,i #aagth ,,congress #ast ,session ,h4 ,r4 #ai ,,in ,,the ,,house ,,of ,,representatives ,april #ba1 #bjba,mrs4 ,rodgers of ,washington 7for herself1 ,mr4 ,brady1 ,ms4 ,foxx1 ,mr4 ,guthrie1 ,mr4 ,nunes1 and ,mr4 ,allen7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 and the ,judiciary1 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 provide for certain reforms with respect to the ,medicare program under title ,,xviii of the ,social ,security ,act1 the ,medicaid program under title ,,xix of such ,act1 the ,food and ,drug ,administration1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,lower ,costs1 ,more ,cures ,act of #bjba4 #b4 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title4,sec4 #b4 ,table of contents4,title ,i--,medicare ,parts ,b and ,d,subtitle ,a--,medicare ,part ,b ,provisions ,sec4 #aja4 ,improvements to ,medicare site-of-service transparency4,sec4 #ajb4 ,requiring manufacturers of certain single-dose container or single-use package drugs payable under part ,b of the ,medicare program to provide refunds with respect to discarded amounts of such drugs4,sec4 #ajc4 ,providing for variation in payment for certain drugs covered under part ,b of the ,medicare program4,sec4 #ajd4 ,establishment of maximum add-on payment for drugs and biologicals4,sec4 #aje4 ,treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider4,subtitle ,b--,drug ,price ,transparency,sec4 #aaa4 ,reporting on explanation for drug price increases4,sec4 #aab4 ,public disclosure of drug discounts4,sec4 #aac4 ,study of pharmaceutical supply chain intermediaries and merger activity4,sec4 #aad4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities4,sec4 #aae4 ,sense of ,congress regarding the need to expand commercially available drug pricing comparison platforms4,subtitle ,c--,medicare ,part ,d ,benefit ,redesign,sec4 #aba4 ,medicare part ,d benefit redesign4,subtitle ,d--,other ,medicare ,part ,d ,provisions,sec4 #aca4 ,allowing the offering of additional prescription drug plans under ,medicare part ,d4,sec4 #acb4 ,allowing certain enrollees of prescription drug plans and ,,ma-,,pd plans under ,medicare program to spread out cost-sharing under certain circumstances4,sec4 #acc4 ,establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or ,,ma-,,pd plan4,sec4 #acd4 ,growth rate of ,medicare part ,d out-of-pocket cost threshold4,title ,,ii--,medicaid,sec4 #bja4 ,medicaid pharmacy and therapeutics committee improvements4,sec4 #bjb4 ,,gao report on conflicts of interest in ,state ,medicaid program drug use review boards and pharmacy and therapeutics 7,p,t7 committees4,sec4 #bjc4 ,ensuring the accuracy of manufacturer price and drug product information under the ,medicaid drug rebate program4,sec4 #bjd4 ,improving transparency and preventing the use of abusive spread pricing and related practices in ,medicaid4,sec4 #bje4 ,t-,,msis drug data analytics reports4,sec4 #bjf4 ,risk-sharing value-based payment agreements for covered outpatient drugs under ,medicaid4,sec4 #bjg4 ,applying ,medicaid drug rebate requirement to drugs provided as part of outpatient hospital services4,title ,,iii--,food and ,drug ,administration,subtitle ,a--,pay-for-,delay,sec4 #cja4 ,unlawful agreements4,sec4 #cjb4 ,notice and certification of agreements4,sec4 #cjc4 ,forfeiture of #ahj-;day exclusivity period4,sec4 #cjd4 ,commission litigation authority4,sec4 #cje4 ,statute of limitations4,subtitle ,b--,advancing ,education on ,biosimilars,sec4 #cba4 ,education on biological products4,subtitle ,c--,other ,provisions,sec4 #cca4 ,clarifying the meaning of new chemical entity4,title ,,iv--,revenue ,provision,sec4 #dja4 ,safe harbor for high deductible health plans without deductible for insulin4,title ,v--,miscellaneous,sec4 #eja4 ,payment for biosimilar biological products during initial period4,sec4 #ejb4 ,,gao study and report on average sales price4,sec4 #ejc4 ,requiring prescription drug plans and ,,ma-,,pd plans to report potential fraud1 waste1 and abuse to the ,secretary of ,,hhs4,sec4 #ejd4 ,establishment of pharmacy quality measures under ,medicare part ,d4,sec4 #eje4 ,improving coordination between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services4,sec4 #ejf4 ,patient consultation in ,medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives4,sec4 #ejg4 ,med,p,a,c report on shifting coverage of certain ,medicare part ,b drugs to ,medicare part ,d4,sec4 #ejh4 ,requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information4,sec4 #eji4 ,chief ,pharmaceutical ,negotiator at the ,office of the ,united ,states ,trade ,representative4 ,i ,medicare ,parts ,b and ,d ,a ,medicare ,part ,b ,provisions #aja4 ,improvements to ,medicare site-of-service transparency ,section #ahcd7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7t77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the heading1 by striking ,in general and inserting ,site payment2 7,b7 in the matter preceding subparagraph 7,a7-- 7i7 by striking or to and inserting 1 to2 7ii7 by inserting 1 or to a physician for services furnished in a physician's office after surgical center2 and 7iii7 by inserting 7or #bjbb with respect to a physician for services furnished in a physician's office7 after #bjah2 and 7,c7 in subparagraph 7,a7-- 7i7 by striking and the and inserting 1 the2 and 7ii7 by inserting 1 and the physician fee schedule under section #ahdh 7with respect to the practice expense component of such payment amount7 after such section2 7#b7 by redesignating paragraphs 7#b7 through 7#d7 as paragraphs 7#c7 through 7#e71 respectively2 and 7#c7 by inserting after paragraph 7#a7 the following new paragraph3 7#b7 ,physician payment ,beginning in #bjbb1 the ,secretary shall expand the information included on the ,internet website described in paragraph 7#a7 to include-- 7,a7 the amount paid to a physician under section #ahdh for an item or service for the settings described in paragraph 7#a72 and 7,b7 the estimated amount of beneficiary liability applicable to the item or service4 4 #ajb4 ,requiring manufacturers of certain single-dose container or single-use package drugs payable under part ,b of the ,medicare program to provide refunds with respect to discarded amounts of such drugs ,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 7i7 ,refund for certain discarded single-,dose container or single-,use package drugs 7#a7 ,secretarial provision of information 7,a7 ,in general ,for each calendar quarter beginning on or after ,january #a1 #bjbb1 the ,secretary shall1 with respect to a refundable single-dose container or single-use package drug 7as defined in paragraph 7#h771 report to each manufacturer 7as defined in subsection 7c77#f77;,a77 of such refundable single-dose container or single-use package drug the following for the calendar quarter3 7i7 ,subject to subparagraph 7,c71 information on the total number of units of the billing and payment code of such drug1 if any1 that were discarded during such quarter1 as determined using a mechanism such as the ,,jw modifier used as of the date of enactment of this subsection 7or any such successor modifier that includes such data as determined appropriate by the ,secretary74 7ii7 ,the refund amount that the manufacturer is liable for pursuant to paragraph 7#c74 7,b7 ,determination of discarded amounts ,for purposes of subparagraph 7,a77i71 with respect to a refundable single-dose container or single-use package drug furnished during a quarter1 the amount of such drug that was discarded shall be determined based on the amount of such drug that was unused and discarded for each drug on the date of service4 7,c7 ,exclusion of units of packaged drugs ,the total number of units of the billing and payment code of a refundable single-dose container or single-use package drug of a manufacturer furnished during a calendar quarter for purposes of subparagraph 7,a77i71 and the determination of the estimated total allowed charges for the drug in the quarter for purposes of paragraph 7#c77;,a77ii71 shall not include such units that are packaged into the payment amount for an item or service and are not separately payable4 7#b7 ,manufacturer requirement ,for each calendar quarter beginning on or after ,january #a1 #bjbb1 the manufacturer of a refundable single-dose container or single-use package drug shall1 for such drug1 provide to the ,secretary a refund that is equal to the amount specified in paragraph 7#c7 for such drug for such quarter4 7#c7 ,refund amount 7,a7 ,in general ,the amount of the refund specified in this paragraph is1 with respect to a refundable single-dose container or single-use package drug of a manufacturer assigned to a billing and payment code for a calendar quarter beginning on or after ,january #a1 #bjbb1 an amount equal to the estimated amount 7if any7 by which-- 7i7 the product of-- 7,i7 the total number of units of the billing and payment code for such drug that were discarded during such quarter 7as determined under paragraph 7#a772 and 7,,ii7 7aa7 in the case of a refundable single-dose container or single-use package drug that is a single source drug or biological1 the amount of payment determined for such drug or biological under subsection 7b77#a77;,b7 for such quarter2 or 7bb7 in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product1 the amount of payment determined for such product under subsection 7b77#a77;,c7 for such quarter2 exceeds 7ii7 an amount equal to the applicable percentage 7as defined in subparagraph 7,b77 of the estimated total allowed charges for such drug under this part during the quarter4 7,b7 ,applicable percentage defined 7i7 ,in general ,for purposes of subparagraph 7,a77ii71 the term applicable percentage means-- 7,i7 subject to subclause 7,,ii71 #aj percent2 and 7,,ii7 if applicable1 in the case of a refundable single-dose container or single-use package drug described in clause 7ii71 a percentage specified by the ,secretary pursuant to such clause4 7ii7 ,treatment of drugs that have unique circumstances ,in the case of a refundable single-dose container or single-use package drug that has unique circumstances involving similar loss of product as that described in paragraph 7#h77;,b77ii71 the ,secretary1 through notice and comment rulemaking1 may increase the applicable percentage otherwise applicable under clause 7i77,i7 as determined appropriate by the ,secretary4 7#d7 ,frequency ,amounts required to be refunded pursuant to paragraph 7#b7 shall be paid in regular intervals 7as determined appropriate by the ,secretary74 7#e7 ,refund deposits ,amounts paid as refunds pursuant to paragraph 7#b7 shall be deposited into the ,federal ,supplementary ,medical ,insurance ,trust ,fund established under section #ahda4 7#f7 ,enforcement 7,a7 ,audits 7i7 ,manufacturer audits ,each manufacturer of a refundable single-dose container or single-use package drug that is required to provide a refund under this subsection shall be subject to periodic audit with respect to such drug and such refunds by the ,secretary4 7ii7 ,provider audits ,the ,secretary shall conduct periodic audits of claims submitted under this part with respect to refundable single-dose container or single-use package drugs in accordance with the authority under section #ahcc7;e7 to ensure compliance with the requirements applicable under this subsection4 7,b7 ,civil money penalty 7i7 ,in general ,the ,secretary shall impose a civil money penalty on a manufacturer of a refundable single-dose container or single-use package drug who has failed to comply with the requirement under paragraph 7#b7 for such drug for a calendar quarter in an amount equal to the sum of-- 7,i7 the amount that the manufacturer would have paid under such paragraph with respect to such drug for such quarter2 and 7,,ii7 #be percent of such amount4 7ii7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7#g7 ,implementation ,the ,secretary shall implement this subsection through notice and comment rulemaking4 7#h7 ,definition of refundable single-dose container or single-use package drug 7,a7 ,in general ,except as provided in subparagraph 7,b71 in this subsection1 the term refundable single-dose container or single-use package drug means a single source drug or biological 7as defined in section #ahdg;,a7c77#f77;,d77 or a biosimilar biological product 7as defined in section #ahdg;,a7c77#f77;,h77 for which payment is made under this part and that is furnished from a single-dose container or single-use package4 7,b7 ,exclusions ,the term refundable single-dose container or single-use package drug does not include-- 7i7 a drug or biological that is either a radiopharmaceutical or an imaging agent2 7ii7 a drug or biological approved by the ,food and ,drug ,administration for which dosage and administration instructions included in the labeling require filtration during the drug preparation process1 prior to dilution and administration1 and require that any unused portion of such drug after the filtration process be discarded after the completion of such filtration process2 or 7iii7 a drug or biological approved by the ,food and ,drug ,administration on or after the date of enactment of this subsection and with respect to which payment has been made under this part for fewer than #ah months4 7#i7 ,report to ,congress ,not later than #c years after the date of enactment of this subsection1 the ,office of the ,inspector ,general1 after consultation with the ,centers for ,medicare ,medicaid ,services and the ,food and ,drug ,administration1 shall submit to the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance in the ,senate1 a report on any impact this section is reported to have on the licensure1 market entry1 market retention1 or marketing of biosimilar biological products4 ,such report shall be updated periodically at the direction of the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives and the ,committee on ,finance in the ,senate4 4 #ajc4 ,providing for variation in payment for certain drugs covered under part ,b of the ,medicare program 7a7 ,in general ,section #ahdg;,a7b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7b77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by inserting after or #ajf percent the following3 7or1 for a multiple source drug 7other than autologous cellular immunotherapy7 furnished on or after ,january #a1 #bjbb1 the applicable percent specified in paragraph 7#i77;,a7 for the drug and quarter involved72 and 7,b7 in subparagraph 7,b7 of paragraph 7#a71 by inserting after #ajf percent the following3 7or1 for a single source drug or biological 7other than autologous cellular immunotherapy7 furnished on or after ,january #a1 #bjbb1 the applicable percent specified in paragraph 7#i77;,a7 for the drug or biological and quarter involved72 and 7#b7 by adding at the end the following new paragraph3 7#i7 ,application of variable percentages based on percentile ranking of per beneficiary allowed charges 7,a7 ,applicable percent to be applied 7i7 ,in general ,subject to clauses 7ii71 with respect to a drug or biological furnished in a calendar quarter beginning on or after ,january #a1 #bjbb1 if the ,secretary determines that the percentile rank of a drug or biological under subparagraph 7,b77i77,,iii71 with respect to per beneficiary allowed charges for all such drugs or biologicals1 is-- 7,i7 at least equal to the #heth percentile1 the applicable percent for the drug for such quarter under this subparagraph is #ajd percent2 7,,ii7 at least equal to the #gjth percentile1 but less than the #heth percentile1 such applicable percent is #ajf percent2 7,,iii7 at least equal to the #ejth percentile1 but less than the #gjth percentile1 such applicable percent is #ajh percent2 or 7,,iv7 less than the #ejth percentile1 such applicable percent is #aaj percent4 7ii7 ,cases where data not sufficiently available to compute per beneficiary allowed charges ,subject to clause 7iii71 in the case of a drug or biological furnished for which the amount of payment is determined under subparagraph 7,a7 or 7,b7 of paragraph 7#a7 and not under subsection 7c77#d71 for calendar quarters during a period in which data are not sufficiently available to compute a per beneficiary allowed charges for the drug or biological1 the applicable percent is #ajf percent4 7,b7 ,determination of percentile rank of per beneficiary allowed charges of drugs 7i7 ,in general ,with respect to a calendar quarter beginning on or after ,january #a1 #bjbb1 for drugs and biologicals for which the amount of payment is determined under subparagraph 7,a7 or 7,b7 of paragraph 7#a71 except for drugs or biologicals for which data are not sufficiently available1 the ,secretary shall-- 7,i7 compute the per beneficiary allowed charges 7as defined in subparagraph 7,c77 for each such drug or biological2 7,,ii7 adjust such per beneficiary allowed charges for the quarter1 to the extent provided under subparagraph 7,d72 and 7,,iii7 array such adjusted per beneficiary allowed charges for all such drugs or biologicals from high to low and rank such drugs or biologicals by percentile of such arrayed per beneficiary allowed charges4 7ii7 ,frequency ,the ,secretary shall make the computations under clause 7i77,i7 every #f months 7or1 if necessary1 as determined by the ,secretary1 every #i or #ab months7 and such computations shall apply to succeeding calendar quarters until a new computation has been made4 7iii7 ,applicable data period ,for purposes of this paragraph1 the term applicable data period means the most recent period for which the data necessary for making the computations under clause 7i7 are available1 as determined by the ,secretary4 7,c7 ,per beneficiary allowed charges defined ,in this paragraph1 the term per beneficiary allowed charges means1 with respect to a drug or biological for which the amount of payment is determined under subparagraph 7,a7 or 7,b7 of paragraph 7#a7-- 7i7 the allowed charges for the drug or biological for which payment is so made for the applicable data period1 as estimated by the ,secretary2 divided by 7ii7 the number of individuals for whom any payment for the drug or biological was made under paragraph 7#a7 for the applicable data period1 as estimated by the ,secretary4 7,d7 ,adjustment to reflect changes in average sales price ,in applying this paragraph for a particular calendar quarter1 the ,secretary shall adjust the per beneficiary allowed charges for a drug or biological by multiplying such per beneficiary allowed charges under subparagraph 7,c7 for the applicable data period by the ratio of-- 7i7 the average sales price for the drug or biological for the most recent calendar quarter used under subsection 7c77#e77;,b72 to 7ii7 the average sales price for the drug or biological for the calendar quarter 7or the weighted average for the quarters involved7 included in the applicable data period4 4 7b7 ,application of judicial review provisions ,section #ahdg;,a7g7 of the ,social ,security ,act is amended-- 7#a7 by striking and at the end of paragraph 7#d72 7#b7 by striking the period at the end of paragraph 7#e7 and inserting 2 and2 and 7#c7 by adding at the end the following new paragraph3 7#f7 the determination of per beneficiary allowed charges of drugs or biologicals and ranking of such charges under subsection 7b77#i74 4 #ajd4 ,establishment of maximum add-on payment for drugs and biologicals 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a71 as amended by section #ajc1 is further amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking paragraph 7#g7 and inserting paragraphs 7#g7 and 7#aj72 and 7,b7 by adding at the end the following new paragraph3 7#aj7 ,maximum add-on payment amount 7,a7 ,in general ,in determining the payment amount under the provisions of subparagraph 7,a71 7,b71 or 7,c7 of paragraph 7#a7 of this subsection1 subsection 7c77#d77;,a77ii71 or subsection 7d77#c77;,c7 for a drug or biological furnished on or after ,january #a1 #bjbb1 if the applicable add-on payment 7as defined in subparagraph 7,b77 for each drug or biological on a claim for a date of service exceeds the maximum add-on payment amount specified under subparagraph 7,c7 for the drug or biological1 then the payment amount otherwise determined for the drug or biological under those provisions1 as applicable1 shall be reduced by the amount of such excess4 7,b7 ,applicable add-on payment defined ,in this paragraph1 the term applicable add-on payment means the following amounts1 determined without regard to the application of subparagraph 7,a73 7i7 ,in the case of a multiple source drug1 an amount equal to the difference between-- 7,i7 the amount that would otherwise be applied under paragraph 7#a77;,a72 and 7,,ii7 the amount that would be applied under such paragraph if #ajj percent were substituted for the applicable percent 7as defined in paragraph 7#i77 for such drug4 7ii7 ,in the case of a single source drug or biological1 an amount equal to the difference between-- 7,i7 the amount that would otherwise be applied under paragraph 7#a77;,b72 and 7,,ii7 the amount that would be applied under such paragraph if #ajj percent were substituted for the applicable percent 7as defined in paragraph 7#i77 for such drug or biological4 7iii7 ,in the case of a biosimilar biological product1 the amount otherwise determined under paragraph 7#h77;,b74 7iv7 ,in the case of a drug or biological during the initial period described in subsection 7c77#d77;,a71 an amount equal to the difference between-- 7,i7 the amount that would otherwise be applied under subsection 7c77#d77;,a77ii72 and 7,,ii7 the amount that would be applied under such subsection if #ajj percent were substituted1 as applicable1 for-- 7aa7 #ajc percent in subclause 7,i7 of such subsection2 or 7bb7 any percent in excess of #ajj percent applied under subclause 7,,ii7 of such subsection4 7v7 ,in the case of a drug or biological to which subsection 7d77#c77;,c7 applies1 an amount equal to the difference between-- 7,i7 the amount that would otherwise be applied under such subsection2 and 7,,ii7 the amount that would be applied under such subsection if #ajj percent were substituted1 as applicable1 for-- 7aa7 any percent in excess of #ajj percent applied under clause 7i7 of such subsection2 or 7bb7 #ajc percent in clause 7ii7 of such subsection4 7,c7 ,maximum add-on payment amount specified ,for purposes of subparagraph 7,a71 the maximum add-on payment amount specified in this subparagraph is-- 7i7 