II 

117TH CONGRESS 

1ST SESSION S. 2649 

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 

AUGUST 5, 2021 

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 disease, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Bringing Enhanced 

5 Treatments and Therapies to ESRD Recipients Kidney 

6 Care Act’’ or the ‘‘BETTER Kidney Care Act’’. 

7 SEC. 2. FINDINGS. 

8 Congress finds the following: 

9 (1) Although the relative rate of end-stage renal 

10 disease (referred to in this section as ‘‘ESRD’’) 


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1 among the Nation’s minority populations has de2 clined, significant disparities remain. Compared to 

3 Whites, Black Americans are 2.6 times more likely 

4 to have kidney failure, while Native Americans and 

5 Alaska Natives are 1.2 times more likely. Hispanics 

6 are 1.3 times more likely to have kidney failure com7 pared to non-Hispanics. 

8 (2) Disparities also exist with respect to treat9 ment modalities. Specifically, although home dialysis 

10 can offer advantages, Black, Hispanic, and Native 

11 American and Alaska Native ESRD patients are less 

12 likely to initiate home treatment than White ESRD 

13 patients. 

14 (3) Numerous studies show that individuals 

15 with low incomes and in low-income communities are 

16 at greater risk for ESRD. 

17 (4) In addition to their kidney disease, ESRD 

18 patients across all races and ethnicities often suffer 

19 from one or more comorbidities. Eighty-eight per20 cent of ESRD patients have a history of hyper21 tension, 42 percent have diabetes, and nearly 30 

22 percent have congestive heart failure. 

23 (5) Each month, ESRD patients see multiple 

24 providers and take several medications to manage 

25 their kidney disease and comorbid conditions. Of all 


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1 patients, those with ESRD stand to benefit greatly 

2 from better coordinated care. 

3 (6) The Executive Order on Advancing Amer4 ican Kidney Health recognizes the need to develop 

5 and implement new ESRD care delivery models to 

6 improve quality and value for ESRD patients and 

7 the Medicare program. 

8 (7) In alignment with that goal, it is imperative 

9 that Medicare test new models that have at their 

10 core an interdisciplinary care team, among other 

11 structural requirements, to— 

12 (A) help ESRD patients better navigate 

13 the health care system; 

14 (B) empower such patients to manage 

15 their plan of care and medication regimen; 

16 (C) support such patients in receiving the 

17 treatment modality, including a kidney trans18 plant, as prescribed by their nephrologist; 

19 (D) access services to meet the nonclinical 

20 needs of such patients that can affect care out21 comes; and 

22 (E) receive additional services, such as 

23 transplant evaluation, palliative care, evaluation 

24 for hospice eligibility, and vascular access care. 


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1 SEC. 3. DEMONSTRATION PROGRAM TO PROVIDE INTE2 GRATED CARE FOR MEDICARE BENE3 FICIARIES WITH END-STAGE RENAL DISEASE. 

4 (a) IN GENERAL.—Title XVIII of the Social Security 

5 Act is amended by inserting after section 1866F the fol6 lowing new section: 

7 ‘‘DEMONSTRATION PROGRAM TO PROVIDE INTEGRATED

8 CARE FOR MEDICARE BENEFICIARIES WITH END9 STAGE RENAL DISEASE

10 ‘‘SEC. 1866G. (a) ESTABLISHMENT.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall con12 duct under this section the ESRD Fee-For-Service 

13 Integrated Care Demonstration Program (in this 

14 section referred to as the ‘Program’), which is vol15 untary for Program-eligible beneficiaries and eligible 

16 participating providers, to assess the effects of alter17 native care delivery models and payment methodolo18 gies on patient care improvements under this title 

19 for such beneficiaries. Under the Program— 

20 ‘‘(A) Program-eligible beneficiaries shall be 

21 considered original Medicare Fee-For-Service 

22 beneficiaries (as defined in section 1899(h)(3)) 

23 for the duration of the participation of such 

24 beneficiaries under the Program; 

25 ‘‘(B) eligible participating providers may 

26 form an ESRD Fee-For-Service Integrated 


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1 Care Organization (in this section referred to as 

2 an ‘Organization’); and 

3 ‘‘(C) an Organization shall integrate care 

4 under the original Medicare Fee-For-Service 

5 program under parts A and B for Program-eli6 gible beneficiaries. 

7 ‘‘(2) DEFINITIONS.—In this section: 

8 ‘‘(A) ELIGIBLE PARTICIPATING PRO9 VIDER.—The term ‘eligible participating pro10 vider’ means any of the following: 

11 ‘‘(i) A facility certified as a renal di12 alysis facility under this title. 

13 ‘‘(ii) An entity that owns one or more 

14 of such facilities described in clause (i). 

15 ‘‘(iii) A nephrologist (including a pedi16 atric nephrologist) or nephrology practice. 

17 ‘‘(iv) Any other physician or physician 

18 group practice. 

19 ‘‘(v) A nurse practitioner, physician 

20 assistant, or clinical nurse specialist (as 

21 such terms are defined in section 

22 1861(aa)(5)) or a clinical social worker (as 

23 defined in section 1861(hh)(1)) working in 

24 conjunction with such a nurse practitioner, 


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1 physician assistant, or clinical nurse spe2 cialist. 

3 ‘‘(B) ELIGIBLE PARTICIPATING PART4 NER.—The term ‘eligible participating partner’ 

5 means, with respect to an Organization, any of 

6 the following: 

7 ‘‘(i) A Medicare Advantage plan de8 scribed in section 1851(a)(2) or a Medi9 care Advantage organization offering such 

10 a plan. 

11 ‘‘(ii) A medicaid managed care organi12 zation (as defined in section 1903(m)). 

13 ‘‘(iii) A hospital or an academic med14 ical center experienced in the care of pa15 tients receiving dialysis. 

16 ‘‘(iv) Any other entity determined ap17 propriate by the Secretary. 

18 ‘‘(C) PROGRAM-ELIGIBLE BENEFICIARY.— 

19 ‘‘(i) IN GENERAL.—The term ‘Pro20 gram-eligible beneficiary’ means, with re21 spect to an Organization offering an 

22 ESRD Fee-For-Service Integrated Care 

23 Model, an individual entitled to benefits 

24 under part A and enrolled under part B 

25 (including such an individual entitled to 


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1 medical assistance under a State plan 

2 under title XIX) who— 

3 ‘‘(I) is identified by the Secretary 

4 as having end-stage renal disease and 

5 who is receiving renal dialysis services 

6 under the original Medicare Fee-For7 Service program under parts A and B, 

8 and is not enrolled in a Medicare Ad9 vantage plan under part C or group 

10 health insurance coverage or indi11 vidual health insurance coverage (as 

12 defined in section 2791(b) of the Pub13 lic Health Service Act (42 U.S.C. 

14 300gg–91(b))) that is primary to cov15 erage under this title; 

16 ‘‘(II) receives renal dialysis serv17 ices primarily from an eligible partici18 pating provider of such Organization, 

19 including such renal dialysis services 

20 received after being identified as a 

21 suitable candidate for transplantation; 

22 and 

23 ‘‘(III) has attained the age of 18 

24 years. 


