[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4469 Introduced in Senate (IS)]
<DOC>
118th CONGRESS
2d Session
S. 4469
To improve the understanding of, and promote access to treatment for,
chronic kidney disease, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 5, 2024
Mr. Cardin (for himself and Mrs. Blackburn) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To improve the understanding of, and promote access to treatment for,
chronic kidney disease, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Chronic Kidney
Disease Improvement in Research and Treatment Act of 2024''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--PREVENTING KIDNEY DISEASE BY EXPANDING EDUCATION AND AWARENESS
Sec. 101. Expanding Medicare annual wellness benefit to include kidney
disease screening.
Sec. 102. Increasing access to Medicare kidney disease education
benefit.
Sec. 103. Understanding the progression of kidney disease and treatment
of kidney failure in minority populations.
TITLE II--INCENTIVIZING KIDNEY CARE INNOVATION
Sec. 201. Refining the end-stage renal disease payment system to
improve accuracy in payment and support
therapies.
Sec. 202. Ensuring Medicare Advantage supports kidney care innovative
therapies.
Sec. 203. Improving patient lives and quality of care through research
and innovation.
TITLE III--ADDRESSING THE KIDNEY CARE WORKFORCE CRISIS.
Sec. 301. Improving patient decision making and transparency by
consolidating and modernizing quality
programs.
Sec. 302. Ensuring accuracy and stability in kidney care payment.
TITLE IV--EXPANDING PATIENT CHOICE OF COVERAGE
Sec. 401. Medigap coverage for beneficiaries with end-stage renal
disease.
TITLE I--PREVENTING KIDNEY DISEASE BY EXPANDING EDUCATION AND AWARENESS
SEC. 101. 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 moving subparagraph (N) 2 ems to the left;
(2) by redesignating subparagraph (O) as subparagraph (P);
and
(3) 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 apply to
items and services furnished on or after January 1, 2025.
SEC. 102. 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
indenting appropriately; 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 apply to
kidney disease education services furnished on or after January 1,
2025.
SEC. 103. UNDERSTANDING THE PROGRESSION OF KIDNEY DISEASE AND TREATMENT
OF KIDNEY FAILURE IN MINORITY POPULATIONS.
(a) Study.--The Secretary of Health and Human Services (in this
section referred to as the ``Secretary'') shall conduct a study on--
(1) the social, behavioral, and biological factors
associated with kidney disease onset and progression;
(2) efforts to slow the progression of kidney disease in
minority populations that are disproportionately affected by
such disease; and
(3) treatment patterns associated with providing care,
under the Medicare program under title XVIII of the Social
Security Act, the Medicaid program under title XIX of such Act,
and through private health insurance, to minority populations
that are disproportionately affected by kidney disease.
(b) Report.--Not later than 1 year after the date of the enactment
of this Act, the Secretary shall submit to Congress a report on the
study conducted under subsection (a), together with such
recommendations as the Secretary determines to be appropriate.
TITLE II--INCENTIVIZING KIDNEY CARE INNOVATION
SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAYMENT SYSTEM TO
IMPROVE ACCURACY IN PAYMENT AND SUPPORT THERAPIES.
(a) In General.--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
for which there is a functional category as defined in section
413.234(a) of title 42, Code of Federal Regulations that
received a transitional drug add-on adjustment (referred to in
this subparagraph as `TDAPA') under section 413.234(c)(2) 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, 2025,
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).''.
(b) Extension of Transitional Drug Add-On Adjustment Under the Drug
Designation Policy.--The Secretary shall pay the transitional drug add-
on adjustment under paragraph (c) of section 413.234 of title 42, Code
of Federal Regulations (or a successor regulation) for a total of 3
years for any new renal dialysis drug or biological product that--
(1) is used to treat or manage a condition for which there
is a functional category as defined in paragraph (a) of such
section;
(2) qualifies for such adjustment under paragraph (c)(2) of
such section; and
(3) is furnished on or after January 1, 2024.
(c) New Devices and Other Technologies.--
(1) In general.--As part of the promulgation of the annual
rule for the Medicare end-stage renal disease prospective
payment system under section 1881(b)(14) of the Social Security
Act (42 U.S.C. 1395rr(b)(14)) for calendar year 2026, and in
consultation with stakeholders, the Secretary of Health and
Human Services (referred to in this subsection as the
``Secretary'') shall--
(A) ensure that the single payment amount is
adequate to cover the cost of any new innovative device
or other technology with substantial clinical
improvement; and
(B) increase the single payment amount if the
Secretary determines such payment amount is not
adequate to cover such cost.
