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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5027 Introduced in House (IH)]

<DOC>

118th CONGRESS
  1st Session
                                H. R. 5027

 To improve the understanding of, and promote access to treatment for, 
            chronic kidney disease, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             July 27, 2023

 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 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.

    This Act may be cited as the ``Chronic Kidney Disease Improvement 
in Research and Treatment Act of 2023''.

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

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 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 apply to 
items and services furnished on or after January 1, 2022.

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
                            (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, 
2022.

             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. 1395ww(b)(14)) is amended by adding the following new 
subparagraph:
                    ``(J) Payment for new and innovative drugs, 
                biologicals, and devices that are renal dialysis 
                services.--
                            ``(i) In general.--For drugs or biologicals 
                        defined as within a functional category and 
                        furnished on or after January 1, 2024, the 
                        Secretary shall implement an add-on adjustment 
                        for claims that include such drugs or 
                        biologicals that, among other things, shall--
                                    ``(I) calculate a per-treatment 
                                cost using the most recent cost and 
                                utilization data collected during a 
                                transitional payment period of not less 
                                than 3 years by dividing the total 
                                spending for such drug or biological 
                                during such transitional period by the 
                                total number of treatments for which 
                                such drug or biological was listed on 
                                such claim during such period of time;
                                    ``(II) offset the amount of the 
                                add-on adjustment by an amount that 
                                corresponds with the reduction in 
                                expenditures for other formerly 
                                separately billed renal dialysis drugs 
                                that were directly the result of the 
                                inclusion of the new product;
                                    ``(III) update the add-on 
                                adjustment annually to account for 
                                inflationary changes; and
                                    ``(IV) be applied immediately upon 
                                the expiration of the TDAPA period for 
                                a product to avoid a gap between the 
                                TDAPA and availability of the post-
                                TDAPA add-on adjustment.
                            ``(ii) Implementation.--This policy shall 
                        not be implemented in a budget neutral 
                        manner.''.
    (b) New Devices and Other Technologies.--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 2022, 
and in consultation with stakeholders, the Secretary of Health and 
Human Services (in this section referred to as the ``Secretary'') shall 
ensure that the single payment amount is adequate to cover the cost of 
the new innovative device or other technology with substantial clinical 
improvement and increase the single payment amount if the Secretary 
determines such payment amount is not adequate to cover such cost. In 
carrying out the preceding sentence, the Secretary shall use the cost 
and utilization data collected during a 3-year transitional payment 
period, as otherwise described in the final regulation published on 
November 9, 2020 (85 Fed. Reg. 71398 et seq.).

SEC. 202. ENSURING MEDICARE ADVANTAGE SUPPORTS KIDNEY CARE INNOVATIVE 
              THERAPIES.

    Section 1853(c) of the Social Security Act (42 U.S.C. 1395ww-23(c)) 
is amended by adding the following new paragraph:
            ``(8) Adjustment for innovative products for enrolles with 
        end stage renal disease.--If the Secretary makes a 
        determination with respect to the application of the End Stage 
        Renal Disease Transitional Drug Add-On Payment Adjustment or 
        the Transitional Add-on Payment Adjustment for New and 
        Innovative Equipment and Supplies to a product under this title 
        that will result in an increase in the costs to Medicare+Choice 
        of providing benefits under contracts under this part for the 
        period of the Transitional Drug Add-On Payment Adjustment or 
        the Transitional Add-on Payment Adjustment for New and 
        Innovative Equipment and Supplies, the Secretary shall directly 
        make the payments adjustments to providers of services or 
        independent dialysis facilities consistent with the application 
        of such adjustments under the ESRD prospective payment system 
        outlined in section 1881(b)(14) of this title for the complete 
        duration that the adjustment applies under such section. After 
        the duration of such adjustment, the Secretary shall adjust 
        appropriately the payments to such organizations under this 
        part.
            ``(9) Post-TDAPA payment add-on adjustment.--The Secretary 
        shall require providers of services or independent dialysis 
        facilities to apply the adjustment required under subparagraph 
        (J) of section 1881(b)(14) to payments made under this part.''.

SEC. 203. IMPROVING PATIENT LIVES AND QUALITY OF CARE THROUGH RESEARCH 
              AND INNOVATION.

    (a) Study.--The Secretary of Health and Human Services (in this 
section referred to 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 States with higher than average 
        donation rates and whether those practices and policies could 
        be successfully utilized in other States.
            (3) Practices and policies that could increase deceased 
        donation rates of minority populations.
            (4) Whether cultural and policy barriers exist to 
        increasing living donation rates, including an examination of 
        how to better facilitate chained donations.
            (5) Other areas determined appropriate by the Secretary.
    (b) Report.--Not later than 18 months 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 III--ADDRESSING THE KIDNEY CARE WORKFORCE CRISIS

SEC. 301. ENSURING ACCURACY AND STABILITY IN KIDNEY CARE PAYMENT.

    Section 1881(b)(14) of the Social Security Act (42 U.S.C. 
1395ww(b)(14)) is amended by adding the following new subparagraph:
                    ``(K) Beginning with calendar year 2024, the 
                Secretary shall compute an adjustment to the annual 
                update of the previous calendar year's rate to account 
                for forecast error. The initial adjustment (in calendar 
                year 2024) to the update of the previous calendar 
                year's rate will take into account the cumulative 
                forecast error between calendar years 2021 and 2022. 
                Subsequent adjustments in succeeding fiscal years will 
                take into account the forecast error from the most 
                recently available calendar year for which there is 
                final data. The forecast error adjustment shall apply 
                whenever the difference between the forecasted and 
                actual percentage change in the ESRD market basket 
                index exceeds the threshold of 0.5 percentage 
                points.''.

SEC. 302. ENCOURAGING KIDNEY CARE WORKFORCE IN UNDER SERVED AREAS.

    (a) Definition of Primary Care Services.--Section 331(a)(3)(D) of 
the Public Health Service Act (42 U.S.C. 254d(a)(3)(D)) is amended by 
inserting ``renal dialysis,'' after ``dentistry,''.
    (b) National Health Service Corps Scholarship Program.--Section 
338A(a)(2) of the Public Health Service Act (42 U.S.C. 254l(a)(2)) is 
amended by inserting ``, which may include nephrology health 
professionals'' before the period at the end.
    (c) National Health Service Corps Loan Repayment Program.--Section 
338B(a)(2) of the Public Health Service Act (42 U.S.C. 254l-1(a)(2)) is 
amended by inserting ``, which may include nephrology health 
professionals'' before the period at the end.

             TITLE IV--EXPANDING PATIENT CHOICE OF COVERAGE

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, 2022.
    (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, 2023, and shall end June 30, 2023.
            (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)).
                                 <all>
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