H.R. 6214

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6214 Introduced in House (IH)]

<DOC>

119th CONGRESS
1st Session
H. R. 6214

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 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 
consideration 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 purposes.

Be it enacted by the Senate and House of Representatives 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''.
(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.
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 INNOVATION

SEC. 101. REFINING THE END-STAGE RENAL DISEASE PAYMENT SYSTEM TO 
IMPROVE ACCESS TO INNOVATIVE TREATMENT OPTIONS.

(a) Extension of Transitional Drug Add-On Payment Adjustment 
(TDAPA) Period.--The Secretary of Health and Human Services (in this 
section referred 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--
(1) approved by the Food and Drug Administration 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.--Section 1881(b)(14) of the 
Social Security Act (42 U.S.C. 1395rr(b)(14)) is amended by adding at 
the end the following new subparagraph:
``(J) Payment for new and innovative drugs, biologicals, 
and devices that are renal dialysis services.--
``(i) In general.--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 `TDAPA') 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.
``(ii) Calculation of the post-tdapa add-on 
adjustment.--In calculating the add-on adjustment 
described in clause (i), the Secretary 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 
acquisition cost (as defined in section 
1847A(c)(6)) of such drug or product; 
or
``(cc) if the wholesale acquisition 
cost is not available, the drug 
manufacturer's invoice;
``(II) 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;
``(III) set the amount of the add-on 
adjustment as an amount equal to 65 percent of 
the amount calculated under subclause (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 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).''.
(c) Clarification to Definition of Renal Dialysis 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 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--
``(aa) that have been approved by the Food 
and Drug Administration after December 31, 
2025; and
``(bb) do not substitute for a drug or 
biological included in the ESRD prospective 
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 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).''.
(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 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--
(A) qualifies for such adjustment; and
(B) is furnished on or after January 1, 2026.
(2) Eligibility of breakthrough devices.--Beginning January 
1, 2026, a device designated for expedited development and 
priority review under section 515B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e-3) 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).
(3) 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.--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.
(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 Security 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 disease.--
``(A) In general.--Beginning January 1, 2026, the 
Secretary shall make direct payment adjustments to 
providers of services or renal dialysis facilities 
for--
``(i) 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
``(ii) 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.
``(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 subparagraph (A) for the 
duration of the transitional payment under the end-
stage renal disease 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 amended--
(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),''.

TITLE II--ADDRESSING STAFFING BARRIERS WITH ESRD MARKET BASKET LABOR 
ADJUSTMENTS

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 subclause:
``(IV) 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 `forecast 
error adjustment'). 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.''.

TITLE III--PREVENTING KIDNEY DISEASE AND EXPANDING AWARENESS AND 
EDUCATION

SEC. 301. EXPANDING MEDICARE ANNUAL WELLNESS BENEFIT TO INCLUDE KIDNEY 
DISEASE SCREENING.

(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 subparagraph (P); 
and
(2) by inserting after subparagraph (N) the following new 
subparagraph:
``(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 DISEASE 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);
(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), respectively; and
(v) by adding at the end the following:
``(C) a renal dialysis facility subject to the 
requirements of section 1881(b)(1) with personnel who--
``(i) provide the services described in 
paragraph (1); and
``(ii) 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)).''.
(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 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.''.
(c) Effective Date.--The amendments made by this section shall 
apply to kidney disease education services furnished on or after 
January 1, 2026.
<all>