Title: Chronic Kidney Disease Improvement in Research and Treatment Act of 2021
Policy area: Health

Summary:
Chronic Kidney Disease Improvement in Research and Treatment Act of 2021
This bill modifies provisions relating to Medicare coverage of treatments for chronic kidney disease.
Specifically, the bill expands the Medicare annual wellness visit to include chronic kidney disease screening and allows certain Medicare beneficiaries who have End Stage Renal Disease to enroll in Medicare supplemental policies. It also (1) provides for alternative payment methodologies for certain new drugs, biologics, and devices that are renal dialysis services; (2) revises quality measures; (3) establishes an incentive payment methodology; and (4) increases access to kidney disease education services.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1971 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 1971

 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 8, 2021

 Mr. Cardin (for himself and Mr. Blunt) 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 2021''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
   TITLE I--INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND 
                      IMPROVING CARE COORDINATION

Sec. 101. Expanding Medicare annual wellness benefit to include kidney 
                            disease screening.
Sec. 102. Increasing access to Medicare kidney disease education 
                            benefit.
Sec. 103. Improving patient lives and quality of care through research 
                            and innovation.
Sec. 104. Understanding the progression of kidney disease and treatment 
                            of kidney failure in minority populations.
 TITLE II--CREATING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE AND 
                        INCENTIVIZING INNOVATION

Sec. 201. Refining the end-stage renal disease payment system to 
                            improve accuracy in payment and support 
                            therapies.
    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.
                     TITLE IV--EMPOWERING PATIENTS

Sec. 401. Medigap coverage for beneficiaries with end-stage renal 
                            disease.
Sec. 402. Network adequacy requirements for dialysis services.

   TITLE I--INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND 
                      IMPROVING CARE COORDINATION

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.

SEC. 103. 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 
        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.

SEC. 104. 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 leading 
        to kidney disease;
            (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 failure.
    (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--CREATING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE AND 
                        INCENTIVIZING 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--
            (1) in subparagraph (D), in the matter preceding clause 
        (i), by striking ``Such system'' and inserting ``Subject to 
        subparagraph (J), such system''; and
            (2) by adding at the end the following new subparagraph:
                    ``(J) For payment for renal dialysis services 
                furnished on or after January 1, 2024, under the system 
                under this paragraph--
                            ``(i) the payment adjustment described in 
                        clause (i) of subparagraph (D)--
                                    ``(I) shall not take into account 
                                comorbidities; and
                                    ``(II) shall take into account age 
                                for purposes of distinguishing between 
                                individuals who are under 18 years of 
                                age and those who are 18 years of age 
                                and older but shall not include any 
                                other adjustment for age for patients 
                                18 years of age and older;
                            ``(ii) the Secretary shall reassess any 
                        adjustments related to patient weight under 
                        such clause;
                            ``(iii) the payment adjustment described in 
                        clause (ii) of such subparagraph shall not be 
                        included; and
                            ``(iv) take into account reasonable costs 
                        for determining the payment rate consistent 
                        with paragraph (2)(B).''.
    (b) Inclusion of Network Fee as an Allowable Cost.--Section 
1881(b)(14) of the Social Security Act (42 U.S.C. 1395rr(b)(14)), as 
amended by subsection (a), is amended by adding at the end the 
following new subparagraph:
                    ``(K) Not later than January 1, 2022, the Secretary 
                shall amend the ESRD facility cost report to include 
                the per treatment network fee (as described in 
                paragraph (7)) as an allowable cost or offset to 
                revenue.''.
    (c) Determination of Productivity Adjustment.--Section 
1886(b)(3)(B)(xi) of the Social Security Act (42 U.S.C. 
1395ww(b)(3)(B)(xi)) is amended--
            (1) in subclause (I), by striking ``For 2012'' and 
        inserting ``Subject to subclause (IV), for 2012''; and
            (2) by adding at the end, the following new subclause:
                                    ``(IV) For each of 2022 through 
                                2025, the productivity adjustment 
                                described in subclause (II) shall be 
                                zero for a payment system in any year 
                                in which the Medicare Payment Advisory 
                                Commission estimates that payments 
                                under this title pursuant to such 
                                payment system, on an aggregate 
                                national basis, exceed costs, on an 
                                aggregate national basis, by 3.0 
                                percent or less.''.
    (d) Payment for New and Innovative Drugs and Biologicals That Are 
Renal Dialysis Services.--Section 1881(b)(14) of the Social Security 
Act (42 U.S.C. 1395ww(b)(14)), as amended by subsections (a) and (b), 
is amended by adding the following new subparagraph--
                    ``(L) Payment for new and innovative drugs, 
                biologicals, and devices that are renal dialysis 
                services.--
                            ``(i) In general.--For drugs or biologicals 
                        determined to be within a functional category, 
                        the Secretary, in consultation with 
                        stakeholders, shall ensure that the single 
                        payment amount is adequate to cover the cost of 
                        new innovative drugs or biologicals 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 
                        the three-year transitional payment period, as 
                        otherwise described in the final regulation 
                        published on November 14, 2018 (83 Fed. Reg. 
                        56922 et seq.).
                            ``(ii) Money to follow the patient.--The 
                        Secretary, through notice and comment 
                        rulemaking, shall implement a policy for any 
                        drug or biological that is not provided to the 
                        `average' patient that results in the amount by 
                        which the single payment amount is increased 
                        pursuant to this subparagraph shall be paid 
                        only when a provider or renal dialysis facility 
                        has demonstrated that it has administered the 
                        drug or biological to a patient.''.
    (e) 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 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 three-year transitional payment 
period, as otherwise described in the final regulation published on 
November 9, 2020 (85 Fed. Reg. 71398 et seq.).

