,,ii #aafth ,,congress #b;d ,session ,s4 #degd ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #ae1 #bjbj,mr4 ,young 7for himself and ,ms4 ,sinema7 introduced the following bill2 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 disease1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,bringing ,enhanced ,treatments and ,therapies to ,,esrd ,recipients 7,,better7 ,kidney ,care ,act4 #b4 ,findings ,congress finds the following3 7#a7 ,although the relative rate of end-stage renal disease 7referred to in this section as ,,esrd7 among the ,nation's minority populations has declined1 significant disparities remain4 ,compared to ,whites1 ,black ,americans are #b4f times more likely to have kidney failure1 while ,native ,americans and ,alaska ,natives are #a4b times more likely4 ,hispanics are #a4c times more likely to have kidney failure compared to non-,hispanics4 7#b7 ,disparities also exist with respect to treatment modalities4 ,specifically1 although home dialysis can offer advantages1 ,black1 ,hispanic1 and ,native ,american and ,alaska ,native ,,esrd patients are less likely to initiate home treatment than ,white ,,esrd patients4 7#c7 ,numerous studies show that individuals with low incomes and in low-income communities are at greater risk for ,,esrd4 7#d7 ,in addition to their kidney disease1 ,,esrd patients across all races and ethnicities often suffer from one or more comorbidities4 ,eighty-eight percent of ,,esrd patients have a history of hypertension1 #db percent have diabetes1 and nearly #cj percent have congestive heart failure4 7#e7 ,each month1 ,,esrd patients see multiple providers and take several medications to manage their kidney disease and comorbid conditions4 ,of all patients1 those with ,,esrd stand to benefit greatly from better coordinated care4 7#f7 ,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 program4 7#g7 ,in alignment with that goal1 it is imperative that ,medicare test new models that have at their core an interdisciplinary care team1 among other structural requirements1 to-- 7,a7 help ,,esrd patients better navigate the health care system2 7,b7 empower such patients to manage their plan of care and medication regimen2 7,c7 support such patients in receiving the treatment modality1 including a kidney transplant1 as prescribed by their nephrologist2 7,d7 access services to meet the nonclinical needs of such patients that can affect care outcomes2 and 7,e7 receive additional services1 such as transplant evaluation1 palliative care1 evaluation for hospice eligibility1 and vascular access care4 #c4 ,demonstration program to provide integrated care for ,medicare beneficiaries with end-stage renal disease 7a7 ,in general ,title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahff;,f the following new section3 #ahff;,g4 ,demonstration program to provide integrated care for ,medicare beneficiaries with end-stage renal disease 7a7 ,establishment 7#a7 ,in general ,the ,secretary shall conduct under this section the ,,esrd ,fee-,for-,service ,integrated ,care ,demonstration ,program 7in this section referred to as the ,program71 which is voluntary for ,program-eligible beneficiaries and eligible participating providers1 to assess the effects of alternative care delivery models and payment methodologies on patient care improvements under this title for such beneficiaries4 ,under the ,program-- 7,a7 ,program-eligible beneficiaries shall be considered original ,medicare fee-for-service beneficiaries 7as defined in section #ahii7;h77#c77 for the duration of the participation of such beneficiaries under the ,program2 7,b7 eligible participating providers may form an ,,esrd ,fee-,for-,service ,integrated ,care ,organization 7in this section referred to as an ,organization72 and 7,c7 an ,organization shall integrate care under the original ,medicare fee-for-service program under parts ,a and ,b for ,program-eligible beneficiaries4 7#b7 ,definitions ,in this section3 7,a7 ,eligible participating provider ,the term eligible participating provider means any of the following3 7i7 ,a facility certified as a renal dialysis facility under this title4 7ii7 ,an entity that owns one or more of such facilities described in clause 7i74 7iii7 ,a nephrologist 7including a pediatric nephrologist7 or nephrology practice4 7iv7 ,any other physician or physician group practice4 7v7 ,a nurse practitioner1 physician assistant1 or clinical nurse specialist 7as such terms are defined in section #ahfa7;aa77#e77 or a clinical social worker 7as defined in section #ahfa7;hh77#a77 working in conjunction with such a nurse practitioner1 physician assistant1 or clinical nurse specialist4 7,b7 ,eligible participating partner ,the term eligible participating partner means1 with respect to an ,organization1 any of the following3 7i7 ,a ,medicare ,advantage plan described in section #ahea7;a77#b7 or a ,medicare ,advantage organization offering such a plan4 7ii7 ,a medicaid managed care organization 7as defined in section #aijc7m774 7iii7 ,a hospital or an academic medical center experienced in the care of