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1 ‘‘(ii) AFFIRMATION OF PROGRAM ELI2 GIBILITY UPON HOSPICE ELECTION OR

3 KIDNEY TRANSPLANT.—A Program-eligible 

4 beneficiary who was assigned to or elected 

5 an ESRD Fee-For-Service Integrated Care 

6 Model offered by an Organization and 

7 who— 

8 ‘‘(I) elects to receive hospice ben9 efits under section 1852(d)(1); or 

10 ‘‘(II) receives a kidney transplant 

11 as covered under this title and main12 tains entitlement to benefits under 

13 part A and enrollment in part B on 

14 the basis of end stage renal disease, 

15 shall continue to meet the definition of 

16 Program-eligible beneficiary established 

17 under this subparagraph. 

18 ‘‘(b) ESRD FEE-FOR-SERVICE INTEGRATED CARE

19 ORGANIZATION ELIGIBILITY REQUIREMENTS.— 

20 ‘‘(1) ORGANIZATIONS.— 

21 ‘‘(A) IN GENERAL.—One or more eligible 

22 participating providers may establish an Orga23 nization and may enter into, subject to sub24 paragraph (B), one or more partnership, owner25 ship, or co-ownership agreements with one or 


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1 more eligible participating partners to establish 

2 an Organization or to offer one or more ESRD 

3 Fee-For-Service Integrated Care Models in ac4 cordance with paragraph (2). 

5 ‘‘(B) LIMITATION ON NUMBER OF AGREE6 MENTS.—The Secretary may specify a limita7 tion on the number of Organizations in which 

8 an eligible participating partner may participate 

9 for purposes of offering one or more ESRD 

10 Fee-For-Service Integrated Care Models under 

11 partnership, ownership, or co-ownership agree12 ments described in subparagraph (A). 

13 ‘‘(C) MINIMUM PROGRAM ELIGIBLE BENE14 FICIARY PARTICIPATION REQUIREMENT.— 

15 ‘‘(i) IN GENERAL.—Subject to clause 

16 (ii), the Secretary may not enter into or 

17 continue an agreement with an Organiza18 tion unless the Organization has at least 

19 350 Program-eligible beneficiaries, or at 

20 least 60 percent of Program-eligible bene21 ficiaries receiving care from the Organiza22 tion’s facilities, who are assigned to or 

23 elect an ESRD Fee-For-Service Integrated 

24 Model offered by the Organization and who 


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1 continue their assignment to or election of 

2 the Organization. 

3 ‘‘(ii) ALLOWING TRANSITION.—The 

4 Secretary may waive the requirement 

5 under clause (i) for an Organization dur6 ing the first agreement year with respect 

7 to the Organization. 

8 ‘‘(D) FISCAL SOUNDNESS REQUIRE9 MENTS.— 

10 ‘‘(i) IN GENERAL.—The Secretary 

11 shall enter into appropriate agreements 

12 under this section only with Organizations 

13 that demonstrate sufficient capital re14 serves, measured as a percentage of 

15 monthly prospective payments described in 

16 subsection (e) and consistent with capital 

17 reserve requirements established by each 

18 State in which the Organization operates, 

19 subject to clause (ii). 

20 ‘‘(ii) ALTERNATIVE MECHANISM TO

21 DEMONSTRATE RISK-BEARING CAPACITY.— 

22 An Organization shall be considered to 

23 meet the requirement in clause (i) if the 

24 Organization includes at least one eligible 


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1 participating provider or eligible partici2 pating partner that— 

3 ‘‘(I)(aa) is licensed under State 

4 law as a risk-bearing entity eligible to 

5 offer health insurance or health bene6 fits coverage in each State in which 

7 the Organization participates in the 

8 demonstration under this section; or 

9 ‘‘(bb) is otherwise authorized by 

10 each state in which the Organization 

11 participates in the demonstration 

12 under this section to bear risk for of13 fering health insurance or health ben14 efits; 

15 ‘‘(II) agrees to bear risk under 

16 the Organization; and 

17 ‘‘(III) has the capacity to bear 

18 risk commensurate with the Organiza19 tion’s expected expenditures under an 

20 agreement under this section. 

21 ‘‘(iii) DISCLOSURE.—Each Organiza22 tion with an agreement under this section 

23 shall, in accordance with current regula24 tions of the Secretary that govern similar 

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1 cial information consistent with such infor2 mation required to be reported by a Medi3 care Advantage organization under part C 

4 to demonstrate that the Organization has 

5 a fiscally sound operation. 

6 ‘‘(E) GOVERNANCE REQUIREMENTS.— 

7 Each Organization with an agreement under 

8 this section shall establish a governing body 

9 with oversight responsibility for the Organiza10 tion’s compliance with Program requirements 

11 that includes— 

12 ‘‘(i) representation from each eligible 

13 participating provider of such Organiza14 tion; 

15 ‘‘(ii) at least two nephrologists, one of 

16 which may be affiliated with an eligible 

17 participating provider; and 

18 ‘‘(iii) at least one beneficiary advo19 cate. 

20 ‘‘(2) ESRD FEE-FOR-SERVICE INTEGRATED

21 CARE MODEL.— 

22 ‘‘(A) BENEFIT REQUIREMENTS.— 

23 ‘‘(i) IN GENERAL.—Subject to clause 

24 (iii), an Organization shall offer an ESRD 


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1 Fee-For-Service Integrated Care Model 

2 that shall— 

3 ‘‘(I) cover all benefits under 

4 parts A and B (subject to payment 

5 rules regarding the treatment of and 

6 payment for kidney organ acquisitions 

7 and hospice described in subsections 

8 (e)(3) and (4)); and 

9 ‘‘(II) include services for transi10 tion (particularly including education) 

11 into transplantation, palliative care, 

12 and hospice. 

13 ‘‘(ii) DETERMINATION AND TREAT14 MENT OF SAVINGS.— 

15 ‘‘(I) IN GENERAL.—The Sec16 retary shall require any Organization 

17 offering an ESRD Fee-For-Service 

18 Integrated Care Model to provide for 

19 the return under subclause (VI) to a 

20 Program-eligible beneficiary assigned 

21 to or who elects an Organization sav22 ings equal to the amount, if any, by 

23 which the payment amount described 

24 in subclause (V) with respect to the 

25 Program-eligible beneficiary for a year 


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1 exceeds the average revenue amount 

2 described in subclause (IV) with re3 spect to the Program-eligible bene4 ficiary for the year. 

5 ‘‘(II) SAVINGS DETERMINATION

6 PROCESS.—The Secretary shall deter7 mine the savings described in sub8 clause (I) in the same manner as the 

9 rebate calculation for individuals with 

10 end-stage renal disease enrolled in 

11 Medicare Advantage organizations 

12 under section 1859(b)(6)(B)(iii). 

13 ‘‘(III) APPLICATION OF MEDICAL

14 LOSS RATIO REQUIREMENTS.—Noth15 ing shall preclude the Secretary from 

16 applying medical loss ratio require17 ments described in section 1857(e)(4) 

18 under this section. 

19 ‘‘(IV) AVERAGE REVENUE

20 AMOUNT DESCRIBED.—The revenue 

21 amount described in this subclause, 

22 with respect to an Organization offer23 ing an ESRD Fee-For-Service Inte24 grated Care Model and a Program-eli25 gible beneficiary assigned to or who 


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1 elects such Organization, is the Orga2 nization’s estimated average revenue 

3 requirements, including administrative 

4 costs and return on investment, for 

5 the Organization to provide the bene6 fits described in clause (i) under the 

7 Model for the Program-eligible bene8 ficiary for the year. 

9 ‘‘(V) PAYMENT AMOUNT DE10 SCRIBED.—The payment amount de11 scribed in this subclause, with respect 

12 to an Organization offering an ESRD 

13 Fee-For-Service Integrated Care 

14 Model and a Program-eligible bene15 ficiary assigned to or who elects such 

16 Organization, is the payment amount 

17 to the Organization under subsection 

18 (e)(1) (adjusted pursuant to sub19 section (e)(2) and subject to the treat20 ment of payments for kidney acquisi21 tions and hospice care described in 

22 paragraphs (3) and (4) of subsection 

23 (e), respectively) made with respect to 

24 the Program-eligible beneficiary for 

25 the year. 


