<enum>I</enum><header>Protecting patient access to kidney care innovation</header><section id="id3ce61e2c91c84e92bfa98f8e1062f230"><enum>101.</enum><header>Refining the end-stage renal disease payment system to improve access to innovative treatment options</header><subsection id="id34d392adba504d12914446c20747e600" commented="no"><enum>(a)</enum><header>Extension of Transitional Drug Add-On Payment Adjustment (TDAPA) period</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall pay the transitional drug add-on payment adjustment under section 413.234(c) of title 42, Code of Federal Regulations (or a successor regulation), for not less than 3 years for any new renal dialysis drug or biological product—</text><paragraph id="id434d425aab2a4deeb006b53ff17788d5" commented="no"><enum>(1)</enum><text>approved by the Food and Drug Administration on or after January 1, 2020, under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>);</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id73a4f00a00e04086a361b2e206403417"><enum>(2)</enum><text display-inline="yes-display-inline">that qualifies for such adjustment under such section; and</text></paragraph><paragraph id="idb62d7e91187f423997c42262c495ad95" commented="no"><enum>(3)</enum><text>that is furnished on or after January 1, 2026.</text></paragraph></subsection><subsection id="idca592632b379477e818e3f81c6eac5d5"><enum>(b)</enum><header>Permanent post-TDAPA adjustment</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="ida3d04adc91464267893d6a00cd08a253"><subparagraph id="id1392fc37ceef4d26ba4351172a28a186" indent="up1"><enum>(J)</enum><header>Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services</header><clause id="id7ab25dc0a83d4425b4dc2ee7460e781f"><enum>(i)</enum><header>In general</header><text>For any new renal dialysis drug or biological product that is used to treat or manage a condition as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on payment adjustment (referred to in this subparagraph as <quote>TDAPA</quote>) under section 413.234(c) 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, 2026, that includes the administration of such drugs or biologicals.</text></clause><clause id="ide630676c027849b5a40a9d45e3ce1073"><enum>(ii)</enum><header>Calculation of the post-TDAPA add-on adjustment</header><text>In calculating the add-on adjustment described in clause (i), the Secretary shall—</text><subclause id="id8e8b72ddb3fc4a4c83095843edafe3e2"><enum>(I)</enum><text>base the calculation on—</text><item id="id03ca6698a5b74928a56de012523e464a"><enum>(aa)</enum><text>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></item><item id="id844998aabebb49b1b462b66fb785d370"><enum>(bb)</enum><text>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></item><item id="id3663adeae850470eac8bcaae03948d34"><enum>(cc)</enum><text>if the wholesale acquisition cost is not available, the drug manufacturer’s invoice;</text></item></subclause><subclause id="idfec6d03131db42a7a972ffcb8d5dc301"><enum>(II)</enum><text>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></subclause><subclause id="idae6643d490d24f5eaa55cbb7a404c13f"><enum>(III)</enum><text>set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);</text></subclause><subclause id="id417a840d277f49d4962964ad777c02dc"><enum>(IV)</enum><text>update the add-on adjustment annually to account for inflationary changes; and</text></subclause><subclause id="idcb3889dda93f4a66abe970cf33331c08"><enum>(V)</enum><text>apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.</text></subclause></clause><clause id="idcfc3e435f4e84c16bd31a8b2af180180"><enum>(iii)</enum><header>Implementation</header><text>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></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="idf046db574a80440ea03651cc5335aca5"><enum>(c)</enum><header>Clarification to definition of renal dialysis services</header><text>Section 1881(b)(14)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)(B)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="idbc1b527967844e54b1dec3c1a36da608"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating clauses (i) through (iv) as subclauses (I) through (IV), respectively;</text></paragraph><paragraph id="id0ffef8401a634633b6f62a9689d3d65c"><enum>(2)</enum><text>by inserting <quote>(i)</quote> after <quote>(B)</quote>;</text></paragraph><paragraph id="idedc85335e40d499298aa2993a3e10725"><enum>(3)</enum><text>in clause (i)(IV), as added by paragraph (2), by striking <quote> clause (i)</quote> and inserting <quote>subclause (I)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2677e2f3083c4926832c51d84b12a100"><enum>(4)</enum><text display-inline="yes-display-inline">in the flush text at the end, by striking <quote>Such term does not</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ida41f627824914d87bbc73fc7feccb696"><clause id="ida7662e6302d9488296126037883ac8b7" indent="up2"><enum>(ii)</enum><text>Such term—</text><subclause commented="no" display-inline="no-display-inline" id="id2fed0ef3647545958f3d1aeec5d9c70c"><enum>(I)</enum><text display-inline="yes-display-inline">does not</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9e1a1ac4ef9a401b969d4d81f73056cc"><enum>(5)</enum><text display-inline="yes-display-inline">in clause (ii), as added by paragraph (2)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ida7c41d1472ea47a6a3fe86c1925f4d2d"><enum>(A)</enum><text display-inline="yes-display-inline">in subclause (I), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddeea5e7ec3da439d8bd68677debcf816"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id49de0cfdb3f443188eac3531d0bf676a"><subclause commented="no" display-inline="no-display-inline" id="ide085d641838a4a92916d356f72a85be8" indent="up3"><enum>(II)</enum><text display-inline="yes-display-inline">does not include drugs or biological products used to treat a comorbid disease or condition (including cardiovascular disease, an inflammatory condition, cancer, diabetes, and obesity) that may occur in an individual who has been determined to have end-stage renal diseases and is receiving dialysis and—</text><item commented="no" display-inline="no-display-inline" id="idf98a6a25930747bd97a6ad24eba937b4" indent="down1"><enum>(aa)</enum><text display-inline="yes-display-inline">that have been approved by the Food and Drug Administration after December 31, 2025; and</text></item><item commented="no" display-inline="no-display-inline" id="id797dd628e2094d57a364733dc12dd974" indent="down1"><enum>(bb)</enum><text display-inline="yes-display-inline">do not substitute for a drug or biological included in the ESRD prospective payment system base rate.