Chronic Kidney Disease Improvement in Research and Treatment Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 4065 To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes. IN THE HOUSE OF REPRESENTATIVES JUNE 22, 2021 Ms. SEWELL (for herself 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 subse- quently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL To improve the understanding of, and promote access to treatment for, chronic kidney disease, and for other purposes. Be it enacted by the Senate and House of 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. VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6211 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 4065 IH 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 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. Sec. 403. Allowing individuals with kidney failure to retain access to private in- surance. 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 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 4065 IH (2) by inserting after subparagraph (N) the fol- 1 lowing new subparagraph: 2 ‘‘(O) Chronic kidney disease screening as 3 defined by the Secretary.’’. 4 (b) EFFECTIVE DATE.—The amendments made by 5 this section apply to items and services furnished on or 6 after January 1, 2022. 7 SEC. 102. INCREASING ACCESS TO MEDICARE KIDNEY DIS- 8 EASE EDUCATION BENEFIT. 9 (a) IN GENERAL.—Section 1861(ggg) of the Social 10 Security Act (42 U.S.C. 1395x(ggg)) is amended— 11 (1) in paragraph (1)— 12 (A) in subparagraph (A), by inserting ‘‘or 13 stage V’’ after ‘‘stage IV’’; and 14 (B) in subparagraph (B), by inserting ‘‘or 15 of a physician assistant, nurse practitioner, or 16 clinical nurse specialist (as defined in section 17 1861(aa)(5)) assisting in the treatment of the 18 individual’s kidney condition’’ after ‘‘kidney 19 condition’’; and 20 (2) in paragraph (2)— 21 (A) by striking subparagraph (B); and 22 (B) in subparagraph (A)— 23 (i) by striking ‘‘(A)’’ after ‘‘(2)’’; 24 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 4065 IH (ii) by striking ‘‘and’’ at the end of 1 clause (i); 2 (iii) by striking the period at the end 3 of clause (ii) and inserting ‘‘; and’’; 4 (iv) by redesignating clauses (i) and 5 (ii) as subparagraphs (A) and (B), respec- 6 tively; and 7 (v) by adding at the end the following: 8 ‘‘(C) a renal dialysis facility subject to the 9 requirements of section 1881(b)(1) with per- 10 sonnel who— 11 ‘‘(i) provide the services described in 12 paragraph (1); and 13 ‘‘(ii) is a physician (as defined in sub- 14 section (r)(1)) or a physician assistant, 15 nurse practitioner, or clinical nurse spe- 16 cialist (as defined in subsection (aa)(5)).’’. 17 (b) PAYMENT TO RENAL DIALYSIS FACILITIES.— 18 Section 1881(b) of the Social Security Act (42 U.S.C. 19 1395rr(b)) is amended by adding at the end the following 20 new paragraph: 21 ‘‘(15) For purposes of paragraph (14), the sin- 22 gle payment for renal dialysis services under such 23 paragraph shall not take into account the amount of 24 payment for kidney disease education services (as 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 4065 IH defined in section 1861(ggg)). Instead, payment for 1 such services shall be made to the renal dialysis fa- 2 cility on an assignment-related basis under section 3 1848.’’. 4 (c) EFFECTIVE DATE.—The amendments made by 5 this section apply to kidney disease education services fur- 6 nished on or after January 1, 2022. 7 SEC. 103. IMPROVING PATIENT LIVES AND QUALITY OF 8 CARE THROUGH RESEARCH AND INNOVA- 9 TION. 10 (a) STUDY.—The Secretary of Health and Human 11 Services (in this section referred to as the ‘‘Secretary’’) 12 shall conduct a study on increasing kidney transplantation 13 rates. Such study shall include an analysis of each of the 14 following: 15 (1) Any disincentives in the payment systems 16 under the Medicare program under title XVIII of 17 the Social Security Act that create barriers to kid- 18 ney transplants and post-transplant care for bene- 19 ficiaries with end-stage renal disease. 