,,ii #aadth ,,congress #b;d ,session ,s4 #cjij ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bc1 #bjaf,mr4 ,heller 7for himself and ,mr4 ,nelson7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act 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 ,dialysis ,,patient ,demonstration ,act of #bjaf or the ,patient ,access ,to ,integrated-care1 ,empowerment1 ,nephrologists and ,treatment ,demonstration ,act of #bjaf4 #b4 ,demonstration program to provide integrated care for ,medicare beneficiaries with end-stage renal disease ,title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahff;,e the following new section3 #ahff;,f4 ,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 ,integrated ,care ,demonstration ,program 7in this section referred to as the ,program7 which is voluntary for patients and providers to assess the effects of alternative care delivery models on patient care improvements under this title for ,program-eligible beneficiaries 7as defined in paragraph 7#b774 ,under the ,program1 eligible participating providers 7as defined in such paragraph7 may form an ,,esrd ,integrated ,care ,organization 7in this section referred to as an ,organization74 ,an ,organization shall integrate care and serve as the medical home for ,program-eligible beneficiaries4 7#b7 ,definitions ,in this section3 7,a7 ,eligible participating provider ,the term eligible participating provider means the following3 7i7 ,a facility certified as a renal dialysis facility under this title4 7ii7 ,a dialysis organization that owns one or more of such facilities described in clause 7i74 7iii7 ,a nephrologist or nephrology practice4 7iv7 ,any other physician group practice or a group of affiliated physicians4 7,b7 ,eligible participating partner ,the term eligible participating partner means the following3 7i7 ,a ,medicare ,advantage plan described in section #ahea7;a77#b7 or a ,medicare ,advantage organization offering such a plan4 7ii7 ,a prescription drug plan 7as defined in section #ahfj;,d-#da7;a77#ad774 7iii7 ,a medicaid managed care organization 7as defined in section #aijc7m774 7iv7 ,an entity able to bear risk as deemed by a ,state4 7v7 ,a third party-administrator organization4 7,c7 ,program-eligible beneficiary ,the term ,program-eligible beneficiary means1 with respect to an ,organization offering an ,,esrd ,integrated ,care ,model1 an individual entitled to benefits under part ,a and enrolled under part ,b who-- 7i7 is #ah years of age or older2 7ii7 is identified by the ,secretary or the ,organization as receiving renal dialysis services under the original medicare fee-for-service program under parts ,a and ,b2 7iii7 resides in the service area of such ,organization2 7iv7 receives renal dialysis services primarily from a facility that participates in such ,organization2 and 7v7 has not received a successful kidney transplant4 7b7 ,,esrd integrated care organization eligibility requirements 7#a7 ,organizations 7,a7 ,in general ,one or more eligible participating providers may establish an ,organization or 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 ,organization4 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 under agreements described in subparagraph 7,a74 7#b7 ,,esrd integrated care model 7,a7 ,benefits requirements 7i7 ,in general ,subject to clause 7iii71 an ,organization shall offer at least one ,,esrd ,integrated ,care ,model that is an open network model 7as described in subparagraph 7,b77i77 in each of its service areas and may offer one or more ,,esrd ,integrated ,care ,models that is a preferred network model 7as described in subparagraph 7,b77ii77 in each of its service areas4 ,for purposes of this section an ,,esrd ,integrated ,care ,model 7in this section referred to as the ,model7-- 7,i7 shall cover all benefits under parts ,a and ,b 7other than hospice care7 and include benefits for transition 7including education7 into palliative care2 and 7,,ii7 may1 through a partnership or other agreement with an ,,ma-,,pd plan under part ,c or prescription drug plan under part ,d1 cover all prescription drug benefits under such part ,d4 7ii7 ,treatment of savings 7,i7 ,in general ,any ,organization offering an ,,esrd ,integrated ,care ,model shall provide for the return under subclause 7,,iv7 to a ,program-eligible beneficiary enrolled in the ,organization of the amount1 if any1 by which the payment amount described in subclause 7,,iii7 with respect to the ,program-eligible beneficiary for a year exceeds the revenue amount described in subclause 7,,ii7 with respect to the ,program-eligible beneficiary for the year4 7,,ii7 ,revenue amount described ,the revenue amount described in this subclause1 with respect to an ,organization offering an ,,esrd ,integrated ,care ,model and a ,program-eligible beneficiary enrolled in 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,,iii7 ,payment amount described ,the payment amount described in this subclause1 with respect to an ,organization offering an ,,esrd ,integrated ,care ,model and a ,program-eligible beneficiary enrolled