</text></item></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8463d2179ff34a1bac926e5ddf6ac630"><enum>(6)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ideae612fb441f40b8a9f7e98b9f4ea38c"><clause id="id147ab44b719346a2ace0d074ce46d23c" indent="up2"><enum>(iii)</enum><header>Implementation</header><text>Beginning on the date of enactment of this clause, for purposes of implementing clause (ii)(II), the Secretary shall require that a claim for a drug or biological product described in such clause, that is payable under this part and is furnished by a provider of services or renal dialysis facility, contain the AY modifier (or a successor modifier).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="idb10b894746c648208f15fed898d76d2b"><enum>(d)</enum><header>Revisions to Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)</header><paragraph id="id296567de88e444e59f720b9256a73ca7"><enum>(1)</enum><header>Extension of period</header><text>The Secretary shall pay the transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of title 42, Code of Federal Regulations (or a successor regulation), for not less than 3 years for any new renal dialysis device that—</text><subparagraph commented="no" display-inline="no-display-inline" id="id5365762876134e66903d027945f2284f"><enum>(A)</enum><text display-inline="yes-display-inline">qualifies for such adjustment; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfb8b87e6c5364212af3b467756fbf692"><enum>(B)</enum><text display-inline="yes-display-inline">is furnished on or after January 1, 2026.</text></subparagraph></paragraph><paragraph id="idcfecd87ebeac4ec39218b2aee0d6907a" commented="no"><enum>(2)</enum><header>Eligibility of breakthrough devices</header><text>Beginning January 1, 2026, a device designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-3">21 U.S.C. 360e–3</external-xref>) shall be eligible for a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of title 42, Code of Federal Regulations (or a successor regulation).</text></paragraph><paragraph id="id338052a5cad4495ba7bded652409e5ac" commented="no"><enum>(3)</enum><header>Inclusion of capital-related assets in the transitional add-on payment adjustment for new and innovative equipment and supplies and post-Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies</header><text>Beginning January 1, 2026, the Secretary shall not apply the criterion described in section 413.236(b)(6) of title 42, Code of Federal Regulations (or a successor regulation), that excludes capital-related assets from the transitional add-on payment adjustment for new and innovative equipment and supplies and shall calculate such adjustment for capital-related assets that are devices that otherwise meet the requirements for the transitional add-on payment adjustment for new and innovative equipment.</text></paragraph></subsection><subsection id="id0556db7e47494dbb8e51e7f11d165a9c"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on January 1, 2026, and apply to items and services furnished on or after such date.</text></subsection></section><section id="idcf727482d4c148e9b66e10fe6361fea8"><enum>102.</enum><header>Ensuring Medicare Advantage supports kidney care innovative therapies</header><subsection id="idfba0cc3bd3324338993e6b2bfcc29cff"><enum>(a)</enum><header>In general</header><text>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="id028add7022ff4a42924330b7441c25a1"><paragraph id="id20be53a6f11c45f2913b5385f313881a"><enum>(8)</enum><header>Treatment of innovative products for enrollees with end-stage renal disease</header><subparagraph id="id2523ce3c87fe49429c03813512520a12"><enum>(A)</enum><header>In general</header><text>Beginning January 1, 2026, the Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—</text><clause id="id01e12ff757ba46a794e8e1a3f3a58786"><enum>(i)</enum><text>any new renal dialysis drug or biological product that receives a transitional drug add-on payment adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or</text></clause><clause id="idc33ac4562ed545c9ab83e937cfc11159"><enum>(ii)</enum><text>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 id="id4b3aecd699674978b15dceccf75c137a"><enum>(B)</enum><header>Amount of direct payment</header><text>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 id="id3a81d22d020747b9889cb1cb537997e2"><enum>(C)</enum><header>Duration of direct payment</header><text>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></subsection><subsection id="id7d5c1839b07f43d0b0f465386ee924b9" commented="no"><enum>(b)</enum><header>Conforming amendments</header><text>Section 1851(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21</external-xref>) is amended—</text><paragraph id="id3029c9fc1f0b488cb1f5cafc53ebd210"><enum>(1)</enum><text>in paragraph (1), by inserting <quote>1853(c)(8),</quote> after <quote>1886(h)(3)(D),</quote>; and</text></paragraph><paragraph id="id1cbe885d89df490ba1e060ffceb8c432"><enum>(2)</enum><text>in paragraph (2), by inserting <quote>1853(c)(8),</quote> after <quote>1853(h),</quote>.</text></paragraph></subsection></section>

