,i #aaith ,,congress #b;d ,session ,h4 ,r4 #ihia ,,in ,,the ,,house ,,of ,,representatives ,july #bb1 #bjbf,mr4 ,wilson of ,south ,carolina introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to direct the ,secretary of ,health and ,human ,services to conduct a demonstration program to share savings with plans that invest in preventing the progression of kidney disease to end-stage renal disease4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,,prevent ,,esrd ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,findings4 ,sec4 #c4 ,kidney disease listening session4 ,sec4 #d4 ,multipayer kidney care medicare savings demonstration program4 #b4 ,findings ,congress finds the following3 7#a7 ,kidney disease impacts nearly #cf1jjj1jjj ,americans1 with many not getting the education1 screening1 or care that they need to delay or prevent progression to kidney failure or end-stage renal disease 7,,esrd74 ,indeed1 #i in #aj ,united ,states patients with kidney disease are unaware they have the disease4 7#b7 ,kidney disease accounts for #abf1jjj1jjj1jjj in direct health care spending each year1 with an outsized impact on the ,medicare program1 which covers most patients once they progress to ,,esrd4 ,currently1 ,medicare spends more than #ej1jjj1jjj1jjj each year on treatment related to ,,esrd4 7#c7 ,given the tremendous burden that ,,esrd places on ,medicare and the ,nation's health care system1 the ,federal ,government has a unique role to play in advancing policies intended to slow or prevent progression to ,,esrd4 7#d7 ,a voluntary payment model that allows health insurance plans1 including group health insurance and individual health insurance plans sold in the commercial market1 to share in the savings they create for ,medicare by preventing or delaying ,,esrd could help promote earlier screening and enhanced treatment for patients with kidney disease4 #c4 ,kidney disease listening session ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall host a listening session to raise awareness regarding kidney disease and to identify policy solutions to improve rates of screening1 diagnosis1 and treatment of earlier stages of kidney disease in an effort to prevent or delay the onset of ,,esrd4 ,the ,secretary shall include experts in all elements of kidney disease1 including clinical experts1 patients and patient advocates1 health plans1 and innovators1 as participants in the listening session4 #d4 ,multipayer kidney care medicare savings demonstration program ,title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 is amended by inserting after section #ahff;,g 7#db ,u4,s4,c4 #acie;cc-#g7 the following new section3 #ahff;,h4 ,multipayer kidney care medicare savings demonstration program 7a7 ,implementation of demonstration program 7#a7 ,in general ,not later than ,january #a1 #bjbg1 the ,secretary of ,health and ,human ,services shall implement a #aj-year demonstration program 7in this section referred to as the ,program7 for the purpose of increasing access for qualifying kidney disease enrollees to specified kidney care services to prevent the progression to end-stage renal disease 7,,esrd74 7#b7 ,specified kidney care services defined 7,a7 ,for the purposes of this section1 the term specified kidney care services means items and services furnished to individuals diagnosed with kidney disease to prevent the progression to ,,esrd and that would be covered under this title if furnished to an individual entitled to part ,a or enrolled in part ,b1 to include prescription drugs eligible for coverage under part ,d4 7,b7 ,the ,secretary shall specify the scope of specified kidney care services1 which shall include at a minimum items and services within the following categories and align with the typical scope of benefits offered by insurers for each type of insurance coverage specified in paragraph 7#c73 7i7 ,screening measures1 including urinalysis 7e4g41 proteinuria and kidney-specific dipsticks71 blood-based testing1 genetic testing1 and other forms of screening necessary to screen for and diagnose kidney disease4 7ii7 ,all drugs approved under section #cee of title #ba1 ,united ,states ,code1 and all biologicals licensed under section #bfb of title #db1 ,united ,states ,code1 by the ,food and ,drug ,administration with an indication for slowing the decline or loss of kidney function or to reduce the risk of decline in kidney function4 7ii7 ,nutrition services and education4 7iii7 ,disease management support1 including patient education1 follow-up support to link diagnoses to care1 genetic counseling1 access to community health workers1 and referrals to services to support health-related social needs4 7iv7 ,consultation and evaluation regarding kidney health4 7v7 ,other items and services specified by the ,secretary4 7,c7 ,the specified kidney care services shall include items and services furnished via telehealth if medically appropriate and consistent with other applicable requirements4 7#c7 ,eligible plans ,in this section1 the term eligible plan means a group health plan 7as defined under section #bgia7;b77#d7 of the ,public ,health ,service ,act71 a plan offered by a health insurance issuer 7as defined under section #bgia7;b77#b7 of such ,act71 a ,state ,medicaid program1 a ,medicaid managed care plan1 a plan that enrolls individuals under part ,c of this title1 or any other type of plan specified by the ,secretary4 7#d7 ,participating plans ,in this section1 the term participating plan means an eligible plan that voluntarily applied for the ,program1 was selected to participate pursuant to an application and selection process established by the ,secretary1 and signs an agreement with the ,secretary to participate in the ,program4 7#e7 ,eligible enrollees ,in this section1 the term qualifying kidney disease enrollee means an individual who is enrolled in a participating