118 S4469 IS: Chronic Kidney Disease Improvement in Research and Treatment Act of 2024
U.S. Senate
2024-06-05
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EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents(a)This Act may be cited as the Chronic Kidney Disease Improvement in Research and Treatment Act of 2024
.(b)The table of contents for this Act is as follows:Sec. 1. Short title; table of contents.TITLE I—Preventing kidney disease by expanding education and awarenessSec. 101. Expanding Medicare annual wellness benefit to include kidney disease screening.Sec. 102. Increasing access to Medicare kidney disease education benefit.Sec. 103. Understanding the progression of kidney disease and treatment of kidney failure in minority populations.TITLE II—Incentivizing kidney care innovationSec. 201. Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies.Sec. 202. Ensuring Medicare Advantage supports kidney care innovative therapies.Sec. 203. Improving patient lives and quality of care through research and innovation.TITLE III—Addressing the kidney care workforce crisis.Sec. 301. Improving patient decision making and transparency by consolidating and modernizing quality programs.Sec. 302. Ensuring accuracy and stability in kidney care payment.TITLE IV—Expanding patient choice of coverageSec. 401. Medigap coverage for beneficiaries with end-stage renal disease.<enum>I</enum><header>Preventing kidney disease by expanding education and awareness</header><section id="id3df38f21b46841a7ae31a89ea05522b9"><enum>101.</enum><header>Expanding Medicare annual wellness benefit to include kidney disease screening</header><subsection id="id986C36D8EC3F4BAD9BCCD214156F48B9"><enum>(a)</enum><header>In general</header><text>Section 1861(ww)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(ww)(2)</external-xref>) is amended—</text><paragraph id="id4F84D2CBCFD1427DADF0A6920E913A30"><enum>(1)</enum><text>by moving subparagraph (N) 2 ems to the left;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida65db5b5dbad4f01a8f996b817965939"><enum>(2)</enum><text display-inline="yes-display-inline">by redesignating subparagraph (O) as subparagraph (P); and</text></paragraph><paragraph id="id4B180066F71849EDB7C55B116A8DDD3D"><enum>(3)</enum><text>by inserting after subparagraph (N) the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id1DA4AB9B1EE147CAB0104FEA8314DD43"><paragraph id="idADA513CF79FF46EABB6080417C7DFCD8"><enum>(O)</enum><text>Chronic kidney disease screening as defined by the Secretary.</text></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="id4ECE62E5DA504EC0ACE8DC96C95B26FC" commented="no"><enum>(b)</enum><header>Effective date</header><text>The amendments made by this section apply to items and services furnished on or after January 1, 2025.</text></subsection></section><section id="idBA003F7B90D748929B4902A661527E53"><enum>102.</enum><header>Increasing access to Medicare kidney disease education benefit</header><subsection id="id9b7a47a957a24d4980f4167b46fadbe3"><enum>(a)</enum><header>In general</header><text>Section 1861(ggg) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395x">42 U.S.C. 1395x(ggg)</external-xref>) is amended—</text><paragraph id="ide5ddb20389fe4769a62538a06e532e04"><enum>(1)</enum><text>in paragraph (1)—</text><subparagraph id="idb47def8b766a482089a5717903fc3629"><enum>(A)</enum><text>in subparagraph (A), by inserting <quote>or stage V</quote> after <quote>stage IV</quote>; and</text></subparagraph><subparagraph id="id19c0a029a0dc4bd8ac38cf64907691b7"><enum>(B)</enum><text>in subparagraph (B), by inserting <quote>or of a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5)) assisting in the treatment of the individual's kidney condition</quote> after <quote>kidney condition</quote>; and</text></subparagraph></paragraph><paragraph id="ide6815f17e0ba4ac1b87ebb8001c3f55d"><enum>(2)</enum><text>in paragraph (2)—</text><subparagraph id="idbdc6d8d84aa84d7a9cf31b7dcfb01bde"><enum>(A)</enum><text>by striking subparagraph (B); and</text></subparagraph><subparagraph id="id376367a0567542158497bfe809a7930d"><enum>(B)</enum><text>in subparagraph (A)—</text><clause id="idfa848a7c58da4490a66590a42ebaef00"><enum>(i)</enum><text>by striking <quote>(A)</quote> after <quote>(2)</quote>;</text></clause><clause id="id509e17e912e94675bff7486076ae7101"><enum>(ii)</enum><text>by striking <quote>and</quote> at the