in such ,organization1 is the payment amount to the ,organization under subsection 7f77#a7 made with respect to the ,program-eligible beneficiary for the year4 7,,iv7 ,means of returning savings to program-eligible beneficiaries enrolled in ,organizations ,an ,organization shall return the amount under subclause 7,i7 to a ,program-eligible beneficiary enrolled in the ,organization in a manner specified by the ,organization1 which may include cost-sharing lower than otherwise applicable1 benefits not covered under the original medicare fee-for-service program1 or financial incentives 7such as reduced cost sharing7 for ,program-eligible beneficiaries enrolled in the ,organization to promote the delivery of high-value and efficient care and services4 7iii7 ,benefit requirements for dual eligibles ,in the case of a ,program-eligible beneficiary who is eligible for benefits under this title and title ,,xix1 an ,organization1 in accordance with an agreement entered into under subsection 7f77#d7-- 7,i7 may be responsible for providing1 or arranging for the provision of1 all benefits 7other than long-term services and supports7 for which the ,program-eligible beneficiary is eligible for under the ,state ,medicaid program under title ,,xix in which the ,program-eligible beneficiary is enrolled2 and 7,,ii7 may elect to provide1 or arrange for the provision of1 long-term services and supports available to the ,program-eligible beneficiary under the ,state ,medicaid program4 7,b7 ,requirements for open network and preferred network models 7i7 ,open network model ,under an ,,esrd ,integrated ,care ,model offered by an ,organization that is an open network model1 the ,organization shall-- 7,i7 allow ,program-eligible beneficiaries to receive such covered benefits from any provider of services or supplier regardless of whether such provider is within the network assembled under subclause 7,i72 7,,ii7 pay any ,medicare-certified provider or supplier that is not within the network assembled under subclause 7,i7 for such covered benefits an amount equal to the amount the provider or supplier would otherwise receive under this title2 and 7,,iii7 not apply any additional premium or cost sharing requirements for such covered benefits in addition to premium or cost sharing requirements1 respectively1 that would be applicable under part ,a or part ,b for such benefits4 7ii7 ,preferred network model ,under an ,,esrd ,integrated ,care ,model offered by an ,organization that is a preferred network model1 the ,organization-- 7,i7 shall assemble a network of providers of services and suppliers identified by the ,organization and confirmed by the ,secretary as including providers of services and suppliers with significant expertise in caring for individuals with end-stage renal disease through which ,program-eligible beneficiaries shall receive covered benefits as described in subparagraph 7,a7 that are required to be covered under the ,model2 7,,ii7 may apply premium and cost-sharing requirements1 in addition to premium or cost-sharing requirements1 respectively1 that would be applicable under part ,b1 for benefits in addition to those required to be covered under the ,model2 and 7,,iii7 shall apply network standards as defined by the ,secretary4 7iii7 ,promoting access to high quality providers ,an ,organization offering an ,,esrd ,integrated ,care ,model may develop and implement performance-based incentives for providers of services and suppliers to promote delivery of high quality and efficient care4 ,such incentives shall be based on clinical measures and non-clinical measures1 such as with respect to notification of patient discharge from a hospital1 patient education 7such as with respect to treatment options and nutrition71 and the interoperability of electronic health records developed by an ,organization according to requirements and standards specified by the ,secretary pursuant to subparagraph 7,c74 7,c7 ,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 consistent with those measures submitted by organizations participating in the ,comprehensive ,,esrd ,care ,initiative operated by the ,center for ,medicare and ,medicaid ,innovation as of ,october #a1 #bjaf1 to assess the quality of care provided2 7,,ii7 establish requirements for participating ,organizations to report to the ,secretary1 in a form and manner specified by the ,secretary1 information on such measures2 and 7,,iii7 establish quality performance standards on such measures to assess the quality of care4 7ii7 ,requirement for stakeholder input ,in developing requirements and standards under subclauses 7,,ii7 and 7,,iii7 of clause 7i71 the ,secretary shall request and consider input from a stakeholder board1 at least one nephrologist1 other suppliers and providers of services1 renal dialysis facilities1 and beneficiary advocates1 and respond in writing to such input4 7iii7 ,additional assessments and reporting requirements ,the ,secretary shall assess the extent to which an ,organization delivers integrated and patient-centered care through