[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 4574 Introduced in Senate (IS)]

<DOC>






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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Bringing Enhanced Treatments and 
Therapies to ESRD Recipients (BETTER) Kidney Care Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Although the relative rate of end-stage renal disease 
        (referred to in this section as ``ESRD'') among the Nation's 
        minority populations has declined, significant disparities 
        remain. Compared to Whites, Black Americans are 2.6 times more 
        likely to have kidney failure, while Native Americans and 
        Alaska Natives are 1.2 times more likely. Hispanics are 1.3 
        times more likely to have kidney failure compared to non-
        Hispanics.
            (2) Disparities also exist with respect to treatment 
        modalities. Specifically, although home dialysis can offer 
        advantages, Black, Hispanic, and Native American and Alaska 
        Native ESRD patients are less likely to initiate home treatment 
        than White ESRD patients.
            (3) Numerous studies show that individuals with low incomes 
        and in low-income communities are at greater risk for ESRD.
            (4) In addition to their kidney disease, ESRD patients 
        across all races and ethnicities often suffer from one or more 
        comorbidities. Eighty-eight percent of ESRD patients have a 
        history of hypertension, 42 percent have diabetes, and nearly 
        30 percent have congestive heart failure.
            (5) Each month, ESRD patients see multiple providers and 
        take several medications to manage their kidney disease and 
        comorbid conditions. Of all patients, those with ESRD stand to 
        benefit greatly from better coordinated care.
            (6) The Executive Order on Advancing American Kidney Health 
        recognizes the need to develop and implement new ESRD care 
        delivery models to improve quality and value for ESRD patients 
        and the Medicare program.
            (7) In alignment with that goal, it is imperative that 
        Medicare test new models that have at their core an 
        interdisciplinary care team, among other structural 
        requirements, to--
                    (A) help ESRD patients better navigate the health 
                care system;
                    (B) empower such patients to manage their plan of 
                care and medication regimen;
                    (C) support such patients in receiving the 
                treatment modality, including a kidney transplant, as 
                prescribed by their nephrologist;
                    (D) access services to meet the nonclinical needs 
                of such patients that can affect care outcomes; and
                    (E) receive additional services, such as transplant 
                evaluation, palliative care, evaluation for hospice 
                eligibility, and vascular access care.

SEC. 3. DEMONSTRATION PROGRAM TO PROVIDE INTEGRATED CARE FOR MEDICARE 
              BENEFICIARIES WITH END-STAGE RENAL DISEASE.

    (a) In General.--Title XVIII of the Social Security Act is amended 
by inserting after section 1866F the following new section:

    ``demonstration program to provide integrated care for medicare 
               beneficiaries with end-stage renal disease

    ``Sec. 1866G.  (a) Establishment.--
            ``(1) In general.--The Secretary shall conduct under this 
        section the ESRD Fee-For-Service Integrated Care Demonstration 
        Program (in this section referred to as the `Program'), which 
        is voluntary for Program-eligible beneficiaries and eligible 
        participating providers, to assess the effects of alternative 
        care delivery models and payment methodologies on patient care 
        improvements under this title for such beneficiaries. Under the 
        Program--
                    ``(A) Program-eligible beneficiaries shall be 
                considered original Medicare fee-for-service 
                beneficiaries (as defined in section 1899(h)(3)) for 
                the duration of the participation of such beneficiaries 
                under the Program;
                    ``(B) eligible participating providers may form an 
                ESRD Fee-For-Service Integrated Care Organization (in 
                this section referred to as an `Organization'); and
                    ``(C) an Organization shall integrate care under 
                the original Medicare fee-for-service program under 
                parts A and B for Program-eligible beneficiaries.
            ``(2) Definitions.--In this section:
                    ``(A) Eligible participating provider.--The term 
                `eligible participating provider' means any of the 
                following:
                            ``(i) A facility certified as a renal 
                        dialysis facility under this title.
                            ``(ii) An entity that owns one or more of 
                        such facilities described in clause (i).
                            ``(iii) A nephrologist (including a 
                        pediatric nephrologist) or nephrology practice.
                            ``(iv) Any other physician or physician 
                        group practice.
                            ``(v) A nurse practitioner, physician 
                        assistant, or clinical nurse specialist (as 
                        such terms are defined in section 1861(aa)(5)) 
                        or a clinical social worker (as defined in 
                        section 1861(hh)(1)) working in conjunction 
                        with such a nurse practitioner, physician 
                        assistant, or clinical nurse specialist.
                    ``(B) Eligible participating partner.--The term 
                `eligible participating partner' means, with respect to 
                an Organization, any of the following:
                            ``(i) A Medicare Advantage plan described 
                        in section 1851(a)(2) or a Medicare Advantage 
                        organization offering such a plan.
                            ``(ii) A medicaid managed care organization 
                        (as defined in section 1903(m)).
                            ``(iii) A hospital or an academic medical 
                        center experienced in the care of patients 
                        receiving dialysis.
                            ``(iv) Any other entity determined 
                        appropriate by the Secretary.
                    ``(C) Program-eligible beneficiary.--
                            ``(i) In general.--The term `Program-
                        eligible beneficiary' means, with respect to an 
                        Organization offering an ESRD Fee-For-Service 
                        Integrated Care Model, an individual entitled 
                        to benefits under part A and enrolled under 
                        part B (including such an individual entitled 
                        to medical assistance under a State plan under 
                        title XIX) who--
                                    ``(I) is identified by the 
                                Secretary as having end-stage renal 
                                disease and who is receiving renal 
                                dialysis services under the original 
                                Medicare fee-for-service program under 
                                parts A and B, and is not enrolled in a 
                                Medicare Advantage plan under part C or 
                                group health insurance coverage or 
                                individual health insurance coverage 
                                (as defined in section 2791(b) of the 
                                Public Health Service Act (42 U.S.C. 
                                300gg-91(b))) that is primary to 
                                coverage under this title;
                                    ``(II) receives renal dialysis 
                                services primarily from an eligible 
                                participating provider of such 
                                Organization, including such renal 
                                dialysis services received after being 
                                identified as a suitable candidate for 
                                transplantation; and
                                    ``(III) has attained the age of 18 
                                years.
