′ N and the mouth of the Douglas River (59°04.0′ N, 153°46.0′ W); all waters of Kachemak Bay east of 151°40.0′ W; and waters of the Kenai River below the Warren Ames bridge at Kenai, Alaska.
                    </P>
                    <P>
                        The Cook Inlet beluga whale population is estimated to have declined from 1,300 animals in the 1970s (Calkins, 1989) to about 340 animals in 2014 (Shelden 
                        <E T="03">et al.,</E>
                         2015). The current population estimate is 279 animals (Shelden 
                        <E T="03">et al.,</E>
                         2019). The precipitous decline documented in the mid-1990s was attributed to unsustainable subsistence practices by Alaska Native hunters (harvest of more than 50 whales per year) (Mahoney and Shelden, 2000). In 2006, a moratorium of the harvest of Cook Inlet beluga whales was agreed upon through a cooperative agreement between the Cook Inlet Marine Mammal Council and NMFS.
                    </P>
                    <P>
                        During late spring, summer, and fall, beluga whales concentrate near the Susitna River mouth, Knik Arm, Turnagain Arm, and Chickaloon Bay (Nemeth 
                        <E T="03">et al.,</E>
                         2007) where they feed on migrating eulachon and salmon (Moore 
                        <E T="03">et al.,</E>
                         2000). Critical Habitat Area 1 reflects this summer distribution. During winter, beluga whales concentrate in deeper waters in the mid-inlet to Kalgin Island, and in the waters along the west shore of Cook Inlet to Kamishak Bay. Although belugas may be found throughout Cook Inlet at any time of year, they generally spend the ice-free months in Upper Cook Inlet and expand their distribution south and into more offshore waters of Upper Cook Inlet in winter. These seasonal movements appear to be related to changes in the physical environment from sea ice and currents and shifts in prey resources (NMFS, 2016). Belugas spend most of their time year-round in the coastal areas of Knik Arm, Turnagain Arm, Susitna Delta, Chickaloon Bay, and Trading Bay (Goetz 
                        <E T="03">et al.,</E>
                         2012). During the open-water months in Upper Cook Inlet (north of the Forelands), beluga whales are typically concentrated near river mouths (Rugh 
                        <E T="03">et al.,</E>
                         2010).
                    </P>
                    <P>
                        Satellite tags from 10 whales tagged from 2000 through 2002 transmitted through the fall, and of those, three tags deployed on adult males transmitted through April and late May. None of the tagged beluga moved south of Chinitna Bay on the western side of Cook Inlet. A review of marine mammal surveys conducted in the Gulf of Alaska from 1936 to 2000 discovered only 31 beluga sightings among 23,000 marine mammal sightings, indicating that very few belugas occur in the Gulf of Alaska outside of Cook Inlet (Laidre 
                        <E T="03">et al.,</E>
                         2000 cited in Allen and Angliss, 2014).
                    </P>
                    <P>
                        Based on these studies, it is anticipated that beluga whales are most likely to occur near the Marine Terminal in moderate densities during the period when sea ice is typically present in Cook Inlet north of the Forelands (December through May; Goetz 
                        <E T="03">et al.,</E>
                         2012). Few belugas may occur near the Marine Terminal during the ice-free period (June through November). Belugas would not be expected to focus their foraging (dive) efforts near the proposed Marine Terminal location. If belugas do forage near the Marine Terminal, their foraging dives are more likely to be long and deep during the sea-ice season (December through May; Goetz 
                        <E T="03">et al.,</E>
                         2012).
                    </P>
                    <P>
                        Beluga whales could be found in the vicinities of the Mainline crossing during summer-fall and the Marine Terminal construction area during 
                        <PRTPAGE P="50736"/>
                        winter. Previous marine mammal surveys conducted between the Beluga River and the West Forelands (Nemeth 
                        <E T="03">et al.,</E>
                         2007; Brueggeman 
                        <E T="03">et al.,</E>
                         2007a, b; Lomac-MacNair 
                        <E T="03">et al.,</E>
                         2013, 2014; Kendall 
                        <E T="03">et al.,</E>
                         2015) suggest that beluga whale numbers near the proposed Mainline MOF on the west side of Cook Inlet and the pipeline landing peak in May and again in October, with few whales observed in the months in between.
                    </P>
                    <P>
                        Beluga whales are expected to occur along the entire portion of the Mainline route within Upper Cook Inlet year-round; but, as discussed previously, beluga distribution is concentrated in mustow coastal waters near Knik Arm, Chickaloon Bay, and Trading Bay during the ice-free season (June through November), and in deeper waters of the Susitna Delta, and offshore between East and West Forelands, and around Fire Island during the sea-ice season (December through May) (Goetz 
                        <E T="03">et al.,</E>
                         2012). Belugas may remain near the Mainline route during the winter (December through May).
                    </P>
                    <P>
                        Belugas forage in the Trading Bay area from June to through November (Goetz 
                        <E T="03">et al.,</E>
                         2012). Belugas may remain near the Mainline route during the winter (December through May) (Goetz 
                        <E T="03">et al.,</E>
                         2012). Belugas would be expected to focus their foraging (dive) efforts near the Trading Bay area during June to November, south of where the proposed Mainline would enter Cook Inlet.
                    </P>
                    <HD SOURCE="HD2">Harbor Porpoise</HD>
                    <P>
                        The Gulf of Alaska harbor porpoise stock is distributed from Cape Suckling to Unimak Pass (Allen and Angliss, 2015). They are found primarily in coastal waters less than 328 feet deep (Hobbs and Waite, 2010) where they feed on Pacific herring (
                        <E T="03">Clupea pallasii</E>
                        ), other schooling fishes, and cephalopods.
                    </P>
                    <P>
                        Although harbor porpoises have been frequently observed during aerial surveys in Cook Inlet, most sightings are of single animals, and the sightings have been concentrated nearshore between Iliamna and Tuxedni bays on the lower west side of Lower Cook Inlet (Rugh 
                        <E T="03">et al.,</E>
                         2005; Shelden 
                        <E T="03">et al.,</E>
                         2013). No harbor porpoises were recorded near Nikiski during NMFS aerial surveys conducted between 1993 and 2012 (Shelden 
                        <E T="03">et al.,</E>
                         2013). Dahlheim 
                        <E T="03">et al.</E>
                         (2000) estimated the 1991 Cook Inlet-wide population at 136 animals. However, they are one of the three marine mammals (besides belugas and harbor seals) regularly seen in Upper Cook Inlet (Nemeth 
                        <E T="03">et al.,</E>
                         2007), especially during spring eulachon and summer salmon runs. Brueggeman 
                        <E T="03">et al.</E>
                         (2007a, b) also reported small numbers of harbor porpoise between Granite Point and the Beluga River. Recent industry monitoring programs in Lower and Middle Cook Inlet reported harbor porpoise sightings in all summer months (Lomac-MacNair 
                        <E T="03">et al.,</E>
                         2013, 2014; Kendall 
                        <E T="03">et al.,</E>
                         2015). Because harbor porpoise have been observed throughout Cook Inlet during the summer months, they represent a species that could be encountered during all phases and locations of construction.
                    </P>
                    <HD SOURCE="HD2">Harbor Seal</HD>
                    <P>Harbor seals inhabit coastal and estuarine waters along the West Coast, including southeast Alaska west through the Gulf of Alaska and Aleutian Islands, in the Bering Sea and Pribilof Islands (Allen and Angliss, 2015). At more than 150,000 animals state-wide, harbor seals are one of the more common marine mammal species in Alaskan waters (Allen and Angliss, 2015). Harbor seals haul out on rocks, reefs, beaches, and drifting glacial ice (Allen and Angliss, 2015).</P>
                    <P>
                        Large numbers of harbor seals concentrate at the river mouths and embayments of Lower Cook Inlet, including the Fox River mouth in Kachemak Bay (Rugh 
                        <E T="03">et al.,</E>
                         2005). Montgomery 
                        <E T="03">et al.</E>
                         (2007) recorded over 200 haulout sites in Lower Cook Inl
                        <E T="03">et al</E>
                        one. However, only a few hundred seals seasonally occur in Upper Cook Inlet (Rugh 
                        <E T="03">et al.,</E>
                         2005; Shelden 
                        <E T="03">et al.,</E>
                         2013), mostly at the mouth of the Susitna River where their numbers vary in concert with the spring eulachon and summer salmon runs (Nemeth 
                        <E T="03">et al.,</E>
                         2007; Boveng 
                        <E T="03">et al.,</E>
                         2012). In 2012, up to 83 harbor seals were observed hauled out at the mouths of the Theodore and Lewis rivers during April to May monitoring activity associated with a Cook Inlet seismic program (Brueggeman, 2007a). Montgomery 
                        <E T="03">et al.</E>
                         (2007) also found seals elsewhere in Cook Inlet to move in response to local steelhead (
                        <E T="03">Onchorhynchus mykiss</E>
                        ) and salmon runs. Recent industry monitoring programs in Lower and Middle Cook Inlet reported harbor seal sightings in all summer months, both in-water and on haulouts (Lomac-MacNair 
                        <E T="03">et al.,</E>
                         2013, 2014; Kendall 
                        <E T="03">et al.,</E>
                         2015). During summer, small numbers of harbor seals are expected to occur near the Marine Terminal construction area near Nikiski, and along the proposed Mainline pipeline crossing route.
                    </P>
                    <HD SOURCE="HD2">Marine Mammal Hearing</HD>
                    <P>
                        Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (
                        <E T="03">e.g.,</E>
                         Richardson 
                        <E T="03">et al.,</E>
                         1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall 
                        <E T="03">et al.</E>
                         (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes (
                        <E T="03">i.e.,</E>
                         low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 dB threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall 
                        <E T="03">et al.</E>
                         (2007) retained. The functional groups and the associated frequencies are indicated below (note that these frequency ranges correspond to the range for the composite group, with the entire range not necessarily reflecting the capabilities of every species within that group):
                    </P>
                    <P>• Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz;</P>
                    <P>• Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz;</P>
                    <P>
                        • High-frequency cetaceans (porpoises, river dolphins, and members of the genera 
                        <E T="03">Kogia</E>
                         and 
                        <E T="03">Cephalorhynchus;</E>
                         including two members of the genus 
                        <E T="03">Lagenorhynchus,</E>
                         on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz;
                    </P>
                    <P>• Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 Hz to 86 kHz; and</P>
                    <P>• Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz.</P>
                    <P>
                        The pinniped functional hearing group was modified from Southall 
                        <E T="03">et al.</E>
                         (2007) on the basis of data indicating 
                        <PRTPAGE P="50737"/>
                        that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä 
                        <E T="03">et al.,</E>
                         2006; Kastelein 
                        <E T="03">et al.,</E>
                         2009; Reichmuth and Holt, 2013).
                    </P>
                    <P>
                        For more detail concerning these groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Five marine mammal species (4 cetacean and 1 pinniped (phocid) species) have the reasonable potential to co-occur with the proposed construction activities. Please refer to Table 3. Of the cetacean species that may be present, one species is classified as low-frequency cetaceans (
                        <E T="03">i.e.,</E>
                         humpback whale), two are classified as mid-frequency cetaceans (killer and beluga whales), and one is classified as high-frequency cetaceans (
                        <E T="03">i.e.,</E>
                         harbor porpoise).
                    </P>
                    <HD SOURCE="HD1">Potential Effects of Specified Activities on Marine Mammals and Their Habitat</HD>
                    <P>
                        This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The 
                        <E T="03">Estimated Take by Incidental Harassment</E>
                         section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take by Incidental Harassment section, and the Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks.
                    </P>
                    <P>Potential impacts to marine mammals from the Alaska LNG project are from noise generated during in-water pile driving and anchor handling activities.</P>
                    <HD SOURCE="HD2">Acoustic Effects</HD>
                    <P>Acoustic effects to marine mammals from the proposed Alaska LNG facilities construction mainly include behavioral disturbances and temporary masking of animals in the area. A few individual animals could experience mild levels of temporary and/or permanent hearing threshold shift.</P>
                    <P>The AGDC's LNG facilities construction project using in-water pile driving and anchor handling during trenching and pipe laying could adversely affect marine mammal species and stocks by exposing them to elevated noise levels in the vicinity of the activity area.</P>
                    <P>
                        <E T="03">Threshold Shift (noise-induced loss of hearing)</E>
                        —Exposure to high intensity sound for a sufficient duration may result in auditory effects such as a noise-induced threshold shift (TS)—an increase in the auditory threshold after exposure to noise (Finneran 
                        <E T="03">et al.,</E>
                         2005). Factors that influence the amount of threshold shift include the amplitude, duration, frequency content, temporal pattern, and energy distribution of noise exposure. The magnitude of hearing threshold shift normally decreases over time following cessation of the noise exposure. The amount of TS just after exposure is the initial TS. If the TS eventually returns to zero (
                        <E T="03">i.e.,</E>
                         the threshold returns to the pre-exposure value), it is a temporary threshold shift (TTS) (Southall 
                        <E T="03">et al.,</E>
                         2007). When animals exhibit reduced hearing sensitivity (
                        <E T="03">i.e.,</E>
                         sounds must be louder for an animal to detect them) following exposure to an intense sound or sound for long duration, it is referred to as a noise-induced TS. An animal can experience TTS or permanent threshold shift (PTS). TTS can last from minutes or hours to days (
                        <E T="03">i.e.,</E>
                         there is complete recovery), can occur in specific frequency ranges (
                        <E T="03">i.e.,</E>
                         an animal might only have a temporary loss of hearing sensitivity between the frequencies of 1 and 10 kHz), and can be of varying amounts (for example, an animal's hearing sensitivity might be reduced initially by only 6 dB or reduced by 30 dB). PTS is permanent, but some recovery is possible. PTS can also occur in a specific frequency range and amount as mentioned above for TTS.
                    </P>
                    <P>
                        For marine mammals, published data are limited to the captive bottlenose dolphin, beluga, harbor porpoise, and Yangtze finless porpoise (Finneran, 2015). For pinnipeds in water, data are limited to measurements of TTS in harbor seals, an elephant seal, and California sea lions (Kastak 
                        <E T="03">et al.,</E>
                         1999, 2005; Kastelein 
                        <E T="03">et al.,</E>
                         2012b).
                    </P>
                    <P>
                        Lucke 
                        <E T="03">et al.</E>
                         (2009) found a TS of a harbor porpoise after exposing it to airgun noise with a received sound pressure level (SPL) at 200.2 dB (peak-to-peak) re: 1 micropascal (μPa), which corresponds to a sound exposure level (SEL) of 164.5 dB re: 1 μPa
                        <SU>2</SU>
                         s after integrating exposure. Because the airgun noise is a broadband impulse, one cannot directly determine the equivalent of root mean square (rms) SPL from the reported peak-to-peak SPLs. However, applying a conservative conversion factor of 16 dB for broadband signals from seismic surveys (McCauley, 
                        <E T="03">et al.,</E>
                         2000) to correct for the difference between peak-to-peak levels reported in Lucke 
                        <E T="03">et al.</E>
                         (2009) and rms SPLs, the rms SPL for TTS would be approximately 184 dB re: 1 μPa, and the received levels associated with PTS (Level A harassment) would be higher. Therefore, based on these studies, NMFS recognizes that TTS of harbor porpoises is lower than other cetacean species empirically tested (Finneran &amp; Schlundt, 2010; Finneran 
                        <E T="03">et al.,</E>
                         2002; Kastelein and Jennings, 2012).
                    </P>
                    <P>
                        Marine mammal hearing plays a critical role in communication with conspecifics, and interpretation of environmental cues for purposes such as predator avoidance and prey capture. Depending on the degree (elevation of threshold in dB), duration (
                        <E T="03">i.e.,</E>
                         recovery time), and frequency range of TTS, and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to serious (similar to those discussed in auditory masking, below). For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that occurs during a time where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during time when communication is critical for successful mother/calf interactions could have more serious impacts. Also, depending on the degree and frequency range, the effects of PTS on an animal could range in severity, although it is considered generally more serious because it is a permanent condition. Of note, reduced hearing sensitivity as a simple function of aging has been observed in marine mammals, as well as humans and other taxa (Southall 
                        <E T="03">et al.,</E>
                         2007), so one can infer that strategies exist for coping with this condition to some degree, though likely not without cost.
                    </P>
                    <P>
                        <E T="03">Masking</E>
                        —In addition, chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals, which utilize sound for vital biological functions (Clark 
                        <E T="03">et al.,</E>
                         2009). Acoustic masking is when other noises such as from human sources interfere with animal detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction.
