Title: Chronic Kidney Disease Improvement in Research and Treatment Act of 2019
Policy area: Health

Summary:
Chronic Kidney Disease Improvement in Research and Treatment Act of 2019
This bill addresses Medicare coverage for and access to treatment for chronic kidney disease. Specifically, the bill modifies provisions related to coverage by (1) allowing certain Medicare beneficiaries who have End Stage Renal Disease to enroll in Medicare supplemental policies, and (2) establishing new Medicare payment structures for renal dialysis services. Among other changes, the bill (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.
In addition, the bill requires information sharing between hospitals and renal dialysis centers in some circumstances as well as federal studies on issues related to kidney disease, including the use of palliative care and ways to increase transplantation rates.
The Department of Health and Human Services may also award National Health Services Corps scholarships and loan repayment to nephrology health professionals.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1676 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                S. 1676

 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

                 May 23 (legislative day, May 22), 2019

 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 2019''.
    (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. Increasing access to Medicare kidney disease education 
                            benefit.
Sec. 102. Improving patient lives and quality of care through research 
                            and innovation.
Sec. 103. Understanding current utilization of palliative care 
                            services.
Sec. 104. Understanding the progression of kidney disease and treatment 
                            of kidney failure in minority populations.
Sec. 105. Improving access in underserved areas.
Sec. 106. Improving care coordination for dialysis patients by 
                            requiring hospitals to provide information.
  TITLE II--INCENTIVIZING INNOVATION FOR TRULY INNOVATIVE NEW DRUGS, 
              BIOLOGICALS, DEVICES, AND OTHER TECHNOLOGIES

Sec. 201. Maintaining an economically stable dialysis infrastructure.
 TITLE III--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.

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

SEC. 101. 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, 
2020.

SEC. 102. 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. 103. UNDERSTANDING CURRENT UTILIZATION OF PALLIATIVE CARE 
              SERVICES.

    (a) Study.--
            (1) In general.--The Comptroller General of the United 
        States (in this section referred to as the ``Comptroller 
        General'') shall conduct a study on the utilization of 
        palliative care in treating individuals with advanced kidney 
        disease, from stage IV through stage V, including individuals 
        with kidney failure on dialysis through any progression of the 
        disease. Such study shall include an analysis of--
                    (A) how palliative care can be utilized to improve 
                the quality of life of those with kidney disease and 
                facilitate care tailored to their individual goals and 
                values;
                    (B) the successful use of palliative care in the 
                care of patients with other chronic diseases and 
                serious illnesses;
                    (C) the utilization of palliative care at any point 
                in an illness, including when used at the same time as 
                curative treatment; and
                    (D) other areas determined appropriate by the 
                Comptroller General.
            (2) Definition of palliative care.--In this section, the 
        term ``palliative care'' means patient and family centered care 
        that optimizes quality of life by anticipating, preventing, and 
        treating suffering. Such term includes care that is furnished 
        throughout the continuum of the illness that addresses 
        physical, intellectual, emotional, social, and spiritual needs 
        and that facilitates patient autonomy, access to information 
        and choice.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall submit to the Congress a 
report on the study conducted under subsection (a), together with such 
recommendations as the Comptroller General 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.

SEC. 105. IMPROVING ACCESS IN UNDERSERVED 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.

SEC. 106. IMPROVING CARE COORDINATION FOR DIALYSIS PATIENTS BY 
              REQUIRING HOSPITALS TO PROVIDE INFORMATION.

    Section 1881 of the Social Security Act (42 U.S.C. 1395rr) is 
amended by adding at the end the following new subsection:
    ``(i) Hospitals Required To Provide Information.--
            ``(1) In general.--The Secretary shall establish a process 
        under which a hospital or a critical access hospital shall 
        provide a renal dialysis facility with health and treatment 
        information with respect to an individual who is discharged 
        from the hospital or critical access hospital and who 
        subsequently receives treatment at the facility.
            ``(2) Elements.--Under the process established under 
        paragraph (1)--
                    ``(A) the request for health and treatment 
                information may be initiated by the individual prior to 
                discharge or upon request by the renal dialysis 
                facility after the individual is discharged; and
                    ``(B) the information requested must be provided to 
                the facility within 7 days of the request being 
                made.''.

  TITLE II--INCENTIVIZING INNOVATION FOR TRULY INNOVATIVE NEW DRUGS, 
              BIOLOGICALS, DEVICES, AND OTHER TECHNOLOGIES

SEC. 201. MAINTAINING AN ECONOMICALLY STABLE DIALYSIS INFRASTRUCTURE.

    (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, 2020, 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 only 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;
                            ``(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;
                            ``(iv) the standardization factor described 
                        in the final rule published in the Federal 
                        Register on November 8, 2012 (77 Fed. Reg. 
                        67470), shall be established using the most 
                        currently available data (and not historical 
                        data) and adjusted on an annual basis, based on 
                        such available data, to account for any change 
                        in utilization of drugs and any modification in 
                        adjustors applied under this paragraph; and
                            ``(v) 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, 2020, 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 2020 through 
                                2024, 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 two-year transitional payment period, as 
                        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 2021, 
and in consultation with stakeholders, the Secretary shall establish a 
process for identifying and determining appropriate payment amounts for 
incorporating new devices and technologies into the bundled payment 
under such system.

 TITLE III--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, 2020.

                     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, 2021.
    (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, 2021, and shall end June 30, 2021.
            (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>