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1 ‘‘(VI) RETURNING SAVINGS TO

2 PROGRAM-ELIGIBLE BENE3 FICIARIES.—An Organization shall, in 

4 a manner specified by the Secretary 

5 and consistent with returning Medi6 care Advantage rebates to individuals 

7 under part C, return the amount 

8 under subclause (I) to a Program-eli9 gible beneficiary through offering ben10 efits not covered under the original 

11 Medicare Fee-For-Service program 

12 consistent with the types of benefits, 

13 including non-health related benefits, 

14 that Medicare Advantage organiza15 tions may offer. 

16 ‘‘(iii) BENEFIT REQUIREMENTS FOR

17 DUAL ELIGIBLES.—In the case of a Pro18 gram-eligible beneficiary who is entitled to 

19 medical assistance under a State plan 

20 under title XIX, an Organization, in ac21 cordance with a mutual agreement entered 

22 into between the State and Organization 

23 under subsection (e)(7)— 

24 ‘‘(I) shall provide, or arrange for 

25 the provision of, all benefits (other 


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1 than long-term services and supports) 

2 for which the Program-eligible bene3 ficiary is entitled to under a State 

4 plan under title XIX; and 

5 ‘‘(II) may elect to provide, or ar6 range for the provision of, long-term 

7 services and supports for which the 

8 Program-eligible beneficiary is entitled 

9 under a State plan under title XIX, 

10 including services related to the tran11 sition into palliative care or hospice. 

12 ‘‘(iv) APPLICATION OF MEDICARE FFS

13 PROVIDER CHOICE AND COST-SHARING RE14 QUIREMENTS.—Under an ESRD Fee-For15 Service Integrated Care Model offered by 

16 an Organization, the Organization shall— 

17 ‘‘(I) allow Program-eligible bene18 ficiaries to receive benefits as de19 scribed in subsection (b)(2)(A)(i)(I) 

20 from any provider of services or sup21 plier enrolled under this title and who 

22 otherwise meets all applicable require23 ments under this title; and 

24 ‘‘(II) not apply any cost-sharing 

25 requirements for benefits described in 


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1 subsection (b)(2)(A)(i)(I) in addition 

2 to premium and cost-sharing require3 ments, respectively, that would be ap4 plicable under part A or part B for 

5 such benefits. 

6 ‘‘(v) PROMOTING ACCESS TO HIGH7 QUALITY PROVIDERS.—An Organization 

8 offering an ESRD Fee-For-Service Inte9 grated Care Model shall develop and imple10 ment performance-based incentives, includ11 ing financial incentives funded through 

12 payments made to an Organization under 

13 subsection (e), for providers of services and 

14 suppliers to promote delivery of high qual15 ity and efficient care. Such incentives shall 

16 comply with section 1852(j)(4) and section 

17 422.208 of title 42, Code of Federal regu18 lations (as in effect on the date of enact19 ment of this section) and be based on clin20 ical measures or non-clinical measures, 

21 such as with respect to notification of pa22 tient discharge from a hospital, patient 

23 education (such as with respect to treat24 ment options, including disease mainte25 nance, and nutrition), rates of completion 


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1 of patient education categorized by race, 

2 rates of completion of transplant evalua3 tion for patients who are clinically eligible 

4 for transplant, rates of completion of 

5 transplant evaluation categorized by race, 

6 and the interoperability of electronic health 

7 records developed by an Organization ac8 cording to requirements and standards 

9 specified by the Secretary pursuant to sub10 paragraph (B). 

11 ‘‘(B) QUALITY AND REPORTING REQUIRE12 MENTS.— 

13 ‘‘(i) CLINICAL MEASURES.—Under the 

14 Program, the Secretary shall— 

15 ‘‘(I) require each participating 

16 Organization to submit to the Sec17 retary data on clinical measures devel18 oped using, as a reference, measures 

19 submitted by organizations partici20 pating in the Comprehensive ESRD 

21 Care Initiative operated by the Center 

22 for Medicare and Medicaid Innovation 

23 to assess the quality of care provided; 

24 ‘‘(II) establish requirements for 

25 participating Organizations to submit 


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1 to the Secretary, in a form and man2 ner specified by the Secretary, infor3 mation on such measures; and 

4 ‘‘(III) establish standards for 

5 making information on quality under 

6 the Program established under this 

7 section as assessed using clinical 

8 measures described in subclause (I) 

9 available to the public. 

10 As part of the standards described in sub11 clause (III) the Secretary shall, in con12 sultation with relevant stakeholders, de13 velop standards that would establish a 

14 minimum threshold for the volume of indi15 vidual patients to be listed for transplant 

16 in an Organ Procurement and Transplant 

17 Network under contract with the Secretary 

18 and that would measure the number of in19 dividuals that an Organization moved on 

20 to, kept on, or removed from the trans21 plant list and the number of individuals 

22 that receive a transplant after partici23 pating in the Organization. The number of 

24 Program-eligible beneficiaries assigned to 

25 an Organization on the transplant list that 


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1 have not opted out at the time of the 

2 agreement between the Secretary and an 

3 Organization shall be noted as part of such 

4 agreement. Organizations shall submit 

5 such measures as a condition of payment 

6 and Program-eligible beneficiary assign7 ment under this subsection. 

8 ‘‘(ii) REQUIREMENT FOR STAKE9 HOLDER INPUT.—In developing measures 

10 and requirements under subclauses (I) and 

11 (II) of clause (i), the Secretary shall re12 quest and consider input from a stake13 holder board that includes at least one 

14 nephrologist, a pediatric nephrologist, 

15 other suppliers and providers of services as 

16 determined appropriate by the Secretary, 

17 renal dialysis facilities, beneficiary advo18 cates, a health equity expert, a mental 

19 health provider, a transplant surgeon, and 

20 Medicare-approved transplant programs. 

21 Section 14 of the Federal Advisory Com22 mittee Act shall not apply to the stake23 holder board. 

24 ‘‘(iii) ADDITIONAL ASSESSMENTS AND

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1 retary shall assess the extent to which an 

2 Organization offers integrated and patient3 centered care through analysis of informa4 tion obtained from Program-eligible bene5 ficiaries assigned to or who elect the Orga6 nization through surveys, such as the In7 Center Hemodialysis Consumer Assess8 ment of Healthcare Providers and Sys9 tems. 

10 ‘‘(iv) NO EFFECT ON OTHER RENAL

11 DIALYSIS FACILITY QUALITY REQUIRE12 MENTS.—Nothing in this section shall be 

13 construed as affecting the requirements es14 tablished under section 1881(h). 

15 ‘‘(v) PRIORITIZATION OF QUALITY

16 MEASURE REPORTING.—The Secretary 

17 shall give priority to the development and 

18 reporting of quality measures that allow 

19 the assessment of health outcomes of pa20 tients, care coordination, patient experi21 ence and satisfaction, medication reconcili22 ation, patient safety, and other evidence23 based quality measures determined appro24 priate by the Secretary. 