with respect to a drug or biological 7other than autologous cellular immunotherapy7-- 7,i7 for each of #bjbb through #bjbi1 #a1jjj2 and 7,,ii7 for a subsequent year1 the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers 7all items2 ,united ,states city average7 for the #ab-month period ending with ,june of the previous year2 or 7ii7 with respect to a drug or biological consisting of autologous cellular immunotherapy-- 7,i7 for each of #bjbb through #bjbi1 #b1jjj2 and 7,,ii7 for a subsequent year1 the amount specified in this subparagraph for the preceding year increased by the percentage increase in the consumer price index for all urban consumers 7all items2 ,united ,states city average7 for the #ab-month period ending with ,june of the previous year4 ,any amount determined under this subparagraph that is not a multiple of #aj shall be rounded to the nearest multiple of #aj4 2 and 7#b7 in subsection 7c77#d77;,a77ii71 by striking in the case and inserting subject to subsection 7b77#aj71 in the case4 7b7 ,conforming amendments relating to separately payable drugs 7#a7 ,,opps ,section #ahcc7t77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#ad77 is amended-- 7,a7 in subparagraph 7,a77iii77,,ii71 by inserting 1 subject to subparagraph 7,i7 after are not available2 and 7,b7 by adding at the end the following new subparagraph3 7,i7 ,application of maximum add-on payment for separately payable drugs and biologicals ,in establishing the amount of payment under subparagraph 7,a7 for a specified covered outpatient drug that is furnished as part of a covered ,,opd service 7or group of services7 on or after ,january #a1 #bjbb1 if such payment is determined based on the average price for the year established under section #ahdg;,a pursuant to clause 7iii77,,ii7 of such subparagraph1 the provisions of subsection 7b77#aj7 of section #ahdg;,a shall apply to the amount of payment so established in the same manner as such provisions apply to the amount of payment under section #ahdg;,a4 4 7#b7 ,,asc ,section #ahcc7;i77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7i77#b77;,d77 is amended-- 7,a7 by moving clause 7v7 #f ems to the left2 7,b7 by redesignating clause 7vi7 as clause 7vii72 and 7,c7 by inserting after clause 7v7 the following new clause3 7vi7 ,if there is a separate payment under the system described in clause 7i7 for a drug or biological furnished on or after ,january #a1 #bjbb1 the provisions of subsection 7t77#ad77;,i7 shall apply to the establishment of the amount of payment for the drug or biological under such system in the same manner in which such provisions apply to the establishment of the amount of payment under subsection 7t77#ad77;,a74 4 #aje4 ,treatment of drug administration services furnished by certain excepted off-campus outpatient departments of a provider ,section #ahcc7t77#af7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#af77 is amended by adding at the end the following new subparagraph3 7,g7 ,special payment rule for drug administration services furnished by an excepted department of a provider 7i7 ,in general ,in the case of a covered ,,opd service that is a drug administration service 7as defined by the ,secretary7 furnished by a department of a provider described in clause 7ii7 or 7iv7 of paragraph 7#ba77;,b71 the payment amount for such service furnished on or after ,january #a1 #bjbb1 shall be the same payment amount 7as determined in paragraph 7#ba77;,c77 that would apply if the drug administration service was furnished by an off-campus outpatient department of a provider 7as defined in paragraph 7#ba77;,b774 7ii7 ,application without regard to budget neutrality ,the reductions made under this subparagraph-- 7,i7 shall not be considered an adjustment under paragraph 7#b77;,e72 and 7,,ii7 shall not be implemented in a budget neutral manner4 4 ,b ,drug ,price ,transparency #aaa4 ,reporting on explanation for drug price increases 7a7 ,in general ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,drug ,price ,reporting2 ,drug ,value ,fund #cii,,oo4 ,reporting on explanation for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of this ,act2 or 7,b7 who is responsible for setting the wholesale acquisition cost for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more1 adjusted for inflation occurring after the date of enactment of this section1 for a month's supply or a typical course of treatment that lasts less than a month1 and is-- 7i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 administered or otherwise dispensed to treat a disease or condition affecting more than #bjj1jjj persons in the ,united ,states2 and 7iii7 not a vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary for each increase in the price of a qualifying drug that results in an increase in the wholesale acquisition cost of that drug that is equal to-- 7,a7 #aj percent or more within a single calendar year beginning on or after ,january #a1 #bjba2 or 7,b7 #be percent or more within three consecutive calendar years for which the first such calendar year begins on or after ,january #a1 #bjba4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary-- 7,a7 in the case of a report with respect to an increase in the price of a qualifying drug that occurs during the period beginning on ,january #a1 #bjba1 and ending on the day that is #fj days after the date of enactment of this section1 not later than #ij days after such date of enactment2 and 7,b7 in the case of a report with respect to an increase in the price of a qualifying drug that occurs after the period described in subparagraph 7,a71 not later than #cj days prior to the planned effective date of such price increase for such qualifying drug4 7c7 ,contents ,a report under subsection 7b71 consistent with the standard for disclosures described in section #bac4c7;d7 of title #ab1 ,code of ,federal ,regulations 7as in effect on the date of enactment of this section71 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug within the calendar year or three consecutive calendar years as described in subsection 7b77#a77;,a7 or 7b77#a77;,b71 if applicable1 and the effective date of such price increase2 7,b7 an explanation for1 and description of1 each price increase for such drug that will occur during the calendar year period described in subsection 7b77#a77;,a7 or the three consecutive calendar year period described in subsection 7b77#a77;,b71 as applicable2 7,c7 if known and different from the manufacturer of the qualifying drug1 the identity of-- 7i7 the sponsor or sponsors of any investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act for clinical investigations with respect to such drug1 for which the full reports are submitted as part of the application-- 7,i7 for approval of the drug under section #eje of such ,act2 or 7,,ii7 for licensure of the drug under section #cea of this ,act2 and 7ii7 the sponsor of an application for the drug approved under such section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of this ,act2 7,d7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea of this ,act1 or since the manufacturer acquired such approved application or license1 if applicable2 7,e7 the current wholesale acquisition cost of the drug2 7,f7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 the total expenditures of the manufacturer on research and development for such drug that is necessary to demonstrate that it meets applicable statutory standards for approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea of this ,act1 as applicable2 7,i7 the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for such drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act2 7,j7 the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,k7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,l7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer for each of the #a-year period described in subsection 7b77#a77;,a7 or the #c-year period described in subsection 7b77#a77;,b71 as applicable2 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation for each of the #a-year period described in subsection 7b77#a77;,a7 or the #c-year period described in subsection 7b77#a77;,b71 as applicable2 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials1 including on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate and as specified by the ,secretary through notice-and-comment rulemaking4 7d7 ,information provided ,the manufacturer of a qualifying drug that is required to submit a report under subsection 7b71 shall ensure that such report and any explanation for1 and description of1 each price increase described in subsection 7c77#a77;,b7 shall be truthful1 not misleading1 and accurate4 7e7 ,civil monetary penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section1 following notification by the ,secretary to the manufacturer that the manufacturer is not in compliance with this section1 shall be subject to a civil monetary penalty of #ge1jjj for each day on which the violation continues4 7f7 ,false information ,any manufacturer that submits a report for a drug as required by this section that knowingly provides false information in such report is subject to a civil monetary penalty in an amount not to exceed #ge1jjj for each item of false information4 7g7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 the ,secretary shall post each report submitted under subsection 7b7 on the public website of the ,department of ,health and ,human ,services the day the price increase of a qualifying drug is scheduled to go into effect4 7#b7 ,format ,in developing the format in which reports will be publicly posted under paragraph 7#a71 the ,secretary shall consult with stakeholders1 including beneficiary groups1 and shall seek feedback from consumer advocates and readability experts on the format and presentation of the content of such reports to ensure that such reports are-- 7,a7 user-friendly to the public2 and 7,b7 written in plain language that consumers can readily understand4 7#c7 ,protected information ,nothing in this section shall be construed to authorize the public disclosure of information submitted by a manufacturer that is prohibited from disclosure by applicable laws concerning the protection of trade secrets1 commercial information1 and other information covered under such laws4 #cii,,oo-#a4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 and post on the public website of the ,department of ,health and ,human ,services in a way that is user-friendly to the public and written in plain language that consumers can readily understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section2 7#c7 detailing the costs and expenditures incurred by the ,department of ,health and ,human ,services in carrying out section #cii,,oo2 and 7#d7 explaining how the ,department of ,health and ,human ,services is improving consumer and provider information about drug value and drug price transparency4 7b7 ,protected information ,nothing in this section shall be construed to authorize the public disclosure of information submitted by a manufacturer that is prohibited from disclosure by applicable laws concerning the protection of trade secrets1 commercial information1 and other information covered under such laws4 4 7b7 ,effective date ,the amendment made by subsection 7a7 takes effect on the date of enactment of this ,act4 #aab4 ,public disclosure of drug discounts ,section #aaej;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is amended-- 7#a7 in subsection 7c71 in the matter preceding paragraph 7#a71 by inserting 7other than as permitted under subsection 7e77 after disclosed by the ,secretary2 and 7#b7 by adding at the end the following new subsection3 7e7 ,public availability of certain information 7#a7 ,in general ,in order to allow the comparison of ,p,b,ms' ability to negotiate rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions and the amount of such rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions that are passed through to plan sponsors1 beginning ,january #a1 #bjbb1 the ,secretary shall make available on the ,internet website of the ,department of ,health and ,human ,services the information with respect to the second preceding calendar year provided to the ,secretary on generic dispensing rates 7as described in paragraph 7#a7 of subsection 7b77 and information provided to the ,secretary under paragraphs 7#b7 and 7#c7 of such subsection that1 as determined by the ,secretary1 is with respect to each ,,pbm4 7#b7 ,availability of data ,in carrying out paragraph 7#a71 the ,secretary shall ensure the following3 7,a7 ,confidentiality ,the information described in such paragraph is displayed in a manner that prevents the disclosure of information1 with respect to an individual drug or an individual plan1 on rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions4 7,b7 ,class of drug ,the information described in such paragraph is made available by class of drug1 using an existing classification system1 but only if the class contains such number of drugs1 as specified by the ,secretary 7but not fewer than three drugs71 to ensure confidentiality of proprietary information or other information that is prevented to be disclosed under subparagraph 7,a74 4 #aac4 ,study of pharmaceutical supply chain intermediaries and merger activity 7a7 ,initial report ,not later than #a year after the date of enactment of this ,act1 the ,commission shall submit to the appropriate committees of ,congress a report that-- 7#a7 addresses at minimum-- 7,a7 whether pharmacy benefit managers-- 7i7 charge payers a higher price than the reimbursement rate at which the pharmacy benefit managers reimburse competing pharmacies2 7ii7 steer patients for anticompetitive purposes to any pharmacies1 including retail1 mail-order1 or any other type of pharmacy1 in which the pharmacy benefit manager has an ownership interest2 7iii7 audit or review proprietary data1 including acquisition costs1 patient information1 or dispensing information1 of competing pharmacies that can be used for anticompetitive purposes2 or 7iv7 use formulary designs to increase the market share of higher cost prescription drugs and depress the market share of lower cost prescription drugs 7each net of rebates and discounts72 7,b7 how companies and payers assess the benefits1 costs1 and risks of contracting with intermediaries1 including pharmacy services administrative organizations1 and whether more information about the roles of intermediaries should be available to consumers and payers2 and 7,c7 whether there are any specific legal or regulatory obstacles the ,commission currently faces in ensuring a competitive and transparent marketplace in the pharmaceutical supply chain1 including the pharmacy benefit manager marketplace and pharmacy services administrative organizations2 and 7#b7 provides-- 7,a7 observations or conclusions drawn from the ,november #bjag roundtable entitled ,understanding ,competition in ,prescription ,drug ,markets3 ,entry and ,supply ,chain ,dynamics1 and any similar efforts2 7,b7 specific actions the ,commission intends to take as a result of the ,november #bjag roundtable1 and any similar efforts1 including a detailed description of relevant forthcoming actions1 additional research or roundtable discussions1 consumer education efforts1 or enforcement actions2 and 7,c7 policy or legislative recommendations to-- 7i7 improve transparency and competition in the pharmaceutical supply chain2 7ii7 prevent and deter anticompetitive behavior in the pharmaceutical supply chain2 and 7iii7 best ensure that consumers benefit from any cost savings or efficiencies that may result from mergers and consolidations4 7b7 ,interim report ,not later than #ahj days after the date of enactment of this ,act1 the ,commission shall submit to the appropriate committees of ,congress an interim report on the progress of the report required by subsection 7a71 along with preliminary findings and conclusions based on information collected to that date4 7c7 ,definitions ,in this section3 7#a7 ,appropriate committees of ,congress ,the term appropriate committees of ,congress means-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on the ,judiciary of the ,senate2 and 7,c7 the ,committee on the ,judiciary of the ,house of ,representatives4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 #aad4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities 7a7 ,in general ,section #aabh;,h of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;i7 is amended-- 7#a7 by redesignating subsection 7b7 as subsection 7e72 and 7#b7 by inserting after subsection 7a7 the following new subsections3 7b7 ,data sharing agreements 7#a7 ,in general ,the ,secretary shall enter into agreements with the specified data sharing individuals and entities described in paragraph 7#b7 under which-- 7,a7 upon request of such an individual or entity1 as applicable1 the ,secretary makes available to such individual or entity the information submitted under subsection 7a7 by manufacturers and authorized distributors of record2 and 7,b7 such individual or entity agrees to not disclose publicly or to another individual or entity any information that identifies a particular practitioner or health care facility4 7#b7 ,specified data sharing individuals and entities ,for purposes of paragraph 7#a71 the specified data sharing individuals and entities described in this paragraph are the following3 7,a7 ,oversight agencies ,health oversight agencies 7as defined in section #afd4eja of title #de1 ,code of ,federal ,regulations71 including the ,centers for ,medicare ,medicaid ,services1 the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 the ,government ,accountability ,office1 the ,congressional ,budget ,office1 the ,medicare ,payment ,advisory ,commission1 and the ,medicaid and ,,chip ,payment and ,access ,commission4 7,b7 ,researchers ,individuals who conduct scientific research 7as defined in section #afd4eja of title #de1 ,code of ,federal ,regulations7 in relevant areas as determined by the ,secretary4 7,c7 ,payers ,private and public health care payers1 including group health plans1 health insurance coverage offered by health insurance issuers1 ,federal health programs1 and ,state health programs4 7#c7 ,exemption from ,freedom of ,information ,act ,except as described in paragraph 7#a71 the ,secretary may not be compelled to disclose the information submitted under subsection 7a7 to any individual or entity4 ,for purposes of section #eeb of title #e1 ,united ,states ,code 7commonly referred to as the ,freedom of ,information ,act71 this paragraph shall be considered a statute described in subsection 7b77#c77;,b7 of such section4 7c7 ,penalties 7#a7 ,data sharing agreements ,subject to paragraph 7#c71 any specified data sharing individual or entity described in subsection 7b77#b7 that violates the terms of a data sharing agreement the individual or entity has with the ,secretary under subsection 7b77#a7 shall be subject to a civil money penalty of not less than #a1jjj1 but not more than #aj1jjj1 for each such violation4 ,such penalty shall be imposed and collected in the same manner as civil money penalties under subsection 7a7 of section #aabh;,a are imposed and collected under that section4 7#b7 ,failure to report ,subject to paragraph 7#c71 any manufacturer or authorized distributor of record of an applicable drug under subsection 7a7 that fails to submit information required under such subsection in a timely manner in accordance with rules or regulations promulgated to carry out such subsection shall be subject to a civil money penalty of not less than #a1jjj1 but not more than #aj1jjj1 for each such failure4 ,such penalty shall be imposed and collected in the same manner as civil money penalties under subsection 7a7 of section #aabh;,a are imposed and collected under that section4 7#c7 ,limitation ,the total amount of civil money penalties imposed under paragraph 7#a7 or 7#b7 with respect to a year and an individual or entity described in paragraph 7#a7 or a manufacturer or distributor described in paragraph 7#b71 respectively1 shall not exceed #aej1jjj4 7d7 ,drug sample distribution information 7#a7 ,in general ,not later than ,january #a of each year 7beginning with #bjbb71 the ,secretary shall maintain a list containing information related to the distribution of samples of applicable drugs4 ,such list shall provide the following information with respect to the preceding year3 7,a7 ,the name of the manufacturer or authorized distributor of record of an applicable drug for which samples were requested or distributed under this section4 7,b7 ,the quantity and class of drug samples requested4 7,c7 ,the quantity and class of drug samples distributed4 7#b7 ,public availability ,the ,secretary shall make the information in such list available to the public on the ,internet website of the ,food and ,drug ,administration4 4 7b7 ,,fda maintenance of information ,the ,food and ,drug ,administration shall maintain information available to affected reporting companies to ensure their ability to fully comply with the requirements of section #aabh;,h of the ,social ,security ,act4 7c7 ,prohibition on distribution of samples of opioids ,section #ejc7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is amended-- 7#a7 by moving the margin of paragraph 7#d7 #b ems to the left2 and 7#b7 by adding at the end the following3 7#e7 ,no person may distribute a drug sample of a drug that is-- 7,a7 an applicable drug 7as defined in section #aabh;,h7e7 of the ,social ,security ,act72 7,b7 a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act7 for which the findings required under section #bjb7;b77#b7 of such ,act have been made2 and 7,c7 approved under section #eje for use in the management or treatment of pain 7other than for the management or treatment of a substance use disorder74 4 7d7 ,med,p,a,c report ,not later than #c years after the date of the enactment of this ,act1 the ,medicare ,payment ,advisory ,commission shall conduct a study on the impact of drug samples on provider prescribing practices and health care costs and may1 as the ,commission deems appropriate1 make recommendations on such study4 #aae4 ,sense of ,congress regarding the need to expand commercially available drug pricing comparison platforms ,it is the sense of ,congress that-- 7#a7 commercially available drug pricing comparison platforms can1 at no