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 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 (BET6 TER) 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 pro5 gram under parts A and B for Program-eligible 

6 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 ‘‘(C) REQUIREMENTS FOR ESRD FEE-FOR16 SERVICE INTEGRATED CARE STRATEGY.— 

17 ‘‘(i) IN GENERAL.—An Organization 

18 seeking a contract under this section to 

19 offer one or more ESRD Fee-For-Service 

20 Integrated Care Models shall develop and 

21 submit for the Secretary’s approval as part 

22 of the application of the Organization to 

23 participate in the Program under this sec24 tion, subject to clauses (ii) and (iii), an 


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1 ESRD Fee-For-Service Integrated Care 

2 Strategy. 

3 ‘‘(ii) ESRD FEE-FOR-SERVICE INTE4 GRATED CARE STRATEGY.—In assessing an 

5 ESRD Fee-For-Service Integrated Care 

6 Strategy under clause (i), the Secretary 

7 shall consider the extent to which the 

8 Strategy includes elements such as the fol9 lowing: 

10 ‘‘(I) Use of interdisciplinary care 

11 teams led by at least one nephrologist, 

12 and comprised of registered nurses, 

13 social workers, renal dialysis facility 

14 managers, and as appropriate other 

15 representatives from alternative set16 tings described in subclause (VIII). 

17 ‘‘(II) Use of a decision process 

18 for care plans and care management 

19 that includes the nephrologist, a mem20 ber of the transplant evaluation team, 

21 and other practitioners responsible for 

22 direct delivery of care to Program-eli23 gible beneficiaries assigned to or who 

24 elect the Organization involved. 


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1 ‘‘(III) Use of health risk and 

2 other assessments to determine the 

3 physical, psychosocial, nutrition, lan4 guage, cultural, and other needs of 

5 Program-eligible beneficiaries assigned 

6 to or who elect the Organization in7 volved. 

8 ‘‘(IV) Development and at least 

9 annual updating of individualized care 

10 plans that incorporate at least the 

11 medical, social, and functional needs, 

12 preferences, and care goals of Pro13 gram-eligible beneficiaries assigned to 

14 or who elect the Organization, includ15 ing a discussion on reconsideration of 

16 the method and location of dialysis. 

17 ‘‘(V) Coordination and furnishing 

18 of non-clinical coordination benefits, 

19 such as transportation, aimed at im20 proving the adherence of Program-eli21 gible beneficiaries assigned to or who 

22 elect the Organization with care rec23 ommendations. 

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1 uation, palliative care, evaluation for 

2 hospice eligibility, and vascular access 

3 care. 

4 ‘‘(VII) In the case of an indi5 vidual who, during an assignment to, 

6 or an election of an ESRD Fee-For7 Service Integrated Care model offered 

8 by an Organization, receives confirma9 tion that a kidney transplant is immi10 nent, the provision of counseling serv11 ices by an interdisciplinary care team 

12 described in subclause (I) to such in13 dividual on preparation for and poten14 tial benefits and risks associated with 

15 such transplant. 

16 ‘‘(VIII) Delivery of benefits and 

17 services in settings alternative to tra18 ditional clinical settings, such as the 

19 home of the Program-eligible bene20 ficiary. 

21 ‘‘(IX) Use of patient reminder 

22 systems. 

23 ‘‘(X) Education programs for pa24 tients, families, and caregivers. 


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1 ‘‘(XI) Use of health care advice 

2 resources, such as nurse advice lines. 

3 ‘‘(XII) Use of team-based health 

4 care delivery models that provide com5 prehensive and continuous medical 

6 care, such as medical homes. 

7 ‘‘(XIII) Co-location of providers 

8 and services. 

9 ‘‘(XIV) Use of a demonstrated 

10 capacity to share electronic health 

11 record information across sites of 

12 care. 

13 ‘‘(XV) Use of programs to pro14 mote better adherence to rec15 ommended treatment regimens, in16 cluding prescription drug, by individ17 uals, including by addressing barriers 

18 to access to care by such individuals, 

19 including strategies to coordinate any 

20 prescription drug benefits under any 

21 prescription drug plan under part D 

22 in which a Program-eligible bene23 ficiary is enrolled. 

