Bringing Enhanced Treatments and Therapies to ESRD Recipients (BETTER) Kidney Care Act

II 116TH CONGRESS 2D SESSION S. 4574 To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal disease, and for other purposes. IN THE SENATE OF THE UNITED STATES SEPTEMBER 15, 2020 Mr. YOUNG (for himself and Ms. SINEMA) introduced the following bill; which was read twice and referred to the Committee on Finance A BILL To establish a demonstration program to provide integrated care for Medicare beneficiaries with end-stage renal dis- ease, 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. 3 This Act may be cited as the ‘‘Bringing Enhanced 4 Treatments and Therapies to ESRD Recipients (BET- 5 TER) Kidney Care Act’’. 6 SEC. 2. FINDINGS. 7 Congress finds the following: 8 (1) Although the relative rate of end-stage renal 9 disease (referred to in this section as ‘‘ESRD’’) 10 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 2 •S 4574 IS among the Nation’s minority populations has de- 1 clined, significant disparities remain. Compared to 2 Whites, Black Americans are 2.6 times more likely 3 to have kidney failure, while Native Americans and 4 Alaska Natives are 1.2 times more likely. Hispanics 5 are 1.3 times more likely to have kidney failure com- 6 pared to non-Hispanics. 7 (2) Disparities also exist with respect to treat- 8 ment modalities. Specifically, although home dialysis 9 can offer advantages, Black, Hispanic, and Native 10 American and Alaska Native ESRD patients are less 11 likely to initiate home treatment than White ESRD 12 patients. 13 (3) Numerous studies show that individuals 14 with low incomes and in low-income communities are 15 at greater risk for ESRD. 16 (4) In addition to their kidney disease, ESRD 17 patients across all races and ethnicities often suffer 18 from one or more comorbidities. Eighty-eight per- 19 cent of ESRD patients have a history of hyper- 20 tension, 42 percent have diabetes, and nearly 30 21 percent have congestive heart failure. 22 (5) Each month, ESRD patients see multiple 23 providers and take several medications to manage 24 their kidney disease and comorbid conditions. Of all 25 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 3 •S 4574 IS patients, those with ESRD stand to benefit greatly 1 from better coordinated care. 2 (6) The Executive Order on Advancing Amer- 3 ican Kidney Health recognizes the need to develop 4 and implement new ESRD care delivery models to 5 improve quality and value for ESRD patients and 6 the Medicare program. 7 (7) In alignment with that goal, it is imperative 8 that Medicare test new models that have at their 9 core an interdisciplinary care team, among other 10 structural requirements, to— 11 (A) help ESRD patients better navigate 12 the health care system; 13 (B) empower such patients to manage 14 their plan of care and medication regimen; 15 (C) support such patients in receiving the 16 treatment modality, including a kidney trans- 17 plant, as prescribed by their nephrologist; 18 (D) access services to meet the nonclinical 19 needs of such patients that can affect care out- 20 comes; and 21 (E) receive additional services, such as 22 transplant evaluation, palliative care, evaluation 23 for hospice eligibility, and vascular access care. 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 4 •S 4574 IS SEC. 3. DEMONSTRATION PROGRAM TO PROVIDE INTE- 1 GRATED CARE FOR MEDICARE BENE- 2 FICIARIES WITH END-STAGE RENAL DISEASE. 3 (a) IN GENERAL.—Title XVIII of the Social Security 4 Act is amended by inserting after section 1866F the fol- 5 lowing new section: 6 ‘‘DEMONSTRATION PROGRAM TO PROVIDE INTEGRATED 7 CARE FOR MEDICARE BENEFICIARIES WITH END- 8 STAGE RENAL DISEASE 9 ‘‘SEC. 1866G. (a) ESTABLISHMENT.— 10 ‘‘(1) IN GENERAL.—The Secretary shall con- 11 duct under this section the ESRD Fee-For-Service 12 Integrated Care Demonstration Program (in this 13 section referred to as the ‘Program’), which is vol- 14 untary for Program-eligible beneficiaries and eligible 15 participating providers, to assess the effects of alter- 16 native care delivery models and payment methodolo- 17 gies on patient care improvements under this title 18 for such beneficiaries. Under the Program— 19 ‘‘(A) Program-eligible beneficiaries shall be 20 considered original Medicare fee-for-service 21 beneficiaries (as defined in section 1899(h)(3)) 22 for the duration of the participation of such 23 beneficiaries under the Program; 24 ‘‘(B) eligible participating providers may 25 form an ESRD Fee-For-Service Integrated 26 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 5 •S 4574 IS Care Organization (in this section referred to as 1 an ‘Organization’); and 2 ‘‘(C) an Organization shall integrate care 3 under the original Medicare fee-for-service pro- 4 gram under parts A and B for Program-eligible 5 beneficiaries. 