Chronic Kidney Disease Improvement in Research and Treatment Act of 2021

II 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘Chronic Kidney Disease Improvement in Research and 5 Treatment Act of 2021’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 Sec. 1. Short title; table of contents. TITLE I—INCREASING AWARENESS, EXPANDING PREVENTIVE SERVICES, AND IMPROVING CARE COORDINATION VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1971 IS 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 in- novation. 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 accu- racy in payment and support therapies. TITLE III—INCREASING PATIENT ACCESS TO QUALITY PERFORM- ANCE 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 AWARE- 1 NESS, EXPANDING PREVEN- 2 TIVE SERVICES, AND IMPROV- 3 ING CARE COORDINATION 4 SEC. 101. EXPANDING MEDICARE ANNUAL WELLNESS BEN- 5 EFIT TO INCLUDE KIDNEY DISEASE SCREEN- 6 ING. 7 (a) IN GENERAL.—Section 1861(ww)(2) of the Social 8 Security Act (42 U.S.C. 1395x(ww)(2)) is amended— 9 (1) by redesignating subparagraph (O) as sub- 10 paragraph (P); and 11 (2) by inserting after subparagraph (N) the fol- 12 lowing new subparagraph: 13 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1971 IS ‘‘(O) Chronic kidney disease screening as 1 defined by the Secretary.’’. 2 (b) EFFECTIVE DATE.—The amendments made by 3 this section apply to items and services furnished on or 4 after January 1, 2022. 5 SEC. 102. INCREASING ACCESS TO MEDICARE KIDNEY DIS- 6 EASE EDUCATION BENEFIT. 7 (a) IN GENERAL.—Section 1861(ggg) of the Social 8 Security Act (42 U.S.C. 1395x(ggg)) is amended— 9 (1) in paragraph (1)— 10 (A) in subparagraph (A), by inserting ‘‘or 11 stage V’’ after ‘‘stage IV’’; and 12 (B) in subparagraph (B), by inserting ‘‘or 13 of a physician assistant, nurse practitioner, or 14 clinical nurse specialist (as defined in section 15 1861(aa)(5)) assisting in the treatment of the 16 individual’s kidney condition’’ after ‘‘kidney 17 condition’’; and 18 (2) in paragraph (2)— 19 (A) by striking subparagraph (B); and 20 (B) in subparagraph (A)— 21 (i) by striking ‘‘(A)’’ after ‘‘(2)’’; 22 (ii) by striking ‘‘and’’ at the end of 23 clause (i); 24 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1971 IS (iii) by striking the period at the end 1 of clause (ii) and inserting ‘‘; and’’; 2 (iv) by redesignating clauses (i) and 3 (ii) as subparagraphs (A) and (B), respec- 4 tively; and 5 (v) by adding at the end the following: 6 ‘‘(C) a renal dialysis facility subject to the 7 requirements of section 1881(b)(1) with per- 8 sonnel who— 9 ‘‘(i) provide the services described in 10 paragraph (1); and 11 ‘‘(ii) is a physician (as defined in sub- 12 section (r)(1)) or a physician assistant, 13 nurse practitioner, or clinical nurse spe- 14 cialist (as defined in subsection (aa)(5)).’’. 15 (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 16 Section 1881(b) of the Social Security Act (42 U.S.C. 17 1395rr(b)) is amended by adding at the end the following 18 new paragraph: 19 ‘‘(15) For purposes of paragraph (14), the sin- 20 gle payment for renal dialysis services under such 21 paragraph shall not take into account the amount of 22 payment for kidney disease education services (as 23 defined in section 1861(ggg)). Instead, payment for 24 such services shall be made to the renal dialysis fa- 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1971 IS cility on an assignment-related basis under section 1 1848.’’. 2 (c) EFFECTIVE DATE.—The amendments made by 3 this section apply to kidney disease education services fur- 4 nished on or after January 1, 2022. 5 SEC. 103. IMPROVING PATIENT LIVES AND QUALITY OF 6 CARE THROUGH RESEARCH AND INNOVA- 7 TION. 8 (a) STUDY.—The Secretary of Health and Human 9 Services (in this section referred to as the ‘‘Secretary’’) 10 shall conduct a study on increasing kidney transplantation 11 rates. Such study shall include an analysis of each of the 12 following: 13 (1) Any disincentives in the payment systems 14 under the Medicare program under title XVIII of 15 the Social Security Act that create barriers to kid- 16 ney transplants and post-transplant care for bene- 17 ficiaries with end-stage renal disease. 