24 ‘‘(XVI) Use of defined protocols, 

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1 diatric nephrology community, to fa2 cilitate the transition of pediatric indi3 viduals into adult end-stage renal dis4 ease care. 

5 ‘‘(XVII) Use of health equity ex6 perts to implement programs and pro7 tocols which seek to decrease gender, 

8 racial, ethnic, and language inequities. 

9 ‘‘(XVIII) Other services, strate10 gies, and approaches identified by the 

11 Organization to improve care coordi12 nation and delivery. 

13 ‘‘(3) BENEFICIARY PROTECTIONS.— 

14 ‘‘(A) SEAMLESS ACCESS TO CARE.—The 

15 Secretary shall ensure that the Organization es16 tablishes processes and takes steps necessary, 

17 including educating relevant providers of serv18 ices and suppliers about the Program, to ensure 

19 that Program-eligible beneficiaries assigned to 

20 or who elected an ESRD Fee-For-Service Inte21 grated Care Model offered by an Organization 

22 do not experience any disruption in access to 

23 providers of services and suppliers furnishing 

24 benefits under this title due to such assignment 

25 or election. Assignment to or an election of an 


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1 ESRD Fee-For-Service Integrated Care Model 

2 offered by an Organization shall not be con3 strued as affecting a Program-eligible bene4 ficiary’s ability to receive benefits described in 

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

6 services or suppliers enrolled and who otherwise 

7 meets requirements under this title, as de8 scribed in subsection (b)(2)(A)(iv). 

9 ‘‘(B) ANTI-DISCRIMINATION.—Each agree10 ment between the Secretary and an Organiza11 tion under this section shall— 

12 ‘‘(i) provide that each eligible partici13 pating provider of such Organization may 

14 not deny, limit, or condition the furnishing 

15 of services, or affect the quality of services 

16 furnished, under this title to Program-eli17 gible beneficiaries on whether or not such 

18 a beneficiary is assigned to or elects the 

19 Organization; and 

20 ‘‘(ii) prohibit the Organization from 

21 engaging in any activity that could reason22 ably be expected to have the effect of deny23 ing or discouraging assignment to or an 

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1 tion by a Program-eligible beneficiary 

2 whose medical condition or history indi3 cates a need for substantial future medical 

4 services. 

5 ‘‘(C) QUALITY ASSURANCE; PATIENT SAFE6 GUARDS.—Each agreement between the Sec7 retary and an Organization under this section 

8 shall require that such Organization have in ef9 fect at a minimum— 

10 ‘‘(i) a written plan of quality assur11 ance and improvement, and procedures im12 plementing such plan, in accordance with 

13 regulations; and 

14 ‘‘(ii) written safeguards of the rights 

15 of Program-eligible beneficiaries assigned 

16 to or who elect the Organization (including 

17 a patient bill of rights and procedures for 

18 grievances and appeals) in accordance with 

19 regulations and with other requirements of 

20 this title and applicable Federal and State 

21 laws designed to protect Program-eligible 

22 beneficiaries (including those who are enti23 tled to medical assistance under a State 

24 plan under title XIX). 


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

2 develop and implement an oversight program to 

3 monitor an Organization’s compliance with Pro4 gram requirements under an agreement under 

5 this section. 

6 ‘‘(4) TREATMENT AS ALTERNATIVE PAYMENT

7 MODEL AND ELIGIBLE ALTERNATIVE PAYMENT EN8 TITY.— 

9 ‘‘(A) TREATMENT OF PROGRAM.—The 

10 ESRD Fee-for-Service Integrated Care Dem11 onstration Program established under this sec12 tion shall meet the definition of an alternative 

13 payment model described in section 

14 1833(z)(3)(C)(iv). 

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

16 Organization offering one or more ESRD Fee17 for-Service Integrated Care Models shall be 

18 treated under this section as an eligible alter19 native payment entity as described in clauses (i) 

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

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

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

23 a process such that an Organization can apply to 

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


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1 Care Models. Such application shall include informa2 tion on at least the following: 

3 ‘‘(A) The estimated average revenue 

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

5 for the Organization to cover benefits described 

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

7 ‘‘(B) Any benefits offered by the Organiza8 tion beyond those described in such subsection. 