patients receiving dialysis4 7iv7 ,any other entity determined appropriate by the ,secretary4 7,c7 ,program-eligible beneficiary 7i7 ,in general ,the term ,program-eligible beneficiary means1 with respect to an ,organization offering an ,,esrd ,fee-,for-,service ,integrated ,care ,model1 an individual entitled to benefits under part ,a and enrolled under part ,b 7including such an individual entitled to medical assistance under a ,state plan under title ,,xix7 who-- 7,i7 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 ,b1 and is not enrolled in a ,medicare ,advantage plan under part ,c or group health insurance coverage or individual health insurance coverage 7as defined in section #bgia7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b777 that is primary to coverage under this title2 7,,ii7 receives renal dialysis services primarily from an eligible participating provider of such ,organization1 including such renal dialysis services received after being identified as a suitable candidate for transplantation2 and 7,,iii7 has attained the age of #ah years4 7ii7 ,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-- 7,i7 elects to receive hospice benefits under section #aheb7;d77#a72 or 7,,ii7 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 disease1 shall continue to meet the definition of ,program-eligible beneficiary established under this subparagraph4 7b7 ,,esrd fee-for-,service integrated care organization eligibility requirements 7#a7 ,organizations 7,a7 ,in general ,one or more eligible participating providers may establish an ,organization and may enter into1 subject to subparagraph 7,b71 one or more partnership1 ownership1 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 7#b74 7,b7 ,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 partnership1 ownership1 or co-ownership agreements described in subparagraph 7,a74 7,c7 ,minimum ,program ,eligible ,beneficiary ,participation ,requirement 7i7 ,in general ,subject to clause 7ii71 the ,secretary may not enter into or continue an agreement with an ,organization unless the ,organization has at least #cej ,program-eligible beneficiaries1 or at least #fj percent of ,program-eligible beneficiaries receiving care from the ,organization's facilities1 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 ,organization4 7ii7 ,allowing transition ,the ,secretary may waive the requirement under clause 7i7 for an ,organization during the first agreement year with respect to the ,organization4 7,d7 ,fiscal soundness requirements 7i7 ,in general ,the ,secretary shall enter into appropriate agreements under this section only with ,organizations that demonstrate sufficient capital reserves1 measured as a percentage of monthly prospective payments described in subsection 7e7 and consistent with capital reserve requirements established by each ,state in which the ,organization operates1 subject to clause 7ii74 7ii7 ,alternative ,mechanism to ,demonstrate ,risk-,bearing ,capacity ,an ,organization shall be considered to meet the requirement in clause 7i7 if the ,organization includes at least one eligible participating provider or eligible participating partner that-- 7,i7 7aa7 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 section2 or 7bb7 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 benefits2 7,,ii7 agrees to bear risk under the ,organization2 and 7,,iii7 has the capacity to bear risk commensurate with the ,organization's expected expenditures under an agreement under this section4 7iii7 ,disclosure ,each ,organization with an agreement under this section shall1 in accordance with current regulations of the ,secretary that govern similar disclosures1 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 operation4 7,e7 ,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-- 7i7 representation from each eligible participating provider of such ,organization2 7ii7 at least two nephrologists1 one of which may be affiliated with an eligible participating provider2 and 7iii7 at least one beneficiary advocate4 7#b7 ,,esrd ,fee-,for-,service ,integrated ,care ,model 7,a7 ,benefit requirements 7i7 ,in general ,subject to clause 7iii71 an ,organization shall offer an ,,esrd ,fee-,for-,service ,integrated ,care ,model that shall-- 7,i7 cover all benefits under parts ,a and ,b 7subject to payment rules regarding the treatment of and payment for kidney organ acquisitions and hospice described in subsections 7e77#c7 and 7#d772 and 7,,ii7 include services for transition 7particularly including education7 into transplantation1 palliative care1 and hospice4 7ii7 ,determination and treatment of savings 7,i7 ,in general ,the ,secretary shall require any ,organization offering an ,,esrd ,fee-,for-,service ,integrated ,care ,model to provide for the return under subclause 7,,vi7 to a ,program-eligible beneficiary assigned to or who elects an ,organization savings equal to the amount1 if any1 by which the payment amount described in subclause 7,v7 with respect to the ,program-eligible beneficiary for a year exceeds the average revenue amount described in