1.Short title; table of contents
(a)This Act may be cited as the ESRD Modernization Act of 2004
.
(b)The table of contents of this Act is as follows:
Sec. 1. Short title; table of contents
Title I—Modernizing the medicare ESRD payment system
Sec. 101. Establishment of annual update framework for the medicare ESRD composite rate
Title II—Patient education, quality, access and safety initiatives
Sec. 201. Support of public and patient education initiatives regarding kidney disease
Sec. 202. Medicare coverage of kidney disease patient education services
Sec. 203. Blood flow monitoring demonstration projects
Title III—Financing and coverage for ESRD patients
Sec. 301. Improving the home dialysis benefit
Sec. 302. Institute of Medicine evaluation and report on home dialysis
Title IV—Sustainable economics
Sec. 401. Modification of physician surgical reimbursement for dialysis access procedures to align incentives for cost and quality
Sec. 402. Demonstration project for outcomes-based ESRD reimbursement system
Sec. 403. GAO study and report on impact of G-codes
<enum>I</enum><header>Modernizing the medicare ESRD payment system</header>
<section id="H0815B69A2BFC4EA0A71EE5672F7B9013"><enum>101.</enum><header>Establishment of annual update framework for the medicare ESRD composite rate</header>
<subsection id="HFA809177AE314D789314A0C75BEB915B"><enum>(a)</enum><header>In general</header><text>Section 1881(b)(12)(F) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(12)(F)</external-xref>), as added by section 623(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2313), is amended to read as follows:</text>
<quoted-block act-name="Social Security Act" id="H9503B6BF157C4AC1984EBD33AF8C3FD6">
<subparagraph indent="up2" id="H77AB108E315746ECA0EBAAD55600D4D"><enum>(F)</enum><text>Beginning with 2006, the Secretary shall annually increase the basic case-mix adjusted payment amounts established under this paragraph—</text>
<clause id="H6A3099E689934F13A319756F0090F90"><enum>(i)</enum><text>with respect to the composite rate component of the basic case-mix adjusted system described in subparagraph (B)(i), by the ESRD market basket percentage increase (as defined in paragraph (14)(A) and including any additional factors that may increase costs described in paragraph (14)(B)) above such composite rate payment amounts for such services furnished on December 31 of the previous year; and</text></clause>
<clause id="HB35482E41DAB437291C808F9945DD46"><enum>(ii)</enum><text>with respect to the component of the basic case-mix adjusted system described in clause (ii) of subparagraph (B), by—</text>
<subclause id="H0927C7CEC4F7472DBF00AF1BEB19CAFD"><enum>(I)</enum><text>applying the estimated growth in expenditures for drugs and biologicals (including erythropoietin) that are separately billable to such component; and</text></subclause>
<subclause id="HF082ED563A4A4F17B309E816E8D88E36"><enum>(II)</enum><text>converting the amount determined in subclause (I) to an increase applicable to the basic case-mix adjusted payment amounts established under such subparagraph.</text></subclause></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection>
<subsection id="H525BB7C874C14C14B9A132838812C83D"><enum>(b)</enum><header>ESRD market basket percentage increase defined</header><text>Section 1881(b) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)</external-xref>), as amended by section 623(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2313) is amended by adding at the end the following new paragraph:</text>
<quoted-block act-name="Social Security Act" id="H4ACB522DFD8E483A91B6B3AF04A041B5">
<paragraph indent="up1" id="HFEBF0EF1431F4D1FAA57B555B25FA5B0"><enum>(14)</enum>
<subparagraph display-inline="yes-display-inline" id="H46EC1A0905A945C3A9DB787EC36E10DD"><enum>(A)</enum><text>For purposes of this title, the term <term>ESRD market basket percentage increase</term> means, with respect to a calendar year, the percentage (estimated by the Secretary before the beginning of such year) by which—</text>
<clause indent="up1" id="H23BCA0C03A5F4AE0A4BAD27953D70062"><enum>(i)</enum><text>the cost of the mix of goods and services included in the provision of dialysis services (including the costs described in subparagraph (D)) that is determined based on an index of appropriately weighted indicators of changes in wages and prices which are representative of the mix of goods and services included in such dialysis services for the calendar year; exceeds</text></clause>