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

10 ESRD Fee-For-Service integrated care strategy 

11 specified in subsection (b)(2)(D), including a 

12 detailed explanation of the Organization’s ap13 proach to fulfill the requirement to coordinate 

14 the delivery of multidisciplinary health and so15 cial services that, pursuant to a mutual agree16 ment between a State and Organization, inte17 grates acute and long-term care services and 

18 supports. 

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

20 shall initiate the Program such that Organizations 

21 begin serving Program-eligible beneficiaries not later 

22 than January 1, 2024. 

23 ‘‘(3) INITIAL AGREEMENT PERIOD.—The Sec24 retary shall enter into agreements for an initial pe25 riod of not less than 5 years with all Organizations 


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1 that meet all Program requirements established 

2 under this section, as determined by the Secretary 

3 through the application process described in para4 graph (1). 

5 ‘‘(4) ALLOWANCE FOR SERVICE AREA EXPAN6 SIONS.—During each year of the Program’s oper7 ation, the Secretary shall allow an Organization with 

8 an agreement under this section to expand its serv9 ice area during the initial agreement period upon the 

10 Secretary’s determination, through the application 

11 process described in paragraph (1), that the Organi12 zation meets all Program requirements established 

13 under this section. 

14 ‘‘(5) CONTRACT SUSPENSION AND TERMI15 NATION PROCESS.— 

16 ‘‘(A) IN GENERAL.—Subject to subpara17 graph (B)(ii), the Secretary may suspend as18 signment to or an election of an ESRD Fee19 For-Service Integrated Care Model offered by 

20 an Organization if the Organization fails to 

21 comply with any Program requirements speci22 fied in an agreement under this section. An Or23 ganization also shall be considered not in com24 pliance if, for any calendar month during an 

25 agreement year, more than 50 percent of the 


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1 total number of Program-eligible beneficiaries 

2 assigned to or who elect an ESRD Fee-For3 Service Integrated Care Model offered by the 

4 Organization opt out of the Program. 

5 ‘‘(B) OPPORTUNITY FOR CORRECTIVE AC6 TION PLAN AND APPEAL.— 

7 ‘‘(i) IN GENERAL.—Prior to sus8 pending assignment to or an election of an 

9 ESRD Fee-For-Service Integrated Care 

10 Model offered by an Organization or termi11 nating an agreement under this section, 

12 the Secretary shall afford an Organization 

13 sufficient opportunity to remedy any defi14 ciencies in complying with any Program re15 quirements under this section by imple16 menting a corrective action plan. Any cor17 rective action plan implemented under this 

18 subparagraph shall specify a date by which 

19 the Organization shall resolve such defi20 ciencies and shall remain in effect until 

21 such time that the Secretary confirms that 

22 the Organization has achieved compliance. 

23 ‘‘(ii) IMPOSITION OF AGREEMENT SUS24 PENSION OR TERMINATION.—In the case 

25 of an Organization that fails to achieve 


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1 compliance by the date specified in correc2 tive action plan, subject to clause (iii) and 

3 depending on the severity of a compliance 

4 deficiency, the Secretary in a manner con5 sistent with processes established under 

6 part C of this title may— 

7 ‘‘(I) suspend Program-eligible 

8 beneficiaries’ assignments to or an 

9 election of an ESRD Fee-For-Service 

10 Integrated Care Model offered by an 

11 Organization; or 

12 ‘‘(II) terminate an agreement 

13 with an Organization under this sec14 tion. 

15 ‘‘(iii) IMMEDIATE AGREEMENT TERMI16 NATION FOR VIOLATING THE PROHIBITION

17 ON DISCRIMINATION.—Notwithstanding 

18 the corrective action plan process estab19 lished under clause (i), the Secretary may, 

20 in addition to the circumstances under 

21 which a contract under part C may be im22 mediately terminated, immediately termi23 nate an agreement under this section with 

24 an Organization if the Secretary— 


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1 ‘‘(I) notifies the Organization of 

2 the intent to investigate allegations of 

3 systematic activities with the intent of 

4 violating the prohibition on discrimi5 nation established under subsection 

6 (b)(3)(B)(ii); 

7 ‘‘(II) determines, after con8 ducting a rigorous analysis of all 

9 available data based on a sufficient 

10 sample size, that the Organization en11 gaged in systematic activities with the 

12 intent of violating the prohibition on 

13 discrimination established in sub14 section (b)(3)(B)(ii); and 

15 ‘‘(III) discloses credible evidence 

16 to the Organization regarding a deter17 mination made under subclause (II). 