end of clause (i);</text></clause><clause id="idd3ddc3f609a643a69da77160bc5bd755"><enum>(iii)</enum><text>by striking the period at the end of clause (ii) and inserting <quote>; and</quote>;</text></clause><clause id="id4b0fc2423e714b7ba3cb64ca7b5a4118"><enum>(iv)</enum><text>by redesignating clauses (i) and (ii) as subparagraphs (A) and (B), respectively, and indenting appropriately; and</text></clause><clause id="idd00db5099a7f428e88127fae0009aa9e"><enum>(v)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idbdf46d5ef7824d12877f7f6046014aa8"><subparagraph id="id7fec8168e14a47258d20470f18eab85b"><enum>(C)</enum><text>a renal dialysis facility subject to the requirements of section 1881(b)(1) with personnel who—</text><clause id="id45cf2429e9f44bf19e644921c73b9ae4"><enum>(i)</enum><text>provide the services described in paragraph (1); and</text></clause><clause id="id18693a06f6e043babe5316a783a52c65"><enum>(ii)</enum><text>is a physician (as defined in subsection (r)(1)) or a physician assistant, nurse practitioner, or clinical nurse specialist (as defined in subsection (aa)(5)).</text></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></clause></subparagraph></paragraph></subsection><subsection id="id863837a0ddeb4da2b513198c8e17c810"><enum>(b)</enum><header>Payment to renal dialysis facilities</header><text>Section 1881(b) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id707c8e307cd64019a8502a4687d692c8"><subsection id="id1e63731d2b604075add4b4db11007c99"><enum>(15)</enum><text>For purposes of paragraph (14), the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services (as defined in section 1861(ggg)). Instead, payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section 1848.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="iddc45981fcc1241778f194d60745bf1b0"><enum>(c)</enum><header>Effective date</header><text>The amendments made by this section apply to kidney disease education services furnished on or after January 1, 2025.</text></subsection></section><section id="ideaaeed60ca124ec0aef75413a16f600e"><enum>103.</enum><header>Understanding the progression of kidney disease and treatment of kidney failure in minority populations</header><subsection id="id08E3BB510DC04CDC8CE4252E88AE236B"><enum>(a)</enum><header>Study</header><text display-inline="yes-display-inline">The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall conduct a study on—</text><paragraph id="id9dfb4f85dc1e48318a1f589792a439c0"><enum>(1)</enum><text>the social, behavioral, and biological factors associated with kidney disease onset and progression;</text></paragraph><paragraph id="id4293422daa114d74b2f08aa267f8fef6"><enum>(2)</enum><text>efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease; and</text></paragraph><paragraph id="id9e57d3d5ecbb4d5fab681335f859514c"><enum>(3)</enum><text>treatment patterns associated with providing care, under the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, and through private health insurance, to minority populations that are disproportionately affected by kidney disease.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id22F1C29C6E274FC99351E1E992E36193"><enum>(b)</enum><header>Report</header><text>Not later than 1 year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the study conducted under subsection (a), together with such recommendations as the Secretary determines to be appropriate.</text></subsection></section><enum>II</enum><header>Incentivizing kidney care innovation</header><section id="iddeba14b064ee4129a1bd2340222f2763"><enum>201.</enum><header>Refining the end-stage renal disease payment system to improve accuracy in payment and support therapies</header><subsection id="id2998619d50b94d9389b339929d8beafd"><enum>(a)</enum><header>In general</header><text>Section 1881(b)(14) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)</external-xref>) is amended by adding at the end the following new subparagraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idE512562816F74EE280BFBE8EECEE21C6"><subsection id="id25f0796e41db42e38620c46d96a4fff2"><enum>(J)</enum><header>Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services</header><paragraph commented="no" display-inline="no-display-inline" id="id9115bb8983e443d2b99e1d5dc8bdcd9f"><enum>(i)</enum><header display-inline="yes-display-inline">In general</header><text>For any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on adjustment (referred to in this subparagraph as <quote>TDAPA</quote>) under section 413.234(c)(2) of such title, and was furnished on or after January 1, 2024, the Secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after January 1, 2025, that includes the administration of such drugs or biologicals.