analysis of information obtained from ,program-eligible beneficiaries enrolled in the ,organization through surveys1 such as the ,in-,center ,hemodialysis ,consumer ,assessment of ,healthcare ,providers and ,systems4 7,d7 ,requirements for ,,esrd integrated care strategy 7i7 ,in general ,an ,organization seeking a contract under this section to offer one or more ,,esrd ,integrated ,care ,models must develop and submit for the ,secretary's approval1 subject to clause 7ii71 an ,,esrd ,integrated ,care ,strategy4 7ii7 ,,esrd integrated care strategy ,in assessing an ,,esrd ,integrated ,care ,strategy under clause 7i71 the ,secretary shall consider the extent to which the ,strategy includes elements1 such as the following3 7,i7 ,interdisciplinary care teams led by at least one nephrologist1 and comprised of registered nurses1 social workers1 renal dialysis facility managers1 and other representatives from alternative settings described in subclause 7,,vi74 7,,ii7 ,health risk and other assessments to determine the physical1 psychosocial1 nutrition1 language1 cultural1 and other needs of ,program-eligible beneficiaries enrolled in the ,organization involved4 7,,iii7 ,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 enrolled in the ,organization4 7,,iv7 ,coordination and delivery of non-clinical services1 such as transportation1 aimed at improving the adherence of ,program-eligible beneficiaries enrolled in the ,organization with care recommendations4 7,v7 ,services1 such as transplant evaluation and vascular access care4 7,,vi7 ,in the case of an individuals who1 while enrolled in the ,organization1 receives confirmation that a kidney transplant is imminent1 the provision by an interdisciplinary care team described in subclause 7,i7 of counseling services to such individual on preparation for and potential challenges surrounding such transplant4 7,,vii7 ,delivery of benefits and services in alternative settings1 such as the home of the ,program-eligible beneficiary enrolled in the ,organization1 in coordination with the provider or other appropriate stakeholder involved in such delivery serving on an interdisciplinary care team described in subclause 7,i74 7,,viii7 ,use of patient reminder systems4 7,,ix7 ,education programs for patients1 families1 and caregivers4 7,x7 ,use of health care advice resources1 such as nurse advice lines4 7,,xi7 ,use of team-based health care delivery models that provide comprehensive and continuous medical care1 such as medical homes4 7,,xii7 ,co-location of providers and services4 7,,xiii7 ,use of a demonstrated capacity to share electronic health record information across sites of care4 7,,xiv7 ,use of programs to promote better adherence to recommended treatment regimens by individuals1 including by addressing barriers to access to care by such individuals4 7,,xv7 ,other services1 strategies1 and approaches identified by the ,organization to improve care coordination and delivery4 7#c7 ,dialysis facility ownership requirement ,the ,secretary shall enter into contracts under this section only with ,organizations that have at least one eligible participating provider with an ownership interest in a renal dialysis facility in the ,organization's service area4 7#d7 ,requirement for capital reserves 7,a7 ,in general ,the ,secretary shall enter into contracts under this section only with ,organizations that demonstrate sufficient capital reserves1 measured as a percentage of capitated payments and consistent with requirements established by the ,state in which the ,organization operates4 7,b7 ,alternative mechanism to demonstrate capacity to bear risk ,an ,organization shall be considered to meet the requirement in subparagraph 7,a7 if the ,organization includes at least one eligible participating provider or eligible participating partner that is licensed as a risk-bearing entity or deemed by a ,state as able to bear risk4 7#e7 ,non-,application of certain provisions of law ,for purposes of sections #afb7m77#f7 and #dad7m7 of the ,internal ,revenue ,code of #aihf and section #ijaj of the ,patient ,protection and ,affordable ,care ,act 7#bf ,u4,s4,c4 #djja note prec471 in the case of an eligible participating provider that establishes an ,organization or that enters into a partnership1 ownership1 or co-ownership agreement to establish an ,organization1 or an ,organization with a contract under this section1 risk-based payments in exchange for providing medical care shall not be considered premiums for health insurance coverage4 7#f7 ,treatment as ,medicare advanced alternative payment model ,alternative care delivery models under the ,program shall be treated under this title as an advanced alternative payment model4 7c7 ,program operation and scope 7#a7 ,in general ,not later than #f months after the date of enactment of this section1 the ,secretary shall establish a process through which an ,organization can apply to offer one or more ,,esrd ,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 deliver benefits described in subsection 7b77#b77;,a74 7,b7 ,any