18 ‘‘(iv) RECOVERY OF MONTHLY PRO19 SPECTIVE PAYMENTS.—The Secretary may 

20 recover the prorated share of any monthly 

21 prospective payments described in sub22 section (e) covering the period of the 

23 month following an agreement termination 

24 if such agreement termination is effective 

25 in the middle of a calendar month. 


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1 ‘‘(v) NOTIFICATION OF PROGRAM-ELI2 GIBLE BENEFICIARY UPON AGREEMENT

3 TERMINATION.—Each agreement under 

4 this section between the Secretary and an 

5 Organization shall require the Organiza6 tion to provide and pay for written notice 

7 in advance of an agreement’s termination, 

8 as well as a description of alternatives for 

9 obtaining benefits under this title, in a 

10 manner consistent with beneficiary notifi11 cation requirements in the event of a con12 tract termination under part C. 

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

14 shall conduct an evaluation of the Program under 

15 this section to inform a determination regarding a 

16 Program expansion under paragraph (7). Such eval17 uation shall include an analysis of— 

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

19 the Program, including the measurement of pa20 tient-level outcomes and patient experience and 

21 patient-reported outcome measures determined 

22 appropriate by the Secretary; and 

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

24 A and B by reason of the Program. 

25 ‘‘(7) PROGRAM EXPANSION.— 


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

2 through rulemaking, expand the duration and 

3 scope of the Program under this section, to the 

4 extent determined appropriate by the Secretary, 

5 if— 

6 ‘‘(i) the Secretary determines that 

7 such expansion is expected to— 

8 ‘‘(I) reduce spending under this 

9 title without reducing the quality of 

10 patient care; or 

11 ‘‘(II) improve the quality of pa12 tient care without increasing spending 

13 under this title; 

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

15 for Medicare & Medicaid Services certifies 

16 that such expansion would reduce (or 

17 would not result in any increase in) net 

18 program spending under this title; and 

19 ‘‘(iii) the Secretary determines that 

20 such expansion would not deny or limit the 

21 coverage or provision of benefits under this 

22 title for applicable individuals. 

23 ‘‘(B) ENSURING PROGRAM CONTINUITY.— 

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1 graph in a manner that ensures that Program2 eligible beneficiaries and Organizations with an 

3 agreement under this section do not experience 

4 any disruptions in the Program. 

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

6 The Secretary on a monthly basis shall, in accord7 ance with the regulations promulgated under section 

8 264(c) of the Health Insurance Portability and Ac9 countability Act of 1996, provide access to Organiza10 tions to part D data claims that include part D data 

11 on Program-eligible beneficiaries assigned to or an 

12 election of an ESRD Fee-For-Service Integrated 

13 Care Model offered by an Organization unless a Pro14 gram-eligible beneficiary opts out of such data shar15 ing. 

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

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

18 implement and evaluate the demonstration program 

19 established under this section. 

20 ‘‘(d) IDENTIFICATION AND ASSIGNMENT OF PRO21 GRAM-ELIGIBLE BENEFICIARIES.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall estab23 lish a process for the initial and ongoing identifica24 tion of Program-eligible beneficiaries. 


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1 ‘‘(2) ASSIGNMENT OF PROGRAM-ELIGIBLE

2 BENEFICIARIES TO AN ORGANIZATION’S ESRD FEE3 FOR-SERVICE INTEGRATED CARE MODEL.— 

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

5 the Secretary shall assign all Program-eligible 

6 beneficiaries to an ESRD Fee-For-Service Inte7 grated Care Model offered by an Organization 

8 that includes the dialysis facility at which the 

9 Program-eligible beneficiary primarily receives 

10 renal dialysis services. 

11 ‘‘(B) OPT-OUT PERIOD AND CHANGES

12 UPON INITIAL ASSIGNMENT OR ELECTION.— 

13 The Secretary shall provide for a 90-day period 

14 beginning on the date on which the assignment 

15 of or election made by a Program-eligible bene16 ficiary into an ESRD Fee-For-Service Inte17 grated Care Model offered by an Organization 

18 becomes effective during which a Program-eligi19 ble beneficiary may— 

20 ‘‘(i) opt out of the Program; or 

21 ‘‘(ii) make a one-time change of as22 signment or election into an ESRD Fee23 For-Service Integrated Care Model offered 

24 by a different Organization. 