                            ``(ii) Affirmation of program eligibility 
                        upon hospice election or kidney transplant.--A 
                        Program-eligible beneficiary who was assigned 
                        to or elected an ESRD Fee-For-Service 
                        Integrated Care Model offered by an 
                        Organization and who--
                                    ``(I) elects to receive hospice 
                                benefits under section 1852(d)(1); or
                                    ``(II) receives a kidney transplant 
                                as covered under this title and 
                                maintains entitlement to benefits under 
                                part A and enrollment in part B on the 
                                basis of end-stage renal disease,
                        shall continue to meet the definition of 
                        Program-eligible beneficiary established under 
                        this subparagraph.
    ``(b) ESRD Fee-for-Service Integrated Care Organization Eligibility 
Requirements.--
            ``(1) Organizations.--
                    ``(A) In general.--One or more eligible 
                participating providers may establish an Organization 
                and may enter into, subject to subparagraph (B), one or 
                more partnership, ownership, or co-ownership agreements 
                with one or more eligible participating partners to 
                establish an Organization or to offer one or more ESRD 
                Fee-for-Service Integrated Care Models in accordance 
                with paragraph (2).
                    ``(B) Limitation on number of agreements.--The 
                Secretary may specify a limitation on the number of 
                Organizations in which an eligible participating 
                partner may participate for purposes of offering one or 
                more ESRD Fee-for-Service Integrated Care Models under 
                partnership, ownership, or co-ownership agreements 
                described in subparagraph (A).
                    ``(C) Minimum program eligible beneficiary 
                participation requirement.--
                            ``(i) In general.--Subject to clause (ii), 
                        the Secretary may not enter into or continue an 
                        agreement with an Organization unless the 
                        Organization has at least 350 Program-eligible 
                        beneficiaries, or at least 60 percent of 
                        Program-eligible beneficiaries receiving care 
                        from the Organization's facilities, who are 
                        assigned to or elect an ESRD Fee-For-Service 
                        Integrated Model offered by the Organization 
                        and who continue their assignment to or 
                        election of the Organization.
                            ``(ii) Allowing transition.--The Secretary 
                        may waive the requirement under clause (i) for 
                        an Organization during the first agreement year 
                        with respect to the Organization.
                    ``(D) Fiscal soundness requirements.--
                            ``(i) In general.--The Secretary shall 
                        enter into appropriate agreements under this 
                        section only with Organizations that 
                        demonstrate sufficient capital reserves, 
                        measured as a percentage of monthly prospective 
                        payments described in subsection (e) and 
                        consistent with capital reserve requirements 
                        established by each State in which the 
                        Organization operates, subject to clause (ii).
                            ``(ii) Alternative mechanism to demonstrate 
                        risk-bearing capacity.--An Organization shall 
                        be considered to meet the requirement in clause 
                        (i) if the Organization includes at least one 
                        eligible participating provider or eligible 
                        participating partner that--
                                    ``(I)(aa) is licensed under State 
                                law as a risk-bearing entity eligible 
                                to offer health insurance or health 
                                benefits coverage in each State in 
                                which the Organization participates in 
                                the demonstration under this section; 
                                or
                                    ``(bb) is otherwise authorized by 
                                each State in which the Organization 
                                participates in the demonstration under 
                                this section to bear risk for offering 
                                health insurance or health benefits;
                                    ``(II) agrees to bear risk under 
                                the Organization; and
                                    ``(III) has the capacity to bear 
                                risk commensurate with the 
                                Organization's expected expenditures 
                                under an agreement under this section.
                            ``(iii) Disclosure.--Each Organization with 
                        an agreement under this section shall, in 
                        accordance with current regulations of the 
                        Secretary that govern similar disclosures, 
                        report to the Secretary financial information 
                        consistent with such information required to be 
                        reported by a Medicare Advantage organization 
                        under part C to demonstrate that the 
                        Organization has a fiscally sound operation.
                    ``(E) Governance requirements.--Each Organization 
                with an agreement under this section shall establish a 
                governing body with oversight responsibility for the 
                Organization's compliance with Program requirements 
                that includes--
                            ``(i) representation from each eligible 
                        participating provider of such Organization;
                            ``(ii) at least two nephrologists, one of 
                        which may be affiliated with an eligible 
                        participating provider; and
                            ``(iii) at least one beneficiary advocate.
            ``(2) ESRD fee-for-service integrated care model.--
                    ``(A) Benefit requirements.--
                            ``(i) In general.--Subject to clause (iii), 
                        an Organization shall offer an ESRD Fee-For-
                        Service Integrated Care Model that shall--
                                    ``(I) cover all benefits under 
                                parts A and B (subject to payment rules 
                                regarding the treatment of and payment 
                                for kidney organ acquisitions and 
                                hospice described in subsections (e)(3) 
                                and (4)); and
                                    ``(II) include services for 
                                transition (particularly including 
                                education) into transplantation, 
                                palliative care, and hospice.
                            ``(ii) Determination and treatment of 
                        savings.--
                                    ``(I) In general.--The Secretary 
                                shall require any Organization offering 
                                an ESRD Fee-For-Service Integrated Care 
                                Model to provide for the return under 
                                subclause (VI) to a Program-eligible 
                                beneficiary assigned to or who elects 
                                an Organization savings equal to the 
                                amount, if any, by which the payment 
                                amount described in subclause (V) with 
                                respect to the Program-eligible 
                                beneficiary for a year exceeds the 
                                average revenue amount described in 
                                subclause (IV) with respect to the 
                                Program-eligible beneficiary for the 
                                year.
                                    ``(II) Savings determination 
                                process.--The Secretary shall determine 
                                the savings described in subclause (I) 
                                in the same manner as the rebate 
                                calculation for individuals with end-
                                stage renal disease enrolled in 
                                Medicare Advantage organizations under 
                                section 1859(b)(6)(B)(iii).
                                    ``(III) Application of medical loss 
                                ratio requirements.--Nothing shall 
                                preclude the Secretary from applying 
                                medical loss ratio requirements 
                                described in section 1857(e)(4) under 
                                this section.
                                    ``(IV) Average revenue amount 
                                described.--The revenue amount 
                                described in this subclause, with 
                                respect to an Organization offering an 
                                ESRD Fee-For-Service Integrated Care 
                                Model and a Program-eligible 
                                beneficiary assigned to or who elects 
                                such Organization, is the 
                                Organization's estimated average 
                                revenue requirements, including 
                                administrative costs and return on 
                                investment, for the Organization to 
                                provide the benefits described in 
                                clause (i) under the Model for the 
                                Program-eligible beneficiary for the 
                                year.