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2479c844b40e4a0e85345c452ea6952f"><enum>(ii)</enum><header>Calculation of the Post-TDAPA Add-on adjustment</header><text display-inline="yes-display-inline">In calculating the add-on adjustment described in clause (i), the Secretary shall—</text><subparagraph commented="no" display-inline="no-display-inline" id="id63428302984743b9a407e9b95a547ab0"><enum>(I)</enum><text display-inline="yes-display-inline">base the calculation on— </text><clause commented="no" display-inline="no-display-inline" id="id602e6beeb0ae4ab685dbbf02b054f348"><enum>(aa)</enum><text display-inline="yes-display-inline">except as provided in items (bb) and (cc), the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product;</text></clause><clause commented="no" display-inline="no-display-inline" id="id1288e5368cb342418b8d1fb507f3c9de"><enum>(bb)</enum><text display-inline="yes-display-inline">if the most recent available full calendar quarter of average sales price data reflects 0 or negative sales, 100 percent of the wholesale acquisition cost (as defined in section 1847A(c)(6)) of such drug or product; or</text></clause><clause commented="no" display-inline="no-display-inline" id="id05061c627aab4d6f8b0a22558b286718"><enum>(cc)</enum><text display-inline="yes-display-inline">if the wholesale acquisition cost is not available, the drug manufacturer's invoice;</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idac5527d49bfa4111a017fce32e3d76f8"><enum>(II)</enum><text display-inline="yes-display-inline">calculate the post-TDAPA add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period;</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idcfe6a1bb6d4f4919b33ab7efddedc81e"><enum>(III)</enum><text display-inline="yes-display-inline">set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id47077d1a60dd404ca64bc83f16556df5"><enum>(IV)</enum><text display-inline="yes-display-inline">update the add-on adjustment annually to account for inflationary changes; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idb0b1735e06ab49ae94889151efc9e09d"><enum>(V)</enum><text display-inline="yes-display-inline">apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.</text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idfe04d7db6e19429b9d4e356e675e3665"><enum>(iii)</enum><header>Implementation</header><text display-inline="yes-display-inline">This subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section 413.235 of title 42, Code of Federal Regulations (or any successor regulation).</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection commented="no" display-inline="no-display-inline" id="id603f8ea68e7b4446b6d58d82f4547274"><enum>(b)</enum><header>Extension of transitional drug add-On adjustment under the drug designation policy</header><text>The Secretary shall pay the transitional drug add-on adjustment under paragraph (c) of section 413.234 of title 42, Code of Federal Regulations (or a successor regulation) for a total of 3 years for any new renal dialysis drug or biological product that—</text><paragraph commented="no" display-inline="no-display-inline" id="id9c58ba0eba7c413b9fb72f8eae751f80"><enum>(1)</enum><text display-inline="yes-display-inline">is used to treat or manage a condition for which there is a functional category as defined in paragraph (a) of such section;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id37632d9cc42d4087b2a7599112c4726a"><enum>(2)</enum><text>qualifies for such adjustment under paragraph (c)(2) of such section; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id4cd73498f4cf4f95bc901d867c867c9e"><enum>(3)</enum><text>is furnished on or after January 1, 2024.