                    </P>
                    <P>
                        Masking occurs at the frequency band that the animals utilize. Therefore, since noise generated from vibratory pile driving is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds 
                        <PRTPAGE P="50738"/>
                        by odontocetes (toothed whales). However, lower frequency man-made noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. It may also affect communication signals when they occur near the noise band and thus reduce the communication space of animals (
                        <E T="03">e.g.,</E>
                         Clark 
                        <E T="03">et al.,</E>
                         2009) and cause increased stress levels (
                        <E T="03">e.g.,</E>
                         Foote 
                        <E T="03">et al.,</E>
                         2004; Holt 
                        <E T="03">et al.,</E>
                         2009).
                    </P>
                    <P>Unlike TS, masking, which can occur over large temporal and spatial scales, can potentially affect the species at population, community, or even ecosystem levels, as well as individual levels. Masking affects both senders and receivers of the signals and could have long-term chronic effects on marine mammal species and populations. Recent science suggests that low frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, and most of these increases are from distant shipping (Hildebrand, 2009). For AGDC's LNG facilities construction project, noises from pile driving contribute to the elevated ambient noise levels in the project area, thus increasing potential for or severity of masking. Baseline ambient noise levels in the vicinity of project area are high due to ongoing shipping, construction and other activities in Cook Inlet.</P>
                    <P>
                        <E T="03">Behavioral Disturbance</E>
                        —Finally, marine mammals' exposure to certain sounds could lead to behavioral disturbance (Richardson 
                        <E T="03">et al.,</E>
                         1995), such as changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where noise sources are located; and/or flight responses (
                        <E T="03">e.g.,</E>
                         pinnipeds flushing into water from haulouts or rookeries).
                    </P>
                    <P>
                        The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography) and is also difficult to predict (Southall 
                        <E T="03">et al.,</E>
                         2007). Currently NMFS uses a received level of 160 dB re 1 μPa (rms) to predict the onset of behavioral disturbance from impulse noises (such as impact pile driving), and 120 dB re 1 μPa (rms) for continuous noises (such as vibratory pile driving). For the AGDC's LNG facilities construction project, both 160- and 120-dB levels are considered for effects analysis because AGDC plans to conduct both impact and vibratory pile driving.
                    </P>
                    <P>The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification could be biologically significant if the change affects growth, survival, and/or reproduction, which depends on the severity, duration, and context of the effects.</P>
                    <HD SOURCE="HD2">Potential Effects on Marine Mammal Habitat</HD>
                    <P>Project activities that could potentially impact marine mammal habitats by causing acoustical injury to prey resources and disturbing benthic habitat include dredging/trenching, disposal of dredged material, and facility installation, as well as impacting marine mammal prey from noise generated by in-water pile driving.</P>
                    <P>Approximately 42 hectares (103 acres) would be disturbed directly by dredging of the Marine Terminal MOF and trenching for the Mainline crossing, and another 486 hectares (1,200 acres) would be disturbed by the disposal of dredged material. Approximately 26 hectares (64 acres) of seafloor would be disturbed by installation of the Marine Terminal MOF, Mainline MOF, and Mainline Crossing. Additional area would be indirectly affected by the re-deposition of sediments suspended in the water column by the dredging/trenching and dredge disposal. However, such disturbances are expected to be temporary and mild. Recovery and re-colonization of the benthic habitat are expected to occur as soon as any anthropogenic stressors are removed.</P>
                    <P>
                        With regard to fish as a prey source for cetaceans and pinnipeds, fish are known to hear and react to sounds and to use sound to communicate (Tavolga 
                        <E T="03">et al.,</E>
                         1981) and possibly avoid predators (Wilson and Dill, 2002). Experiments have shown that fish can sense both the strength and direction of sound (Hawkins, 1981). Primary factors determining whether a fish can sense a sound signal, and potentially react to it, are the frequency of the signal and the strength of the signal in relation to the natural background noise level.
                    </P>
                    <P>
                        The level of sound at which a fish will react or alter its behavior is usually well above the detection level. Fish have been found to react to sounds when the sound level increased to about 20 dB above the detection level of 120 dB (Ona, 1988); however, the response threshold can depend on the time of year and the fish's physiological condition (Engas 
                        <E T="03">et al.,</E>
                         1993). In general, fish react more strongly to pulses of sound (such as noise from impact pile driving) rather than continuous signals (such as noise from vibratory pile driving) (Blaxter 
                        <E T="03">et al.,</E>
                         1981), and a quicker alarm response is elicited when the sound signal intensity rises rapidly compared to sound rising more slowly to the same level.
                    </P>
                    <P>During the Alaska LNG facilities construction, only a small fraction of the available habitat would be ensonified at any given time. Disturbance to fish species would be short-term, and fish would return to their pre-disturbance behavior once the pile driving activity ceases. Thus, the proposed construction would have little, if any, impact on marine mammals' prey availability in the area where construction work is planned.</P>
                    <HD SOURCE="HD1">Estimated Take</HD>
                    <P>This section provides an estimate of the number of incidental takes authorized through the LOA under the rulemaking, which will inform both NMFS' consideration of “small numbers” and the negligible impact determination. We note several changes that have been made to this section since the Proposed Rule was published, including: The density of beluga whales used for take estimation has changed; take methodologies and estimates for Cook Inlet beluga whale and harbor seal have changed for Level B harassment. These changes are described in more detail below. In addition, take of fin whale, grey whale, Dall's porpoise, California sea lion, and Steller sea lion is no longer proposed for authorization because these species are unlikely to occur in the AGDC's LNG facilities construction area in Cook Inlet. This is explained in the Description of Marine Mammals in the Area of Specified Activities section above.</P>
                    <P>Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).</P>
                    <P>
                        Authorized takes would primarily be by Level B harassment, as noise 
                        <PRTPAGE P="50739"/>
                        generated from in-water pile driving (vibratory and impact) and anchor handling has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for low- and high-frequency cetacean species and phocids because predicted auditory injury zones are larger than for mid-frequency cetacean species. Auditory injury is unlikely to occur for mid-frequency cetacean species. The prescribed mitigation and monitoring measures are expected to minimize the severity of such taking to the extent practicable.
                    </P>
                    <P>As described previously, no serious injury or mortality is anticipated or authorized for this activity. Below we describe how the take is estimated.</P>
                    <P>
                        Generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally disturbed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. We note that while these basic factors can contribute to a basic calculation to provide an initial prediction of takes, additional information that can qualitatively inform take estimates is also sometimes available (
                        <E T="03">e.g.,</E>
                         previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the proposed take estimate. 
                    </P>
                    <HD SOURCE="HD2">Acoustic Thresholds</HD>
                    <P>Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to experience behavioral disturbance (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).</P>
                    <P>
                        <E T="03">Level B Harassment for non-explosive sources</E>
                        —Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (
                        <E T="03">e.g.,</E>
                         frequency, predictability, duty cycle), the environment (
                        <E T="03">e.g.,</E>
                         bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall 
                        <E T="03">et al.,</E>
                         2007, Ellison 
                        <E T="03">et al.,</E>
                         2012). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of Level B harassment. NMFS predicts that marine mammals are likely to experience behavioral disturbance in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa (rms) for continuous (
                        <E T="03">e.g.,</E>
                         vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (
                        <E T="03">e.g.,</E>
                         seismic airguns) or intermittent (
                        <E T="03">e.g.,</E>
                         scientific sonar) sources.
                    </P>
                    <P>Because AGDC's Alaska LNG facilities project involves the generation of non-impulsive (vibratory pile driving and anchor handling) and impulsive (impact pile driving) sources, both 120 and 160 dB re 1 μPa (rms) thresholds are used to evaluate Level B harassment as explained above.</P>
                    <P>
                        <E T="03">Level A harassment for non-explosive sources</E>
                        —NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). AGDC's Alaska LNG facilities project involves the generation of impulsive (impact pile driving) and non-impulsive (vibratory pile driving and anchor handling) sources.
                    </P>
                    <P>
                        These thresholds are provided in the Table 4 below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: 
                        <E T="03">http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.</E>
                    </P>
                    <GPOTABLE COLS="5" OPTS="L2,i1" CDEF="s50,r25,r25,r25,r25">
                        <TTITLE>Table 4—Thresholds Identifying the Onset of Permanent Threshold Shift</TTITLE>
                        <BOXHD>
                            <CHED H="1">Hearing group</CHED>
                            <CHED H="1">PTS onset thresholds</CHED>
                            <CHED H="2">Impulsive</CHED>
                            <CHED H="2">Non-impulsive</CHED>
                            <CHED H="1">Behavioral thresholds</CHED>
                            <CHED H="2">Impulsive</CHED>
                            <CHED H="2">Non-impulsive</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Low-Frequency (LF) Cetaceans</ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">pk,flat</E>
                                <E T="03">:</E>
                                 219 dB; 
                                <E T="03">L</E>
                                <E T="0732">E,LF,24h</E>
                                <E T="03">:</E>
                                 183 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">E,LF,24h</E>
                                <E T="03">:</E>
                                 199 dB
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Mid-Frequency (MF) Cetaceans</ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">pk,flat</E>
                                <E T="03">:</E>
                                 230 dB; 
                                <E T="03">L</E>
                                <E T="0732">E,MF,24h</E>
                                <E T="03">:</E>
                                 185 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">E,MF,24h</E>
                                <E T="03">:</E>
                                 198 dB
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">High-Frequency (HF) Cetaceans</ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">pk,flat</E>
                                <E T="03">:</E>
                                 202 dB; 
                                <E T="03">L</E>
                                <E T="0732">E,HF,24h</E>
                                <E T="03">:</E>
                                 155 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">E,HF,24h</E>
                                <E T="03">:</E>
                                 173 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">rms,flat</E>
                                <E T="03">:</E>
                                 160 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">rms,flat</E>
                                <E T="03">:</E>
                                 120 dB.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Phocid Pinnipeds (PW) (Underwater)</ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">pk,flat</E>
                                <E T="03">:</E>
                                 218 dB; 
                                <E T="03">L</E>
                                <E T="0732">E,PW,24h</E>
                                <E T="03">:</E>
                                 185 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">E,PW,24h</E>
                                <E T="03">:</E>
                                 201 dB
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Otariid Pinnipeds (OW) (Underwater)</ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">pk,flat</E>
                                <E T="03">:</E>
                                 232 dB; 
                                <E T="03">L</E>
                                <E T="0732">E,OW,24h</E>
                                <E T="03">:</E>
                                 203 dB
                            </ENT>
                            <ENT>
                                <E T="03">L</E>
                                <E T="0732">E,OW,24h</E>
                                <E T="03">:</E>
                                 219 dB
                            </ENT>
                        </ROW>
                        <TNOTE>* Dual metric acoustic thresholds for impulsive sounds: Use whichever results in the largest isopleth for calculating PTS onset. If a non-impulsive sound has the potential of exceeding the peak sound pressure level thresholds associated with impulsive sounds, these thresholds should also be considered.</TNOTE>
                        <TNOTE>
                            <E T="02">Note:</E>
                             Peak sound pressure (L
                            <E T="0732">pk</E>
                            ) has a reference value of 1 μPa, and cumulative sound exposure level (LE) has a reference value of 1 μPa2s. In this Table, thresholds are abbreviated to reflect American National Standards Institute standards (ANSI 2013). However, peak sound pressure is defined by ANSI as incorporating frequency weighting, which is not the intent for this Technical Guidance. Hence, the subscript “flat” is being included to indicate peak sound pressure should be flat weighted or unweighted within the generalized hearing range. The subscript associated with cumulative sound exposure level thresholds indicates the designated marine mammal auditory weighting function (LF, MF, and HF cetaceans, and PW and OW pinnipeds) and that the recommended accumulation period is 24 hours. The cumulative sound exposure level thresholds could be exceeded in a multitude of ways (
                            <E T="03">i.e.,</E>
                             varying exposure levels and durations, duty cycle). When possible, it is valuable for action proponents to indicate the conditions under which these acoustic thresholds will be exceeded.
                        </TNOTE>
                    </GPOTABLE>
                    <PRTPAGE P="50740"/>
                    <HD SOURCE="HD2">Ensonified Area</HD>
                    <P>Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds, which include source levels and transmission loss coefficient.</P>
                    <HD SOURCE="HD3">Source Levels</HD>
                    <P>The project includes impact pile driving and vibratory pile driving and anchor handling associated with trenching and cable laying activities. Source levels of pile driving activities are based on reviews of measurements of the same or similar types and dimensions of piles available in the literature (Caltrans, 2015). Based on this review, the following source levels are assumed for the underwater noise produced by construction activities:</P>
                    <P>• Source levels of impact driving of 18- and 24-inch steel piles are based on those of 24-inch steel pile impact driving reported by California Department of Transportation (Caltrans) in a pile driving source level compendium document (Caltrans, 2015);</P>
                    <P>• Source level of impact driving of 60-inch steel pile is based on that of same type and size of steel pile reported in the Caltrans compendium document (Caltrans, 2015) in shallow-water (5 m);</P>
                    <P>
                        • Source levels of impact driving of 48-inch steel pile is based on that of same type and size of steel pile reported by Austin 
                        <E T="03">et al.</E>
                         (2016) on the Anchorage Port Modernization Project Test Pile Program in water depth 18 m;
                    </P>
                    <P>• Source level of impact pile driving of steel sheet pile is based on that of 24-in steel AZ sheet pile impact driving reported in the Caltrans compendium (Caltrans, 2015);</P>
                    <P>• Source levels of vibratory pile driving of 18- and 24-in steel piles are based on that of 36-inch steel pile vibratory driving reported in the Caltrans compendium (Caltrans, 2015);</P>
                    <P>• Source levels of vibratory pile driving of 48- and 60-in steel piles are based on that of 72-inch steel pile vibratory driving reported in the Caltrans compendium (Caltrans, 2015);</P>
                    <P>• Source level of vibratory pile driving of steel sheet pile is based on that of 24-in steel AZ sheet pile vibratory driving reported in the Caltrans compendium (Caltrans, 2015); and</P>
                    <P>• Underwater sound levels associated with offshore pipe laying and trenching operations when engaging thrusters and anchor handling were based on measurements by Blackwell and Greene (2003) of a tug pushing a full barge near the Port of Alaska when engaging thrusters during docking. The levels are calculated from measured 149 dB re 1 μPa rms at 100 meters/328 feet applying 15*log(r), which yield a source level of 178.9 dB re 1 μPa rms at 1 meter.</P>
                    <P>A summary of source levels from different pile driving activities is provided in Table 5.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,r40,12,12,14,r40">
                        <TTITLE>Table 5—Summary of In-Water Pile Driving Source Levels</TTITLE>
                        <TDESC>[At 10 m from source]</TDESC>
                        <BOXHD>
                            <CHED H="1">Method</CHED>
                            <CHED H="1">Pile type/size</CHED>
                            <CHED H="1">
                                SPL
                                <E T="0732">pk</E>
                                <LI>(dB re 1 µPa)</LI>
                            </CHED>
                            <CHED H="1">
                                SPL
                                <E T="0732">rms</E>
                                <LI>(dB re 1 µPa)</LI>
                            </CHED>
                            <CHED H="1">
                                SEL
                                <LI>
                                    (dB re 1 µPa
                                    <SU>2</SU>
                                    -s)
                                </LI>
                            </CHED>
                            <CHED H="1">Reference</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact driving</ENT>
                            <ENT>18-in steel pipe pile</ENT>
                            <ENT>207</ENT>
                            <ENT>194</ENT>
                            <ENT>178</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact driving</ENT>
                            <ENT>24-in steel pipe pile</ENT>
                            <ENT>207</ENT>
                            <ENT>194</ENT>
                            <ENT>178</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact driving</ENT>
                            <ENT>48-in steel pipe pile</ENT>
                            <ENT>210</ENT>
                            <ENT>200</ENT>
                            <ENT>185</ENT>
                            <ENT>
                                Austin 
                                <E T="03">et al.</E>
                                 2016.