<clause indent="up1" id="HA030E617448D403FB27CA8E7F1E10086"><enum>(ii)</enum><text>the cost of such mix of goods and services for the preceding calendar year.</text></clause></subparagraph>
<subparagraph indent="up1" id="H7076CE61DE364961A76F0799FFE17381"><enum>(B)</enum><text>In addition to determining the percentage update under subparagraph (A), the Secretary shall also take into account any change in the costs of furnishing the mix of goods and services described in such subparagraph resulting from—</text>
<clause id="H36F23DD12DE2412ABC38C6794BF427B"><enum>(i)</enum><text>the adoption of scientific and technological innovations used to provide dialysis services;</text></clause>
<clause id="H34E168B7F8D4439894B99625D600A92B"><enum>(ii)</enum><text>changes in the manner or method of delivering dialysis services;</text></clause>
<clause id="H600788E89372451CAACE2595E8541C98"><enum>(iii)</enum><text>productivity improvements in the provision of dialysis services; and</text></clause>
<clause id="H71E03652766E4F6A83DD6FAD37C67313"><enum>(iv)</enum><text>any other relevant factor.</text></clause></subparagraph>
<subparagraph indent="up1" id="H8ACFEBEAF5A14919BBF5D943C29300B6"><enum>(C)</enum><text>The Secretary shall annually review and update the items and services included in the mix of goods and services used to determine the percentage under subparagraph (A).</text></subparagraph>
<subparagraph indent="up1" id="H91CF3AB614A5470BBF9D9641EA319990"><enum>(D)</enum><text>The costs described in this subparagraph include—</text>
<clause id="HD49FBBC06A5A41999041B223C6413DAE"><enum>(i)</enum><text>labor costs, including direct patient care costs and administrative labor costs, vacation and holiday pay, payroll taxes, and employee benefits;</text></clause>
<clause id="H0EFD295DE28046E5A2D3166668CB3EDD"><enum>(ii)</enum><text>other direct costs, including drugs, supplies, and laboratory fees;</text></clause>
<clause id="H6A639A109E564533A92E2F055DBB0062"><enum>(iii)</enum><text>overhead costs, including medical director fees, temporary services, general and administrative costs, interest expenses, and bad debt;</text></clause>
<clause id="HE25D910A81214224BFF1AAE71D7DA181"><enum>(iv)</enum><text>capital costs, including rent, real estate taxes, depreciation, utilities, repairs, and maintenance; and</text></clause>
<clause id="H04AFC07BEB51456B86F77B09D58D0000"><enum>(v)</enum><text>such other allowable costs as the Secretary may specify.</text></clause></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<enum>II</enum><header>Patient education, quality, access and safety initiatives</header>
<section id="H2F3149B8CEE44DAD972DB3F203EC4C8D"><enum>201.</enum><header>Support of public and patient education initiatives regarding kidney disease</header>
<subsection id="H2C1AFE2D9D5D4D95B8B008E74DAE64F"><enum>(a)</enum><header>Chronic kidney disease demonstration projects</header>
<paragraph id="HABEDCCC38A5940B0A7BAED363DD2F519"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish demonstration projects to—</text>
<subparagraph id="H2F991D3E871B4BADAF00BE9D015A5F6"><enum>(A)</enum><text>increase public awareness about the factors that lead to chronic kidney disease, how to prevent it, how to treat it, and how to avoid kidney failure; and</text></subparagraph>
<subparagraph id="H09334F3B8ABC48C5BF21F2BEBCB0C496"><enum>(B)</enum><text>enhance surveillance systems and expand research to better assess the prevalence and incidence of chronic kidney disease.</text></subparagraph></paragraph>
<paragraph id="H69CADF13BE0C471D9E6D1E44019B1295"><enum>(2)</enum><header>Scope and duration</header>
<subparagraph id="HE7F69219651748048EF4B0A01D3051F9"><enum>(A)</enum><header>Scope</header><text>The Secretary shall select at least 3 States in which to conduct demonstration projects under this subsection. In selecting the States under this subparagraph, the Secretary shall take into account the size of the population of medicare beneficiaries with end-stage renal disease and ensure the participation of individuals who reside in rural and urban areas.</text></subparagraph>
<subparagraph id="H730039F76EF4481ABDF5668215E68DB6"><enum>(B)</enum><header>Duration</header><text>The demonstration projects under this subsection shall be conducted for a period that is not longer than 5 years that begins on January 1, 2006.</text></subparagraph></paragraph>
<paragraph id="H22DE92E72CD24B84841F52C8E8DDF675"><enum>(3)</enum><header>Evaluation and report</header>
