,,ii #aafth ,,congress #ast ,session ,s4 #bjha ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #aj1 #bjai ,mr4 ,peters 7for himself and ,ms4 ,stabenow7 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 drug manufacturers to provide rebates for drugs furnished under ,medicare part ,b for which the growth in average sales price has exceeded inflation1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,stop ,drug ,companies from ,overcharging ,seniors in ,medicare ,part ,b ,act of #bjai4 #b4 ,requiring drug manufacturers to provide rebates for drugs furnished under ,medicare part ,b for which ,,asp growth has exceeded inflation ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended by adding at the end the following new subsection3 7h7 ,prescription drug rebate agreement 7#a7 ,requirement 7,a7 ,in general ,subject to subparagraphs 7,b7 and 7,c71 in order for payment to be made under this part for an applicable part ,b drug 7as defined in paragraph 7#g77;,a77 of a manufacturer furnished on or after ,january #a1 #bjbj1 the manufacturer shall have entered into and have in effect a rebate agreement described in paragraph 7#b7 with the ,secretary4 7,b7 ,exceptions ,this subsection shall not apply with respect to an applicable part ,b drug of a manufacturer-- 7i7 if the ,secretary determines that the estimated average annual cost per user for the associated drug billing code as determined in such manner as the ,secretary determines appropriate1 including with respect to an applicable part ,b drug for which a ,,hcpcs code has not been assigned1 is less than-- 7,i7 for #bjbj1 #ajj2 and 7,,ii7 for a subsequent year1 the amount determined under this clause for the preceding year increased by the percentage increase in the consumer price index for all urban consumers 7,u4,s4 city average7 for the #ab-month period ending with ,june of the previous year2 7ii7 if the drug is included on the drug shortage list under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e74 7,c7 ,establishment of procedures to avoid duplication ,the ,secretary shall establish procedures to ensure that there is no duplication with respect to drug rebates provided by manufacturers with respect to applicable part ,b drugs under this subsection and either of the following3 7i7 ,purchase by a covered entity of covered outpatient drugs pursuant to an agreement under section #cdj;,b of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bef;b74 7ii7 ,drug rebates provided by manufacturers with respect to covered outpatient drugs pursuant to section #aibg4 7#b7 ,rebate agreement ,a rebate agreement under this subsection shall require the manufacturer to provide to the ,secretary 7to be deposited in the ,treasury to the credit of the ,federal ,supplementary ,medical ,insurance ,trust ,fund7 a rebate for each rebate period 7as defined in paragraph 7#g77;,b77 ending after ,december #ca1 #bjai1 in an amount specified in paragraph 7#d7 for applicable part ,b drugs of the manufacturer furnished after ,december #ca1 #bjai1 for which payment was made under this section or under a separate ambulatory classification group pursuant to section #ahcc7t7 for such period4 ,such rebate shall be paid by the manufacturer not later than #cj days after the date of receipt of the information described in paragraph 7#c7 for the period involved4 7#c7 ,secretary provision of information 7,a7 ,in general ,the ,secretary shall report to each manufacturer not later than #ahj days after the end of each rebate period and in a form consistent with a standard reporting format established by the ,secretary1 information on the total number of units of each dosage form and strength and package size of each applicable part ,b drug of the manufacturer furnished after ,december #ca1 #bjai1 for which payment was made under this section or under a separate ambulatory classification group pursuant to section #ahcc7t7 during the period4 7,b7 ,audits by manufacturer of information provided ,a manufacturer may1 as determined by the ,secretary1 audit the information provided 7or required to be provided7 under subparagraph 7,a74 7,c7 ,audits by ,secretary ,the ,secretary may audit the information provided 7or required to be provided7 under subparagraph 7,a7 and the determination of the billing-code level rebate amount1 including the manufacturer-level billing-code level ,,asp and inflation-adjusted billing-code level ,,asp1 under paragraph 7#d74 7,d7 ,adjustments based on audit results ,the ,secretary shall make adjustments to rebates and average sales price as appropriate based on the results of an audit conducted under subparagraph 7,b7 or 7,c74 7#d7 ,determination of billing-code level rebate amount 7,a7 ,in general ,the amount of the rebate specified under this paragraph for a manufacturer for a rebate period1 with respect to applicable part ,b drugs of a manufacturer assigned to a billing code1 shall be equal to the product of-- 7i7 the total number of units of such drugs of the manufacturer assigned to the billing code for which payment was made under this section or under a separate ambulatory classification group pursuant to section #ahcc7t7 for the rebate period2 and 7ii7 the amount 7if any7 by which-- 7,i7 the manufacturer-level billing-code level ,,asp 7as defined in subparagraph 7,b77 for the manufacturer for the rebate period1 exceeds 7,,ii7 the inflation-adjusted billing-code level ,,asp 7as defined in subparagraph 7,c77 for the rebate period4 7,b7 ,manufacturer-level billing-code level ,,asp defined ,in this subsection1 the term manufacturer-level billing-code level ,,asp means1 with respect to a manufacturer and a billing code for a rebate period1 subject to subparagraph 7,e77i71 the weighted average sales price 7per unit7 across all of the ,national ,drug ,codes for a manufacturer assigned to the billing code1 as determined by the ,secretary1 for the quarter used to establish payment rates for such ,codes during the rebate period4 7,c7 ,inflation-adjusted billing-code level ,,asp defined ,in this subsection1 the term inflation-adjusted billing-code level ,,asp means1 with respect to a billing code and a rebate period1 the product of-- 7i7 subject to subparagraph 7,e77ii71 the average sales price for all ,national ,drug ,codes1 regardless of manufacturer1 assigned to the billing code1 as determined by the ,secretary1 for the calendar quarter beginning ,january #a1 #bjag2 and 7ii7 the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 between ,december #bjaf1 and the month prior to the quarter described in subparagraph 7,b74 7,d7 ,treatment of subsequently approved drugs ,in the case of an applicable part ,b drug first marketed after ,september #cj1 #bjaf1 clause 7i7 of subparagraph 7,c7 shall be applied by substituting the second full calendar quarter after the day on which the drug was first marketed for the calendar quarter beginning ,january #a1 #bjag and clause 7ii7 of such subparagraph shall be applied by substituting the month prior to the first month of the second full calendar quarter after the day on which the drug was first marketed for ,december #bjaf4 7,e7 ,authority to modify methodology 7i7 ,determination of manufacturer-level billing-code level ,,asp ,in the case where the ,secretary does not have manufacturer level data with respect to a billing code1 the ,secretary may request such additional data as needed1 allocate total volume for all ,national ,drug ,codes1 regardless of manufacturer1 assigned to the billing ,code as determined by the ,secretary1 or use an alternate methodology as necessary in order to determine the manufacturer-level billing-code level ,,asp under subparagraph 7,b74 7ii7 ,determination of inflation-adjusted billing-code level ,,asp ,in the case where the ,secretary does not have sufficient data with respect to the average sales price for applicable part ,b drugs assigned to a billing code in order to determine the inflation-adjusted billing-code level ,,asp for the period described in subparagraph 7,c77i71 including through the application of subparagraph 7,d7 to such subparagraph 7,c77i71 the ,secretary may modify the methodology or period as necessary for purposes of determining an inflation-adjusted billing-code level ,,asp for such period4 7#e7 ,submission of data ,a rebate agreement under this subsection shall require a manufacturer of an applicable part ,b drug to submit to the ,secretary at such time1 and in such manner1 as the ,secretary may specify such data as the ,secretary determines is necessary in order to carry out this subsection4 7#f7 ,length of agreement ,the provisions of paragraph 7#d7 of section #aibg7;b7 7other than clauses 7iv7 and 7v7 of subparagraph 7,b77 shall apply to rebate agreements under this subsection in the same manner as such paragraph applies to a rebate agreement under such section4 7#g7 ,other terms and conditions ,the ,secretary shall establish other terms and conditions of the rebate agreement under this subsection1 including terms and conditions related to compliance1 that are consistent with this subsection4 7#h7 ,definitions ,in this subsection3 7,a7 ,applicable part ,b drug ,the term applicable part ,b drug means-- 7i7 a drug or biological described in section #ahdb7o77#a77;,c7 for which payment is made under this section2 or 7ii7 a drug or biological for which the ,secretary has established a separate ambulatory classification group under the prospective payment system for hospital outpatient department services under section #ahcc7t74 7,b7 ,rebate period ,the term rebate period means1 with respect to an agreement under paragraph 7#b71 a calendar quarter or other period specified by the ,secretary with respect to the payment of rebates under such agreement4 4 #c4 ,protection against high out-of-pocket expenditures for part ,b drugs ,title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 is amended by inserting after section #ahdg;,b the following new section3 #ahdg;,c4 ,protection against high out-of-pocket expenditures for part ,b drugs 7a7 ,in general ,notwithstanding any other provision of this title1 in the case of an individual enrolled under this part1 if the amount of the out-of-pocket cost-sharing for part ,b drugs 7as defined in subsection 7b77 of such individual for a year 7beginning with #bjbj7 equals or exceeds the part ,b drug annual out-of-pocket threshold specified in subsection 7c7 for the year1 section #ahcc7;a77#a77,s7 shall be applied by substituting #ajj percent for #hj percent4 7b7 ,out-of-,pocket ,cost-,sharing for part ,b drugs defined ,in this section1 the term out-of-pocket cost-sharing for part ,b drugs means1 with respect to an individual1 the amount of the expenses incurred by the individual that are attributable to drugs or biologicals furnished under this part4 7c7 ,part ,b drug annual out-of-,pocket threshold 7#a7 ,in general ,for purposes of this section1 the part ,b drug annual out-of-pocket threshold specified in this subsection-- 7,a7 for #bjbj1 is equal to the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b7 for #bjai1 increased by the annual percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period ending in ,july of the #bjai2 and 7,b7 for a subsequent year1 is equal to the amount specified in this subsection for the previous year1 increased by the annual percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 for the #ab-month period ending in ,july of the previous year4 7#b7 ,rounding ,any amount determined under paragraph 7#a7 that is not a multiple of #ej shall be rounded to the nearest multiple of #ej4 4