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="id5c2717b8f8c34aba94906183bd9b9fed"><enum>(c)</enum><header>New devices and other technologies</header><paragraph commented="no" display-inline="no-display-inline" id="id25643ed6c03345d9ace796b85b65705d"><enum>(1)</enum><header display-inline="yes-display-inline">In general</header><text>As part of the promulgation of the annual rule for the Medicare end-stage renal disease prospective payment system under section 1881(b)(14) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)</external-xref>) for calendar year 2026, and in consultation with stakeholders, the Secretary of Health and Human Services (referred to in this subsection as the <quote>Secretary</quote>) shall— </text><subparagraph commented="no" display-inline="no-display-inline" id="id968154d50c7345a2983cabe36d9b71df"><enum>(A)</enum><text display-inline="yes-display-inline">ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement; and </text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="id73ae2161c50c4311bab1674a1a62f884"><enum>(B)</enum><text display-inline="yes-display-inline">increase the single payment amount if the Secretary determines such payment amount is not adequate to cover such cost. </text></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="iddb50cdecad3244a3b2b69dd4a44af5d5"><enum>(2)</enum><header>Cost and utilization data</header><text>In carrying out paragraph (1), the Secretary shall use the cost and utilization data collected during a 3-year transitional payment period, as described in the final regulation published on November 9, 2020 (85 Fed. Reg. 71398).</text></paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="id6c3218532db348f795962e277c09e4e9"><enum>202.</enum><header>Ensuring Medicare Advantage supports kidney care innovative therapies</header><text display-inline="no-display-inline">Section 1853(c) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-23">42 U.S.C. 1395w–23(c)</external-xref>) is amended by adding at the end the following new paragraph:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id9748D9F96C41482B9421A68AD03F7253"><paragraph id="id7204e4a4477c4ab68bf716ff6d666678"><enum>(8)</enum><header>Treatment of innovative products for enrollees with end stage renal disease</header><subparagraph commented="no" display-inline="no-display-inline" id="id1d11853d182a4adea7ff71be546679c0"><enum>(A)</enum><header display-inline="yes-display-inline">In general</header><text>The Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—</text><clause commented="no" display-inline="no-display-inline" id="idb694615e3bc5429e81a632552a888d8f"><enum>(i)</enum><text display-inline="yes-display-inline">any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or </text></clause><clause commented="no" display-inline="no-display-inline" id="id903bed3fa93247ffb02bdab6f6c10d6f"><enum>(ii)</enum><text display-inline="yes-display-inline">an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of such title.</text></clause></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idab7050e1f69e4331b40817ec932f5234"><enum>(B)</enum><header>Amount of direct payment</header><text display-inline="yes-display-inline">The amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section 1881(b)(14).</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idc262e7a36531439c9a6baf4445e570d5"><enum>(C)</enum><header>Duration of direct payment</header><text display-inline="yes-display-inline">The Secretary shall make payments under subparagraph (A) for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section.</text></subparagraph></paragraph><after-quoted-block>.</after-quoted-block></quoted-block></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="idd91e7dbb1df14931a05e1373d6f37cf2"><enum>203.</enum><header>Improving patient lives and quality of care through research and innovation</header><subsection commented="no" display-inline="no-display-inline" id="ida8433af7fba34d21b080d41b145fc6cd"><enum>(a)</enum><header display-inline="yes-display-inline">Study</header><text>The Secretary of Health and Human Services (referred to in this section as the <term>Secretary</term>) shall conduct a study on increasing kidney transplantation rates. Such study shall include an analysis of each of the following:</text><paragraph commented="no" display-inline="no-display-inline" id="idb9850689cbf04a8891653759fe915740"><enum>(1)</enum><text>Any disincentives in the payment systems under the Medicare program under title XVIII of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395">42 U.S.C. 1395 et seq.