<subparagraph id="H493E8612C6D5469383C4D0E36405EE00"><enum>(A)</enum><header>Evaluation</header><text>The Secretary shall conduct an evaluation of the demonstration projects conducted under this subsection.</text></subparagraph>
<subparagraph id="HFA8863F6DB3A4EF9B82954356EC8A88D"><enum>(B)</enum><header>Report</header><text>Not later than 6 months after the date on which the demonstration projects under this subsection are completed, the Secretary shall submit to Congress a report on the evaluation conducted under subparagraph (A) together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text></subparagraph></paragraph>
<paragraph id="H1A2A0AC14BC64495B402A5B302C70046"><enum>(4)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2006 through 2010.</text></paragraph></subsection>
<subsection id="H953994E9F6CF4C2F83CC8E33C46C20D7"><enum>(b)</enum><header>ESRD self-management demonstration projects</header>
<paragraph id="H94123F773905488DA78D3CE49B3287E7"><enum>(1)</enum><header>In general</header><text>The Secretary shall establish demonstration projects to enable individuals with end-stage renal disease to develop self-management skills.</text></paragraph>
<paragraph id="H151C4289CE7D49DF80E0E0589E36CDB7"><enum>(2)</enum><header>Scope and duration</header>
<subparagraph id="HBD7994696F7B47968DED00934338752E"><enum>(A)</enum><header>Scope</header><text>The Secretary shall select at least 3 States in which to conduct demonstration projects under this subsection. In selecting the States under this subparagraph, the Secretary shall take into account the size of the population of medicare beneficiaries with end-stage renal disease and ensure the participation of individuals who reside in rural and urban areas.</text></subparagraph>
<subparagraph id="HDFEF9C98756B4EF7BFA9EF958E6854E3"><enum>(B)</enum><header>Duration</header><text>The demonstration projects under this section shall be conducted for a period that is not longer than 5 years that begins on January 1, 2006.</text></subparagraph></paragraph>
<paragraph id="H98DADE2D265D442D8FF0F0A294C03E8D"><enum>(3)</enum><header>Evaluation and report</header>
<subparagraph id="H6572480468234208002913369DC8A816"><enum>(A)</enum><header>Evaluation</header><text>The Secretary shall conduct an evaluation of the demonstration projects conducted under this subsection.</text></subparagraph>
<subparagraph id="HEDB20D175A7A46D79065E11347731DD9"><enum>(B)</enum><header>Report</header><text>Not later than 6 months after the date on which the demonstration projects under this subsection are completed, the Secretary shall submit to Congress a report on the evaluation conducted under subparagraph (A) together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text></subparagraph></paragraph>
<paragraph id="HEECA0C532B26420793DFBEB2A4495EF6"><enum>(4)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated to carry out this subsection $2,000,000 for each of fiscal years 2006 through 2010.”.</text></paragraph></subsection></section>
<section id="H53FEBF2144254DDC93ED004B3246289D"><enum>202.</enum><header>Medicare coverage of kidney disease patient education services</header>
<subsection id="HB84C2C7D2DAF4005B335F07332D17E21"><enum>(a)</enum><header>Coverage of kidney disease education services</header>
<paragraph id="HA786908E700643C800B8C57FD71F2B78"><enum>(1)</enum><header>Coverage</header><text>Section 1861(s)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>), as amended by section 642(a)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2322), is amended—</text>
<subparagraph id="HD4FD70B3AD4F43E2BD0223E264C1FF3"><enum>(A)</enum><text>in subparagraph (Y), by striking <quote>and</quote> after the semicolon at the end;</text></subparagraph>
<subparagraph id="HAE9B26EC825049C8978933D0F1BDF90"><enum>(B)</enum><text>in subparagraph (Z), by adding <quote>and</quote> after the semicolon at the end; and</text></subparagraph>
<subparagraph id="HDE0A602BF1D04EFF0030734866EF9522"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="H83BC4C9AF1EC467280955CDF3E9CF0AB">
<subitem indent="up5" id="HD1BCE1AD7F5C44E79261C50060D07DAF"><enum>(AA)</enum><text>kidney disease education services (as defined in subsection (bbb));</text></subitem><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="HB44BD5C476E9441A961875B733A86C"><enum>(2)</enum><header>Services described</header><text>Section 1861 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x</external-xref>), as amended by section 706(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2339), is amended by adding at the end the following new subsection:</text>