                                    ``(V) Payment amount described.--
                                The payment amount described in this 
                                subclause, with respect to an 
                                Organization offering an ESRD Fee-For-
                                Service Integrated Care Model and a 
                                Program-eligible beneficiary assigned 
                                to or who elects such Organization, is 
                                the payment amount to the Organization 
                                under subsection (e)(1) (adjusted 
                                pursuant to subsection (e)(2) and 
                                subject to the treatment of payments 
                                for kidney acquisitions and hospice 
                                care described in paragraphs (3) and 
                                (4) of subsection (e), respectively) 
                                made with respect to the Program-
                                eligible beneficiary for the year.
                                    ``(VI) Returning savings to 
                                program-eligible beneficiaries.--An 
                                Organization shall, in a manner 
                                specified by the Secretary and 
                                consistent with returning Medicare 
                                Advantage rebates to individuals under 
                                part C, return the amount under 
                                subclause (I) to a Program-eligible 
                                beneficiary through offering benefits 
                                not covered under the original Medicare 
                                Fee-For-Service program consistent with 
                                the types of benefits, including non-
                                health related benefits, that Medicare 
                                Advantage organizations may offer.
                            ``(iii) Benefit requirements for dual 
                        eligibles.--In the case of a Program-eligible 
                        beneficiary who is entitled to medical 
                        assistance under a State plan under title XIX, 
                        an Organization, in accordance with a mutual 
                        agreement entered into between the State and 
                        Organization under subsection (e)(7)--
                                    ``(I) shall provide, or arrange for 
                                the provision of, all benefits (other 
                                than long-term services and supports) 
                                for which the Program-eligible 
                                beneficiary is entitled to under a 
                                State plan under title XIX; and
                                    ``(II) may elect to provide, or 
                                arrange for the provision of, long-term 
                                services and supports for which the 
                                Program-eligible beneficiary is 
                                entitled under a State plan under title 
                                XIX, including services related to the 
                                transition into palliative care or 
                                hospice.
                            ``(iv) Application of medicare ffs provider 
                        choice and cost-sharing requirements.--Under an 
                        ESRD Fee-For-Service Integrated Care Model 
                        offered by an Organization, the Organization 
                        shall--
                                    ``(I) allow Program-eligible 
                                beneficiaries to receive benefits as 
                                described in subsection (b)(2)(A)(i)(I) 
                                from any provider of services or 
                                supplier enrolled under this title and 
                                who otherwise meets all applicable 
                                requirements under this title; and
                                    ``(II) not apply any cost-sharing 
                                requirements for benefits described in 
                                subsection (b)(2)(A)(i)(I) in addition 
                                to premium and cost-sharing 
                                requirements, respectively, that would 
                                be applicable under part A or part B 
                                for such benefits.
                            ``(v) Promoting access to high-quality 
                        providers.--An Organization offering an ESRD 
                        Fee-For-Service Integrated Care Model shall 
                        develop and implement performance-based 
                        incentives, including financial incentives 
                        funded through payments made to an Organization 
                        under subsection (e), for providers of services 
                        and suppliers to promote delivery of high 
                        quality and efficient care. Such incentives 
                        shall comply with section 1852(j)(4) and 
                        section 422.208 of title 42, Code of Federal 
                        regulations (as in effect on the date of 
                        enactment of this section) and be based on 
                        clinical measures or non-clinical measures, 
                        such as with respect to notification of patient 
                        discharge from a hospital, patient education 
                        (such as with respect to treatment options, 
                        including disease maintenance, and nutrition), 
                        rates of completion of patient education 
                        categorized by race, rates of completion of 
                        transplant evaluation for patients who are 
                        clinically eligible for transplant, rates of 
                        completion of transplant evaluation categorized 
                        by race, and the interoperability of electronic 
                        health records developed by an Organization 
                        according to requirements and standards 
                        specified by the Secretary pursuant to 
                        subparagraph (B).
                    ``(B) Quality and reporting requirements.--
                            ``(i) Clinical measures.--Under the 
                        Program, the Secretary shall--
                                    ``(I) require each participating 
                                Organization to submit to the Secretary 
                                data on clinical measures developed 
                                using, as a reference, measures 
                                submitted by organizations 
                                participating in the Comprehensive ESRD 
                                Care Initiative operated by the Center 
                                for Medicare and Medicaid Innovation to 
                                assess the quality of care provided;
                                    ``(II) establish requirements for 
                                participating Organizations to submit 
                                to the Secretary, in a form and manner 
                                specified by the Secretary, information 
                                on such measures; and
                                    ``(III) establish standards for 
                                making information on quality under the 
                                Program established under this section 
                                as assessed using clinical measures 
                                described in subclause (I) available to 
                                the public.
                        As part of the standards described in subclause 
                        (III) the Secretary shall, in consultation with 
                        relevant stakeholders, develop standards that 
                        would establish a minimum threshold for the 
                        volume of individual patients to be listed for 
                        transplant in an Organ Procurement and 
                        Transplant Network under contract with the 
                        Secretary and that would measure the number of 
                        individuals that an Organization moved on to, 
                        kept on, or removed from the transplant list 
                        and the number of individuals that receive a 
                        transplant after participating in the 
                        Organization. The number of Program-eligible 
                        beneficiaries assigned to an Organization on 
                        the transplant list that have not opted out at 
                        the time of the agreement between the Secretary 
                        and an Organization shall be noted as part of 
                        such agreement. Organizations shall submit such 
                        measures as a condition of payment and Program-
                        eligible beneficiary assignment under this 
                        subsection.
                            ``(ii) Requirement for stakeholder input.--
                        In developing measures and requirements under 
                        subclauses (I) and (II) of clause (i), the 
                        Secretary shall request and consider input from 
                        a stakeholder board that includes at least one 
                        nephrologist, a pediatric nephrologist, other 
                        suppliers and providers of services as 
                        determined appropriate by the Secretary, renal 
                        dialysis facilities, beneficiary advocates, a 
                        health equity expert, a mental health provider, 
                        a transplant surgeon, and Medicare-approved 
                        transplant programs. Section 14 of the Federal 
                        Advisory Committee Act shall not apply to the 
                        stakeholder board.
                            ``(iii) Additional assessments and 
                        reporting requirements.--The Secretary shall 
                        assess the extent to which an Organization 
                        offers integrated and patient-centered care 
                        through analysis of information obtained from 
                        Program-eligible beneficiaries assigned to or 
                        who elect the Organization through surveys, 
                        such as the In-Center Hemodialysis Consumer 
                        Assessment of Healthcare Providers and Systems.
