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

Summary:
Chronic Kidney Disease Improvement in Research and Treatment Act
This bill expands, establishes, and otherwise modifies requirements under Medicare and other health care programs relating to individuals with end-stage renal disease (ESRD).
Among other things, the bill

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3912 Introduced in House (IH)]

<DOC>






116th CONGRESS
  1st Session
                                H. R. 3912

To amend title XVIII of the Social Security Act to increase awareness, 
  expand preventative services, and improve care for individuals with 
            end-stage renal disease, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 23, 2019

Mr. Lewis (for himself and Mr. Buchanan) introduced the following bill; 
  which was referred to the Committee on Energy and Commerce, and in 
    addition to the Committee on Ways and Means, 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 amend title XVIII of the Social Security Act to increase awareness, 
  expand preventative services, and improve care for individuals with 
            end-stage renal 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.

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

  TITLE I--INCREASING AWARENESS, EXPANDING PREVENTATIVE 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. 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 4 through stage 5, 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. 103. 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 ``and includes renal dialysis services'' before the period at 
the end.
    (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 ``, including 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 ``, including nephrology health professionals'' 
before the period at the end.

SEC. 104. IMPROVING CARE COORDINATION FOR DIALYSIS PATIENTS.

    (a) Hospitals Required 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 facility.
            ``(2) Elements.--Under the process established under 
        paragraph (1)--
                    ``(A) the request for the health information may be 
                initiated by the individual prior to discharge or upon 
                request by the renal dialysis facility after the 
                patient is discharged; and
                    ``(B) the information 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. MAINTAIN 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) Affirmation of Availability of Bad Debt Reimbursement for Non-
Composite Rate Services.--
            (1) Repeal of mippa bad debt rule of contruction.--Section 
        153(b)(4) of the Medicare Improvements for Patients and 
        Providers Act (42 U.S.C. 1395rr note) is repealed.
            (2) Bad debt payments.--Section 1881(b)(14) of the Social 
        Security Act (42 U.S.C. 1395rr(b)), as amended by subsections 
        (a) and (b), is further amended by adding at the end the 
        following new subparagraphs:
            ``(L) Notwithstanding any other provision of this title, 
        the Secretary shall provide payments for any unrecovered amount 
        for any bad debt attributable to deductible and coinsurance for 
        any item or service reimbursed under the system under this 
        paragraph or bad debt described in section 153(b)(4) of the 
        Medicare Improvements for Patients and Providers Act of 2008. 
        Such payments for any unrecovered amount shall be made in 
        addition to payments made under such system and such drug 
        designation process.
            ``(M) The additional payments made under subparagraph (L)--
                    ``(i) shall not be considered an adjustment under 
                subparagraph (D); and
                    ``(ii) shall not be implemented in a budget neutral 
                manner.''.
            (3) Effective date.--Paragraph (1) and the amendments made 
        by paragraph (2) shall apply to payments beginning on January 
        1, 2020.
    (d) 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 2020 through 2024, the 
                                productivity adjustment described in 
                                subclause (II) shall be zero for a 
                                payment system for any year in which 
                                the Medicare Payment Advisory 
                                Commission established under section 
                                1805 estimates that payments provided 
                                under such payment system, on an 
                                aggregate national basis, exceed costs, 
                                on an aggregate national basis, by 3.0 
                                percent or less.''.
    (e) 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), (b), and 
(c), is further amended by adding the following new subparagraph:
                    ``(N) 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 it is 
                        not. The Secretary shall use the cost and 
                        utilization data collected during the two-year 
                        transitional period, as set forth in the final 
                        regulation entitled `Medicare Program; End-
                        Stage Renal Disease Prospective Payment System, 
                        Payment for Renal Dialysis Services Furnished 
                        to Individuals With Acute Kidney Injury, End-
                        Stage Renal Disease Quality Incentive Program, 
                        Durable Medical Equipment, Prosthetics, 
                        Orthotics and Supplies (DMEPOS) Competitive 
                        Bidding Program (CBP) and Fee Schedule Amounts, 
                        and Technical Amendments To Correct Existing 
                        Regulations Related to the CBP for Certain 
                        DMEPOS' 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 clause shall be paid only when a provider 
                        or renal dialysis facility has demonstrated 
                        that it has administered the drug or biological 
                        to a patient.''.
    (f) 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 of Health and 
Human Services 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. IMPROVE 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) In general.--The measures specified under 
                this paragraph with respect to the year involved shall 
                be selected 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) by adding at the end the following new subparagraphs:
                    ``(F) 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.
                    ``(G) 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 
                shall--
                            ``(i) assign stars using the same 
                        methodology and total performance score results 
                        from the quality incentive program under this 
                        subsection;
                            ``(ii) determine the stars using the same 
                        methodology used under such quality incentive 
                        program; and
                            ``(iii) not use a forced bell curve when 
                        determining the stars or rebaselining the 
                        stars.''.
    (d) Incentive Payments.--
            (1) In general.--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.''.
            (2) 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 at 
                        the end and inserting the following: ``is--
                            ``(i) 65 years of age or older and is 
                        enrolled for benefits under part B; or
                            ``(ii) is 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 paragraph (2), 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));
                    (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. ALLOWING INDIVIDUALS WITH KIDNEY FAILURE TO RETAIN ACCESS TO 
              PRIVATE INSURANCE.

    (a) In General.--Section 1862(b)(1)(C) of the Social Security Act 
(42 U.S.C. 1395y(b)(1)(C)) is amended--
            (1) in the last sentence, by inserting ``and before January 
        1, 2020'' after ``prior to such date''; and
            (2) by adding at the end the following new sentence: 
        ``Effective for items and services furnished on or after 
        January 1, 2020 (with respect to periods beginning on or after 
        the date that is 42 months prior to such date), clauses (i) and 
        (ii) shall be applied by substituting `42-month' for `12-month' 
        each place it appears.''.
    (b) Effective Date.--The amendments made by this subsection shall 
take effect on the date of enactment of this Act. For purposes of 
determining an individual's status under section 1862(b)(1)(C) of the 
Social Security Act (42 U.S.C. 1395y(b)(1)(C)), as amended by 
subsection (a), an individual who is within the coordinating period as 
of the date of enactment of this Act shall have that period extended to 
the full 42 months described in the last sentence of such section, as 
added by the amendment made by subsection (a)(2).
                                 <all>