119 S2730 IS: Kidney Care Access Protection Act U.S. Senate 2025-09-08 text/xml 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.

Short title

(a)

In general

This Act may be cited as the

Kidney Care Access Protection Act

.(b)

Table of contents

The table of contents of this Act is as follows:

Sec. 1. Short title.

TITLE I—Protecting patient access to kidney care innovation

Sec. 101. Refining the end-stage renal disease payment system to improve access to innovative treatment options.

Sec. 102. Ensuring Medicare Advantage supports kidney care innovative therapies.

TITLE II—Addressing staffing barriers with ESRD market basket labor adjustments

Sec. 201. Ensuring accuracy and stability in kidney care payment.

<enum>I</enum><header>Protecting patient access to kidney care innovation</header><section id="id3ce61e2c91c84e92bfa98f8e1062f230"><enum>101.</enum><header>Refining the end-stage renal disease payment system to improve access to innovative treatment options</header><subsection id="id34d392adba504d12914446c20747e600" commented="no"><enum>(a)</enum><header>Extension of Transitional Drug Add-On Payment Adjustment (TDAPA) period</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall pay the transitional drug add-on payment adjustment under section 413.234(c) of title 42, Code of Federal Regulations (or a successor regulation), for not less than 3 years for any new renal dialysis drug or biological product—</text><paragraph id="id434d425aab2a4deeb006b53ff17788d5" commented="no"><enum>(1)</enum><text>approved by the Food and Drug Administration on or after January 1, 2020, under section 505 of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/355">21 U.S.C. 355</external-xref>) or section 351 of the Public Health Service Act (<external-xref legal-doc="usc" parsable-cite="usc/42/262">42 U.S.C. 262</external-xref>);</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id73a4f00a00e04086a361b2e206403417"><enum>(2)</enum><text display-inline="yes-display-inline">that qualifies for such adjustment under such section; and</text></paragraph><paragraph id="idb62d7e91187f423997c42262c495ad95" commented="no"><enum>(3)</enum><text>that is furnished on or after January 1, 2026.</text></paragraph></subsection><subsection id="idca592632b379477e818e3f81c6eac5d5"><enum>(b)</enum><header>Permanent post-TDAPA adjustment</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="ida3d04adc91464267893d6a00cd08a253"><subparagraph id="id1392fc37ceef4d26ba4351172a28a186" indent="up1"><enum>(J)</enum><header>Payment for new and innovative drugs, biologicals, and devices that are renal dialysis services</header><clause id="id7ab25dc0a83d4425b4dc2ee7460e781f"><enum>(i)</enum><header>In general</header><text>For any new renal dialysis drug or biological product that is used to treat or manage a condition as defined in section 413.234(a) of title 42, Code of Federal Regulations that received a transitional drug add-on payment adjustment (referred to in this subparagraph as <quote>TDAPA</quote>) under section 413.234(c) 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, 2026, that includes the administration of such drugs or biologicals.</text></clause><clause id="ide630676c027849b5a40a9d45e3ce1073"><enum>(ii)</enum><header>Calculation of the post-TDAPA add-on adjustment</header><text>In calculating the add-on adjustment described in clause (i), the Secretary shall—</text><subclause id="id8e8b72ddb3fc4a4c83095843edafe3e2"><enum>(I)</enum><text>base the calculation on—</text><item id="id03ca6698a5b74928a56de012523e464a"><enum>(aa)</enum><text>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></item><item id="id844998aabebb49b1b462b66fb785d370"><enum>(bb)</enum><text>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></item><item id="id3663adeae850470eac8bcaae03948d34"><enum>(cc)</enum><text>if the wholesale acquisition cost is not available, the drug manufacturer’s invoice;</text></item></subclause><subclause