I 
119TH CONGRESS 
1ST SESSION H. R. 6214 
To amend title XVIII of the Social Security Act to improve access to innova-
tive treatment options for end-stage renal disease under the Medicare 
program, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 20, 2025 
Mrs. MILLER of West Virginia (for herself and Ms. SEWELL) introduced the 
following bill; which was referred to the Committee on Ways and Means, 
and in addition to the Committee on Energy and Commerce, for a period 
to be subsequently determined by the Speaker, in each case for consider-
ation of such provisions as fall within the jurisdiction of the committee 
concerned 
A BILL 
To amend title XVIII of the Social Security Act to improve 
access to innovative treatment options for end-stage renal 
disease under the Medicare program, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
(a) IN GENERAL.—This Act may be cited as the 
‘‘Kidney Care Access Protection Act’’. 
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(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 ac-
cess to innovative treatment options. 
Sec. 102. Ensuring Medicare Advantage supports kidney care innovative thera-
pies. 
TITLE II—ADDRESSING STAFFING BARRIERS WITH ESRD 
MARKET BASKET LABOR ADJUSTMENTS 
Sec. 201. Ensuring accuracy and stability in kidney care payment. 
TITLE III—PREVENTING KIDNEY DISEASE AND EXPANDING 
AWARENESS AND EDUCATION 
Sec. 301. Expanding medicare annual wellness benefit to include kidney disease 
screening. 
Sec. 302. Increasing access to medicare kidney disease education benefit. 
TITLE I—PROTECTING PATIENT 
ACCESS TO KIDNEY CARE IN-
NOVATION 
SEC. 101. REFINING THE END-STAGE RENAL DISEASE PAY-
MENT SYSTEM TO IMPROVE ACCESS TO INNO-
VATIVE TREATMENT OPTIONS. 
(a) EXTENSION OF TRANSITIONAL DRUG ADD-ON 
PAYMENT ADJUSTMENT (TDAPA) PERIOD.—The Sec-
retary of Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’) 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— 
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(1) approved by the Food and Drug Adminis-
tration on or after January 1, 2020, under section 
505 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355) or section 351 of the Public Health 
Service Act (42 U.S.C. 262); 
(2) that qualifies for such adjustment under 
such section; and 
(3) that is furnished on or after January 1, 
2026. 
(b) PERMANENT POST-TDAPA ADJUSTMENT.—Sec-
tion 1881(b)(14) of the Social Security Act (42 U.S.C. 
1395rr(b)(14)) is amended by adding at the end the fol-
lowing new subparagraph: 
‘‘(J) PAYMENT
FOR
NEW
AND
INNOVATIVE 
DRUGS, BIOLOGICALS, AND
DEVICES
THAT
ARE 
RENAL DIALYSIS SERVICES.— 
‘‘(i) IN GENERAL.—For any new renal di-
alysis drug or biological product that is used to 
treat or manage a condition as defined in sec-
tion 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 ‘TDAPA’) under section 
413.234(c) of such title, and was furnished on 
or after January 1, 2024, the Secretary shall 
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establish a permanent add-on adjustment to the 
base rate for claims submitted on or after Jan-
uary 1, 2026, that includes the administration 
of such drugs or biologicals. 
‘‘(ii) CALCULATION
OF
THE
POST-TDAPA 
ADD-ON ADJUSTMENT.—In calculating the add- 
on adjustment described in clause (i), the Sec-
retary shall— 
‘‘(I) base the calculation on— 
‘‘(aa) 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; 
‘‘(bb) if the most recent available 
full calendar quarter of average sales 
price data reflects 0 or negative sales, 
100 percent of the wholesale acquisi-
tion cost (as defined in section 
1847A(c)(6)) of such drug or product; 
or 
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‘‘(cc) if the wholesale acquisition 
cost is not available, the drug manu-
facturer’s invoice; 
‘‘(II) calculate the post-TDAPA add- 
on payment adjustment as the expendi-
tures for the new renal dialysis drug or bi-
ological product divided by the total num-
ber of renal dialysis services during which 
such drug or biological was administered 
during the same period; 
‘‘(III) set the amount of the add-on 
adjustment as an amount equal to 65 per-
cent of the amount calculated under sub-
clause (II); 
‘‘(IV) update the add-on adjustment 
annually 
to 
account 
for 
inflationary 
changes; and 
‘‘(V) apply the add-on adjustment 
amount immediately upon the expiration of 
the TDAPA period and availability of the 
post-TDAPA add-on adjustment. 
