,i #aafth ,,congress #ast ,session ,h4 ,r4 #ai ,,in ,,the ,,house ,,of ,,representatives ,december #i1 #bjai,mr4 ,walden 7for himself1 ,mr4 ,brady1 ,ms4 ,foxx of ,north ,carolina1 ,mr4 ,collins of ,georgia1 ,mr4 ,burgess1 ,mr4 ,nunes1 ,mr4 ,walberg1 ,mr4 ,sensenbrenner1 ,mr4 ,scalise1 ,ms4 ,cheney1 ,mr4 ,upton1 ,mr4 ,shimkus1 ,mr4 ,latta1 ,mr4 ,guthrie1 ,mrs4 ,rodgers of ,washington1 ,mr4 ,olson1 ,mr4 ,mc,kinley1 ,mr4 ,kinzinger1 ,mr4 ,griffith1 ,mr4 ,bilirakis1 ,mr4 ,johnson of ,ohio1 ,mr4 ,long1 ,mr4 ,bucshon1 ,mr4 ,flores1 ,mrs4 ,brooks of ,indiana1 ,mr4 ,mullin1 ,mr4 ,hudson1 ,mr4 ,carter of ,georgia1 ,mr4 ,gianforte1 ,mr4 ,palmer1 ,mr4 ,cole1 ,mr4 ,williams1 ,mr4 ,abraham1 ,mr4 ,keller1 ,mr4 ,rutherford1 ,mr4 ,ferguson1 ,mr4 ,kustoff of ,tennessee1 ,mr4 ,riggleman1 ,mr4 ,westerman1 ,mr4 ,graves of ,louisiana1 ,mr4 ,la,malfa1 ,mr4 ,baird1 ,mr4 ,huizenga1 ,mr4 ,murphy of ,north ,carolina1 ,mr4 ,conaway1 ,mr4 ,allen1 ,mr4 ,weber of ,texas1 ,mr4 ,newhouse1 ,mr4 ,babin1 ,mr4 ,hagedorn1 ,mr4 ,rouzer1 ,mr4 ,rice of ,south ,carolina1 ,mr4 ,wilson of ,south ,carolina1 ,mr4 ,pence1 ,mr4 ,hill of ,arkansas1 ,mr4 ,marshall1 ,mr4 ,balderson1 ,mr4 ,aderholt1 ,mr4 ,rodney ,davis of ,illinois1 ,mr4 ,mitchell1 ,mr4 ,crenshaw1 ,mr4 ,joyce of ,pennsylvania1 ,mr4 ,johnson of ,south ,dakota1 ,mr4 ,green of ,tennessee1 ,mrs4 ,miller1 ,ms4 ,stefanik1 ,mr4 ,banks1 ,mr4 ,comer1 ,mr4 ,mc,caul1 ,mr4 ,diaz-,balart1 ,mr4 ,amodei1 ,mr4 ,norman1 ,mr4 ,david ,p4 ,roe of ,tennessee1 ,mr4 ,budd1 ,mr4 ,cook1 ,mr4 ,kevin ,hern of ,oklahoma1 ,mr4 ,chabot1 ,mr4 ,steube1 ,mr4 ,curtis1 ,mr4 ,grothman1 ,mr4 ,steil1 ,mr4 ,joyce of ,ohio1 ,mr4 ,smith of ,new ,jersey1 ,mr4 ,gonzalez of ,ohio1 ,mr4 ,stauber1 ,mr4 ,buchanan1 ,mr4 ,smith of ,nebraska1 ,mr4 ,arrington1 ,mr4 ,marchant1 ,mrs4 ,walorski1 ,mr4 ,kelly of ,pennsylvania1 ,mr4 ,smith of ,missouri1 ,mr4 ,la,hood1 ,mr4 ,holding1 ,mr4 ,estes1 ,mr4 ,reed1 ,mr4 ,schweikert1 ,mr4 ,wenstrup1 ,mrs4 ,roby1 ,mr4 ,reschenthaler1 ,mr4 ,hurd of ,texas1 ,mr4 ,watkins1 ,mr4 ,luetkemeyer1 ,mr4 ,turner1 ,mr4 ,thompson of ,pennsylvania1 ,ms4 ,herrera ,beutler1 ,mr4 ,guest1 ,mrs4 ,hartzler1 ,mrs4 ,wagner1 ,mr4 ,waltz1 ,mr4 ,wright1 and ,mr4 ,gibbs7 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 #bjai4 #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 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program4 ,sec4 #aae4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities4 ,sec4 #aaf4 ,requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the ,medicare program4 ,sec4 #aag4 ,sense of ,congress regarding the need to expand commercially available drug pricing comparison platforms4 ,sec4 #aah4 ,technical corrections4 ,subtitle ,c--,medicare ,part ,d ,benefit ,redesign ,sec4 #aba4 ,medicare part ,d benefit redesign4 ,subtitle ,d--,other ,medicare ,part ,d ,provisions ,sec4 #aca4 ,transitional coverage and retroactive ,medicare part ,d coverage for certain low-income beneficiaries4 ,sec4 #acb4 ,allowing the offering of additional prescription drug plans under ,medicare part ,d4 ,sec4 #acc4 ,allowing certain enrollees of prescription drugs plans and ,,ma-,,pd plans under ,medicare program to spread out cost-sharing under certain circumstances4 ,sec4 #acd4 ,establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or ,,ma-,,pd plan4 ,sec4 #ace4 ,growth rate of ,medicare part ,d out-of-pocket cost threshold4 ,subtitle ,e--,med,p,a,c ,sec4 #ada4 ,providing the ,medicare ,payment ,advisory ,commission and ,medicaid and ,,chip ,payment and ,access ,commission with access to certain drug payment information1 including certain rebate information4 ,title ,,ii--,medicaid ,sec4 #bja4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs4 ,sec4 #bjb4 ,medicaid pharmacy and therapeutics committee improvements4 ,sec4 #bjc4 ,,gao report on conflicts of interest in ,state ,medicaid program drug use review boards and pharmacy and therapeutics 7,p,t7 committees4 ,sec4 #bjd4 ,ensuring the accuracy of manufacturer price and drug product information under the ,medicaid drug rebate program4 ,sec4 #bje4 ,improving transparency and preventing the use of abusive spread pricing and related practices in ,medicaid4 ,sec4 #bjf4 ,t-,,msis drug data analytics reports4 ,sec4 #bjg4 ,risk-sharing value-based payment agreements for covered outpatient drugs under ,medicaid4 ,sec4 #bjh4 ,applying ,medicaid drug rebate requirement to drugs provided as part of outpatient hospital services4 ,title ,,iii--,food and ,drug ,administration ,subtitle ,a--,,creates ,act ,sec4 #cja4 ,actions for delays of generic drugs and biosimilar biological products4 ,sec4 #cjb4 ,,rems approval process for subsequent filers4 ,sec4 #cjc4 ,rule of construction4 ,subtitle ,b--,pay-for-,delay ,sec4 #caa4 ,unlawful agreements4 ,sec4 #cab4 ,notice and certification of agreements4 ,sec4 #cac4 ,forfeiture of #ahj-;day exclusivity period4 ,sec4 #cad4 ,commission litigation authority4 ,sec4 #cae4 ,statute of limitations4 ,subtitle ,c--,,blocking ,act ,sec4 #cba4 ,change conditions of first generic exclusivity to spur access and competition4 ,subtitle ,d--,purple ,book ,sec4 #cca4 ,public listing4 ,sec4 #ccb4 ,review and report on types of information to be listed4 ,subtitle ,e--,orange ,book ,sec4 #cda4 ,orange ,book4 ,sec4 #cdb4 ,,gao report to ,congress4 ,subtitle ,f--,advancing ,education on ,biosimilars ,sec4 #cea4 ,education on biological products4 ,subtitle ,g--,streamlining ,transition of ,biological ,products ,sec4 #cfa4 ,streamlining the transition of biological products4 ,subtitle ,h--,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,sec4 #cgj4 ,short title2 references in subtitle4 ,part #a--,,otc ,drug ,review ,sec4 #cga4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application4 ,sec4 #cgb4 ,misbranding4 ,sec4 #cgc4 ,drugs excluded from the over-the-counter drug review4 ,sec4 #cgd4 ,treatment of ,sunscreen ,innovation ,act4 ,sec4 #cge4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs4 ,sec4 #cgf4 ,technical corrections4 ,part #b--,user ,fees ,sec4 #cha4 ,short title2 finding4 ,sec4 #chb4 ,fees relating to over-the-counter drugs4 ,subtitle ,i--,other ,provisions ,sec4 #cia4 ,protecting access to biological products4 ,sec4 #cib4 ,orphan drug clarification4 ,sec4 #cic4 ,conditions of use for biosimilar biological products4 ,sec4 #cid4 ,clarifying the meaning of new chemical entity4 ,title ,,iv--,revenue ,provisions ,sec4 #dja4 ,permanent extension of reduction in medical expense deduction floor4 ,sec4 #djb4 ,safe harbor for high deductible health plans without deductible for insulin4 ,sec4 #djc4 ,inclusion of certain over-the-counter medical products as qualified medical expenses4 ,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 ,sec4 #eaj4 ,waiving ,medicare coinsurance for colorectal cancer screening tests4 ,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 #bjba 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 #bjba1 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 #acie-c;a7 is amended by adding at the end the following new subsection3 7h7 ,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 ,july #a1 #bjba1 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 ,july #a1 #bjba1 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 ,july #a1 #bjba1 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 determined for such drug under subsection 7b77#d72 or 7bb7 in the case of a refundable single-dose container or single-use package drug that is a biosimilar biological product1 the average sales price determined under subsection 7b77#h77;,a72 exceeds 7ii7 an amount equal