subclause 7,,iv7 with respect to the ,program-eligible beneficiary for the year4 7,,ii7 ,savings determination process ,the ,secretary shall determine the savings described in subclause 7,i7 in the same manner as the rebate calculation for individuals with end-stage renal disease enrolled in ,medicare ,advantage organizations under section #ahei7;b77#f77;,b77iii74 7,,iii7 ,application of medical loss ratio requirements ,nothing shall preclude the ,secretary from applying medical loss ratio requirements described in section #aheg7;e77#d7 under this section4 7,,iv7 ,average revenue amount described ,the revenue amount described in this subclause1 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 ,organization1 is the ,organization's estimated average revenue requirements1 including administrative costs and return on investment1 for the ,organization to provide the benefits described in clause 7i7 under the ,model for the ,program-eligible beneficiary for the year4 7,v7 ,payment amount described ,the payment amount described in this subclause1 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 ,organization1 is the payment amount to the ,organization under subsection 7e77#a7 7adjusted pursuant to subsection 7e77#b7 and subject to the treatment of payments for kidney acquisitions and hospice care described in paragraphs 7#c7 and 7#d7 of subsection 7e71 respectively7 made with respect to the ,program-eligible beneficiary for the year4 7,,vi7 ,returning savings to program-eligible beneficiaries ,an ,organization shall1 in a manner specified by the ,secretary and consistent with returning ,medicare ,advantage rebates to individuals under part ,c1 return the amount under subclause 7,i7 to a ,program-eligible beneficiary through offering benefits not covered under the original ,medicare ,fee-,for-,service program consistent with the types of benefits1 including non-health related benefits1 that ,medicare ,advantage organizations may offer4 7iii7 ,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 ,,xix1 an ,organization1 in accordance with a mutual agreement entered into between the ,state and ,organization under subsection 7e77#g7-- 7,i7 shall provide1 or arrange for the provision of1 all benefits 7other than long-term services and supports7 for which the ,program-eligible beneficiary is entitled to under a ,state plan under title ,,xix2 and 7,,ii7 may elect to provide1 or arrange for the provision of1 long-term services and supports for which the ,program-eligible beneficiary is entitled under a ,state plan under title ,,xix1 including services related to the transition into palliative care or hospice4 7iv7 ,application of ,medicare ,,ffs provider choice and cost-sharing requirements ,under an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by an ,organization1 the ,organization shall-- 7,i7 allow ,program-eligible beneficiaries to receive benefits as described in subsection 7b77#b77;,a77i77,i7 from any provider of services or supplier enrolled under this title and who otherwise meets all applicable requirements under this title2 and 7,,ii7 not apply any cost-sharing requirements for benefits described in subsection 7b77#b77;,a77i77,i7 in addition to premium and cost-sharing requirements1 respectively1 that would be applicable under part ,a or part ,b for such benefits4 7v7 ,promoting access to high-quality providers ,an ,organization offering an ,,esrd ,fee-,for-,service ,integrated ,care ,model shall develop and implement performance-based incentives1 including financial incentives funded through payments made to an ,organization under subsection 7e71 for providers of services and suppliers to promote delivery of high quality and efficient care4 ,such incentives shall comply with section #aheb7;j77#d7 and section #dbb4bjh of title #db1 ,code of ,federal regulations 7as in effect on the date of enactment of this section7 and be based on clinical measures or non-clinical measures1 such as with respect to notification of patient discharge from a hospital1 patient education 7such as with respect to treatment options1 including disease maintenance1 and nutrition71 rates of completion of patient education categorized by race1 rates of completion of transplant evaluation for patients who are clinically eligible for transplant1 rates of completion of transplant evaluation categorized by race1 and the interoperability of electronic health records developed by an ,organization according to requirements and standards specified by the ,secretary pursuant to subparagraph 7,b74 7,b7 ,quality and reporting requirements 7i7 ,clinical measures ,under the ,program1 the ,secretary shall-- 7,i7 require each participating ,organization to submit to the ,secretary data on clinical measures developed using1 as a reference1 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 provided2 7,,ii7 establish requirements for participating ,organizations to submit to the ,secretary1 in a form and manner specified by the ,secretary1 information on such measures2 and 7,,iii7 establish standards for making information on quality under