‘‘(iii) IMPLEMENTATION.—This subpara-
graph shall not be implemented in a budget 
neutral manner and shall not be adjusted by 
any applicable patient-level case-mix adjust-
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ments described in section 413.235 of title 42, 
Code of Federal Regulations (or any successor 
regulation).’’. 
(c) CLARIFICATION TO DEFINITION OF RENAL DI-
ALYSIS SERVICES.—Section 1881(b)(14)(B) of the Social 
Security Act (42 U.S.C. 1395rr(b)(14)(B)) is amended— 
(1) by redesignating clauses (i) through (iv) as 
subclauses (I) through (IV), respectively; 
(2) by inserting ‘‘(i)’’ after ‘‘(B)’’; 
(3) in clause (i)(IV), as added by paragraph 
(2), by striking ‘‘clause (i)’’ and inserting ‘‘subclause 
(I)’’; 
(4) in the flush text at the end, by striking 
‘‘Such term does not’’ and inserting the following: 
‘‘(ii) Such term— 
‘‘(I) does not’’; 
(5) in clause (ii), as added by paragraph (2)— 
(A) in subclause (I), by striking the period 
at the end and inserting ‘‘; and’’; and 
(B) by adding at the end the following: 
‘‘(II) does not include drugs or biological prod-
ucts 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 
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have end-stage renal diseases and is receiving dialy-
sis and— 
‘‘(aa) that have been approved by the 
Food and Drug Administration after De-
cember 31, 2025; and 
‘‘(bb) do not substitute for a drug or 
biological included in the ESRD prospec-
tive payment system base rate.’’; and 
(6) by adding at the end the following new 
clause: 
‘‘(iii) IMPLEMENTATION.—Beginning on the 
date of enactment of this clause, for purposes of im-
plementing clause (ii)(II), the Secretary shall require 
that a claim for a drug or biological product de-
scribed 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).’’. 
(d) REVISIONS TO TRANSITIONAL ADD-ON PAYMENT 
ADJUSTMENT FOR NEW AND INNOVATIVE EQUIPMENT 
AND SUPPLIES (TPNIES).— 
(1) EXTENSION
OF
PERIOD.—The Secretary 
shall pay the transitional add-on payment adjust-
ment for new and innovative equipment and supplies 
under section 413.236 of title 42, Code of Federal 
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Regulations (or a successor regulation), for not less 
than 3 years for any new renal dialysis device that— 
(A) qualifies for such adjustment; and 
(B) is furnished on or after January 1, 
2026. 
(2) ELIGIBILITY
OF
BREAKTHROUGH
DE-
VICES.—Beginning January 1, 2026, a device des-
ignated for expedited development and priority re-
view under section 515B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e–3) shall be eligi-
ble for a transitional add-on payment adjustment for 
new and innovative equipment and supplies under 
section 413.236 of title 42, Code of Federal Regula-
tions (or a successor regulation). 
(3) INCLUSION
OF
CAPITAL-RELATED
ASSETS 
IN THE TRANSITIONAL ADD-ON PAYMENT ADJUST-
MENT FOR NEW AND INNOVATIVE EQUIPMENT AND 
SUPPLIES
AND
POST-TRANSITIONAL
ADD-ON
PAY-
MENT
ADJUSTMENT
FOR
NEW
AND
INNOVATIVE 
EQUIPMENT AND SUPPLIES.—Beginning January 1, 
2026, the Secretary shall not apply the criterion de-
scribed 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 
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equipment and supplies and shall calculate such ad-
justment for capital-related assets that are devices 
that otherwise meet the requirements for the transi-
tional add-on payment adjustment for new and inno-
vative equipment. 
(e) EFFECTIVE DATE.—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. 
SEC. 102. ENSURING MEDICARE ADVANTAGE SUPPORTS 
KIDNEY CARE INNOVATIVE THERAPIES. 
(a) IN GENERAL.—Section 1853(c) of the Social Se-
curity Act (42 U.S.C. 1395w–23(c)) is amended by adding 
at the end the following new paragraph: 
‘‘(8) TREATMENT
OF
INNOVATIVE
PRODUCTS 
FOR
ENROLLEES
WITH
END
STAGE
RENAL
DIS-
EASE.— 
‘‘(A) IN GENERAL.—Beginning January 1, 
2026, the Secretary shall make direct payment 
adjustments to providers of services or renal di-
alysis facilities for— 
‘‘(i) any new renal dialysis drug or bi-
ological product that receives a transitional 
drug add-on payment adjustment under 
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section 413.234(c) of title 42, Code of 
Federal Regulations; or 
‘‘(ii) an item or service that receives a 
transitional add-on payment adjustment 
for new and innovative equipment and sup-
plies under section 413.236 of such title. 
