,,ii #aahth ,,congress #ast ,session ,s4 #babi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #bb1 #bjbc ,mr4 ,lankford 7for himself and ,mr4 ,menendez7 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 require ,,pdp sponsors of a prescription drug plan and ,medicare ,advantage organizations offering an ,,ma-,,pd plan under part ,d of the ,medicare program that use a formulary to include certain generic drugs and biosimilar biological products on such formulary1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,access to ,lower-,cost ,medicines for ,seniors ,act4 #b4 ,requirements for ,,pdp sponsors of prescription drug plans and ,medicare advantage organizations offering ,,ma-,,pd plans under part ,d of the ,medicare program that use formularies 7a7 ,in general ,section #ahfj;,d-#d7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77 is amended by adding at the end the following new subparagraphs3 7,j7 ,required inclusion of certain generic drugs and biosimilar biological products 7i7 ,in general ,subject to the succeeding provisions of this subparagraph1 with respect to a plan year beginning on or after ,january #a1 #bjbe1 the following rules shall apply3 7,i7 ,if the formulary includes a part ,d reference drug1 the formulary shall include each part ,d generic drug of such part ,d reference drug for which the wholesale acquisition cost is less than the wholesale acquisition cost of such part ,d reference drug4 7,,ii7 ,if the formulary includes a part ,d reference biological product1 the formulary shall include at least one part ,d biosimilar biological of such part ,d reference biological product for which the wholesale acquisition cost is less than the wholesale acquisition cost of such part ,d reference biological product 7if one or more such part ,d biosimilar biologicals is available74 7ii7 ,determinations and implementation ,determinations of part ,d generic drugs and part ,d biosimilar biological products described in subclauses 7,i7 and 7,,ii7 of clause 7i7 and implementation of formulary requirements under clause 7i7 shall be made by ,,pdp sponsors offering prescription drug plans in accordance with uniform requirements established by the ,secretary 7by program instruction or otherwise71 which shall provide for such determinations to be made as of specified dates 7in the case of determinations during a plan year1 on a quarterly basis71 and for any associated formulary changes to be implemented promptly thereafter 7in accordance with timeframes specified by the ,secretary74 ,such uniform requirements shall also specify circumstances under which a part ,d generic drug or part ,d biosimilar biological product shall be deemed for purposes of subclauses 7,i7 and 7,,ii7 of clause 7i7 to have a lower wholesale acquisition cost than its part ,d reference drug or part ,d reference biological product 7so as to require its inclusion on formularies71 including where no wholesale acquisition cost is published for such part ,d reference drug or part ,d reference biological product or the part ,d reference drug or part ,d reference biological product is not available for purchase by the ,,pdp sponsor 7or its network pharmacies7 from its manufacturer at the published wholesale acquisition cost4 7iii7 ,prohibition on certain limits on access ,the ,,pdp sponsor offering the prescription drug plan may not impose limits on access to a part ,d generic drug required to be included on the formulary under clause 7i77,i7 or a part ,d biosimilar biological product required to be included on the formulary under clause 7i77,,ii71 including through prior authorization1 utilization management1 or step therapy1 that are more restrictive than any such limits imposed on access to the part ,d reference drug of such part ,d generic drug or part ,d reference biological product of such part ,d biosimilar biological product1 respectively1 or that otherwise have the effect of giving preferred status to such part ,d reference drug or part ,d reference biological product over such part ,d generic drug or part ,d biosimilar biological product1 respectively4 7iv7 ,definitions ,in this subparagraph and subparagraph 7,k73 7,i7 ,part ,d biosimilar biological product ,the term part ,d biosimilar biological product means a covered part ,d drug that is a biosimilar biological product 7as defined in section #ahdg;,a7c77#f77;,h774 7,,ii7 ,part ,d generic drug ,the term part ,d generic drug means a covered part ,d drug that is approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,,iii7 ,part ,d reference biological product ,the term part ,d reference biological product means a covered part ,d drug that is a reference biological product 7as defined in section #ahdg;,a7c77#f77;,i774 7,,iv7 ,part ,d reference drug ,the term part ,d reference drug means1 with respect to a part ,d generic drug1 a covered part ,d drug that is the listed drug 7as described in clause 7i7 of section #eje7;j77#b77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 that is referred to in the abbreviated application for such part ,d generic drug under such section4 7,v7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b74 7,k7 ,cost-,sharing tiering requirements with respect to part ,d generic drugs and part ,d biosimilar biological products 7i7 ,generic drug and