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1 ‘‘(C) REQUIREMENTS FOR ESRD FEE-FOR2 SERVICE INTEGRATED CARE STRATEGY.— 

3 ‘‘(i) IN GENERAL.—An Organization 

4 seeking a contract under this section to 

5 offer one or more ESRD Fee-For-Service 

6 Integrated Care Models shall develop and 

7 submit for the Secretary’s approval as part 

8 of the application of the Organization to 

9 participate in the Program under this sec10 tion, subject to clauses (ii) and (iii), an 

11 ESRD Fee-For-Service Integrated Care 

12 Strategy. 

13 ‘‘(ii) ESRD FEE-FOR-SERVICE INTE14 GRATED CARE STRATEGY.—In assessing an 

15 ESRD Fee-For-Service Integrated Care 

16 Strategy under clause (i), the Secretary 

17 shall consider the extent to which the 

18 Strategy includes elements such as the fol19 lowing: 

20 ‘‘(I) Use of interdisciplinary care 

21 teams led by at least one nephrologist, 

22 and comprised of registered nurses, 

23 social workers, renal dialysis facility 

24 managers, and as appropriate other 


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1 representatives from alternative set2 tings described in subclause (VIII). 

3 ‘‘(II) Use of a decision process 

4 for care plans and care management 

5 that includes the nephrologist, a mem6 ber of the transplant evaluation team, 

7 and other practitioners responsible for 

8 direct delivery of care to Program-eli9 gible beneficiaries assigned to or who 

10 elect the Organization involved. 

11 ‘‘(III) Use of health risk and 

12 other assessments to determine the 

13 physical, psychosocial, nutrition, lan14 guage, cultural, and other needs of 

15 Program-eligible beneficiaries assigned 

16 to or who elect the Organization in17 volved. 

18 ‘‘(IV) Development and at least 

19 annual updating of individualized care 

20 plans that incorporate at least the 

21 medical, social, and functional needs, 

22 preferences, and care goals of Pro23 gram-eligible beneficiaries assigned to 

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1 ing a discussion on reconsideration of 

2 the method and location of dialysis. 

3 ‘‘(V) Coordination and furnishing 

4 of non-clinical coordination benefits, 

5 such as transportation, aimed at im6 proving the adherence of Program-eli7 gible beneficiaries assigned to or who 

8 elect the Organization with care rec9 ommendations. 

10 ‘‘(VI) As appropriate, coordina11 tion services, such as transplant eval12 uation, palliative care, evaluation for 

13 hospice eligibility, and vascular access 

14 care. 

15 ‘‘(VII) In the case of an indi16 vidual who, during an assignment to, 

17 or an election of an ESRD Fee-For18 Service Integrated Care model offered 

19 by an Organization, receives confirma20 tion that a kidney transplant is immi21 nent, the provision of counseling serv22 ices by an interdisciplinary care team 

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1 tial benefits and risks associated with 

2 such transplant. 

3 ‘‘(VIII) Delivery of benefits and 

4 services in settings alternative to tra5 ditional clinical settings, such as the 

6 home of the Program-eligible bene7 ficiary. 

8 ‘‘(IX) Use of patient reminder 

9 systems. 

10 ‘‘(X) Education programs for pa11 tients, families, and caregivers. 

12 ‘‘(XI) Use of health care advice 

13 resources, such as nurse advice lines. 

14 ‘‘(XII) Use of team-based health 

15 care delivery models that provide com16 prehensive and continuous medical 

17 care, such as medical homes. 

18 ‘‘(XIII) Co-location of providers 

19 and services. 

20 ‘‘(XIV) Use of a demonstrated 

21 capacity to share electronic health 

22 record information across sites of 

23 care. 

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1 ommended treatment regimens, in2 cluding prescription drug, by individ3 uals, including by addressing barriers 

4 to access to care by such individuals, 

5 including strategies to coordinate any 

6 prescription drug benefits under any 

7 prescription drug plan under part D 

8 in which a Program-eligible bene9 ficiary is enrolled. 

10 ‘‘(XVI) Use of defined protocols, 

11 developed in conjunction with the pe12 diatric nephrology community, to fa13 cilitate the transition of pediatric indi14 viduals into adult end-stage renal dis15 ease care. 

16 ‘‘(XVII) Use of health equity ex17 perts to implement programs and pro18 tocols which seek to decrease gender, 

19 racial, ethnic, and language inequities. 

20 ‘‘(XVIII) Other services, strate21 gies, and approaches identified by the 

22 Organization to improve care coordi23 nation and delivery. 

24 ‘‘(3) BENEFICIARY PROTECTIONS.— 


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1 ‘‘(A) SEAMLESS ACCESS TO CARE.—The 

2 Secretary shall ensure that the Organization es3 tablishes processes and takes steps necessary, 

4 including educating relevant providers of serv5 ices and suppliers about the Program, to ensure 

6 that Program-eligible beneficiaries assigned to 

7 or who elected an ESRD Fee-For-Service Inte8 grated Care Model offered by an Organization 

9 do not experience any disruption in access to 

10 providers of services and suppliers furnishing 

11 benefits under this title due to such assignment 

12 or election. Assignment to or an election of an 

13 ESRD Fee-For-Service Integrated Care Model 

14 offered by an Organization shall not be con15 strued as affecting a Program-eligible bene16 ficiary’s ability to receive benefits described in 

17 subsection (b)(2)(A)(i)(I) from any provider of 

18 services or suppliers enrolled and who otherwise 

19 meets requirements under this title, as de20 scribed in subsection (b)(2)(A)(iv). 

21 ‘‘(B) ANTI-DISCRIMINATION.—Each agree22 ment between the Secretary and an Organiza23 tion under this section shall— 

24 ‘‘(i) provide that each eligible partici25 pating provider of such Organization may 


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1 not deny, limit, or condition the furnishing 

2 of services, or affect the quality of services 

3 furnished, under this title to Program-eli4 gible beneficiaries on whether or not such 

5 a beneficiary is assigned to or elects the 

6 Organization; and 

7 ‘‘(ii) prohibit the Organization from 

8 engaging in any activity that could reason9 ably be expected to have the effect of deny10 ing or discouraging assignment to or an 

11 election of an ESRD Fee-For-Service Inte12 grated Care Model offered by an Organiza13 tion by a Program-eligible beneficiary 

14 whose medical condition or history indi15 cates a need for substantial future medical 

16 services. 

17 ‘‘(C) QUALITY ASSURANCE; PATIENT SAFE18 GUARDS.—Each agreement between the Sec19 retary and an Organization under this section 

20 shall require that such Organization have in ef21 fect at a minimum— 

22 ‘‘(i) a written plan of quality assur23 ance and improvement, and procedures im24 plementing such plan, in accordance with 

25 regulations; and 


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1 ‘‘(ii) written safeguards of the rights 

2 of Program-eligible beneficiaries assigned 

3 to or who elect the Organization (including 

4 a patient bill of rights and procedures for 

5 grievances and appeals) in accordance with 

6 regulations and with other requirements of 

7 this title and applicable Federal and State 

8 laws designed to protect Program-eligible 

9 beneficiaries (including those who are enti10 tled to medical assistance under a State 

11 plan under title XIX). 

12 ‘‘(D) OVERSIGHT.—The Secretary shall 

13 develop and implement an oversight program to 

14 monitor an Organization’s compliance with Pro15 gram requirements under an agreement under 

16 this section. 

17 ‘‘(4) TREATMENT AS ALTERNATIVE PAYMENT

18 MODEL AND ELIGIBLE ALTERNATIVE PAYMENT EN19 TITY.— 

20 ‘‘(A) TREATMENT OF PROGRAM.—The 

21 ESRD Fee-For-Service Integrated Care Dem22 onstration Program established under this sec23 tion shall meet the definition of an alternative 

24 payment model described in section 

25 1833(z)(3)(C)(iv). 