‘‘(B) AMOUNT OF DIRECT PAYMENT.—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). 
‘‘(C) DURATION OF DIRECT PAYMENT.— 
The Secretary shall make payments under sub-
paragraph (A) for the duration of the transi-
tional payment under the end-stage renal dis-
ease prospective payment system described in 
such section.’’. 
(b) CONFORMING AMENDMENTS.—Section 1851(i) of 
the Social Security Act (42 U.S.C. 1395w–21) is amend-
ed— 
(1) 
in 
paragraph 
(1), 
by 
inserting 
‘‘1853(c)(8),’’ after ‘‘1886(h)(3)(D),’’; and 
(2) 
in 
paragraph 
(2), 
by 
inserting 
‘‘1853(c)(8),’’ after ‘‘1853(h),’’. 
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TITLE II—ADDRESSING STAFF-
ING BARRIERS WITH ESRD 
MARKET BASKET LABOR AD-
JUSTMENTS 
SEC. 201. ENSURING ACCURACY AND STABILITY IN KIDNEY 
CARE PAYMENT. 
Section 1881(b)(14)(F)(i) of the Social Security Act 
(42 U.S.C. 1395rr(b)(14)(F)(i)) is amended— 
(1) in subclause (I), by striking ‘‘subclauses 
(II) and (III)’’ and inserting ‘‘subclauses (II), (III), 
and (IV)’’; 
(2) in subclause (II), by inserting ‘‘and after 
application of subclause (IV)’’ after ‘‘subclause (I)’’; 
and 
(3) by adding at the end the following new sub-
clause: 
‘‘(IV) Beginning with 2026, the Sec-
retary 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 fore-
cast error (referred to in this subclause as 
the ‘forecast error adjustment’). The initial 
adjustment (in 2026) to the increase factor 
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shall take into account the cumulative fore-
cast 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 ad-
justment under this subclause shall apply 
whenever the difference between the fore-
casted 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.’’. 
TITLE III—PREVENTING KIDNEY 
DISEASE 
AND 
EXPANDING 
AWARENESS AND EDUCATION 
SEC. 301. EXPANDING MEDICARE ANNUAL WELLNESS BEN-
EFIT TO INCLUDE KIDNEY DISEASE SCREEN-
ING. 
(a) IN GENERAL.—Section 1861(ww)(2) of the Social 
Security Act (42 U.S.C. 1395x(ww)(2)) is amended— 
(1) by redesignating subparagraph (O) as sub-
paragraph (P); and 
(2) by inserting after subparagraph (N) the fol-
lowing new subparagraph: 
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‘‘(O) Chronic kidney disease screening as 
defined by the Secretary.’’. 
(b) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after January 1, 2026. 
SEC. 302. INCREASING ACCESS TO MEDICARE KIDNEY DIS-
EASE EDUCATION BENEFIT. 
(a) IN GENERAL.—Section 1861(ggg) of the Social 
Security Act (42 U.S.C. 1395x(ggg)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A), by inserting ‘‘or 
stage V’’ after ‘‘stage IV’’; and 
(B) in subparagraph (B), by inserting ‘‘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’’ after ‘‘kidney 
condition’’; and 
(2) in paragraph (2)— 
(A) by striking subparagraph (B); and 
(B) in subparagraph (A)— 
(i) by striking ‘‘(A)’’ after ‘‘(2)’’; 
(ii) by striking ‘‘and’’ at the end of 
clause (i); 
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(iii) by striking the period at the end 
of clause (ii) and inserting ‘‘; and’’; 
(iv) by redesignating clauses (i) and 
(ii) as subparagraphs (A) and (B), respec-
tively; and 
(v) by adding at the end the following: 
‘‘(C) a renal dialysis facility subject to the 
requirements of section 1881(b)(1) with per-
sonnel who— 
‘‘(i) provide the services described in 
paragraph (1); and 
‘‘(ii) is a physician (as defined in sub-
section (r)(1)) or a physician assistant, 
nurse practitioner, or clinical nurse spe-
cialist (as defined in subsection (aa)(5)).’’. 
(b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 
Section 1881(b) of the Social Security Act (42 U.S.C. 
1395rr(b)) is amended by adding at the end the following 
new paragraph: 
‘‘(15) For purposes of paragraph (14), the single pay-
ment 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 
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made to the renal dialysis facility on an assignment-re-
lated basis under section 1848.’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to kidney disease education serv-
ices furnished on or after January 1, 2026. 
Æ 
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