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1 ‘‘(C) DEEMED RE-ASSIGNMENT AND RE2 ELECTION.—The Secretary shall establish a 

3 process through which a Program-eligible bene4 ficiary assigned to or who elects an ESRD Fee5 For-Service Integrated Care Model offered by 

6 an Organization with respect to a year is 

7 deemed, unless the Program-eligible beneficiary 

8 otherwise changes such assignment or election 

9 under this paragraph, to have elected to con10 tinue such assignment or election with respect 

11 to the subsequent year. 

12 ‘‘(D) ANNUAL OPPORTUNITY TO OPT OUT

13 OR ELECT AN ESRD FEE-FOR-SERVICE INTE14 GRATED CARE MODEL OFFERED BY A DIF15 FERENT ORGANIZATION.— 

16 ‘‘(i) IN GENERAL.—Annually, a Pro17 gram-eligible beneficiary shall be given a 

18 90-day period to— 

19 ‘‘(I) opt out of the Program; or 

20 ‘‘(II) make a one-time change of 

21 assignment or election into an ESRD 

22 Fee-For-Service Integrated Care 

23 Model offered by a different Organiza24 tion. 


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1 ‘‘(ii) ALIGNMENT WITH MEDICARE AD2 VANTAGE OPEN ENROLLMENT PERIOD.— 

3 To the extent practicable, the Secretary 

4 shall align the annual 90-day period de5 scribed in clause (i) with the Medicare Ad6 vantage open enrollment period. 

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

8 DIAGNOSIS OR ENTERING HOME DIALYSIS

9 TREATMENT.—In addition to any other period 

10 during which a Program-eligible beneficiary 

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

12 Program, in the case of a Program-eligible ben13 eficiary who, after assignment under this para14 graph, is diagnosed with a principal diagnosis 

15 (as defined by the Secretary) other than end16 stage renal disease or enters into home dialysis 

17 treatment, such individual shall be given the op18 portunity to opt out of the Program during 

19 such period as specified by the Secretary. 

20 ‘‘(3) PROGRAM-ELIGIBLE BENEFICIARY NOTIFI21 CATION.— 

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

23 ensure that an Organization notifies Program24 eligible beneficiaries about the Program under 


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1 this section and provides them with materials 

2 explaining the Program, including— 

3 ‘‘(i) information about receiving bene4 fits under this title through such Organiza5 tion; and 

6 ‘‘(ii) an explanation that they retain 

7 the right to receive care from any Medicare 

8 provider. 

9 ‘‘(B) TIMING OF NOTIFICATION.—Upon as10 signment to or election of an ESRD Fee-For11 Service Integrated Care Model offered by an 

12 Organization, the Secretary shall provide the 

13 Organization written notification confirming the 

14 beneficiary’s assignment or election and not 

15 later than 15 business days after the date of re16 ceipt of such notification, the Organization shall 

17 provide written notice to the Program-eligible 

18 beneficiary of such assignment or election. 

19 ‘‘(C) CONTENT OF WRITTEN NOTICE.— 

20 Subject to subparagraph (D), such notification 

21 shall— 

22 ‘‘(i) inform Program-eligible bene23 ficiaries about the Program using an infor24 mation guide developed by the Organiza25 tion and approved by the Secretary; 


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1 ‘‘(ii) include the distribution of other 

2 Program materials developed by the Orga3 nization and approved by the Secretary; 

4 ‘‘(iii) inform Program-eligible bene5 ficiaries about the importance of transplan6 tation as the best outcome, as well as min7 imum requirements for transplant eligi8 bility before and during dialysis treatment; 

9 and 

10 ‘‘(iv) provide contact information for 

11 representatives of the Organization to re12 spond to Program-eligible beneficiaries’ 

13 questions. 

14 ‘‘(D) LIMITATION ON UNSOLICITED NOTI15 FICATION.— 

16 ‘‘(i) IN GENERAL.—Under the Pro17 gram, no person or entity (other than the 

18 Secretary, an employee of the Secretary, or 

19 an employee or volunteer of a federally au20 thorized State Health Insurance Assistance 

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

22 may provide any information about the 

23 Program, including information, materials, 

24 and assistance described in subparagraph 

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1 less such Program-eligible beneficiary re2 quests such information, materials, or as3 sistance. 