cost1 help patients find the lowest price for their medications at their local pharmacy2 7#b7 such platforms should be integrated1 to the maximum extent possible1 in the health care delivery ecosystem2 and 7#c7 pharmacy benefit managers should work to disclose generic and brand name drug prices to such platforms to ensure that-- 7,a7 patients can benefit from the lowest possible price available to them2 and 7,b7 overall drug prices can be reduced as more educated purchasing decisions are made based on price transparency4 ,c ,medicare ,part ,d ,benefit ,redesign #aba4 ,medicare part ,d benefit redesign 7a7 ,benefit structure redesign ,section #ahfj;,d-#b7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew- #ajb7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb and for costs above the annual deductible specified in paragraph 7#a7 and up to the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for #bjbb and each subsequent year after paragraph 7#c72 7ii7 in clause 7i71 by inserting after #be percent the following3 7or1 for #bjbb and each subsequent year1 #ae percent72 and 7iii7 in clause 7ii71 by inserting 7or1 for #bjbb and each subsequent year1 #ae percent7 after #be percent2 7,b7 in subparagraph 7,c7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7ii7 in clause 7ii77,,iii71 by striking and each subsequent year and inserting and #bjba2 and 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7,,ii7 in subclause 7,i77bb71 by striking a year after #bjah and inserting each of years #bjah through #bjba2 and 7ii7 in clause 7ii77,v71 by striking #bjai and each subsequent year and inserting each of years #bjai through #bjba2 7#b7 in paragraph 7#c77;,a7-- 7,a7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb1 after and 7#d712 and 7,b7 in clause 7ii71 by striking for a subsequent year and inserting for each of years #bjjg through #bjba2 7#c7 in paragraph 7#d7-- 7,a7 in subparagraph 7,a7-- 7i7 in clause 7i7-- 7,i7 by redesignating subclauses 7,i7 and 7,,ii7 as items 7aa7 and 7bb71 respectively1 and indenting appropriately2 7,,ii7 in the matter preceding item 7aa71 as redesignated by subclause 7,i71 by striking is equal to the greater of-- and inserting is equal to-- 7,i7 for a year preceding #bjbb1 the greater of-- 2 7,,iii7 by striking the period at the end of item 7bb71 as redesignated by subclause 7,i71 and inserting 2 and2 and 7,,iv7 by adding at the end the following3 7,,ii7 for #bjbb and each succeeding year1 #j4 2 and 7ii7 in clause 7ii7-- 7,i7 by striking clause 7i77,i7 and inserting clause 7i77,i77aa72 and 7,,ii7 by adding at the end the following new sentence3 ,the ,secretary shall continue to calculate the dollar amounts specified in clause 7i77,i77aa71 including with the adjustment under this clause1 after #bjba for purposes of section #ahfj;,d-#ad7;a77#a77;,d77iii742 7,b7 in subparagraph 7,b7-- 7i7 in clause 7i7-- 7,i7 in subclause 7,v71 by striking or at the end2 7,,ii7 in subclause 7,,vi7-- 7aa7 by striking for a subsequent year and inserting for #bjba2 and 7bb7 by striking the period at the end and inserting a semicolon2 and 7,,iii7 by adding at the end the following new subclauses3 7,,vii7 for #bjbb1 is equal to #c1ajj2 or 7,,viii7 for a subsequent year1 is equal to the amount specified in this subparagraph for the previous year1 increased by the annual percentage increase described in paragraph 7#f7 for the year involved4 2 and 7ii7 in clause 7ii71 by striking clause 7i77,,ii7 and inserting clause 7i72 7,c7 in subparagraph 7,c77i71 by striking and for amounts and inserting and for a year preceding #bjbb for amounts2 and 7,d7 in subparagraph 7,e71 by striking ,in applying and inserting ,for each of #bjaa through #bjba1 in applying4 7b7 ,decreasing reinsurance payment amount ,section #ahfj;,d-#ae7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77#a77 is amended-- 7#a7 by striking equal to #hj percent and inserting equal to- 7,a7 for a year preceding #bjbb1 #hj percent 2 7#b7 in subparagraph 7,a71 as added by paragraph 7#a71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new subparagraph3 7,b7 for #bjbb and each subsequent year1 the sum of-- 7i7 an amount equal to #bj percent of the allowable reinsurance costs 7as specified in paragraph 7#b77 attributable to that portion of gross covered prescription drug costs as specified in paragraph 7#c7 incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b7 with respect to applicable drugs 7as defined in section #ahfj;,d-#ad;,b7g77#b772 and 7ii7 an amount equal to #cj percent of the allowable reinsurance costs 7as specified in paragraph 7#b77 attributable to that portion of gross covered prescription drug costs as specified in paragraph 7#c7 incurred in the coverage year after such individual has incurred costs that exceed the annual out-of-pocket threshold specified in section #ahfj;,d-#b7;b77#d77;,b7 with respect to covered part ,d drugs that are not applicable drugs 7as so defined74 4 7c7 ,manufacturer discount program 7#a7 ,in general ,part ,d of title ,,xviii of the ,social ,security ,act is amended by inserting after section #ahfj;,d-#ad;,a 7#db ,u4,s4,c4 #adiew-#aad7 the following new section3 #ahfj;,d-#ad;,b4 ,manufacturer discount program 7a7 ,establishment ,the ,secretary shall establish a manufacturer discount program 7in this section referred to as the program74 ,under the program1 the ,secretary shall enter into agreements described in subsection 7b7 with manufacturers and provide for the performance of the duties described in subsection 7c74 ,the ,secretary shall establish a model agreement for use under the program by not later than ,january #a1 #bjbc1 in consultation with manufacturers1 and allow for comment on such model agreement4 7b7 ,terms of agreement 7#a7 ,in general 7,a7 ,agreement ,an agreement under this section shall require the manufacturer to provide applicable beneficiaries access to discounted prices for applicable drugs of the manufacturer that are dispensed on or after ,january #a1 #bjbd4 7,b7 ,provision of discounted prices at the point-of-sale ,the discounted prices described in subparagraph 7,a7 shall be provided to the applicable beneficiary at the pharmacy or by the mail order service at the point-of-sale of an applicable drug4 7#b7 ,provision of appropriate data ,each manufacturer with an agreement in effect under this section shall collect and have available appropriate data1 as determined by the ,secretary1 to ensure that it can demonstrate to the ,secretary compliance with the requirements under the program4 7#c7 ,compliance with requirements for administration of program ,each manufacturer with an agreement in effect under this section shall comply with requirements imposed by the ,secretary or a third party with a contract under subsection 7d77#c71 as applicable1 for purposes of administering the program1 including any determination under subparagraph 7,a7 of subsection 7c77#a7 or procedures established under such subsection 7c77#a74 7#d7 ,length of agreement 7,a7 ,in general ,an agreement under this section shall be effective for an initial period of not less than #ab months and shall be automatically renewed for a period of not less than #a year unless terminated under subparagraph 7,b74 7,b7 ,termination 7i7 ,by the ,secretary ,the ,secretary may provide for termination of an agreement under this section for a knowing and willful violation of the requirements of the agreement or other good cause shown4 ,such termination shall not be effective earlier than #cj days after the date of notice to the manufacturer of such termination4 ,the ,secretary shall provide1 upon request1 a manufacturer with a hearing concerning such a termination1 and such hearing shall take place prior to the effective date of the termination with sufficient time for such effective date to be repealed if the ,secretary determines appropriate4 7ii7 ,by a manufacturer ,a manufacturer may terminate an agreement under this section for any reason4 ,any such termination shall be effective1 with respect to a plan year-- 7,i7 if the termination occurs before ,january #cj of a plan year1 as of the day after the end of the plan year2 and 7,,ii7 if the termination occurs on or after ,january #cj of a plan year1 as of the day after the end of the succeeding plan year4 7iii7 ,effectiveness of termination ,any termination under this subparagraph shall not affect discounts for applicable drugs of the manufacturer that are due under the agreement before the effective date of its termination4 7iv7 ,notice to third party ,the ,secretary shall provide notice of such termination to a third party with a contract under subsection 7d77#c7 within not less than #cj days before the effective date of such termination4 7#e7 ,effective date of agreement ,an agreement under this section shall take effect on a date determined appropriate by the ,secretary1 which may be at the start of a calendar quarter4 7c7 ,duties described ,the duties described in this subsection are the following3 7#a7 ,administration of program ,administering the program1 including-- 7,a7 the determination of the amount of the discounted price of an applicable drug of a manufacturer2 7,b7 the establishment of procedures under which discounted prices are provided to applicable beneficiaries at pharmacies or by mail order service at the point-of-sale of an applicable drug2 7,c7 the establishment of procedures to ensure that1 not later than the applicable number of calendar days after the dispensing of an applicable drug by a pharmacy or mail order service1 the pharmacy or mail order service is reimbursed for an amount equal to the difference between-- 7i7 the negotiated price of the applicable drug2 and 7ii7 the discounted price of the applicable drug2 7,d7 the establishment of procedures to ensure that the discounted price for an applicable drug under this section is applied before any coverage or financial assistance under other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of applicable beneficiaries as the ,secretary may specify2 and 7,e7 providing a reasonable dispute resolution mechanism to resolve disagreements between manufacturers1 applicable beneficiaries1 and the third party with a contract under subsection 7d77#c74 7#b7 ,monitoring compliance 7,a7 ,in general ,the ,secretary shall monitor compliance by a manufacturer with the terms of an agreement under this section4 7,b7 ,notification ,if a third party with a contract under subsection 7d77#c7 determines that the manufacturer is not in compliance with such agreement1 the third party shall notify the ,secretary of such noncompliance for appropriate enforcement under subsection 7e74 7#c7 ,collection of data from prescription drug plans and ,,ma-,,pd plans ,the ,secretary may collect appropriate data from prescription drug plans and ,,ma-,,pd plans in a timeframe that allows for discounted prices to be provided for applicable drugs under this section4 7d7 ,administration 7#a7 ,in general ,subject to paragraph 7#b71 the ,secretary shall provide for the implementation of this section1 including the performance of the duties described in subsection 7c74 7#b7 ,limitation ,in providing for the implementation of this section1 the ,secretary shall not receive or distribute any funds of a manufacturer under the program4 7#c7 ,contract with third parties ,the ,secretary shall enter into a contract with #a or more third parties to administer the requirements established by the ,secretary in order to carry out this section4 ,at a minimum1 the contract with a third party under the preceding sentence shall require that the third party-- 7,a7 receive and transmit information between the ,secretary1 manufacturers1 and other individuals or entities the ,secretary determines appropriate2 7,b7 receive1 distribute1 or facilitate the distribution of funds of manufacturers to appropriate individuals or entities in order to meet the obligations of manufacturers under agreements under this section2 7,c7 provide adequate and timely information to manufacturers1 consistent with the agreement with the manufacturer under this section1 as necessary for the manufacturer to fulfill its obligations under this section2 and 7,d7 permit manufacturers to conduct periodic audits1 directly or through contracts1 of the data and information used by the third party to determine discounts for applicable drugs of the manufacturer under the program4 7#d7 ,performance requirements ,the ,secretary shall establish performance requirements for a third party with a contract under paragraph 7#c7 and safeguards to protect the independence and integrity of the activities carried out by the third party under the program under this section4 7#e7 ,administration ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to the program under this section4 7e7 ,enforcement 7#a7 ,audits ,each manufacturer with an agreement in effect under this section shall be subject to periodic audit by the ,secretary4 7#b7 ,civil money penalty 7,a7 ,in general ,the ,secretary shall impose a civil money penalty on a manufacturer that fails to provide applicable beneficiaries discounts for applicable drugs of the manufacturer in accordance with such agreement for each such failure in an amount the ,secretary determines is commensurate with the sum of-- 7i7 the amount that the manufacturer would have paid with respect to such discounts under the agreement1 which will then be used to pay the discounts which the manufacturer had failed to provide2 and 7ii7 #be percent of such amount4 7,b7 ,application ,the provisions of section #aabh;,a 7other than subsections 7a7 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 7f7 ,clarification regarding availability of other covered part ,d drugs ,nothing in this section shall prevent an applicable beneficiary from purchasing a covered part ,d drug that is not on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in4 7g7 ,definitions ,in this section3 7#a7 ,applicable beneficiary ,the term applicable beneficiary means an individual who1 on the date of dispensing a covered part ,d drug-- 7,a7 is enrolled in a prescription drug plan or an ,,ma-,,pd plan2 7,b7 is not enrolled in a qualified retiree prescription drug plan2 and 7,c7 has incurred costs for covered part ,d drugs in the year that are equal to or exceed the annual deductible specified in section #ahfj;,d-#b7;b77#a7 for such year4 7#b7 ,applicable drug ,the term applicable drug means1 with respect to an applicable beneficiary1 a covered part ,d drug-- 7,a7 approved under a new drug application under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or1 in the case of a biologic product1 licensed under section #cea of the ,public ,health ,service ,act 7including a product licensed under subsection 7k7 of such section72 and 7,b7 7i7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan uses a formulary1 which is on the formulary of the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 7ii7 if the ,,pdp sponsor of the prescription drug plan or the ,,ma organization offering the ,,ma-,,pd plan does not use a formulary1 for which benefits are available under the prescription drug plan or ,,ma-,,pd plan that the applicable beneficiary is enrolled in2 or 7iii7 is provided through an exception or appeal4 7#c7 ,applicable number of calendar days ,the term applicable number of calendar days means-- 7,a7 with respect to claims for reimbursement submitted electronically1 #ad days2 and 7,b7 with respect to claims for reimbursement submitted otherwise1 #cj days4 7#d7 ,discounted price 7,a7 ,in general ,the term discounted price means1 with respect to an applicable drug of a manufacturer furnished during a year to an applicable beneficiary1 #ij percent of the negotiated price of such drug4 7,b7 ,clarification ,nothing in this section shall be construed as affecting the responsibility of an applicable beneficiary for payment of a dispensing fee for an applicable drug4 7,c7 ,special case for claims spanning deductible ,in the case where the entire amount of the negotiated price of an individual claim for an applicable drug with respect to an applicable beneficiary does not fall at or above the annual deductible specified in section #ahfj;,d-#b7;b77#a7 for the year1 the manufacturer of the applicable drug shall provide the discounted price under this section on only the portion of the negotiated price of the applicable drug that falls at or above such annual deductible4 7#e7 ,manufacturer ,the term manufacturer means any entity which is engaged in the production1 preparation1 propagation1 compounding1 conversion1 or processing of prescription drug products1 either directly or indirectly by extraction from substances of natural origin1 or independently by means of chemical synthesis1 or by a combination of extraction and chemical synthesis4 ,such term does not include a wholesale distributor of drugs or a retail pharmacy licensed under ,state law4 7#f7 ,negotiated price ,the term negotiated price has the meaning given such term in section #ahfj;,d-#b7;d77#a77;,b71 except that such negotiated price shall not include any dispensing fee for an applicable drug4 7#g7 ,qualified retiree prescription drug plan ,the term qualified retiree prescription drug plan has the meaning given such term in section #aahfj;,d-#bb7;a77#b74 4 7#b7 ,sunset of ,medicare coverage gap discount program ,section #ahfj;,d-#ad;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acie-aad;a7 is amended-- 7,a7 in subsection 7a71 in the first sentence1 by striking ,the ,secretary and inserting ,subject to subsection 7h71 the ,secretary2 and 7,b7 by adding at the end the following new subsection3 7h7 ,sunset of program 7#a7 ,in general ,the program shall not apply to applicable drugs dispensed on or after ,january #a1 #bjbd1 and1 subject to paragraph 7#b71 agreements under this section shall be terminated as of such date4 7#b7 ,continued application for applicable drugs dispensed prior to sunset ,the provisions of this section 7including all responsibilities and duties7 shall continue to apply after ,january #a1 #bjbd1 with respect to applicable drugs dispensed prior to such date4 4 7#c7 ,inclusion of actuarial value of manufacturer discounts in bids ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended-- 7,a7 in subsection 7b77#b77;,c77iii7-- 7i7 by striking assumptions regarding the reinsurance and inserting assumptions regarding-- 7,i7 the reinsurance 2 and 7ii7 by adding at the end the following3 7,,ii7 for #bjbd and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d- #ad;,b subtracted from the actuarial value to produce such bid2 and 2 and 7,b7 in subsection 7c77#a77;,c7-- 7i7 by striking an actuarial valuation of the reinsurance and inserting an actuarial valuation of-- 7i7 the reinsurance 2 7ii7 in clause 7i71 as added by clause 7i7 of this subparagraph1 by adding and at the end2 and 7iii7 by adding at the end the following3 7ii7 for #bjbd and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,b2 4 7#d7 ,clarification regarding exclusion of manufacturer discounts from ,tr,o,o,p ,section #ahfj;,d-#b7;b77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is amended-- 7,a7 in subparagraph 7,c71 by inserting and subject to subparagraph 7,f7 after subparagraph 7,e72 and 7,b7 by adding at the end the following new subparagraph3 7,f7 ,clarification regarding exclusion of manufacturer discounts ,in applying subparagraph 7,a71 incurred costs shall not include any manufacturer discounts provided under section #ahfj;,d-#ad;,b4 4 7d7 ,determination of allowable reinsurance costs ,section #ahfj;,d-#ae7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking ,costs4--,for purposes and inserting ,costs4-- 7,a7 ,in general ,subject to subparagraph 7,b71 for purposes 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,inclusion of manufacturer discounts on applicable drugs ,for purposes of applying subparagraph 7,a71 the term allowable reinsurance costs shall include the portion of the negotiated price 7as defined in section #ahfj;,d-#ad;,b7g77#f77 of an applicable drug 7as defined in section #ahfj;,d-#ad7;g77#b77 that was paid by a manufacturer under the manufacturer discount program under section #ahfj;,d-#ad;,b4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in the first sentence1 by striking ,for purposes and inserting ,subject to paragraph 7#b77;,b71 for purposes2 and 7,b7 in the second sentence1 by inserting or1 in the case of an applicable drug1 by a manufacturer after by the individual or under the plan4 7e7 ,updating risk adjustment methodologies to account for part ,d modernization redesign ,section #ahfj;,d-#ae7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;c77 is amended by adding at the end the following new paragraph3 7#c7 ,updating risk adjustment methodologies to account for part ,d modernization redesign ,the ,secretary shall update the risk adjustment model used to adjust bid amounts pursuant to this subsection as appropriate to take into account changes in benefits under this part pursuant to the amendments made by section #aba of the ,lower ,costs1 ,more ,cures ,act of #bjba4 4 7f7 ,conditions for coverage of drugs under this part ,section #ahfj;,d-#dc of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aec7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#b71 by striking and at the end2 7,b7 in paragraph 7#c71 by striking the period at the end and inserting a semicolon2 and 7,c7 by adding at the end the following new paragraphs3 7#d7 participate in the manufacturer discount program under section #ahfj;,d-#ad;,b2 7#e7 have entered into and have in effect an agreement described in subsection 7b7 of such section #ahfj;,d-#ad;,b with the ,secretary2 and 7#f7 have entered into and have in effect1 under terms and conditions specified by the ,secretary1 a contract with a third party that the ,secretary has entered into a contract with under subsection 7d77#c7 of such section #ahfj;,d-#ad;,b4 2 7#b7 by striking subsection 7b7 and inserting the following3 7b7 ,effective date ,paragraphs 7#a7 through 7#c7 of subsection 7a7 shall apply to covered part ,d drugs dispensed under this part on or after ,january #a1 #bjaa1 and before ,january #a1 #bjbd1 and paragraphs 7#d7 through 7#f7 of such subsection shall apply to covered part ,d drugs dispensed on or after ,january #a1 #bjbd4 2 and 7#c7 in subsection 7c71 by striking paragraph 7#b7 and inserting the following3 7#b7 the ,secretary determines that in the period beginning