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1 ‘‘(B) TREATMENT OF ORGANIZATION.—An 

2 Organization offering one or more ESRD Fee3 For-Service Integrated Care Models shall be 

4 treated under this section as an eligible alter5 native payment entity as described in clauses (i) 

6 and (ii)(I) of section 1833(z)(3)(D). 

7 ‘‘(c) PROGRAM OPERATION AND SCOPE.— 

8 ‘‘(1) IN GENERAL.—The Secretary shall develop 

9 a process such that an Organization can apply to 

10 offer one or more ESRD Fee-For-Service Integrated 

11 Care Models. Such application shall include informa12 tion on at least the following: 

13 ‘‘(A) The estimated average revenue 

14 amount described in subsection (b)(2)(A)(ii)(II) 

15 for the Organization to cover benefits described 

16 in subsection (b)(2)(A)(i)(I). 

17 ‘‘(B) Any benefits offered by the Organiza18 tion beyond those described in such subsection. 

19 ‘‘(C) A description of the Organization’s 

20 ESRD Fee-For-Service Integrated Care strat21 egy specified in subsection (b)(2)(D), including 

22 a detailed explanation of the Organization’s ap23 proach to fulfill the requirement to coordinate 

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1 ment between a State and Organization, inte2 grates acute and long-term care services and 

3 supports. 

4 ‘‘(2) PROGRAM INITIATION.—The Secretary 

5 shall initiate the Program such that Organizations 

6 begin serving Program-eligible beneficiaries not later 

7 than January 1, 2024. 

8 ‘‘(3) INITIAL AGREEMENT PERIOD.—The Sec9 retary shall enter into agreements for an initial pe10 riod of not less than 5 years with all Organizations 

11 that meet all Program requirements established 

12 under this section, as determined by the Secretary 

13 through the application process described in para14 graph (1). 

15 ‘‘(4) ALLOWANCE FOR SERVICE AREA EXPAN16 SIONS.—During each year of the Program’s oper17 ation, the Secretary shall allow an Organization with 

18 an agreement under this section to expand its serv19 ice area during the initial agreement period upon the 

20 Secretary’s determination, through the application 

21 process described in paragraph (1), that the Organi22 zation meets all Program requirements established 

23 under this section. 

24 ‘‘(5) CONTRACT SUSPENSION AND TERMI25 NATION PROCESS.— 


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1 ‘‘(A) IN GENERAL.—Subject to subpara2 graph (B)(ii), the Secretary may suspend as3 signment to or an election of an ESRD Fee4 For-Service Integrated Care Model offered by 

5 an Organization if the Organization fails to 

6 comply with any Program requirements speci7 fied in an agreement under this section. An Or8 ganization also shall be considered not in com9 pliance if, for any calendar month during an 

10 agreement year, more than 50 percent of the 

11 total number of Program-eligible beneficiaries 

12 assigned to or who elect an ESRD Fee-For13 Service Integrated Care Model offered by the 

14 Organization opt out of the Program. 

15 ‘‘(B) OPPORTUNITY FOR CORRECTIVE AC16 TION PLAN AND APPEAL.— 

17 ‘‘(i) IN GENERAL.—Prior to sus18 pending assignment to or an election of an 

19 ESRD Fee-For-Service Integrated Care 

20 Model offered by an Organization or termi21 nating an agreement under this section, 

22 the Secretary shall afford an Organization 

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1 menting a corrective action plan. Any cor2 rective action plan implemented under this 

3 subparagraph shall specify a date by which 

4 the Organization shall resolve such defi5 ciencies and shall remain in effect until 

6 such time that the Secretary confirms that 

7 the Organization has achieved compliance. 

8 ‘‘(ii) IMPOSITION OF AGREEMENT SUS9 PENSION OR TERMINATION.—In the case 

10 of an Organization that fails to achieve 

11 compliance by the date specified in correc12 tive action plan, subject to clause (iii) and 

13 depending on the severity of a compliance 

14 deficiency, the Secretary in a manner con15 sistent with processes established under 

16 part C of this title may— 

17 ‘‘(I) suspend Program-eligible 

18 beneficiaries’ assignments to or an 

19 election of an ESRD Fee-For-Service 

20 Integrated Care Model offered by an 

21 Organization; or 

22 ‘‘(II) terminate an agreement 

23 with an Organization under this sec24 tion. 


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1 ‘‘(iii) IMMEDIATE AGREEMENT TERMI2 NATION FOR VIOLATING THE PROHIBITION

3 ON DISCRIMINATION.—Notwithstanding 

4 the corrective action plan process estab5 lished under clause (i), the Secretary may, 

6 in addition to the circumstances under 

7 which a contract under part C may be im8 mediately terminated, immediately termi9 nate an agreement under this section with 

10 an Organization if the Secretary— 

11 ‘‘(I) notifies the Organization of 

12 the intent to investigate allegations of 

13 systematic activities with the intent of 

14 violating the prohibition on discrimi15 nation established under subsection 

16 (b)(3)(B)(ii); 

17 ‘‘(II) determines, after con18 ducting a rigorous analysis of all 

19 available data based on a sufficient 

20 sample size, that the Organization en21 gaged in systematic activities with the 

22 intent of violating the prohibition on 

23 discrimination established in sub24 section (b)(3)(B)(ii); and 


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1 ‘‘(III) discloses credible evidence 

2 to the Organization regarding a deter3 mination made under subclause (II). 

4 ‘‘(iv) RECOVERY OF MONTHLY PRO5 SPECTIVE PAYMENTS.—The Secretary may 

6 recover the prorated share of any monthly 

7 prospective payments described in sub8 section (e) covering the period of the 

9 month following an agreement termination 

10 if such agreement termination is effective 

11 in the middle of a calendar month. 

12 ‘‘(v) NOTIFICATION OF PROGRAM-ELI13 GIBLE BENEFICIARY UPON AGREEMENT

14 TERMINATION.—Each agreement under 

15 this section between the Secretary and an 

16 Organization shall require the Organiza17 tion to provide and pay for written notice 

18 in advance of an agreement’s termination, 

19 as well as a description of alternatives for 

20 obtaining benefits under this title, in a 

21 manner consistent with beneficiary notifi22 cation requirements in the event of a con23 tract termination under part C. 

24 ‘‘(6) PROGRAM EVALUATION.—The Secretary 

25 shall conduct an evaluation of the Program under 


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1 this section to inform a determination regarding a 

2 Program expansion under paragraph (7). Such eval3 uation shall include an analysis of— 

4 ‘‘(A) the quality of care furnished under 

5 the Program, including the measurement of pa6 tient-level outcomes and patient experience and 

7 patient-reported outcome measures determined 

8 appropriate by the Secretary; and 

9 ‘‘(B) the changes in spending under parts 

10 A and B by reason of the Program. 

11 ‘‘(7) PROGRAM EXPANSION.— 

12 ‘‘(A) IN GENERAL.—The Secretary may, 

13 through rulemaking, expand the duration and 

14 scope of the Program under this section, to the 

15 extent determined appropriate by the Secretary, 

16 if— 

17 ‘‘(i) the Secretary determines that 

18 such expansion is expected to— 

19 ‘‘(I) reduce spending under this 

20 title without reducing the quality of 

21 patient care; or 

22 ‘‘(II) improve the quality of pa23 tient care without increasing spending 

24 under this title; 


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1 ‘‘(ii) the Chief Actuary of the Centers 

2 for Medicare & Medicaid Services certifies 

3 that such expansion would reduce (or 

4 would not result in any increase in) net 

5 program spending under this title; and 

6 ‘‘(iii) the Secretary determines that 

7 such expansion would not deny or limit the 

8 coverage or provision of benefits under this 

9 title for applicable individuals. 