the ,program established under this section as assessed using clinical measures described in subclause 7,i7 available to the public4 ,as part of the standards described in subclause 7,,iii7 the ,secretary shall1 in consultation with relevant stakeholders1 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 to1 kept on1 or removed from the transplant list and the number of individuals that receive a transplant after participating in the ,organization4 ,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 agreement4 ,organizations shall submit such measures as a condition of payment and ,program-eligible beneficiary assignment under this subsection4 7ii7 ,requirement for stakeholder input ,in developing measures and requirements under subclauses 7,i7 and 7,,ii7 of clause 7i71 the ,secretary shall request and consider input from a stakeholder board that includes at least one nephrologist1 a pediatric nephrologist1 other suppliers and providers of services as determined appropriate by the ,secretary1 renal dialysis facilities1 beneficiary advocates1 a health equity expert1 a mental health provider1 a transplant surgeon1 and ,medicare-approved transplant programs4 ,section #ad of the ,federal ,advisory ,committee ,act shall not apply to the stakeholder board4 7iii7 ,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 surveys1 such as the ,in-,center ,hemodialysis ,consumer ,assessment of ,healthcare ,providers and ,systems4 7iv7 ,no effect on other renal dialysis facility quality requirements ,nothing in this section shall be construed as affecting the requirements established under section #ahha7;h74 7,c7 ,requirements for esrd fee-for-service integrated care strategy 7i7 ,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 section1 subject to clauses 7ii7 and 7iii71 an ,,esrd ,fee-,for-,service ,integrated ,care ,strategy4 7ii7 ,,esrd fee-for-service integrated care strategy ,in assessing an ,,esrd ,fee-,for-,service ,integrated ,care ,strategy under clause 7i71 the ,secretary shall consider the extent to which the ,strategy includes elements such as the following3 7,i7 ,use of interdisciplinary care teams led by at least one nephrologist1 and comprised of registered nurses1 social workers1 renal dialysis facility managers1 and as appropriate other representatives from alternative settings described in subclause 7,,viii74 7,,ii7 ,use of a decision process for care plans and care management that includes the nephrologist1 a member of the transplant evaluation team1 and other practitioners responsible for direct delivery of care to ,program-eligible beneficiaries assigned to or who elect the ,organization involved4 7,,iii7 ,use of health risk and other assessments to determine the physical1 psychosocial1 nutrition1 language1 cultural1 and other needs of ,program-eligible beneficiaries assigned to or who elect the ,organization involved4 7,,iv7 ,development and at least annual updating of individualized care plans that incorporate at least the medical1 social1 and functional needs1 preferences1 and care goals of ,program-eligible beneficiaries assigned to or who elect the ,organization1 including a discussion on reconsideration of the method and location of dialysis4 7,v7 ,coordination and furnishing of non-clinical coordination benefits1 such as transportation1 aimed at improving the adherence of ,program-eligible beneficiaries assigned to or who elect the ,organization with care recommendations4 7,,vi7 ,as appropriate1 coordination services1 such as transplant evaluation1 palliative care1 evaluation for hospice eligibility1 and vascular access care4 7,,vii7 ,in the case of an individual who1 during an assignment to1 or an election of an ,,esrd ,fee-,for-,service ,integrated ,care model offered by an ,organization1 receives confirmation that a kidney transplant is imminent1 the provision of counseling services by an interdisciplinary care team described in subclause 7,i7 to such individual on preparation for and potential benefits and risks associated with such transplant4 7,,viii7 ,delivery of benefits and services in settings alternative to traditional clinical settings1 such as the home of the ,program-eligible beneficiary4 7,,ix7 ,use of patient reminder systems4 7,x7 ,education programs for patients1 families1 and caregivers4 7,,xi7 ,use of health care advice resources1 such as nurse advice lines4 7,,xii7 ,use of team-based health care delivery models that provide comprehensive and continuous medical care1 such as medical homes4 7,,xiii7 ,co-location of providers and services4 7,,xiv7 ,use of a demonstrated capacity to share electronic health record information across sites of care4 7,,xv7 ,use of programs to promote better adherence to recommended treatment regimens1 including prescription drug1 by individuals1 including by addressing barriers to access to care by such individuals1 including strategies to coordinate any prescription drug benefits under any prescription drug plan under part ,d in which a ,program-eligible beneficiary is enrolled4 7,,xvi7 ,use of defined protocols1 developed in