                            ``(iv) No effect on other renal dialysis 
                        facility quality requirements.--Nothing in this 
                        section shall be construed as affecting the 
                        requirements established under section 1881(h).
                    ``(C) Requirements for esrd fee-for-service 
                integrated care strategy.--
                            ``(i) In general.--An Organization seeking 
                        a contract under this section to offer one or 
                        more ESRD Fee-For-Service Integrated Care 
                        Models shall develop and submit for the 
                        Secretary's approval as part of the application 
                        of the Organization to participate in the 
                        Program under this section, subject to clauses 
                        (ii) and (iii), an ESRD Fee-For-Service 
                        Integrated Care Strategy.
                            ``(ii) ESRD fee-for-service integrated care 
                        strategy.--In assessing an ESRD Fee-For-Service 
                        Integrated Care Strategy under clause (i), the 
                        Secretary shall consider the extent to which 
                        the Strategy includes elements such as the 
                        following:
                                    ``(I) Use of interdisciplinary care 
                                teams led by at least one nephrologist, 
                                and comprised of registered nurses, 
                                social workers, renal dialysis facility 
                                managers, and as appropriate other 
                                representatives from alternative 
                                settings described in subclause (VIII).
                                    ``(II) Use of a decision process 
                                for care plans and care management that 
                                includes the nephrologist, a member of 
                                the transplant evaluation team, and 
                                other practitioners responsible for 
                                direct delivery of care to Program-
                                eligible beneficiaries assigned to or 
                                who elect the Organization involved.
                                    ``(III) Use of health risk and 
                                other assessments to determine the 
                                physical, psychosocial, nutrition, 
                                language, cultural, and other needs of 
                                Program-eligible beneficiaries assigned 
                                to or who elect the Organization 
                                involved.
                                    ``(IV) Development and at least 
                                annual updating of individualized care 
                                plans that incorporate at least the 
                                medical, social, and functional needs, 
                                preferences, and care goals of Program-
                                eligible beneficiaries assigned to or 
                                who elect the Organization, including a 
                                discussion on reconsideration of the 
                                method and location of dialysis.
                                    ``(V) Coordination and furnishing 
                                of non-clinical coordination benefits, 
                                such as transportation, aimed at 
                                improving the adherence of Program-
                                eligible beneficiaries assigned to or 
                                who elect the Organization with care 
                                recommendations.
                                    ``(VI) As appropriate, coordination 
                                services, such as transplant 
                                evaluation, palliative care, evaluation 
                                for hospice eligibility, and vascular 
                                access care.
                                    ``(VII) In the case of an 
                                individual who, during an assignment 
                                to, or an election of an ESRD Fee-For-
                                Service Integrated Care model offered 
                                by an Organization, receives 
                                confirmation that a kidney transplant 
                                is imminent, the provision of 
                                counseling services by an 
                                interdisciplinary care team described 
                                in subclause (I) to such individual on 
                                preparation for and potential benefits 
                                and risks associated with such 
                                transplant.
                                    ``(VIII) Delivery of benefits and 
                                services in settings alternative to 
                                traditional clinical settings, such as 
                                the home of the Program-eligible 
                                beneficiary.
                                    ``(IX) Use of patient reminder 
                                systems.
                                    ``(X) Education programs for 
                                patients, families, and caregivers.
                                    ``(XI) Use of health care advice 
                                resources, such as nurse advice lines.
                                    ``(XII) Use of team-based health 
                                care delivery models that provide 
                                comprehensive and continuous medical 
                                care, such as medical homes.
                                    ``(XIII) Co-location of providers 
                                and services.
                                    ``(XIV) Use of a demonstrated 
                                capacity to share electronic health 
                                record information across sites of 
                                care.
                                    ``(XV) Use of programs to promote 
                                better adherence to recommended 
                                treatment regimens, including 
                                prescription drug, by individuals, 
                                including by addressing barriers to 
                                access to care by such individuals, 
                                including strategies to coordinate any 
                                prescription drug benefits under any 
                                prescription drug plan under part D in 
                                which a Program-eligible beneficiary is 
                                enrolled.
                                    ``(XVI) Use of defined protocols, 
                                developed in conjunction with the 
                                pediatric nephrology community, to 
                                facilitate the transition of pediatric 
                                individuals into adult end-stage renal 
                                disease care.
                                    ``(XVII) Use of health equity 
                                experts to implement programs and 
                                protocols which seek to decrease 
                                gender, racial, ethnic, and language 
                                inequities.
                                    ``(XVIII) Other services, 
                                strategies, and approaches identified 
                                by the Organization to improve care 
                                coordination and delivery.
            ``(3) Beneficiary protections.--
                    ``(A) Seamless access to care.--The Secretary shall 
                ensure that the Organization establishes processes and 
                takes steps necessary, including educating relevant 
                providers of services and suppliers about the Program, 
                to ensure that Program-eligible beneficiaries assigned 
                to or who elected an ESRD Fee-For-Service Integrated 
                Care Model offered by an Organization do not experience 
                any disruption in access to providers of services and 
                suppliers furnishing benefits under this title due to 
                such assignment or election. Assignment to or an 
                election of an ESRD Fee-For-Service Integrated Care 
                Model offered by an Organization shall not be construed 
                as affecting a Program-eligible beneficiary's ability 
                to receive benefits described in subsection 
                (b)(2)(A)(i)(I) from any provider of services or 
                suppliers enrolled and who otherwise meets requirements 
                under this title, as described in subsection 
                (b)(2)(A)(iv).
                    ``(B) Anti-discrimination.--Each agreement between 
                the Secretary and an Organization under this section 
                shall--
                            ``(i) provide that each eligible 
                        participating provider of such Organization may 
                        not deny, limit, or condition the furnishing of 
                        services, or affect the quality of services 
                        furnished, under this title to Program-eligible 
                        beneficiaries on whether or not such a 
                        beneficiary is assigned to or elects the 
                        Organization; and
                            ``(ii) prohibit the Organization from 
                        engaging in any activity that could reasonably 
                        be expected to have the effect of denying or 
                        discouraging assignment to or an election of an 
                        ESRD Fee-For-Service Integrated Care Model 
                        offered by an Organization by a Program-
                        eligible beneficiary whose medical condition or 
                        history indicates a need for substantial future 
                        medical services.