</external-xref>) that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="ida63405b1160b4aa38cf4f9a162922a0e"><enum>(2)</enum><text>The practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcbcec02d88c94fa2aa49788dc976e6ab"><enum>(3)</enum><text display-inline="yes-display-inline">Practices and policies that could increase donation rates among minority populations.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idcddf9373b44246d18d72ec4693ae9baa"><enum>(4)</enum><text>Whether cultural and policy barriers exist to increasing living donation rates, including an examination of how to better facilitate kidney paired donations.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idccbb41d8b1db4dcc805cda17a6500ebf"><enum>(5)</enum><text display-inline="yes-display-inline">Criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney.</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8b264fd7571e4892998cd5b7c934e21b"><enum>(6)</enum><text>Other areas determined appropriate by the Secretary.</text></paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="idd02258a948cd49efb822c665474f313a"><enum>(b)</enum><header>Report</header><text>Not later than 18 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the study conducted pursuant to subsection (a), together with such recommendations as the Secretary determines to be appropriate.</text></subsection></section><enum>III</enum><header>Increasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs</header><section id="id2ceb0c9d9f374f9489391767b2c85e6c"><enum>301.</enum><header>Improving patient decision making and transparency by consolidating and modernizing quality programs</header><subsection id="id6d4dafd185864e5d982096ab9bd678d3"><enum>(a)</enum><header>Measures</header><text>Section 1881(h)(2) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(h)(2)</external-xref>) is amended—</text><paragraph id="id6335359b0a854e6b981ab68e8965b927"><enum>(1)</enum><text>by striking subparagraph (A) and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="idFCEACB2B09394342B01242A4E7805CDC"><subparagraph id="idC62DAAC69F9D4DB7AFB6F16D6568338B"><enum>(A)</enum><text>The measures specified under this paragraph with respect to the year involved shall be selected by the Secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers. When selecting measures specified under this paragraph, the Secretary shall take into account clinical gaps in care, underutilization that may lead to beneficiary harm, patient safety, and outcomes.</text></subparagraph><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph id="id97F0ED72799C47A8B35BB9455D6845F1"><enum>(2)</enum><text>in subparagraph (B)(i), by striking <quote>subparagraph (A)(iv)</quote> and inserting <quote>subparagraph (A)</quote>;</text></paragraph><paragraph id="id06992EA252ED442BB57E5FC49D9E2969"><enum>(3)</enum><text>by striking subparagraph (E); and</text></paragraph><paragraph id="id06cee6751d1c4caaa1eac4c7db207b36"><enum>(4)</enum><text>by adding at the end the following new subparagraphs:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id4F84313F4BD044139E3A67E1792FFD53"><subparagraph id="idf8a510117651478795667ae75d9af4c0"><enum>(E)</enum><header>Weighting limitation</header><text>No single measure specified by the Secretary or individual measure within a composite measure so specified may be weighted less than 10 percent of the total performance score.</text></subparagraph><subparagraph id="idb44dd259331d44bb822bfeefa60a6b4c"><enum>(F)</enum><header>Statistically valid and reliable</header><text>In specifying measures under subparagraph (A), the Secretary shall only specify measures that have been shown to be statistically valid and reliable through testing.</text></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="idfb32bdf7d9c94759b65de65442c149ac"><enum>(b)</enum><header>Endorsement</header><text>Section 1881(h)(2)(B)(ii) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(h)(2)(B)(ii)</external-xref>) is amended by adding at the end the following new sentence: <quote>The exception under the preceding sentence shall not apply to a measure that the entity with a contract under section 1890(a) (or a similar entity) considered but failed to endorse.</quote>.</text></subsection><subsection id="id3009ce2719ad4f5195eb39fe41014e38"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall apply to items and services furnished on or after January 1, 2025.</text></subsection></section><enum>IV</enum><header>Empowering patients</header><section id="idf4b220c886f046d6b5ce53b18e6d8531"><enum>401.