benefits offered by the ,organization beyond those described in such subsection4 7,c7 ,a listing of network providers of services and supplier4 7,d7 ,information on the expertise of network providers of services and suppliers in serving ,,esrd patients4 7,e7 ,a description of the ,,esrd ,integrated ,care ,strategy of the ,organization described in subsection 7b77#b77;,d74 7#b7 ,program initiation ,the ,secretary shall initiate the ,program such that ,organizations begin serving ,program-eligible beneficiaries not later than ,january #a1 #bjah4 7#c7 ,contract award and period ,the ,secretary shall enter into contracts for an initial period of not less than #e years with all ,organizations that meet ,program requirements4 7#d7 ,program expansion ,the ,secretary may expand the duration and scope of the ,program under this section1 to the extent determined appropriate by the ,secretary1 if the ,secretary determines that such expansion will result in improved quality of care under the ,medicare program under this title4 7#e7 ,allowance for larger service areas and expansion of service areas ,organizations shall demonstrate in their application that the proposed service area has the capacity to serve ,program-eligible beneficiaries through an adequate provider network and is reflective of the communities in which beneficiaries live1 work1 and obtain health care services4 7#f7 ,contract termination 7,a7 ,in general ,the ,secretary may terminate a contract with an ,organization under this section if the ,secretary determines that an ,organization has failed to meet quality requirements described in subsection 7b7 or violates other terms of the contract4 7,b7 ,remedy and appeals process ,prior to the ,secretary terminating a contract with an ,organization under this section1 the ,secretary shall afford such ,organization sufficient opportunity to remedy any contract violations and appeal a contract termination4 7,c7 ,program-eligible beneficiary ,notice at ,time of ,contract ,termination ,each contract under this section with an ,organization shall require the ,organization to provide 7and pay for7 written notice in advance of the contract's termination1 as well as a description of alternatives for obtaining benefits under this title1 to each ,program-eligible beneficiary assigned to or who elected to receive benefits through the ,organization under this section4 7d7 ,identification of program-,eligible beneficiaries ,the ,secretary shall establish a process for the initial and ongoing identification of ,program-eligible beneficiaries that provides for the identification of ,program-eligible beneficiaries by ,organizations4 7e7 ,program-,eligible ,beneficiaries assigned ,into an ,,esrd ,integrated ,care ,organization ,open ,network ,model 7#a7 ,assignment 7,a7 ,in general ,under the ,program1 subject to the succeeding provisions of this paragraph1 the ,secretary shall1 upon the ,secretary or an ,organization identifying a beneficiary as a ,program-eligible beneficiary1 assign such ,program-eligible beneficiary to an open network model offered by an ,organization that includes the dialysis facility at which the ,program-eligible beneficiary primarily receives renal dialysis services4 7,b7 ,program-eligible beneficiary notification of assignment 7i7 ,in general ,upon assignment of a ,program-eligible beneficiary to an ,organization1 the ,secretary shall provide to the ,organization written notification of such assignment of such ,program-eligible beneficiary and not later than #ae business days after the date of receipt of such notification1 the ,organization shall provide written notice of such assignment to the ,program-eligible beneficiary4 7ii7 ,opt-out period and changes upon initial assignment ,the ,secretary shall provide for a #ge-;day period beginning on the date on which the assignment of a ,program-eligible beneficiary into an open network model offered by an ,organization becomes effective during which a ,program-eligible beneficiary may-- 7,i7 opt out of the ,program2 7,,ii7 make a one-time change of assignment into an open network model offered by a different ,organization2 or 7,,iii7 elect a preferred network model offered by the same or different ,organization4 7,c7 ,deemed re-enrollment ,a ,program-eligible beneficiary assigned under this paragraph to an ,,esrd ,integrated ,care ,model offered by an ,organization with respect to a year is deemed1 unless the individual elects otherwise under this paragraph1 to have elected to continue such assignment with respect to the subsequent year4 7,d7 ,additional opportunity to opt out or elect different model or organization ,on the date that is one year after the effective date of the initial assignment of a ,program-eligible beneficiary to an open network model offered by an ,organization 7and annually thereafter71 a ,program-eligible beneficiary shall be given the opportunity to-- 7i7 opt out of the ,program2 7ii7 make a one-time change of assignment into an open network model offered by a different ,organization2 or 7iii7 elect a preferred network