id="idfec6d03131db42a7a972ffcb8d5dc301"><enum>(II)</enum><text>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></subclause><subclause id="idae6643d490d24f5eaa55cbb7a404c13f"><enum>(III)</enum><text>set the amount of the add-on adjustment as an amount equal to 65 percent of the amount calculated under subclause (II);</text></subclause><subclause id="id417a840d277f49d4962964ad777c02dc"><enum>(IV)</enum><text>update the add-on adjustment annually to account for inflationary changes; and</text></subclause><subclause id="idcb3889dda93f4a66abe970cf33331c08"><enum>(V)</enum><text>apply the add-on adjustment amount immediately upon the expiration of the TDAPA period and availability of the post-TDAPA add-on adjustment.</text></subclause></clause><clause id="idcfc3e435f4e84c16bd31a8b2af180180"><enum>(iii)</enum><header>Implementation</header><text>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></clause></subparagraph><after-quoted-block>.</after-quoted-block></quoted-block></subsection><subsection id="idf046db574a80440ea03651cc5335aca5"><enum>(c)</enum><header>Clarification to definition of renal dialysis services</header><text>Section 1881(b)(14)(B) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)(B)</external-xref>) is amended—</text><paragraph commented="no" display-inline="no-display-inline" id="idbc1b527967844e54b1dec3c1a36da608"><enum>(1)</enum><text display-inline="yes-display-inline">by redesignating clauses (i) through (iv) as subclauses (I) through (IV), respectively;</text></paragraph><paragraph id="id0ffef8401a634633b6f62a9689d3d65c"><enum>(2)</enum><text>by inserting <quote>(i)</quote> after <quote>(B)</quote>;</text></paragraph><paragraph id="idedc85335e40d499298aa2993a3e10725"><enum>(3)</enum><text>in clause (i)(IV), as added by paragraph (2), by striking <quote> clause (i)</quote> and inserting <quote>subclause (I)</quote>;</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id2677e2f3083c4926832c51d84b12a100"><enum>(4)</enum><text display-inline="yes-display-inline">in the flush text at the end, by striking <quote>Such term does not</quote> and inserting the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ida41f627824914d87bbc73fc7feccb696"><clause id="ida7662e6302d9488296126037883ac8b7" indent="up2"><enum>(ii)</enum><text>Such term—</text><subclause commented="no" display-inline="no-display-inline" id="id2fed0ef3647545958f3d1aeec5d9c70c"><enum>(I)</enum><text display-inline="yes-display-inline">does not</text></subclause></clause><after-quoted-block>;</after-quoted-block></quoted-block></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id9e1a1ac4ef9a401b969d4d81f73056cc"><enum>(5)</enum><text display-inline="yes-display-inline">in clause (ii), as added by paragraph (2)—</text><subparagraph commented="no" display-inline="no-display-inline" id="ida7c41d1472ea47a6a3fe86c1925f4d2d"><enum>(A)</enum><text display-inline="yes-display-inline">in subclause (I), by striking the period at the end and inserting <quote>; and</quote>; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="iddeea5e7ec3da439d8bd68677debcf816"><enum>(B)</enum><text>by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id49de0cfdb3f443188eac3531d0bf676a"><subclause commented="no" display-inline="no-display-inline" id="ide085d641838a4a92916d356f72a85be8" indent="up3"><enum>(II)</enum><text display-inline="yes-display-inline">does not include drugs or biological products used to treat a comorbid disease or condition (including cardiovascular disease, an inflammatory condition, cancer, diabetes, and obesity) that may occur in an individual who has been determined to have end-stage renal diseases and is receiving dialysis and—</text><item commented="no" display-inline="no-display-inline" id="idf98a6a25930747bd97a6ad24eba937b4" indent="down1"><enum>(aa)</enum><text display-inline="yes-display-inline">that have been approved by the Food and Drug Administration after December 31, 2025; and</text></item><item commented="no" display-inline="no-display-inline" id="id797dd628e2094d57a364733dc12dd974" indent="down1"><enum>(bb)</enum><text display-inline="yes-display-inline">do not substitute for a drug or biological included in the ESRD prospective payment system base rate.