on ,january #a1 #bjaa1 and ending on ,december #ca1 #bjaa 7with respect to paragraphs 7#a7 through 7#c7 of subsection 7a77 or the period beginning on ,january #a1 #bjbd1 and ending ,december #ca1 #bjbd 7with respect to paragraphs 7#d7 through 7#f7 of such subsection71 there were extenuating circumstances4 4 7g7 ,conforming amendments 7#a7 ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7,a7 in subsection 7a77#b77;,a77i77,i71 by striking 1 or an increase in the initial and inserting or for a year preceding #bjbd an increase in the initial2 7,b7 in subsection 7c77#a77;,c7-- 7i7 in the subparagraph heading1 by striking at initial coverage limit2 and 7ii7 by inserting for a year preceding #bjbd or the annual out-of-pocket threshold specified in subsection 7b77#d77;,b7 for the year for #bjbd and each subsequent year after subsection 7b77#c7 for the year each place it appears2 and 7,c7 in subsection 7d77#a77;,a71 by striking or an initial and inserting or for a year preceding #bjbd1 an initial4 7#b7 ,section #ahfj;,d-#d7;a77#d77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;a77#d77;,b77i77 is amended by striking the initial and inserting for a year preceding #bjbd1 the initial4 7#c7 ,section #ahfj;,d-#ad7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbd1 the continuation2 7ii7 in subparagraph 7,d77iii71 by striking #ahfj;,d-#b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa72 and 7iii7 in subparagraph 7,e71 by striking ,the elimination and inserting ,for a year preceding #bjbd1 the elimination2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbd1 the continuation2 and 7ii7 in subparagraph 7,e7-- 7,i7 by inserting for a year preceding #bjbd1 after subsection 7c72 and 7,,ii7 by striking #ahfj;,d- #b7;b77#d77;,a77i77,i7 and inserting #ahfj;,d-#b7;b77#d77;,a77i77,i77aa74 7#d7 ,section #ahfj;,d-#ba7;d77#g7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aca7;d77#g77 is amended by striking section #ahfj;,d-#b7;b77#d77;,b77i7 and inserting section #ahfj;,d-#b7;b77#d77;,c77i74 7#e7 ,section #ahfj;,d-#bb7;a77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#acb7;a77#b77;,a77 is amended-- 7,a7 by striking the value of any discount and inserting the following3 the value of-- 7i7 for years prior to #bjbd1 any discount 2 7,b7 in clause 7i71 as inserted by subparagraph 7,a7 of this paragraph1 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following new clause3 7ii7 for #bjbd and each subsequent year1 any discount provided pursuant to section #ahfj;,d-#ad;,b4 4 7#f7 ,section #ahfj;,d-#da7;a77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aea7;a77#f77 is amended-- 7,a7 by inserting for a year before #bjbd after #ahfj;,d-#b7;b77#c72 and 7,b7 by inserting for such year before the period4 7h7 ,effective date ,the amendments made by this section shall apply to plan year #bjbd and subsequent plan years4 ,d ,other ,medicare ,part ,d ,provisions #aca4 ,allowing the offering of additional prescription drug plans under ,medicare part ,d 7a7 ,rescinding and issuance of new guidance ,not later than one year after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall-- 7#a7 rescind sections of any sub-regulatory guidance that limit the number of prescription drug plans in each ,,pdp region that may be offered by a ,,pdp sponsor under part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq472 and 7#b7 issue new guidance specifying that a ,,pdp sponsor may offer up to #d 7or a greater number if determined appropriate by the ,secretary7 prescription drug plans in each ,,pdp region1 except in cases where the ,,pdp sponsor may offer up to #b additional plans in a ,,pdp region pursuant to section #ahfj;,d-#aa7;d77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77#d771 as added by subsection 7b74 7b7 ,offering of additional plans ,section #ahfj;,d-#aa7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7;d77 is amended by adding at the end the following new paragraph3 7#d7 ,offering of additional plans 7,a7 ,in general ,for plan year #bjbb and each subsequent plan year1 a ,,pdp sponsor may offer up to #b additional prescription drug plans in a ,,pdp region 7in addition to any limit established by the ,secretary under this part7 provided that the ,,pdp sponsor complies with subparagraph 7,b7 with respect to at least one such prescription drug plan4 7,b7 ,requirements ,in order to be eligible to offer up to #b additional plans in a ,,pdp region pursuant to subparagraph 7,a71 a ,,pdp sponsor must ensure that1 with respect to at least one such prescription drug plan1 the sponsor or any entity that provides pharmacy benefits management services under a contract with any such sponsor or plan does not receive direct or indirect remuneration1 as defined in section #dbc4cjh of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 unless at least #be percent of the aggregate reductions in price or other remuneration received by the ,,pdp sponsor or entity from drug manufacturers with respect to the plan and plan year-- 7i7 are reflected at the point-of-sale to the enrollee2 or 7ii7 are used to reduce total beneficiary cost-sharing estimated by the ,,pdp sponsor for prescription drug coverage under the plan in the annual bid submitted by the ,,pdp sponsor under section #ahfj;,d-#aa7;b74 7,c7 ,definition of reductions in price ,for purposes of subparagraph 7,b71 the term reductions in price refers only to collectible amounts1 as determined by the ,secretary1 which excludes amounts which after adjudication and reconciliation with pharmacies and manufacturers are duplicate in nature1 contrary to other contractual clauses1 or otherwise ineligible 7such as due to beneficiary disenrollment or coordination of benefits74 4 7c7 ,rule of construction ,nothing in the provisions of1 or amendments made by1 this section shall be construed as limiting the ability of the ,secretary to increase any limit otherwise applicable on the number of prescription drug plans that a ,,pdp sponsor may offer1 at the discretion of the ,,pdp sponsor1 in a ,,pdp region under part ,d of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aja et seq474 #acb4 ,allowing certain enrollees of prescription drug plans and ,,ma-,,pd plans under ,medicare program to spread out cost-sharing under certain circumstances 7a7 ,standard prescription drug coverage ,section #ahfj;,d-#b7;b77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#b771 as amended by section #aba1 is further amended-- 7#a7 in subparagraph 7,a71 by striking ,subject to subparagraphs 7,c7 and 7,d7 and inserting ,subject to subparagraphs 7,c71 7,d71 and 7,e72 and 7#b7 by adding at the end the following new subparagraph3 7,e7 ,enrollee option regarding spreading cost-sharing 7i7 ,in general ,the ,secretary shall establish by regulation a process under which1 with respect to plan year #bjbb and subsequent plan years1 a prescription drug plan or an ,,ma-,,pd plan shall1 in the case of a part ,d eligible individual enrolled with such plan for such plan year with respect to whom the plan projects that the dispensing of a covered part ,d drug to such individual will result in the individual incurring costs within a #cj-;day period that are equal to a significant percentage 7as specified by the ,secretary pursuant to such regulation7 of the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for such plan year1 provide such individual with the option to make the coinsurance payment required under subparagraph 7,a7 for such costs in the form of equal monthly installments over the remainder of such plan year4 7ii7 ,significant percentage limitations ,in specifying a significant percentage pursuant to the regulation established by the ,secretary under clause 7i71 the ,secretary may not specify a percentage that is less than #cj percent or greater than #ajj percent4 4 7b7 ,alternative prescription drug coverage ,section #ahfj;,d-#b7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;c77 is amended by adding at the end the following new paragraph3 7#d7 ,same enrollee option regarding spreading cost-sharing ,for plan year #bjbb and subsequent plan years1 the coverage provides the enrollee option regarding spreading cost-sharing described in and required under subsection 7b77#b77;,e74 4 #acc4 ,establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or ,,ma-,,pd plan 7a7 ,in general ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb71 as amended by sections #aba and #acc1 is further amended-- 7#a7 in subsection 7b77#b7-- 7,a7 in subparagraph 7,a71 by striking and 7,e7 and inserting 7,e71 and 7,f72 7,b7 in subparagraph 7,b71 by striking and 7,d7 and inserting 7,d71 and 7,f72 and 7,c7 by adding at the end the following new subparagraph3 7,f7 ,cap on incurred costs for insulin products and supplies 7i7 ,in general ,the coverage provides benefits1 for costs above the annual deductible specified in paragraph 7#a7 and up to the annual out-of-pocket threshold described in paragraph 7#d77;,b7 and with respect to a month 7beginning with ,january of #bjbb71 with cost sharing that is equal to #j for a specified covered part ,d drug 7as defined in clause 7iii77 furnished to an individual who has incurred costs during such month with respect to specified covered part ,d drugs equal to-- 7,i7 for months occurring in #bjbb1 #ej2 or 7,,ii7 for months occurring in a subsequent year1 the amount applicable under this clause for months occurring in the year preceding such subsequent year1 increased by the annual percentage increase specified in paragraph 7#f7 for such subsequent year and rounded to the nearest dollar4 7ii7 ,application ,the provisions of clauses 7i7 through 7iii7 of paragraph 7#d77;,c7 shall apply with respect to the determination of the incurred costs for specified covered part ,d drugs for purposes of clause 7i7 in the same manner as such provisions apply with respect to the determination of incurred costs for covered part ,d drugs for purposes of paragraph 7#d77;,a74 7iii7 ,specified covered part ,d drug ,for purposes of this subparagraph1 the term specified covered part ,d drug means a covered part ,d drug that is-- 7,i7 insulin2 or 7,,ii7 a medical supply associated with the injection of insulin 7as defined in regulations of the ,secretary promulgated pursuant to subsection 7e77#a77;,b774 2 and 7#b7 in subsection 7c71 by adding at the end the following new paragraph3 7#e7 ,same protection with respect to expenditures for insulin and certain medical supplies ,the coverage provides the coverage required under subsection 7b77#b77;,f74 4 7b7 ,conforming amendments 7#a7 ,in general ,section #ahfj;,d-#ad7;a77#a77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7;a77#a77;,d771 as amended by section #aba1 is further amended-- 7,a7 in clause 7ii71 by striking section #ahfj;,d-#b7;b77#b7 and inserting section #ahfj;,d-#b7;b77#b77;,a72 and 7,b7 in clause 7iii71 by striking section #ahfj;,d-#b7;b77#b7 and inserting section #ahfj;,d-#b7;b77#b77;,a74 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply with respect to plan year #bjbb and each subsequent plan year4 #acd4 ,growth rate of ,medicare part ,d out-of-pocket cost threshold 7a7 ,providing ,medicare part ,d beneficiaries with certain #bjbj offset payments ,section #ahfj;,d-#b7;b77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is amended by adding at the end the following new subparagraph3 7,f7 #bjbj offset payments 7i7 ,in general ,subject to clause 7iv71 the ,secretary shall provide for payment from the ,medicare ,prescription ,drug ,account as follows3 7,i7 ,in the case of a specified individual 7as defined in clause 7ii77,i77 who as of the last day of a calendar quarter in #bjbj has incurred costs for covered part ,d drugs so that the individual has exceeded the annual out-of-pocket threshold applied under subparagraph 7,b77i77,v7 for #bjbj1 payment to the individual by not later than #aeth day of the third month following the end of such quarter of the amount by which such threshold so applied exceeded the target threshold for #bjbj4 7,,ii7 ,in the case of a specified individual who is not described in subclause 7,i7 and who as of the last day of #bjbj has incurred costs for covered part ,d drugs so that the individual has exceeded the target threshold for #bjbj1 payment to the individual by not later than ,december #ca1 #bjba1 of the amount by which such incurred costs exceeded the target threshold for #bjbj4 7ii7 ,definitions ,for purposes of this subparagraph3 7,i7 ,specified individual ,the term specified individual means an individual who-- 7aa7 is enrolled in a prescription drug plan or an ,,ma- ,,pd plan2 7bb7 is not enrolled in a qualified retiree prescription drug plan2 and 7cc7 is not entitled to an income-related subsidy under section #ahfj;,d-#ad7;a74 7,,ii7 ,target threshold for #bjbj ,the term target threshold for #bjbj means the annual out-of-pocket threshold that would have been applied under subparagraph 7,b77i7 for #bjbj if such threshold had been determined in accordance with subclause 7,,iv7 of such subparagraph instead of subclause 7,v7 of such subparagraph4 7iii7 ,notification ,in the case of any specified individual who during #bjbj has incurred costs for covered part ,d drugs so that the individual has exceeded the target threshold for #bjbj1 the ,secretary shall1 not later than ,september #cj1 #bjba1 provide to such individual a notification informing such individual of such individual's right to a payment described in clause 7i7 and the estimated timing of such payment4 7iv7 ,clarification ,the ,secretary shall provide only #a payment under this subparagraph with respect to any individual4 7v7 ,implementation ,the ,secretary may implement this subparagraph by program instruction or otherwise4 4 7b7 ,reduced growth rate for #bjba of ,medicare part ,d out-of-,pocket cost threshold ,section #ahfj;,d-#b7;b77#d77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77;,b77i77 is amended-- 7#a7 in subclause 7,v71 by striking at the end or2 7#b7 by redesignating subclause 7,,vi7 as subclause 7,,viii72 and 7#c7 by inserting after subclause 7,v7 the following new subclauses3 7,,vi7 for #bjba1 is equal to the amount that would have been applied under this subparagraph for #bjbj if such amount had been determined in accordance with subclause 7,,iv7 instead of subclause 7,v71 increased by the lesser of-- 7aa7 the annual percentage increase described in paragraph 7#g7 for #bjba1 plus #b percentage points2 or 7bb7 the annual percentage increase described in paragraph 7#f7 for #bjba2 7,,vii7 for #bjbb1 is equal to the amount that would have been applied under this subparagraph for #bjbb if the amendments made by section #aaja7;d77#a7 of the ,health ,care and ,education ,reconciliation ,act of #bjaj and by section #acd of the ,lower ,costs1 ,more ,cures ,act of #bjba had not been enacted2 or 4 ,,ii ,medicaid #bja4 ,medicaid pharmacy and therapeutics committee improvements 7a7 ,in general ,subparagraph 7,a7 of section #aibg7;d77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;d77#d77 is amended to read as follows3 7,a7 7i7 ,the formulary is developed and reviewed by a pharmacy and therapeutics committee consisting of physicians1 pharmacists1 and other appropriate individuals appointed by the ,governor of the ,state4 7ii7 ,subject to clause 7vi71 the ,state establishes and implements a conflict of interest policy for the pharmacy and therapeutics committee that-- 7,i7 is publicly accessible2 7,,ii7 requires all committee members to complete1 on at least an annual basis1 a disclosure of relationships1 associations1 and financial dealings that may affect their independence of judgement in committee matters2 and 7,,iii7 contains clear processes1 such as recusal from voting or discussion1 for those members who report a conflict of interest1 along with appropriate processes to address any instance where a member fails to report a conflict of interest4 7iii7 ,the membership of the pharmacy and therapeutics committee-- 7,i7 includes at least #a actively practicing physician and at least #a actively practicing pharmacist1 each of whom-- 7aa7 is independent and free of conflict with respect to manufacturers and ,medicaid participating plans or subcontractors1 including pharmacy benefit managers2 and 7bb7 has expertise in the care of #a or more ,medicaid-specific populations such as elderly or disabled individuals1 children with complex medical needs1 or low-income individuals with chronic illnesses2 and 7,,ii7 is made publicly available4 7iv7 ,at the option of the ,state1 the ,state's drug use review board established under subsection 7g77#c7 may serve as the pharmacy and therapeutics committee provided the ,state ensures that such board meets the requirements of clauses 7ii7 and 7iii74 7v7 ,the ,state reviews and has final approval of the formulary established by the pharmacy and therapeutics committee4 7vi7 ,if the ,secretary determines it appropriate or necessary based on the findings and recommendations of the ,comptroller ,general of the ,united ,states in the report submitted to ,congress under section #bjc of the ,lower ,costs1 ,more ,cures ,act of #bjba1 the ,secretary shall issue guidance that ,states must follow for establishing conflict of interest policies for the pharmacy and therapeutics committee in accordance with the requirements of clause 7ii71 including appropriate standards and requirements for identifying1 addressing1 and reporting on conflicts of interest4 4 7b7 ,application to ,medicaid managed care organizations ,clause 7xiii7 of section #aijc7m77#b77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a77 is amended-- 7#a7 by striking and 7,,iii7 and inserting 7,,iii72 7#b7 by striking the period at the end and inserting 1 and 7,,iv7 any formulary used by the entity for covered outpatient drugs dispensed to individuals eligible for medical assistance who are enrolled with the entity is developed and reviewed by a pharmacy and therapeutics committee that meets the requirements of clauses 7ii7 and 7iii7 of section #aibg7;d77#d77;,a742 and 7#c7 by moving the left margin #b ems to the left4 7c7 ,effective date ,the amendments made by this section shall take effect on the date that is #a year after the date of enactment of this ,act4 #bjb4 ,,gao report on conflicts of interest in ,state ,medicaid program drug use review boards and pharmacy and therapeutics 7,p,t7 committees 7a7 ,investigation ,the ,comptroller ,general of the ,united ,states shall conduct an investigation of potential or existing conflicts of interest among members of ,state ,medicaid program ,state drug use review boards 7in this section referred to as ,,dur ,boards7 and pharmacy and therapeutics committees 7in this section referred to as ,p,t ,committees74 7b7 ,report ,not later than #bd months after the date of enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report on the investigation conducted under subsection 7a7 that includes the following3 7#a7 ,a description outlining how ,,dur ,boards and ,p,t ,committees operate in ,states1 including details with respect to-- 7,a7 the structure and operation of ,,dur ,boards and statewide ,p,t ,committees2 7,b7 ,states that operate separate ,p,t ,committees for their fee-for-service ,medicaid program and their ,medicaid managed care organizations or other ,medicaid managed care arrangements 7collectively referred to in this section as ,medicaid ,m,c,os72 and 7,c7 ,states that allow ,medicaid ,m,c,os to have their own ,p,t ,committees and the extent to which pharmacy benefit managers administer or participate in such ,p,t ,committees4 7#b7 ,a description outlining the differences between ,,dur ,boards established in accordance with section #aibg7;g77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr7g77#c77 and ,p,t ,committees4 7#c7 ,a description outlining the tools ,p,t ,committees may use to determine ,medicaid drug coverage and utilization management policies4 7#d7 ,an analysis of whether and how ,states or ,p,t ,committees establish participation and independence requirements for ,,dur ,boards and ,p,t ,committees1 including with respect to entities with connections with drug manufacturers1 ,state ,medicaid programs1 managed care organizations1 and other entities or individuals in the pharmaceutical industry4 7#e7 ,a description outlining how ,states1 ,,dur ,boards1 or ,p,t ,committees define conflicts of interest4 7#f7 ,a description of how ,,dur ,boards and ,p,t ,committees address conflicts of interest1 including who is responsible for implementing such policies4 7#g7 ,a description of the tools1 if any1 ,states use to ensure that there are no conflicts of interest on ,,dur ,boards and ,p,t ,committees4 7#h7 ,an analysis of the effectiveness of tools ,states use to ensure that there are no conflicts of interest on ,,dur ,boards and ,p,t ,committees and1 if applicable1 recommendations as to how such tools could be improved4 7#i7 ,a review of strategies ,states may use to guard against conflicts of interest on ,,dur ,boards and ,p,t ,committees and to ensure compliance with the requirements of titles ,,xi and ,,xix of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq41 #acif et seq47 and access to effective1 clinically appropriate1 and medically necessary drug treatments for ,medicaid beneficiaries1 including recommendations for such legislative and administrative actions as the ,comptroller ,general determines appropriate4 #bjc4 ,ensuring the accuracy of manufacturer price and drug product information under the ,medicaid drug rebate program 7a7 ,audit of manufacturer price and drug product information 7#a7 ,in general ,subparagraph 7,b7 of section #aibg7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77 is amended to read as follows3 7,b7 ,audits and surveys of manufacturer price and drug product information 7i7 ,audits ,the ,secretary shall conduct ongoing audits of the price and drug product information reported by manufacturers under subparagraph 7,a7 for the most recently ended rebate period to ensure the accuracy and timeliness of such information4 ,in conducting such audits1 the ,secretary may employ evaluations1 surveys1 statistical sampling1 predictive analytics and other relevant tools and methods4 7ii7 ,verifications surveys of average manufacturer price and manufacturer's average sales price ,in addition to the audits required under clause 7i71 the ,secretary may survey wholesalers and manufacturers 7including manufacturers that directly distribute their covered