18 (2) The practices used by States with higher 19 than average donation rates and whether those prac- 20 tices and policies could be successfully utilized in 21 other States. 22 (3) Practices and policies that could increase 23 deceased donation rates of minority populations. 24 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1971 IS (4) Whether cultural and policy barriers exist to 1 increasing living donation rates, including an exam- 2 ination of how to better facilitate chained donations. 3 (5) Other areas determined appropriate by the 4 Secretary. 5 (b) REPORT.—Not later than 18 months after the 6 date of the enactment of this Act, the Secretary shall sub- 7 mit to Congress a report on the study conducted under 8 subsection (a), together with such recommendations as the 9 Secretary determines to be appropriate. 10 SEC. 104. UNDERSTANDING THE PROGRESSION OF KIDNEY 11 DISEASE AND TREATMENT OF KIDNEY FAIL- 12 URE IN MINORITY POPULATIONS. 13 (a) STUDY.—The Secretary of Health and Human 14 Services (in this section referred to as the ‘‘Secretary’’) 15 shall conduct a study on— 16 (1) the social, behavioral, and biological factors 17 leading to kidney disease; 18 (2) efforts to slow the progression of kidney dis- 19 ease in minority populations that are disproportion- 20 ately affected by such disease; and 21 (3) treatment patterns associated with pro- 22 viding care, under the Medicare program under title 23 XVIII of the Social Security Act, the Medicaid pro- 24 gram under title XIX of such Act, and through pri- 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1971 IS vate health insurance, to minority populations that 1 are disproportionately affected by kidney failure. 2 (b) REPORT.—Not later than 1 year after the date 3 of the enactment of this Act, the Secretary shall submit 4 to Congress a report on the study conducted under sub- 5 section (a), together with such recommendations as the 6 Secretary determines to be appropriate. 7 TITLE II—CREATING AN ECO- 8 NOMICALLY STABLE DIALY- 9 SIS INFRASTRUCTURE AND 10 INCENTIVIZING INNOVATION 11 SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAY- 12 MENT SYSTEM TO IMPROVE ACCURACY IN 13 PAYMENT AND SUPPORT THERAPIES. 14 (a) IN GENERAL.—Section 1881(b)(14) of the Social 15 Security Act (42 U.S.C. 1395rr(b)(14)) is amended— 16 (1) in subparagraph (D), in the matter pre- 17 ceding clause (i), by striking ‘‘Such system’’ and in- 18 serting ‘‘Subject to subparagraph (J), such system’’; 19 and 20 (2) by adding at the end the following new sub- 21 paragraph: 22 ‘‘(J) For payment for renal dialysis serv- 23 ices furnished on or after January 1, 2024, 24 under the system under this paragraph— 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1971 IS ‘‘(i) the payment adjustment de- 1 scribed in clause (i) of subparagraph (D)— 2 ‘‘(I) shall not take into account 3 comorbidities; and 4 ‘‘(II) shall take into account age 5 for purposes of distinguishing between 6 individuals who are under 18 years of 7 age and those who are 18 years of age 8 and older but shall not include any 9 other adjustment for age for patients 10 18 years of age and older; 11 ‘‘(ii) the Secretary shall reassess any 12 adjustments related to patient weight 13 under such clause; 14 ‘‘(iii) the payment adjustment de- 15 scribed in clause (ii) of such subparagraph 16 shall not be included; and 17 ‘‘(iv) take into account reasonable 18 costs for determining the payment rate 19 consistent with paragraph (2)(B).’’. 20 (b) INCLUSION OF NETWORK FEE AS AN ALLOW- 21 ABLE COST.—Section 1881(b)(14) of the Social Security 22 Act (42 U.S.C. 1395rr(b)(14)), as amended by subsection 23 (a), is amended by adding at the end the following new 24 subparagraph: 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1971 IS ‘‘(K) Not later than January 1, 2022, the 1 Secretary shall amend the ESRD facility cost 2 report to include the per treatment network fee 3 (as described in paragraph (7)) as an allowable 4 cost or offset to revenue.’’. 5 (c) DETERMINATION OF PRODUCTIVITY ADJUST- 6 MENT.