to the applicable percentage 7as defined in subparagraph 7,b77 of the estimated total allowed charges for such drug 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;,b71 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 established 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 for which dosage and administration instructions approved by the ,commissioner of ,food and ,drugs 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 less than #ah months4 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 #bjba1 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 #bjba1 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 #bjba1 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 #bjba1 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 #bjba1 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 #bjba through #bjbh1 #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 #bjba through #bjbh1 #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 #bjba1 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 #bjba1 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 #ab ,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 #bjba1 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-- 7,a7 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-- 7i7 #aj percent or more within a single calendar year beginning on or after ,january #a1 #bjai2 or 7ii7 #be percent or more within three consecutive calendar years for which the first such calendar year begins on or after ,january #a1 #bjai2 and 7,b7 in the case that the qualifying drug is first covered under title ,,xviii with respect to an applicable year1 if the estimated cost or spending under such title per individual or per user of such drug 7as estimated by the ,secretary7 for such applicable year 7or per course of treatment in such applicable year1 as defined by the ,secretary7 is at least #bf1jjj4 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 #bjai1 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 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 drug2 and 7,c7 in the case of a report with respect to a qualifying drug that meets the criteria described in paragraph 7#a77;,b71 not later than #cj days after such drug meets such criteria4 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 #bjbj1 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 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#b77;,a71 by inserting or subsection 7f77#b71 as applicable before the period at the end2 7,b7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7,c7 in paragraph 7#f77;,a71 in the matter preceding clause 7i71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7#b7 in subsection 7f7-- 7,a7 by striking ,for requirements and inserting the following3 7#a7 ,in general ,for requirements 2 and 7,b7 by adding at the end the following new paragraph3 7#b7 ,manufacturers without a rebate agreement under title ,,xix 7,a7 ,in general ,if the manufacturer of a drug or biological described in subparagraph 7,c71 7,e71 or 7,g7 of section #ahdb7o77#a7 or in section #ahha7;b77#ad77;,b7 that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection 7b7 of section #aibg1 for calendar quarters beginning on or after ,january #a1 #bjbj1 such manufacturer shall report to the ,secretary the information described in subsection 7b77#c77;,a77iii7 of such section #aibg with respect to such drug or biological in a time and manner specified by the ,secretary4 ,for purposes of applying this paragraph1 a drug or biological described in the previous sentence includes items1 services1 supplies1 and products that are payable under this part as a drug or biological4 7,b7 ,audit ,information reported under subparagraph 7,a7 is subject to audit by the ,inspector ,general of the ,department of ,health and ,human ,services4 7,c7 ,verification ,the ,secretary may survey wholesalers and manufacturers that directly distribute drugs described in subparagraph 7,a71 when necessary1 to verify manufacturer prices and manufacturer's average sales prices 7including wholesale acquisition cost7 if required to make payment reported under subparagraph 7,a74 ,the ,secretary may impose a civil monetary penalty in an amount not to exceed #ajj1jjj on a wholesaler1 manufacturer1 or direct seller1 if the wholesaler1 manufacturer1 or direct seller of such a drug refuses a request for information about charges or prices by the ,secretary in connection with a 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 subparagraph in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a7a74 7,d7 ,confidentiality ,notwithstanding any other provision of law1 information disclosed by manufacturers or wholesalers under this paragraph 7other than the wholesale acquisition cost for purposes of carrying out this section7 is confidential and shall not be disclosed by the ,secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler1 except-- 7i7 as the ,secretary determines to be necessary to carry out this section 7including the determination and implementation of the payment amount71 or to carry out section #ahdg;,b2 7ii7 to permit the ,comptroller ,general of the ,united ,states to review the information provided2 and 7iii7 to permit the ,director of the ,congressional ,budget ,office to review the information provided4 4 7b7 ,enforcement ,section #ahdg;,a of such ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is further amended-- 7#a7 in subsection 7d77#d7-- 7,a7 in subparagraph 7,a71 by striking ,in general and inserting ,misrepresentation2 7,b7 in subparagraph 7,b71 by striking subparagraph 7,b7 and inserting subparagraph 7,a71 7,b71 or 7,c72 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,d72 and 7,d7 by inserting after subparagraph 7,a7 the following new subparagraphs3 7,b7 ,failure to provide timely information ,if the ,secretary determines that a manufacturer described in subsection 7f77#b7 has failed to report on information described in section #aibg7;b77#c77;,a77iii7 with respect to a drug or biological in accordance with such subsection1 the ,secretary shall apply a civil money penalty in an amount of #aj1jjj for each day the manufacturer has failed to report such information and such amount shall be paid to the ,treasury4 7,c7 ,false information ,any manufacturer required to submit information under subsection 7f77#b7 that knowingly provides false information is subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalties are in addition to other penalties as may be prescribed by law4 2 and 7#b7 in subsection 7c77#f77;,a71 by striking the period at the end and inserting 1 except that1 for purposes of subsection 7f77#b71 the ,secretary may1 if the ,secretary determines appropriate1 exclude repackagers of a drug or biological from such term44 7c7 ,manufacturers with a rebate agreement 7#a7 ,in general ,section #aibg7;b77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is amended by adding at the end the following new sentence3 ,for purposes of applying clause 7iii71 a drug or biological described in the flush matter following such clause includes items1 services1 supplies1 and products that are payable under this part as a drug or biological44 7#b7 ,technical amendment ,section #aibg7;b77#c77;,a77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is amended by striking section #ahha7;b77#ac77;,a77ii7 and inserting section #ahha7;b77#ad77;,b74 7d7 ,report ,not later than ,january #a1 #bjba1 the ,inspector ,general of the ,department of ,health and ,human ,services shall assess and submit to ,congress a report on the accuracy