                            </ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact driving</ENT>
                            <ENT>60-in steel pipe pile</ENT>
                            <ENT>210</ENT>
                            <ENT>195</ENT>
                            <ENT>185</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact driving</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>205</ENT>
                            <ENT>190</ENT>
                            <ENT>180</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory driving</ENT>
                            <ENT>18-in steel pipe pile</ENT>
                            <ENT>180</ENT>
                            <ENT>170</ENT>
                            <ENT>170</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory driving</ENT>
                            <ENT>24-in steel pipe pile</ENT>
                            <ENT>180</ENT>
                            <ENT>170</ENT>
                            <ENT>170</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory driving</ENT>
                            <ENT>48-in steel pipe pile</ENT>
                            <ENT>183</ENT>
                            <ENT>170</ENT>
                            <ENT>170</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory driving</ENT>
                            <ENT>60-in steel pipe pile</ENT>
                            <ENT>183</ENT>
                            <ENT>170</ENT>
                            <ENT>170</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory driving</ENT>
                            <ENT>Sheet pile</ENT>
                            <ENT>175</ENT>
                            <ENT>160</ENT>
                            <ENT>160</ENT>
                            <ENT>Caltrans 2015.</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling and thruster</ENT>
                            <ENT/>
                            <ENT>NA</ENT>
                            <ENT>178.9</ENT>
                            <ENT>178.9</ENT>
                            <ENT>Blackwell &amp; Greene 2003.</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>These source levels are used to compute the Level A harassment zones and to estimate the Level B harassment zones.</P>
                    <HD SOURCE="HD2">Estimating Injury Zones</HD>
                    <P>When the NMFS' Technical Guidance (2016) was published, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which may result in some degree of overestimate of Level A harassment take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. In the prior analysis for the Proposed Rule, AGDC used NMFS User Spreadsheet and simple geometric spreading model with transmission loss coefficient 15 to calculate Level A and Level B harassment distances, respectively. However, after the public comment period, in response to NMFS' concern of needing a more sophisticated acoustic model to have estimates of the expected ensonified zones, AGDC contracted SLR Corporation to perform a quantitative noise modeling assessment to identify the ensonified distances and areas. Using the dBSea software package, this modeling incorporates one-third octave band spectral sound level for each of the sources, bathymetry for each project location, water depth, sound speed profiles (temperature and salinity for both spring and summer profiles), and seafloor characteristics.</P>
                    <P>
                        Specifically, pile driving noise was modelled as a single stationary, omni-directional point source in each of the three main construction areas (PLF, Temporary MOF, and Mainline MOF) for each pile and hammer type. Source spectral shape information for each noise source and location were used from other studies. All piling sources were assumed to be located midway down the water column. Noise associated with anchor handling during pipe laying is represented as a series of five points on a line along the route, assuming a depth midway in the water 
                        <PRTPAGE P="50741"/>
                        column (see Figure 12 of AGDC LOA application).
                    </P>
                    <P>Modelling for this assessment used the dBSea software package. The fluid parabolic equation modelling algorithm has been used with 5 Padé terms to calculate the transmission loss between the source and the receiver at low frequencies (16 Hz up to 1 kHz). For higher frequencies (1 kHz up to 8 kHz) the ray tracing model has been used with 1000 reflections for each ray.</P>
                    <P>The received noise levels throughout the project have been calculated following the procedure outlined below:</P>
                    <P>• One-third octave source spectral levels are obtained via reference spectral curves with subsequent corrections based on their corresponding overall source levels;</P>
                    <P>• Transmission loss is modelled at one-third octave band central frequencies along 100 radial paths at regular increments around each source location, out to the maximum range of the bathymetry data set or until constrained by land;</P>
                    <P>• The bathymetry variation of the vertical plane along each modelling path is obtained via interpolation of the bathymetry dataset which has 50 m grid resolution;</P>
                    <P>• The one-third octave source levels and transmission loss are combined to obtain the received levels as a function of range, depth and frequency at 100 m intervals; and</P>
                    <P>• The overall received levels are calculated at a 1-m depth resolution along each propagation path by summing all frequency band spectral levels.</P>
                    <P>
                        The predicted distances to the thresholds and ensonified areas for pile driving and anchor handling are summarized in Table 6. In practice, the distances to the Level A harassment thresholds are controlled by the cumulative sound exposure levels (SEL
                        <E T="52">cum</E>
                        ) within 24 hours.
                    </P>
                    <P>For the low frequency cetaceans (humpback whale), the predicted distances to the Level A harassment distances range from 238 meters for the vibratory driving of sheet piles at the temporary MOF to 3,239 meters for the impact pile diving of 48-inch pipe piles at the temporary MOF. For the mid-frequency cetaceans (beluga and killer whales), the predicted distances to the Level SELs range from 0 to 248 meters for the impact driving of sheet piles at the Mainline MOF. For the high frequency cetaceans (harbor porpoise), the predicted distances to the Level A harassment distances ranges from 0 to 2,350 meters at for impact pile driving of 48-inch and 60-inch pipe piles at the PLF. For phocids (harbor seals), the predicted distances to the Level A harassment distances ranges from 0 to 1,018 meters impact pile driving of 48-inch and 60-inch pipe piles at the PLF.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s100,12,12,12,12,12">
                        <TTITLE>Table 6—Modeled Harassment Zones and Maximum Distances</TTITLE>
                        <BOXHD>
                            <CHED H="1">Activity description</CHED>
                            <CHED H="1">
                                Level A distance (m)
                                <LI>
                                    (Level A area (km
                                    <SU>2</SU>
                                    ))
                                </LI>
                            </CHED>
                            <CHED H="2">LF</CHED>
                            <CHED H="2">MF</CHED>
                            <CHED H="2">HF</CHED>
                            <CHED H="2">PW</CHED>
                            <CHED H="1">
                                Level B
                                <LI>distance (m)</LI>
                                <LI>
                                    (area (km
                                    <SU>2</SU>
                                    ))
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact drive of 48-inch pipe piles at PLF</ENT>
                            <ENT>3,175 (10.914)</ENT>
                            <ENT>211 (0.065)</ENT>
                            <ENT>2,350 (8.703)</ENT>
                            <ENT>1,018 (1.984)</ENT>
                            <ENT>3,593 (13.24)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive of 60-inch pipe piles at PLF</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2,254 (6.39)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive of sheet piles at temporary MOF</ENT>
                            <ENT>238 (0.039)</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>4,377 (18.23)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive of 24-inch pipe piles at temporary MOF</ENT>
                            <ENT>1,639 (2.142)</ENT>
                            <ENT>238 (0.018)</ENT>
                            <ENT>1,762 (3.829)</ENT>
                            <ENT>558 (0.477)</ENT>
                            <ENT>2,271 (3.91)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive of 48-inch pipe piles at temporary MOF</ENT>
                            <ENT>3,239 (7.442)</ENT>
                            <ENT>238 (0.060)</ENT>
                            <ENT>679 (0.585)</ENT>
                            <ENT>955 (0.935)</ENT>
                            <ENT>3,546 (9.21)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive of all size pipe piles at temporary MOF</ENT>
                            <ENT>285 (0.125)</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>246 (0.012)</ENT>
                            <ENT>5,584 (27.70)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive of sheet piles at Mainline MOF</ENT>
                            <ENT>244 (0.055)</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>212 (0.020)</ENT>
                            <ENT>3,179 (14.75)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive of sheet piles at Mainline MOF</ENT>
                            <ENT>1,161 (2.365)</ENT>
                            <ENT>248 (0.058)</ENT>
                            <ENT>896 (1.196)</ENT>
                            <ENT>617 (0.696)</ENT>
                            <ENT>764 (1.13)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling location 1</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>1,896 (8.17)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling location 2</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2,855 (20.67)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling location 3</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2,446 (16.50)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling location 4</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2,349 (15.16)</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling location 5</ENT>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT/>
                            <ENT>2,195 (5.01)</ENT>
                        </ROW>
                        <TNOTE>
                            <E T="03">LF: Low-Frequency Cetaceans; MF: Mid-Frequency Cetaceans; HF: High-Frequency Cetaceans; PW: Phocid Pinnipeds, Underwater; OW: Otariid Pinnipeds, Underwater.</E>
                        </TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD2">Marine Mammal Occurrence</HD>
                    <P>In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.</P>
                    <P>Marine mammal density data in the proposed rule were based on NMFS aerial survey in Cook Inlet from 2000 to 2016. In the final rule, additional density from the 2018 aerial survey were also included.</P>
                    <P>In addition, Cook Inlet beluga whale density was further updated based on the latest population estimated that became available in January 2020 (NMFS, 2020), and take estimate of this species was reanalyzed using a more refined density grid than what was used for the proposed rule (see below). Take numbers for harbor seals were adjusted to account for animals that were hauled out,</P>
                    <P>
                        Density estimates were calculated for marine mammals (except beluga whales) using aerial survey data collected by NMFS in Cook Inlet between 2000 and 2018 (summarized in Shelden 
                        <E T="03">et al.,</E>
                         2017; 2019). To estimate the densities of marine mammals, the total number of animals of each species for each year observed over the 19-year survey period was divided by the total area surveyed each year (Tables 7).
                    </P>
                    <P>Table 7 summarizes the number of marine mammals, other than beluga whales, observed each year during the NMFS Annual Aerial Surveys and the area covered. To calculate a conservative density for exposure estimation, the total number of individuals per species observed in each survey year was divided by the area covered during that year and then averaged across all years. The total number of animals observed accounts for the entire Cook Inlet, so these densities may not be representative of the expected densities at Project locations. The raw densities were not corrected for animals missed during the aerial surveys as no accurate correction factors are currently available for these species except for harbor seal.</P>
                    <P>
                        For harbor seal take estimates, density numbers were adjusted using a correction factor of 2.33 from Boveng 
                        <E T="03">et al.</E>
                         (2012) to revise the yearly abundance estimates and resulting density estimates and recalculate the number of takes accordingly.
                        <PRTPAGE P="50742"/>
                    </P>
                    <P>The averaged marine mammal densities other than beluga whale is provided in Table 8.</P>
                    <GPOTABLE COLS="17" OPTS="L2,p6,6/7,i1" CDEF="s25,6,6,6,6,6,6,6,6,6,6,6,6,6,6,6,6">
                        <TTITLE>Table 7—Sighting and Densities of Marine Mammals Other Than Beluga Whale During NMFS Aerial Survey Between 2000 and 2018</TTITLE>
                        <BOXHD>
                            <CHED H="1">Species</CHED>
                            <CHED H="1">2000</CHED>
                            <CHED H="1">2001</CHED>
                            <CHED H="1">2002</CHED>
                            <CHED H="1">2003</CHED>
                            <CHED H="1">2004</CHED>
                            <CHED H="1">2005</CHED>
                            <CHED H="1">2006</CHED>
                            <CHED H="1">2007</CHED>
                            <CHED H="1">2008</CHED>
                            <CHED H="1">2009</CHED>
                            <CHED H="1">2010</CHED>
                            <CHED H="1">2011</CHED>
                            <CHED H="1">2012</CHED>
                            <CHED H="1">2014</CHED>
                            <CHED H="1">2016</CHED>
                            <CHED H="1">2018</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Humpback whale</E>
                            </ENT>
                            <ENT>11</ENT>
                            <ENT>26</ENT>
                            <ENT>20</ENT>
                            <ENT>20</ENT>
                            <ENT>16</ENT>
                            <ENT>18</ENT>
                            <ENT>14</ENT>
                            <ENT>3</ENT>
                            <ENT>7</ENT>
                            <ENT>5</ENT>
                            <ENT>2</ENT>
                            <ENT>9</ENT>
                            <ENT>1</ENT>
                            <ENT>11</ENT>
                            <ENT>6</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Killer whale</E>
                            </ENT>
                            <ENT>0</ENT>
                            <ENT>15</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>33</ENT>
                            <ENT>0</ENT>
                            <ENT>9</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Harbor porpoise</E>
                            </ENT>
                            <ENT>29</ENT>
                            <ENT>26</ENT>
                            <ENT>0</ENT>
                            <ENT>0</ENT>
                            <ENT>101</ENT>
                            <ENT>2</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>6</ENT>
                            <ENT>42</ENT>
                            <ENT>10</ENT>
                            <ENT>31</ENT>
                            <ENT>11</ENT>
                            <ENT>128</ENT>
                            <ENT>17</ENT>
                            <ENT>0</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Harbor seal</E>
                            </ENT>
                            <ENT>1,800</ENT>
                            <ENT>1,485</ENT>
                            <ENT>1,606</ENT>
                            <ENT>974</ENT>
                            <ENT>956</ENT>
                            <ENT>1,087</ENT>
                            <ENT>1,798</ENT>
                            <ENT>1,474</ENT>
                            <ENT>2,037</ENT>
                            <ENT>1,415</ENT>
                            <ENT>1,156</ENT>
                            <ENT>1,811</ENT>
                            <ENT>1,812</ENT>
                            <ENT>2,115</ENT>
                            <ENT>1,909</ENT>
                            <ENT>1,380</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Harbor seal (adjusted)</E>
                            </ENT>
                            <ENT>4,194</ENT>
                            <ENT>3,460</ENT>
                            <ENT>3,742</ENT>
                            <ENT>2,269</ENT>
                            <ENT>2,227</ENT>
                            <ENT>2,533</ENT>
                            <ENT>4,189</ENT>
                            <ENT>3,434</ENT>
                            <ENT>4,746</ENT>
                            <ENT>3,297</ENT>
                            <ENT>2,693</ENT>
                            <ENT>4,220</ENT>
                            <ENT>4,222</ENT>
                            <ENT>4,928</ENT>
                            <ENT>4,448</ENT>
                            <ENT>3,215</ENT>
                        </ROW>
                        <ROW RUL="s">
                            <ENT I="01">
                                Area surveyed (km
                                <SU>2</SU>
                                )
                            </ENT>
                            <ENT>6,911</ENT>
                            <ENT>5,445</ENT>
                            <ENT>5,445</ENT>
                            <ENT>5,236</ENT>
                            <ENT>6,492</ENT>
                            <ENT>5,445</ENT>
                            <ENT>6,702</ENT>
                            <ENT>5,236</ENT>
                            <ENT>7,121</ENT>
                            <ENT>5,864</ENT>
                            <ENT>6,074</ENT>
                            <ENT>6,702</ENT>
                            <ENT>6,283</ENT>
                            <ENT>6,702</ENT>
                            <ENT>8,377</ENT>
                            <ENT>10,471</ENT>
                        </ROW>
                        <ROW EXPSTB="16" RUL="s">
                            <ENT I="21">
                                <E T="02">Density estimates (x10</E>
                                <E T="51">−</E>
                                <E T="02">
                                    3 individuals/km
                                    <SU>2</SU>
                                    )
                                </E>
                            </ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">
                                <E T="03">Humpback whale</E>
                            </ENT>
                            <ENT>1.59</ENT>
                            <ENT>4.78</ENT>
                            <ENT>3.67</ENT>
                            <ENT>3.82</ENT>
                            <ENT>2.46</ENT>
                            <ENT>3.31</ENT>
                            <ENT>2.09</ENT>
                            <ENT>0.57</ENT>
                            <ENT>0.98</ENT>
                            <ENT>0.85</ENT>
                            <ENT>0.33</ENT>
                            <ENT>1.34</ENT>
                            <ENT>0.16</ENT>
                            <ENT>1.64</ENT>
                            <ENT>0.72</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Killer whale</E>
                            </ENT>
                            <ENT>0.00</ENT>
                            <ENT>2.76</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>5.43</ENT>
                            <ENT>0.00</ENT>
                            <ENT>1.43</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Harbor porpoise</E>
                            </ENT>
                            <ENT>4.20</ENT>
                            <ENT>4.78</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.00</ENT>
                            <ENT>15.6</ENT>
                            <ENT>3.67</ENT>
                            <ENT>0.00</ENT>
                            <ENT>0.76</ENT>
                            <ENT>0.84</ENT>
                            <ENT>7.16</ENT>
                            <ENT>1.65</ENT>
                            <ENT>4.63</ENT>
                            <ENT>1.75</ENT>
                            <ENT>19.1</ENT>
                            <ENT>2.03</ENT>
                            <ENT>0.00</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">
                                <E T="03">Harbor seal</E>
                            </ENT>
                            <ENT>607</ENT>
                            <ENT>635</ENT>
                            <ENT>687</ENT>
                            <ENT>433</ENT>
                            <ENT>343</ENT>
                            <ENT>465</ENT>
                            <ENT>625</ENT>
                            <ENT>656</ENT>
                            <ENT>667</ENT>
                            <ENT>562</ENT>
                            <ENT>443</ENT>
                            <ENT>630</ENT>
                            <ENT>672</ENT>
                            <ENT>735</ENT>
                            <ENT>531</ENT>
                            <ENT>307</ENT>
                        </ROW>
                    </GPOTABLE>
                    <GPOTABLE COLS="2" OPTS="L2,i1" CDEF="s25,12">
                        <TTITLE>Table 8—Density Estimates for Marine Mammals Other Than Beluga Whales</TTITLE>
                        <BOXHD>
                            <CHED H="1">Species</CHED>
                            <CHED H="1">
                                Mean density
                                <LI>
                                    (animals/km
                                    <SU>2</SU>
                                    )
                                </LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Humpback whale</ENT>
                            <ENT>0.00177</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Killer whale</ENT>
                            <ENT>0.00060</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Harbor porpoise</ENT>
                            <ENT>0.00439</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Harbor seal</ENT>
                            <ENT>0.56246</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>Beluga whale density estimates were based on the maximum number of beluga whales observed during each survey year of the NMFS Annual Aerial Surveys and the area covered. To estimate beluga densities, the maximum number of belugas observed each survey year was divided by the area covered, and these annual densities were then averaged across all 16 survey years. The survey area can be separated into Upper, Middle, and Lower Cook Inlet, resulting in different densities for beluga whales in each area. Using these combined data for Middle and Lower Cook Inlet, the density for beluga whales using the NMFS Annual Aerial Surveys for all Project components is 0.00050 whales per square kilometer, which is what was used for take estimation in the Proposed Rule.</P>
                    <P>
                        Goetz 
                        <E T="03">et al.</E>
                         (2012) modeled aerial survey data collected by NMFS between 1993 and 2008 and developed beluga whale summer densities for each 1-square-kilometer (0.4-square-mile) cell of Cook Inlet. Given the clumped and distinct distribution of beluga whales in Cook Inlet during the summer months, these results provide a more precise estimate of beluga whale density at a given location than multiplying all aerial observations by the total survey effort. Accordingly, NMFS used more refined density estimates to inform the take calculations in this Final Rule. To develop a density estimate associated with Project components, the GIS files of the predicted ensonified area for both Level A and B associated with each location and pile type, size, and hammer were overlain with the GIS file of the 1-square-kilometer (0.4-square-mile) beluga density cells. The cells falling within each ensonified area were provided in an output spreadsheet, and an average cell density for each Project component was calculated. Table 9 shows beluga density for each project component.
