,,ii #aaith ,,congress #ast ,session ,s4 #afcg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #g1 #bjbe ,mr4 ,mullin 7for himself1 ,ms4 ,hassan1 and ,mr4 ,scott of ,south ,carolina7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xix of the ,social ,security ,act to codify value-based purchasing arrangements under the ,medicaid program and reforms related to price reporting under such arrangements1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicaid ,v,b,ps for ,patients ,act or the ,,mvp ,act4 #b4 ,codifying value-based purchasing arrangements under ,medicaid and reforms related to price reporting under such arrangements 7a7 ,codifying multiple best price points 7#a7 ,in general ,section #aibg7;c77#a77;,c77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77 is amended-- 7,a7 in subclause 7,,iii71 by adding a semicolon at the end2 7,b7 in subclause 7,,iv71 by striking and at the end2 7,c7 in subclause 7,v71 by striking the period and inserting 2 and2 and 7,d7 by adding at the end the following new subclause3 7,,vi7 may include multiple best price points for a single dosage form and strength of a drug of a manufacturer subject to a value-based purchasing arrangement 7as defined in subsection 7k77#ab771 but only if such manufacturer offers such arrangement to all ,states4 4 7#b7 ,rule of construction ,nothing in the amendments made by this subsection may be construed to prohibit a manufacturer from treating a value-based purchasing arrangement as a bundled sale4 7b7 ,definition of average manufacturer price 7#a7 ,in general ,section #aibg7k77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77 is amended-- 7,a7 in subparagraph 7,b77i7-- 7i7 in subclause 7,,iv71 by adding a semicolon at the end2 7ii7 in subclause 7,,vii71 by striking at the end and2 7iii7 in subclause 7,,viii71 by striking the period at the end and inserting 2 and2 and 7iv7 by adding at the end the following new subclause3 7,,ix7 with respect to a covered outpatient drug that is sold under a value-based purchasing arrangement 7as defined in paragraph 7#ab77 during the rebate period1 including such a drug that is an inhalation1 infusion1 instilled1 implanted1 or injectable drug that is not generally dispensed through a retail community pharmacy-- 7aa7 a refund1 rebate1 reimbursement1 or free goods from the manufacturer or third party on behalf of the manufacturer2 or 7bb7 the withholding or reduction of a payment to the manufacturer or third party on behalf of the manufacturer2 that is triggered by a patient who fails to achieve outcomes or measures defined under the terms of such value-based purchasing arrangement during the period for which such arrangement is effective4 2 and 7,b7 by adding at the end the following new subparagraph3 7,d7 ,special rule for certain value-based purchasing arrangements ,for purposes of subparagraph 7,a71 in determining the average price paid to a manufacturer for a covered outpatient drug that is sold under a value-based purchasing arrangement 7as defined in paragraph 7#ab77 that provides that payment for such drug is made in installments over the course of such arrangement1 such price shall be determined as if the aggregate price per the terms of the arrangement were paid in full in the first installment during the rebate period4 4 7#b7 ,rulemaking ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall implement the amendments made by this subsection through rulemaking4 7c7 ,definition of value-,based purchasing arrangement ,section #aibg7k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is amended by adding at the end the following paragraph3 7#ab7 ,value-,based ,purchasing ,arrangement ,the term value-based purchasing arrangement has the meaning given such term in section #ddg4ejb of title #db1 ,code of ,federal ,regulations 7or any successor regulation74 4 #c4 ,calculation of average sales price under ,medicare ,section #ahdg;,a7c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is amended-- 7#a7 by striking ,in calculating and inserting the following3 7,a7 ,in general ,subject to subparagraph 7,b71 in calculating 2 and 7#b7 by adding at the end the following new subparagraph3 7,b7 ,certain remuneration under value-based purchasing arrangements excluded ,in calculating the manufacturer's average sales price under this subsection for a drug or biological that is sold under a value-based purchasing arrangement 7as defined in section #aibg7k77#ab77 and with respect to which the manufacturer of such drug or biological has elected to include multiple best price points 7as described in section #aibg7;c77#a77;,c77ii77,,vi77 in reporting the best price of such drug under section #aibg7;b71 such manufacturer's average sales price shall not include any amount that is excluded from the calculation of the average manufacturer price of such drug or biological under section #aibg7k77#a77;,b77i77,,ix74 4 #d4 ,guidance on value-based purchasing arrangements for inpatient drugs under ,medicaid ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance to ,state ,medicaid agencies on the option of entering into a value-based purchasing arrangement 7as defined in section #aibg7k77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#ab777 with manufacturers for drugs or biological products provided as part of1 or as incident to and in the same setting as1 inpatient hospital services furnished under a ,state plan under title ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acif et seq471 or under a waiver of such plan1 where such drugs or biological products are reimbursed directly and not paid for as part of payment for such inpatient hospital services1 including guidance on how multiple ,states may enter into agreements with one another and with manufacturers which permit the transfer of funds between the participating ,states so that individuals who reside in a ,state different from the ,state in which they receive a drug subject to a value-based purchasing arrangement as an inpatient may be treated as if they received such drug in the ,state in which they reside4 #e4 ,exception under the antikickback statute 7a7 ,in general ,section #aabh;,b7b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;b7b77#c77 is amended-- 7#a7 in subparagraph 7,j71 by moving the left margin of such subparagraph #b ems to the left2 7#b7 in subparagraph 7,k7-- 7,a7 by moving the left margin of such subparagraph #b ems to the left2 and 7,b7 by striking and at the end2 7#c7 in subparagraph 7,l77iii71 by striking the period and inserting 2 and2 and 7#d7 by adding at the end the following new subparagraph3 7,m7 any remuneration provided by a manufacturer or third party on behalf of a manufacturer to a ,state under a value-based purchasing arrangement 7as defined in section #aibg7k77#ab77 under a ,state plan under title ,,xix 7or waiver of such plan7 in the case a patient fails to achieve outcomes or measures defined in such arrangement following the administration of a covered outpatient drug 7as defined in section #aibg7k77#b774 4 7b7 ,rulemaking ,not later than #ahj days after the date of the enactment of this ,act1 the ,inspector ,general of the ,department of ,health and ,human ,services shall through rulemaking implement the amendments made by this section4 #f4 ,,gao study and report on use of value-based purchasing arrangements 7a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the extent to which value-based purchasing arrangements 7as defined in section #aibg7k77#ab7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#ab777 facilitate patient access to covered outpatient drugs1 improve patient outcomes1 lower overall health system costs1 and lower costs for patients in ,federal health care programs4 ,in conducting such study1 the ,comptroller ,general shall-- 7#a7 study the impact of this ,act on-- 7,a7 access to transformative therapies1 including rare disease gene therapies1 generally2 7,b7 mitigating socioeconomic disparities in accessing covered outpatient drugs sold under value-based purchasing arrangements through its requirement that ,state ,medicaid programs have access to the same value-based purchasing arrangement pricing structure that are available in the commercial market for such drugs2 7,c7 the ,medicaid drug rebate program under section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h71 the #cdj;,b drug pricing program under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b71 and part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq471 including compliance with such programs2 7,d7 expenditures under ,state ,medicaid programs2 and 7,e7 prices for such drugs under the ,medicaid program in ,states that do not enter into such arrangements2 7#b7 analyze all the types of value-based purchasing arrangement pricing structures1 which structures are working well 7as measured by price and ease of implementing71 and which need improvement2 and 7#c7 study the potential long-term savings for ,states that enter into such arrangements under ,state ,medicaid programs4 7b7 ,report ,not later than ,june #cj1 #bjbi1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the study conducted under subsection 7a74