                    ``(C) Quality assurance; patient safeguards.--Each 
                agreement between the Secretary and an Organization 
                under this section shall require that such Organization 
                have in effect at a minimum--
                            ``(i) a written plan of quality assurance 
                        and improvement, and procedures implementing 
                        such plan, in accordance with regulations; and
                            ``(ii) written safeguards of the rights of 
                        Program-eligible beneficiaries assigned to or 
                        who elect the Organization (including a patient 
                        bill of rights and procedures for grievances 
                        and appeals) in accordance with regulations and 
                        with other requirements of this title and 
                        applicable Federal and State laws designed to 
                        protect Program-eligible beneficiaries 
                        (including those who are entitled to medical 
                        assistance under a State plan under title XIX).
                    ``(D) Oversight.--The Secretary shall develop and 
                implement an oversight program to monitor an 
                Organization's compliance with Program requirements 
                under an agreement under this section.
            ``(4) Treatment as alternative payment model and eligible 
        alternative payment entity.--
                    ``(A) Treatment of program.--The ESRD Fee-for-
                Service Integrated Care Demonstration Program 
                established under this section shall meet the 
                definition of an alternative payment model described in 
                section 1833(z)(3)(C)(iv).
                    ``(B) Treatment of organization.--An Organization 
                offering one or more ESRD Fee-for-Service Integrated 
                Care Models shall be treated under this section as an 
                eligible alternative payment entity as described in 
                clauses (i) and (ii)(I) of section 1833(z)(3)(D).
    ``(c) Program Operation and Scope.--
            ``(1) In general.--The Secretary shall develop a process 
        such that an Organization can apply to offer one or more ESRD 
        Fee-For-Service Integrated Care Models. Such application shall 
        include information on at least the following:
                    ``(A) The estimated average revenue amount 
                described in subsection (b)(2)(A)(ii)(II) for the 
                Organization to cover benefits described in subsection 
                (b)(2)(A)(i)(I).
                    ``(B) Any benefits offered by the Organization 
                beyond those described in such subsection.
                    ``(C) A description of the Organization's ESRD Fee-
                For-Service integrated care strategy specified in 
                subsection (b)(2)(D), including a detailed explanation 
                of the Organization's approach to fulfill the 
                requirement to coordinate the delivery of 
                multidisciplinary health and social services that, 
                pursuant to a mutual agreement between a State and 
                Organization, integrates acute and long-term care 
                services and supports.
            ``(2) Program initiation.--The Secretary shall initiate the 
        Program such that Organizations begin serving Program-eligible 
        beneficiaries not later than January 1, 2024.
            ``(3) Initial agreement period.--The Secretary shall enter 
        into agreements for an initial period of not less than 5 years 
        with all Organizations that meet all Program requirements 
        established under this section, as determined by the Secretary 
        through the application process described in paragraph (1).
            ``(4) Allowance for service area expansions.--During each 
        year of the Program's operation, the Secretary shall allow an 
        Organization with an agreement under this section to expand its 
        service area during the initial agreement period upon the 
        Secretary's determination, through the application process 
        described in paragraph (1), that the Organization meets all 
        Program requirements established under this section.
            ``(5) Contract suspension and termination process.--
                    ``(A) In general.--Subject to subparagraph (B)(ii), 
                the Secretary may suspend assignment to or an election 
                of an ESRD Fee-For-Service Integrated Care Model 
                offered by an Organization if the Organization fails to 
                comply with any Program requirements specified in an 
                agreement under this section. An Organization also 
                shall be considered not in compliance if, for any 
                calendar month during an agreement year, more than 50 
                percent of the total number of Program-eligible 
                beneficiaries assigned to or who elect an ESRD Fee-For-
                Service Integrated Care Model offered by the 
                Organization opt out of the Program.
                    ``(B) Opportunity for corrective action plan and 
                appeal.--
                            ``(i) In general.--Prior to suspending 
                        assignment to or an election of an ESRD Fee-
                        For-Service Integrated Care Model offered by an 
                        Organization or terminating an agreement under 
                        this section, the Secretary shall afford an 
                        Organization sufficient opportunity to remedy 
                        any deficiencies in complying with any Program 
                        requirements under this section by implementing 
                        a corrective action plan. Any corrective action 
                        plan implemented under this subparagraph shall 
                        specify a date by which the Organization shall 
                        resolve such deficiencies and shall remain in 
                        effect until such time that the Secretary 
                        confirms that the Organization has achieved 
                        compliance.
                            ``(ii) Imposition of agreement suspension 
                        or termination.--In the case of an Organization 
                        that fails to achieve compliance by the date 
                        specified in corrective action plan, subject to 
                        clause (iii) and depending on the severity of a 
                        compliance deficiency, the Secretary in a 
                        manner consistent with processes established 
                        under part C of this title may--
                                    ``(I) suspend Program-eligible 
                                beneficiaries' assignments to or an 
                                election of an ESRD Fee-For-Service 
                                Integrated Care Model offered by an 
                                Organization; or
                                    ``(II) terminate an agreement with 
                                an Organization under this section.
                            ``(iii) Immediate agreement termination for 
                        violating the prohibition on discrimination.--
                        Notwithstanding the corrective action plan 
                        process established under clause (i), the 
                        Secretary may, in addition to the circumstances 
                        under which a contract under part C may be 
                        immediately terminated, immediately terminate 
                        an agreement under this section with an 
                        Organization if the Secretary--
                                    ``(I) notifies the Organization of 
                                the intent to investigate allegations 
                                of systematic activities with the 
                                intent of violating the prohibition on 
                                discrimination established under 
                                subsection (b)(3)(B)(ii);
                                    ``(II) determines, after conducting 
                                a rigorous analysis of all available 
                                data based on a sufficient sample size, 
                                that the Organization engaged in 
                                systematic activities with the intent 
                                of violating the prohibition on 
                                discrimination established in 
                                subsection (b)(3)(B)(ii); and
                                    ``(III) discloses credible evidence 
                                to the Organization regarding a 
                                determination made under subclause 
                                (II).
                            ``(iv) Recovery of monthly prospective 
                        payments.--The Secretary may recover the 
                        prorated share of any monthly prospective 
                        payments described in subsection (e) covering 
                        the period of the month following an agreement 
                        termination if such agreement termination is 
                        effective in the middle of a calendar month.