outpatient drugs 7in this subparagraph referred to as direct sellers771 when necessary1 to verify manufacturer prices and manufacturer's average sales prices 7including wholesale acquisition cost7 to make payment reported under subparagraph 7,a74 7iii7 ,penalties ,in addition to other penalties as may be prescribed by law1 including under subparagraph 7,c7 of this paragraph1 the ,secretary may impose a civil monetary penalty in an amount not to exceed #ahe1jjj on an annual basis on a wholesaler1 manufacturer1 or direct seller1 if the wholesaler1 manufacturer1 or direct seller of a covered outpatient drug refuses a request for information about charges or prices by the ,secretary in connection with an audit or survey under this subparagraph or knowingly provides false information4 ,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 clause in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7iv7 ,reports 7,i7 ,report to ,congress ,the ,secretary shall1 not later than #ah months after date of enactment of this subparagraph1 submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,finance of the ,senate regarding additional regulatory or statutory changes that may be required in order to ensure accurate and timely reporting and oversight of manufacturer price and drug product information1 including whether changes should be made to reasonable assumption requirements to ensure such assumptions are reasonable and accurate or whether another methodology for ensuring accurate and timely reporting of price and drug product information should be considered to ensure the integrity of the drug rebate program under this section4 7,,ii7 ,annual reports ,the ,secretary shall1 on at least an annual basis1 submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,finance of the ,senate summarizing the results of the audits and surveys conducted under this subparagraph during the period that is the subject of the report4 7,,iii7 ,content ,each report submitted under subclause 7,,ii7 shall1 with respect to the period that is the subject of the report1 include summaries of-- 7aa7 error rates in the price1 drug product1 and other relevant information supplied by manufacturers under subparagraph 7,a72 7bb7 the timeliness with which manufacturers1 wholesalers1 and direct sellers provide information required under subparagraph 7,a7 or under clause 7i7 or 7ii7 of this subparagraph2 7cc7 the number of manufacturers1 wholesalers1 and direct sellers and drug products audited under this subparagraph2 7dd7 the types of price and drug product information reviewed under the audits conducted under this subparagraph2 7ee7 the tools and methodologies employed in such audits2 7ff7 the findings of such audits1 including which manufacturers1 if any1 were penalized under this subparagraph2 and 7gg7 such other relevant information as the ,secretary shall deem appropriate4 7,,iv7 ,protection of information ,in preparing a report required under subclause 7,,ii71 the ,secretary shall redact such proprietary information as the ,secretary determines appropriate to prevent disclosure of1 and to safeguard1 such information4 7v7 ,appropriations ,out of any funds in the ,treasury not otherwise appropriated1 there is appropriated to the ,secretary #b1jjj1jjj for fiscal year #bjbb and each fiscal year thereafter to carry out this subparagraph4 4 7#b7 ,effective date ,the amendments made by this subsection shall take effect on the first day of the first fiscal quarter that begins after the date of enactment of this ,act4 7b7 ,increased penalties for noncompliance with reporting requirements 7#a7 ,increased penalty for late reporting of information ,section #aibg7;b77#c77;,c77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77i77 is amended by striking increased by #aj1jjj for each day in which such information has not been provided and such amount shall be paid to the ,treasury and inserting 1 for each covered outpatient drug with respect to which such information is not provided1 #ej1jjj for the first day that such information is not provided on a timely basis and #ai1jjj for each subsequent day that such information is not provided4 7#b7 ,increased penalty for knowingly reporting false information ,section #aibg7;b77#c77;,c77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,c77ii77 is amended by striking #ajj1jjj and inserting #ejj1jjj4 7#c7 ,effective date ,the amendments made by this subsection shall take effect on the first day of the first fiscal quarter that begins after the date of enactment of this ,act4 #bjd4 ,improving transparency and preventing the use of abusive spread pricing and related practices in ,medicaid 7a7 ,pass-,through pricing required 7#a7 ,in general ,section #aibg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is amended by adding at the end the following3 7#f7 ,pass-through pricing required ,a contract between the ,state and a pharmacy benefit manager 7referred to in this paragraph as a ,,pbm71 or a contract between the ,state and a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d77 that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity1 shall require that payment for such drugs and related administrative services 7as applicable71 including payments made by a ,,pbm on behalf of the ,state or entity1 is based on a pass-through pricing model under which-- 7,a7 any payment made by the entity of the ,,pbm 7as applicable7 for such a drug-- 7i7 is limited to-- 7,i7 ingredient cost2 and 7,,ii7 a professional dispensing fee that is not less than the professional dispensing fee that the ,state plan or waiver would pay if the plan or waiver was making the payment directly2 7ii7 is passed through in its entirety by the entity or ,,pbm to the pharmacy that dispenses the drug2 and 7iii7 is made in a manner that is consistent with section #aijb7;a77#cj77;,a7 and sections #ddg4eab1 #ddg4ead1 and #ddg4eah of title #db1 ,code of ,federal ,regulations 7or any successor regulation71 as if such requirements applied directly to the entity or the ,,pbm2 7,b7 payment to the entity or the ,,pbm 7as applicable7 for administrative services performed by the entity or ,,pbm is limited to a reasonable administrative fee that covers the reasonable cost of providing such services2 7,c7 the entity or the ,,pbm 7as applicable7 shall make available to the ,state1 and the ,secretary upon request1 all costs and payments related to covered outpatient drugs and accompanying administrative services incurred1 received1 or made by the entity or the ,,pbm1 including ingredient costs1 professional dispensing fees1 administrative fees1 post-sale and post-in-voice fees4 ,discounts1 or related adjustments such as direct and indirect remuneration fees1 and any and all remuneration2 and 7,d7 any form of spread pricing whereby any amount charged or claimed by the entity or the ,,pbm 7as applicable7 is in excess of the amount paid to the pharmacies on behalf of the entity1 including any post-sale or post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees or assessments 7after allowing for a reasonable administrative fee as described in subparagraph 7,b77 is not allowable for purposes of claiming ,federal matching payments under this title4 4 7#b7 ,conforming amendment ,clause 7xiii7 of section #aijc7m77#b77;,a7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77#b77;,a771 as amended by section #bjb1 is further amended-- 7,a7 by striking and 7,,iv7 and inserting 7,,iv72 and 7,b7 by inserting before the period at the end the following3 1 and 7,v7 pharmacy benefit management services provided by the entity1 or provided by a pharmacy benefit manager on behalf of the entity under a contract or other arrangement between the entity and the pharmacy benefit manager1 shall comply with the requirements of section #aibg7;e77#f74 7#c7 ,effective date ,the amendments made by this subsection apply to contracts between ,states and managed care entities1 other specified entities1 or pharmacy benefits managers that are entered into or renewed on or after the date that is #ah months after the date of enactment of this ,act4 7b7 ,survey of retail prices 7#a7 ,in general ,section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is amended-- 7,a7 by striking and after the semicolon at the end of paragraph 7#a77;,a77i7 and all that precedes it through 7#a7 and inserting the following3 7#a7 ,survey of retail prices ,the ,secretary shall conduct a survey of retail community drug prices1 to include at least the national average drug acquisition cost1 as follows3 7,a7 ,use of vendor ,the ,secretary may contract services for-- 7i7 with respect to retail community pharmacies1 the determination on a monthly basis of retail survey prices of the national average drug acquisition cost for covered outpatient drugs for such pharmacies1 net of all discounts and rebates 7to the extent any information with respect to such discounts and rebates is available71 the average reimbursement received for such drugs by such pharmacies from all sources of payment1 including third parties1 and1 to the extent available1 the usual and customary charges to consumers for such drugs2 and 2 7,b7 by adding at the end of paragraph 7#a7 the following3 7,f7 ,survey reporting ,in order to meet the requirement of section #aijb7;a77#ed71 a ,state shall require that any retail community pharmacy in the ,state that receives any payment1 administrative fee1 discount1 or rebate related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title1 regardless of whether such payment1 fee1 discount1 or rebate is received from the ,state or a managed care entity directly or from a pharmacy benefit manager or another entity that has a contract with the ,state or a managed care entity1 shall respond to surveys of retail prices conducted under this subsection4 7,g7 ,survey information ,information on retail community prices obtained under this paragraph shall be made publicly available and shall include at least the following3 7i7 ,the monthly response rate of the survey including a list of pharmacies not in compliance with subparagraph 7,f74 7ii7 ,the sampling frame and number of pharmacies sampled monthly4 7iii7 ,characteristics of reporting pharmacies1 including type 7such as independent or chain71 geographic or regional location1 and dispensing volume4 7iv7 ,reporting of a separate national average drug acquisition cost for each drug for independent retail pharmacies and chain operated pharmacies4 7v7 ,information on price concessions including on and off invoice discounts1 rebates1 and other price concessions4 7vi7 ,information on average professional dispensing fees paid4 7,h7 ,penalties 7i7 ,failure to provide timely information ,a retail community pharmacy that fails to respond to a survey conducted under this subsection on a timely basis may be subject to a civil monetary penalty in the amount of #aj1jjj for each day in which such information has not been provided4 7ii7 ,false information ,a retail community pharmacy that knowingly provides false information in response to a survey conducted under this subsection may be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 7iii7 ,other penalties ,any civil money penalties imposed under this subparagraph shall be in addition to other penalties as may be prescribed by law4 ,the provisions of section #aabh;,a 7other than subsections 7a7 and 7b77 shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceedings under section #aabh;,a7a74 7,i7 ,report on specialty pharmacies 7i7 ,in general ,not later than #a year after the effective date of this subparagraph1 the ,secretary shall submit a report to ,congress examining specialty drug coverage and reimbursement under this title4 7ii7 ,content of report ,such report shall include a description of how ,state ,medicaid programs define specialty drugs1 how much ,state ,medicaid programs pay for specialty drugs1 how ,states and managed care plans determine payment for specialty drugs1 the settings in which specialty drugs are dispensed 7such as retail community pharmacies or specialty pharmacies71 whether acquisition costs for specialty drugs are captured in the national average drug acquisition cost survey1 and recommendations as to whether specialty pharmacies should be included in the survey of retail prices to ensure national average drug acquisition costs capture drugs sold at specialty pharmacies and how such specialty pharmacies should be defined4 2 7,c7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting 1 including payments rates under ,medicaid managed care plans1 after under this title2 and 7ii7 in subparagraph 7,b71 by inserting and the basis for such dispensing fees before the semicolon2 and 7,d7 in paragraph 7#d71 by inserting 1 and #e1jjj1jjj for fiscal year #bjbb and each fiscal year thereafter1 after #bjaj4 7#b7 ,effective date ,the amendments made by this subsection take effect on the #ast day of the #ast quarter that begins on or after the date that is #ah months after the date of enactment of this ,act4 7c7 ,manufacturer reporting of wholesale acquisition cost ,section #aibg7;b77#c7 of such ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c771 as amended by section #ada1 is further amended-- 7#a7 in subparagraph 7,a77i7-- 7,a7 in subclause 7,i71 by striking and after the semicolon2 7,b7 in subclause 7,,ii71 by adding and after the semicolon2 7,c7 by moving the left margins of subclauses 7,i7 and 7,,ii7 #b ems to the right2 and 7,d7 by adding at the end the following3 7,,iii7 in the case of rebate periods that begin on or after the date of enactment of this subclause1 on the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 for covered outpatient drugs for the rebate period under the agreement 7including for all such drugs that are sold under a new drug application approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 2 and 7#b7 in subparagraph 7,d7-- 7,a7 in the matter preceding clause 7i71 by inserting and clause 7vii7 of this subparagraph after #ahdg;,a2 7,b7 in clause 7vi71 by striking and after the comma2 7,c7 in clause 7vii71 by striking the period and inserting 1 and2 and 7,d7 by inserting after clause 7vii7 the following3 7viii7 to the ,secretary to disclose 7through a website accessible to the public7 the most recently reported wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 for each covered outpatient drug 7including for all such drugs that are sold under a new drug application approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 as reported under subparagraph 7,a77i77,,iii74 4 #bje4 ,t-,,msis drug data analytics reports 7a7 ,in general ,not later than ,may #a of each calendar year beginning with calendar year #bjbc1 the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall publish on a website of the ,centers for ,medicare ,medicaid ,services that is accessible to the public a report of the most recently available data on provider prescribing patterns under the ,medicaid program4 7b7 ,content of report 7#a7 ,required content ,each report required under subsection 7a7 for a calendar year shall include the following information with respect to each ,state 7and1 to the extent available1 with respect to ,puerto ,rico1 the ,united ,states ,virgin ,islands1 ,guam1 the ,northern ,mariana ,islands1 and ,american ,samoa73 7,a7 ,a comparison of covered outpatient drug 7as defined in section #aibg7k77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#b777 prescribing patterns under the ,state ,medicaid plan or waiver of such plan 7including drugs prescribed on a fee-for-service basis and drugs prescribed under managed care arrangements under such plan or waiver7-- 7i7 across all forms or models of reimbursement used under the plan or waiver2 7ii7 within specialties and subspecialties1 as defined by the ,secretary2 7iii7 by episodes of care for-- 7,i7 each chronic disease category1 as defined by the ,secretary1 that is represented in the #aj conditions that accounted for the greatest share of total spending under the plan or waiver during the year that is the subject of the report2 7,,ii7 procedural groupings2 and 7,,iii7 rare disease diagnosis codes2 7iv7 by patient demographic characteristics1 including race 7to the extent that the ,secretary determines that there is sufficient data available with respect to such characteristic in a majority of ,states71 gender1 and age2 7v7 by patient high-utilizer or risk status2 and 7vi7 by high and low resource settings by facility and place of service categories1 as determined by the ,secretary4 7,b7 ,in the case of medical assistance for covered outpatient drugs 7as so defined7 provided under a ,state ,medicaid plan or waiver of such plan in a managed care setting1 an analysis of the differences in managed care prescribing patterns when a covered outpatient drug is prescribed in a managed care setting as compared to when the drug is prescribed in a fee-for-service setting4 7#b7 ,additional content ,a report required under subsection 7a7 for a calendar year may include ,state-specific information about prescription utilization management tools under ,state ,medicaid plans or waivers of such plans1 including-- 7,a7 a description of prescription utilization management tools under ,state programs to provide long-term services and supports under a ,state ,medicaid plan or a waiver of such plan2 7,b7 a comparison of prescription utilization management tools applicable to populations covered under a ,state ,medicaid plan waiver under section #aaae of the ,social ,security ,act 7#db ,u4,s4,c4 #acae7 and the models applicable to populations that are not covered under the waiver2 7,c7 a comparison of the prescription utilization management tools employed by different ,medicaid managed care organizations1 pharmacy benefit managers1 and related entities within the ,state2 7,d7 a comparison of the prescription utilization management tools applicable to each enrollment category under a ,state ,medicaid plan or waiver2 and 7,e7 a comparison of the prescription utilization management tools applicable under the ,state ,medicaid plan or waiver by patient high-utilizer or risk status4 7#c7 ,additional analysis ,to the extent practicable1 the ,secretary shall include in each report published under subsection 7a7-- 7,a7 analyses of national1 ,state1 and local patterns of ,medicaid population-based prescribing behaviors2 and 7,b7 recommendations for administrative or legislative action to improve the effectiveness of1 and reduce costs for1 covered outpatient drugs under ,medicaid while ensuring timely beneficiary access to medically necessary covered outpatient drugs4 7c7 ,use of ,t-,,msis data ,each report required under subsection 7a7 shall-- 7#a7 be prepared using data and definitions from the ,transformed ,medicaid ,statistical ,information ,system 7,t-,,msis7 data set 7or a successor data set7 that is not more than #bd months old on the date that the report is published2 and 7#b7 as appropriate1 include a description with respect to each ,state of the quality and completeness of the data1 as well as any necessary caveats describing the limitations of the data reported to the ,secretary by the ,state that are sufficient to communicate the appropriate uses for the information4 7d7 ,preparation of report ,each report required under subsection 7a7 shall be prepared by the ,administrator for the ,centers for ,medicare ,medicaid ,services4 7e7 ,appropriation ,for fiscal year #bjbb and each fiscal year thereafter1 there is appropriated to the ,secretary #b1jjj1jjj to carry out this section4 #bjf4 ,risk-sharing value-based payment agreements for covered outpatient drugs under ,medicaid 7a7 ,in general ,section #aibg of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7 is amended by adding at the end the following new subsection3 7l7 ,state option ,to pay for covered outpatient drugs through risk-,sharing value-,based agreements 7#a7 ,in general ,beginning ,january #a1 #bjbb1 a ,state shall have the option to pay 7whether on a fee-for-service or managed care basis7 for covered outpatient drugs that are potentially curative treatments intended for one-time use that are administered to individuals under this title by entering into a risk-sharing value-based payment agreement with the manufacturer of the drug in accordance with the requirements of this subsection4 7#b7 ,secretarial approval 7,a7 ,in general ,a ,state shall submit a request to the ,secretary to enter into a risk-sharing value based payment agreement1 and the ,secretary shall not approve a proposed risk-sharing value-based payment agreement between a ,state and a manufacturer for payment for a covered outpatient drug of the manufacturer unless the following requirements are met3 7i7 ,manufacturer is party to rebate agreement and in compliance with requirements ,the manufacturer has a rebate agreement in effect as required under subsections 7a7 and 7b7 of this section and is in compliance with all applicable requirements under this title4 7ii7 ,no increase to projected net ,federal spending 7,i7 ,in general ,the ,chief ,actuary certifies that the projected payments for each covered outpatient drug under such proposed agreement would not result in greater estimated ,federal spending under this title than the net ,federal spending that would result in the absence of the agreement4 7,,ii7 ,net federal spending defined ,for purposes of this subsection1 the term net ,federal spending means the amount of ,federal payments the ,chief ,actuary estimates would be made under this title for administering a covered outpatient drug to an individual eligible for medical assistance under a ,state plan or a waiver of such plan1 reduced by the amount of all rebates the ,chief ,actuary estimates would be paid with respect to the administering of such drug1 including all rebates under this title and any supplemental or other additional rebates1 in the absence of such an agreement4 7,,iii7 ,information ,the ,chief ,actuary shall make the certifications required under this clause based on the most recently available and reliable drug pricing and product information4 ,the ,state and manufacturer shall provide the ,secretary and the ,chief ,actuary with all necessary information required to make the estimates needed for such certifications4 7iii7 ,launch and list price justifications ,the manufacturer submits all relevant information and supporting documentation necessary for pricing decisions as deemed appropriate by