20 (2) The practices used by States with higher 21 than average donation rates and whether those prac- 22 tices and policies could be successfully utilized in 23 other States. 24 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 4065 IH (3) Practices and policies that could increase 1 deceased donation rates of minority populations. 2 (4) Whether cultural and policy barriers exist to 3 increasing living donation rates, including an exam- 4 ination of how to better facilitate chained donations. 5 (5) Other areas determined appropriate by the 6 Secretary. 7 (b) REPORT.—Not later than 18 months after the 8 date of the enactment of this Act, the Secretary shall sub- 9 mit to Congress a report on the study conducted under 10 subsection (a), together with such recommendations as the 11 Secretary determines to be appropriate. 12 SEC. 104. UNDERSTANDING THE PROGRESSION OF KIDNEY 13 DISEASE AND TREATMENT OF KIDNEY FAIL- 14 URE IN MINORITY POPULATIONS. 15 (a) STUDY.—The Secretary of Health and Human 16 Services (in this section referred to as the ‘‘Secretary’’) 17 shall conduct a study on— 18 (1) the social, behavioral, and biological factors 19 leading to kidney disease; 20 (2) efforts to slow the progression of kidney dis- 21 ease in minority populations that are disproportion- 22 ately affected by such disease; and 23 (3) treatment patterns associated with pro- 24 viding care, under the Medicare program under title 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 7 •HR 4065 IH XVIII of the Social Security Act, the Medicaid pro- 1 gram under title XIX of such Act, and through pri- 2 vate health insurance, to minority populations that 3 are disproportionately affected by kidney failure. 4 (b) REPORT.—Not later than 1 year after the date 5 of the enactment of this Act, the Secretary shall submit 6 to Congress a report on the study conducted under sub- 7 section (a), together with such recommendations as the 8 Secretary determines to be appropriate. 9 TITLE II—CREATING AN ECO- 10 NOMICALLY STABLE DIALY- 11 SIS INFRASTRUCTURE AND 12 INCENTIVIZING INNOVATION 13 SEC. 201. REFINING THE END-STAGE RENAL DISEASE PAY- 14 MENT SYSTEM TO IMPROVE ACCURACY IN 15 PAYMENT AND SUPPORT THERAPIES. 16 (a) IN GENERAL.—Section 1881(b)(14) of the Social 17 Security Act (42 U.S.C. 1395rr(b)(14)) is amended— 18 (1) in subparagraph (D), in the matter pre- 19 ceding clause (i), by striking ‘‘Such system’’ and in- 20 serting ‘‘Subject to subparagraph (J), such system’’; 21 and 22 (2) by adding at the end the following new sub- 23 paragraph: 24 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 8 •HR 4065 IH ‘‘(J) For payment for renal dialysis serv- 1 ices furnished on or after January 1, 2024, 2 under the system under this paragraph— 3 ‘‘(i) the payment adjustment de- 4 scribed in clause (i) of subparagraph (D)— 5 ‘‘(I) shall not take into account 6 comorbidities; and 7 ‘‘(II) shall take into account age 8 for purposes of distinguishing between 9 individuals who are under 18 years of 10 age and those who are 18 years of age 11 and older but shall not include any 12 other adjustment for age for patients 13 18 years of age and older; 14 ‘‘(ii) the Secretary shall reassess any 15 adjustments related to patient weight 16 under such clause; 17 ‘‘(iii) the payment adjustment de- 18 scribed in clause (ii) of such subparagraph 19 shall not be included; and 20 ‘‘(iv) take into account reasonable 21 costs for determining the payment rate 22 consistent with paragraph (2)(B).’’. 23 (b) INCLUSION OF NETWORK FEE AS AN ALLOW- 24 ABLE COST.—Section 1881(b)(14) of the Social Security 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 9 •HR 4065 IH Act (42 U.S.C. 1395rr(b)(14)), as amended by subsection 1 (a), is amended by adding at the end the following new 2 subparagraph: 3 ‘‘(K) Not later than January 1, 2022, the 4 Secretary shall amend the ESRD facility cost 5 report to include the per treatment network fee 6 (as described in paragraph (7)) as an allowable 7 cost or offset to revenue.’’