,,ii #aacth ,,congress #b;d ,session ,s4 #bghc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #aj1 #bjad,mr4 ,thune 7for himself and ,ms4 ,stabenow7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to establish a demonstration program requiring the utilization of ,value-,based ,insurance ,design to demonstrate that reducing the copayments or coinsurance charged to ,medicare beneficiaries for selected high-value prescription medications and clinical services can increase their utilization and ultimately improve clinical outcomes and lower health care expenditures4 #a4 ,short title ,this ,act may be cited as the ,value ,based ,insurance ,design for ,better ,care ,act of #bjad or the ,,vbid for ,better ,care ,act of #bjad4 #b4 ,findings ,congress makes the following findings3 7#a7 ,a growing body of evidence demonstrates that increases in patient-level financial barriers 7including deductibles1 copayments1 and coinsurance7 for high-value medical services 7such as prescription medications1 clinician visits1 diagnostic tests1 and procedures7 systematically reduce their use4 ,savings attributable to cost-related decreased utilization of specific services may lead to an increase in total medical expenditures due to increased use of other related clinical services1 such as hospitalizations and emergency room visits4 7#b7 ,empirical research studies demonstrate that reductions in beneficiary out-of-pocket expenses for high-value prescription medications and clinical services can mitigate the adverse health and financial consequences attributable to cost-related decreased utilization of high-value services4 7#c7 ,financial barriers to prescription medications and clinical services that are deemed to be high value should be reduced or eliminated to increase their use4 7#d7 ,value-,based ,insurance ,design is a methodology that adjusts patient out-of-pocket costs for prescription medications and clinical services according to the clinical value--not exclusively the cost4 ,value-,based ,insurance ,design is based on the concept of clinical nuance that recognizes-- 7,a7 prescription medications and clinical services differ in the clinical benefit provided2 and 7,b7 the clinical benefit derived from a specific prescription medication or clinical service depends on the clinical situation1 the provider1 and where the care is delivered4 7#e7 ,the current one-size-fits-all copayment or coinsurance design for prescription medications and clinical services provided under the ,medicare program does not recognize the well-established value differences in health outcomes produced by various medical interventions4 7#f7 ,the establishment by ,medicare of copayment and coinsurance requirements using ,value-,based ,insurance ,design methodologies will improve patient-centered health outcomes1 enhance personal responsibility1 and afford a more efficient use of taxpayer dollars4 #c4 ,demonstration program 7a7 ,in general ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish a #c-year demonstration program to test the use of value-based insurance design methodologies 7as defined in subsection 7c77#a77 under eligible ,medicare ,advantage plans offered by ,medicare ,advantage organizations under part ,c of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq474 7b7 ,demonstration program design 7#a7 ,selection of ,,ma region and eligible ,medicare ,advantage plans ,the ,secretary shall-- 7,a7 select at least two ,,ma regions 7as defined in section #aheh7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg;a7a77#b777 with respect to which to conduct the demonstration program under this section2 and 7,b7 approve eligible ,medicare ,advantage plans to participate in such demonstration program4 7#b7 ,start of demonstration ,the demonstration program shall begin with respect to the first plan year beginning after the date on which at least two eligible ,medicare ,advantage plans have been approved by the ,secretary in at least one ,,ma region selected under paragraph 7#a74 7#c7 ,eligible ,medicare ,advantage plans ,for purposes of this section1 the term eligible ,medicare ,advantage plan means a ,medicare ,advantage plan under part ,c of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba et seq47 that meets the following requirements3 7,a7 ,the plan is an ,,ma regional plan 7as defined in paragraph 7#d7 of section #ahei7;b7 of such ,act 7#db ,u4,s4,c4 #aciew-#bh7;b777 or ,,ma local plan 7as defined in paragraph 7#e7 of such section7 offered in the ,,ma region selected under paragraph 7#a77;,a74 7,b7 ,the plan has-- 7i7 a quality rating under section #ahec7n77#d7 of such ,act 7#db ,u4,s4,c4 #aciew-#bc7n77#d77 of #d stars or higher based on the most recent data available for such year2 7ii7 in the case of a specialized ,,ma plan for special needs individuals1 as defined in subsection 7b77#f77;,a7 of section #ahei7;b77#f77;,a7 of such ,act 7#db ,u4,s4,c4 #aciew-#bh7;b77#f77;,a771 received a multi-year approval by the ,national ,committee for ,quality ,assurance under subsection 7f77#g7 of such section2 or 7iii7 at least #bj percent of the population to whom the plan is offered consists of subsidy eligible individuals 7as defined in section #ahfj;,d-#ad7;a77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#c77;,a7774 7c7 ,value-,based insurance design methodologies 7#a7 ,definition ,for purposes of this section1 the term value-based insurance design methodology means a methodology for identifying specific prescription medications1 and clinical services that are reimbursable under title ,,xviii of the ,social ,security ,act1 for which copayments1 coinsurance1 or both should be reduced or eliminated because of the high value and effectiveness of such medications and services for specific chronic clinical conditions 7as approved by the ,secretary74 7#b7 ,use of methodologies to reduce copayments and coinsurance ,a ,medicare ,advantage organization offering an eligible ,medicare ,advantage plan selected to participate under the demonstration program1 for each plan year for which the plan is so selected and using value-based insurance design methodologies-- 7,a7 shall identify each prescription medication and clinical service covered under such plan for which the amount of the copayment or coinsurance should be reduced or eliminated1 with respect to the management of specific chronic clinical conditions 7as specified by the ,secretary7 of ,,ma eligible individuals 7as defined in section #ahea7;a77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7;a77#c777 enrolled under such plans1 for such plan year2 and 7,b7 may1 for such plan year1 reduce or eliminate copayments1 coinsurance1 or both for such prescription medication and clinical services