10 ‘‘(B) ENSURING PROGRAM CONTINUITY.— 

11 The Secretary shall implement any Program ex12 pansion made in accordance with this para13 graph in a manner that ensures that Program14 eligible beneficiaries and Organizations with an 

15 agreement under this section do not experience 

16 any disruptions in the Program. 

17 ‘‘(8) PART D DATA SHARING ARRANGEMENT.— 

18 The Secretary on a monthly basis shall, in accord19 ance with the regulations promulgated under section 

20 264(c) of the Health Insurance Portability and Ac21 countability Act of 1996, provide access to Organiza22 tions to part D data claims that include part D data 

23 on Program-eligible beneficiaries assigned to or an 

24 election of an ESRD Fee-For-Service Integrated 

25 Care Model offered by an Organization unless a ProVerDate Sep 11 2014 04:52 Aug 08, 2021 Jkt 019200 PO 00000 Frm 00038 Fmt 6652 Sfmt 6201 E:\BILLS\S2649.IS S2649

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1 gram-eligible beneficiary opts out of such data shar2 ing. 

3 ‘‘(9) FUNDING.—The Secretary shall allocate 

4 funds made available under section 1115A(f)(1) to 

5 implement and evaluate the demonstration program 

6 established under this section. 

7 ‘‘(d) IDENTIFICATION AND ASSIGNMENT OF PRO8 GRAM-ELIGIBLE BENEFICIARIES.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall estab10 lish a process for the initial and ongoing identifica11 tion of Program-eligible beneficiaries. 

12 ‘‘(2) ASSIGNMENT OF PROGRAM-ELIGIBLE

13 BENEFICIARIES TO AN ORGANIZATION’S ESRD FEE14 FOR-SERVICE INTEGRATED CARE MODEL.— 

15 ‘‘(A) IN GENERAL.—Under the Program, 

16 the Secretary shall assign all Program-eligible 

17 beneficiaries to an ESRD Fee-For-Service Inte18 grated Care Model offered by an Organization 

19 that includes the dialysis facility at which the 

20 Program-eligible beneficiary primarily receives 

21 renal dialysis services. 

22 ‘‘(B) OPT-OUT PERIOD AND CHANGES

23 UPON INITIAL ASSIGNMENT OR ELECTION.— 

24 The Secretary shall provide for a 90-day period 

25 beginning on the date on which the assignment 


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1 of or election made by a Program-eligible bene2 ficiary into an ESRD Fee-For-Service Inte3 grated Care Model offered by an Organization 

4 becomes effective during which a Program-eligi5 ble beneficiary may— 

6 ‘‘(i) opt out of the Program; or 

7 ‘‘(ii) make a one-time change of as8 signment or election into an ESRD Fee9 For-Service Integrated Care Model offered 

10 by a different Organization. 

11 ‘‘(C) DEEMED RE-ASSIGNMENT AND RE12 ELECTION.—The Secretary shall establish a 

13 process through which a Program-eligible bene14 ficiary assigned to or who elects an ESRD Fee15 For-Service Integrated Care Model offered by 

16 an Organization with respect to a year is 

17 deemed, unless the Program-eligible beneficiary 

18 otherwise changes such assignment or election 

19 under this paragraph, to have elected to con20 tinue such assignment or election with respect 

21 to the subsequent year. 

22 ‘‘(D) ANNUAL OPPORTUNITY TO OPT OUT

23 OR ELECT AN ESRD FEE-FOR-SERVICE INTE24 GRATED CARE MODEL OFFERED BY A DIF25 FERENT ORGANIZATION.— 


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1 ‘‘(i) IN GENERAL.—Annually, a Pro2 gram-eligible beneficiary shall be given a 

3 90-day period to— 

4 ‘‘(I) opt out of the Program; or 

5 ‘‘(II) make a one-time change of 

6 assignment or election into an ESRD 

7 Fee-For-Service Integrated Care 

8 Model offered by a different Organiza9 tion. 

10 ‘‘(ii) ALIGNMENT WITH MEDICARE AD11 VANTAGE OPEN ENROLLMENT PERIOD.— 

12 To the extent practicable, the Secretary 

13 shall align the annual 90-day period de14 scribed in clause (i) with the Medicare Ad15 vantage open enrollment period. 

16 ‘‘(E) OPT OUT FOR CHANGE IN PRINCIPAL

17 DIAGNOSIS OR ENTERING HOME DIALYSIS

18 TREATMENT.—In addition to any other period 

19 during which a Program-eligible beneficiary 

20 may, pursuant to this paragraph, opt out of the 

21 Program, in the case of a Program-eligible ben22 eficiary who, after assignment under this para23 graph, is diagnosed with a principal diagnosis 

24 (as defined by the Secretary) other than end25 stage renal disease or enters into home dialysis 


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1 treatment, such individual shall be given the op2 portunity to opt out of the Program during 

3 such period as specified by the Secretary. 

4 ‘‘(3) PROGRAM-ELIGIBLE BENEFICIARY NOTIFI5 CATION.— 

6 ‘‘(A) IN GENERAL.—The Secretary shall 

7 ensure that an Organization notifies Program8 eligible beneficiaries about the Program under 

9 this section and provides them with materials 

10 explaining the Program, including— 

11 ‘‘(i) information about receiving bene12 fits under this title through such Organiza13 tion; and 

14 ‘‘(ii) an explanation that they retain 

15 the right to receive care from any Medicare 

16 provider. 

17 ‘‘(B) TIMING OF NOTIFICATION.—Upon as18 signment to or election of an ESRD Fee-For19 Service Integrated Care Model offered by an 

20 Organization, the Secretary shall provide the 

21 Organization written notification confirming the 

22 beneficiary’s assignment or election and not 

23 later than 15 business days after the date of re24 ceipt of such notification, the Organization shall 


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1 provide written notice to the Program-eligible 

2 beneficiary of such assignment or election. 

3 ‘‘(C) CONTENT OF WRITTEN NOTICE.— 

4 Subject to subparagraph (D), such notification 

5 shall— 

6 ‘‘(i) inform Program-eligible bene7 ficiaries about the Program using an infor8 mation guide developed by the Organiza9 tion and approved by the Secretary; 

10 ‘‘(ii) include the distribution of other 

11 Program materials developed by the Orga12 nization and approved by the Secretary; 

13 ‘‘(iii) inform Program-eligible bene14 ficiaries about the importance of transplan15 tation as the best outcome, as well as min16 imum requirements for transplant eligi17 bility before and during dialysis treatment; 

18 and 

19 ‘‘(iv) provide contact information for 

20 representatives of the Organization to re21 spond to Program-eligible beneficiaries’ 

22 questions. 

23 ‘‘(D) LIMITATION ON UNSOLICITED NOTI24 FICATION.— 


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1 ‘‘(i) IN GENERAL.—Under the Pro2 gram, no person or entity (other than the 

3 Secretary, an employee of the Secretary, or 

4 an employee or volunteer of a federally au5 thorized State Health Insurance Assistance 

6 Program (SHIP)), subject to clause (ii), 

7 may provide any information about the 

8 Program, including information, materials, 

9 and assistance described in subparagraph 

10 (B), to a Program-eligible beneficiary un11 less such Program-eligible beneficiary re12 quests such information, materials, or as13 sistance. 