<quoted-block style="other" other-style="archaic" act-name="Social Security Act" id="HDB5655DB04C748349E0955B246077D42">
<subsection id="H606A685527814632876C5E282FB93C8E"><enum>(bbb)</enum><header>Kidney disease education services</header>
<paragraph display-inline="yes-display-inline" id="HA507BFF641F44A289B82EA5C2354D443"><enum>(1)</enum><text>The term <term>kidney disease education services</term> means educational services that are—</text>
<subparagraph indent="up1" id="HA258921BBE964F9C8ED16D61CEC52B78"><enum>(A)</enum><text>furnished to an individual with kidney disease who, according to accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney transplant;</text></subparagraph>
<subparagraph indent="up1" id="HE59CADA618E647F9B71BE2B0E534B2ED"><enum>(B)</enum><text>furnished, upon the referral of the physician managing the individual’s kidney condition, by a qualified person (as defined in paragraph (2)); and</text></subparagraph>
<subparagraph indent="up1" id="HA31E85BC38324AA4879F0070733889B2"><enum>(C)</enum><text>designed—</text>
<clause id="H6B9D393B79844442A625235F2DE42370"><enum>(i)</enum><text>to provide comprehensive information regarding—</text>
<subclause id="H87144240B7D840098EFA96CC7F995C0"><enum>(I)</enum><text>the management of co-morbidities;</text></subclause>
<subclause id="HA421269152CC4741B7541F97F17DCA18"><enum>(II)</enum><text>the prevention of uremic complications; and</text></subclause>
<subclause id="HFA7EA519BE2843B69EF45C50ADF0854B"><enum>(III)</enum><text>each option for renal replacement therapy (including home and in-center, as well as vascular access options and transplantation); and</text></subclause></clause>
<clause id="HF4E71B9B4D6F48A78302A8C27E68DFF8"><enum>(ii)</enum><text>to ensure that the individual has the opportunity to actively participate in the choice of therapy.</text></clause></subparagraph></paragraph>
<paragraph indent="up1" id="H5AC7E150D970415F00CA9252BC6B5EB5"><enum>(2)</enum><text>The term <term>qualified person</term> means—</text>
<subparagraph id="H5C579B976DCF429DB84677D75515CFF8"><enum>(A)</enum><text>a physician (as described in subsection (r)(1));</text></subparagraph>
<subparagraph id="H80DDA57055F941C89E8922B8401E00E9"><enum>(B)</enum><text>an individual who—</text>
<clause id="H4892347D30D74A6BBCA077601DCC3B48"><enum>(i)</enum><text>is—</text>
<subclause id="H85DB39098DD24DFCAA6EB5F63BB03546"><enum>(I)</enum><text>a registered nurse;</text></subclause>
<subclause id="HB8857D78E57844789556E0C6FFD06000"><enum>(II)</enum><text>a registered dietitian or nutrition professional (as defined in subsection (vv)(2));</text></subclause>
<subclause id="H22C86F1A47F14D3D94DA0731D5B4CE13"><enum>(III)</enum><text>a clinical social worker (as defined in subsection (hh)(1));</text></subclause>
<subclause id="HF059853D9C964608A5832192E01142D3"><enum>(IV)</enum><text>a physician assistant, nurse practitioner, or clinical nurse specialist (as those terms are defined in subsection (aa)(5)); or</text></subclause>
<subclause id="H5DB0D367A603498FB597E9BEFB26AFEC"><enum>(V)</enum><text>a transplant coordinator; and</text></subclause></clause>
<clause id="H0A731DE8FBDA481694C6BF6E02CC3E6"><enum>(ii)</enum><text>meets such requirements related to experience and other qualifications that the Secretary finds necessary and appropriate for furnishing the services described in paragraph (1); or</text></clause></subparagraph>
<subparagraph id="H1F551197E5BB4277934F7E5C442C49F8"><enum>(C)</enum><text>a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—</text>
<clause id="HD712A95AB13249CDABE5676D69816DE4"><enum>(i)</enum><text>provide the services described in paragraph (1); and</text></clause>
<clause id="H12DF05D9BEC84BDAB4473C613519F6C1"><enum>(ii)</enum><text>meet the requirements of subparagraph (A) or (B).</text></clause></subparagraph></paragraph>
<paragraph indent="up1" id="HF2A008AF42A340B382DB1D828BD2D716"><enum>(3)</enum><text>The Secretary shall develop the requirements under paragraphs (1)(C)(i) and (2)(B)(ii) after consulting with physicians, health educators, professional organizations, accrediting organizations, kidney patient organizations, dialysis facilities, transplant centers, network organizations described in section 1881(c)(2), and other knowledgeable persons.</text></paragraph>