—Section 1886(b)(3)(B)(xi) of the Social Security 7 Act (42 U.S.C. 1395ww(b)(3)(B)(xi)) is amended— 8 (1) in subclause (I), by striking ‘‘For 2012’’ 9 and inserting ‘‘Subject to subclause (IV), for 2012’’; 10 and 11 (2) by adding at the end, the following new sub- 12 clause: 13 ‘‘(IV) For each of 2022 through 14 2025, the productivity adjustment de- 15 scribed in subclause (II) shall be zero 16 for a payment system in any year in 17 which the Medicare Payment Advisory 18 Commission estimates that payments 19 under this title pursuant to such pay- 20 ment system, on an aggregate na- 21 tional basis, exceed costs, on an ag- 22 gregate national basis, by 3.0 percent 23 or less.’’. 24 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1971 IS (d) PAYMENT FOR NEW AND INNOVATIVE DRUGS 1 AND BIOLOGICALS THAT ARE RENAL DIALYSIS SERV- 2 ICES.—Section 1881(b)(14) of the Social Security Act (42 3 U.S.C. 1395ww(b)(14)), as amended by subsections (a) 4 and (b), is amended by adding the following new subpara- 5 graph— 6 ‘‘(L) PAYMENT FOR NEW AND INNOVATIVE 7 DRUGS, BIOLOGICALS, AND DEVICES THAT ARE 8 RENAL DIALYSIS SERVICES.— 9 ‘‘(i) IN GENERAL.—For drugs or 10 biologicals determined to be within a func- 11 tional category, the Secretary, in consulta- 12 tion with stakeholders, shall ensure that 13 the single payment amount is adequate to 14 cover the cost of new innovative drugs or 15 biologicals and increase the single payment 16 amount if the Secretary determines such 17 payment amount is not adequate to cover 18 such cost. In carrying out the preceding 19 sentence, the Secretary shall use the cost 20 and utilization data collected during the 21 three-year transitional payment period, as 22 otherwise described in the final regulation 23 published on November 14, 2018 (83 Fed. 24 Reg. 56922 et seq.). 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 11 •S 1971 IS ‘‘(ii) MONEY TO FOLLOW THE PA- 1 TIENT.—The Secretary, through notice 2 and comment rulemaking, shall implement 3 a policy for any drug or biological that is 4 not provided to the ‘average’ patient that 5 results in the amount by which the single 6 payment amount is increased pursuant to 7 this subparagraph shall be paid only when 8 a provider or renal dialysis facility has 9 demonstrated that it has administered the 10 drug or biological to a patient.’’. 11 (e) NEW DEVICES AND OTHER TECHNOLOGIES.—As 12 part of the promulgation of the annual rule for the Medi- 13 care end-stage renal disease prospective payment system 14 under section 1881(b)(14) of the Social Security Act (42 15 U.S.C. 1395rr(b)(14)) for calendar year 2022, and in con- 16 sultation with stakeholders, the Secretary shall ensure 17 that the single payment amount is adequate to cover the 18 cost of the new innovative device or other technology with 19 substantial clinical improvement and increase the single 20 payment amount if the Secretary determines such pay- 21 ment amount is not adequate to cover such cost. In car- 22 rying out the preceding sentence, the Secretary shall use 23 the cost and utilization data collected during a three-year 24 transitional payment period, as otherwise described in the 25 VerDate Sep 11 2014 02:35 Jun 17, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S1971.IS S1971 kjohnson on DSK79L0C42PROD with BILLS 12 •S 1971 IS final regulation published on November 9, 2020 (85 Fed. 1 Reg. 71398 et seq.). 2 TITLE III—INCREASING PATIENT 3 ACCESS TO QUALITY PER- 4 FORMANCE BY IMPROVING 5 THE ACCURACY AND TRANS- 6 PARENCY OF END-STAGE 7 RENAL DISEASE QUALITY 8 PROGRAMS 9 SEC. 301. IMPROVING PATIENT DECISION MAKING AND 10 TRANSPARENCY BY CONSOLIDATING AND 11 MODERNIZING QUALITY PROGRAMS. 12 (a) MEASURES.—Section 1881(h)(2) of the Social 13 Security Act (42 U.S.C. 1395rr(h)(2)) is amended— 14 (1) by striking subparagraph (A) and inserting 15 the following: 16 ‘‘(A) The measures specified under this 17 paragraph with respect to the year involved 18 shall be selected by the Secretary in consulta- 19 tion with stakeholders to promote improvement 20 in beneficiary outcomes and shared deci [Text truncated for display. Full text available on Congress.gov.]