conjunction with the pediatric nephrology community1 to facilitate the transition of pediatric individuals into adult end-stage renal disease care4 7,,xvii7 ,use of health equity experts to implement programs and protocols which seek to decrease gender1 racial1 ethnic1 and language inequities4 7,,xviii7 ,other services1 strategies1 and approaches identified by the ,organization to improve care coordination and delivery4 7#c7 ,beneficiary protections 7,a7 ,seamless access to care ,the ,secretary shall ensure that the ,organization establishes processes and takes steps necessary1 including educating relevant providers of services and suppliers about the ,program1 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 election4 ,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 7b77#b77;,a77i77,i7 from any provider of services or suppliers enrolled and who otherwise meets requirements under this title1 as described in subsection 7b77#b77;,a77iv74 7,b7 ,anti-discrimination ,each agreement between the ,secretary and an ,organization under this section shall-- 7i7 provide that each eligible participating provider of such ,organization may not deny1 limit1 or condition the furnishing of services1 or affect the quality of services furnished1 under this title to ,program-eligible beneficiaries on whether or not such a beneficiary is assigned to or elects the ,organization2 and 7ii7 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 services4 7,c7 ,quality assurance2 patient safeguards ,each agreement between the ,secretary and an ,organization under this section shall require that such ,organization have in effect at a minimum-- 7i7 a written plan of quality assurance and improvement1 and procedures implementing such plan1 in accordance with regulations2 and 7ii7 written safeguards of the rights of ,program-eligible beneficiaries assigned to or who elect the ,organization 7including a patient bill of rights and procedures for grievances and appeals7 in accordance with regulations and with other requirements of this title and applicable ,federal and ,state laws designed to protect ,program-eligible beneficiaries 7including those who are entitled to medical assistance under a ,state plan under title ,,xix74 7,d7 ,oversight ,the ,secretary shall develop and implement an oversight program to monitor an ,organization's compliance with ,program requirements under an agreement under this section4 7#d7 ,treatment as alternative payment model and eligible alternative payment entity 7,a7 ,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 #ahcc7z77#c77;,c77iv74 7,b7 ,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 7i7 and 7ii77,i7 of section #ahcc7z77#c77;,d74 7c7 ,program operation and scope 7#a7 ,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 ,models4 ,such application shall include information on at least the following3 7,a7 ,the estimated average revenue amount described in subsection 7b77#b77;,a77ii77,,ii7 for the ,organization to cover benefits described in subsection 7b77#b77;,a77i77,i74 7,b7 ,any benefits offered by the ,organization beyond those described in such subsection4 7,c7 ,a description of the ,organization's ,,esrd ,fee-,for-,service integrated care strategy specified in subsection 7b77#b77;,d71 including a detailed explanation of the ,organization's approach to fulfill the requirement to coordinate the delivery of multidisciplinary health and social services that1 pursuant to a mutual agreement between a ,state and ,organization1 integrates acute and long-term care services and supports4 7#b7 ,program initiation ,the ,secretary shall initiate the ,program such that ,organizations begin serving ,program-eligible beneficiaries not later than ,january #a1 #bjbd4 7#c7 ,initial agreement period ,the ,secretary shall enter into agreements for an initial period of not less than #e years with all ,organizations that meet all ,program requirements established under this section1 as determined by the ,secretary through the application process described in paragraph 7#a74 7#d7 ,allowance for service area expansions ,during each year of the ,program's operation1 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 determination1 through the application process described in paragraph 7#a71 that the ,organization meets all ,program requirements established under this section4 7#e7 ,contract suspension and termination process 7,a7 ,in general ,subject to subparagraph 7,b77ii71 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 section4 ,an ,organization also shall be considered not in compliance if1 for any calendar month during an agreement year1 more than #ej 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 ,program4 7,b7 ,opportunity for corrective action plan and appeal 7i7 ,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 section1 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 plan4 ,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 compliance4 7ii7 ,imposition of agreement suspension or termination ,in the case of an ,organization that fails to achieve compliance by the date