<paragraph indent="up1" id="HE1AC854BB64A4FF4AC324061D4FB486C"><enum>(4)</enum><text>In promulgating regulations to carry out this subsection, the Secretary shall ensure that each beneficiary who is entitled to kidney disease education services under this title receives such services in a timely manner to maximize the benefit of those services.</text></paragraph>
<paragraph indent="up1" id="H9B067920AB634BBA989D4DAC9E3D1777"><enum>(5)</enum><text>The Secretary shall monitor the implementation of this subsection to ensure that beneficiaries who are eligible for kidney disease education services receive such services in the manner described in paragraph (4).</text></paragraph>
<paragraph indent="up1" id="HC71F6AD5372446E1A8B546E45E1BA45C"><enum>(6)</enum><text>No individual shall be eligible to be provided more than 6 sessions of kidney disease education services under this title.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H169F6417212B4D8F8FD1628416DEA390"><enum>(3)</enum><header>Payment under physician fee schedule</header><text>Section 1848(j)(3) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(j)(3)</external-xref>), as amended by section 611(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2304), is amended by inserting <quote>(2)(AA),</quote> after <quote>(2)(W),</quote>.</text></paragraph>
<paragraph id="HE2840A5C80EE4A5F8817FBA6C7306EAF"><enum>(4)</enum><header>Payment to renal dialysis facilities</header><text>Section 1881(b) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)</external-xref>), as amended by section 2(b), is amended by adding at the end the following new paragraph:</text>
<quoted-block act-name="Social Security Act" id="H4CE35A3846CC4C31859FDDB0C4A44900">
<paragraph id="HE6B6D12EEC374E868200B1633195DD06"><enum>(15)</enum><text>For purposes of paragraph (12), the single composite weighted formulas determined under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(bbb)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph>
<paragraph id="H0222229B63064AA4BB3E1C051365ED9B"><enum>(5)</enum><header>Limitation on number of sessions</header><text>Section 1862(a)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395y">42 U.S.C. 1395y(a)(1)</external-xref>), as amended by section 613(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (<external-xref legal-doc="public-law" parsable-cite="pl/108/173">Public Law 108–173</external-xref>; 117 Stat. 2306), is amended—</text>
<subparagraph id="H801296BD6C4F4BB79E00E0758BA48814"><enum>(A)</enum><text>by striking <quote>and</quote> at the end of subparagraph (L);</text></subparagraph>
<subparagraph id="HA746453C0B4C4539B77FCC594D53E5EB"><enum>(B)</enum><text>by striking the semicolon at the end of subparagraph (M) and inserting <quote>, and</quote>; and</text></subparagraph>
<subparagraph id="HA8E6CFB3B83D4FAFBF2755DBCF43D7D"><enum>(C)</enum><text>by adding at the end the following new subparagraph:</text>
<quoted-block id="H130ABE5E71124D808C66DBEA0172D9D6">
<subparagraph indent="up1" id="H98AE7EEAB07549C083A1277860E2FD"><enum>(N)</enum><text>in the case of kidney disease education services (as defined in section 1861(bbb)), which are performed in excess of the number of sessions covered under such section;</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subparagraph></paragraph>
<paragraph id="H2334E2DD4F8D428E882637DE3B8CE1E6"><enum>(6)</enum><header>Annual report to Congress</header><text>Not later than April 1, 2005, and annually thereafter, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall submit to Congress a report on the number of medicare beneficiaries who are entitled to kidney disease education services (as defined in section 1861(bbb) of the <act-name parsable-cite="SSA">Social Security Act</act-name>, as added by paragraph (1)) under title XVIII of such Act and who receive such services, together with such recommendations for legislative and administrative action as the Secretary determines to be appropriate to fulfill the legislative intent that resulted in the enactment of that subsection.</text></paragraph></subsection>
<subsection id="HAD7FA49AFA914B17B95D00D4371BEBF9"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section shall apply to services furnished on and after January 1, 2006.</text></subsection></section>
<section id="H752BC48244324806AB171EEBAC51EBA5"><enum>203.</enum><header>Blood flow monitoring demonstration projects</header>
<subsection id="HFD7870D42CF34C22B2F78532AAEA1F11"><enum>(a)</enum><header>Establishment</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish demonstration projects to evaluate how blood flow monitoring affects the quality and cost of care for medicare beneficiaries with end-stage renal disease.</text></subsection>