    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) of the Social Security Act 
(42 U.S.C. 1395rr(h)(2)(B)) is amended--
            (1) in clause (ii), 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.''; and
            (2) by adding at the end the following new clause:
                            ``(iii) Composite measures.--Clauses (i) 
                        and (ii) shall apply to composite measures in 
                        the same manner as such clauses apply to 
                        individual measures.''.
    (c) Requirements for Dialysis Facility Compare Star Rating 
Program.--Section 1881(h)(6) of the Social Security Act (42 U.S.C. 
1395rr(h)(6)) is amended by adding at the end the following new 
subparagraph:
                    ``(E) Requirements for any dialysis facility 
                compare star rating program.--To the extent that the 
                Secretary maintains a dialysis facility compare star 
                rating program, under such a program the Secretary--
                            ``(i) shall assign stars using the same 
                        methodology and total performance score results 
                        from the quality incentive program under this 
                        subsection;
                            ``(ii) shall determine the stars using the 
                        same methodology used under such quality 
                        incentive program; and
                            ``(iii) shall not use a forced bell curve 
                        when determining the stars or rebaselining the 
                        stars.''.
    (d) Incentive Payments.--Section 1881(h)(1) of the Social Security 
Act (42 U.S.C. 1395rr(h)(1)) is amended by adding at the end the 
following new subparagraph:
                    ``(D) Incentive payments.--
                            ``(i) In general.--In the case of a 
                        provider of services or a renal dialysis 
                        facility that the Secretary determines exceeds 
                        the attainment performance standards under 
                        paragraph (4) with respect to a year, the 
                        Secretary may make a bonus payment to the 
                        provider or facility (pursuant to a process 
                        established by the Secretary).
                            ``(ii) Funding.--The total amount of bonus 
                        payments under clause (i) in a year shall be 
                        equal to the total amount of reduced payments 
                        in a year under subparagraph (A).
                            ``(iii) No effect in subsequent years.--The 
                        provisions of subparagraph (C) shall apply to a 
                        bonus payment under this subparagraph in the 
                        same manner subparagraph (C) applies to a 
                        reduction under such subparagraph.''.
    (e) Effective Date.--The amendments made by this section shall 
apply to items and services furnished on or after January 1, 2022.

                     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, 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)).

SEC. 402. NETWORK ADEQUACY STANDARDS FOR DIALYSIS SERVICES.

    Section 1852(d) of the Social Security Act (42 U.S.C. 1395w-22(d)) 
is amended by adding at the end the following new paragraph:
            ``(7) Network adequacy requirements for dialysis 
        services.--For plan year 2022 and subsequent plan years, the 
        Secretary shall apply the network adequacy standards under this 
        subsection with respect to access to dialysis services--
                    ``(A) using the time and distance standards in 
                effect for plan year 2020; and
                    ``(B) without regard to the final rule titled 
                `Medicare Program; Contract Year 2021 Policy and 
                Technical Changes to the Medicare Advantage Program, 
                Medicare Prescription Drug Benefit Program, and 
                Medicare Cost Plan Program' (85 Fed. Reg. 33796).''.
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