6 ‘‘(2) DEFINITIONS.—In this section: 7 ‘‘(A) ELIGIBLE PARTICIPATING PRO- 8 VIDER.—The term ‘eligible participating pro- 9 vider’ means any of the following: 10 ‘‘(i) A facility certified as a renal di- 11 alysis facility under this title. 12 ‘‘(ii) An entity that owns one or more 13 of such facilities described in clause (i). 14 ‘‘(iii) A nephrologist (including a pedi- 15 atric nephrologist) or nephrology practice. 16 ‘‘(iv) Any other physician or physician 17 group practice. 18 ‘‘(v) A nurse practitioner, physician 19 assistant, or clinical nurse specialist (as 20 such terms are defined in section 21 1861(aa)(5)) or a clinical social worker (as 22 defined in section 1861(hh)(1)) working in 23 conjunction with such a nurse practitioner, 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 6 •S 4574 IS physician assistant, or clinical nurse spe- 1 cialist. 2 ‘‘(B) ELIGIBLE PARTICIPATING PART- 3 NER.—The term ‘eligible participating partner’ 4 means, with respect to an Organization, any of 5 the following: 6 ‘‘(i) A Medicare Advantage plan de- 7 scribed in section 1851(a)(2) or a Medi- 8 care Advantage organization offering such 9 a plan. 10 ‘‘(ii) A medicaid managed care organi- 11 zation (as defined in section 1903(m)). 12 ‘‘(iii) A hospital or an academic med- 13 ical center experienced in the care of pa- 14 tients receiving dialysis. 15 ‘‘(iv) Any other entity determined ap- 16 propriate by the Secretary. 17 ‘‘(C) PROGRAM-ELIGIBLE BENEFICIARY.— 18 ‘‘(i) IN GENERAL.—The term ‘Pro- 19 gram-eligible beneficiary’ means, with re- 20 spect to an Organization offering an 21 ESRD Fee-For-Service Integrated Care 22 Model, an individual entitled to benefits 23 under part A and enrolled under part B 24 (including such an individual entitled to 25 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 7 •S 4574 IS medical assistance under a State plan 1 under title XIX) who— 2 ‘‘(I) is identified by the Secretary 3 as having end-stage renal disease and 4 who is receiving renal dialysis services 5 under the original Medicare fee-for- 6 service program under parts A and B, 7 and is not enrolled in a Medicare Ad- 8 vantage plan under part C or group 9 health insurance coverage or indi- 10 vidual health insurance coverage (as 11 defined in section 2791(b) of the Pub- 12 lic Health Service Act (42 U.S.C. 13 300gg–91(b))) that is primary to cov- 14 erage under this title; 15 ‘‘(II) receives renal dialysis serv- 16 ices primarily from an eligible partici- 17 pating provider of such Organization, 18 including such renal dialysis services 19 received after being identified as a 20 suitable candidate for transplantation; 21 and 22 ‘‘(III) has attained the age of 18 23 years. 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 8 •S 4574 IS ‘‘(ii) AFFIRMATION OF PROGRAM ELI- 1 GIBILITY UPON HOSPICE ELECTION OR 2 KIDNEY TRANSPLANT.—A Program-eligible 3 beneficiary who was assigned to or elected 4 an ESRD Fee-For-Service Integrated Care 5 Model offered by an Organization and 6 who— 7 ‘‘(I) elects to receive hospice ben- 8 efits under section 1852(d)(1); or 9 ‘‘(II) receives a kidney transplant 10 as covered under this title and main- 11 tains entitlement to benefits under 12 part A and enrollment in part B on 13 the basis of end-stage renal disease, 14 shall continue to meet the definition of 15 Program-eligible beneficiary established 16 under this subparagraph. 17 ‘‘(b) ESRD FEE-FOR-SERVICE INTEGRATED CARE 18 ORGANIZATION ELIGIBILITY REQUIREMENTS.— 19 ‘‘(1) ORGANIZATIONS.— 20 ‘‘(A) IN GENERAL.—One or more eligible 21 participating providers may establish an Orga- 22 nization and may enter into, subject to sub- 23 paragraph (B), one or more partnership, owner- 24 ship, or co-ownership agreements with one or 25 VerDate Sep 11 2014 22:52 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 9 •S 4574 IS more eligible participating partners to establish 1 an Organization or to offer one or more ESRD 2 Fee-for-Service Integrated Care Models in ac- 3 cordance with paragraph (2). 4 ‘‘(B) LIMITATION ON NUMBER OF AGREE- 5 MENTS.—The Secretary may specify a limita- 6 tion on the number of Organizations in which 7 an eligible participating partner may participate 8 for purposes of offering one or more ESRD 9 Fee-for-Service Integrated Care Models under 10 partnership, ownership, or co-ownership agree- 11 ments described in subparagraph (A). 