                    </P>
                    <GPOTABLE COLS="3" OPTS="L2,i1" CDEF="s50,14,14">
                        <TTITLE>
                            Table 9—Average Beluga Whale Density (Animals/
                            <E T="01">km</E>
                            <SU>2</SU>
                            ) Within Predicted Level A and Level B Harassment Areas for Each Project Component
                        </TTITLE>
                        <BOXHD>
                            <CHED H="1">Project component</CHED>
                            <CHED H="1">
                                Average density
                                <LI>within Level A</LI>
                                <LI>harassment zone</LI>
                            </CHED>
                            <CHED H="1">
                                Average density
                                <LI>within Level B</LI>
                                <LI>harassment zone</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact drive for 48-inch pipe piles at PLF</ENT>
                            <ENT>0.00004</ENT>
                            <ENT>0.00005</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive for 60-inch pipe piles at PLF</ENT>
                            <ENT>0.00005</ENT>
                            <ENT>0.00005</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive for 24-inch pipe piles at temporary MOF</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00005</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive for 48-inch pipe piles at temporary MOF</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00005</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive for all size pipe piles at temporary MOF</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00005</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive for sheet piles at temporary MOF</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00006</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact drive for sheet piles at Mainline MOF</ENT>
                            <ENT>0.04150</ENT>
                            <ENT>0.04146</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory drive for sheet piles at Mainline MOF</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.03245</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at Location 1</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.02199</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at Location 2</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00180</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at Location 3</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00075</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at Location 4</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00284</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at Location 5</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.02323</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling at all locations</ENT>
                            <ENT>0.00000</ENT>
                            <ENT>0.00551</ENT>
                        </ROW>
                    </GPOTABLE>
                    <HD SOURCE="HD2">Take Calculation and Estimation</HD>
                    <P>Here we describe how the information provided above is brought together to produce a quantitative take estimate. For all marine mammals, estimated takes are calculated based on ensonified area for a specific pile driving activity multiplied by the marine mammal density in the action area, multiplied by the number of pile driving days.</P>
                    <P>For both Level A and Level B harassment, estimated exposure are calculated using the following steps:</P>
                    <P>
                        • Number of takes per activity = density (average number of animals per km
                        <SU>2</SU>
                        ) * area of ZOI (km
                        <SU>2</SU>
                        ) * number of days;
                    </P>
                    <P>
                        • Marine mammal densities in the project area are provided in Tables 8 and 9;
                        <PRTPAGE P="50743"/>
                    </P>
                    <P>• The number of days for each activity component is provided in Table 1; and</P>
                    <P>• Takes by Level A and Level B harassment are calculated separately based on the respective ZOIs for each type of activity, providing a maximum estimate for each type of take which corresponds to the authorization requested under the MMPA.</P>
                    <P>For beluga whale, NMFS considered group size from the long-term scientific monitoring effort and opportunistic observation data at Port of Alaska to determine if these numbers represented realistic scenarios. The Alaska Pacific University (APU) scientific monitoring data set documented 390 beluga whale sightings. Group size exhibits a mode of 1 and a median of 2, indicating that over half of the beluga groups observed over the 5-year span of the monitoring program were of individual beluga whales or pairs. The 95th percentile of group size from the APU scientific monitoring data set is 11.1 beluga whales. This means that, of the 390 documented beluga whale groups in this data set, 95 percent consisted of fewer than 11.1 whales; 5 percent of the groups consisted of more than 11.1 whales. Therefore, a group number of 11 is added to the estimated value to allow for one encounter with a larger group of whales.</P>
                    <P>For killer whale and harbor porpoise, a group number of 3 is added to the estimated value to adjust for estimated takes of these two species.</P>
                    <P>The estimated numbers of instances of acoustic harassment (takes) by year, species and severity (Level A or Level B) are shown in Table 10.</P>
                    <GPOTABLE COLS="7" OPTS="L2,i1" CDEF="s10,r25,12,12,12,12,12">
                        <TTITLE>Table 10—Estimated Numbers of Marine Mammals That May Be Exposed to Received Noise Levels That Cause Level A and Level B Harassment</TTITLE>
                        <BOXHD>
                            <CHED H="1">Year</CHED>
                            <CHED H="1">Species</CHED>
                            <CHED H="1">
                                Estimated
                                <LI>Level A</LI>
                                <LI>harassment</LI>
                            </CHED>
                            <CHED H="1">
                                Estimated
                                <LI>Level B</LI>
                                <LI>harassment</LI>
                            </CHED>
                            <CHED H="1">
                                Estimated
                                <LI>total take</LI>
                            </CHED>
                            <CHED H="1">Abundance</CHED>
                            <CHED H="1">
                                Percentage
                                <LI>(instances</LI>
                                <LI>take versus</LI>
                                <LI>abundance)</LI>
                            </CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">1</ENT>
                            <ENT>Humpback whale *</ENT>
                            <ENT>0</ENT>
                            <ENT>1</ENT>
                            <ENT>1</ENT>
                            <ENT>1,107</ENT>
                            <ENT>0.09</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Killer whale</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>4</ENT>
                            <ENT>2,347</ENT>
                            <ENT>0.17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beluga whale</ENT>
                            <ENT>0</ENT>
                            <ENT>11</ENT>
                            <ENT>11</ENT>
                            <ENT>279</ENT>
                            <ENT>3.94</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor porpoise</ENT>
                            <ENT>0</ENT>
                            <ENT>5</ENT>
                            <ENT>5</ENT>
                            <ENT>31,046</ENT>
                            <ENT>0.02</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor seal</ENT>
                            <ENT>1</ENT>
                            <ENT>316</ENT>
                            <ENT>317</ENT>
                            <ENT>28,411</ENT>
                            <ENT>1.12</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">2</ENT>
                            <ENT>Humpback whale *</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>4</ENT>
                            <ENT>1,107</ENT>
                            <ENT>0.36</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Killer whale</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>4</ENT>
                            <ENT>2,347</ENT>
                            <ENT>0.17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beluga whale</ENT>
                            <ENT>0</ENT>
                            <ENT>14</ENT>
                            <ENT>14</ENT>
                            <ENT>279</ENT>
                            <ENT>5.02</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor porpoise</ENT>
                            <ENT>0</ENT>
                            <ENT>12</ENT>
                            <ENT>12</ENT>
                            <ENT>31,046</ENT>
                            <ENT>0.04</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor seal</ENT>
                            <ENT>4</ENT>
                            <ENT>1,080</ENT>
                            <ENT>1,084</ENT>
                            <ENT>28,411</ENT>
                            <ENT>3.82</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">3</ENT>
                            <ENT>Humpback whale *</ENT>
                            <ENT>1</ENT>
                            <ENT>2</ENT>
                            <ENT>3</ENT>
                            <ENT>1,107</ENT>
                            <ENT>0.27</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Killer whale</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>4</ENT>
                            <ENT>2,347</ENT>
                            <ENT>0.04</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beluga whale</ENT>
                            <ENT>0</ENT>
                            <ENT>12</ENT>
                            <ENT>12</ENT>
                            <ENT>279</ENT>
                            <ENT>4.30</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor porpoise</ENT>
                            <ENT>4</ENT>
                            <ENT>5</ENT>
                            <ENT>9</ENT>
                            <ENT>31,046</ENT>
                            <ENT>0.03</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor seal</ENT>
                            <ENT>21</ENT>
                            <ENT>169</ENT>
                            <ENT>190</ENT>
                            <ENT>28,411</ENT>
                            <ENT>0.67</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">4</ENT>
                            <ENT>Humpback whale *</ENT>
                            <ENT>1</ENT>
                            <ENT>2</ENT>
                            <ENT>3</ENT>
                            <ENT>1,107</ENT>
                            <ENT>0.27</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Killer whale</ENT>
                            <ENT>0</ENT>
                            <ENT>5</ENT>
                            <ENT>5</ENT>
                            <ENT>2,347</ENT>
                            <ENT>0.21</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beluga whale</ENT>
                            <ENT>0</ENT>
                            <ENT>13</ENT>
                            <ENT>13</ENT>
                            <ENT>279</ENT>
                            <ENT>4.66</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor porpoise</ENT>
                            <ENT>4</ENT>
                            <ENT>6</ENT>
                            <ENT>10</ENT>
                            <ENT>31,046</ENT>
                            <ENT>0.03</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor seal</ENT>
                            <ENT>17</ENT>
                            <ENT>236</ENT>
                            <ENT>253</ENT>
                            <ENT>28,411</ENT>
                            <ENT>0.89</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">5</ENT>
                            <ENT>Humpback whale *</ENT>
                            <ENT>1</ENT>
                            <ENT>1</ENT>
                            <ENT>2</ENT>
                            <ENT>1,107</ENT>
                            <ENT>0.18</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Killer whale</ENT>
                            <ENT>0</ENT>
                            <ENT>4</ENT>
                            <ENT>4</ENT>
                            <ENT>2,347</ENT>
                            <ENT>0.17</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Beluga whale</ENT>
                            <ENT>0</ENT>
                            <ENT>11</ENT>
                            <ENT>11</ENT>
                            <ENT>279</ENT>
                            <ENT>3.94</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor porpoise</ENT>
                            <ENT>5</ENT>
                            <ENT>5</ENT>
                            <ENT>10</ENT>
                            <ENT>31,046</ENT>
                            <ENT>0.03</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="22"> </ENT>
                            <ENT>Harbor seal</ENT>
                            <ENT>45</ENT>
                            <ENT>190</ENT>
                            <ENT>235</ENT>
                            <ENT>28,411</ENT>
                            <ENT>0.83</ENT>
                        </ROW>
                        <TNOTE>* Includes Hawaii, Western North Pacific, and Mexico DPS's.</TNOTE>
                    </GPOTABLE>
                    <HD SOURCE="HD1">Mitigation</HD>
                    <P>In order to issue an LOA under Section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).</P>
                    <P>In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:</P>
                    <P>(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned); and</P>
                    <P>
                        (2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
                        <PRTPAGE P="50744"/>
                    </P>
                    <P>Additional mitigation measures that were not included in the proposed rule but were added to the final rule include:</P>
                    <P>(1) Time/area restriction of pile driving and noise generating activities during summer months in the western portion of Cook Inlet at the Mainline Material Offloading Facility (Mainline MOF). The density of beluga whales is notably higher in this area and the measure was added in order to further reduce the number of takes of beluga whales.</P>
                    <P>(2) Deployment of air bubble curtains for in-water pile driving activities if the air bubble curtains can show to reduce noise level by 2 dB. This measure is to reduce the noise level from pile driving, as air bubble curtain system would reduce potential takes of marine mammals by reducing the ensonified zones. The in situ measurement will determine whether continued implementation is warrant by measuring the likely conservation benefit (degree of sound reduction) versus the financial cost to the company.</P>
                    <P>(3) Vessel speed and transits restriction in western portion of Cook Inlet during summer months. This measure would minimize disturbances to beluga whales in the Susitna Delta during the time when beluga whales are likely to congregate in the area.</P>
                    <P>NMFS included these mitigation measures after working with AGDC and determined that they are practicable to further reduce potential impacts to Cook Inlet beluga whales.</P>
                    <HD SOURCE="HD2">Time/Area Restriction</HD>
                    <P>For pile driving, work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted. Other construction activities, such as pipe laying, anchor handling, and dredging could occur outside of daylight hours or during periods of low visibility.</P>
                    <P>Pile driving associated with the Mainline MOF will not occur from June 1 to September 7 (pile driving can occur from September 8 to May 31).</P>
                    <P>
                        Other than the activities described in the Description of Proposed Activity section (
                        <E T="03">e.g.,</E>
                         sheet pile driving, anchor handling, trenching, pipe-laying and support vessels), AGDC will not engage in in-water sound-producing activities within 10 miles (16 km) of the mean higher high water (MHHW) line of the Susitna Delta (Beluga River to the Little Susitna River) between April 15 and October 15 for activities with underwater noise levels in excess of 120 dB rms re 1µPa @1 m.
                    </P>
                    <HD SOURCE="HD2">Establishing and Monitoring Level A and Level B Harassment Zones, and Exclusion Zones</HD>
                    <P>
                        Before the commencement of in-water construction activities, which include impact pile driving and vibratory pile driving, AGDC must establish Level A harassment zones where received underwater SEL
                        <E T="52">cum</E>
                         could cause PTS (see Table 6 above).
                    </P>
                    <P>
                        AGDC must also establish Level B harassment zones where received underwater SPLs are higher than 160 dB
                        <E T="52">rms</E>
                         re 1 µPa for impulsive noise sources (impact pile driving) and 120 dB
                        <E T="52">rms</E>
                         re 1 µPa for non-impulsive noise sources (vibratory pile driving).