4 ‘‘(ii) EXCEPTION FOR PROVIDERS

5 TREATING BENEFICIARIES.—An eligible 

6 participating provider that is part of an 

7 Organization may provide information, ma8 terials, and assistance described in sub9 paragraph (B) to a Program-eligible bene10 ficiary, without prior request of such bene11 ficiary, if such beneficiary is receiving 

12 renal dialysis services from a facility that 

13 participates in such Organization. 

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

15 the case that an eligible participating pro16 vider that is part of an Organization par17 ticipates in notifying Program-eligible 

18 beneficiaries about the Program under this 

19 subparagraph, such notification shall be 

20 provided in the same manner to all Pro21 gram-eligible beneficiaries to which, pursu22 ant to clause (ii), such eligible partici23 pating provider may provide information, 

24 materials, and assistance described in such 

25 clause. 


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1 ‘‘(E) PROGRAM-ELIGIBLE BENEFICIARY

2 GRIEVANCE AND APPEAL RIGHTS.—Program-el3 igible beneficiaries participating in the Program 

4 under this section shall have grievance and ap5 peal rights and procedures consistent with those 

6 rights and procedures established under sub7 sections (f) and (g) of section 1852. 

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

9 PROGRAM MONTHLY PAYMENT AND CLAIMS PROCESSING

10 MECHANISM.— 

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

12 beneficiary receiving care through an Organization, 

13 the Secretary shall make a monthly prospective pay14 ment in accordance with payment rates that would 

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

16 ‘‘(2) APPLICATION OF HEALTH STATUS RISK

17 ADJUSTMENT METHODOLOGY.—The Secretary shall 

18 adjust the monthly prospective payment to an Orga19 nization under this subsection in the same manner 

20 in which the payment amount to a Medicare Advan21 tage plan is adjusted under section 1853(a)(1)(C). 

22 ‘‘(3) TREATMENT OF AND PAYMENT FOR KID23 NEY ACQUISITION COSTS.— 

24 ‘‘(A) EXCLUDING COSTS FOR KIDNEY AC25 QUISITIONS FROM MA BENCHMARK.—The SecVerDate Sep 11 2014 19:29 Sep 22, 2020 Jkt 099200 PO 00000 Frm 00045 Fmt 6652 Sfmt 6201 E:\BILLS\S4574.IS S4574

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1 retary shall adjust the payment amount to an 

2 Organization to exclude from such payment 

3 amount the Secretary’s estimate of the stand4 ardized costs for payments for organ acquisi5 tions for kidney transplants in the area involved 

6 for the year. 

7 ‘‘(B) FFS TREATMENT OF AND PAYMENT

8 FOR KIDNEY ACQUISITIONS.—An Organization 

9 shall provide all benefits described in subsection 

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

11 Payment for kidney acquisition costs covered 

12 under this title furnished to a Program-eligible 

13 beneficiary shall be made in accordance with 

14 this title and in such amounts as would other15 wise be made and determined for such items 

16 and services provided to such a beneficiary not 

17 participating in the Program under this section. 

18 ‘‘(4) TREATMENT OF AND PAYMENT FOR HOS19 PICE CARE.— 

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

21 this section shall require an Organization to in22 form each Program-eligible beneficiary who is 

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

24 Integrated Care Model offered by the Organiza25 tion about the availability of hospice care if— 


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1 ‘‘(i) a hospice program participating 

2 under this title is located within the Orga3 nization’s service area; or 

4 ‘‘(ii) it is common practice to refer pa5 tients to hospice programs outside such 

6 service area. 