plan1 has a current diagnosis of kidney disease1 and meets such other criteria as the ,secretary determines appropriate4 7b7 ,program design 7#a7 ,program agreement ,under the ,program1 the ,secretary shall enter into agreements with participating plans1 pursuant to which the participating plans-- 7,a7 must implement certain activities1 as specified by the ,secretary1 designed to ensure access to specified kidney care services1 including to develop a screening plan to ensure regular screening of all enrollees for kidney disease during annual exams with primary care providers and otherwise2 7,b7 must submit historical and plan year data1 including protected health information1 as necessary 7as defined in regulations issued pursuant to section #agiba7ab7 of title #db1 ,united ,states ,code71 in a form and manner specified by the ,secretary1 subject to verification and audit by the ,secretary1 including-- 7i7 the prevalence and incidence of kidney disease and ,,esrd and the stage of chronic kidney disease 7,,ckd7 or other type of kidney disease2 7ii7 the rate of transition to the next stage of ,,ckd 7if applicable7 and from ,,ckd to ,,ersd among its enrollee population2 7iii7 the utilization of specified kidney care services by qualifying kidney disease enrollees2 7iv7 the quality of care and health outcomes among qualifying kidney disease enrollees2 and 7v7 kidney disease screening rates for all plan enrollees and for specific at-risk subpopulations as the ,secretary may specify1 such as enrollees diagnosed with diabetes or hypertension and enrollees residing in rural areas2 7,c7 must cover all specified kidney care services and must apply the lowest level of cost sharing under the plan's benefit design to such services and shall not apply utilization management to specified kidney care services that are drugs and biologicals in a manner more restrictive than the ,food and ,drug ,administration-approved labeling2 7,d7 must provide coverage without cost-sharing for all plan enrollees for screening for kidney disease2 and 7,e7 may be eligible to receive payment for a portion of the savings that accrue to ,medicare1 as estimated by the ,secretary under subsection 7c77#c71 if the number of the plan's qualifying kidney disease enrollees who progress to the next stage of ,,ckd or to ,,esrd is below the risk-adjusted benchmark established by the ,secretary under subsection 7c77#a77;,c74 7#b7 ,termination 7,a7 ,termination by the ,secretary ,the ,secretary may terminate an agreement with a participating plan if the plan fails to comply with the terms of the program agreement described in paragraph 7#a74 7,b7 ,treatment of shared savings in the event of termination ,if the agreement between the ,secretary and a participating plan is terminated in the middle of a year of the ,program1 the participating plan is not eligible for any shared savings payments under the ,program for that year and the ,secretary may recoup shared savings paid for a prior year4 7#c7 ,evaluation ,the ,secretary shall design the ,program in a manner to enable independent evaluation1 using novel methods1 of the extent to which the ,program-- 7,a7 preserves kidney function or otherwise delays the development of ,,esrd among qualifying kidney disease enrollees in participating plans and matched control groups from nonparticipating plans1 with controls selected based on demographic1 clinical1 and geographic characteristics2 and 7,b7 reduces expenditures under the ,medicare program1 as estimated through a comparison between participating plans and appropriate control groups1 adjusting for relevant demographic1 clinical1 and geographic factors4 7#d7 ,consultation ,in designing the ,program1 including in implementing the definition of specified kidney care services as described in subsection 7a77#b71 the ,secretary shall1 not later than #c months after the date of enactment of this section1 solicit public input in the form of a request for information and public listening sessions and shall consult with specialists in the field of kidney care1 sponsors and administrators of eligible plans1 and representatives of patient advocacy groups4 7c7 ,shared savings payments 7#a7 ,eligibility for shared savings payments 7,a7 ,in general ,under the ,program1 subject to the prohibition in this subsection on avoidance of at-risk individuals and any other conditions established by the ,secretary1 for each year a participating plan has an agreement in effect under the ,program1 the plan shall be eligible to receive a shared savings payment under paragraph 7#c71 provided that-- 7i7 the participating plan covers specified kidney care services1 including kidney disease screening as described in subsection 7a77#b77;,b77i72 and 7ii7 the participating plan's ,,ckd and ,,esrd progression rates1 adjusted for enrollee characteristics1 are below the benchmark described in subparagraph 7,b7 by at least the minimum percentage specified by the ,secretary4 ,this minimum percentage shall reflect normal variation in kidney disease progression rates4 7,b7 ,benchmark ,for each year of the ,program1 the ,secretary shall establish a benchmark for each participating plan based on-- 7i7 the plan's historical progression rates to the next stage of ,,ckd or from ,,ckd to ,,esrd over the most recent #c years using data submitted by the plan1 which may be subject to verification and audit by the ,secretary to validate its accuracy2 7ii7 national and regional disease prevalence over the most recent #c years2 7iii7 adjustments for enrollee characteristics2 7iv7 adjustments for increased screening rates during the plan's participation in the ,program2 and 7v7 such other factors as determined appropriate by the ,secretary4 ,the benchmark shall be reset at the start of each year of the ,program4 7#b7 ,quality performance standards ,the ,secretary shall establish quality