of average sales price information submitted by manufacturers under section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,such report shall include any recommendations on how to improve the accuracy of such information4 #aae4 ,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 #bjba71 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 #aaf4 ,requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the ,medicare program ,section #ahfj;,d-#d7;e77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking ,to the extent and inserting ,except as provided in subparagraph 7,f71 to the extent2 and 7#b7 by adding at the end the following new subparagraph3 7,f7 ,real-time benefit information 7i7 ,in general ,not later than ,january #a1 #bjba1 the program shall implement real-time benefit tools that are capable of integrating with a prescribing health care professional's electronic prescribing or electronic health record system for the transmission of formulary and benefit information in real time to prescribing health care professionals4 ,with respect to a covered part ,d drug1 such tools shall be capable of transmitting such information specific to an individual enrolled in a prescription drug plan4 ,such information shall include the following3 7,i7 ,a list of any clinically-appropriate alternatives to such drug included in the formulary of such plan4 7,,ii7 ,cost-sharing information for such drug and such alternatives1 including a description of any variance in cost-sharing based on the pharmacy dispensing such drug or such alternatives4 7,,iii7 ,information relating to whether such drug is included in the formulary of such plan and any prior authorization or other utilization management requirements applicable to such drug and such alternatives so included4 7ii7 ,electronic transmission ,the provisions of subclauses 7,i7 and 7,,ii7 of clause 7ii7 of subparagraph 7,e7 shall apply to an electronic transmission described in clause 7i7 in the same manner as such provisions apply with respect to an electronic transmission described in clause 7i7 of such subparagraph4 7iii7 ,special rule for #bjba ,the program shall be deemed to be in compliance with clause 7i7 for #bjba if the program complies with the provisions of section #dbc4afj7;b77#g7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 for such year4 7iv7 ,rule of construction ,nothing in this subparagraph shall be construed as to allow a real-time benefits tool to steer an individual1 without the consent of the individual1 to a particular pharmacy or pharmacy setting over their preferred pharmacy setting nor prohibit the designation of a preferred pharmacy under such tool4 4 #aag4 ,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 #aah4 ,technical corrections 7a7 ,in general ,section #cjbb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is amended by adding at the end the following new paragraph3 7#d7 ,application of authorities under ,inspector ,general ,act of #aigh ,in carrying out this subsection1 the ,inspector ,general shall have the same authorities as provided under section #f of the ,inspector ,general ,act of #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if included in the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee74 ,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 and 7ii7 in clause 7i71 by inserting after #be percent the following3 7or1 for #bjbb and each subsequent year1 #ae percent72 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 and 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 #bjba1 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 #bjbb4 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 #bjbb1 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 #bjbb1 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 #bjbb 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 #bjbb and each subsequent year1 the manufacturer discounts provided under section #ahfj;,d-#ad;,b2 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 #bjai4 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 #bjbb1 and paragraphs 7#d7 through 7#f7 of such subsection shall apply to covered part ,d drugs dispensed on or after ,january #a1 #bjbb4 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 7a771 or the period beginning on ,january #a1 #bjbb1 and ending ,december #ca1 #bjbb 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 #bjbb 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 #bjbb or the annual out-of-pocket threshold specified in subsection 7b77#d77;,b7 for the year for #bjbb 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 #bjbb1 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 #bjbb1 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 #bjbb1 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 #bjbb1 the elimination2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,c71 by striking ,the continuation and inserting ,for a year preceding #bjbb1 the continuation2 and 7ii7 in subparagraph 7,e7-- 7,i7 by inserting for a year preceding #bjbb1 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 #bjbb1 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 #bjbb 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 #bjbb 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 #bjbb and subsequent plan years4 ,d ,other ,medicare ,part ,d ,provisions #aca4 ,transitional coverage and retroactive ,medicare part ,d coverage for certain low-income beneficiaries ,section #ahfj;,d-#ad of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aad7 is amended-- 7#a7 by redesignating subsection 7e7 as subsection 7f72 and 7#b7 by adding after subsection 7d7 the following new subsection3 7e7 ,limited income newly eligible transition program 7#a7 ,in general ,beginning not later than ,january #a1 #bjba1 the ,secretary shall carry out a program to provide transitional coverage for covered part ,d drugs for ,,li ,,net eligible individuals in accordance with this subsection4 7#b7 ,,li net eligible individual defined ,for purposes of this subsection1 the term ,,li ,,net eligible individual means a part ,d eligible individual who-- 7,a7 meets the requirements of clauses 7ii7 and 7iii7 of subsection 7a77#c77;,a72 and 7,b7 has not yet enrolled in a prescription drug plan or an ,,ma-,,pd plan1 or1 who has so enrolled1 but with respect to whom coverage under such plan has not yet taken effect4 7#c7 ,transitional coverage ,for purposes of this subsection1 the term transitional coverage means1 with respect to an ,,li ,,net eligible individual-- 7,a7 immediate access to covered part ,d drugs at the point-of-sale during the period that begins on the first day of the month such individual is determined to meet the requirements of clauses 7ii7 and 7iii7 of subsection 7a77#c77;,a7 and ends on the date that coverage under a prescription drug plan or ,,ma-,,pd plan takes effect with respect to such individual2 and 7,b7 in the case of an ,,li ,,net eligible individual who is a full-benefit dual eligible individual 7as defined in section #aice7;c77#f77 or a recipient of supplemental security income benefits under title ,,xvi1 retroactive coverage 7in the form of reimbursement of the amounts that would have been paid under this part had such individual been enrolled in a prescription drug plan or ,,ma-,,pd plan7 of covered part ,d drugs purchased by such individual during the period that begins on the date that is the later of-- 7i7 the date that such individual was first eligible for a low-income subsidy under this part2 or 7ii7 the date that is #cf months prior to the date such