so identified with respect to the management of such conditions of such individuals-- 7i7 if such reduction or elimination is evidence-based1 for the purpose of encouraging such individuals in such plan to use such prescription medications and clinical services 7such as preventive care1 primary care1 specialty visits1 diagnostic tests1 procedures1 and durable medical equipment7 with respect to such conditions2 and 7ii7 for the purpose of encouraging such individuals in such plan to use health care providers that such organization has identified with respect to such plan year4 7#c7 ,prohibition of increases of copayments and coinsurance ,in no case may any ,medicare ,advantage plan participating in the demonstration program increase1 for any plan year for which the plan is so participating1 the amount of copayments or coinsurance for any item or service covered under such plan for purposes of discouraging the use of such item or service4 7d7 ,report on implementation 7#a7 ,in general ,not later than #a year after the date on which the demonstration program under this section begins under subsection 7b77#b71 the ,secretary shall submit to ,congress a report on the status of the implementation of the demonstration program4 7#b7 ,elements ,the report required by paragraph 7#a7 shall1 with respect to eligible ,medicare ,advantage plans participating in the demonstration program for the first plan year of such program1 include the following3 7,a7 ,a list of each medication and service identified pursuant to subsection 7c77#b77;,a7 for such plan with respect to such plan year4 7,b7 ,for each such medication or service so identified1 the amount of the copayment or coinsurance required under such plan with respect to such plan year for such medication or service and the amount of the reduction of such copayment or coinsurance from the previous plan year4 7,c7 ,for each provider identified pursuant to subsection 7c77#b77;,b77ii7 for such plan with respect to such plan year1 a statement of the amount of the copayment or coinsurance required under such plan with respect to such plan year and the amount of the reduction of such copayment or coinsurance from the previous plan year4 7e7 ,review and assessment of utilization of value-,based insurance design methodologies 7#a7 ,in general ,the ,secretary shall enter into a contract or agreement with an independent1 non-biased entity having expertise in value-based insurance design methodologies to review and assess the implementation of the demonstration program under this section4 ,the review and assessment shall include the following3 7,a7 ,an assessment of the utilization of value-based insurance design methodologies by ,medicare ,advantage plans participating under such program4 7,b7 ,an analysis of whether reducing or eliminating the copayment or coinsurance for each medication and clinical service identified pursuant to subsection 7c77#b77;,a7 resulted in increased adherence to medication regimens1 increased service utilization1 improvement in quality metrics1 better health outcomes1 and enhanced beneficiary experience4 7,c7 ,an analysis of the extent to which costs to ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act participating in the demonstration program is less than costs to ,medicare ,advantage plans under such part that are not participating in the demonstration program4 7,d7 ,an analysis of whether reducing or eliminating the copayment or coinsurance for providers identified pursuant to subsection 7c77#b77;,b77ii7 resulted in improvement in quality metrics1 better health outcomes1 and enhanced beneficiary experience4 7,e7 ,an analysis1 for each provider so identified1 the extent to which costs to ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act participating in the demonstration program is less than costs to ,medicare ,advantage plans under such part that are not participating in the demonstration program4 7,f7 ,such other matters1 as the ,secretary considers appropriate4 7#b7 ,report ,the contract or agreement entered into under paragraph 7#a7 shall require such entity to submit to the ,secretary a report on the review and assessment conducted by the entity under such paragraph in time for the inclusion of the results of such report in the report required by paragraph 7#c74 7#c7 ,report to ,congress ,not later than #c years after the date on which the demonstration program begins under subsection 7b77#b71 the ,secretary shall submit to ,congress a report on the review and assessment of the demonstration program conducted under this subsection4 ,the report shall include the following3 7,a7 ,a description of the results of the review and assessment included in the report submitted pursuant to paragraph 7#b74 7,b7 ,such recommendations as the ,secretary considers appropriate for enhancing the utilization of the methodologies applied under the demonstration program to all ,medicare ,advantage plans under part ,c of title ,,xviii of the ,social ,security ,act so as to reduce copayments and coinsurance under such plans paid by ,medicare beneficiaries for high-value prescription medications and clinical services for which coverage is provided under such plans and to otherwise improve the quality of health care provided under such plans4 7f7 ,expansion of demonstration program ,the ,secretary shall expand the demonstration program1 pursuant to notice and comment rulemaking1 to implement1 on a permanent basis1 the components of the demonstration program that are beneficial to ,medicare beneficiaries and the ,medicare program1 unless the report under subsection 7d7 or 7e77#c7 contains an evaluation that the demonstration program-- 7#a7 increases expenditures under title ,,xviii with respect to ,medicare beneficiaries participating in the demonstration program2 or 7#b7 decreases the quality of health care services furnished to such ,medicare beneficiaries participating in the demonstration program4 7g7 ,waiver authority ,the ,secretary may waive such provisions of titles ,,xi and ,,xviii of the ,social ,security ,act as may be necessary to carry out the demonstration program under this section4 7h7 ,implementation funding ,for purposes of carrying out the demonstration program under this section1 the ,secretary shall provide for the transfer from the ,federal ,hospital ,insurance ,trust ,fund under section #ahag of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;i7 and the ,federal ,supplementary ,insurance ,trust ,fund under section #ahda of the ,social ,security ,act 7#db ,u4,s4,c4 #aciet71 including the ,medicare ,prescription ,drug ,account in such ,trust ,fund1 in such proportion as determined appropriate by the ,secretary1 of such sums as may be necessary4