14 ‘‘(ii) EXCEPTION FOR PROVIDERS

15 TREATING BENEFICIARIES.—An eligible 

16 participating provider that is part of an 

17 Organization may provide information, ma18 terials, and assistance described in sub19 paragraph (B) to a Program-eligible bene20 ficiary, without prior request of such bene21 ficiary, if such beneficiary is receiving 

22 renal dialysis services from a facility that 

23 participates in such Organization. 

24 ‘‘(iii) PARITY IN NOTIFICATION.—In 

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1 vider that is part of an Organization par2 ticipates in notifying Program-eligible 

3 beneficiaries about the Program under this 

4 subparagraph, such notification shall be 

5 provided in the same manner to all Pro6 gram-eligible beneficiaries to which, pursu7 ant to clause (ii), such eligible partici8 pating provider may provide information, 

9 materials, and assistance described in such 

10 clause. 

11 ‘‘(E) PROGRAM-ELIGIBLE BENEFICIARY

12 GRIEVANCE AND APPEAL RIGHTS.—Program-el13 igible beneficiaries participating in the Program 

14 under this section shall have grievance and ap15 peal rights and procedures consistent with those 

16 rights and procedures established under sub17 sections (f) and (g) of section 1852. 

18 ‘‘(e) ESRD FEE-FOR-SERVICE INTEGRATED CARE

19 PROGRAM MONTHLY PAYMENT AND CLAIMS PROCESSING

20 MECHANISM.— 

21 ‘‘(1) IN GENERAL.—For each Program-eligible 

22 beneficiary receiving care through an Organization, 

23 the Secretary shall make a monthly prospective pay24 ment in accordance with payment rates that would 

25 be determined under section 1853(a)(1)(H). 


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1 ‘‘(2) APPLICATION OF HEALTH STATUS RISK

2 ADJUSTMENT METHODOLOGY.—The Secretary shall 

3 adjust the monthly prospective payment to an Orga4 nization under this subsection in the same manner 

5 in which the payment amount to a Medicare Advan6 tage plan is adjusted under section 1853(a)(1)(C). 

7 ‘‘(3) TREATMENT OF AND PAYMENT FOR KID8 NEY ACQUISITION COSTS.— 

9 ‘‘(A) EXCLUDING COSTS FOR KIDNEY AC10 QUISITIONS FROM MA BENCHMARK.—The Sec11 retary shall adjust the payment amount to an 

12 Organization to exclude from such payment 

13 amount the Secretary’s estimate of the stand14 ardized costs for payments for organ acquisi15 tions for kidney transplants in the area involved 

16 for the year. 

17 ‘‘(B) FFS TREATMENT OF AND PAYMENT

18 FOR KIDNEY ACQUISITIONS.—An Organization 

19 shall provide all benefits described in subsection 

20 (b)(2)(A)(i), except for kidney acquisition costs. 

21 Payment for kidney acquisition costs covered 

22 under this title furnished to a Program-eligible 

23 beneficiary shall be made in accordance with 

24 this title and in such amounts as would other25 wise be made and determined for such items 


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1 and services provided to such a beneficiary not 

2 participating in the Program under this section. 

3 ‘‘(4) TREATMENT OF AND PAYMENT FOR HOS4 PICE CARE.— 

5 ‘‘(A) IN GENERAL.—An agreement under 

6 this section shall require an Organization to in7 form each Program-eligible beneficiary who is 

8 assigned to or elects an ESRD Fee-For-Service 

9 Integrated Care Model offered by the Organiza10 tion about the availability of hospice care if— 

11 ‘‘(i) a hospice program participating 

12 under this title is located within the Orga13 nization’s service area; or 

14 ‘‘(ii) it is common practice to refer pa15 tients to hospice programs outside such 

16 service area. 

17 ‘‘(B) PAYMENT.—If a Program-eligible 

18 beneficiary who is assigned to or elects an 

19 ESRD Fee-For-Service Integrated Care Model 

20 offered by an Organization with an agreement 

21 under this section makes an election under sec22 tion 1812(d)(1) to receive hospice care from a 

23 particular hospice program— 

24 ‘‘(i) payment for the care furnished to 

25 the Program-eligible beneficiary shall be 


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1 made by the Secretary to the hospice pro2 gram elected by the Program-eligible bene3 ficiary; 

4 ‘‘(ii) payment for other services for 

5 which the Program-eligible beneficiary in6 dividual is eligible notwithstanding the 

7 Program-eligible beneficiary’s election of 

8 hospice care under section 1812(d)(1), in9 cluding services not related to the Pro10 gram-eligible beneficiary’s terminal illness, 

11 shall be made by the Secretary to the Or12 ganization or the provider or supplier of 

13 the service instead of the monthly prospec14 tive payment determined under subsection 

15 (f); and 

16 ‘‘(iii) the Secretary shall continue to 

17 make monthly payments to the Organiza18 tion in an amount equal to the value of 

19 benefits and services determined under 

20 subsection (b)(2)(A)(ii)(IV). 

21 ‘‘(5) APPLICATION OF CMI CLAIMS PROCESSING

22 FRAMEWORK.— 

23 ‘‘(A) IN GENERAL.—Under the Program, 

24 the Secretary shall apply a claims processing 

25 framework based on those that the Center for 


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1 Medicare and Medicaid Innovation applies 

2 under various direct contracting models under 

3 section 1115A such that— 

4 ‘‘(i) providers of services and suppliers 

5 serving Program-eligible beneficiaries con6 tinue to submit claims to a medicare ad7 ministrative contractor; 

8 ‘‘(ii) the Secretary forwards claims to 

9 the Organization for payment; and 

10 ‘‘(iii) the Organization pays providers 

11 of services and suppliers an amount equal 

12 to the amount that they would otherwise 

13 receive under the original Medicare Fee14 For-Service program plus any additional 

15 amount to which the provider may be eligi16 ble under subsection (b)(2)(A)(v) of this 

17 section. 

18 ‘‘(B) APPLICATION OF BALANCE BILLING

19 LIMITATIONS.—Section 1852(a)(2)(A) (relating 

20 to payments made by an MA organization to a 

21 non-contract provider of services), section 

22 1852(k)(1) (relating to limitations on balance 

23 billing), and section 1866(a)(1)(o) (relating to 

24 payments made by an MA organization to a 


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1 non-contract supplier) shall apply to the Pro2 gram. 

3 ‘‘(C) PAYMENTS FOR GRADUATE MEDICAL

4 EDUCATION.—Section 1886(d)(11) and section 

5 1886(h)(3)(D) (relating to payments for grad6 uate medical education) shall apply to Organi7 zations and providers of services under the Pro8 gram. 

9 ‘‘(6) NO EFFECT ON MA ESRD RATE SETTING

10 OR RISK ADJUSTMENT MODEL.—To ensure the in11 tegrity of the Medicare Advantage end stage renal 

12 disease rate setting process and risk adjustment fac13 tors applied to Medicare Advantage end stage renal 

14 disease rates, claims paid on behalf of Program-eligi15 ble beneficiaries shall not be included in neither the 

16 determination of such rates nor the development of 

17 such risk adjustment factors. 

18 ‘‘(7) AGREEMENT BETWEEN A STATE AND OR19 GANIZATION FOR MEDICAID BENEFITS.—In the case 

20 that a State and Organization enter into a mutual 

21 agreement under which the Organization coordinates 

22 benefits under title XIX for Program-eligible bene23 ficiaries eligible for benefits under this title and title 

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1 ment from the State for providing or arranging for 

2 the provision of such benefits. 