specified in corrective action plan1 subject to clause 7iii7 and depending on the severity of a compliance deficiency1 the ,secretary in a manner consistent with processes established under part ,c of this title may-- 7,i7 suspend ,program-eligible beneficiaries' assignments to or an election of an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by an ,organization2 or 7,,ii7 terminate an agreement with an ,organization under this section4 7iii7 ,immediate agreement termination for violating the prohibition on discrimination ,notwithstanding the corrective action plan process established under clause 7i71 the ,secretary may1 in addition to the circumstances under which a contract under part ,c may be immediately terminated1 immediately terminate an agreement under this section with an ,organization if the ,secretary-- 7,i7 notifies the ,organization of the intent to investigate allegations of systematic activities with the intent of violating the prohibition on discrimination established under subsection 7b77#c77;,b77ii72 7,,ii7 determines1 after conducting a rigorous analysis of all available data based on a sufficient sample size1 that the ,organization engaged in systematic activities with the intent of violating the prohibition on discrimination established in subsection 7b77#c77;,b77ii72 and 7,,iii7 discloses credible evidence to the ,organization regarding a determination made under subclause 7,,ii74 7iv7 ,recovery of monthly prospective payments ,the ,secretary may recover the prorated share of any monthly prospective payments described in subsection 7e7 covering the period of the month following an agreement termination if such agreement termination is effective in the middle of a calendar month4 7v7 ,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 termination1 as well as a description of alternatives for obtaining benefits under this title1 in a manner consistent with beneficiary notification requirements in the event of a contract termination under part ,c4 7#f7 ,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#g74 ,such evaluation shall include an analysis of-- 7,a7 the quality of care furnished under the ,program1 including the measurement of patient-level outcomes and patient experience and patient-reported outcome measures determined appropriate by the ,secretary2 and 7,b7 the changes in spending under parts ,a and ,b by reason of the ,program4 7#g7 ,program expansion 7,a7 ,in general ,the ,secretary may1 through rulemaking1 expand the duration and scope of the ,program under this section1 to the extent determined appropriate by the ,secretary1 if-- 7i7 the ,secretary determines that such expansion is expected to-- 7,i7 reduce spending under this title without reducing the quality of patient care2 or 7,,ii7 improve the quality of patient care without increasing spending under this title2 7ii7 the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services certifies that such expansion would reduce 7or would not result in any increase in7 net program spending under this title2 and 7iii7 the ,secretary determines that such expansion would not deny or limit the coverage or provision of benefits under this title for applicable individuals4 7,b7 ,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 ,program4 7#h7 ,part ,d data sharing arrangement ,the ,secretary on a monthly basis shall1 in accordance with the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 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 sharing4 7#i7 ,funding ,the ,secretary shall allocate funds made available under section #aaae;,a7f77#a7 to implement and evaluate the demonstration program established under this section4 7d7 ,identification and assignment of program-,eligible beneficiaries 7#a7 ,in general ,the ,secretary shall establish a process for the initial and ongoing identification of ,program-eligible beneficiaries4 7#b7 ,assignment of program-,eligible ,beneficiaries to an organization's ,,esrd ,fee-,for-,service ,integrated ,care ,model 7,a7 ,in general ,under the ,program1 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 services4 7,b7 ,opt-out period and changes upon initial assignment or election ,the ,secretary shall provide for a #ij-;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-- 7i7 opt out of the ,program2 or 7ii7 make a one-time change of assignment or election into an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by a different ,organization4 7,c7 ,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 deemed1 unless the ,program-eligible beneficiary otherwise changes such assignment or election under this paragraph1 to have elected to continue such assignment or election with respect to the subsequent year4 7,d7 ,annual opportunity to opt out or elect an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by a different organization 7i7 ,in general ,annually1 a ,program-eligible beneficiary shall be given a #ij-;day period to-- 7,i7 opt out of the ,program2 or 7,,ii7 make a one-time change of assignment or election into an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by