the ,secretary1 which shall be truthful and non-misleading1 including manufacturer information and supporting documentation for launch price or list price increases1 and any applicable justification required under section #aabh,l4 7iv7 ,confidentiality of information2 penalties ,the provisions of subparagraphs 7,c7 and 7,d7 of subsection 7b77#c7 shall apply to a manufacturer that fails to submit the information and documentation required under clauses 7ii7 and 7iii7 on a timely basis1 or that knowingly provides false or misleading information1 in the same manner as such provisions apply to a manufacturer with a rebate agreement under this section4 7,b7 ,consideration of ,state request for approval 7i7 ,in general ,the ,secretary shall treat a ,state request for approval of a risk-sharing value-based payment agreement in the same manner that the ,secretary treats a ,state plan amendment1 and subpart ,b of part #dcj of title #db1 ,code of ,federal ,regulations1 including1 subject to clause 7ii71 the timing requirements of section #dcj4af of such title 7as in effect on the date of enactment of this subsection71 shall apply to a request for approval of a risk-sharing value-based payment agreement in the same manner as such subpart applies to a ,state plan amendment4 7ii7 ,timing ,the ,secretary shall consult with the ,commissioner of ,food and ,drugs as required under subparagraph 7,c7 and make a determination on whether to approve a request from a ,state for approval of a proposed risk-sharing value-based payment agreement 7or request additional information necessary to allow the ,secretary to make a determination with respect to such request for approval7 within the time period1 to the extent practicable1 specified in section #dcj4af of title #db1 ,code of ,federal ,regulations 7as in effect on the date of enactment of this subsection71 but in no case shall the ,secretary take more than #ahj days after the receipt of such request for approval or response to such request for additional information to make such a determination 7or request additional information74 7,c7 ,consultation with the ,commissioner of ,food and ,drugs ,in considering whether to approve a risk-sharing value-based payment agreement1 the ,secretary1 to the extent necessary1 shall consult with the ,commissioner of ,food and ,drugs to determine whether the relevant clinical parameters specified in such agreement are appropriate4 7#c7 ,installment-based payment structure 7,a7 ,in general ,a risk-sharing value-based payment agreement shall provide for a payment structure under which1 for every installment year of the agreement 7subject to subparagraph 7,b771 the ,state shall pay the total installment year amount in equal installments to be paid at regular intervals over a period of time that shall be specified in the agreement4 7,b7 ,requirements for installment payments 7i7 ,timing of first payment ,the ,state shall make the first of the installment payments described in subparagraph 7,a7 for an installment year not later than #cj days after the end of such year4 7ii7 ,length of installment period ,the period of time over which the ,state shall make the installment payments described in subparagraph 7,a7 for an installment year shall not be longer than #e years4 7iii7 ,nonpayment or reduced payment of installments following a failure to meet clinical parameter ,if1 prior to the payment date 7as specified in the agreement7 of any installment payment described in subparagraph 7,a7 or any other alternative date or time frame 7as otherwise specified in the agreement71 the covered outpatient drug which is subject to the agreement fails to meet a relevant clinical parameter of the agreement1 the agreement shall provide that-- 7,i7 the installment payment shall not be made2 or 7,,ii7 the installment payment shall be reduced by a percentage specified in the agreement that is based on the outcome achieved by the drug relative to the relevant clinical parameter4 7#d7 ,notice of intent 7,a7 ,in general ,subject to subparagraph 7,b71 a manufacturer of a covered outpatient drug shall not be eligible to enter into a risk-sharing value-based payment agreement under this subsection with respect to such drug unless the manufacturer notifies the ,secretary that the manufacturer is interested in entering into such an agreement with respect to such drug4 ,the decision to submit and timing of a request to enter into a proposed risk-sharing value-based payment agreement shall remain solely within the discretion of the ,state and shall only be effective upon ,secretarial approval as required under this subsection4 7,b7 ,treatment of subsequently approved drugs 7i7 ,in general ,in the case of a manufacturer of a covered outpatient drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of the ,public ,health ,service ,act after the date of enactment of this subsection1 not more than #ij days after meeting with the ,food and ,drug ,administration following phase ,,ii clinical trials for such drug 7or1 in the case of a drug described in clause 7ii71 not later than ,march #ca1 #bjbb71 the manufacturer must notify the ,secretary of the manufacturer's intent to enter into a risk-sharing value-based payment agreement under this subsection with respect to such drug4 ,if no such meeting has occurred1 the ,secretary may use discretion as to whether a potentially curative treatment intended for one-time use may qualify for a risk-sharing value-based payment agreement under this section4 ,a manufacturer notification of interest shall not have any influence on a decision for approval by the ,food and ,drug ,administration4 7ii7 ,application to certain subsequently approved drugs ,a drug described in this clause is a covered outpatient drug of a manufacturer-- 7,i7 that is approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of the ,public ,health ,service ,act after the date of enactment of this subsection2 and 7,,ii7 with respect to which1 as of ,january #a1 #bjbb1 more than #ij days have passed after the manufacturer's meeting with the ,food and ,drug ,administration following phase ,,ii clinical trials for such drug4 7iii7 ,parallel approval ,the ,secretary1 in coordination with the ,administrator of the ,centers for ,medicare ,medicaid ,services and the ,commissioner of ,food and ,drugs1 shall1 to the extent practicable1 approve a ,state's request to enter into a proposed risk-sharing value-based payment agreement that otherwise meets the requirements of this subsection at the time that such a drug is approved by the ,food and ,drug ,administration to help provide that no ,state that wishes to enter into such an agreement is required to pay for the drug in full at one time if the ,state is seeking to pay over a period of time as outlined in the proposed agreement4 7iv7 ,rule of construction ,nothing in this paragraph shall be applied or construed to modify or affect the timeframes or factors involved in the ,secretary's determination of whether to approve or license a drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of the ,public ,health ,service ,act4 7#e7 ,special payment rules 7,a7 ,in general ,except as otherwise provided in this paragraph1 with respect to an individual who is administered a unit of a covered outpatient drug that is purchased under a ,state plan by a ,state ,medicaid agency under a risk-sharing value-based payment agreement in an installment year1 the ,state shall remain liable to the manufacturer of such drug for payment for such unit without regard to whether the individual remains enrolled in the ,state plan under this title 7or a waiver of such plan7 for each installment year for which the ,state is to make installment payments for covered outpatient drugs purchased under the agreement in such year4 7,b7 ,death ,in the case of an individual described in subparagraph 7,a7 who dies during the period described in such subparagraph1 the ,state plan shall not be liable for any remaining payment for the unit of the covered outpatient drug administered to the individual which is owed under the agreement described in such subparagraph4 7,c7 ,withdrawal of approval ,in the case of a covered outpatient drug that is the subject of a risk-sharing value-based agreement between a ,state and a manufacturer under this subsection1 including a drug approved in accordance with section #ejf7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and such drug is the subject of an application that has been withdrawn by the ,secretary1 the ,state plan shall not be liable for any remaining payment that is owed under the agreement4 7,d7 ,alternative arrangement under agreement ,subject to approval by the ,secretary1 the terms of a proposed risk-sharing value-based payment agreement submitted for approval by a ,state may provide that subparagraph 7,a7 shall not apply4 7,e7 ,guidance ,not later than ,january #a1 #bjbb1 the ,secretary shall issue guidance to ,states establishing a process for ,states to notify the ,secretary when an individual who is administered a unit of a covered outpatient drug that is purchased by a ,state plan under a risk-sharing value-based payment agreement ceases to be enrolled under the ,state plan under this title 7or a waiver of such plan7 or dies before the end of the installment period applicable to such unit under the agreement4 7#f7 ,treatment of payments under risk-sharing value-based agreements for purposes of average manufacturer price2 best price ,the ,secretary shall treat any payments made to the manufacturer of a covered outpatient drug under a risk-sharing value-based payment agreement under this subsection during a rebate period in the same manner that the ,secretary treats payments made under a ,state supplemental rebate agreement under sections #ddg4ejd7;c77#ai7 and #ddg4eje7;c77#g7 of title #db1 ,code of ,federal ,regulations 7or any successor regulations71 for purposes of determining average manufacturer price and best price under this section with respect to the covered outpatient drug and a rebate period and for purposes of offsets required under subsection 7b77#a77;,b74 7#g7 ,assessments and report to ,congress 7,a7 ,assessments 7i7 ,in general ,not later than #ahj days after the end of each assessment period of any risk-sharing value-based payment agreement for a ,state approved under this subsection1 the ,secretary shall conduct an evaluation of such agreement which shall include an evaluation by the ,chief ,actuary to determine whether program spending under the risk-sharing value-based payment agreement aligned with the projections for the agreement made under paragraph 7#b77;,a77ii71 including an assessment of whether actual ,federal spending under this title under the agreement was less or more than net ,federal spending would have been in the absence of the agreement4 7ii7 ,assessment period ,for purposes of clause 7i7-- 7,i7 the first assessment period for a risk-sharing value-based payment agreement shall be the period of time over which payments are scheduled to be made under the agreement for the first #aj individuals who are administered covered outpatient drugs under the agreement except that such period shall not exceed the #e-year period after the date on which the ,secretary approves the agreement2 and 7,,ii7 each subsequent assessment period for a risk-sharing value-based payment agreement shall be the #e-year period following the end of the previous assessment period4 7,b7 ,results of assessments 7i7 ,termination option ,if the ,secretary determines as a result of the assessment by the ,chief ,actuary under subparagraph 7,a7 that the actual ,federal spending under this title for any covered outpatient drug that was the subject of the ,state's risk-sharing value-based payment agreement was greater than the net ,federal spending that would have resulted in the absence of the agreement1 the ,secretary may terminate approval of such agreement and shall immediately conduct an assessment under this paragraph of any other ongoing risk-sharing value-based payment agreement to which the same manufacturer is a party4 7ii7 ,repayment required 7,i7 ,in general ,if the ,secretary determines as a result of the assessment by the ,chief ,actuary under subparagraph 7,a7 that the ,federal spending under the risk-sharing value-based agreement for a covered outpatient drug that was subject to such agreement was greater than the net ,federal spending that would have resulted in the absence of the agreement1 the manufacturer shall repay the difference to the ,state and ,federal governments in a timely manner as determined by the ,secretary4 7,,ii7 ,termination for failure to pay ,the failure of a manufacturer to make repayments required under subclause 7,i7 in a timely manner shall result in immediate termination of all risk-sharing value-based agreements to which the manufacturer is a party4 7,,iii7 ,additional penalties ,in the case of a manufacturer that fails to make repayments required under subclause 7,i71 the ,secretary may treat such manufacturer in the same manner as a manufacturer that fails to pay required rebates under this section1 and the ,secretary may-- 7aa7 suspend or terminate the manufacturer's rebate agreement under this section2 and 7bb7 pursue any other remedy that would be available if the manufacturer had failed to pay required rebates under this section4 7,c7 ,report to ,congress ,not later than #e years after the first risk-sharing value-based payment agreement is approved under this subsection1 the ,secretary shall submit to ,congress and make available to the public a report that includes-- 7i7 an assessment of the impact of risk-sharing value-based payment agreements on access for individuals who are eligible for benefits under a ,state plan or waiver under this title to medically necessary covered outpatient drugs and related treatments2 7ii7 an analysis of the impact of such agreements on overall ,state and ,federal spending under this title2 7iii7 an assessment of the impact of such agreements on drug prices1 including launch price and price increases2 and 7iv7 such recommendations to ,congress as the ,secretary deems appropriate4 7#h7 ,guidance and regulations 7,a7 ,in general ,not later than ,january #a1 #bjbb1 the ,secretary shall issue guidance to ,states seeking to enter into risk-sharing value-based payment agreements under this subsection that includes a model template for such agreements4 ,the ,secretary may issue any additional guidance or promulgate regulations as necessary to implement and enforce the provisions of this subsection4 7,b7 ,model agreements 7i7 ,in general ,if a ,state expresses an interest in pursuing a risk-sharing value-based payment agreement under this subsection with a manufacturer for the purchase of a covered outpatient drug1 the ,secretary may share with such ,state any risk-sharing value-based agreement between a ,state and the manufacturer for the purchase of such drug that has been approved under this subsection4 ,while such shared agreement may serve as a template for a ,state that wishes to propose1 the use of a previously approved agreement shall not affect the submission and approval process for approval of a proposed risk-sharing value-based payment agreement under this subsection1 including the requirements under paragraph 7#b77;,a74 7ii7 ,confidentiality ,in the case of a risk-sharing value-based payment agreement that is disclosed to a ,state by the ,secretary under this subparagraph and that is only in effect with respect to a single ,state1 the confidentiality of information provisions described in subsection 7b77#c77;,d7 shall apply to such information4 7,c7 ,,oig consultation 7i7 ,in general ,the ,secretary shall consult with the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services to determine whether there are potential program integrity concerns with agreement approvals or templates and address accordingly4 7ii7 ,,oig policy updates as necessary ,the ,inspector ,general of the ,department of ,health and ,human ,services shall review and update1 as necessary1 any policies or guidelines of the ,office of the ,inspector ,general of the ,department of ,human ,services 7including policies related to the enforcement of section #aabh;,b7 to accommodate the use of risk-sharing value-based payment agreements in accordance with this section4 7#i7 ,rules of construction 7,a7 ,modifications ,nothing in this subsection or any regulations promulgated under this subsection shall prohibit a ,state from requesting a modification from the ,secretary to the terms of a risk-sharing value-based payment agreement4 ,a modification that is expected to result in any increase to projected net ,state or ,federal spending under the agreement shall be subject to recertification by the ,chief ,actuary as described in paragraph 7#b77;,a77ii7 before the modification may be approved4 7,b7 ,rebate agreements ,nothing in this subsection shall be construed as requiring a ,state to enter into a risk-sharing value-based payment agreement or as limiting or superseding the ability of a ,state to enter into a supplemental rebate agreement for a covered outpatient drug4 7,c7 ,,ffp for payments under risk-sharing value-based payment agreements ,federal financial participation shall be available under this title for any payment made by a ,state to a manufacturer for a covered outpatient drug under a risk-sharing value-based payment agreement in accordance with this subsection1 except that no ,federal financial participation shall be available for any payment made by a ,state to a manufacturer under such an agreement on and after the effective date of a disapproval of such agreement by the ,secretary4 7,d7 ,continued application of other provisions ,except as expressly provided in this subsection1 nothing in this subsection or in any regulations promulgated under this subsection shall affect the application of any other provision of this ,act4 7#aj7 ,appropriations ,for fiscal year #bjbb and each fiscal year thereafter1 there are appropriated to the ,secretary #e1jjj1jjj for the purpose of carrying out this subsection4 7#aa7 ,definitions ,in this subsection3 7,a7 ,chief ,actuary ,the term ,chief ,actuary means the ,chief ,actuary of the ,centers for ,medicare ,medicaid ,services4 7,b7 ,installment year ,the term installment year means1 with respect to a risk-sharing value-based payment agreement1 a #ab-month period during which a covered outpatient drug is administered under the agreement4 7,c7 ,potentially curative treatment intended for one-time use ,the term potentially curative treatment intended for one-time use means a treatment that consists of the administration of a covered outpatient drug that-- 7i7 is a form of gene therapy for a rare disease1 as defined by the ,commissioner of ,food and ,drugs1 designated under section #ebf of the ,federal ,food1 ,drug1 and ,cosmetics ,act1 and approved under section #eje of such ,act or licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act to treat a serious or life-threatening disease or condition2 7ii7 if administered in accordance with the labeling of such drug1 is expected to result in either-- 7,i7 the cure of such disease or condition2 or 7,,ii7 a reduction in the symptoms of such disease or condition to the extent that such disease or condition is not expected to lead to early mortality2 and 7iii7 is expected to achieve a result described in clause 7ii71 which may be achieved over an extended period of time1 after not more than #c administrations4 7,d7 ,relevant clinical parameter ,the term relevant clinical parameter means1 with respect to a covered outpatient drug that is the subject of a risk-sharing value-based payment agreement-- 7i7 a clinical endpoint specified in the drug's labeling or supported by one or more of the compendia described in section #ahfa7t77#b77;,b77ii77,i7 that-- 7,i7 is able to be measured or evaluated on an annual basis for each year of the agreement on an independent basis by a provider or other entity2 and 7,,ii7 is required to be achieved 7based on observed metrics in patient populations7 under the terms of the agreement2 or 7ii7 a surrogate endpoint 7as defined in section #ejg7;e77#i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act71 including those developed by patient-focused drug development tools1 that-- 7,i7 is able to be measured or evaluated on an annual basis for each year of the agreement on an independent basis by a provider or other entity2 and 7,,ii7 has been qualified by the ,food and ,drug ,administration4 7,e7 ,risk-sharing value-based payment agreement ,the term risk-sharing value-based payment agreement means an agreement between a ,state plan and a manufacturer-- 7i7 for the purchase of a covered outpatient drug of the manufacturer that is a potentially curative treatment intended for one-time use2 7ii7 under which payment for such drug shall be made pursuant to an installment-based payment structure that meets the requirements of paragraph 7#c72 7iii7 which conditions payment on the achievement of at least #b relevant clinical parameters 7as defined in subparagraph 7,c772 7iv7 which provides that-- 7,i7 the ,state plan will directly reimburse the manufacturer for the drug2 or 7,,ii7 a third party will reimburse the manufacture in a manner approved by the ,secretary2 and 7v7 is approved by the ,secretary in accordance with paragraph 7#b74 7,f7 ,total installment year amount ,the term total installment year amount means1 with respect to a risk-sharing value-based payment agreement for the purchase of a covered outpatient drug and an installment year1 an amount equal to the product of-- 7i7 the unit price of the drug charged under the agreement2 and 7ii7 the number of units of such drug administered under the agreement during such installment year4 4 7b7 ,conforming amendments 7#a7 ,section #aijc7;i77#aj77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;b7i77#aj77;,a77 is amended by striking or unless section #aibg7;a77#c7 applies and inserting 1 section #aibg7;a77#c7 applies with respect to such drugs1 or such drugs are the subject of a risk-sharing value-based payment agreement under section #aibg7l74 7#b7 ,section #aibg7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77 is amended-- 7,a7 in paragraph 7#a77;,a71 by inserting 7except for drugs for which payment is made by a ,state under a risk-sharing value-based payment agreement under subsection 7l77 after under the ,state plan for such period2 and 7,b7 in paragraph 7#c7-- 7i7 in subparagraph 7,c77i71 by inserting or subsection 7l77#b77;,a7 after subparagraph 7,a72 and 7ii7 in subparagraph 7,d71 in the matter preceding clause 7i71 by inserting 1 under subsection 7l77#b77;,a71 after under this paragraph4 #bjg4 ,applying ,medicaid drug rebate requirement to drugs provided as part of outpatient hospital services 7a7 ,in general ,section #aibg7k77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#c77 is amended to read as follows3 7#c7 ,limiting definition 7,a7 ,in general ,the term covered outpatient drug does not include any drug1 biological product1 or insulin provided as part of1 or as incident to and in the same setting as1 any of the following 7and for which payment may be made under this title as part of payment for the following and not as direct reimbursement for the drug73 7i7 ,inpatient hospital services4 7ii7 ,hospice services4 7iii7 ,dental services1 except that drugs for which the ,state plan authorizes direct reimbursement to the dispensing dentist are covered outpatient drugs4 7iv7 ,physicians' services4 7v7 ,outpatient hospital services4 7vi7 ,nursing facility services and services provided by an intermediate care facility for the mentally retarded4 7vii7 ,other laboratory and x-ray services4 7viii7 ,renal dialysis4 7,b7 ,other exclusions ,such term also does not include any such drug or product for which a ,national ,drug ,code number is not required by the ,food and ,drug ,administration or a drug or biological used for a medical indication which is not a medically accepted indication4 7,c7 ,state option ,at the option of a ,state1 such term may include any drug1 biological product1 or insulin for which the ,state is the primary payer under this title or a demonstration project concerning this title1 and that is provided on an outpatient basis as part of1 or as incident to and in the same setting as1 described in clause 7iv7 or 7v7 of subparagraph 7,a7 and for which payment is made as part of payment for such services4 7,d7 ,no effect on best price ,any drug1 biological product1 or insulin excluded from the definition of such term as a result of this paragraph shall be treated as a covered outpatient drug for purposes of determining the best price 7as defined in subsection 7c77#a77;,c77 for such drug1 biological product1 or insulin4 4 7b7 ,effective date2 implementation guidance 7#a7 ,in general ,the amendment made by subsection 7a7 shall take effect on the date that is #a year after the date of enactment of this ,act4 7#b7 ,implementation and guidance ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall issue guidance and relevant informational bulletins for ,states1 manufacturers 7as defined in section #aibg7k77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#e7771 and other relevant stakeholders1 including health care providers1 regarding implementation of the amendment made by subsection 7a74 ,,iii ,food and ,drug ,administration ,a ,pay-for-,delay #cja4 ,unlawful agreements 7a7 ,agreements prohibited ,subject to subsections 7b7 and 7c71 it shall be unlawful for an ,,nda or ,,bla holder and a subsequent filer 7or for two subsequent filers7 to enter into1 or carry out1 an agreement resolving or settling a covered patent infringement claim on a final or interim basis if under such agreement-- 7#a7 a subsequent filer directly or indirectly receives from such holder 7or in the case of such an agreement between two subsequent filers1 the other subsequent filer7 anything of value1 including a license2 and 7#b7 the subsequent filer agrees to limit or forego research on1 or development1 manufacturing1 marketing1 or sales1 for any period of time1 of the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h74 7b7 ,exclusion ,it shall not be unlawful under subsection 7a7 if a party to an agreement described in such subsection demonstrates by clear and convincing evidence that the value described in subsection 7a77#a7 is compensation solely for other goods or services that the subsequent filer has promised to provide4 7c7 ,limitation ,nothing in this section shall prohibit an agreement resolving or settling a covered patent infringement claim in which the consideration granted by the ,,nda or ,,bla holder to the subsequent filer 7or from one subsequent filer to another7 as part of the resolution or settlement includes only one or more of the following3 7#a7 ,the right to market the covered product that is the subject of the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 in the ,united ,states before the expiration of-- 7,a7 any patent that is the basis of the covered patent infringement claim2 or 7,b7 any patent right or other statutory exclusivity that would prevent the marketing of such covered product4 7#b7 ,a payment for reasonable litigation expenses not to exceed #g1ejj1jjj in the aggregate4 7#c7 ,a covenant not to sue on any claim that such covered product infringes a patent4 7d7 ,enforcement by ,federal ,trade ,commission 7#a7 ,general application ,the requirements of this section apply1 according to their terms1 to an ,,nda or ,,bla holder or subsequent filer that is-- 7,a7 a person1 partnership1 or corporation over which the ,commission has authority pursuant to section #e7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#b772 or 7,b7 a person1 partnership1 or corporation over which the ,commission would have authority pursuant to such section but for the fact that such person1 partnership1 or corporation is not organized to carry on business for its own profit or that of its members4 7#b7 ,unfair or deceptive acts or practices enforcement authority 7,a7 ,in general ,a violation of this section shall be treated as an unfair or deceptive act or practice in violation of section #e7;a77#a7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7;a77#a774 7,b7 ,powers of ,commission ,except as provided in subparagraph 7,c7 and paragraphs 7#a77;,b7 and 7#c7-- 7i7 the ,commission shall enforce this section in the same manner1 by the same means1 and with the same jurisdiction1 powers1 and duties as though all applicable terms and provisions of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #da et seq47 were incorporated into and made a part of this section2 and 7ii7 any ,,nda or ,,bla holder or subsequent filer that violates this section shall be subject to the penalties and entitled to the privileges and immunities provided in the ,federal ,trade ,commission ,act4 7,c7 ,judicial review ,in the case of a cease and desist order issued by the ,commission under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section1 a party to such order may obtain judicial review of such order as provided in such section #e1 except that-- 7i7 such review may only be obtained in-- 7,i7 the ,united ,states ,court of ,appeals for the ,district of ,columbia ,circuit2 7,,ii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as defined in section #hja4a7;a77#c7 of title #af1 ,code of ,federal ,regulations1 or any successor thereto1 of the ,,nda or ,,bla holder 7if any such holder is a party to such order7 is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 or an approved application that is deemed to be a license for a biological product under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh2 #abd ,stat4 #hag7 is submitted to the ,commissioner of ,food and ,drugs2 or 7,,iii7 the ,united ,states ,court of ,appeals for the circuit in which the ultimate parent entity1 as so defined1 of any subsequent filer that is a party to such order is incorporated as of the date that the application described in subparagraph 7,a7 or 7,b7 of subsection 7g77#h7 is submitted to the ,commissioner of ,food and ,drugs2 and 7ii7 the petition for review shall be filed in the court not later than #cj days after such order is served on the party seeking review4 7#c7 ,additional enforcement authority 7,a7 ,civil penalty ,the ,commission may commence a civil action to recover a civil penalty in a district court of the ,united ,states against any ,,nda or ,,bla holder or subsequent filer that violates this section4 7,b7 ,special rule for recovery of penalty if cease and desist order issued 7i7 ,in general ,if the ,commission has issued a cease and desist order in a proceeding under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of this section-- 7,i7 the ,commission may commence a civil action under subparagraph 7,a7 to recover a civil penalty against any party to such order at any time before the expiration of the #a-year period beginning on the date on which such order becomes final under section #e7;g7 of such ,act 7#ae ,u4,s4,c4 #de7;g772 and 7,,ii7 in such civil action1 the findings of the ,commission as to the material facts in such proceeding shall be conclusive1 unless-- 7aa7 the terms of such order expressly provide that the ,commission's findings shall not be conclusive2 or 7bb7 such order became final by reason of section #e7;g77#a7 of such ,act 7#ae ,u4,s4,c4 #de7;g77#a771 in which case such findings shall be conclusive if supported by evidence4 7ii7 ,relationship to penalty for violation of an order ,the penalty provided in clause 7i7 for violation of this section is separate from and in addition to any penalty that may be incurred for violation of an order of the ,commission under section #e7l7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7l774 7,c7 ,amount of penalty 7i7 ,in general ,the amount of a civil penalty imposed in a civil action under subparagraph 7,a7 on a party to an agreement described in subsection 7a7 shall be sufficient to deter violations of this section1 but in no event greater than-- 7,i7 if such party is the ,,nda or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 the greater of-- 7aa7 #c times the value received by such ,,nda or ,,bla holder 7or by such subsequent filer7 that is reasonably attributable to the violation of this section2 or 7bb7 #c times the value given to the subsequent filer 7or to the other subsequent filer7 reasonably attributable to the violation of this section2 and 7,,ii7 if such party is the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 #c times the value received by such subsequent filer that is reasonably attributable to the violation of this section4 7ii7 ,factors for consideration ,in determining such amount1 the court shall take into account-- 7,i7 the nature1 circumstances1 extent1 and gravity of the violation2 7,,ii7 with respect to the violator1 the degree of culpability1 any history of violations1 the ability to pay1 any effect on the ability to continue doing business1 profits earned by the ,,nda or ,,bla holder 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who gave the value described in subsection 7a77#a771 compensation received by the subsequent filer 7or1 in the case of an agreement between two subsequent filers1 the subsequent filer who received the value described in subsection 7a77#a771 and the amount of commerce affected2 and 7,,iii7 other matters that justice requires4 7,d7 ,injunctions and other equitable relief ,in a civil action under subparagraph 7,a71 the ,united ,states district courts are empowered to grant mandatory injunctions and such other and further equitable relief as they deem appropriate4 7#d7 ,remedies in addition ,remedies provided in this subsection are in addition to1 and not in lieu of1 any other remedy provided by ,federal law4 7#e7 ,preservation of authority of ,commission ,nothing in this section shall be construed to affect any authority of the ,commission under any other provision of law4 7e7 ,federal ,trade ,commission rulemaking ,the ,commission may1 in its discretion1 by rule promulgated under section #eec of title #e1 ,united ,states ,code1 exempt from this section certain agreements described in subsection 7a7 if the ,commission finds such agreements to be in furtherance of market competition and for the benefit of consumers4 7f7 ,antitrust laws ,nothing in this section shall modify1 impair1 limit1 or supersede the applicability of the antitrust laws as defined in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 and of section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section #e applies to unfair methods of competition4 ,nothing in this section shall modify1 impair1 limit1 or supersede the right of a subsequent filer to assert claims or counterclaims against any person1 under the antitrust laws or other laws relating to unfair competition4 7g7 ,definitions ,in this section3 7#a7 ,agreement resolving or settling a covered patent infringement claim ,the term agreement resolving or settling a covered patent infringement claim means any agreement that-- 7,a7 resolves or settles a covered patent infringement claim2 or 7,b7 is contingent upon1 provides for a contingent condition for1 or is otherwise related to the resolution or settlement of a covered patent infringement claim4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 7#c7 ,covered patent infringement claim ,the term covered patent infringement claim means an allegation made by the ,,nda or ,,bla holder to a subsequent filer 7or1 in the case of an agreement between two subsequent filers1 by one subsequent filer to another71 whether or not included in a complaint filed with a court of law1 that-- 7,a7 the submission of the application described in subparagraph 7,a7 or 7,b7 of paragraph 7#i71 or the manufacture1 use1 offering for sale1 sale1 or importation into the ,united ,states of a covered product that is the subject of such an application-- 7i7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 infringes any patent owned by1 or exclusively licensed to1 the ,,nda or ,,bla holder of the covered product2 or 7ii7 in the case of an agreement between two subsequent filers1 infringes any patent owned by the subsequent filer2 or 7,b7 in the case of an agreement between an ,,nda or ,,bla holder and a subsequent filer1 the covered product to be manufactured under such application uses a covered product as claimed in a published patent application4 7#d7 ,covered product ,the term covered product means a drug 7as defined in section #bja7;g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g7771 including a biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;i7774 7#e7 ,,nda or ,,bla holder ,the term ,,nda or ,,bla holder means-- 7,a7 the holder of-- 7i7 an approved new drug application filed under section #eje7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 for a covered product2 or 7ii7 a biologics license application filed under section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 with respect to a biological product2 7,b7 a person owning or controlling enforcement of the patent on-- 7i7 the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 in connection with the application described in subparagraph 7,a77i72 or 7ii7 any list published under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 comprised of patents associated with biologics license applications filed under section #cea7;a7 of such ,act 7#db ,u4,s4,c4 #bfb7;a772 or 7,c7 the predecessors1 subsidiaries1 divisions1 groups1 and affiliates controlled by1 controlling1 or under common control with any entity described in subparagraph 7,a7 or 7,b7 7such control to be presumed by direct or indirect share ownership of #ej percent or greater71 as well as the licensees1 licensors1 successors1 and assigns of each of the entities4 7#f7 ,patent ,the term patent means a patent issued by the ,united ,states ,patent and ,trademark ,office4 7#g7 ,statutory exclusivity ,the term statutory exclusivity means those prohibitions on the submission or approval of drug applications under clauses 7ii7 through 7iv7 of section #eje7;c77#c77;,e7 7#e- and #c-year exclusivity71 clauses 7ii7 through 7iv7 of section #eje7;j77#e77;,f7 7#e-year and #c-year exclusivity71 section #eje7;j77#e77;,b77iv7 7#ahj-;day exclusivity71 section #ebg 7orphan drug exclusivity71 section #eje;,a 7pediatric exclusivity71 or section #eje;,e 7qualified infectious disease product exclusivity7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;c77#c77;,e71 #cee7;j77#e77;,b77iv71 #cee7;j77#e77;,f71 #cfj;cc1 #cee;a1 #cee;f71 or prohibitions on the submission or licensing of biologics license applications under section #cea7k77#f7 7interchangeable biological product exclusivity7 or section #cea7k77#g7 7biological product reference product exclusivity7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#f71 7#g774 7#h7 ,subsequent filer ,the term subsequent filer means-- 7,a7 in the case of a drug1 a party that owns or controls an abbreviated new drug application submitted pursuant to section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77 or a new drug application submitted pursuant to section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77#b77 and filed under section #eje7;b77#a7 of such ,act 7#ba ,u4,s4,c4 #cee7;b77#a77 or has the exclusive rights to distribute the covered product that is the subject of such application2 or 7,b7 in the case of a biological product1 a party that owns or controls an application filed with the ,food and ,drug ,administration under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 or has the exclusive rights to distribute the biological product that is the subject of such application4 7h7 ,effective date ,this section applies with respect to agreements described in subsection 7a7 entered into on or after the date of the enactment of this ,act4 #cjb4 ,notice and certification of agreements 7a7 ,notice of all agreements ,section #aaaa7g7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note7 is amended by inserting or the owner of a patent for which a claim of infringement could reasonably be asserted against any person for making1 using1 offering to sell1 selling1 or importing into the ,united ,states a biological product that is the subject of a biosimilar biological product application before the period at the end4 7b7 ,certification of agreements ,section #aaab of such ,act 7#ba ,u4,s4,c4 #cee note7 is amended by adding at the end the following3 7d7 ,certification ,the ,chief ,executive ,officer or the company official responsible for negotiating any agreement under subsection 7a7 or 7b7 that is required to be filed under subsection 7c7 shall1 within #cj days of such filing1 execute and file with the ,assistant ,attorney ,general and the ,commission a certification as follows3,i declare that the following is true1 correct1 and complete to the best of my knowledge3 ,the materials filed with the ,federal ,trade ,commission and the ,department of ,justice under section #aaab of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc1 with respect to the agreement referenced in this certification-- 7#a7 represent the complete1 final1 and exclusive agreement between the parties2 7#b7 include any ancillary agreements that are contingent upon1 provide a contingent condition for1 were entered into within #cj days of1 or are otherwise related to1 the referenced agreement2 and 7#c7 include written descriptions of any oral agreements1 representations1 commitments1 or promises between the parties that are responsive to subsection 7a7 or 7b7 of such section #aaab and have not been reduced to writing4 4 #cjc4 ,forfeiture of #ahj-;day exclusivity period ,section #eje7;j77#e77;,d77i77,v7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,d77i77,v77 is amended by inserting section #cja of the ,lower ,costs1 ,more ,cures ,act of #bjba or after that the agreement has violated4 #cjd4 ,commission litigation authority ,section #af7;a77#b7 of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #ef7;a77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking or after the semicolon2 7#b7 in subparagraph 7,e71 by moving the margin #b ems to the left and inserting or after the semicolon2 and 7#c7 by inserting after subparagraph 7,e7 the following3 7,f7 under section #cja7;d77#c77;,a7 of the ,lower ,costs1 ,more ,cures ,act of #bjba2 4 #cje4 ,statute of limitations 7a7 ,in general ,except as provided in subsection 7b71 the ,commission shall commence any administrative proceeding or civil action to enforce section #cja of this ,act not later than #f years after the date on which the parties to the agreement file the ,notice of ,agreement as provided by section #aaab7;c77#b7 and 7d7 of the ,medicare ,prescription ,drug1 ,improvement1 and ,modernization ,act of #bjjc 7#ba ,u4,s4,c4 #cee note74 7b7 ,civil action after issuance of cease and desist order ,if the ,commission has issued a cease and desist order under section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 for violation of section #cja of this ,act and the proceeding for the issuance of such order was commenced within the period required by subsection 7a7 of this section1 such subsection does not prohibit the commencement1 after such period1 of a civil action under section #cja7;d77#c77;,a7 against a party to such order or a civil action under subsection 7l7 of such section #e for violation of such order4 ,b ,advancing ,education on ,biosimilars #cba4 ,education on biological products 7a7 ,website2 continuing education ,subpart #a of part ,f of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb et seq47 is amended by adding at the end the following3 #ceb;,a4 ,education on biological products 7a7 ,internet website 7#a7 ,in general ,the ,secretary shall maintain and operate an internet website to provide educational materials for health care providers1 patients1 and caregivers1 regarding the meaning of the terms1 and the standards for review and licensing of1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 7#b7 ,content ,educational materials provided under paragraph 7#a7 may include-- 7,a7 explanations of key statutory and regulatory terms1 including biosimilar and interchangeable1 and clarification regarding the use of interchangeable biosimilar biological products2 7,b7 information related to development programs for biological products1 including biosimilar biological products and interchangeable biosimilar biological products and relevant clinical considerations for prescribers1 which may include1 as appropriate and applicable1 information related to the comparability of such biological products2 7,c7 an explanation of the process for reporting adverse events for biological products1 including biosimilar biological products and interchangeable biosimilar biological products2 and 7,d7 an explanation of the