</enum><header>Medigap coverage for beneficiaries with end-stage renal disease</header><subsection id="id5ca22bdbd2484ad2aad447813ecdc875"><enum>(a)</enum><header>Guaranteed availability of Medigap policies to all ESRD Medicare beneficiaries</header><paragraph id="idb569e3015b844ccbab24898441a391ae"><enum>(1)</enum><header>In general</header><text>Section 1882(s) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss(s)</external-xref>) is amended—</text><subparagraph id="id9fe3b218cdaf42f6b12cffeb5c03b289"><enum>(A)</enum><text>in paragraph (2)—</text><clause id="idbf637790b7454562ab7c3f0e9b782ba7"><enum>(i)</enum><text>in subparagraph (A), by striking <quote>is 65</quote> and all that follows through the period and inserting the following: “is—</text><quoted-block style="OLC" display-inline="no-display-inline" id="id6b7b7adcb5714247bf3dbf00bcd56f10"><clause id="ided63cd965145454884df00ca21f371c4" indent="up2"><enum>(i)</enum><text>65 years of age or older and is enrolled for benefits under part B; or</text></clause><clause id="id4c5835fab16443e3a0f8d2c1f245b38a" indent="up2"><enum>(ii)</enum><text>entitled to benefits under 226A(b) and is enrolled for benefits under part B.</text></clause><after-quoted-block>; and</after-quoted-block></quoted-block></clause><clause id="id7ca3e5f011fb43bfb8de1d2f56a9c6e0"><enum>(ii)</enum><text>in subparagraph (D), in the matter preceding clause (i), by inserting <quote>(or is entitled to benefits under 226A(b))</quote> after <quote>is 65 years of age or older</quote>; and</text></clause></subparagraph><subparagraph id="id638ae370e9ca418eacca87f890748168"><enum>(B)</enum><text>in paragraph (3)(B)—</text><clause id="id4a4b285453f249298de6dfe20cd903e6"><enum>(i)</enum><text>in clause (ii), by inserting <quote>(or is entitled to benefits under 226A(b))</quote> after <quote>is 65 years of age or older</quote>; and</text></clause><clause id="idc342ec7cf9054188939461fb3c3aa497"><enum>(ii)</enum><text>in clause (vi), by inserting <quote>(or under 226A(b))</quote> after <quote>at age 65</quote>.</text></clause></subparagraph></paragraph><paragraph id="id8d52a2a1944a464e85204bd256a998ea"><enum>(2)</enum><header>Effective date</header><text>The amendments made by paragraph (1) shall apply to Medicare supplemental policies effective on or after January 1, 2026.</text></paragraph></subsection><subsection id="idcef908c8f2104b1893e42012d873e9a9"><enum>(b)</enum><header>Additional enrollment period for certain individuals</header><paragraph id="idf780c850f0fe4cbea64005ebd5fde313"><enum>(1)</enum><header>One-time enrollment period</header><subparagraph id="id56fb2383fc5f4b0fba32c3de1f0eec50"><enum>(A)</enum><header>In general</header><text>In the case of an individual described in subparagraph (B), the Secretary of Health and Human Services shall establish a one-time enrollment period during which such an individual may enroll in any Medicare supplemental policy under section 1882 of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss</external-xref>) of the individual's choosing.</text></subparagraph><subparagraph id="id51b46f77f0e54e2a90e5eabc7014b45e"><enum>(B)</enum><header>Enrollment period</header><text>The enrollment period established under subparagraph (A) shall begin on January 1, 2026, and shall end June 30, 2026.</text></subparagraph></paragraph><paragraph id="id6ea13ac812d94553bd2e428b75885fa9"><enum>(2)</enum><header>Individual described</header><text>An individual described in this paragraph is an individual who—</text><subparagraph id="id66c7ad7fffbf4ef0b83d286074b026d5"><enum>(A)</enum><text>is entitled to hospital insurance benefits under part A of title XVIII of the Social Security Act under section 226A(b) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/426-1">42 U.S.C. 426–1</external-xref>);</text></subparagraph><subparagraph id="idadf6b9153dda4571ae3cc929ff69e2b9"><enum>(B)</enum><text>is enrolled for benefits under part B of such title XVIII; and</text></subparagraph><subparagraph id="ideff7c5cb08ee45e09067b2cc14dfd5a7"><enum>(C)</enum><text>would not, but for the provisions of, and amendments made by, subsection (a) be eligible for the guaranteed issue of a Medicare supplemental policy under paragraph (2) or (3) of section 1882(s) of such Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395ss">42 U.S.C. 1395ss(s)</external-xref>).</text></subparagraph></paragraph></subsection></section>