individual enrolls in a prescription drug plan or ,,ma-,,pd plan1 and ends on the date that coverage under such plan takes effect4 7#d7 ,program administration 7,a7 ,single point of contact ,the ,secretary shall1 to the extent feasible1 administer the program under this subsection through a contract with a single program administrator4 7,b7 ,benefit design ,the ,secretary shall ensure that the transitional coverage provided to ,,li ,,net eligible individuals under this subsection-- 7i7 provides access to all covered part ,d drugs under an open formulary2 7ii7 permits all pharmacies determined by the ,secretary to be in good standing to process claims under the program2 7iii7 is consistent with such requirements as the ,secretary considers necessary to improve patient safety and ensure appropriate dispensing of medication2 and 7iv7 meets such other requirements as the ,secretary may establish4 7#e7 ,relationship to other provisions of this title2 waiver authority 7,a7 ,in general ,the following provisions shall not apply with respect to the program under this subsection3 7i7 ,paragraphs 7#a7 and 7#c77;,b7 of section #ahfj;,d-#d7;a7 7relating to dissemination of general information2 availability of information on changes in formulary through the internet74 7ii7 ,subparagraphs 7,a7 and 7,b7 of section #ahfj;,d-#d7;b77#c7 7relating to requirements on development and application of formularies2 formulary development74 7iii7 ,paragraphs 7#a77;,c7 and 7#b7 of section #ahfj;,d-#d7;c7 7relating to medication therapy management program74 7,b7 ,waiver authority ,the ,secretary may waive such other requirements of title ,,xi and this title as may be necessary to carry out the purposes of the program established under this subsection4 4 #acb4 ,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 #acc4 ,allowing certain enrollees of prescription drugs 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 #acd4 ,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 #ace4 ,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 #ace of the ,lower ,costs1 ,more ,cures ,act of #bjai had not been enacted2 or 4 ,e ,med,p,a,c #ada4 ,providing the ,medicare ,payment ,advisory ,commission and ,medicaid and ,,chip ,payment and ,access ,commission with access to certain drug payment information1 including certain rebate information 7a7 ,access to certain part ,d payment data ,section #ahfj;,d-#ae7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;f77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a77ii71 by striking and at the end2 7,b7 in subparagraph 7,b71 by striking the period at the end and inserting 2 and2 and 7,c7 by inserting at the end the following new subparagraph3 7,c7 by the ,executive ,director of the ,medicare ,payment ,advisory ,commission for purposes of monitoring1 making recommendations1 and analysis of the program under this title and by the ,executive ,director of the ,medicaid and ,,chip ,payment and ,access ,commission for purposes of monitoring1 making recommendations1 and analysis of the ,medicaid program established under title ,,xix and the ,children's ,health ,insurance ,program under title ,,xxi4 2 and 7#b7 by adding at the end the following new paragraph3 7#c7 ,additional restrictions on disclosure of information ,the ,executive ,directors described in paragraph 7#b77;,c7 shall not disclose any of the following information disclosed to such ,executive ,directors or obtained by such ,executive ,directors pursuant to such paragraph1 with respect to a prescription drug plan offered by a ,,pdp sponsor3 7,a7 ,the specific amounts or the identity of the source of any rebates1 price concessions1 or other forms of direct or indirect remuneration under such prescription drug plan4 7,b7 ,information submitted with the bid submitted under section #ahfj;,d-#aa by such ,,pdp sponsor4 7,c7 ,in the case of such information from prescription drug event records1 in a form that would not be permitted under section #dbc4eje7m7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation1 if made by the ,centers for ,medicare ,medicaid ,services4 4 7b7 ,access to certain rebate and payment data under ,medicare and ,medicaid ,section #aibg7;b77#c77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,d77 is amended-- 7#a7 in the matter before clause 7i71 by striking subsection 7a77#f77;,a77ii7 and inserting subsection 7a77#f77;,a72 7#b7 in clause 7v71 by striking and at the end2 7#c7 in clause 7vi71 by striking the period at the end and inserting 1 and2 7#d7 by inserting after clause 7vi7 the following new clause3 7vii7 to permit the ,executive ,director of the ,medicare ,payment ,advisory ,commission and the ,executive ,director of the ,medicaid and ,,chip ,payment and ,access ,commission to review the information provided4 2 7#e7 in the matter at the end1 by striking #ahfj;,d-#d7;c77#b77;,e7 and inserting #ahfj;,d-#d7;c77#b77;,g72 and 7#f7 by adding at the end the following new sentence3 ,any information disclosed to the ,executive ,director of the ,medicare ,payment ,advisory ,commission or the ,executive ,director of the ,medicaid and ,,chip ,payment and ,access ,commission pursuant to this subparagraph shall not be disclosed by either such ,executive ,director in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs by such manufacturer or wholesaler44 ,,ii ,medicaid #bja4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs ,section #aibg7;c77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is amended by inserting after ,december #ca1 #bjji1 the following3 and before ,january #a1 #bjbc14 #bjb4 ,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 #bjai1 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 #bjc4 ,,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 #bjd4 ,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 #bjbj 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 #bje4 ,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 #bjbj 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 #bjf4 ,t-,,msis drug data analytics reports 7a7 ,in general ,not later than ,may #a of each calendar year beginning with calendar year #bjba1 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 #bjbj and each fiscal year thereafter1 there is appropriated to the ,secretary #b1jjj1jjj to carry out this section4 #bjg4 ,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 #bjbj 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 #bjh4 ,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 ,,creates ,act #cja4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage2 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has submitted a written request to purchase sufficient quantities of the covered product to the license holder and such request-- 7,i7 was sent to a named corporate officer of the license holder2 7,,ii7 was made by certified or registered mail with return receipt requested2 7,,iii7 specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered product to the eligible product developer and a means for electronic and written communications with that individual2 and 7,,iv7 specified an address to which the covered product was to be shipped upon reaching an agreement to transfer the covered product2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a rems with etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to the individual specified pursuant to paragraph 7#b77;,a77iii77,,iii71 by a means of communication 7electronic1 written1 or both7 specified pursuant to such paragraph1 to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #cja7;a7 of the ,lower ,costs1 ,more ,cures ,act of #bjai7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #cjb4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by section #cja1 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 #cjc4 ,rule of construction 7a7 ,in general ,nothing in this subtitle1 the amendments made by this subtitle1 or in section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 shall be construed as-- 7#a7 prohibiting a license holder from providing an eligible product developer access to a covered product in the absence of an authorization under this subtitle2 or 7#b7 in any way negating the applicability of a ,,rems with ,,etasu1 as otherwise required under such section #eje-a1 with respect to such covered product4 7b7 ,definitions ,in this section1 the terms covered product1 eligible product developer1 license holder1 and ,,rems with ,,etasu have the meanings given such terms in section #cja7;a74 ,b ,pay-for-,delay #caa4 ,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 #cab4 ,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 4 #cac4 ,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 #caa of the ,lower ,costs1 ,more ,cures ,act of #bjai or after that the agreement has violated4 #cad4 ,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 inserting or after the semicolon2 and 7#c7 by inserting after subparagraph 7,e7 the following3 7,f7 under section #caa7;d77#c77;,a7 of the ,lower ,costs1 ,more ,cures ,act of #bjai2 4 #cae4 ,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 #caa 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 #caa 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 #caa7;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 ,c ,,blocking ,act #cba4 ,change conditions of first generic exclusivity to spur access and competition 7a7 ,in general ,section #eje7;j77#e77;,b77iv7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#e77;,b77iv77 is amended-- 7#a7 in subclause 7,i71 by striking #ahj days after and all that follows through the period at the end and inserting the following3 #ahj days after the earlier of-- 7aa7 the date of the first commercial marketing of the drug 7including the commercial marketing of the listed drug7 by any first applicant2 or 7bb7 the applicable date specified in subclause 7,,iii74 2 and 7#b7 by adding at the end the following new subclause3 7,,iii7 ,applicable date ,the applicable date specified in this subclause1 with respect to an application for a drug described in subclause 7,i71 is the date on which each of the following conditions is first met3 7aa7 ,the approval of such an application could be made effective1 but for the eligibility of a first applicant for #ahj-;day exclusivity under this clause4 7bb7 ,at least #cj months have passed since the date of submission of an application for the drug by at least one first applicant4 7cc7 ,approval of an application for the drug submitted by at least one first applicant is not precluded under clause 7iii74 7dd7 ,no application for the drug submitted by any first applicant is approved at the time the conditions under items 7aa71 7bb71 and 7cc7 are all met1 regardless of whether such an application is subsequently approved4 4 7b7 ,information ,the ,secretary of ,health and ,human ,services shall-- 7#a7 not later than #abj days after the date of enactment of this ,act1 publish1 as appropriate and available1 information sufficient to allow applicants to assess whether the conditions described in section #eje7;j77#e77;,b77iv77,,iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as added by subsection 7a77 are satisfied for all applications where the exclusivity period under clause 7iv77,i7 of section #eje7;j77#e77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7as amended by such subsection7 has not expired2 and 7#b7 publish updates to such information to reflect the most recent information available to the ,secretary4 ,d ,purple ,book #cca4 ,public listing ,section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77 is amended by adding at the end the following3 7#i7 ,public listing 7,a7 ,in general 7i7 ,initial publication ,not later than #ahj days after the date of enactment of the ,lower ,costs1 ,more ,cures ,act of #bjai1 the ,secretary shall publish and make available to the public in a searchable1 electronic format-- 7,i7 a list in alphabetical order of the nonproprietary or proper name of each biological product for which a biologics license under subsection 7a7 or this subsection is in effect1 or that has been deemed to be licensed under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji1 as of such date of enactment2 7,,ii7 the date of approval of the marketing application and the application number2 and 7,,iii7 the marketing or licensure status of the biological product for which a biologics license under subsection 7a7 or this subsection is in effect or that has been deemed to be licensed under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 7ii7 ,revisions ,every #cj days after the publication of the first list under clause 7i71 the ,secretary shall revise the list to include each biological product which has been licensed under subsection 7a7 or this subsection during the #cj-;day period4 7iii7 ,patent information ,not later than #cj days after a list of patents under subsection 7l77#c77;,a71 or a supplement to such list under subsection 7l77#g71 has been provided by the reference product sponsor to the subsection 7k7 applicant respecting a biological product included on the list published under this subparagraph1 the reference product sponsor shall provide such list of patents 7or supplement thereto7 and their corresponding expiry dates to the ,secretary1 and the ,secretary shall1 in revisions made under clause 7ii71 include such information for such biological product4 ,within #cj days of providing any subsequent or supplemental list of patents to any subsequent subsection 7k7 applicant under subsection 7l77#c77;,a7 or 7l77#g71 the reference product sponsor shall update the information provided to the ,secretary under this clause with any additional patents from such subsequent or supplemental list and their corresponding expiry dates4 7iv7 ,listing of exclusivities ,for each biological product included on the list published under this subparagraph1 the ,secretary shall specify each exclusivity period that is applicable and has not concluded under paragraph 7#f7 or paragraph 7#g74 7,b7 ,withdrawal or suspension of licensure ,if the licensing of a biological product was withdrawn or suspended for safety1 purity1 or potency reasons1 it may not be published in the list under subparagraph 7,a74 ,if the withdrawal or suspension occurred after its publication in such list1 the reference product sponsor shall notify the ,secretary that-- 7i7 the biological product shall be immediately removed from such list-- 7,i7 for the same period as the withdrawal or suspension2 or 7,,ii7 if the biological product has been withdrawn from sale1 for the period of withdrawal from sale or1 if earlier1 the period ending on the date the ,secretary determines that the withdrawal from sale is not for safety1 purity1 or potency reasons2 and 7ii7 a notice of the removal shall be published in the ,federal ,register4 4 #ccb4 ,review and report on types of information to be listed ,not later than #c years after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall-- 7#a7 solicit public comment regarding the type of information1 if any1 that should be added to or removed from the list required by paragraph 7#i7 of