<subsection id="H21C6E30E17534DBF0017DD23D0E05E00"><enum>(b)</enum><header>Duration</header><text>The demonstration projects under this section shall be conducted for a period of not longer than 5 years that begins on January 1, 2006.</text></subsection>
<subsection id="H1DD8DD7FBB7C4B3285726ED9726D3FA5"><enum>(c)</enum><header>Evaluation and report</header>
<paragraph id="H945BF37EDF19433D97BE76962CC073FA"><enum>(1)</enum><header>Evaluation</header><text>The Secretary shall conduct an evaluation of the demonstration projects conducted under this section.</text></paragraph>
<paragraph id="HBC37B4DED0874130AE30D53280A4D289"><enum>(2)</enum><header>Report</header><text>Not later than 6 months after the date on which the demonstration projects under this section are completed, the Secretary shall submit to Congress a report on the evaluation conducted under paragraph (1) together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text></paragraph></subsection>
<subsection id="HEAA3AB3D824D48E4B929CAF96DE689C4"><enum>(d)</enum><header>Waiver authority</header><text>The Secretary shall waive compliance with the requirements of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) to such extent and for such period as the Secretary determines is necessary to conduct the demonstration projects.</text></subsection>
<subsection id="H830E16481B764411A4E879050059CC4"><enum>(e)</enum><header>Authorization of appropriations</header>
<paragraph id="HA73775B6CCFA42C496166BC1DAE26C1E"><enum>(1)</enum><header>In general</header><text>Payments for the costs of carrying out the demonstration project under this section shall be made from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395t">42 U.S.C. 1395t</external-xref>).</text></paragraph>
<paragraph id="H97F38A7A92AA4733A7BBDF0830812A"><enum>(2)</enum><header>Amount</header><text>There are authorized to be appropriated from such Trust Fund $1,000,000 for each of fiscal years 2006 through 2010 to carry out this section.</text></paragraph></subsection></section>
<enum>III</enum><header>Financing and coverage for ESRD patients</header>
<section id="H2119039F60F14D6F9759C170D34DF082"><enum>301.</enum><header>Improving the home dialysis benefit</header>
<subsection id="H23719C8D259F41A5B8BA625671B086C6"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall provide appropriate incentives to improve the home dialysis benefit for individuals on behalf of whom payment may be made under section 1881 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr</external-xref>).</text></subsection>
<subsection id="HC1C4C108A9B9483B8C2CC7F9555B3D01"><enum>(b)</enum><header>Considerations</header><text>In developing the incentives under subsection (a), the Secretary shall consider revising the fee schedule for physicians’ services under section 1848 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4</external-xref>) so that the amount paid for services related to end-stage renal disease furnished to home dialysis patients is equal to the amount paid for services related to end-stage renal disease furnished to other patients with 4 or more face-to-face physician visits per month.</text></subsection></section>
<section id="H292CC683B768441A820100DE16085F77"><enum>302.</enum><header>Institute of Medicine evaluation and report on home dialysis</header>
<subsection id="H1031B201F1C04ACF91DD2B0010EDEB8E"><enum>(a)</enum><header>Evaluation</header>
<paragraph id="H8045FF6A8AA3419B9779DC2CC94F80"><enum>(1)</enum><header>In general</header><text>Not later than the date that is 2 months after the date of enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall enter into an arrangement under which the Institute of Medicine of the National Academy of Sciences (in this section referred to as the <quote>Institute</quote>) shall conduct an evaluation of the barriers that exist to increasing the number of individuals with end-stage renal disease who elect to receive home dialysis services under the medicare program under title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>).</text></paragraph>
<paragraph id="H3E9E6008E5C541ABAC5314B9B1B29DC1"><enum>(2)</enum><header>Specific matters evaluated</header><text>In conducting the evaluation under paragraph (1), the Institute shall—</text>
<subparagraph id="HAED5C8340F204610BC3F8020FB232E6E"><enum>(A)</enum><text>compare current medicare home dialysis payments with current in-center and hospital dialysis payments;</text></subparagraph>