3 ‘‘(8) AFFIRMATION OF STATE OBLIGATIONS TO

4 PAY PREMIUM AND COST-SHARING AMOUNTS.—A 

5 State shall continue to make medical assistance 

6 under the State plan under title XIX available for 

7 the duration of the Program for Medicare cost-shar8 ing (as defined in section 1905(p)(3)) under this 

9 title for qualified Medicare beneficiaries described in 

10 section 1905(p)(1) and other individuals who are 

11 Program-eligible beneficiaries assigned to or who 

12 elect an Organization and entitled to medical assist13 ance for premiums and such cost-sharing under the 

14 State plan under title XIX in an amount equal to 

15 the amount of medical assistance that would be 

16 made available by such State if such Program-eligi17 ble beneficiaries were not participating in the Pro18 gram under this section. 

19 ‘‘(f) WAIVER AUTHORITY.— 

20 ‘‘(1) IN GENERAL.—The Secretary shall waive 

21 those requirements waived under section 1899 deter22 mined by the Secretary to be relevant and necessary 

23 for the operation of the Program under this section 

24 and may waive, as necessary, such additional re25 quirements that have been or may be waived based 


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1 on authority established under section 1115A for 

2 purposes of models tested by the Centers for Medi3 care and Medicaid Innovation in order to carry out 

4 the Program under this section. 

5 ‘‘(2) NOTICE OF WAIVERS.—Not later than 3 

6 months after the date of enactment of this section, 

7 the Secretary shall publish a notice of waivers that 

8 will apply in connection with the Program. The no9 tice shall include the specific conditions that an Or10 ganization must meet to qualify for each waiver, and 

11 commentary explaining the waiver requirements. 

12 ‘‘(g) REPORT.—Not later than December 31, 2025, 

13 the Medicare Payment Advisory Commission shall submit 

14 to Congress an interim report on the Program.’’. 

15 (b) RULES OF CONSTRUCTION.— 

16 (1) USE OF MEDICARE SUPPLEMENTAL POLICY

17 UNDER AN ESRD FEE-FOR-SERVICE INTEGRATED

18 CARE MODEL.—Nothing in the provisions of, or 

19 amendments made by, this Act shall be construed to 

20 prevent a Program-eligible beneficiary assigned to, 

21 or who elects, an ESRD Fee-For-Service Integrated 

22 Care Model offered by an Organization with an 

23 agreement under this section from enrolling in or 

24 continuing enrollment in a medicare supplemental 

25 policy available to such Program-eligible beneficiary 


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1 or receiving benefits under such medicare supple2 mental policy throughout the duration of the Pro3 gram-eligible beneficiary’s participation in an ESRD 

4 Fee-For-Service Integrated Care model offered by an 

5 Organizations with an agreement under this section. 

6 (2) APPLICATION OF STATE RULES REGARDING

7 ISSUANCE OF MEDICARE SUPPLEMENTAL POLICIES

8 TO INDIVIDUAL UNDER AGE 65.—Nothing in the pro9 visions of, or amendments made by, this Act shall be 

10 construed to establish a Federal requirement on an 

11 issuer of a medicare supplemental policy to offer 

12 such medicare supplemental policy to individuals 

13 under age 65. 

14 (3) CONTINUED AVAILABILITY OF MEDICARE

15 SUPPLEMENTAL POLICIES TO INDIVIDUALS UNDER

16 AGE 65.—Nothing in the provisions of, or amend17 ments made by, this Act shall be construed to affect 

18 a State’s authority to require an issuer of a medi19 care supplemental policy to offer such medicare sup20 plemental policy to individual. 

21 (4) CONTINUED APPLICATION OF EDUCATION

22 REQUIREMENT.—Nothing in the provisions of, or the 

23 amendments made by, this Act shall be construed to 

24 exempt dialysis facilities participating in an Organi25 zation from complying with Medicare rules that reVerDate Sep 11 2014 04:52 Aug 08, 2021 Jkt 019200 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\S2649.IS S2649

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1 quire such Organizations to educate their patients 

2 about all treatment modalities, including home dialy3 sis and transplantation. 

4 (5) PARTICIPATION IN ESRD TREATMENT

5 CHOICES DEMONSTRATION.—Nothing in the provi6 sions of, or the amendments made by, this Act shall 

7 be construed to exempt an Organization under the 

8 ESRD FFS Integrated Care demonstration from 

9 participating in the Centers for Medicare & Medicaid 

10 Innovation’s mandatory ESRD Treatment Choices 

11 demonstration. 

12 (c) GAO STUDY AND REPORT ON PAYMENT ADE13 QUACY FOR PEDIATRIC ESRD SERVICES.— 

14 (1) STUDY ON PAYMENT FOR PEDIATRIC ESRD

15 SERVICES.—The Comptroller General of the United 

16 States shall conduct a study to examine the accuracy 

17 of pediatric data reported to the Centers for Medi18 care & Medicaid Services as part of the ESRD pro19 spective payment system. The study shall evaluate 

20 whether the organizations described in section 

21 1866G of the Social Security Act, as added by sub22 section (a), and the existing prospective payment 

23 system accurately capture and reimburse costs of pe24 diatric dialysis care and include an analysis of the 

25 following factors that influence such costs: 


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1 (A) Increased acuity of nursing care com2 pared to adult dialysis patients, especially for 

3 smaller and younger pediatric hemodialysis pa4 tients. 

5 (B) Need for developmental and behavioral 

6 specialists, including child life specialists. 

7 (C) Need for more frequent assessment by 

8 pediatric dieticians to adjust formulas and diet 

9 for the specialized growth and nutrition require10 ments of children treated with dialysis. 

11 (D) Need for social workers, school liai12 sons, and other trained individuals designated 

13 to help families navigate challenging psycho14 social situations and to coordinate with schools 

15 to ensure school attendance and optimize school 

16 performance among pediatric dialysis patients. 

17 (E) Need for a broader array of dialysis 

18 supplies, including different-sized dialyzers, tub19 ing, and peritoneal fluid bags to accommodate 

20 care provided infants through young adults. 

21 (2) REPORT.—Not later than 18 months after 

22 the date of the enactment of this Act, the Comp23 troller General shall submit to Congress a report 

24 containing the results of the study conducted under 

25 paragraph (1), together with recommendations for 


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1 such legislation and administrative action as the 

2 Comptroller General determines appropriate. 

3 (d) GAO STUDY AND REPORT ON THE IMPACT OF

4 RACE-BASED CORRECTION OF EGFR ON REFERRAL OF

5 ESRD PATIENTS FOR TRANSPLANT EVALUATION.— 

6 (1) STUDY ON IMPACT OF RACE-BASED COR7 RECTION OF EGFR ON REFERRAL OF ESRD PA8 TIENTS FOR TRANSPLANT EVALUATION.—The 

9 Comptroller General of the United States shall con10 duct a study to examine the impact of race-based 

11 correction of the estimated glomerular filtration rate 

12 (referred to in this subsection as ‘‘eGFR’’) on the 

13 referral of ESRD patients for transplant evaluation. 

14 (2) REPORT.—Not later than 18 months after 

15 the date of enactment of this Act, the Comptroller 

16 General shall submit to Congress a report containing 

17 the results of the study conducted under paragraph 

18 (1), together with recommendations for such legisla19 tion and administrative action as the Comptroller 

20 General determines appropriate. 

Æ 


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