                    </P>
                    <P>For all impact and vibratory pile driving, AGDC is required to establish the exclusion zones and implement shutdown measures for humpback whale and killer whale to prevent Level A harassment. AGDC is required to establish a maximum of 1,000-m exclusion zone and implement shutdown measures for harbor porpoise and harbor seal to minimize Level A harassment. AGDC is required to establish the exclusion zones and implement shutdown measures for beluga whale to prevent Level A and Level B harassment. AGDC is required to establish a 2,900-m clearance zone for beluga whale before activities involving anchor handling can occur.</P>
                    <P>If visibility degrades to where the entire exclusion zones cannot be effectively monitored during pile driving, AGDC may continue to drive the pile section that was being driven to its target depth but will not drive additional sections of pile.</P>
                    <P>Further, AGDC must implement shutdown measures if the number of marine mammals observed within harassment zones and recorded as a takes for any particular marine mammal species reaches the authorized limit, or any marine mammal species/stocks not authorized to take under the LOA, and such species are sighted within the vicinity of the project area and are approaching the Level B harassment zone during in-water construction activities.</P>
                    <P>A summary of these exclusion zones based on Level A and Level B harassment distances for different project components is provided in Table 11.</P>
                    <GPOTABLE COLS="6" OPTS="L2,i1" CDEF="s50,12,12,12,12,12">
                        <TTITLE>Table 11—Marine Mammal Exclusion Zones</TTITLE>
                        <BOXHD>
                            <CHED H="1">Pile driving activities</CHED>
                            <CHED H="1">Exclusion distances (m)</CHED>
                            <CHED H="2">Humpback whale</CHED>
                            <CHED H="2">Killer whale</CHED>
                            <CHED H="2">
                                Harbor
                                <LI>porpoise</LI>
                            </CHED>
                            <CHED H="2">Harbor seal</CHED>
                            <CHED H="2">Beluga whale *</CHED>
                        </BOXHD>
                        <ROW>
                            <ENT I="01">Impact pile driving of 48- and 60-inch piles at PLF</ENT>
                            <ENT>3,200</ENT>
                            <ENT>250</ENT>
                            <ENT>1,000</ENT>
                            <ENT>1,000</ENT>
                            <ENT>3,600</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact pile driving of 24- and 48-inch piles at temporary MOF</ENT>
                            <ENT>3,300</ENT>
                            <ENT>250</ENT>
                            <ENT>1,000</ENT>
                            <ENT>1,000</ENT>
                            <ENT>3,600</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory pile driving of all types and sizes of piles at temporary MOF</ENT>
                            <ENT>300</ENT>
                            <ENT>250</ENT>
                            <ENT>250</ENT>
                            <ENT>250</ENT>
                            <ENT>5,600</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Vibratory pile driving of sheet piles at Mainline MOF</ENT>
                            <ENT>300</ENT>
                            <ENT>250</ENT>
                            <ENT>250</ENT>
                            <ENT>250</ENT>
                            <ENT>3,200</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Impact pile driving of sheet piles at Mainline MOF</ENT>
                            <ENT>1,200</ENT>
                            <ENT>250</ENT>
                            <ENT>1,000</ENT>
                            <ENT>650</ENT>
                            <ENT>800</ENT>
                        </ROW>
                        <ROW>
                            <ENT I="01">Anchor handling</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>NA</ENT>
                            <ENT>** 2,900</ENT>
                        </ROW>
                        <TNOTE>* These zones also apply to all marine mammals if the number of take is approaching to the authorized takes, and to all marine mammals that takes are not authorized.</TNOTE>
                        <TNOTE>** The 2,900m zone will be a clearing zone prior to the start of work, since activities cannot start and stop. Beluga whales occurring within this clearing zone during anchor handling operations will be recorded as having been taken by harassment.</TNOTE>
                    </GPOTABLE>
                    <P>
                        In all cases, a minimum of 10-m exclusion zone must be established for in-water construction and heavy machinery not addressed elsewhere in these measures. If marine mammals are found within the exclusion zone, pile driving of the segment would be delayed until they move out of the area. If a marine mammal is seen above water and then dives below, the contractor would wait 30 minutes for large cetaceans (baleen whales) and 15 minutes for small cetaceans (beluga and killer whales and porpoises) and pinnipeds. If no marine mammals of that species are seen by the observer in that time it can be assumed that the 
                        <PRTPAGE P="50745"/>
                        animal has moved beyond the exclusion zone.
                    </P>
                    <P>If pile driving of a segment ceases for 30 minutes or more and a marine mammal is sighted within the designated exclusion zone prior to commencement of pile driving, the observer(s) must notify the pile driving operator (or other authorized individual) immediately and continue to monitor the exclusion zone. Operations may not resume until the marine mammal has exited the exclusion zone or 30 minutes have elapsed for large cetaceans or 15 minutes have elapsed for small cetaceans and pinnipeds since the last sighting.</P>
                    <HD SOURCE="HD2">Soft Start</HD>
                    <P>Once the exclusion zone has been cleared of all marine mammals, soft-start procedures must be implemented immediately prior to impact pile driving activities. Soft-start is comprised of an initial set of three strikes from the hammer at about 40 percent energy, followed by a 30-seconds waiting period, then two subsequent three-strike sets with associated 30-seconds waiting periods at the reduced energy.</P>
                    <P>If circumstances result in discontinuation of pile driving for greater than 30 minutes, then the PSO will monitor the exclusion zone for 30 minutes prior to the resumption of pile driving and will ensure that the zone remains devoid of marine mammals for the 30 minutes immediately prior to the restarting of pile driving. Impact Pile driving will resume following an additional soft start.</P>
                    <HD SOURCE="HD2">Noise Attenuation</HD>
                    <P>For pile-driving at the Mainline MOF near the Beluga River, and on the east side of Cook Inlet near Nikiski associated with the liquefaction facility, AGDC must deploy air bubble curtains around piles. If the sound source verification (SSV) measurements indicate that the best-performing bubble curtain configuration provides less than a 2 dB reduction in in-water sound beyond the bubble curtain, use of the bubble curtain may be discontinued.</P>
                    <HD SOURCE="HD2">Vessel Transits</HD>
                    <P>
                        Consistent with NMFS marine mammal viewing guidelines (
                        <E T="03">https://alaskafisheries.noaa.gov/pr/mm-viewing-guide</E>
                        ), operators of vessels will, at all times, avoid approaching within 100 yards of marine mammals. Operators will observe direction of travel of marine mammals and attempt to maintain a distance of 100 yards or greater between the animal and the vessel by working to alter vessel course or velocity.
                    </P>
                    <P>
                        The vessel operator will avoid placing the vessel between members of a group of marine mammals in a way that may cause separation of individuals in the group from other individuals in that group. A group is defined as being three or more whales observed within 500-m (1,641-ft) of one-another and displaying behaviors of directed or coordinated activity (
                        <E T="03">e.g.,</E>
                         migration or group feeding).
                    </P>
                    <P>If the vessel approaches within 1.6 km (1 mi) of one or more whales, the vessel operator will take reasonable precautions to avoid potential interaction with the whales by taking one or more of the following actions, as appropriate:</P>
                    <P>(1) Steering to the rear of whale(s) to avoid causing changes in their direction of travel.</P>
                    <P>(2) Maintaining vessel speed of 10 knots (19 km/hr) or less when transiting to minimize the likelihood of lethal vessel strikes.</P>
                    <P>(3) Reducing vessel speed to less than 5 knots (9 km/hour) within 274 m (300 yards) of the whale(s).</P>
                    <P>Project vessels must remain a minimum of 2.8 km (1.5 nm) seaward of the mean lower low water (MLLW) line between the Little Susitna River and -150.80 degrees west longitude (see Figure 2 for line depicting the approximate MLLW line) to minimize the impacts of vessel sound and avoid strikes on Cook Inlet beluga whales within this highly essential portion of their critical habitat during late spring and throughout the summer the Susitna Delta Exclusion Zone is defined as the union of the areas defined by:</P>
                    <P>(1) A 16 km (10-mile) buffer of the Beluga River thalweg seaward of the mean lower low water (MLLW) line,</P>
                    <P>(2) A 16 km (10-mile) buffer of the Little Susitna River thalweg seaward of the MLLW line, and,</P>
                    <P>(3) A 16 km (10-mile) seaward buffer of the MLLW line between the Beluga River and Little Susitna River.</P>
                    <P>(4) The buffer extends landward along the thalweg to include intertidal waters within rivers and streams up to their mean higher high water line (MHHW). The seaward boundary has been simplified so that it is defined by lines connecting readily discernable landmarks.</P>
                    <P>For vessels operating in the Susitna Delta Exclusion Zone, the following will be implemented:</P>
                    <P>(1) All project vessels operating within the designated Susitna Delta area will maintain a speed above ground below 4 knots. PSOs will note the numbers, date, time, coordinates, and proximity to vessels of all belugas observed during operations, and report these observations to NMFS in monthly PSO reports.</P>
                    <P>(2) Vessel crew will be trained to monitor for ESA-listed species prior to and during all vessel movements within the Susitna Delta Exclusion Zone. The vessel crew will report sightings to the PSO team for inclusion in the overall sighting database and reports.</P>
                    <P>(3) Vessel operators will not move their vessels when they are unable to adequately observe the 100-meter zone around vessels under power (in gear) due to darkness, fog, or other conditions, unless necessary for ensuring human safety.</P>
                    <GPH SPAN="3" DEEP="351">
                        <PRTPAGE P="50746"/>
                        <GID>ER17AU20.448</GID>
                    </GPH>
                    <P>Based on our evaluation of the required measures, NMFS has determined that the prescribed mitigation measures provide the means effecting the least practicable adverse impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.</P>
                    <HD SOURCE="HD1">Monitoring and Reporting</HD>
                    <P>In order to issue an LOA for an activity, Section 101(a)(5)(A) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.</P>
                    <P>Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:</P>
                    <P>
                        • Occurrence of marine mammal species or stocks in the area in which take is anticipated (
                        <E T="03">e.g.,</E>
                         presence, abundance, distribution, density).
                    </P>
                    <P>
                        • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
                        <E T="03">e.g.,</E>
                         source characterization, propagation, ambient noise); (2) affected species (
                        <E T="03">e.g.,</E>
                         life history, dive patterns); (3) co-occurrence of marine mammal species with the action; or (4) biological or behavioral context of exposure (
                        <E T="03">e.g.,</E>
                         age, calving or feeding areas).
                    </P>
                    <P>• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors.</P>
                    <P>• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks.</P>
                    <P>
                        • Effects on marine mammal habitat (
                        <E T="03">e.g.,</E>
                         marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat).
                    </P>
                    <P>• Mitigation and monitoring effectiveness.</P>
                    <HD SOURCE="HD2">Visual Monitoring</HD>
                    <P>Marine mammal monitoring must be conducted in accordance with the Marine Mammal Monitoring Plan, dated April 2020. Marine mammal monitoring during pile driving and removal must be conducted by NMFS-approved PSOs in a manner consistent with the following:</P>
                    <P>
                        • Independent PSOs (
                        <E T="03">i.e.,</E>
                         not construction personnel) who have no other assigned tasks during monitoring periods must be used;
                    </P>
                    <P>• Where a team of three or more PSOs are required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience working as a marine mammal observer during construction;</P>
                    <P>
                        • Other PSOs may substitute education (degree in biological science or related field) or training for experience. PSOs may also substitute 
                        <PRTPAGE P="50747"/>
                        Alaska native traditional knowledge for experience. (NMFS recognizes that PSOs with traditional knowledge may also have prior experience and be eligible to serve as the lead PSO.); and
                    </P>
                    <P>• AGDC must submit PSO CVs for approval by NMFS prior to the onset of pile driving.</P>
                    <P>PSOs must have the following additional qualifications:</P>
                    <P>• Ability to conduct field observations and collect data according to assigned protocols;</P>
                    <P>• Experience or training in the field identification of marine mammals, including the identification of behaviors;</P>
                    <P>• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;</P>
                    <P>• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and</P>
                    <P>• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.</P>
                    <P>Marine mammal monitoring must comply with the follow protocols:</P>
                    <P>(1) For pile driving activities, a minimum of two PSOs must be on duty at all times;</P>
                    <P>(2) For pile driving activities, PSOs must be stationed on a bluff with minimum height at 500 feet above sea level immediately above the construction site;</P>
                    <P>(3) For marine mammal monitoring during pipe laying activities, at least one PSO must be on the barge and on watch;</P>
                    <P>(4) PSOs may not exceed 4 consecutive watch hours; must have a minimum two-hour break between watches; and may not exceed a combined watch schedule of more than 12 hours in a 24-hour period;</P>
                    <P>(5) PSOs must have no other construction-related tasks while conducting monitoring;</P>
                    <P>(6) Monitoring must be conducted from 30 minutes prior to commencement of pile driving, throughout the time required to drive a pile, and for 30 minutes following the conclusion of pile driving;</P>
                    <P>(7) Monitoring must be conducted from 30 minutes prior to commencement of pipe laying activity, throughout the time of pipe laying, and for 30 minutes following the conclusion of pipe laying for the segment;</P>
                    <P>(8) During all observation periods, PSOs must use high-magnification (25X), as well as standard handheld (7X) binoculars, and the naked eye to search continuously for marine mammals;</P>
                    <P>(9) Monitoring distances must be measured with range finders. Distances to animals must be based on the best estimate of the PSO, relative to known distances to objects in the vicinity of the PSO; and</P>
                    <P>(10) Bearings to animals must be determined using a compass.</P>
                    <P>PSOs must collect the following information during marine mammal monitoring:</P>
                    <P>(1) Date and time that monitored activity begins and ends for each day conducted (monitoring period);</P>
                    <P>(2) Construction activities occurring during each daily observation period, including how many and what type of piles driven and distances covered during pipe laying;</P>
                    <P>(3) Deviation from initial proposal in pile numbers, pile types, average driving times, and pipe laying distances, etc.;</P>
                    <P>
                        (4) Weather parameters in each monitoring period (
                        <E T="03">e.g.,</E>
                         wind speed, percent cloud cover, visibility);
                    </P>
                    <P>
                        (5) Water conditions in each monitoring period (
                        <E T="03">e.g.,</E>
                         sea state, tide state);
                    </P>
                    <P>(6) For each marine mammal sighting:</P>
                    <P>○ Species, numbers, and, if possible, sex and age class of marine mammals;</P>
                    <P>○ Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving and pipe laying activities, and notable changes in patterns;</P>
                    <P>○ Location and distance from pile driving and pipe laying activities to marine mammals and distance from the marine mammals to the observation point; and</P>
                    <P>○ Estimated amount of time that the animals remained in the Level A and/or Level B harassment zones;</P>
                    <P>
                        (7) Description of implementation of mitigation measures within each monitoring period (
                        <E T="03">e.g.,</E>
                         shutdown or delay); and
                    </P>
                    <P>(8) Other human activity in the area within each monitoring period.</P>
                    <HD SOURCE="HD2">Acoustic Monitoring</HD>
                    <P>AGDC must conduct sound source verification (SSV) in accordance with the Sound Source Verification Plan, dated February 12, 2020, at the beginning of the pile driving to characterize the sound levels associated with different pile and hammer types, as well as to establish the marine mammal monitoring and mitigation zones.</P>
                    <P>(1) A minimum of 2 piles of each type and size must be measured.</P>
                    <P>(2) The following data, at minimum, shall be collected during acoustic monitoring and reported:</P>
                    <P>i. Hydrophone equipment and methods: Recording device, sampling rate, distance from the pile where recordings were made; depth of recording device(s).</P>
                    <P>ii. Type of pile being driven and method of driving during recordings.</P>
                    <P>
                        iii. Mean, median, and maximum sound levels (dB re: 1µPa): Cumulative sound exposure level (SEL
                        <E T="52">cum</E>
                        ), peak sound pressure level (SPL
                        <E T="52">peak</E>
                        ), root mean square sound pressure level (SPL
                        <E T="52">rms</E>
                        ), and single-strike sound exposure level (SEL
                        <E T="52">s-s</E>
                        ).
                    </P>
                    <P>(3) An SSV report must be submitted to NMFS within 72 hours after field measurements for approval of the results.</P>
                    <P>(4) The results of the SSV report may be used to adjust the extent of Level A and Level B harassment zones in-water pile driving.</P>
                    <HD SOURCE="HD2">Reporting</HD>
                    <P>AGDC must notify NMFS 48 hours prior to the start of each activity in Cook Inlet that may cause harassment of marine mammals. If there is a delay in activity, AGDC will also notify NMFS as soon as practicable.</P>
                    <P>AGDC must submit monthly reports via email to NMFS Office of Protected Resources (OPR) and Alaska Regional Office (AKRO) for all months with project activities by the 15th of the month following the monthly reporting period. For example, for the monthly reporting period of June 1-30, the monthly report will be submitted by July 15. The monthly report will contain and summarize the following information:</P>
                    <P>• Dates, times, locations, heading, speed, weather, sea conditions (including Beaufort sea state and wind force), and a list of all in-water sound-producing activities occurring concurrent with marine mammal observations.</P>
                    <P>
                        • Species, number, location, distance from the vessel, and behavior of all observed marine mammals, as well as associated project activity (
                        <E T="03">e.g.,</E>
                         number of power-downs and shutdowns), observed throughout all monitoring activities.
                    </P>
                    <P>• Observation data in (a) and (b) above will be provided in digital spreadsheet format that can be queried.</P>
                    <P>
                        • An estimate of the number of animals (by species) exposed to sound at received levels greater than or equal to either the Level A or Level B harassment thresholds, with a 
                        <PRTPAGE P="50748"/>
                        discussion of any specific behaviors those individuals exhibited.
                    </P>
                    <P>• If the extent of Level B harassment zone is beyond visual observation, AGDC should make appropriate adjustment to estimate the numbers of marine mammals taken based on the portion of the areas that are monitored.</P>
                    <P>• A description of the implementation and effectiveness of the: (i) Terms and conditions of the Biological Opinion's Incidental Take Statement; and (ii) mitigation measures of the LOA. For the Biological Opinion, the report will confirm the implementation of each Term and Condition, as well as any conservation recommendations, and describe their effectiveness for minimizing the adverse effects of the action on ESA-listed marine mammals.</P>
                    <P>In addition, AGDC is required to keep a tally of the estimated number of marine mammals taken, and alert NMFS when the authorized limit is close to being met based on prescribed monitoring measured in the final rule. In addition, AGDC is required to keep a tally of all marine mammal sightings during the pile driving activities.</P>
                    <P>AGDC should immediately notify NMFS if the number of Cook Inlet beluga takes documented reaches 80% of the authorized takes in any given calendar year during which take is authorized.</P>
                    <P>Within 90 calendar days of the cessation of in-water work each year, a comprehensive annual report will be submitted to NMFS for review. The report will synthesize all sighting data and effort during each activity for each year. NMFS will provide comments within 30 days after receiving annual reports, and the action agency or its non-federal designee will address the comments and submit revisions within 30 days after receiving NMFS comments. If no comments are received from the NMFS within 30 days, the annual report is considered completed. The report will include the following information:</P>
                    <P>• Summaries of monitoring effort including total hours, observation rate by species and marine mammal distribution through the study period, accounting for sea state and other factors affecting visibility and detectability of marine mammals.</P>
                    <P>
                        • Analyses of the effects of various factors that may have influenced detectability of marine mammals (
                        <E T="03">e.g.,</E>
                         sea state, number of observers, fog/glare, and other factors as determined by the PSOs).