                            ``(v) Notification of program-eligible 
                        beneficiary upon agreement termination.--Each 
                        agreement under this section between the 
                        Secretary and an Organization shall require the 
                        Organization to provide and pay for written 
                        notice in advance of an agreement's 
                        termination, as well as a description of 
                        alternatives for obtaining benefits under this 
                        title, in a manner consistent with beneficiary 
                        notification requirements in the event of a 
                        contract termination under part C.
            ``(6) Program evaluation.--The Secretary shall conduct an 
        evaluation of the Program under this section to inform a 
        determination regarding a Program expansion under paragraph 
        (7). Such evaluation shall include an analysis of--
                    ``(A) the quality of care furnished under the 
                Program, including the measurement of patient-level 
                outcomes and patient experience and patient-reported 
                outcome measures determined appropriate by the 
                Secretary; and
                    ``(B) the changes in spending under parts A and B 
                by reason of the Program.
            ``(7) Program expansion.--
                    ``(A) In general.--The Secretary may, through 
                rulemaking, expand the duration and scope of the 
                Program under this section, to the extent determined 
                appropriate by the Secretary, if--
                            ``(i) the Secretary determines that such 
                        expansion is expected to--
                                    ``(I) reduce spending under this 
                                title without reducing the quality of 
                                patient care; or
                                    ``(II) improve the quality of 
                                patient care without increasing 
                                spending under this title;
                            ``(ii) the Chief Actuary of the Centers for 
                        Medicare & Medicaid Services certifies that 
                        such expansion would reduce (or would not 
                        result in any increase in) net program spending 
                        under this title; and
                            ``(iii) the Secretary determines that such 
                        expansion would not deny or limit the coverage 
                        or provision of benefits under this title for 
                        applicable individuals.
                    ``(B) Ensuring program continuity.--The Secretary 
                shall implement any Program expansion made in 
                accordance with this paragraph in a manner that ensures 
                that Program-eligible beneficiaries and Organizations 
                with an agreement under this section do not experience 
                any disruptions in the Program.
            ``(8) Part d data sharing arrangement.--The Secretary on a 
        monthly basis shall, in accordance with the regulations 
        promulgated under section 264(c) of the Health Insurance 
        Portability and Accountability Act of 1996, provide access to 
        Organizations to part D data claims that include part D data on 
        Program-eligible beneficiaries assigned to or an election of an 
        ESRD Fee-For-Service Integrated Care Model offered by an 
        Organization unless a Program-eligible beneficiary opts out of 
        such data sharing.
            ``(9) Funding.--The Secretary shall allocate funds made 
        available under section 1115A(f)(1) to implement and evaluate 
        the demonstration program established under this section.
    ``(d) Identification and Assignment of Program-Eligible 
Beneficiaries.--
            ``(1) In general.--The Secretary shall establish a process 
        for the initial and ongoing identification of Program-eligible 
        beneficiaries.
            ``(2) Assignment of program-eligible beneficiaries to an 
        organization's esrd fee-for-service integrated care model.--
                    ``(A) In general.--Under the Program, the Secretary 
                shall assign all Program-eligible beneficiaries to an 
                ESRD Fee-For-Service Integrated Care Model offered by 
                an Organization that includes the dialysis facility at 
                which the Program-eligible beneficiary primarily 
                receives renal dialysis services.
                    ``(B) Opt-out period and changes upon initial 
                assignment or election.--The Secretary shall provide 
                for a 90-day period beginning on the date on which the 
                assignment of or election made by a Program-eligible 
                beneficiary into an ESRD Fee-For-Service Integrated 
                Care Model offered by an Organization becomes effective 
                during which a Program-eligible beneficiary may--
                            ``(i) opt out of the Program; or
                            ``(ii) make a one-time change of assignment 
                        or election into an ESRD Fee-For-Service 
                        Integrated Care Model offered by a different 
                        Organization.
                    ``(C) Deemed re-assignment and re-election.--The 
                Secretary shall establish a process through which a 
                Program-eligible beneficiary assigned to or who elects 
                an ESRD Fee-For-Service Integrated Care Model offered 
                by an Organization with respect to a year is deemed, 
                unless the Program-eligible beneficiary otherwise 
                changes such assignment or election under this 
                paragraph, to have elected to continue such assignment 
                or election with respect to the subsequent year.
                    ``(D) Annual opportunity to opt out or elect an 
                esrd fee-for-service integrated care model offered by a 
                different organization.--
                            ``(i) In general.--Annually, a Program-
                        eligible beneficiary shall be given a 90-day 
                        period to--
                                    ``(I) opt out of the Program; or
                                    ``(II) make a one-time change of 
                                assignment or election into an ESRD 
                                Fee-For-Service Integrated Care Model 
                                offered by a different Organization.
                            ``(ii) Alignment with medicare advantage 
                        open enrollment period.--To the extent 
                        practicable, the Secretary shall align the 
                        annual 90-day period described in clause (i) 
                        with the Medicare Advantage open enrollment 
                        period.
                    ``(E) Opt out for change in principal diagnosis or 
                entering home dialysis treatment.--In addition to any 
                other period during which a Program-eligible 
                beneficiary may, pursuant to this paragraph, opt out of 
                the Program, in the case of a Program-eligible 
                beneficiary who, after assignment under this paragraph, 
                is diagnosed with a principal diagnosis (as defined by 
                the Secretary) other than end-stage renal disease or 
                enters into home dialysis treatment, such individual 
                shall be given the opportunity to opt out of the 
                Program during such period as specified by the 
                Secretary.
            ``(3) Program-eligible beneficiary notification.--
                    ``(A) In general.--The Secretary shall ensure that 
                an Organization notifies Program-eligible beneficiaries 
                about the Program under this section and provides them 
                with materials explaining the Program, including--
                            ``(i) information about receiving benefits 
                        under this title through such Organization; and
                            ``(ii) an explanation that they retain the 
                        right to receive care from any Medicare 
                        provider.
                    ``(B) Timing of notification.--Upon assignment to 
                or election of an ESRD Fee-For-Service Integrated Care 
                Model offered by an Organization, the Secretary shall 
                provide the Organization written notification 
                confirming the beneficiary's assignment or election and 
                not later than 15 business days after the date of 
                receipt of such notification, the Organization shall 
                provide written notice to the Program-eligible 
                beneficiary of such assignment or election.