performance standards to assess the quality of care furnished by participating plans4 ,the ,secretary shall seek to improve the quality of care furnished by participating plans over time by specifying higher standards1 new measures1 or both for purposes of assessing such quality of care4 7#c7 ,amount of shared savings payment 7,a7 ,for each year of the ,program for each participating plan1 the ,secretary shall determine1 and the ,chief ,actuary of the ,centers for ,medicare and ,medicaid ,services shall certify1 the savings that accrue to ,medicare as a result of the participating plan's performance exceeding the benchmark as calculated under paragraph 7#a77;,b71 for example as a result of an individual not obtaining ,medicare eligibility under section #ahha on the basis of progressing to ,,esrd during that year4 7,b7 ,subject to performance with respect to the quality performance standards established by the ,secretary under paragraph 7#b71 if a participating plan meets the eligibility requirements described above for a given year of the ,program1 the participating plan shall be paid #be percent of the ,medicare savings amount described in subparagraph 7,a7 for that plan4 7#d7 ,prohibition on avoidance of at-risk patients ,if the ,secretary determines that a participating plan has taken action to avoid enrolling kidney disease patients at elevated risk of developing ,,esrd1 or failed to adhere to the terms of the participation agreement specified in subsection 7b77#a71 or takes other actions in order to increase the likelihood of receiving shared savings payments under the ,program1 the ,secretary may reduce1 recoup1 or deny shared savings payments or terminate the participating plan from the ,program4 7#e7 ,optional advance investment payment ,the ,secretary may provide1 in an amount determined by the ,secretary1 an advance investment payment to each participating plan for each qualifying kidney disease enrollee for each year of the plan's participation with respect to such enrollee4 ,a participating plan must use such advance investment payment to improve the quality1 efficiency1 or uptake of specified kidney care items and services furnished to beneficiaries1 which may include coming into compliance with the plan's participation requirements under the ,program described in this section4 ,the participating plan must report to the ,administrator of the ,centers for ,medicare and ,medicaid ,services how the plan used such funds not later than #ahj days after the end of the relevant year in a form and manner specified by the ,secretary4 ,the total amount of any such advance investment payment in a given year shall be deducted from the shared savings payment received by the participating plan for the relevant year1 if any1 up to the amount of such shared savings in the event the amount of the advance investment payment exceeds the amount of the shared savings payment4 7d7 ,prohibition on duplicate payments ,the ,secretary shall ensure that no duplicate payments under this section are made by ,medicare with respect to a qualifying kidney disease enrollee4 7e7 ,monitoring1 evaluation1 and reporting by the ,secretary 7#a7 ,monitoring and evaluation ,the ,secretary shall monitor and evaluate the ,program on an ongoing basis and shall conduct an intermediate and final evaluation of the ,program in accordance with the requirements described in subsection 7b77#c74 ,each such evaluation shall determine the extent to which the purpose of increasing access for qualifying kidney disease enrollees to specified kidney care services to prevent the progression to ,,esrd has been accomplished under the ,program4 7#b7 ,reporting ,the ,secretary shall submit to ,congress-- 7,a7 not later than #c years after the date of the implementation of the ,program1 a report with respect to the intermediate evaluation2 and 7,b7 a report with respect to the final evaluation not later than #f years after such date4 7f7 ,funding 7#a7 ,administrative funding ,for purposes of administering and carrying out the ,program1 other than for payments for items and services furnished under this title1 advance investment payment under subsection 7c77#e71 and shared savings payment under subsection 7c77#c71 in addition to funds otherwise appropriated1 there shall be transferred to the ,secretary for the ,centers for ,medicare and ,medicaid ,services ,program ,management ,account from the ,federal ,hospital ,insurance ,trust ,fund under section #ahag and the ,federal ,supplementary ,medical ,insurance ,trust ,fund under section #ahda 7in proportions determined appropriate by the ,secretary7 #e1jjj1jjj for each of fiscal years #bjbf through #bjch4 ,amounts transferred under this subsection for a fiscal year shall be available until expended4 7#b7 ,shared savings payments ,the shared savings payments and advance investment payments under the ,program1 for each of program years #bjbg through #bjcg1 shall be made from the ,federal ,hospital ,insurance ,trust ,fund established under section #ahag and the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda in such proportion as the ,secretary determines reflects the relative weight that benefits under part ,a and under part ,b represents of the actuarial value of the ,medicare savings determined under subsection 7c77#c7 and the advance investment payments determined under subsection 7c77#e74 7g7 ,waiver and implementation authority 7#a7 ,the ,secretary may implement provisions of this section by program instruction1 agreement1 or otherwise4 7#b7 ,the ,secretary may waive any requirement of titles ,,xi or ,,xviii and of sections #aijb7;a77#a71 #aijb7;a77#ac71 and #aijc7m77#b77;,a77iii7 of this ,act as may be necessary to carry out the ,program4 7#c7 ,the ,paperwork ,reduction ,act 7#dd ,u4,s4,c4 #ceja et seq47 shall not apply to implementation and administration of the ,program4 4