                    </P>
                    <P>• Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover.</P>
                    <P>• Marine mammal observation data with a digital record of observation data provided in digital spreadsheet format that can be queried.</P>
                    <P>
                        • Summary of implemented mitigation measures (
                        <E T="03">i.e.,</E>
                         shutdowns and delays).
                    </P>
                    <P>• Number of marine mammals during periods with and without project activities (and other variables that could affect detectability), such as: (i) Initial sighting distances versus project activity at the time of sighting; (ii) closest point of approach versus project activity; (iii) observed behaviors and types of movements versus project activity; (iv) numbers of sightings/individuals seen versus project activity; (v) distribution around the source vessels versus project activity; and (vi) numbers of animals detected in the exclusion zone.</P>
                    <P>• Analyses of the effects of project activities on listed marine mammals.</P>
                    <P>In addition to providing NMFS monthly and annual reporting of marine mammal observations and other parameters described above, AGDC will provide NMFS, within 90 days of project completion at the end of the five-year period, a report of all parameters listed in the monthly and annual report requirements above, noting also all operational shutdowns or delays necessitated due to the proximity of marine mammals. NMFS will provide comments within 30 days after receiving this report, and the action agency or its non-federal designee will address the comments and submit revisions within 30 days after receiving NMFS comments. If no comments are received from the NMFS within 30 days, the final report is considered as final.</P>
                    <P>In the event that personnel involved in the construction activities discover an injured or dead marine mammal, AGDC must immediately cease the specified activities and report the incident to the Office of Protected Resources (OPR) (301-427-8401), NMFS and to the Alaska regional stranding coordinator (907-586-7209) as soon as feasible. If the death or injury was clearly caused by the specified activity, AGDC must immediately cease the specified activities until NMFS is able to review the circumstances of the incident and determine what, if any, additional measures are appropriate to ensure compliance with the terms of the LOA. AGDC must not resume their activities until notified by NMFS.</P>
                    <P>The report must include the following information:</P>
                    <P>• Time, date, and location (latitude/longitude) of the first discovery (and updated location information if known and applicable);</P>
                    <P>• Species identification (if known) or description of the animal(s) involved;</P>
                    <P>• Condition of the animal(s) (including carcass condition if the animal is dead);</P>
                    <P>• Observed behaviors of the animal(s), if alive;</P>
                    <P>• If available, photographs or video footage of the animal(s); and</P>
                    <P>• General circumstances under which the animal was discovered.</P>
                    <HD SOURCE="HD1">Negligible Impact Analysis and Determination</HD>
                    <P>
                        NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
                        <E T="03">i.e.,</E>
                         population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (
                        <E T="03">e.g.,</E>
                         intensity, duration), the context of any responses (
                        <E T="03">e.g.,</E>
                         critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS' implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (
                        <E T="03">e.g.,</E>
                         as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).
                    </P>
                    <P>
                        To avoid repetition, this introductory discussion of our analyses applies to all the species listed in Table 3, given that the anticipated effects of AGDC's Alaska LNG facilities construction project activities involving pile driving and pipe laying on marine mammals are expected to be relatively similar in nature. Among the species that would be affected from AGDC's LNG facilities construction activities, the Cook Inlet beluga whale is expected to be the most vulnerable species due to its small 
                        <PRTPAGE P="50749"/>
                        population and declining status (NMFS, 2020), and additional species-specific information is included in the analysis below.
                    </P>
                    <P>Pile driving and removal activities associated with the project as well as pipe laying activity, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level B harassment, from underwater sounds generated from pile driving and pipe laying. Potential takes could occur if individuals of these species are present in zones ensonified above the thresholds for Level A or Level B harassment, identified above, when these activities are underway.</P>
                    <P>
                        Cook Inlet beluga whale and humpback whales are listed as endangered under the ESA. These stocks are also considered depleted under the MMPA. The estimated annual rate of decline for Cook Inlet beluga whales was 0.6 percent between 2002 and 2012. Data from Calambokidis 
                        <E T="03">et al.</E>
                         (2008) suggest the population of humpback whales may be increasing. The other species that may be taken by harassment during AGDC's LNG facilities construction project are not listed as threatened or endangered under the ESA nor as depleted under the MMPA.
                    </P>
                    <P>
                        Although a few individual marine mammals (up to 3 humpback whales, 13 harbor porpoises, and 88 harbor seals over the entire project duration of 5 years) are estimated to experience Level A harassment in the form of PTS if they stay within the Level A harassment zone during the entire pile driving for the day, the degree of injury that might occur would be expected to be mild and not likely to affect the reproduction or survival of the individual animals. Specifically, it is expected that, if hearing impairments occur, most likely the affected animal would lose a few dB in its hearing sensitivity, limited to the dominant frequency of the noise sources, 
                        <E T="03">i.e.,</E>
                         in the low-frequency region below 2 kHz. While we have considered the potential impacts to any individuals that could incur PTS, and the number authorized, we reiterate that in general marine mammals are likely to avoid areas where sound levels are intense enough to cause hearing impairment and it is unlikely to occur.
                    </P>
                    <P>Under the majority of the circumstances, anticipated takes are expected to be limited to relatively short-term Level B harassment. Marine mammals present in the vicinity of the action area during the construction season and taken by Level B harassment would most likely show overt brief disturbance (startle reaction) and avoidance of the area from elevated noise levels during pile driving. Given the limited estimated number of incidents of Level A and Level B harassment and the limited, anticipated short-term nature of the responses by the individuals, the impacts of the estimated take are not expected to impact the fitness, reproduction, or survival of any individual marine mammals, and further are not expected to rise to the level that they would adversely affect any marine mammal species at the population level, through effects on annual rates of recruitment or survival. While AGDC's LNG facilities construction activities could in general increase the ambient noise level in the vicinity of the project area, the elevated noise levels are only expected during the construction work window during daytime and in the limited area immediately around the construction activities. Additionally, any potential auditory masking occur primarily in the frequency band of the noise, which is generally below 2 kHz for in-water pile driving, and would not be expected to mask most communication vocalizations of the species in the area, or echolocation calls. Given this, any potential auditory masking for marine mammals in the project area is expected to have relatively minor impacts.</P>
                    <P>Mitigation measures such as time/area restrictions, dedicated marine mammal observers, pre-construction exclusion zone clearance, deployment of air bubble curtains, soft-start, and shutdown measures when marine mammals are seen within the exclusion zones reduce both the number and severity of behavioral disturbances and minimize any effects on hearing sensitivity. In most cases, only cause Level B harassment in the form of behavioral disturbance and/or temporary avoidance. While some Level A harassment to a few individual harbor seals, harbor porpoises, and humpback whales may occur, individuals are unlikely to remain in the proximity of the source for a duration of time likely to result in more than a few dB of PTS (low level), and therefore these impacts are unlikely to impact individual fitness, reproduction, or survival incurred would be expected to be of a low level (no more than a few dB).</P>
                    <P>
                        The area where the activities will take place is within the Cook Inlet beluga whale critical habitat. Satellite-tagging studies and aerial survey indicate that seasonal shifts exist in Cook Inlet beluga whale distribution, with the whales spending a great percentage of time in coastal areas during the summer and early fall (June through October or November), and dispersing to larger ranges that extend to the middle of the inlet in winter and spring (November or December through May) (Hansen and Hubbard, 1999; Rugh 
                        <E T="03">et al.,</E>
                         2004; Hobbs 
                        <E T="03">et al.,</E>
                         2005; Goetz 
                        <E T="03">et al.,</E>
                         2012). However, fine scale modeling based on NMFS long-term aerial survey data indicate that the AGDC's proposed LNG facilities construction does not overlap with beluga whale high density areas during the summer and fall (Goetz 
                        <E T="03">et al.,</E>
                         2012). Furthermore, specific mitigation measures are required to offer additional protections to Cook Inlet beluga whales given the vulnerable status of the population. These measures call for time and area restriction for all activities that generate underwater noise greater than 120 dB rms re 1 µPa, including in-water pile driving events, in west Cook Inlet construction area during summer months when beluga whales are likely to use the Susitna River delta for feeding. Additional mitigation measure to protect the Cook Inlet beluga whale also include implementing shutdown measures for beluga whales to prevent Level B harassment. These measures are expected reduce both the number and severity of the takes of beluga whales.
                    </P>
                    <P>There are no known important habitats, such as rookeries or haulouts, in the vicinity of the AGDC's LNG facilities construction project for other marine mammal species. The project also is not expected to have significant adverse effects on affected marine mammals' habitat, including prey, as analyzed in detail in the Anticipated Effects on Marine Mammal Habitat section. Therefore, the exposure of marine mammals to sounds produced by AGDC's LNG facilities construction activities is not anticipated to have an effect on annual rates of recruitment or survival of the affected species or stocks.</P>
                    <P>In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:</P>
                    <P>• No series injury or mortality is anticipated or authorized;</P>
                    <P>• Injury—a small individuals of humpback whales, harbor porpoises, and harbor seals could experience mild level of PTS as a form of injury. However, as mentioned earlier in this section, the level of PTS is expected to be small;</P>
                    <P>
                        • TTS—a small individuals of marine mammals could experience mild level of TTS before the threshold shifts become permanent. However, most of the TTS effects are expected to be brief 
                        <PRTPAGE P="50750"/>
                        in duration, and will not progress into PTS;
                    </P>
                    <P>• Behavioral disturbance—most of the noise effects on marine mammals are expected to be in the form of behavioral disturbance. However, such effects are expected to be in short duration, within the day during the construction activities when the animal is nearby. As construction activities only occur for a maximum of 12 hours during daylight hours between April and October of the year, chronic noise exposure would be limited; and</P>
                    <P>• Important Areas—the area where the activities will take place is within the Cook Inlet beluga whale critical habitat. However, fine scale modeling based on NMFS long-term aerial survey data indicate that the AGDC's proposed LNG facilities construction does not overlap with beluga whale high density areas during the summer and fall.</P>
                    <P>Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.</P>
                    <HD SOURCE="HD1">Small Numbers</HD>
                    <P>As noted above, only small numbers of incidental take may be authorized under section 101(a)(5)(A) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals.</P>
                    <P>The number of authorized takes are below one third of the stock abundance (in fact less than seven percent) of the population for all marine mammals (Table 10).</P>
                    <P>Based on the analysis contained herein of the proposed activity (including the prescribed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.</P>
                    <HD SOURCE="HD1">Unmitigable Adverse Impact Analysis and Determination</HD>
                    <P>In order to issue an LOA, NMFS must find that the specified activity will not have an “unmitigable adverse impact” on the subsistence uses of the affected marine mammal species or stocks by Alaskan Natives. NMFS has defined “unmitigable adverse impact” in 50 CFR 216.103 as an impact resulting from the specified activity: (1) That is likely to reduce the availability of the species to a level insufficient for a harvest to meet subsistence needs by: (i) Causing the marine mammals to abandon or avoid hunting areas; (ii) Directly displacing subsistence users; or (iii) Placing physical barriers between the marine mammals and the subsistence hunters; and (2) That cannot be sufficiently mitigated by other measures to increase the availability of marine mammals to allow subsistence needs to be met.</P>
                    <P>The project is unlikely to affect beluga whale harvests because no beluga harvest will take place in 2020, nor is one likely to occur in the other years that would be covered by the 5-year regulations and associated LOAs.</P>
                    <P>The proposed Marine Terminal construction activities would occur closest to the marine subsistence area used by Nikiski, while the offshore pipeline and Beluga Mainline MOF would occur within the subsistence use area used by Tyonek. However, the proposed action area is not an important native subsistence site for subsistence harvest of marine mammals because subsistence hunt is only conducted opportunistically. Also, because of the relatively small proportion of marine mammals utilizing Cook Inlet, the number harvested is expected to be extremely low (NMFS, 2013c). Therefore, AGDC's program is not expected to have an impact on the subsistence use of marine mammals.</P>
                    <P>Nevertheless, AGDC is required to and has prepared a Stakeholder Engagement Plan to involve subsistence communities in the process, hearing concerns, and responding to issues. Through the Stakeholder Engagement Plan, AGDC would implement the following measures to keep subsistence users in the Cook Inlet region informed of its project activities.</P>
                    <P>• Provide a stakeholder engagement specialist as a local point of contact;</P>
                    <P>• Provide informational letters summarizing planned activities for summer and winter on a periodic basis to a comprehensive list of stakeholders;</P>
                    <P>• Set up a call-in number for interested marine mammal hunters during active construction;</P>
                    <P>• When requested by stakeholders, as resources allow, attend meetings to provide information on upcoming projects; and</P>
                    <P>• Be available periodically at large-scale events in Anchorage for questions from the public and Alaska Native groups, such as the Alaska Federation of Natives or Alaska Forum for the Environment.</P>
                    <P>AGDC has travelled to several operations-related meetings and plans to schedule and plans to attend more meetings throughout the construction and operation period. AGDC has developed a comprehensive stakeholder list of Alaska native communities, organizations, and other interested parties in the Cook Inlet region. This list is a “living” list and will be updated with new stakeholders or as people change positions. The updated listed will be submitted to NMFS as part of the annual reports.</P>
                    <HD SOURCE="HD1">Adaptive Management</HD>
                    <P>The regulations governing the take of marine mammals incidental to AGDC's proposed LNG facilities construction activities would contain an adaptive management component.</P>
                    <P>The reporting requirements associated with this Final Rule are designed to provide NMFS with monitoring data from the previous year to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine (with input from AGDC regarding practicability) on an annual basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.</P>
                    <P>The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.</P>
                    <HD SOURCE="HD1">Endangered Species Act (ESA)</HD>
                    <P>
                        Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531 
                        <E T="03">et seq.</E>
                        ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of ITAs, NMFS consults internally, in this case with the Alaska Protected 
                        <PRTPAGE P="50751"/>
                        Resources Division Office, whenever we propose to authorize take for endangered or threatened species.
                    </P>
                    <P>Pursuant to the MMPA and through these regulations and the associated LOA, NMFS is authorizing take of Cook Inlet beluga whale and Hawaii, Western North Pacific, and Mexico DPS's of humpback whales, which are listed under the ESA.</P>
                    <P>The Permit and Conservation Division requested initiation of section 7 consultation with the Alaska Region for the promulgation of 5-year regulations and the subsequent issuance of a Letter of Authorization. The Alaska Region issued a Biological Opinion concluding that NMFS' action is not likely to adversely affect the listed species named above or adversely modify their critical habitat.</P>
                    <HD SOURCE="HD1">Classification</HD>
                    <P>Pursuant to the procedures established to implement Executive Order 12866, the Office of Management and Budget has determined that this final rule is not significant. Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The AGDC is the only entity that would be subject to the requirements in these final regulations. During construction, AGDC would employ or contract thousands of people and the Alaska LNG Project would generate a market value in the billions of dollars. AGDC is not a small governmental jurisdiction, small organization, or small business, as defined by the RFA. We did not receive any public comments on the certification. Therefore a final regulatory flexibility analysis is not required and none has been prepared.</P>
                    <LSTSUB>
                        <HD SOURCE="HED">List of Subjects in 50 CFR Part 217</HD>
                        <P>Penalties, Reporting and recordkeeping requirements, Seafood, Transportation.</P>
                    </LSTSUB>
                    <SIG>
                        <DATED>Dated: July 13, 2020.</DATED>
                        <NAME>Samuel D. Rauch III,</NAME>
                        <TITLE>Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.</TITLE>
                    </SIG>
                    <P>For reasons set forth in the preamble, 50 CFR part 217 is amended as follows:</P>
                    <PART>
                        <HD SOURCE="HED">PART 217—REGULATIONS GOVERNING THE TAKE OF MARINE MAMMALS INCIDENTAL TO SPECIFIED ACTIVITIES</HD>
                    </PART>
                    <REGTEXT TITLE="50" PART="217">
                        <AMDPAR>1. The authority citation for part 217 continues to read as follows:</AMDPAR>
                        <AUTH>
                            <HD SOURCE="HED">Authority:</HD>
                            <P>
                                 16 U.S.C. 1361 
                                <E T="03">et seq.,</E>
                                 unless otherwise noted.