biosimilar biological product cost-sharing tier ,with respect to a plan year beginning on or after ,january #a1 #bjbe1 if the ,,pdp sponsor offering the prescription drug plan applies tiered cost-sharing 7through copayment or coinsurance tiers7 to covered part ,d drugs on a formulary1 the ,,pdp sponsor shall-- 7,i7 have at least one cost-sharing tier on the formulary that only includes part ,d generic drugs and part ,d biosimilar biological products2 and 7,,ii7 with respect to each cost-sharing tier described in subclause 7,i7 on the formulary1 either apply no cost-sharing requirement or a copayment that is-- 7aa7 in the case where the lowest branded drug tier of such formulary bases cost-sharing on a copayment amount1 an amount at least #bj lower than the copayment for such lowest branded drug tier 7but in no case may such copayment amount be less than zero72 or 7bb7 in the case where the lowest branded drug tier of such formulary bases cost-sharing on a coinsurance percentage1 an amount at least #bj lower than the actuarially expected average cost-sharing amount payable for the covered part ,d drugs included on such lowest branded drug tier1 determined using processes and methods established under section #ahfj;,d-#aa7;c7 7but in no case may such copayment amount be less than zero74 7ii7 ,specialty generic drug and biosimilar biological product cost-sharing tier ,with respect to a plan year beginning on or after ,january #a1 #bjbe1 if the ,,pdp sponsor offering the prescription drug plan has a specialty tier1 the ,,pdp sponsor shall-- 7,i7 have a second specialty tier on such formulary that only includes part ,d generic drugs and part ,d biosimilar biological products-- 7aa7 for which the cost 7as defined by the ,secretary7 is greater than a cost threshold specified by the ,secretary2 and 7bb7 with respect to which the part ,d reference drug for such a part ,d generic drug or the part ,d reference biological product for such a part ,d biosimilar biological product is either included on a cost-sharing tier on such formulary with a cost-sharing requirement that is greater than the cost-sharing requirement applied under subclause 7,,ii71 or excluded from such formulary2 and 7,,ii7 apply a coinsurance cost-sharing requirement with respect to the cost-sharing tier required for the formulary under subclause 7,i7 that is at least #e percentage points lower than the coinsurance percentage applicable to any other specialty tier of the formulary4 7iii7 ,placement of certain generic drugs and biosimilar biological products ,each part ,d generic drug and each part ,d biosimilar biological product required to be included on the formulary under subparagraph 7,j77i7 shall be included either on a cost-sharing tier described in clause 7i77,i7 or1 if applicable1 the cost-sharing tier required for the formulary under clause 7ii77,i74 7iv7 ,application 7,i7 ,in general ,the requirements under clauses 7i7 through 7iii7 shall1 subject to the requirements under section #ahfj;,d-#ad1 apply after the individual has satisfied any deductible under subsections 7a77#b77;,a77i7 or 7b77#a7 of section #ahfj;,d-#b4 7,,ii7 ,limitation ,the ,secretary shall not approve any benefit design for a prescription drug plan or an ,,ma-,,pd plan to which the requirements of this subparagraph apply if such benefit design has any deductible applicable to any part ,d generic drug or part ,d biosimilar biological product unless such deductible1 or a greater deductible1 also applies to all other covered part ,d drugs on the formulary of such plan 7subject to the requirements under section #ahfj;,d-#ad71 except for lesser or zero deductibles applicable only to particular types of covered part ,d drugs which the ,secretary determines warrant favorable cost-sharing when such lesser or zero deductibles are also applicable to part ,d generic drugs and part ,d biosimilar biological products of the given type4 7v7 ,definitions ,in this subparagraph3 7,i7 ,brand drug ,the term brand drug means a covered part ,d drug that is approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea7;a7 of the ,public ,health ,service ,act4 7,,ii7 ,lowest branded drug tier ,the term lowest branded drug tier means the cost-sharing tier of a formulary which includes at least #a brand drug and provides for the lowest level of cost sharing applicable to any such tier1 as determined by the ,secretary4 7,,iii7 ,specialty tier ,the term specialty tier means a cost-sharing tier consisting only of covered part ,d drugs that have a cost 7as defined by the ,secretary7 which equals or exceeds an applicable cost threshold established by the ,secretary for high-cost covered part ,d drugs to be eligible for inclusion on such cost-sharing tier4 4 7b7 ,conforming amendments ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a71 by striking and paragraphs 7#h7 and 7#i7 and inserting 1 paragraphs 7#h7 and 7#i71 and section #ahfj;,d-#d7;b77#c77,k72 and 7,b7 in subparagraph 7,b71 by inserting before the period the following3 and section #ahfj;,d-#d7;b77#c77,k72 and 7#b7 in subsection 7c71 by adding at the end the following new paragraph3 7#g7 ,treatment of cost-sharing for part ,d generic drugs and part ,d biosimilar biological products ,the coverage is provided in accordance with section #ahfj;,d-#d7;b77#c77,k74 4