                    ``(C) Content of written notice.--Subject to 
                subparagraph (D), such notification shall--
                            ``(i) inform Program-eligible beneficiaries 
                        about the Program using an information guide 
                        developed by the Organization and approved by 
                        the Secretary;
                            ``(ii) include the distribution of other 
                        Program materials developed by the Organization 
                        and approved by the Secretary;
                            ``(iii) inform Program-eligible 
                        beneficiaries about the importance of 
                        transplantation as the best outcome, as well as 
                        minimum requirements for transplant eligibility 
                        before and during dialysis treatment; and
                            ``(iv) provide contact information for 
                        representatives of the Organization to respond 
                        to Program-eligible beneficiaries' questions.
                    ``(D) Limitation on unsolicited notification.--
                            ``(i) In general.--Under the Program, no 
                        person or entity (other than the Secretary, an 
                        employee of the Secretary, or an employee or 
                        volunteer of a federally authorized State 
                        Health Insurance Assistance Program (SHIP)), 
                        subject to clause (ii), may provide any 
                        information about the Program, including 
                        information, materials, and assistance 
                        described in subparagraph (B), to a Program-
                        eligible beneficiary unless such Program-
                        eligible beneficiary requests such information, 
                        materials, or assistance.
                            ``(ii) Exception for providers treating 
                        beneficiaries.--An eligible participating 
                        provider that is part of an Organization may 
                        provide information, materials, and assistance 
                        described in subparagraph (B) to a Program-
                        eligible beneficiary, without prior request of 
                        such beneficiary, if such beneficiary is 
                        receiving renal dialysis services from a 
                        facility that participates in such 
                        Organization.
                            ``(iii) Parity in notification.--In the 
                        case that an eligible participating provider 
                        that is part of an Organization participates in 
                        notifying Program-eligible beneficiaries about 
                        the Program under this subparagraph, such 
                        notification shall be provided in the same 
                        manner to all Program-eligible beneficiaries to 
                        which, pursuant to clause (ii), such eligible 
                        participating provider may provide information, 
                        materials, and assistance described in such 
                        clause.
                    ``(E) Program-eligible beneficiary grievance and 
                appeal rights.--Program-eligible beneficiaries 
                participating in the Program under this section shall 
                have grievance and appeal rights and procedures 
                consistent with those rights and procedures established 
                under subsections (f) and (g) of section 1852.
    ``(e) ESRD Fee-for-Service Integrated Care Program Monthly Payment 
and Claims Processing Mechanism.--
            ``(1) In general.--For each Program-eligible beneficiary 
        receiving care through an Organization, the Secretary shall 
        make a monthly prospective payment in accordance with payment 
        rates that would be determined under section 1853(a)(1)(H).
            ``(2) Application of health status risk adjustment 
        methodology.--The Secretary shall adjust the monthly 
        prospective payment to an Organization under this subsection in 
        the same manner in which the payment amount to a Medicare 
        Advantage plan is adjusted under section 1853(a)(1)(C).
            ``(3) Treatment of and payment for kidney acquisition 
        costs.--
                    ``(A) Excluding costs for kidney acquisitions from 
                ma benchmark.--The Secretary shall adjust the payment 
                amount to an Organization to exclude from such payment 
                amount the Secretary's estimate of the standardized 
                costs for payments for organ acquisitions for kidney 
                transplants in the area involved for the year.
                    ``(B) FFS treatment of and payment for kidney 
                acquisitions.--An Organization shall provide all 
                benefits described in subsection (b)(2)(A)(i), except 
                for kidney acquisition costs. Payment for kidney 
                acquisition costs covered under this title furnished to 
                a Program-eligible beneficiary shall be made in 
                accordance with this title and in such amounts as would 
                otherwise be made and determined for such items and 
                services provided to such a beneficiary not 
                participating in the Program under this section.
            ``(4) Treatment of and payment for hospice care.--
                    ``(A) In general.--An agreement under this section 
                shall require an Organization to inform each Program-
                eligible beneficiary who is assigned to or elects an 
                ESRD Fee-For-Service Integrated Care Model offered by 
                the Organization about the availability of hospice care 
                if--
                            ``(i) a hospice program participating under 
                        this title is located within the Organization's 
                        service area; or
                            ``(ii) it is common practice to refer 
                        patients to hospice programs outside such 
                        service area.
                    ``(B) Payment.--If a Program-eligible beneficiary 
                who is assigned to or elects an ESRD Fee-For-Service 
                Integrated Care Model offered by an Organization with 
                an agreement under this section makes an election under 
                section 1812(d)(1) to receive hospice care from a 
                particular hospice program--
                            ``(i) payment for the care furnished to the 
                        Program-eligible beneficiary shall be made by 
                        the Secretary to the hospice program elected by 
                        the Program-eligible beneficiary;
                            ``(ii) payment for other services for which 
                        the Program-eligible beneficiary individual is 
                        eligible notwithstanding the Program-eligible 
                        beneficiary's election of hospice care under 
                        section 1812(d)(1), including services not 
                        related to the Program-eligible beneficiary's 
                        terminal illness, shall be made by the 
                        Secretary to the Organization or the provider 
                        or supplier of the service instead of the 
                        monthly prospective payment determined under 
                        subsection (f); and
                            ``(iii) the Secretary shall continue to 
                        make monthly payments to the Organization in an 
                        amount equal to the value of benefits and 
                        services determined under subsection 
                        (b)(2)(A)(ii)(IV).
            ``(5) Application of cmi claims processing framework.--
                    ``(A) In general.--Under the Program, the Secretary 
                shall apply a claims processing framework based on 
                those that the Center for Medicare and Medicaid 
                Innovation applies under various direct contracting 
                models under section 1115A such that--
                            ``(i) providers of services and suppliers 
                        serving Program-eligible beneficiaries continue 
                        to submit claims to a Medicare administrative 
                        contractor;
                            ``(ii) the Secretary forwards claims to the 
                        Organization for payment; and
                            ``(iii) the Organization pays providers of 
                        services and suppliers an amount equal to the 
                        amount that they would otherwise receive under 
                        the original Medicare Fee-For-Service program 
                        plus any additional amount to which the 
                        provider may be eligible under subsection 
                        (b)(2)(A)(v) of this section.
                    ``(B) Application of balance billing limitations.--
                Section 1852(a)(2)(A) (relating to payments made by an 
                MA organization to a non-contract provider of 
                services), section 1852(k)(1) (relating to limitations 
                on balance billing), and section 1866(a)(1)(o) 
                (relating to payments made by an MA organization to a 
                non-contract supplier) shall apply to the Program.