                            </P>
                        </AUTH>
                    </REGTEXT>
                    <REGTEXT TITLE="50" PART="217">
                        <AMDPAR>2. Add subpart E to part 217 to read as follows:</AMDPAR>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart E—Taking and Importing Marine Mammals; Alaska Gasline Development Corporation Liquefied Natural Gas Facilities Construction</HD>
                        </SUBPART>
                        <CONTENTS>
                            <SECHD>Sec.</SECHD>
                            <SECTNO>217.40 </SECTNO>
                            <SUBJECT>Specified activity and specified geographical region.</SUBJECT>
                            <SECTNO>217.41 </SECTNO>
                            <SUBJECT>Effective dates.</SUBJECT>
                            <SECTNO>217.42 </SECTNO>
                            <SUBJECT>Permissible methods of taking.</SUBJECT>
                            <SECTNO>217.43 </SECTNO>
                            <SUBJECT>Prohibitions.</SUBJECT>
                            <SECTNO>217.44 </SECTNO>
                            <SUBJECT>Mitigation requirements.</SUBJECT>
                            <SECTNO>217.45 </SECTNO>
                            <SUBJECT>Requirements for monitoring and reporting.</SUBJECT>
                            <SECTNO>217.46 </SECTNO>
                            <SUBJECT>Letters of Authorization.</SUBJECT>
                            <SECTNO>217.47 </SECTNO>
                            <SUBJECT>Renewals and modifications of Letters of Authorization.</SUBJECT>
                            <SECTNO>217.48-217.49 </SECTNO>
                            <SUBJECT>[Reserved]</SUBJECT>
                        </CONTENTS>
                        <SUBPART>
                            <HD SOURCE="HED">Subpart E—Taking and Importing Marine Mammals; Alaska Gasline Development Corporation Liquefied Natural Gas Facilities Construction</HD>
                            <SECTION>
                                <SECTNO>§ 217.40 </SECTNO>
                                <SUBJECT>Specified activity and specified geographical region.</SUBJECT>
                                <P>(a) Regulations in this subpart apply only to the Alaska Gasline Development Corporation (AGDC) or successor entities and those persons it authorizes or funds to conduct activities on its behalf for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to the activities described in paragraph (c) of this section.</P>
                                <P>(b) The taking of marine mammals by AGDC may be authorized in a Letter of Authorization (LOA) only if it occurs within AGDC's Alaska liquefied natural gas (LNG) facilities' construction areas, which are located between the Beluga Landing shoreline crossing on the north and the Kenai River south of Nikiski on the south in Cook Inlet, Alaska.</P>
                                <P>(c) The taking of marine mammals during this project is only authorized if it occurs incidental to construction activities associated with the proposed LNG facilities or the Mainline crossing of Cook Inlet.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.41 </SECTNO>
                                <SUBJECT>Effective dates.</SUBJECT>
                                <P>Regulations in this subpart are effective January 1, 2021 through December 31, 2025.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.42 </SECTNO>
                                <SUBJECT>Permissible methods of taking.</SUBJECT>
                                <P>Under LOAs issued pursuant to §§ 216.106 of this chapter and 217.46, the Holder of the LOAs (hereinafter “AGDC”) may incidentally, but not intentionally, take marine mammals within the area described in § 217.40(b) by Level A harassment and Level B harassment associated with pile driving and pipe laying activities, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the applicable LOAs.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.43 </SECTNO>
                                <SUBJECT>Prohibitions.</SUBJECT>
                                <P>Notwithstanding takings contemplated in § 217.42 and authorized by LOAs issued under §§ 216.106 of this chapter and 217.46, no person in connection with the activities described in § 217.40 may:</P>
                                <P>(a) Violate, or fail to comply with, the terms, conditions, and requirements of this subpart or a LOA issued under §§ 216.106 of this chapter and 217.46;</P>
                                <P>(b) Take any marine mammal not specified in such LOAs; and</P>
                                <P>(c) Take any marine mammal specified in such LOAs in any manner other than as specified.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.44 </SECTNO>
                                <SUBJECT>Mitigation requirements.</SUBJECT>
                                <P>When conducting the activities identified in § 217.40(c), the mitigation measures contained in any LOAs issued under §§ 216.106 of this chapter and 217.46 must be implemented. These mitigation measures must include but are not limited to:</P>
                                <P>
                                    (a) 
                                    <E T="03">Time and area restriction.</E>
                                     AGDC must follow the following time and area restrictions.
                                </P>
                                <P>(1) In-water pile driving must occur only during daylight hours. Times for other construction activities, such as pipe laying, anchor handling, and dredging are not restricted.</P>
                                <P>(2) Pile driving associated with the Mainline Material Offloading Facility (Mainline MOF) must not occur from June 1 to September 7 (pile driving can occur from September 8 to May 31).</P>
                                <P>(3) Other than in-water sheet pile driving and pile removal, anchor handling, trenching, pipe laying, and vessel transits related to these activities, AGDC may not engage in in-water sound-producing activities within 10 miles (16 km) of the mean higher high water (MHHW) line of the Susitna Delta (Beluga River to the Little Susitna River) between April 15 and October 15 which produce sound levels in excess of 120 dB rms re 1µPa @ 1 m.</P>
                                <P>
                                    (b) 
                                    <E T="03">Establishment of monitoring and exclusion zones.</E>
                                     (1) For all relevant in-water construction activity, AGDC must designate Level A harassment zones 
                                    <PRTPAGE P="50752"/>
                                    with radial distances as identified in any LOA issued under §§ 216.106 of this chapter and 217.46.
                                </P>
                                <P>(2) For all relevant in-water construction activity, AGDC must designate Level B harassment zones with radial distances as identified in any LOA issued under §§ 216.106 of this chapter and 217.46.</P>
                                <P>(3) For all in-water pile driving work, AGDC must implement an exclusion zone for each specific activity as identified in any LOA issued under §§ 216.106 of this chapter and 217.46. If a marine mammal comes within or enters the exclusion zone, AGDC must cease all operations.</P>
                                <P>(i) For humpback whale and killer whale during in-water pile driving activity, the exclusion zones must be based on the Level A harassment distances, but must not be less than 10 m from the pile.</P>
                                <P>(ii) For harbor porpoise and harbor seal during in-water pile driving activity, the exclusion zones must be based on the Level A harassment distances up to 1,000 m, but must not be less than 10 m from the pile.</P>
                                <P>(iii) For Cook Inlet beluga whale during in-water pile driving activity, the exclusion zones must be based on the Level B harassment distances.</P>
                                <P>(iv) A 2,900-m exclusion zone must be established for Cook Inlet beluga whale before pipe laying activity associated with anchor handling can occur.</P>
                                <P>(v) A minimum of 10-m exclusion zone must be established for in-water construction and heavy machinery not addressed elsewhere in this paragraph (b)(3).</P>
                                <P>
                                    (c) 
                                    <E T="03">Monitoring of exclusion zones.</E>
                                     Pile driving must only take place when the exclusion zones are visible and can be adequately monitored. If visibility degrades to where the entire exclusion zone cannot be effectively monitored during pile driving, AGDC may continue to drive the pile section that was being driven to its target depth, but may not drive additional sections of pile.
                                </P>
                                <P>
                                    (d) 
                                    <E T="03">Shutdown measures.</E>
                                     (1) AGDC must deploy protected species observers (PSOs) to monitor marine mammals during in-water pile driving and pipe laying activities.
                                </P>
                                <P>(2) Monitoring must take place from 30 minutes prior to initiation of pile driving or pipe laying activities through 30 minutes post-completion of pile driving or pipe laying activities.</P>
                                <P>
                                    (i) For pile driving activity, pre-activity monitoring must be conducted for 30 minutes to confirm that the exclusion zone is clear of marine mammals, and pile driving may commence only if observers have declared the exclusion zone clear of marine mammals for that full duration of time. Monitoring must occur throughout the time required to drive a pile. A determination that the exclusion zone is clear must be made during a period of good visibility (
                                    <E T="03">i.e.,</E>
                                     the entire exclusion zone and surrounding waters must be visible to the naked eye).
                                </P>
                                <P>(ii) If marine mammals are found within the exclusion zone, pile driving of the segment must be delayed until they move out of the area. If a marine mammal is seen above water and then dives below, the contractor must wait 30 minutes for large cetaceans (humpback whale) and 15 minutes for small cetaceans (beluga and killer whales and harbor porpoise) and pinnipeds. If no marine mammals of that species are seen by the observer in that time it can be assumed that the animal has moved beyond the exclusion zone.</P>
                                <P>(iii) If pile driving of a segment ceases for 30 minutes or more and a marine mammal is sighted within the designated exclusion zone prior to commencement of pile driving, the observer(s) must notify the pile driving operator (or other authorized individual) immediately and continue to monitor the exclusion zone. Operations may not resume until the marine mammal has exited the exclusion zone or 30 minutes have elapsed for large cetaceans or 15 minutes have elapsed for small cetaceans and pinnipeds since the last sighting.</P>
                                <P>(3) If a marine mammal authorized to be taken by Level B harassment enters or approaches the exclusion zone, if a marine mammal not specified in the LOAs enters the Level B harassment zone, or if the take of a marine mammal species or stock has reached the take limits specified in any LOA issued under §§ 216.106 of this chapter and 217.46 and enters the Level B harassment zone, AGDC must halt all construction activities at that location. If construction is halted or delayed due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily left and been visually confirmed beyond the shutdown or Level B harassment zone, whichever applicable, or 30 minutes have passed without re-detection of the animal if it is a larger cetacean (humpback whale), or 15 minutes have passed without re-detection of the animal if it is a small cetacean (beluga and killer whales and porpoises) or pinniped.</P>
                                <P>
                                    (e) 
                                    <E T="03">Soft start.</E>
                                     (1) AGDC must implement soft start techniques for impact pile driving. AGDC must conduct an initial set of three strikes from the impact hammer at 40 percent energy, followed by a 30-second waiting period, then two subsequent three strike sets with associated 30-seconds waiting periods at the reduced energy.
                                </P>
                                <P>(2) Soft start must be required for any impact driving, including at the beginning of the day, and at any time following a cessation of impact pile driving of 30 minutes or longer.</P>
                                <P>
                                    (f) 
                                    <E T="03">Noise attenuation device.</E>
                                     For pile-driving at the Mainline MOF near the Beluga River, and on the east side of Cook Inlet near Nikiski associated with the liquefaction facility, AGDC must deploy air bubble curtains around piles. If the sound source verification (SSV) measurements indicate that the best-performing bubble curtain configuration provides less than a 2 dB reduction in in-water sound beyond the bubble curtain, use of the bubble curtain may be discontinued.
                                </P>
                                <P>
                                    (g) 
                                    <E T="03">Vessel transit.</E>
                                     (1) Operators of vessels must, at all times, avoid approaching within 100 yards of marine mammals. Operators must observe direction of travel of marine mammals and attempt to maintain a distance of 100 yards or greater between the animal and the vessel by working to alter vessel course or velocity.
                                </P>
                                <P>
                                    (2) The vessel operator must avoid placing the vessel between members of a group of marine mammals in a way that may cause separation of individuals in the group from other individuals in that group. A group is defined as being three or more whales observed within 500-m of one-another and displaying behaviors of directed or coordinated activity (
                                    <E T="03">e.g.,</E>
                                     migration or group feeding).
                                </P>
                                <P>(3) If the vessel approaches within 1.6 km (1 mi) of one or more whales, the vessel operator must take reasonable precautions to avoid potential interaction with the whales by taking one or more of the following actions, as appropriate:</P>
                                <P>(i) Steering to the rear of whale(s) to avoid causing changes in their direction of travel.</P>
                                <P>(ii) Maintaining vessel speed of 10 knots (19 km/hr) or less when transiting to minimize the likelihood of lethal vessel strikes.</P>
                                <P>(iii) Reducing vessel speed to less than 5 knots (9 km/hour) within 274 m (300 yards) of the whale(s).</P>
                                <P>
                                    (4) Project vessels must remain a minimum of 2.8 km (1.5 nm) seaward of the mean lower low water (MLLW) line between the Little Susitna River and −150.80 degrees west longitude to minimize the impacts of vessel sound and avoid strikes on Cook Inlet beluga whales between June 1 and September 7. The Susitna Delta Exclusion Zone is 
                                    <PRTPAGE P="50753"/>
                                    defined as the union of the areas defined by:
                                </P>
                                <P>(i) A 16-km (10-mile) buffer of the Beluga River thalweg seaward of the mean lower low water (MLLW) line;</P>
                                <P>(ii) A 16-km (10-mile) buffer of the Little Susitna River thalweg seaward of the MLLW line; and</P>
                                <P>(iii) A 16-km (10-mile) seaward buffer of the MLLW line between the Beluga River and Little Susitna River.</P>
                                <P>(iv) The buffer extends landward along the thalweg to include intertidal waters within rivers and streams up to their mean higher high water line (MHHW). The seaward boundary has been simplified so that it is defined by lines connecting readily discernable landmarks.</P>
                                <P>(5) For vessels operating in the Susitna Delta Exclusion Zone, the following must be implemented:</P>
                                <P>(i) All project vessels operating within the designated Susitna Delta area must maintain a speed over ground below 4 knots. PSOs must note the numbers, date, time, coordinates, and proximity to vessels of all belugas observed during operations, and report these observations to NMFS in monthly PSO reports.</P>
                                <P>(ii) Vessel crew must be trained to monitor for Endangered Species Act (ESA)-listed species prior to and during all vessel movements within the Susitna Delta Exclusion Zone. The vessel crew must report sightings to the PSO team for inclusion in the overall sighting database and reports.</P>
                                <P>(iii) Vessel operators must not move their vessels when they are unable to adequately observe the 100-m zone around vessels under power (in gear) due to darkness, fog, or other conditions, unless necessary for ensuring human safety.</P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.95 </SECTNO>
                                <SUBJECT>Requirements for monitoring and reporting.</SUBJECT>
                                <P>
                                    (a) 
                                    <E T="03">Marine mammal visual monitoring</E>
                                    —(1) 
                                    <E T="03">Protected species observers.</E>
                                     AGDC must employ trained protected species observers (PSO) to conduct marine mammal monitoring for its LNG facilities construction projects.
