[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4469 Introduced in Senate (IS)]

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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 January 1, 2026.
    (b) Additional Enrollment Period for Certain Individuals.--
            (1) One-time enrollment period.--
                    (A) In general.--In the case of an individual 
                described in subparagraph (B), the Secretary of Health 
                and Human Services shall establish a one-time 
                enrollment period during which such an individual may 
                enroll in any Medicare supplemental policy under 
                section 1882 of the Social Security Act (42 U.S.C. 
                1395ss) of the individual's choosing.
                    (B) Enrollment period.--The enrollment period 
                established under subparagraph (A) shall begin on 
                January 1, 2026, and shall end June 30, 2026.
            (2) Individual described.--An individual described in this 
        paragraph is an individual who--
                    (A) is entitled to hospital insurance benefits 
                under part A of title XVIII of the Social Security Act 
                under section 226A(b) of such Act (42 U.S.C. 426-1);
                    (B) is enrolled for benefits under part B of such 
                title XVIII; and
                    (C) would not, but for the provisions of, and 
                amendments made by, subsection (a) be eligible for the 
                guaranteed issue of a Medicare supplemental policy 
                under paragraph (2) or (3) of section 1882(s) of such 
                Act (42 U.S.C. 1395ss(s)).
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