119-s2730

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 2730 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 2730

 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 SENATE OF THE UNITED STATES

 September 8, 2025

 Mrs. Blackburn (for herself and Mr. Booker) introduced the following 
 bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

 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 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.''.
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