                                </P>
                                <P>(i) The PSOs must observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all construction work. PSOs must have no other assigned tasks during monitoring periods, and must be placed at appropriate and safe vantage point(s) practicable to monitor for marine mammals and implement shutdown or delay procedures, when applicable, through communication with the equipment operator.</P>
                                <P>(ii) [Reserved]</P>
                                <P>
                                    (2) 
                                    <E T="03">Protected species observer qualifications.</E>
                                     AGDC must adhere to the following observer qualifications:
                                </P>
                                <P>
                                    (i) Independent PSOs (
                                    <E T="03">i.e.,</E>
                                     not construction personnel) who have no other assigned tasks during monitoring periods must be used;
                                </P>
                                <P>(ii) Where a team of three or more PSOs are required, a lead observer or monitoring coordinator must be designated. The lead observer must have prior experience working as a marine mammal observer during construction;</P>
                                <P>(iii) Other PSOs may substitute education (degree in biological science or related field) or training for experience;</P>
                                <P>(iv) AGDC must submit PSO CVs for approval by NMFS prior to the onset of pile driving;</P>
                                <P>(v) The PSOs must have the ability to conduct field observations and collect data according to assigned protocols;</P>
                                <P>(vi) The PSOs must have the experience or training in the field identification of marine mammals, including the identification of behaviors;</P>
                                <P>(vii) The PSOs must have sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;</P>
                                <P>(viii) The PSOs must have writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and</P>
                                <P>(ix) The PSOs must have the ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.</P>
                                <P>
                                    (3) 
                                    <E T="03">Marine mammal monitoring protocols.</E>
                                     AGDC must adhere to the following marine mammal monitoring protocols:
                                </P>
                                <P>(i) For pile driving activities, a minimum of two PSOs must be on duty at all times;</P>
                                <P>(ii) For pile driving activities, PSOs must be stationed on a bluff with minimum height 500 feet above sea level immediately above the construction site;</P>
                                <P>(iii) For marine mammal monitoring during pipe laying activities, at least one PSO must be on the barge and on watch;</P>
                                <P>(iv) PSOs may not exceed 4 consecutive watch hours; must have a minimum two-hour break between watches; and may not exceed a combined watch schedule of more than 12 hours in a 24-hour period;</P>
                                <P>(v) PSOs must have no other construction-related tasks while conducting monitoring;</P>
                                <P>(vi) Monitoring must be conducted from 30 minutes prior to commencement of pile driving, throughout the time required to drive a pile, and for 30 minutes following the conclusion of pile driving;</P>
                                <P>(vii) Monitoring must be conducted from 30 minutes prior to commencement of pipe laying activity, throughout the time of pipe laying, and for 30 minutes following the conclusion of pipe laying for the segment;</P>
                                <P>(viii) During all observation periods, PSOs must use high-magnification (25X), as well as standard handheld (7X) binoculars, and the naked eye to search continuously for marine mammals;</P>
                                <P>(ix) Monitoring distances must be measured with range finders. Distances to animals must be based on the best estimate of the PSO, relative to known distances to objects in the vicinity of the PSO; and</P>
                                <P>(x) Bearings to animals must be determined using a compass.</P>
                                <P>
                                    (4) 
                                    <E T="03">Marine mammal monitoring data collection.</E>
                                     PSOs must collect the following information during marine mammal monitoring:
                                </P>
                                <P>(i) Date and time that monitored activity begins and ends for each day conducted (monitoring period);</P>
                                <P>(ii) Construction activities occurring during each daily observation period, including how many and what type of piles driven and distances covered during pipe laying;</P>
                                <P>(iii) Deviation from initial proposal in pile numbers, pile types, average driving times, and pipe laying distances, etc.;</P>
                                <P>
                                    (iv) Weather parameters in each monitoring period (
                                    <E T="03">e.g.,</E>
                                     wind speed, percent cloud cover, visibility);
                                </P>
                                <P>
                                    (v) Water conditions in each monitoring period (
                                    <E T="03">e.g.,</E>
                                     sea state, tide state);
                                </P>
                                <P>(vi) For each marine mammal sighting:</P>
                                <P>(A) Species, numbers, and, if possible, sex and age class of marine mammals;</P>
                                <P>(B) Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving and pipe laying activities, and notable changes in patterns;</P>
                                <P>(C) Location and distance from pile driving and pipe laying activities to marine mammals and distance from the marine mammals to the observation point; and</P>
                                <P>
                                    (D) Estimated amount of time that the animals remained in the Level A and/or Level B harassment zones;
                                    <PRTPAGE P="50754"/>
                                </P>
                                <P>
                                    (vii) Description of implementation of mitigation measures within each monitoring period (
                                    <E T="03">e.g.,</E>
                                     shutdown or delay); and
                                </P>
                                <P>(viii) Other human activity in the area within each monitoring period.</P>
                                <P>
                                    (b) 
                                    <E T="03">Acoustic monitoring.</E>
                                     AGDC must conduct a sound source verification (SSV) in accordance with the requirements in the LOA, at the beginning of the pile driving to characterize the sound levels associated with different pile and hammer types, as well as to establish the marine mammal monitoring and mitigation zones.
                                </P>
                                <P>(1) A minimum of 2 piles of each type and size must be measured.</P>
                                <P>(2) The following data, at minimum, shall be collected during acoustic monitoring and reported:</P>
                                <P>(i) Hydrophone equipment and methods: Recording device, sampling rate, distance from the pile where recordings were made; depth of recording device(s);</P>
                                <P>(ii) Type of pile being driven and method of driving during recordings; and</P>
                                <P>
                                    (iii) Mean, median, and maximum sound levels (dB re: 1µPa): Cumulative sound exposure level (SEL
                                    <E T="52">cum</E>
                                    ), peak sound pressure level (SPL
                                    <E T="52">peak</E>
                                    ), root mean square sound pressure level (SPL
                                    <E T="52">rms</E>
                                    ), and single-strike sound exposure level (SEL
                                    <E T="52">s-s</E>
                                    ).
                                </P>
                                <P>(3) An SSV report must be submitted to NMFS within 72 hours after field measurements for approval of the results.</P>
                                <P>(4) The results of the SSV report may be used to adjust the extent of Level A and Level B harassment zones in-water pile driving.</P>
                                <P>
                                    (c) 
                                    <E T="03">Reporting measures</E>
                                    —(1) 
                                    <E T="03">Notification.</E>
                                     AGDC must notify NMFS 48 hours prior to the start of each activity in Cook Inlet that may cause harassment of marine mammals. If there is a delay in activity, AGDC must also notify NMFS as soon as practicable.
                                </P>
                                <P>
                                    (2) 
                                    <E T="03">Monthly report.</E>
                                     AGDC must submit monthly reports via email to NMFS Office of Protected Resources (OPR) and Alaska Regional Office (AKRO) for all months with project activities by the 15th of the month following the monthly reporting period. The monthly report must contain and summarize the following information:
                                </P>
                                <P>(i) Dates, times, locations, heading, speed, weather, sea conditions (including Beaufort sea state and wind force), and a list of all in-water sound-producing activities occurring concurrent with marine mammal observations;</P>
                                <P>
                                    (ii) Species, number, location, distance from the vessel, and behavior of all observed marine mammals, as well as associated project activity (
                                    <E T="03">e.g.,</E>
                                     number of power-downs and shutdowns), observed throughout all monitoring activities;
                                </P>
                                <P>(iii) Observation data in paragraphs (a) and (b) of this section must be provided in digital spreadsheet format that can be queried;</P>
                                <P>(iv) An estimate of the number of animals (by species) exposed to sound at received levels greater than or equal to either the Level A or Level B harassment thresholds, with a discussion the time spent above those received levels and of any specific behaviors those individuals exhibited;</P>
                                <P>(v) If the extent of Level B harassment zone is beyond visual observation, AGDC must also include an appropriate adjustment to estimate the total numbers of marine mammals taken based on the portion of the areas that are monitored; and</P>
                                <P>(vi) A description of the implementation and effectiveness of the terms and conditions of the Biological Opinion's Incidental Take Statement and mitigation and monitoring measures of the LOA.</P>
                                <P>
                                    (3) 
                                    <E T="03">Marine mammal tally numbers.</E>
                                     (i) AGDC must keep a tally of the estimated number of marine mammals that are taken, based on the number of marine mammals observed within the applicable harassment zones, and alert NMFS when the authorized limit is close to being met based on prescribed monitoring measured in the final rule; and
                                </P>
                                <P>(ii) AGDC must keep a tally of the number of marine mammal that are sighted during the pile driving and pipe laying activities.</P>
                                <P>
                                    (4) 
                                    <E T="03">Beluga whale takes.</E>
                                     AGDC must immediately notify NMFS if the number of Cook Inlet beluga estimated as taken (based on observed exposures above thresholds) reaches 80% of the authorized takes in any given calendar year during which take is authorized.
                                </P>
                                <P>
                                    (5) 
                                    <E T="03">Annual report.</E>
                                     (i) AGDC must submit a comprehensive annual report to NMFS within 90 calendar days of the cessation of in-water work each year for review. The report must synthesize all sighting data and effort during each activity for each year.
                                </P>
                                <P>(ii) NMFS will provide comments within 30 days after receiving annual reports, and AGDC must address the comments and submit revisions within 30 days after receiving NMFS comments.</P>
                                <P>(iii) If no comments are received from the NMFS within 30 days, the annual report is considered completed.</P>
                                <P>(iv) The report must include the following information:</P>
                                <P>(A) Summaries of monitoring effort including total hours, observation rate by species and marine mammal distribution through the study period, accounting for sea state and other factors affecting visibility and detectability of marine mammals.</P>
                                <P>
                                    (B) Analyses of the effects of various factors that may have influenced detectability of marine mammals (
                                    <E T="03">e.g.,</E>
                                     sea state, number of observers, fog/glare, and other factors as determined by the PSOs).
                                </P>
                                <P>(C) Species composition, occurrence, and distribution of marine mammal sightings, including date, water depth, numbers, age/size/gender categories (if determinable), group sizes, and ice cover.</P>
                                <P>(D) Marine mammal observation data with a digital record of observation data provided in digital spreadsheet format that can be queried.</P>
                                <P>
                                    (E) Summary of implemented mitigation measures (
                                    <E T="03">i.e.,</E>
                                     shutdowns and delays).
                                </P>
                                <P>(F) Number of marine mammals during periods with and without project activities (and other variables that could affect detectability), such as:</P>
                                <P>
                                    (
                                    <E T="03">1</E>
                                    ) Initial sighting distances versus project activity at the time of sighting;
                                </P>
                                <P>
                                    (
                                    <E T="03">2</E>
                                    ) Closest point of approach versus project activity;
                                </P>
                                <P>
                                    (
                                    <E T="03">3</E>
                                    ) Observed behaviors and types of movements versus project activity;
                                </P>
                                <P>
                                    (
                                    <E T="03">4</E>
                                    ) Numbers of sightings/individuals seen versus project activity;
                                </P>
                                <P>
                                    (
                                    <E T="03">5</E>
                                    ) Distribution around the source vessels versus project activity; and
                                </P>
                                <P>
                                    (
                                    <E T="03">6</E>
                                    ) Numbers of animals detected in the exclusion zone.
                                </P>
                                <P>(G) Analyses of the effects of project activities on listed marine mammals.</P>
                                <P>
                                    (6) 
                                    <E T="03">Final report.</E>
                                     (i) AGDC must provide NMFS, within 90 days of project completion at the end of the five-year period, a report of all parameters listed in the monthly and annual report requirements in paragraph (c) of this section, noting also all operational shutdowns or delays necessitated due to the proximity of marine mammals.
                                </P>
                                <P>(ii) NMFS will provide comments within 30 days after receiving this report, and AGDC must address the comments and submit revisions within 30 days after receiving NMFS comments.</P>
                                <P>(iii) If no comments are received from the NMFS within 30 days, the final report is considered as final.</P>
                                <P>
                                    (7) 
                                    <E T="03">Reporting of injured or dead marine mammals.</E>
                                     (i) In the unanticipated event that the construction or demolition activities clearly cause the take of a marine mammal in a prohibited manner, such 
                                    <PRTPAGE P="50755"/>
                                    as an injury, serious injury, or mortality, AGDC must immediately cease operations with the potential to impact marine mammals in the vicinity and immediately report the incident to the NMFS Office of Protected Resources, NMFS Alaska Regional Office, and the Alaska Region Stranding Coordinators. The report must include the following information:
                                </P>
                                <P>(A) Time, date, and location (latitude/longitude) of the incident;</P>
                                <P>(B) Description of the incident;</P>
                                <P>(C) Status of all sound source use in the 24 hours preceding the incident;</P>
                                <P>
                                    (D) Environmental conditions (
                                    <E T="03">e.g.,</E>
                                     wind speed and direction, sea state, cloud cover, visibility, and water depth);
                                </P>
                                <P>(E) Description of marine mammal observations in the 24 hours preceding the incident;</P>
                                <P>(F) Species identification or description of the animal(s) involved;</P>
                                <P>(G) The fate of the animal(s); and</P>
                                <P>(H) Photographs or video footage of the animal (if equipment is available).</P>
                                <P>(ii) Activities must not resume until NMFS is able to review the circumstances of the prohibited take. NMFS must work with AGDC to determine what is necessary to minimize the likelihood of further prohibited take and ensure Marine Mammal Protection Act (MMPA) compliance. AGDC may not resume its activities until notified by NMFS via letter, email, or telephone.</P>
                                <P>
                                    (iii) In the event that AGDC discovers an injured or dead marine mammal, and the lead PSO determines that the cause of the injury or death is unknown and the death is relatively recent (
                                    <E T="03">i.e.,</E>
                                     in less than a moderate state of decomposition as described in paragraph (c)(7)(iv) of this section), AGDC must immediately report the incident to the NMFS Office of Protected Resources, NMFS Alaska Regional Office, and the Alaska Regional Stranding Coordinators. The report must include the same information identified in paragraph (b)(3)(i) of this section. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with AGDC to determine whether modifications in the activities are appropriate.
                                </P>
                                <P>
                                    (iv) In the event that AGDC discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized in the LOA (
                                    <E T="03">e.g.,</E>
                                     previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), AGDC must report the incident to the NMFS Office of Protected Resources, NMFS Alaska Regional Office, and the Alaska Regional Stranding Coordinators, within 48 hours of the discovery. AGDC must provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. AGDC may continue its operations under such a case.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.46 </SECTNO>
                                <SUBJECT>Letters of Authorization.</SUBJECT>
                                <P>(a) To incidentally take marine mammals pursuant to the regulations in this subpart, AGDC must apply for and obtain (LOAs) in accordance with § 216.106 of this chapter for conducting the activity identified in § 217.40(c).</P>
                                <P>(b) LOAs, unless suspended or revoked, may be effective for a period of time not to extend beyond the expiration date of the regulations in this subpart.</P>
                                <P>(c) If an LOA(s) expires prior to the expiration date of the regulations in this subpart, AGDC may apply for and obtain a renewal of the LOA(s).</P>
                                <P>(d) In the event of projected changes to the activity or to mitigation, monitoring, reporting (excluding changes made pursuant to the adaptive management provision of § 217.47(c)(1)) required by an LOA, AGDC must apply for and obtain a modification of LOAs as described in § 217.47.</P>
                                <P>(e) Each LOA must set forth:</P>
                                <P>(1) Permissible methods of incidental taking;</P>
                                <P>
                                    (2) Means of effecting the least practicable adverse impact (
                                    <E T="03">i.e.,</E>
                                     mitigation) on the species, their habitat, and the availability of the species for subsistence uses; and
                                </P>
                                <P>(3) Requirements for monitoring and reporting.</P>
                                <P>(f) Issuance of the LOA(s) must be based on a determination that the level of taking must be consistent with the findings made for the total taking allowable under the regulations in this subpart.</P>
                                <P>
                                    (g) Notice of issuance or denial of the LOA(s) must be published in the 
                                    <E T="04">Federal Register</E>
                                     within 30 days of a determination.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ 217.47 </SECTNO>
                                <SUBJECT>Renewals and modifications of Letters of Authorization.</SUBJECT>
                                <P>(a) An LOA issued under §§ 216.106 of this chapter and 217.46 for the activity identified in § 217.40(c) must be renewed or modified upon request by the applicant, provided that:</P>
                                <P>(1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for the regulations in this subpart (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section); and</P>
                                <P>(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA(s) under the regulations in this subpart were implemented.</P>
                                <P>
                                    (b) For LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting measures (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section) that do not change the findings made for the regulations in this subpart or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the 
                                    <E T="04">Federal Register</E>
                                    , including the associated analysis of the change, and solicit public comment before issuing the LOA.
                                </P>
                                <P>(c) An LOA issued under §§ 216.106 of this chapter and 217.46 for the activity identified in § 217.40(c) may be modified by NMFS under the following circumstances:</P>
                                <P>
                                    (1) 
                                    <E T="03">Adaptive management.</E>
                                     After consulting with AGDC regarding the practicability of the modifications, NMFS may modify (including by adding or removing measures) the existing mitigation, monitoring, or reporting measures if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the regulations in this subpart.
                                </P>
                                <P>(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, or reporting measures in an LOA:</P>
                                <P>(A) Results from AGDC's monitoring from the previous year(s);</P>
                                <P>(B) Results from other marine mammal and/or sound research or studies; or</P>
                                <P>(C) Any information that reveals marine mammals may have been taken in a manner, extent or number not authorized by the regulations in this subpart or subsequent LOAs.</P>
                                <P>
                                    (ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS must publish a notice of proposed LOA in the 
                                    <E T="04">Federal Register</E>
                                     and solicit public comment.
                                </P>
                                <PRTPAGE P="50756"/>
                                <P>
                                    (2) 
                                    <E T="03">Emergencies.</E>
                                     If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in LOAs issued pursuant to §§ 216.106 of this chapter and 217.46, an LOA may be modified without prior notice or opportunity for public comment. Notice would be published in the 
                                    <E T="04">Federal Register</E>
                                     within 30 days of the action.
                                </P>
                            </SECTION>
                            <SECTION>
                                <SECTNO>§ § 217.48-217.49</SECTNO>
                                <SUBJECT> [Reserved]</SUBJECT>
                            </SECTION>
                        </SUBPART>
                    </REGTEXT>
                </SUPLINF>
                <FRDOC>[FR Doc. 2020-15404 Filed 8-14-20; 8:45 am]</FRDOC>
                <BILCOD>BILLING CODE 3510-22-P</BILCOD>
            </RULE>
        </RULES>
    </NEWPART>
</FEDREG>