a different ,organization4 7ii7 ,alignment with ,medicare ,advantage open enrollment period ,to the extent practicable1 the ,secretary shall align the annual #ij-;day period described in clause 7i7 with the ,medicare ,advantage open enrollment period4 7,e7 ,opt out for change in principal diagnosis or entering home dialysis treatment ,in addition to any other period during which a ,program-eligible beneficiary may1 pursuant to this paragraph1 opt out of the ,program1 in the case of a ,program-eligible beneficiary who1 after assignment under this paragraph1 is diagnosed with a principal diagnosis 7as defined by the ,secretary7 other than end-stage renal disease or enters into home dialysis treatment1 such individual shall be given the opportunity to opt out of the ,program during such period as specified by the ,secretary4 7#c7 ,program-eligible beneficiary notification 7,a7 ,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 ,program1 including-- 7i7 information about receiving benefits under this title through such ,organization2 and 7ii7 an explanation that they retain the right to receive care from any ,medicare provider4 7,b7 ,timing of notification ,upon assignment to or election of an ,,esrd ,fee-,for-,service ,integrated ,care ,model offered by an ,organization1 the ,secretary shall provide the ,organization written notification confirming the beneficiary's assignment or election and not later than #ae business days after the date of receipt of such notification1 the ,organization shall provide written notice to the ,program-eligible beneficiary of such assignment or election4 7,c7 ,content of written notice ,subject to subparagraph 7,d71 such notification shall-- 7i7 inform ,program-eligible beneficiaries about the ,program using an information guide developed by the ,organization and approved by the ,secretary2 7ii7 include the distribution of other ,program materials developed by the ,organization and approved by the ,secretary2 7iii7 inform ,program-eligible beneficiaries about the importance of transplantation as the best outcome1 as well as minimum requirements for transplant eligibility before and during dialysis treatment2 and 7iv7 provide contact information for representatives of the ,organization to respond to ,program-eligible beneficiaries' questions4 7,d7 ,limitation on unsolicited notification 7i7 ,in general ,under the ,program1 no person or entity 7other than the ,secretary1 an employee of the ,secretary1 or an employee or volunteer of a federally authorized ,state ,health ,insurance ,assistance ,program 7,,ship771 subject to clause 7ii71 may provide any information about the ,program1 including information1 materials1 and assistance described in subparagraph 7,b71 to a ,program-eligible beneficiary unless such ,program-eligible beneficiary requests such information1 materials1 or assistance4 7ii7 ,exception for providers treating beneficiaries ,an eligible participating provider that is part of an ,organization may provide information1 materials1 and assistance described in subparagraph 7,b7 to a ,program-eligible beneficiary1 without prior request of such beneficiary1 if such beneficiary is receiving renal dialysis services from a facility that participates in such ,organization4 7iii7 ,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 subparagraph1 such notification shall be provided in the same manner to all ,program-eligible beneficiaries to which1 pursuant to clause 7ii71 such eligible participating provider may provide information1 materials1 and assistance described in such clause4 7,e7 ,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 7f7 and 7g7 of section #aheb4 7e7 ,,esrd fee-for-,service integrated care program monthly payment and claims processing mechanism 7#a7 ,in general ,for each ,program-eligible beneficiary receiving care through an ,organization1 the ,secretary shall make a monthly prospective payment in accordance with payment rates that would be determined under section #ahec7;a77#a77;,h74 7#b7 ,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 #ahec7;a77#a77;,c74 7#c7 ,treatment of and payment for kidney acquisition costs 7,a7 ,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 year4 7,b7 ,,ffs treatment of and payment for kidney acquisitions ,an ,organization shall provide all benefits described in subsection 7b77#b77;,a77i71 except for kidney acquisition costs4 ,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 section4 7#d7 ,treatment of and payment for hospice care 7,a7 ,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-- 7i7 a hospice program participating under this title is located within the ,organization's service area2 or 7ii7 it is common practice to refer patients to hospice programs outside such service area4 7,b7 ,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 #ahab7;d77#a7 to receive hospice care from a particular hospice program-- 7i7 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 beneficiary2 7ii7 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 #ahab7;d77#a71 including services not related