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

8 beneficiary who is assigned to or elects an 

9 ESRD Fee-For-Service Integrated Care Model 

10 offered by an Organization with an agreement 

11 under this section makes an election under sec12 tion 1812(d)(1) to receive hospice care from a 

13 particular hospice program— 

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

15 the Program-eligible beneficiary shall be 

16 made by the Secretary to the hospice pro17 gram elected by the Program-eligible bene18 ficiary; 

19 ‘‘(ii) payment for other services for 

20 which the Program-eligible beneficiary in21 dividual is eligible notwithstanding the 

22 Program-eligible beneficiary’s election of 

23 hospice care under section 1812(d)(1), in24 cluding services not related to the Pro25 gram-eligible beneficiary’s terminal illness, 


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1 shall be made by the Secretary to the Or2 ganization or the provider or supplier of 

3 the service instead of the monthly prospec4 tive payment determined under subsection 

5 (f); and 

6 ‘‘(iii) the Secretary shall continue to 

7 make monthly payments to the Organiza8 tion in an amount equal to the value of 

9 benefits and services determined under 

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

11 ‘‘(5) APPLICATION OF CMI CLAIMS PROCESSING

12 FRAMEWORK.— 

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

14 the Secretary shall apply a claims processing 

15 framework based on those that the Center for 

16 Medicare and Medicaid Innovation applies 

17 under various direct contracting models under 

18 section 1115A such that— 

19 ‘‘(i) providers of services and suppliers 

20 serving Program-eligible beneficiaries con21 tinue to submit claims to a Medicare ad22 ministrative contractor; 

23 ‘‘(ii) the Secretary forwards claims to 

24 the Organization for payment; and 


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1 ‘‘(iii) the Organization pays providers 

2 of services and suppliers an amount equal 

3 to the amount that they would otherwise 

4 receive under the original Medicare Fee5 For-Service program plus any additional 

6 amount to which the provider may be eligi7 ble under subsection (b)(2)(A)(v) of this 

8 section. 

9 ‘‘(B) APPLICATION OF BALANCE BILLING

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

11 to payments made by an MA organization to a 

12 non-contract provider of services), section 

13 1852(k)(1) (relating to limitations on balance 

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

15 payments made by an MA organization to a 

16 non-contract supplier) shall apply to the Pro17 gram. 

18 ‘‘(C) PAYMENTS FOR GRADUATE MEDICAL

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

20 1886(h)(3)(D) (relating to payments for grad21 uate medical education) shall apply to Organi22 zations and providers of services under the Pro23 gram. 

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

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1 tegrity of the Medicare Advantage end-stage renal 

2 disease rate setting process and risk adjustment fac3 tors applied to Medicare Advantage end-stage renal 

4 disease rates, claims paid on behalf of Program-eligi5 ble beneficiaries shall not be included in neither the 

6 determination of such rates nor the development of 

7 such risk adjustment factors. 

8 ‘‘(7) AGREEMENT BETWEEN A STATE AND OR9 GANIZATION FOR MEDICAID BENEFITS.—In the case 

10 that a State and Organization enter into a mutual 

11 agreement under which the Organization coordinates 

12 benefits under title XIX for Program-eligible bene13 ficiaries eligible for benefits under this title and title 

14 XIX such mutual agreement shall specify the pay15 ment from the State for providing or arranging for 

16 the provision of such benefits. 

17 ‘‘(8) AFFIRMATION OF STATE OBLIGATIONS TO

18 PAY PREMIUM AND COST-SHARING AMOUNTS.—A 

19 State shall continue to make medical assistance 

20 under the State plan under title XIX available for 

21 the duration of the Program for Medicare cost-shar22 ing (as defined in section 1905(p)(3)) under this 

23 title for qualified Medicare beneficiaries described in 

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

25 Program-eligible beneficiaries assigned to or who 


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1 elect an Organization and entitled to medical assist2 ance for premiums and such cost-sharing under the 

3 State plan under title XIX in an amount equal to 

4 the amount of medical assistance that would be 

5 made available by such State if such Program-eligi6 ble beneficiaries were not participating in the Pro7 gram under this section. 

8 ‘‘(f) WAIVER AUTHORITY.— 

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

10 those requirements waived under section 1899 deter11 mined by the Secretary to be relevant and necessary 

12 for the operation of the Program under this section 

13 and may waive, as necessary, such additional re14 quirements that have been or may be waived based 

15 on authority established under section 1115A for 

16 purposes of models tested by the Centers for Medi17 care and Medicaid Innovation in order to carry out 

18 the Program under this section. 

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

20 months after the date of enactment of this section, 

21 the Secretary shall publish a notice of waivers that 

22 will apply in connection with the Program. The no23 tice shall include the specific conditions that an Or24 ganization must meet to qualify for each waiver, and 

25 commentary explaining the waiver requirements. 