relationship between biosimilar biological products and interchangeable biosimilar biological products licensed under section #cea7k7 and reference products 7as defined in section #cea7;i771 including the standards for review and licensing of each such type of biological product4 7#c7 ,format ,the educational materials provided under paragraph 7#a7 may be-- 7,a7 in formats such as webinars1 continuing medical education modules1 videos1 fact sheets1 infographics1 stakeholder toolkits1 or other formats as appropriate and applicable2 and 7,b7 tailored for the unique needs of health care providers1 patients1 caregivers1 and other audiences1 as the ,secretary determines appropriate4 7#d7 ,other information ,in addition to the information described in paragraph 7#b71 the ,secretary shall continue to publish the following information3 7,a7 ,the action package of each biological product licensed under subsection 7a7 or 7k74 7,b7 ,the summary review of each biological product licensed under subsection 7a7 or 7k74 7#e7 ,confidential and trade secret information ,this subsection does not authorize the disclosure of any trade secret1 confidential commercial or financial information1 or other matter described in section #eeb7;b7 of title #e4 7b7 ,continuing education ,the ,secretary shall advance education and awareness among health care providers regarding biological products1 including biosimilar biological products and interchangeable biosimilar biological products1 as appropriate1 including by developing or improving continuing education programs that advance the education of such providers on the prescribing of1 and relevant clinical considerations with respect to1 biological products1 including biosimilar biological products and interchangeable biosimilar biological products4 4 7b7 ,application under the ,medicare ,merit-,based ,incentive ,payment ,system ,section #ahdh7q77#e77;,c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7q77#e77;,c77 is amended by adding at the end the following new clause3 7iv7 ,clinical medical education program on biosimilar biological products ,completion of a clinical medical education program developed or improved under section #ceb;,a7b7 of the ,public ,health ,service ,act by a ,,mips eligible professional during a performance period shall earn such eligible professional one-half of the highest potential score for the performance category described in paragraph 7#b77;,a77iii7 for such performance period4 ,a ,,mips eligible professional may only count the completion of such a program for purposes of such category one time during the eligible professional's lifetime4 4 ,c ,other ,provisions #cca4 ,clarifying the meaning of new chemical entity ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended-- 7#a7 in section #eje 7#ba ,u4,s4,c4 #cee7-- 7,a7 in subsection 7c77#c77;,e7-- 7i7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 in clause 7iii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in subsection 7j77#e77;,f7-- 7i7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 in clause 7iii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,c7 in subsection 7l77#b77;,a77i71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,d7 in subsection 7s71 in the matter preceding paragraph 7#a71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7,e7 in subsection 7u77#a71 in the matter preceding subparagraph 7,a7-- 7i7 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7ii7 by striking same active ingredient and inserting same active moiety2 7#b7 in section #eab7;c77#b77;,f7 7#ba ,u4,s4,c4 #cfj;b7c77#b77;,f77-- 7,a7 in clause 7i71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7,b7 in clause 7ii71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7,c7 in clause 7v71 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#c7 in section #ebd7;a77#d77;,c7 7#ba ,u4,s4,c4 #cfjn7a77#d77;,c771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 7#d7 in section #ebi7;a77#d77;,a77ii7 7#ba ,u4,s4,c4 #cfj;ff7a77#d77;,a77ii771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations772 and 7#e7 in section #efe;,a7a77#d77;,d7 7#ba ,u4,s4,c4 #cfj;bbb-#d;a7a77#d77;,d771 by striking active ingredient 7including any ester or salt of the active ingredient7 and inserting active moiety 7as defined by the ,secretary in section #cad4c of title #ba1 ,code of ,federal ,regulations 7or any successor regulations774 ,,iv ,revenue ,provision #dja4 ,safe harbor for high deductible health plans without deductible for insulin 7a7 ,in general ,section #bbc7;c77#b77;,c7 of the ,internal ,revenue ,code of #aihf is amended by inserting or for insulin or any device for the delivery of insulin before the period at the end4 7b7 ,effective date ,the amendment made by this section shall apply to months beginning after the date of the enactment of this ,act4 ,v ,miscellaneous #eja4 ,payment for biosimilar biological products during initial period ,section #ahdg;,a7c77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#d77 is amended-- 7#a7 in each of subparagraphs 7,a7 and 7,b71 by redesignating clauses 7i7 and 7ii7 as subclauses 7,i7 and 7,,ii71 respectively1 and moving such subclauses #b ems to the right2 7#b7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii7 and moving such clauses #b ems to the right2 7#c7 by striking unavailable4--,in the case and inserting 8unavailable4-- 7,a7 ,in general ,subject to subparagraph 7,b71 in the case 2 and 7#d7 by adding at the end the following new subparagraph3 7,b7 ,limitation on payment amount for biosimilar biological products during initial period ,in the case of a biosimilar biological product furnished on or after ,july #a1 #bjbc1 in lieu of applying subparagraph 7,a7 during the initial period described in such subparagraph with respect to the biosimilar biological product1 the amount payable under this section for the biosimilar biological product is the lesser of the following3 7i7 ,the amount determined under clause 7ii7 of such subparagraph for the biosimilar biological product4 7ii7 ,the amount determined under subsection 7b77#a77;,b7 for the reference biological product4 4 #ejb4 ,,gao study and report on average sales price 7a7 ,study 7#a7 ,in general ,the ,comptroller ,general of the ,united ,states 7in this section referred to as the ,comptroller ,general7 shall conduct a study on spending for applicable drugs under part ,b of title ,,xviii of the ,social ,security ,act4 7#b7 ,applicable drugs defined ,in this section1 the term applicable drugs means drugs and biologicals-- 7,a7 for which reimbursement under such part ,b is based on the average sales price of the drug or biological2 and 7,b7 that account for the largest percentage of total spending on drugs and biologicals under such part ,b 7as determined by the ,comptroller ,general1 but in no case less than #be drugs or biologicals74 7#c7 ,requirements ,the study under paragraph 7#a7 shall include an analysis of the following3 7,a7 ,the extent to which each applicable drug is paid for-- 7i7 under such part ,b for ,medicare beneficiaries2 or 7ii7 by private payers in the commercial market4 7,b7 ,any change in ,medicare spending or ,medicare beneficiary cost-sharing that would occur if the average sales price of an applicable drug was based solely on payments by private payers in the commercial market4 7,c7 ,the extent to which drug manufacturers provide rebates1 discounts1 or other price concessions to private payers in the commercial market for applicable drugs1 which the manufacturer includes in its average sales price calculation1 for-- 7i7 formulary placement2 7ii7 utilization management considerations2 or 7iii7 other purposes4 7,d7 ,barriers to drug manufacturers providing such price concessions for applicable drugs4 7,e7 ,other areas determined appropriate by the ,comptroller ,general4 7b7 ,report ,not later than #b years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report on the study conducted under subsection 7a71 together with recommendations for such legislation and administrative action as the ,secretary determines appropriate4 #ejc4 ,requiring prescription drug plans and ,,ma-,,pd plans to report potential fraud1 waste1 and abuse to the ,secretary of ,,hhs ,section #ahfj;,d-#d of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is amended by adding at the end the following new subsection3 7p7 ,reporting potential fraud1 waste1 and abuse ,beginning ,january #a1 #bjbb1 the ,,pdp sponsor of a prescription drug plan shall report to the ,secretary1 as specified by the ,secretary-- 7#a7 any substantiated or suspicious activities 7as defined by the ,secretary7 with respect to the program under this part as it relates to fraud1 waste1 and abuse2 and 7#b7 any steps made by the ,,pdp sponsor after identifying such activities to take corrective actions4 4 #ejd4 ,establishment of pharmacy quality measures under ,medicare part ,d ,section #ahfj;,d-#d7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;c77 is amended by adding at the end the following new paragraph3 7#h7 ,application of pharmacy quality measures 7,a7 ,in general ,a ,,pdp sponsor that implements incentive payments to a pharmacy or price concessions paid by a pharmacy based on quality measures shall use measures established or approved by the ,secretary under subparagraph 7,b7 with respect to payment for covered part ,d drugs dispensed by such pharmacy4 7,b7 ,standard pharmacy quality measures ,the ,secretary shall establish or approve standard quality measures from a consensus and evidence-based organization for payments described in subparagraph 7,a74 ,such measures shall focus on patient health outcomes and be based on proven criteria measuring pharmacy performance4 7,c7 ,effective date ,the requirement under subparagraph 7,a7 shall take effect for plan years beginning on or after ,january #a1 #bjbc1 or such earlier date specified by the ,secretary if the ,secretary determines there are sufficient measures established or approved under subparagraph 7,b7 to meet the requirement under subparagraph 7,a74 4 #eje4 ,improving coordination between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services 7a7 ,in general 7#a7 ,public meeting 7,a7 ,in general ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall convene a public meeting for the purposes of discussing and providing input on improvements to coordination between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services in preparing for the availability of novel medical products described in subsection 7c7 on the market in the ,united ,states4 7,b7 ,attendees ,the public meeting shall include-- 7i7 representatives of relevant ,federal agencies1 including representatives from each of the medical product centers within the ,food and ,drug ,administration and representatives from the coding1 coverage1 and payment offices within the ,centers for ,medicare ,medicaid ,services2 7ii7 stakeholders with expertise in the research and development of novel medical products1 including manufacturers of such products2 7iii7 representatives of commercial health insurance payers2 7iv7 stakeholders with expertise in the administration and use of novel medical products1 including physicians2 and 7v7 stakeholders representing patients and with expertise in the utilization of patient experience data in medical product development4 7,c7 ,topics ,the public meeting shall include a discussion of-- 7i7 the status of the drug and medical device development pipeline related to the availability of novel medical products2 7ii7 the anticipated expertise necessary to review the safety and effectiveness of such products at the ,food and ,drug ,administration and current gaps in such expertise1 if any2 7iii7 the expertise necessary to make coding1 coverage1 and payment decisions with respect to such products within the ,centers for ,medicare ,medicaid ,services1 and current gaps in such expertise1 if any2 7iv7 trends in the differences in the data necessary to determine the safety and effectiveness of a novel medical product and the data necessary to determine whether a novel medical product meets the reasonable and necessary requirements for coverage and payment under title ,,xviii of the ,social ,security ,act pursuant to section #ahfb7;a77#a77;,a7 of such ,act 7#db ,u4,s4,c4 #aciey7a77#a77;,a772 7v7 the availability of information for sponsors of such novel medical products to meet each of those requirements2 and 7vi7 the coordination of information related to significant clinical improvement over existing therapies for patients between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services with respect to novel medical products4 7,d7 ,trade secrets and confidential information ,no information discussed as a part of the public meeting under this paragraph shall be construed as authorizing the ,secretary to disclose any information that is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7#b7 ,improving transparency of criteria for ,medicare coverage 7,a7 ,draft guidance ,not later than #ah months after the public meeting under paragraph 7#a71 the ,secretary shall update the final guidance titled ,national ,coverage ,determinations with ,data ,collection as a ,condition of ,coverage3 ,coverage with ,evidence ,development to address any opportunities to improve the availability and coordination of information as described in clauses 7iv7 through 7vi7 of paragraph 7#a77;,c74 7,b7 ,final guidance ,not later than #ab months after issuing draft guidance under subparagraph 7,a71 the ,secretary shall finalize the updated guidance to address any such opportunities4 7b7 ,report on coding1 coverage1 and payment processes under medicare for novel medical products ,not later than #ab months after the date of the enactment of this ,act1 the ,secretary shall publish a report on the internet website of the ,department of ,health and ,human ,services regarding processes under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 with respect to the coding1 coverage1 and payment of novel medical products described in subsection 7c74 ,such report shall include the following3 7#a7 ,a description of challenges in the coding1 coverage1 and payment processes under the ,medicare program for novel medical products4 7#b7 ,recommendations to-- 7,a7 incorporate patient experience data 7such as the impact of a disease or condition on the lives of patients and patient treatment preferences7 into the coverage and payment processes within the ,centers for ,medicare ,medicaid ,services2 7,b7 decrease the length of time to make national and local coverage determinations under the ,medicare program 7as those terms are defined in subparagraph 7,a7 and 7,b71 respectively1 of section #ahfb7l77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77#f7772 7,c7 streamline the coverage process under the ,medicare program and incorporate input from relevant stakeholders into such coverage determinations2 and 7,d7 identify potential mechanisms to incorporate novel payment designs similar to those in development in commercial insurance plans and ,state plans under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 into the ,medicare program4 7c7 ,novel medical products described ,for purposes of this section1 a novel medical product described in this subsection is a medical product1 including a drug1 biological 7including gene and cell therapy71 or medical device1 that has been designated as a breakthrough therapy under section #ejf7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7;a771 a breakthrough device under section #eae;,b of such ,act 7#ba ,u4,s4,c4 #cfj;e-#c71 or a regenerative advanced therapy under section #ejf7;g7 of such ,act 7#ba ,u4,s4,c4 #cef7;g774 #ejf4 ,patient consultation in ,medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives ,section #ahfb7l7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciey7l77 is amended by adding at the end the following new paragraph3 7#g7 ,patient consultation in national and local coverage determinations ,the ,secretary may consult with patients and organizations representing patients in making national and local coverage determinations4 4 #ejg4 ,med,p,a,c report on shifting coverage of certain ,medicare part ,b drugs to ,medicare part ,d 7a7 ,study ,the ,medicare ,payment ,advisory ,commission 7in this section referred to as the ,commission7 shall conduct a study on shifting coverage of certain drugs and biologicals for which payment is currently made under part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;j et seq47 to part ,d of such title 7#db ,u4,s4,c4 #aciew-#ba et seq474 ,such study shall include an analysis of-- 7#a7 differences in program structures and payment methods for drugs and biologicals covered under such parts ,b and ,d1 including effects of such a shift on program spending1 beneficiary cost-sharing liability1 and utilization management techniques for such drugs and biologicals2 and 7#b7 the feasibility and policy implications of shifting coverage of drugs and biologicals for which payment is currently made under such part ,b to such part ,d4 7b7 ,report 7#a7 ,in general ,not later than ,june #cj1 #bjbc1 the ,commission shall submit to ,congress a report containing the results of the study conducted under subsection 7a74 7#b7 ,contents ,the report under paragraph 7#a7 shall include information1 and recommendations as the ,commission deems appropriate1 regarding-- 7,a7 formulary design under such part ,d2 7,b7 the ability of the benefit structure under such part ,d to control total spending on drugs and biologicals for which payment is currently made under such part ,b2 7,c7 changes to the bid process under such part ,d1 if any1 that may be necessary to integrate coverage of such drugs and biologicals into such part ,d2 7,d7 any other changes to the program that ,congress should consider in determining whether to shift coverage of such drugs and biologicals from such part ,b to such part ,d2 and 7,e7 the feasibility and policy implications of creating a methodology to preserve the healthcare provider's ability to take title of the drug1 including a methodology under which-- 7i7 prescription drug plans negotiate reimbursement rates and other arrangements with drug manufacturers on behalf of a wholesaler2 7ii7 wholesalers purchase the drugs from the manufacturers at the negotiated rate and ship them through distributors to physicians to administer to patients2 7iii7 physicians and hospitals purchase the drug from the wholesaler via the distributor2 7iv7 after administering the drug1 the physician submits a claim to the ,,mac for their drug administration fee2 7v7 to be reimbursed for the purchase of the drug from the distributor1 the physician furnishes the claim for the drug itself to the wholesaler and the wholesaler would refund the cost of the drug to the physician2 and 7vi7 the wholesaler passes this claim to the ,,pdp to receive reimbursement4 #ejh4 ,requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information ,part ,a of title ,,xi of the ,social ,security ,act is amended by adding at the end the following new section3 #aaej;,c4 ,requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information 7a7 ,in general ,the ,secretary shall require that each direct-to-consumer advertisement for a prescription drug or biological product for which payment is available under title ,,xviii or ,,xix includes an appropriate disclosure of truthful and non-misleading pricing information with respect to the drug or product4 7b7 ,determination by ,,cms ,the ,secretary1 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services1 shall determine the components of the requirement under subsection 7a71 such as the forms of advertising1 the manner of disclosure1 the price point listing1 and the price information for disclosure4 4 #eji4 ,chief ,pharmaceutical ,negotiator at the ,office of the ,united ,states ,trade ,representative 7a7 ,in general ,section #ada of the ,trade ,act of #aigd 7#ai ,u4,s4,c4 #baga7 is amended-- 7#a7 in subsection 7b77#b7-- 7,a7 by striking and one ,chief ,innovation and ,intellectual ,property ,negotiator and inserting one ,chief ,innovation and ,intellectual ,property ,negotiator1 and one ,chief ,pharmaceutical ,negotiator2 7,b7 by striking or the ,chief ,innovation and ,intellectual ,property ,negotiator and inserting the ,chief ,innovation and ,intellectual ,property ,negotiator1 or the ,chief ,pharmaceutical ,negotiator2 and 7,c7 by striking and the ,chief ,innovation and ,intellectual ,property ,negotiator and inserting the ,chief ,innovation and ,intellectual ,property ,negotiator1 and the ,chief ,pharmaceutical ,negotiator2 and 7#b7 in subsection 7c71 by adding at the end the following new paragraph3 7#g7 ,the principal function of the ,chief ,pharmaceutical ,negotiator shall be to conduct trade negotiations and to enforce trade agreements relating to ,united ,states pharmaceutical products and services4 ,the ,chief ,pharmaceutical ,negotiator shall be a vigorous advocate on behalf of ,united ,states pharmaceutical interests4 ,the ,chief ,pharmaceutical ,negotiator shall perform such other functions as the ,united ,states ,trade ,representative may direct4 4 7b7 ,compensation ,section #ecad of title #e1 ,united ,states ,code1 is amended by striking ,chief ,innovation and ,intellectual ,property ,negotiator1 ,office of the ,united ,states ,trade ,representative4 and inserting the following3 ,chief ,innovation and ,intellectual ,property ,negotiator1 ,office of the ,united ,states ,trade ,representative4,chief ,pharmaceutical ,negotiator1 ,office of the ,united ,states ,trade ,representative4 4 7c7 ,report required ,not later than the date that is one year after the appointment of the first ,chief ,pharmaceutical ,negotiator pursuant to paragraph 7#b7 of section #ada7;b7 of the ,trade ,act of #aigd1 as amended by subsection 7a71 and annually thereafter1 the ,united ,states ,trade ,representative shall submit to the ,committee on ,finance of the ,senate and the ,committee on ,ways and ,means of the ,house of ,representatives a report describing in detail-- 7#a7 enforcement actions taken by the ,united ,states ,trade ,representative during the one-year period preceding the submission of the report to ensure the protection of ,united ,states pharmaceutical products and services2 and 7#b7 other actions taken by the ,united ,states ,trade ,representative to advance ,united ,states pharmaceutical products and services4