<subparagraph id="H8B3D5A3E562B48149E296F609841C959"><enum>(B)</enum><text>catalogue and evaluate the incentives and disincentives in the current reimbursement system that influence whether patients receive home dialysis services;</text></subparagraph>
<subparagraph id="H536CD5EA24EB4055A3401CB247C57FBB"><enum>(C)</enum><text>evaluate patient education services and how such services impact the treatment choices made by patients; and</text></subparagraph>
<subparagraph id="H3F08FF05DF9E48D5BB53D0C7781E3C5"><enum>(D)</enum><text>consider such other matters as the Institute determines appropriate.</text></subparagraph></paragraph>
<paragraph id="HDDC37970A8CA474B00AFF26D56BC22F2"><enum>(3)</enum><header>Scope of review</header><text>The Institute shall consider a variety of perspectives, including the perspectives of physicians, other health care professionals, hospitals, dialysis facilities, health plans, purchasers, and patients.</text></paragraph></subsection>
<subsection id="H2365B06B4A4047AEA08E1C7BE55013DC"><enum>(b)</enum><header>Report</header><text>Not later than the date that is 18 months after the date of enactment of this Act, the Institute shall submit to the Secretary and appropriate committees of Congress a report on the evaluation conducted under subsection (a)(1) describing the findings of such evaluation and recommendations for implementing incentives to encourage patients to elect to receive home dialysis services under the medicare program.</text></subsection>
<subsection id="H72B98E69997646ADB2D9AC43F670E37B"><enum>(c)</enum><header>Authorization of appropriations</header><text>There are authorized to be appropriated such sums as may be necessary for purposes of conducting the evaluation and preparing the report required by this section.</text></subsection></section>
<enum>IV</enum><header>Sustainable economics</header>
<section id="HC8FFF7FB8B4547CAAA5C378BABBC2972"><enum>401.</enum><header>Modification of physician surgical reimbursement for dialysis access procedures to align incentives for cost and quality</header>
<subsection id="HAA61850F13A94E6596EEBEF69B4D1210"><enum>(a)</enum><header>Full coverage of dialysis access procedures in the ambulatory surgical center setting</header><text>The Secretary of Health and Human Services shall include in the surgical procedures specified under section 1833(i)(1) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395l">42 U.S.C. 1395l(i)(1)</external-xref>) the full range of dialysis access procedures when provided to individuals with end stage renal disease who are entitled to benefits under part A and enrolled under part B of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> pursuant to section 226A of that Act (<external-xref legal-doc="usc" parsable-cite="usc/42/426">42 U.S.C. 426</external-xref>). For purposes of the preceding sentence, the full range of dialysis services includes all reasonable and necessary intervention procedures for the creation, repair, and maintenance of an individual’s dialysis access, such as the placement, insertion, and maintenance services related to fistulas, synthetic grafts, tunnel catheters, and peritoneal dialysis catheters.</text></subsection>
<subsection id="H91CCA6E00FF348040041C48CEC718C51"><enum>(b)</enum><header>Revision of RBRVS to reflect the difficulty of vascular access procedures</header><text>The Secretary of Health and Human Services shall structure the relative value units determined under section 1848(c)(2) of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-4">42 U.S.C. 1395w–4(c)(2)</external-xref>) that are applicable with respect to physicians’ services for vascular access procedures to encourage clinically appropriate placement of natural vascular access for dialysis patients.</text></subsection></section>
<section id="H9617E7C099C84D66B3869B96B3C19FF"><enum>402.</enum><header>Demonstration project for outcomes-based ESRD reimbursement system</header>
<subsection id="H23CB303664B44F42A094F7AAEC71F3CA"><enum>(a)</enum><header>Establishment</header><text>Subject to the succeeding provisions of this section, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall establish demonstration projects (in this section referred to as <quote>demonstration projects</quote>) under which the Secretary shall evaluate methods that improve the quality of care provided to medicare beneficiaries with end-stage renal disease.</text></subsection>
