,i #aafth ,,congress #ast ,session ,h4 ,r4 #diac ,,in ,,the ,,house ,,of ,,representatives ,october #cj1 #bjai,mr4 ,mc,kinley 7for himself and ,ms4 ,kuster of ,new ,hampshire7 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 amend title ,,xviii of the ,social ,security ,act to require ,,pdp sponsors of a prescription drug 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 ,requirements for ,,pdp sponsors of prescription drug 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,i7 ,required inclusion of certain generic drugs and biosimilar biological products 7i7 ,in general ,with respect to a plan year beginning on or after ,january #a1 #bjba1 the formulary shall include-- 7,i7 each covered generic drug for which the wholesale acquisition cost is less than the wholesale acquisition cost of the reference drug of such covered generic drug2 and 7,,ii7 each covered biosimilar biological product for which the wholesale acquisition cost is less than the wholesale acquisition cost of the reference biological product of such covered biosimilar biological product4 7ii7 ,prohibition on certain limits on access ,the ,,pdp sponsor offering the prescription drug plan may not impose limits on access to a covered generic drug required to be included on the formulary under clause 7i77,i7 or a covered 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 reference drug of such covered generic drug or reference biological product of such covered biosimilar biological product1 respectively1 or that otherwise have the effect of giving preferred status to such reference drug or reference biological product over such covered generic drug or covered biosimilar biological product1 respectively4 7iii7 ,definitions ,in this subparagraph and subparagraph 7,j73 7,i7 ,covered biosimilar biological product ,the term covered 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 ,covered generic drug ,the term covered generic drug means a covered part ,d drug that is a drug described in section #ahfj;,d-#b7;e77#a77;,a7 and approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,,iii7 ,reference biological product ,the term reference biological product has the meaning given such term in section #ahdg;,a7c77#f77;,i74 7,,iv7 ,reference drug ,the term reference drug means1 with respect to a covered generic drug1 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 covered 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,j7 ,cost-,sharing tiering requirements with respect to covered generic drugs and covered biosimilar biological products 7i7 ,generic drug cost-,sharing tier ,with respect to a plan year beginning on or after ,january #a1 #bjba1 the ,,pdp sponsor offering the prescription drug plan shall-- 7,i7 have at least one cost-sharing tier on the formulary that only includes covered generic drugs and covered biosimilar biological products2 and 7,,ii7 apply a cost-sharing requirement with respect to each cost-sharing tier described in subclause 7,i7 on the formulary that is meaningfully lesser than the lowest cost-sharing requirement applicable with respect to any cost-sharing tier on such formulary that includes a brand drug 7referred to in this subparagraph as the lowest brand drug cost-sharing tier74 7ii7 ,specialty generic drug cost-,sharing tier ,with respect to a plan year beginning on or after ,january #a1 #bjba1 if the ,,pdp sponsor offering the prescription drug plan has a cost-sharing tier for specialty brand drugs on the formulary1 the ,,pdp sponsor shall-- 7,i7 have a cost-sharing tier on such formulary that only includes covered generic drugs and covered biosimilar biological products-- 7aa7 for which the wholesale acquisition cost is greater than a threshold specified by the ,secretary2 and 7bb7 with respect to which the reference drug for such a covered generic drug or the reference biological product for such a covered 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 cost-sharing requirement with respect to the cost-sharing tier required for the formulary under subclause 7,i7 that is meaningfully lesser than the cost-sharing requirement applicable with respect to the cost-sharing tier for specialty brand drugs on such formulary4 7iii7 ,placement of certain generic drugs and biosimilar biological products ,each covered generic drug and each covered biosimilar biological product required to be included on the formulary under subparagraph 7,i77i7 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 ,definitions ,in this subparagraph3 7,i7 ,brand drug ,the term brand drug means a covered part ,d drug that is a drug described in section #ahfj;,d-#b7;e77#a77;,a7 and approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act4 7,,ii7 ,meaningfully lesser ,the term meaningfully lesser means-- 7aa7 for purposes of subclause 7,,ii7 of clause 7i71 such a lesser cost-sharing requirement that the ,secretary determines will likely significantly incentivize the utilization of covered generic drugs and covered biosimilar biological products on a cost-sharing tier described in subclause 7,i7 of such clause on a formulary over covered part ,d drugs on the lowest brand drug cost-sharing tier on such formulary2 and 7bb7 for purposes of subclause 7,,ii7 of clause 7ii71 such a lesser cost-sharing requirement that the ,secretary determines will likely significantly incentivize the utilization of covered generic drugs and covered biosimilar biological products on the cost-sharing tier required for the formulary under subclause 7,i7 of such clause over covered part ,d drugs on the cost-sharing tier for specialty brand drugs on such formulary4 7,,iii7 ,specialty brand drug ,the term specialty brand drug means a brand drug for which the wholesale acquisition cost is greater than a threshold specified by the ,secretary4 4 7b7 ,conforming amendment ,section #ahfj;,d-#b7;b77#b77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b77;,b77 is amended by inserting before the period the following3 and section #ahfj;,d-#d7;b77#c77;,j74