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