<subsection id="HEB5EDE1DEC2B450F002B33C9EF177DFD"><enum>(b)</enum><header>Outcomes-based ESRD reimbursement system</header>
<paragraph id="HEE4C6AB2EEC749BD8DC9EC7433C399E"><enum>(1)</enum><header>In general</header><text>Under the demonstration projects, the Secretary shall provide financial incentives to providers of services and renal dialysis facilities that demonstrate improved quality of care to such beneficiaries.</text></paragraph>
<paragraph id="HC70E43ACDFDB4F86A759A5B048ED191"><enum>(2)</enum><header>Consideration of outcomes and case-mix</header><text>In determining whether a provider or facility has demonstrated an improved quality of care under paragraph (1), the Secretary shall take into account the outcomes of individuals receiving services from the provider or facility and the case-mix of the provider or facility.</text></paragraph>
<paragraph id="HCD082988BEC74D9EBDBD79C626195640"><enum>(3)</enum><header>Incentives described</header><text>The financial incentives provided under paragraph (1) shall—</text>
<subparagraph id="HDC1731C8DB1543989050642CF1E9CE35"><enum>(A)</enum><text>reflect the interactions of payments under parts A and B of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name>; and</text></subparagraph>
<subparagraph id="H7B26A0B61EF34E5EAB4252C196A7CAA5"><enum>(B)</enum><text>recognize improvements based on high quality outcomes during previous periods as well as recent changes in performance to reward long-term improvements.</text></subparagraph></paragraph></subsection>
<subsection id="HC2D64974E4F34CFFAA967600E7FAFAE"><enum>(c)</enum><header>Duration</header><text>The Secretary shall conduct the demonstration program under this section for a period that is not longer than 5 years that begins on January 1, 2006.</text></subsection>
<subsection id="H45F3FB1100484524BEDC79E8D22900FA"><enum>(d)</enum><header>Evaluation and report</header>
<paragraph id="HB1B94AC088A348399F78745F5E165F00"><enum>(1)</enum><header>Evaluation</header><text>The Secretary shall conduct an evaluation of the demonstration projects conducted under this section.</text></paragraph>
<paragraph id="HDA452A16D9874862ADEA00CB85C54845"><enum>(2)</enum><header>Report</header><text>Not later than 6 months after the date on which the demonstration projects are completed, the Secretary shall submit to Congress a report on the evaluation conducted under paragraph (1) together with recommendations for such legislation and administrative action as the Secretary determines appropriate.</text></paragraph></subsection>
<subsection id="H8729C4B680844019BC66337542FA88A6"><enum>(e)</enum><header>Waiver authority</header><text>The Secretary shall waive compliance with the requirements of title XVIII of the <act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) to such extent and for such period as the Secretary determines is necessary to conduct the demonstration projects.</text></subsection>
<subsection id="HE44C22D61A8D4F23979C749855969700"><enum>(f)</enum><header>Authorization of appropriations</header>
<paragraph id="H6CB222779E5348A98CD95DA1B7CA6B52"><enum>(1)</enum><header>In general</header><text>Payments for the costs of carrying out the demonstration project under this section shall be made from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395t">42 U.S.C. 1395t</external-xref>).</text></paragraph>
<paragraph id="HEFE82F45BCA2427F9068DA0160AEF875"><enum>(2)</enum><header>Amount</header><text>There are authorized to be appropriated from such Trust Fund such sums as may be necessary to carry out this section.</text></paragraph></subsection></section>
<section id="H73C0E99BDC594AF9802E2CBD2B9BD4F0"><enum>403.</enum><header>GAO study and report on impact of G-codes</header>
<subsection id="H812824070F8F4371A69B9306FE7FF300"><enum>(a)</enum><header>Study</header><text>The Comptroller General of the United States shall conduct a study on the impact of the temporary codes for nephrologists’ services applicable under the fee schedule for physicians’ services under section 1848 of the <act-name parsable-cite="SSA">Social Security Act</act-name> (commonly known as <quote>G-codes</quote>).</text></subsection>
<subsection id="H973DF5FAA6A445B0B225BA52D897FDCE"><enum>(b)</enum><header>Report</header><text>Not later than the date that is 6 months after the date of enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under subsection (a) together with recommendations for such legislation and administrative action as the Comptroller General determines appropriate.</text></subsection></section>