model offered by the same or different ,organization4 7,e7 ,change in principal diagnosis opt out ,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 disease1 such individual shall be given the opportunity to opt out of the ,program during such period as specified by the ,secretary4 7,f7 ,special election periods ,the ,secretary shall offer ,program-eligible beneficiaries special election periods consistent with those described in section #ahea7;e77#d74 7#b7 ,program-eligible beneficiary notification 7,a7 ,in general ,the ,secretary shall notify ,program-eligible beneficiaries about the ,program under this section and provide them with information about receiving benefits under this title through an ,organization4 7,b7 ,requirements ,notwithstanding any other provision of law1 subject to subparagraph 7,c71 such notification shall allow for eligible participating providers that are part of an ,organization to-- 7i7 inform ,program-eligible beneficiaries about the ,program2 7ii7 distribute ,program materials to ,program-eligible beneficiaries2 and 7iii7 assist ,program-eligible beneficiaries in assessing the options of such beneficiaries under the ,program4 7,c7 ,limitation on unsolicited marketing 7i7 ,in general ,under the ,program1 an eligible participating provider may not provide marketing information or materials1 including information1 materials1 and assistance described in subparagraph 7,b71 to a ,program-eligible beneficiary unless the ,program-eligible beneficiary requests such marketing information or materials4 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 such provider4 7#c7 ,program-eligible beneficiary protections ,program-eligible beneficiaries enrolled in an ,organization shall have the same right to appeal any denial of benefits under this title as such a ,program-eligible beneficiary would have under this title if such ,program-eligible beneficiary were not so enrolled4 7f7 ,payment 7#a7 ,in general ,for each ,program-eligible beneficiary receiving care through an ,organization1 the ,secretary shall make a monthly capitated payment equal to the amount that would be determined under section #ahec7;a77#a77;,h74 7#b7 ,application of health status risk adjustment methodology ,the ,secretary shall adjust the payment amount 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 ,payment for part ,d benefits ,in the case where an ,organization elects to offer part ,d prescription drug coverage under the ,program under this section1 payments to the ,organization for such benefits provided to ,program-eligible beneficiaries by the ,organization shall be made in the same manner and amount as those payments would be made in the case of an ,organization with a contract under such part4 7#d7 ,agreement with ,state ,medicaid ,agency ,in the event of an ,organization that elects to cover benefits under title ,,xix for ,program-eligible beneficiaries eligible for benefits under this title and title ,,xix such ,organization shall enter into an agreement with the ,state ,medicaid agency to provide benefits1 or arrange for benefits to be provided1 for which such beneficiaries are entitled to receive medical assistance under title ,,xix and to receive payment from the ,state for providing or arranging for the provision of such benefits4 7#e7 ,affirmation of ,state obligations to pay premium and cost-sharing amounts 7,a7 ,in general ,a ,state shall continue to make medical assistance under the ,state plan under title ,,xix available in the amount described in subparagraph 7,b7 for the duration of the ,program for 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 enrolled in an ,organization and entitled to medical assistance for premiums and such cost-sharing under the ,state plan under title ,,xix4 7,b7 ,amounts made available for cost-sharing ,for purposes of subparagraph 7,a73 7i7 ,in general ,subject to clause 7ii71 the amount of medical assistance described in this clause to be made available for cost-sharing pursuant to subparagraph 7,a7 for an individual described in such subparagraph entitled to medical assistance for such cost-sharing under a ,state plan under title ,,xix shall be equal to the amount of medical assistance that would be made available under such ,state plan as in effect as of ,january #a1 #bjaf4 7ii7 ,amounts in the case of a ,state that increases payments for cost-sharing ,if a ,state increases the amount of medical assistance made available under the ,state plan under title ,,xix for cost-sharing described in subparagraph 7,a7 after such date1 such increased amounts shall be made available under subparagraph 7,a7 for the remaining duration of the ,program4 7g7 ,waiver authority 7#a7 ,in general ,in order to carry out the ,program under this section1 the ,secretary shall waive those requirements waived under section #ahii and may waive such additional requirements consistent with those waived under programs administered through the ,center for ,medicare and ,medicaid ,innovation as may be necessary4 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 4