section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k771 as added by section #cca2 and 7#b7 transmit to ,congress an evaluation of such comments1 including any recommendations about the types of information that should be added to or removed from the list4 ,e ,orange ,book #cda4 ,orange ,book 7a7 ,submission of patent information for brand name drugs ,paragraph 7#a7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended to read as follows3 7b7 7#a7 ,any person may file with the ,secretary an application with respect to any drug subject to the provisions of subsection 7a74 ,such persons shall submit to the ,secretary as part of the application-- 7,a7 full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use2 7,b7 a full list of the articles used as components of such drug2 7,c7 a full statement of the composition of such drug2 7,d7 a full description of the methods used in1 and the facilities and controls used for1 the manufacture1 processing1 and packing of such drug2 7,e7 such samples of such drug and of the articles used as components thereof as the ,secretary may require2 7,f7 specimens of the labeling proposed to be used for such drug2 7,g7 any assessments required under section #eje;,b2 and 7,h7 patent information1 with respect to each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture1 use1 or sale of the drug1 and consistent with the following requirements3 7i7 ,the applicant shall file with the application the patent number and the expiration date of-- 7,i7 any patent which claims the drug for which the applicant submitted the application and is a drug substance 7including active ingredient7 patent or a drug product 7including formulation and composition7 patent2 and 7,,ii7 any patent which claims the method of using such drug4 7ii7 ,if an application is filed under this subsection for a drug and a patent of the type described in clause 7i7 which claims such drug or a method of using such drug is issued after the filing date but before approval of the application1 the applicant shall amend the application to include such patent information4 ,upon approval of the application1 the ,secretary shall publish the information submitted under subparagraph 7,h74 ,the ,secretary shall1 in consultation with the ,director of the ,national ,institutes of ,health and with representatives of the drug manufacturing industry1 review and develop guidance1 as appropriate1 on the inclusion of women and minorities in clinical trials required by subparagraph 7,a74 4 7b7 ,conforming changes to requirements for subsequent submission of patent information ,section #eje7;c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended-- 7#a7 by inserting after the patent number and the expiration date of any patent which the following3 fulfills the criteria in subsection 7b7 and2 7#b7 by inserting after the first sentence the following3 ,patent information that is not the type of patent information required by subsection 7b7 shall not be submitted42 and 7#c7 by inserting after could not file patent information under subsection 7b7 because no patent the following3 of the type required to be submitted in subsection 7b74 7c7 ,listing of exclusivities ,subparagraph 7,a7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7iv7 ,for each drug included on the list1 the ,secretary shall specify each exclusivity period that is applicable and has not concluded under-- 7,i7 clause 7ii71 7iii71 or 7iv7 of subsection 7c77#c77;,e7 of this section2 7,,ii7 clause 7iv7 or 7v7 of paragraph 7#e77;,b7 of this subsection2 7,,iii7 clause 7ii71 7iii71 or 7iv7 of paragraph 7#e77;,f7 of this subsection2 7,,iv7 section #eje;,a2 7,v7 section #eje;,e2 or 7,,vi7 section #ebg7;a74 4 7d7 ,removal of invalid patents 7#a7 ,in general ,section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g77 is amended by adding at the end the following3 7,d7 7i7 ,the holder of an application approved under subsection 7c7 for a drug on the list shall notify within #ad days the ,secretary in writing if either of the following occurs3 7,i7 ,the ,patent ,trial and ,appeals ,board issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid4 7,,ii7 ,a court issues a decision from which no appeal has been or can be taken that a patent for such drug is invalid4 7ii7 ,the holder of an approved application shall include in any notification under clause 7i7 a copy of the decision described in subclause 7,i7 or 7,,ii7 of clause 7i74 7iii7 ,the ,secretary shall remove from the list any patent that is determined to be invalid in a decision described in subclause 7,i7 or 7,,ii7 of clause 7i7-- 7,i7 promptly2 but 7,,ii7 not before the expiration of any #ahj-;day exclusivity period under paragraph 7#e77;,b77iv7 that relies on a certification described in paragraph 7#b77;,a77vii77,,iv7 that such patent was invalid4 4 7#b7 ,applicability ,subparagraph 7,d7 of section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 as added by paragraph 7#a71 applies only with respect to a decision described in such subparagraph that is issued on or after the date of enactment of this ,act4 7e7 ,review and report ,not later than one year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall-- 7#a7 solicit public comment regarding the types of patent information that should be included on the list under section #ejg7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g772 and 7#b7 transmit to the ,congress an evaluation of such comments1 including any recommendations about the types of patent information that should be included on or removed from such list4 #cdb4 ,,gao report to ,congress 7a7 ,in general ,not later than one year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states 7referred to in this section as the ,comptroller ,general7 shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on the patents included in the list published under section #eje7;j77#g7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j77#g771 including an analysis and evaluation of the types of patents included in such list and the claims such patents make about the products they claim4 7b7 ,contents ,the ,comptroller ,general shall include in the report under subsection 7a7-- 7#a7 data on the number of-- 7,a7 patents included in the list published under paragraph 7#g7 of section #eje7;j7 of the ,federal ,food1 ,drug and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;j771 that claim the active ingredient or formulation of a drug in combination with a device that is used for delivery of the drug1 together comprising the finished dosage form of the drug2 and 7,b7 claims in each patent that claim a device that is used for the delivery of the drug1 but do not claim such device in combination with an active ingredient or formulation of a drug2 7#b7 data on the date of inclusion in the list under paragraph 7#g7 of such section #eje7;j7 for all patents under such list1 as compared to patents that claim a method of using the drug in combination with a device2 7#c7 an analysis regarding the impact of including on the list under paragraph 7#g7 of such section #eje7;j7 certain types of patent information for drug product applicants and approved application holders1 including an analysis of whether-- 7,a7 the listing of the patents described in paragraph 7#a77;,a7 delayed the market entry of one or more drugs approved under such section #eje7;j72 and 7,b7 not listing the patents described in paragraph 7#a77;,a7 would delay the market entry of one or more such drugs2 and 7#d7 recommendations about which kinds of patents relating to devices described in paragraph 7#a77;,a7 should