(2) Cost and utilization data.--In carrying out paragraph
(1), the Secretary shall use the cost and utilization data
collected during a 3-year transitional payment period, as
described in the final regulation published on November 9, 2020
(85 Fed. Reg. 71398).
SEC. 202. ENSURING MEDICARE ADVANTAGE SUPPORTS KIDNEY CARE INNOVATIVE
THERAPIES.
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.--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 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.''.
SEC. 203. IMPROVING PATIENT LIVES AND QUALITY OF CARE THROUGH RESEARCH
AND INNOVATION.
(a) Study.--The Secretary of Health and Human Services (referred to
in this section as the ``Secretary'') shall conduct a study on
increasing kidney transplantation rates. Such study shall include an
analysis of each of the following:
(1) Any disincentives in the payment systems under the
Medicare program under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.) that create barriers to kidney
transplants and post-transplant care for beneficiaries with
end-stage renal disease.
(2) The practices used by donation service areas with
higher than average donation rates and whether those practices
and policies could be successfully utilized in other donation
service areas.
(3) Practices and policies that could increase donation
rates among minority populations.
(4) Whether cultural and policy barriers exist to
increasing living donation rates, including an examination of
how to better facilitate kidney paired donations.
(5) Criteria for transplant recipients for referral and for
getting on the waitlist to receive a kidney.
(6) Other areas determined appropriate by the Secretary.
(b) Report.--Not later than 18 months after the date of enactment
of this Act, the Secretary shall submit to Congress a report on the
study conducted pursuant to subsection (a), together with such
recommendations as the Secretary determines to be appropriate.
TITLE III--INCREASING PATIENT ACCESS TO QUALITY PERFORMANCE BY
IMPROVING THE ACCURACY AND TRANSPARENCY OF END-STAGE RENAL DISEASE
QUALITY PROGRAMS
SEC. 301. IMPROVING PATIENT DECISION MAKING AND TRANSPARENCY BY
CONSOLIDATING AND MODERNIZING QUALITY PROGRAMS.
(a) Measures.--Section 1881(h)(2) of the Social Security Act (42
U.S.C. 1395rr(h)(2)) is amended--
(1) by striking subparagraph (A) and inserting the
following:
``(A) The measures specified under this paragraph
with respect to the year involved shall be selected by
the Secretary in consultation with stakeholders to
promote improvement in beneficiary outcomes and shared
decision-making with beneficiaries and their
caregivers. When selecting measures specified under
this paragraph, the Secretary shall take into account
clinical gaps in care, underutilization that may lead
to beneficiary harm, patient safety, and outcomes.'';
(2) in subparagraph (B)(i), by striking ``subparagraph
(A)(iv)'' and inserting ``subparagraph (A)'';
(3) by striking subparagraph (E); and
(4) by adding at the end the following new subparagraphs:
``(E) Weighting limitation.--No single measure
specified by the Secretary or individual measure within
a composite measure so specified may be weighted less
than 10 percent of the total performance score.
``(F) Statistically valid and reliable.--In
specifying measures under subparagraph (A), the
Secretary shall only specify measures that have been
shown to be statistically valid and reliable through
testing.''.
(b) Endorsement.--Section 1881(h)(2)(B)(ii) of the Social Security
Act (42 U.S.C. 1395rr(h)(2)(B)(ii)) is amended by adding at the end the
following new sentence: ``The exception under the preceding sentence
shall not apply to a measure that the entity with a contract under
section 1890(a) (or a similar entity) considered but failed to
endorse.''.
(e) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after January 1, 2025.
TITLE IV--EMPOWERING PATIENTS
SEC. 401. MEDIGAP COVERAGE FOR BENEFICIARIES WITH END-STAGE RENAL
DISEASE.
(a) Guaranteed Availability of Medigap Policies to All ESRD
Medicare Beneficiaries.--
(1) In general.--Section 1882(s) of the Social Security Act
(42 U.S.C. 1395ss(s)) is amended--
(A) in paragraph (2)--
(i) in subparagraph (A), by striking ``is
65'' and all that follows through the period
and inserting the following: ``is--
``(i) 65 years of age or older and is enrolled for benefits
under part B; or
``(ii) entitled to benefits under 226A(b) and is enrolled
for benefits under part B.''; and
(ii) in subparagraph (D), in the matter
preceding clause (i), by inserting ``(or is
entitled to benefits under 226A(b))'' after
``is 65 years of age or older''; and
(B) in paragraph (3)(B)--
(i) in clause (ii), by inserting ``(or is
entitled to benefits under 226A(b))'' after
``is 65 years of age or older''; and
(ii) in clause (vi), by inserting ``(or
under 226A(b))'' after ``at age 65''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply to Medicare supplemental policies effective on or
after J