                    ``(C) Payments for graduate medical education.--
                Section 1886(d)(11) and section 1886(h)(3)(D) (relating 
                to payments for graduate medical education) shall apply 
                to Organizations and providers of services under the 
                Program.
            ``(6) No effect on ma esrd rate setting or risk adjustment 
        model.--To ensure the integrity of the Medicare Advantage end-
        stage renal disease rate setting process and risk adjustment 
        factors applied to Medicare Advantage end-stage renal disease 
        rates, claims paid on behalf of Program-eligible beneficiaries 
        shall not be included in neither the determination of such 
        rates nor the development of such risk adjustment factors.
            ``(7) Agreement between a state and organization for 
        medicaid benefits.--In the case that a State and Organization 
        enter into a mutual agreement under which the Organization 
        coordinates benefits under title XIX for Program-eligible 
        beneficiaries eligible for benefits under this title and title 
        XIX such mutual agreement shall specify the payment from the 
        State for providing or arranging for the provision of such 
        benefits.
            ``(8) Affirmation of state obligations to pay premium and 
        cost-sharing amounts.--A State shall continue to make medical 
        assistance under the State plan under title XIX available for 
        the duration of the Program for Medicare cost-sharing (as 
        defined in section 1905(p)(3)) under this title for qualified 
        Medicare beneficiaries described in section 1905(p)(1) and 
        other individuals who are Program-eligible beneficiaries 
        assigned to or who elect an Organization and entitled to 
        medical assistance for premiums and such cost-sharing under the 
        State plan under title XIX in an amount equal to the amount of 
        medical assistance that would be made available by such State 
        if such Program-eligible beneficiaries were not participating 
        in the Program under this section.
    ``(f) Waiver Authority.--
            ``(1) In general.--The Secretary shall waive those 
        requirements waived under section 1899 determined by the 
        Secretary to be relevant and necessary for the operation of the 
        Program under this section and may waive, as necessary, such 
        additional requirements that have been or may be waived based 
        on authority established under section 1115A for purposes of 
        models tested by the Centers for Medicare and Medicaid 
        Innovation in order to carry out the Program under this 
        section.
            ``(2) Notice of waivers.--Not later than 3 months after the 
        date of enactment of this section, the Secretary shall publish 
        a notice of waivers that will apply in connection with the 
        Program. The notice shall include the specific conditions that 
        an Organization must meet to qualify for each waiver, and 
        commentary explaining the waiver requirements.
    ``(g) Report.--Not later than December 31, 2025, the Medicare 
Payment Advisory Commission shall submit to Congress an interim report 
on the Program.''.
    (b) Rules of Construction.--
            (1) Use of medicare supplemental policy under an esrd fee-
        for-service integrated care model.--Nothing in the provisions 
        of, or amendments made by, this Act shall be construed to 
        prevent a Program-eligible beneficiary assigned to, or who 
        elects, an ESRD Fee-For-Service Integrated Care Model offered 
        by an Organization with an agreement under this section from 
        enrolling in or continuing enrollment in a Medicare 
        supplemental policy available to such Program-eligible 
        beneficiary or receiving benefits under such Medicare 
        supplemental policy throughout the duration of the Program-
        eligible beneficiary's participation in an ESRD Fee-For-Service 
        Integrated Care model offered by an Organizations with an 
        agreement under this section.
            (2) Application of state rules regarding issuance of 
        medicare supplemental policies to individual under age 65.--
        Nothing in the provisions of, or amendments made by, this Act 
        shall be construed to establish a Federal requirement on an 
        issuer of a Medicare supplemental policy to offer such Medicare 
        supplemental policy to individuals under age 65.
            (3) Continued availability of medicare supplemental 
        policies to individuals under age 65.--Nothing in the 
        provisions of, or amendments made by, this Act shall be 
        construed to affect a State's authority to require an issuer of 
        a Medicare supplemental policy to offer such Medicare 
        supplemental policy to individual.
    (c) GAO Study and Report on Payment Adequacy for Pediatric ESRD 
Services.--
            (1) Study on payment for pediatric esrd services.--The 
        Comptroller General of the United States shall conduct a study 
        to examine the accuracy of pediatric data reported to the 
        Centers for Medicare & Medicaid Services as part of the ESRD 
        prospective payment system. The study shall evaluate whether 
        the organizations described in section 1866G of the Social 
        Security Act, as added by subsection (a), and the existing 
        prospective payment system accurately capture and reimburse 
        costs of pediatric dialysis care and include an analysis of the 
        following factors that influence such costs:
                    (A) Increased acuity of nursing care compared to 
                adult dialysis patients, especially for smaller and 
                younger pediatric hemodialysis patients.
                    (B) Need for developmental and behavioral 
                specialists, including child life specialists.
                    (C) Need for more frequent assessment by pediatric 
                dieticians to adjust formulas and diet for the 
                specialized growth and nutrition requirements of 
                children treated with dialysis.
                    (D) Need for social workers, school liaisons, and 
                other trained individuals designated to help families 
                navigate challenging psychosocial situations and to 
                coordinate with schools to ensure school attendance and 
                optimize school performance among pediatric dialysis 
                patients.
                    (E) Need for a broader array of dialysis supplies, 
                including different-sized dialyzers, tubing, and 
                peritoneal fluid bags to accommodate care provided 
                infants through young adults.
            (2) Report.--Not later than 18 months after the date of the 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report containing the results of the study conducted 
        under paragraph (1), together with recommendations for such 
        legislation and administrative action as the Comptroller 
        General determines appropriate.
    (d) GAO Study and Report on the Impact of Race-Based Correction of 
EGFR on Referral of ESRD Patients for Transplant Evaluation.--
            (1) Study on impact of race-based correction of egfr on 
        referral of esrd patients for transplant evaluation.--The 
        Comptroller General of the United States shall conduct a study 
        to examine the impact of race-based correction of the estimated 
        glomerular filtration rate (referred to in this subsection as 
        ``eGFR'') on the referral of ESRD patients for transplant 
        evaluation.
            (2) Report.--Not later than 18 months after the date of 
        enactment of this Act, the Comptroller General shall submit to 
        Congress a report containing the results of the study conducted 
        under paragraph (1), together with recommendations for such 
        legislation and administrative action as the Comptroller 
        General determines appropriate.
                                 <all>