be submitted to the ,secretary of ,health and ,human ,services for inclusion on the list under paragraph 7#g7 of such section #eje7;j7 and which patents should not be required to be so submitted4 ,f ,advancing ,education on ,biosimilars #cea4 ,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 ,g ,streamlining ,transition of ,biological ,products #cfa4 ,streamlining the transition of biological products ,section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji 7,public ,law #aaa-adh7 is amended-- 7#a7 by striking ,an approved application and inserting the following3 7,a7 ,in general ,an approved application 2 7#b7 by adding at the end the following3 7,b7 ,treatment of certain applications 7i7 ,in general ,with respect to an application for a biological product submitted under subsection 7b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 that is filed not later than ,march #bc1 #bjai1 the ,secretary shall continue to review such application under such section #eje1 even if such review continues after ,march #bc1 #bjbj4 7ii7 ,effect on listed drugs ,only for purposes of carrying out clause 7i71 with respect to any applicable listed drug with respect to such application1 the following shall apply3 7,i7 ,any drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subparagraph 7,a7 and that is referenced in an application described in clause 7i71 shall continue to be identified as a listed drug on the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 and the information for such drug on such list shall not be revised after ,march #bj1 #bjbj1 until-- 7aa7 such drug is removed from such list in accordance with subclause 7,,iii7 or subparagraph 7,c7 of such section #eje7;j77#g72 or 7bb7 this subparagraph no longer has force or effect4 7,,ii7 ,any drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 pursuant to subparagraph 7,a7 and that is referenced in an application described in clause 7i7 shall be subject only to requirements applicable to biological products licensed under such section4 7,,iii7 ,upon approval under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act of an application described in clause 7i71 the ,secretary shall remove from the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act any listed drug that is a biological product that has been deemed licensed under section #cea of the ,public ,health ,service ,act pursuant to subparagraph 7,a7 and that is referenced in such approved application1 unless such listed drug is referenced in one or more additional applications described in clause 7i74 7iii7 ,deemed licensure ,upon approval of an application described in clause 7i71 such approved application shall be deemed to be a license for the biological product under section #cea of the ,public ,health ,service ,act1 pursuant to subparagraph 7,a71 and any period of exclusivity1 as applicable1 shall be determined in accordance with such section4 7iv7 ,rule of construction 7,i7 ,application of certain provisions 7aa7 ,patent certification or statement ,an application described in clause 7i7 shall contain a patent certification or statement described in1 as applicable1 section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or clauses 7vii7 and 7viii7 of section #eje7;j77#b77;,a7 of such ,act and1 with respect to any listed drug referenced in such application1 comply with related requirements concerning any timely filed patent information listed pursuant to section #eje7;j77#g74 7bb7 ,date of approval ,the earliest possible date on which any pending application described in clause 7i7 may be approved shall be determined based on-- 7,,aa7 the last expiration date of any applicable period of exclusivity that would prevent such approval and that is described in section #eje7;c77#c77;,e71 #eje7;j77#e77;,b77iv71 #eje7;j77#e77;,f71 #eje;,a1 #eje;,e1 or #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 and 7,,bb7 if the application was submitted under section #eje7;b77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act and references any listed drug1 the last applicable date determined under subparagraph 7,a71 7,b71 or 7,c7 of section #eje7;c77#c7 of such ,act1 or1 if the application was submitted under section #eje7;j7 of such ,act1 the last applicable date determined under clause 7i71 7ii71 or 7iii7 of section #eje7;j77#e77;,b74 7,,ii7 ,rule of construction with respect to exclusivity ,nothing in this subparagraph shall be construed to affect section #cea7k77#g77;,d7 of the ,public ,health ,service ,act4 7v7 ,authorized disclosure ,the ,secretary may continue to review an application after ,march #bc1 #bjbj1 pursuant to clause 7i71 and continue to identify any applicable listed drug pursuant to clause 7ii7 on the list published pursuant to section #eje7;j77#g7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 even if such review or listing may reveal the existence of such application and the identity of any listed drug for which the investigations described in section #eje7;b77#a77;,a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act are relied upon by the applicant for approval of the pending application4 ,nothing in this subparagraph shall be construed as authorizing the ,secretary to disclose any other information that is a trade secret or confidential information described in section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 7vi7 ,sunset ,beginning on ,october #a1 #bjbb1 this subparagraph shall have no force or effect and any applications described in clause 7i7 that have not been approved shall be deemed withdrawn4 4 ,h ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform #cgj4 ,short title2 references in subtitle 7a7 ,short title ,this subtitle may be cited as the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai4 7b7 ,references ,except as otherwise specified1 any reference to this ,act contained in this subtitle shall be treated as referring only to the provisions of this subtitle4 #a ,,otc ,drug ,review #cga4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,in general ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #eje;,f of such ,act 7#ba ,u4,s4,c4 #cee;g7 the following3 #eje;,g4 ,regulation of certain nonprescription drugs that are marketed without an approved drug application 7a7 ,nonprescription drugs marketed without an approved application ,nonprescription drugs marketed without an approved drug application under section #eje1 as of the date of the enactment of this section1 shall be treated in accordance with this subsection4 7#a7 ,drugs subject to a final monograph2 category ,i drugs subject to a tentative final monograph ,a drug is deemed to be generally recognized as safe and effective under section #bja7p77#a71 not a new drug under section #bja7p71 and not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 in conformity with the requirements for nonprescription use of a final monograph issued under part #ccj of title #ba1 ,code of ,federal ,regulations 7except as provided in paragraph 7#b771 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7ii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the proposed requirements for nonprescription use of such tentative final monograph1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsections 7b71 7c71 and 7k72 and 7iii7 except as permitted by an order issued under subsection 7b7 or1 in the case of a minor change in the drug1 in conformity with an order issued under subsection 7c71 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#b7 ,treatment of sunscreen drugs ,with respect to sunscreen drugs subject to this