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

2 the Medicare Payment Advisory Commission shall submit 

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

4 (b) RULES OF CONSTRUCTION.— 

5 (1) USE OF MEDICARE SUPPLEMENTAL POLICY

6 UNDER AN ESRD FEE-FOR-SERVICE INTEGRATED

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

8 amendments made by, this Act shall be construed to 

9 prevent a Program-eligible beneficiary assigned to, 

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

11 Care Model offered by an Organization with an 

12 agreement under this section from enrolling in or 

13 continuing enrollment in a Medicare supplemental 

14 policy available to such Program-eligible beneficiary 

15 or receiving benefits under such Medicare supple16 mental policy throughout the duration of the Pro17 gram-eligible beneficiary’s participation in an ESRD 

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

19 Organizations with an agreement under this section. 

20 (2) APPLICATION OF STATE RULES REGARDING

21 ISSUANCE OF MEDICARE SUPPLEMENTAL POLICIES

22 TO INDIVIDUAL UNDER AGE 65.—Nothing in the pro23 visions of, or amendments made by, this Act shall be 

24 construed to establish a Federal requirement on an 

25 issuer of a Medicare supplemental policy to offer 


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1 such Medicare supplemental policy to individuals 

2 under age 65. 

3 (3) CONTINUED AVAILABILITY OF MEDICARE

4 SUPPLEMENTAL POLICIES TO INDIVIDUALS UNDER

5 AGE 65.—Nothing in the provisions of, or amend6 ments made by, this Act shall be construed to affect 

7 a State’s authority to require an issuer of a Medi8 care supplemental policy to offer such Medicare sup9 plemental policy to individual. 

10 (c) GAO STUDY AND REPORT ON PAYMENT ADE11 QUACY FOR PEDIATRIC ESRD SERVICES.— 

12 (1) STUDY ON PAYMENT FOR PEDIATRIC ESRD

13 SERVICES.—The Comptroller General of the United 

14 States shall conduct a study to examine the accuracy 

15 of pediatric data reported to the Centers for Medi16 care & Medicaid Services as part of the ESRD pro17 spective payment system. The study shall evaluate 

18 whether the organizations described in section 

19 1866G of the Social Security Act, as added by sub20 section (a), and the existing prospective payment 

21 system accurately capture and reimburse costs of pe22 diatric dialysis care and include an analysis of the 

23 following factors that influence such costs: 

24 (A) Increased acuity of nursing care com25 pared to adult dialysis patients, especially for 


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1 smaller and younger pediatric hemodialysis pa2 tients. 

3 (B) Need for developmental and behavioral 

4 specialists, including child life specialists. 

5 (C) Need for more frequent assessment by 

6 pediatric dieticians to adjust formulas and diet 

7 for the specialized growth and nutrition require8 ments of children treated with dialysis. 

9 (D) Need for social workers, school liai10 sons, and other trained individuals designated 

11 to help families navigate challenging psycho12 social situations and to coordinate with schools 

13 to ensure school attendance and optimize school 

14 performance among pediatric dialysis patients. 

15 (E) Need for a broader array of dialysis 

16 supplies, including different-sized dialyzers, tub17 ing, and peritoneal fluid bags to accommodate 

18 care provided infants through young adults. 

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

20 the date of the enactment of this Act, the Comp21 troller General shall submit to Congress a report 

22 containing the results of the study conducted under 

23 paragraph (1), together with recommendations for 

24 such legislation and administrative action as the 

25 Comptroller General determines appropriate. 


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

2 RACE-BASED CORRECTION OF EGFR ON REFERRAL OF

3 ESRD PATIENTS FOR TRANSPLANT EVALUATION.— 

4 (1) STUDY ON IMPACT OF RACE-BASED COR5 RECTION OF EGFR ON REFERRAL OF ESRD PA6 TIENTS FOR TRANSPLANT EVALUATION.—The 

7 Comptroller General of the United States shall con8 duct a study to examine the impact of race-based 

9 correction of the estimated glomerular filtration rate 

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

11 referral of ESRD patients for transplant evaluation. 

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

13 the date of enactment of this Act, the Comptroller 

14 General shall submit to Congress a report containing 

15 the results of the study conducted under paragraph 

16 (1), together with recommendations for such legisla17 tion and administrative action as the Comptroller 

18 General determines appropriate. 

Æ 


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