12 ‘‘(C) MINIMUM PROGRAM ELIGIBLE BENE- 13 FICIARY PARTICIPATION REQUIREMENT.— 14 ‘‘(i) IN GENERAL.—Subject to clause 15 (ii), the Secretary may not enter into or 16 continue an agreement with an Organiza- 17 tion unless the Organization has at least 18 350 Program-eligible beneficiaries, or at 19 least 60 percent of Program-eligible bene- 20 ficiaries receiving care from the Organiza- 21 tion’s facilities, who are assigned to or 22 elect an ESRD Fee-For-Service Integrated 23 Model offered by the Organization and who 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 10 •S 4574 IS continue their assignment to or election of 1 the Organization. 2 ‘‘(ii) ALLOWING TRANSITION.—The 3 Secretary may waive the requirement 4 under clause (i) for an Organization dur- 5 ing the first agreement year with respect 6 to the Organization. 7 ‘‘(D) FISCAL SOUNDNESS REQUIRE- 8 MENTS.— 9 ‘‘(i) IN GENERAL.—The Secretary 10 shall enter into appropriate agreements 11 under this section only with Organizations 12 that demonstrate sufficient capital re- 13 serves, measured as a percentage of 14 monthly prospective payments described in 15 subsection (e) and consistent with capital 16 reserve requirements established by each 17 State in which the Organization operates, 18 subject to clause (ii). 19 ‘‘(ii) ALTERNATIVE MECHANISM TO 20 DEMONSTRATE RISK-BEARING CAPACITY.— 21 An Organization shall be considered to 22 meet the requirement in clause (i) if the 23 Organization includes at least one eligible 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 11 •S 4574 IS participating provider or eligible partici- 1 pating partner that— 2 ‘‘(I)(aa) is licensed under State 3 law as a risk-bearing entity eligible to 4 offer health insurance or health bene- 5 fits coverage in each State in which 6 the Organization participates in the 7 demonstration under this section; or 8 ‘‘(bb) is otherwise authorized by 9 each State in which the Organization 10 participates in the demonstration 11 under this section to bear risk for of- 12 fering health insurance or health ben- 13 efits; 14 ‘‘(II) agrees to bear risk under 15 the Organization; and 16 ‘‘(III) has the capacity to bear 17 risk commensurate with the Organiza- 18 tion’s expected expenditures under an 19 agreement under this section. 20 ‘‘(iii) DISCLOSURE.—Each Organiza- 21 tion with an agreement under this section 22 shall, in accordance with current regula- 23 tions of the Secretary that govern similar 24 disclosures, report to the Secretary finan- 25 VerDate Sep 11 2014 22:52 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 12 •S 4574 IS cial information consistent with such infor- 1 mation required to be reported by a Medi- 2 care Advantage organization under part C 3 to demonstrate that the Organization has 4 a fiscally sound operation. 5 ‘‘(E) GOVERNANCE REQUIREMENTS.— 6 Each Organization with an agreement under 7 this section shall establish a governing body 8 with oversight responsibility for the Organiza- 9 tion’s compliance with Program requirements 10 that includes— 11 ‘‘(i) representation from each eligible 12 participating provider of such Organiza- 13 tion; 14 ‘‘(ii) at least two nephrologists, one of 15 which may be affiliated with an eligible 16 participating provider; and 17 ‘‘(iii) at least one beneficiary advo- 18 cate. 19 ‘‘(2) ESRD FEE-FOR-SERVICE INTEGRATED 20 CARE MODEL.— 21 ‘‘(A) BENEFIT REQUIREMENTS.— 22 ‘‘(i) IN GENERAL.—Subject to clause 23 (iii), an Organization shall offer an ESRD 24 VerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574 pamtmann on DSKBC07HB2PROD with BILLS 13 •S 4574 IS Fee-For-Service Integrated Care Model 1 that shall— 2 ‘‘(I) cover all benefits under 3 parts A and B (subject to payment 4 rules regarding the treatment of and 5 payment for kidney organ acquisitions 6 and hospice described in subsections 7 (e)(3) and (4)); and 8 ‘‘(II) include services for transi- 9 tion (particularly including education) 10 into transplantation, palliative care, 11 and hospice. 12 ‘‘(ii) DETERMINATION AND TREAT- 13 MENT OF SAVINGS.— 14 ‘‘(I) IN GENERAL.—The Sec- 15 retary shall require any Organization 16 offering an ESRD Fee-For-Service 17 Integrated Care Model to provide for 18 the return under subclause (VI) to a 19 Program-eligible beneficiary assigned 20 to or who elects an Organ [Text truncated for display. 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