to the ,program-eligible beneficiary's terminal illness1 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 7f72 and 7iii7 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 7b77#b77;,a77ii77,,iv74 7#e7 ,application of ,,cmi claims processing framework 7,a7 ,in general ,under the ,program1 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 #aaae;,a such that-- 7i7 providers of services and suppliers serving ,program-eligible beneficiaries continue to submit claims to a ,medicare administrative contractor2 7ii7 the ,secretary forwards claims to the ,organization for payment2 and 7iii7 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 7b77#b77;,a77v7 of this section4 7,b7 ,application of balance billing limitations ,section #aheb7;a77#b77;,a7 7relating to payments made by an ,,ma organization to a non-contract provider of services71 section #aheb7k77#a7 7relating to limitations on balance billing71 and section #ahff7;a77#a77o7 7relating to payments made by an ,,ma organization to a non-contract supplier7 shall apply to the ,program4 7,c7 ,payments for graduate medical education ,section #ahhf7;d77#aa7 and section #ahhf7;h77#c77;,d7 7relating to payments for graduate medical education7 shall apply to ,organizations and providers of services under the ,program4 7#f7 ,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 rates1 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 factors4 7#g7 ,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 benefits4 7#h7 ,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 7as defined in section #aije7p77#c77 under this title for qualified ,medicare beneficiaries described in section #aije7p77#a7 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 section4 7f7 ,waiver authority 7#a7 ,in general ,the ,secretary shall waive those requirements waived under section #ahii determined by the ,secretary to be relevant and necessary for the operation of the ,program under this section and may waive1 as necessary1 such additional requirements that have been or may be waived based on authority established under section #aaae;,a for purposes of models tested by the ,centers for ,medicare and ,medicaid ,innovation in order to carry out the ,program under this section4 7#b7 ,notice of waivers ,not later than #c months after the date of enactment of this section1 the ,secretary shall publish a notice of waivers that will apply in connection with the ,program4 ,the notice shall include the specific conditions that an ,organization must meet to qualify for each waiver1 and commentary explaining the waiver requirements4 7g7 ,report ,not later than ,december #ca1 #bjbe1 the ,medicare ,payment ,advisory ,commission shall submit to ,congress an interim report on the ,program4 4 7b7 ,rules of construction 7#a7 ,use of medicare supplemental policy under an ,,esrd ,fee-,for-,service ,integrated ,care ,model ,nothing in the provisions of1 or amendments made by1 this ,act shall be construed to prevent a ,program-eligible beneficiary assigned to1 or who elects1 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 section4 7#b7 ,application of ,state rules regarding issuance of medicare supplemental policies to individual under age #fe ,nothing in the provisions of1 or amendments made by1 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 #fe4 7#c7 ,continued availability of medicare supplemental policies to individuals under age #fe ,nothing in the provisions of1 or amendments made by1 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 individual4 7c7 ,,gao ,study and ,report on ,payment ,adequacy for ,pediatric ,,esrd ,services 7#a7 ,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 system4 ,the study shall evaluate whether the organizations described in section #ahff;,g of the ,social ,security ,act1 as added by subsection 7a71 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 costs3 7,a7 ,increased acuity of nursing care compared to adult dialysis patients1 especially for smaller and younger pediatric hemodialysis patients4 7,b7 ,need for developmental and behavioral specialists1 including child life specialists4 7,c7 ,need for more frequent assessment by pediatric dieticians to adjust formulas and diet for the specialized growth and nutrition requirements of children treated with dialysis4 7,d7 ,need for social workers1 school liaisons1 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 patients4 7,e7 ,need for a broader array of dialysis supplies1 including different-sized dialyzers1 tubing1 and peritoneal fluid bags to accommodate care provided infants through young adults4 7#b7 ,report ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 7d7 ,,gao ,study and ,report on the ,impact of ,race-,based ,correction of e,g,f,r on ,referral of ,,esrd ,patients for ,transplant ,evaluation 7#a7 ,study on ,impact of ,race-based ,correction of e,g,f,r 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 7referred to in this subsection as e,g,f,r7 on the referral of ,,esrd patients for transplant evaluation4 7#b7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4