,i #aafth ,,congress #ast ,session ,h4 ,r4 #dffc ,,in ,,the ,,house ,,of ,,representatives ,october #aa1 #bjai,ms4 ,porter 7for herself1 ,ms4 ,underwood1 ,mr4 ,crow1 and ,mr4 ,blumenauer7 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 drug manufacturers to pay a ,medicare part ,b rebate for certain drugs if the price of such drugs increases faster than inflation4 #a4 ,short title ,this ,act may be cited as the ,freedom from ,price ,gouging ,act4 #b4 ,medicare part ,b prescription drug inflation rebate by manufacturers 7a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7x7 ,rebate by manufacturers for single source drugs with prices increasing faster than inflation 7#a7 ,requirements 7,a7 ,secretarial provision of information ,not later than #f months after the end of each calendar quarter beginning on or after ,july #a1 #bjba1 the ,secretary shall1 for each part ,b rebatable drug1 report to each manufacturer of such part ,b rebatable drug the following for such calendar quarter3 7i7 ,information on the total number of billing units described in subparagraph 7,a77i7 of paragraph 7#c7 with respect to such drug and calendar quarter4 7ii7 ,information on the amount 7if any7 of the excess average sales price increase described in subparagraph 7,a77ii7 of such paragraph for such drug and calendar quarter4 7iii7 ,the rebate amount specified under such paragraph for such part ,b rebatable drug and calendar quarter4 7,b7 ,manufacturer requirement ,for each calendar quarter beginning on or after ,july #a1 #bjba1 the manufacturer of a part ,b rebatable drug shall1 for such drug1 not later than #cj days after the date of receipt from the ,secretary of the information described in subparagraph 7,a7 for such calendar quarter1 provide to the ,secretary a rebate that is equal to the amount specified in paragraph 7#c7 for such drug for such calendar quarter4 7#b7 ,part ,b rebatable drug defined 7,a7 ,in general ,in this subsection1 the term part ,b rebatable drug means a single source drug or biological 7as defined in subparagraph 7,d7 of section #ahdg;,a7c77#f771 including a biosimilar biological product 7as defined in subparagraph 7,h7 of such section71 paid for under this part1 except such term shall not include such a drug or biological-- 7i7 if the average total allowed charges for a year per individual that uses such a drug or biological1 as determined by the ,secretary1 are less than1 subject to subparagraph 7,b71 #ajj2 or 7ii7 that is a vaccine described in subparagraph 7,a7 or 7,b7 of section #ahfa7s77#aj74 7,b7 ,increase ,the dollar amount applied under subparagraph 7,a77i7-- 7i7 for #bjbb1 shall be the dollar amount specified under such subparagraph for #bjba1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 as of the first quarter of the previous year2 and 7ii7 for a subsequent year1 shall be the dollar amount specified in this clause 7or clause 7i77 for the previous year1 increased by the percentage increase in the consumer price index for all urban consumers 7,united ,states city average7 as of the first quarter of the previous year4 ,any dollar amount specified under this subparagraph that is not a multiple of #aj shall be rounded to the nearest multiple of #aj4 7#c7 ,rebate amount 7,a7 ,in general ,for purposes of paragraph 7#a77;,b71 the amount specified in this paragraph for a part ,b rebatable drug assigned to a billing and payment code for a calendar quarter is1 subject to paragraph 7#d71 the amount equal to the product of-- 7i7 subject to subparagraph 7,b71 the total number of billing units1 as described in section #ahdg;,a7b77#f77;,b71 for such part ,b rebatable drug furnished under this part during the calendar quarter2 and 7ii7 the amount 7if any7 by which-- 7,i7 the payment amount under subparagraph 7,b7 or 7,c7 of section #ahdg;,a7b77#a71 as applicable1 for such part ,b rebatable drug during the calendar quarter2 exceeds 7,,ii7 the inflation-adjusted payment amount determined under subparagraph 7,c7 for such part ,b rebatable drug during the calendar quarter4 7,b7 ,excluded units ,for purposes of subparagraph 7,a77i71 the total number of billing units for part ,b rebatable drugs furnished during a calendar quarter shall not include-- 7i7 units packaged into the payment for a related procedure or service under section #ahcc7t7 or under section #ahcc7;i7 7instead of separately payable under such respective section72 7ii7 units included under the single payment system for renal dialysis services under section #ahha7;b77#ad72 or 7iii7 units of a part ,b rebatable drug of a manufacturer that is furnished to an individual1 if such manufacturer1 with respect to the furnishing of such units of such drug1 provides for discounts under section #cdj;,b of the ,public ,health ,service ,act or for rebates under section #aibg4 7,c7 ,determination of inflation-adjusted payment amount ,the inflation-adjusted payment amount determined under this subparagraph for a part ,b rebatable drug for a calendar quarter is-- 7i7 the payment amount for the billing and payment code for such drug in the payment amount benchmark quarter 7as defined in subparagraph 7,d772 increased by 7ii7 the percentage by which the rebate period ,,cpi-,u 7as defined in subparagraph 7,f77 for the calendar quarter exceeds the benchmark period ,,cpi-,u 7as defined in subparagraph 7,e774 7,d7 ,payment amount benchmark quarter ,the term payment amount benchmark quarter means the calendar quarter beginning ,january #a1 #bjaf4 7,e7 ,benchmark period ,,cpi-,u ,the term benchmark period ,,cpi-,u means the consumer price index for all urban consumers 7,united ,states city average7 