. 8 (c) DETERMINATION OF PRODUCTIVITY ADJUST- 9 MENT.—Section 1886(b)(3)(B)(xi) of the Social Security 10 Act (42 U.S.C. 1395ww(b)(3)(B)(xi)) is amended— 11 (1) in subclause (I), by striking ‘‘For 2012’’ 12 and inserting ‘‘Subject to subclause (IV), for 2012’’; 13 and 14 (2) by adding at the end, the following new sub- 15 clause: 16 ‘‘(IV) For each of 2022 through 17 2025, the productivity adjustment de- 18 scribed in subclause (II) shall be zero 19 for a payment system in any year in 20 which the Medicare Payment Advisory 21 Commission estimates that payments 22 under this title pursuant to such pay- 23 ment system, on an aggregate na- 24 tional basis, exceed costs, on an ag- 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 10 •HR 4065 IH gregate national basis, by 3.0 percent 1 or less.’’. 2 (d) PAYMENT FOR NEW AND INNOVATIVE DRUGS 3 AND BIOLOGICALS THAT ARE RENAL DIALYSIS SERV- 4 ICES.—Section 1881(b)(14) of the Social Security Act (42 5 U.S.C. 1395ww(b)(14)), as amended by subsections (a) 6 and (b), is amended by adding the following new subpara- 7 graph— 8 ‘‘(L) PAYMENT FOR NEW AND INNOVATIVE 9 DRUGS, BIOLOGICALS, AND DEVICES THAT ARE 10 RENAL DIALYSIS SERVICES.— 11 ‘‘(i) IN GENERAL.—For drugs or 12 biologicals determined to be within a func- 13 tional category, the Secretary, in consulta- 14 tion with stakeholders, shall ensure that 15 the single payment amount is adequate to 16 cover the cost of new innovative drugs or 17 biologicals and increase the single payment 18 amount if the Secretary determines such 19 payment amount is not adequate to cover 20 such cost. In carrying out the preceding 21 sentence, the Secretary shall use the cost 22 and utilization data collected during the 23 three-year transitional payment period, as 24 otherwise described in the final regulation 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 11 •HR 4065 IH published on November 14, 2018 (83 Fed. 1 Reg. 56922 et seq.). 2 ‘‘(ii) MONEY TO FOLLOW THE PA- 3 TIENT.—The Secretary, through notice 4 and comment rulemaking, shall implement 5 a policy for any drug or biological that is 6 not provided to the ‘average’ patient that 7 results in the amount by which the single 8 payment amount is increased pursuant to 9 this subparagraph shall be paid only when 10 a provider or renal dialysis facility has 11 demonstrated that it has administered the 12 drug or biological to a patient.’’. 13 (e) NEW DEVICES AND OTHER TECHNOLOGIES.—As 14 part of the promulgation of the annual rule for the Medi- 15 care end-stage renal disease prospective payment system 16 under section 1881(b)(14) of the Social Security Act (42 17 U.S.C. 1395rr(b)(14)) for calendar year 2022, and in con- 18 sultation with stakeholders, the Secretary shall ensure 19 that the single payment amount is adequate to cover the 20 cost of the new innovative device or other technology with 21 substantial clinical improvement and increase the single 22 payment amount if the Secretary determines such pay- 23 ment amount is not adequate to cover such cost. In car- 24 rying out the preceding sentence, the Secretary shall use 25 VerDate Sep 11 2014 23:08 Jul 09, 2021 Jkt 019200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4065.IH H4065 kjohnson on DSK79L0C42PROD with BILLS 12 •HR 4065 IH the cost and utilization data collected during a three-year 1 transitional payment period, as otherwise described in the 2 final regulation published on November 9, 2020 (85 Fed. 3 Reg. 71398 et seq.). 4 TITLE III—INCREASING PATIENT 5 ACCESS TO QUALITY PER- 6 FORMANCE BY IMPROVING 7 THE ACCURACY AND TRANS- 8 PARENCY OF END-STAGE 9 RENAL DISEASE QUALITY 10 PROGRAMS 11 SEC. 301. IMPROVING PATIENT DECISION MAKING AND 12 TRANSPARENCY BY CONSOLIDATING AND 13 MODERNIZING QUALITY PROGRAMS. 14 (a) MEASURES.—Section 1881(h)(2) of the Social 15 Security Act (42 U.S.C. 1395 [Text truncated for display. Full text available on Congress.gov.]