</text></item></subclause><after-quoted-block>; and</after-quoted-block></quoted-block></subparagraph></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id8463d2179ff34a1bac926e5ddf6ac630"><enum>(6)</enum><text>by adding at the end the following new clause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="ideae612fb441f40b8a9f7e98b9f4ea38c"><clause id="id147ab44b719346a2ace0d074ce46d23c" indent="up2"><enum>(iii)</enum><header>Implementation</header><text>Beginning on the date of enactment of this clause, for purposes of implementing clause (ii)(II), the Secretary shall require that a claim for a drug or biological product described in such clause, that is payable under this part and is furnished by a provider of services or renal dialysis facility, contain the AY modifier (or a successor modifier).</text></clause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection><subsection id="idb10b894746c648208f15fed898d76d2b"><enum>(d)</enum><header>Revisions to Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES)</header><paragraph id="id296567de88e444e59f720b9256a73ca7"><enum>(1)</enum><header>Extension of period</header><text>The Secretary shall pay the transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of title 42, Code of Federal Regulations (or a successor regulation), for not less than 3 years for any new renal dialysis device that—</text><subparagraph commented="no" display-inline="no-display-inline" id="id5365762876134e66903d027945f2284f"><enum>(A)</enum><text display-inline="yes-display-inline">qualifies for such adjustment; and</text></subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="idfb8b87e6c5364212af3b467756fbf692"><enum>(B)</enum><text display-inline="yes-display-inline">is furnished on or after January 1, 2026.</text></subparagraph></paragraph><paragraph id="idcfecd87ebeac4ec39218b2aee0d6907a" commented="no"><enum>(2)</enum><header>Eligibility of breakthrough devices</header><text>Beginning January 1, 2026, a device designated for expedited development and priority review under section 515B of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/360e-3">21 U.S.C. 360e–3</external-xref>) shall be eligible for a transitional add-on payment adjustment for new and innovative equipment and supplies under section 413.236 of title 42, Code of Federal Regulations (or a successor regulation).</text></paragraph><paragraph id="id338052a5cad4495ba7bded652409e5ac" commented="no"><enum>(3)</enum><header>Inclusion of capital-related assets in the transitional add-on payment adjustment for new and innovative equipment and supplies and post-Transitional Add-On Payment Adjustment for New and Innovative Equipment and Supplies</header><text>Beginning January 1, 2026, the Secretary shall not apply the criterion described in section 413.236(b)(6) of title 42, Code of Federal Regulations (or a successor regulation), that excludes capital-related assets from the transitional add-on payment adjustment for new and innovative equipment and supplies and shall calculate such adjustment for capital-related assets that are devices that otherwise meet the requirements for the transitional add-on payment adjustment for new and innovative equipment.</text></paragraph></subsection><subsection id="id0556db7e47494dbb8e51e7f11d165a9c"><enum>(e)</enum><header>Effective date</header><text>The amendments made by this section shall take effect on January 1, 2026, and apply to items and services furnished on or after such date.</text></subsection></section><section id="idcf727482d4c148e9b66e10fe6361fea8"><enum>102.