for ,july #bjae4 7,f7 ,rebate period ,,cpi-,u ,the term rebate period ,,cpi-,u means1 with respect to a calendar quarter described in subparagraph 7,c71 the greater of the benchmark period ,,cpi-,u and the consumer price index for all urban consumers 7,united ,states city average7 for the first month of the calendar quarter that is two calendar quarters prior to such described calendar quarter4 7#d7 ,special treatment of certain drugs and exemption 7,a7 ,subsequently approved drugs ,subject to subparagraph 7,b71 in the case of a part ,b rebatable drug first approved by the ,food and ,drug ,administration after ,july #a1 #bjae1 clause 7i7 of paragraph 7#c77;,c7 shall be applied as if the term payment amount benchmark quarter were defined under paragraph 7#c77;,d7 as the third full calendar quarter after the day on which the drug was first marketed and clause 7ii7 of paragraph 7#c77;,c7 shall be applied as if the term benchmark period ,,cpi-,u were defined under paragraph 7#c77;,e7 as if the reference to ,july #bjae under such paragraph were a reference to the first month of the first full calendar quarter after the day on which the drug was first marketed4 7,b7 ,timeline for provision of rebates for new drugs ,in the case of a part ,b rebatable drug first approved by the ,food and ,drug ,administration after ,july #a1 #bjae1 clause 7i7 of paragraph 7#a77;,b7 shall be applied as if the reference to ,july #a1 #bjba under such paragraph were a reference to the later of the #fth full calendar quarter after the day on which the drug was first marketed or ,july #a1 #bjba4 7,c7 ,exemption for shortages ,the ,secretary may reduce or waive the rebate under paragraph 7#a77;,b7 with respect to a part ,b rebatable drug that appears on the drug shortage list in effect under section #ejf7;e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or in the case of other exigent circumstances1 as determined by the ,secretary4 7#e7 ,application to beneficiary coinsurance ,in the case of a part ,b rebatable drug for which a rebate is payable under this subsection-- 7,a7 in computing the amount of any coinsurance applicable under this title to an individual with respect to such drug1 the computation of such coinsurance shall be based on the inflation-adjusted payment amount determined under paragraph 7#c77;,c7 for such part ,b rebatable drug2 and 7,b7 the amount of such coinsurance is equal to #bj percent of such inflation-adjusted payment amount so determined4 7#f7 ,rebate deposits ,amounts paid as rebates under paragraph 7#a77;,b7 shall be deposited into the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7#g7 ,civil money penalty ,if a manufacturer of a part ,b rebatable drug has failed to comply with the requirements under paragraph 7#a77;,b7 for such drug for a calendar quarter1 the manufacturer shall be subject to1 in accordance with a process established by the ,secretary pursuant to regulations1 a civil money penalty in an amount equal to at least #abe percent of the amount specified in paragraph 7#c7 for such drug for such calendar quarter4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 shall apply to a civil money penalty under this paragraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7#h7 ,study and report 7,a7 ,study ,the ,secretary shall conduct a study of the feasibility of and operational issues involved with the following3 7i7 ,including multiple source drugs 7as defined in section #ahdg;,a7c77#f77;,c77 in the rebate system under this subsection4 7ii7 ,including drugs and biologicals paid for under ,,ma plans under part ,c in the rebate system under this subsection4 7iii7 ,including drugs excluded under paragraph 7#b77;,a7 and billing units of drugs excluded under paragraph 7#c77;,b7 in the rebate system under this subsection4 7,b7 ,report ,not later than #c years after the date of the enactment of this subsection1 the ,secretary shall submit to ,congress a report on the study conducted under subparagraph 7,a74 7#i7 ,application to multiple source drugs ,the ,secretary may1 based on the report submitted under paragraph 7#h7 and pursuant to rulemaking1 apply the provisions of this subsection to multiple source drugs 7as defined in section #ahdg;,a7c77#f77;,c771 including1 for purposes of determining the rebate amount under paragraph 7#c71 by calculating manufacturer-specific average sales prices for the benchmark period and the rebate period4 4 7b7 ,amounts payable2 cost-,sharing ,section #ahcc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,s71 by striking with respect to and inserting subject to subparagraph 7,,dd71 with respect to2 7,b7 by striking and 7,,cc7 and inserting 7,,cc72 and 7,c7 by inserting before the semicolon at the end the following3 1 and 7,,dd7 with respect to a part ,b rebatable drug 7as defined in paragraph 7#b7 of section #ahcd7x77 for which a rebate is payable under such section1 the amounts paid shall be the difference between 7i7 the payment amount under paragraph 7#c77;,a77ii77,i7 of such section for such drug1 and 7ii7 #bj percent of the inflation-adjusted payment amount under paragraph 7#c77;,a77ii77,,ii7 of such section for such drug2 and 7#b7 by adding at the end of the flush left matter following paragraph 7#i71 the following3 ,for purposes of applying paragraph 7#a77;,,dd7 and section #ahcd7x77#e71 the ,secretary shall make such estimates and use such data as the ,secretary determines appropriate4 4 7c7 ,conforming amendment to part ,b ,,asp calculation ,section #ahdg;,a7c77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#c77 is amended by inserting or section #ahcd7x7 after section #aibg4