</enum><header>Ensuring Medicare Advantage supports kidney care innovative therapies</header><subsection id="idfba0cc3bd3324338993e6b2bfcc29cff"><enum>(a)</enum><header>In general</header><text>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="id028add7022ff4a42924330b7441c25a1"><paragraph id="id20be53a6f11c45f2913b5385f313881a"><enum>(8)</enum><header>Treatment of innovative products for enrollees with end-stage renal disease</header><subparagraph id="id2523ce3c87fe49429c03813512520a12"><enum>(A)</enum><header>In general</header><text>Beginning January 1, 2026, the Secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for—</text><clause id="id01e12ff757ba46a794e8e1a3f3a58786"><enum>(i)</enum><text>any new renal dialysis drug or biological product that receives a transitional drug add-on payment adjustment under section 413.234(c) of title 42, Code of Federal Regulations; or</text></clause><clause id="idc33ac4562ed545c9ab83e937cfc11159"><enum>(ii)</enum><text>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 id="id4b3aecd699674978b15dceccf75c137a"><enum>(B)</enum><header>Amount of direct payment</header><text>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 id="id3a81d22d020747b9889cb1cb537997e2"><enum>(C)</enum><header>Duration of direct payment</header><text>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></subsection><subsection id="id7d5c1839b07f43d0b0f465386ee924b9" commented="no"><enum>(b)</enum><header>Conforming amendments</header><text>Section 1851(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395w-21">42 U.S.C. 1395w–21</external-xref>) is amended—</text><paragraph id="id3029c9fc1f0b488cb1f5cafc53ebd210"><enum>(1)</enum><text>in paragraph (1), by inserting <quote>1853(c)(8),</quote> after <quote>1886(h)(3)(D),</quote>; and</text></paragraph><paragraph id="id1cbe885d89df490ba1e060ffceb8c432"><enum>(2)</enum><text>in paragraph (2), by inserting <quote>1853(c)(8),</quote> after <quote>1853(h),</quote>.</text></paragraph></subsection></section><enum>II</enum><header>Addressing staffing barriers with ESRD market basket labor adjustments</header><section id="idd36d2b0346d841ad90b811b8ee754758"><enum>201.</enum><header>Ensuring accuracy and stability in kidney care payment</header><text display-inline="no-display-inline">Section 1881(b)(14)(F)(i) of the Social Security Act (<external-xref legal-doc="usc" parsable-cite="usc/42/1395rr">42 U.S.C. 1395rr(b)(14)(F)(i)</external-xref>) is amended—</text><paragraph id="ide580374afda2410c836457595a749736"><enum>(1)</enum><text>in subclause (I), by striking <quote>subclauses (II) and (III)</quote> and inserting <quote>subclauses (II), (III), and (IV)</quote>;</text></paragraph><paragraph id="iddc7dcde9294f4c878973876ef43fb468"><enum>(2)</enum><text>in subclause (II), by inserting <quote>and after application of subclause (IV)</quote> after <quote>subclause (I)</quote>; and</text></paragraph><paragraph id="iddcd0a6d300d849beb38755ccdeb38686"><enum>(3)</enum><text>by adding at the end the following new subclause:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id0e762e38795e4d75a8aca7a637ee373b"><subclause id="id5f16cb4dc0004fa7bc81d95021e6a6b2" indent="up1"><enum>(IV)</enum><text>Beginning with 2026, the Secretary shall compute an adjustment to the increase factor described in subclause (I) for the annual update of the payment amounts established under this paragraph for the previous year to account for forecast error (referred to in this subclause as the <quote>forecast error adjustment</quote>). The initial adjustment (in 2026) to the increase factor shall take into account the cumulative forecast error for 2021 and 2022. Subsequent adjustments in succeeding years shall take into account the forecast error from the most recently available year for which there is final data. The forecast error adjustment under this subclause shall apply whenever the difference between the forecasted and actual percentage change in the prices of an appropriate mix of goods and services included in renal dialysis services exceeds 0.5 percentage points.</text></subclause><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>