section1 the applicable requirements in terms of conformity with a final monograph1 for purposes of paragraph 7#a77;,a77i71 shall be the requirements specified in part #ceb of title #ba1 ,code of ,federal ,regulations1 as published on ,may #ba1 #aiii1 beginning on page #bgfhg of volume #fd of the ,federal ,register1 except that the applicable requirements governing effectiveness and labeling shall be those specified in section #bja4cbg of title #ba1 ,code of ,federal ,regulations4 7#c7 ,category ,,iii drugs subject to a tentative final monograph2 category ,i drugs subject to proposed monograph or advance notice of proposed rulemaking ,a drug that is not described in paragraph 7#a71 7#b71 or 7#d7 is not required to be the subject of an application approved under section #eje1 and is not subject to section #ejc7;b77#a71 if-- 7,a7 the drug is-- 7i7 classified in category ,,iii for safety or effectiveness in the preamble of a proposed rule establishing a tentative final monograph that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with-- 7,i7 the conditions of use1 including indication and dosage strength1 if any1 described for such category ,,iii drug in such preamble or in an applicable subsequent proposed rule2 7,,ii7 the proposed requirements for drugs classified in such tentative final monograph in category ,i in the most recently proposed rule establishing requirements related to such tentative final monograph and in any final rule establishing requirements that are applicable to the drug2 and 7,,iii7 the general requirements for nonprescription drugs and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 had been used to a material extent and for a material time under section #bja7p77#b72 or 7,b7 the drug is-- 7i7 classified in category ,i for safety and effectiveness under a proposed monograph or advance notice of proposed rulemaking that is the most recently applicable proposal or determination for such drug issued under part #ccj of title #ba1 ,code of ,federal ,regulations2 7ii7 in conformity with the requirements for nonprescription use of such proposed monograph or advance notice of proposed rulemaking1 any applicable subsequent determination by the ,secretary1 the general requirements for nonprescription drugs1 and conditions or requirements under subsection 7b7 or 7k72 and 7iii7 in a dosage form that1 immediately prior to the date of the enactment of this section1 has been used to a material extent and for a material time under section #bja7p77#b74 7#d7 ,category ,,ii drugs deemed new drugs ,a drug that is classified in category ,,ii for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje beginning on the day that is #ahj calendar days after the date of the enactment of this section1 unless1 before such day1 the ,secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application4 7#e7 ,drugs not ,,grase deemed new drugs ,a drug that the ,secretary has determined not to be generally recognized as safe and effective under section #bja7p77#a7 under a final determination issued under part #ccj of title #ba1 ,code of ,federal ,regulations1 shall be deemed to be a new drug under section #bja7p71 misbranded under section #ejb7;ee71 and subject to the requirement for an approved new drug application under section #eje4 7#f7 ,other drugs deemed new drugs ,except as provided in subsection 7m71 a drug is deemed to be a new drug under section #bja7p7 and misbranded under section #ejb7;ee7 if the drug-- 7,a7 is not subject to section #ejc7;b77#a72 and 7,b7 is not described in paragraph 7#a71 7#b71 7#c71 7#d71 or 7#e71 or subsection 7b77#a77;,b74 7b7 ,administrative orders 7#a7 ,in general 7,a7 ,determination ,the ,secretary may1 on the initiative of the ,secretary or at the request of one or more requestors1 issue an administrative order determining whether there are conditions under which a specific drug1 a class of drugs1 or a combination of drugs1 is determined to be-- 7i7 not subject to section #ejc7;b77#a72 and 7ii7 generally recognized as safe and effective under section #bja7p77#a74 7,b7 ,effect ,a drug or combination of drugs shall be deemed to not require approval under section #eje if such drug or combination of drugs-- 7i7 is determined by the ,secretary to meet the conditions specified in clauses 7i7 and 7ii7 of subparagraph 7,a72 7ii7 is marketed in conformity with an administrative order under this subsection2 7iii7 meets the general requirements for nonprescription drugs2 and 7iv7 meets the requirements under subsections 7c7 and 7k74 7,c7 ,standard ,the ,secretary shall find that a drug is not generally recognized as safe and effective under section #bja7p77#a7 if-- 7i7 the evidence shows that the drug is not generally recognized as safe and effective under section #bja7p77#a72 or 7ii7 the evidence is inadequate to show that the drug is generally recognized as safe and effective under section #bja7p77#a74 7#b7 ,administrative orders initiated by the secretary 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 upon the ,secretary's initiative1 the ,secretary shall-- 7i7 make reasonable efforts to notify informally1 not later than #b business days before the issuance of the proposed order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for the drugs or combination of drugs that will be subject to the administrative order2 7ii7 after any such reasonable efforts of notification-- 7,i7 issue a proposed administrative order by publishing it on the website of the ,food and ,drug ,administration and include in such order the reasons for the issuance of such order2 and 7,,ii7 publish a notice of availability of such proposed order in the ,federal ,register2 7iii7 except as provided in subparagraph 7,b71 provide for a public comment period with respect to such proposed order of not less than #de calendar days2 and 7iv7 if1 after completion of the proceedings specified in clauses 7i7 through 7iii71 the ,secretary determines that it is appropriate to issue a final administrative order-- 7,i7 issue the final administrative order1 together with a detailed statement of reasons1 which order shall not take effect until the time for requesting judicial review under paragraph 7#c77;,d77ii7 has expired2 7,,ii7 publish a notice of such final administrative order in the ,federal ,register2 7,,iii7 afford requestors of drugs that will be subject to such order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which initially must be requested within #de calendar days of the issuance of the order1 and1 for subsequent levels of appeal1 within #cj calendar days of the prior decision2 and 7,,iv7 except with respect to drugs described in paragraph 7#c77;,b71 upon completion of the formal dispute resolution procedure1 inform the persons which sought such dispute resolution of their right to request a hearing4 7,b7 ,exceptions ,when issuing an administrative order under paragraph 7#a7 on the ,secretary's initiative proposing to determine that a drug described in subsection 7a77#c7 is not generally recognized as safe and effective under section #bja7p77#a71 the ,secretary shall follow the procedures in subparagraph 7,a71 except that-- 7i7 the proposed order shall include notice of-- 7,i7 the general categories of data the ,secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section #bja7p77#a72 and 7,,ii7 the format for submissions by interested persons2 7ii7 the ,secretary shall provide for a public comment period of no less than #ahj calendar days with respect to such proposed order1 except when the ,secretary determines1 for good cause1 that a shorter period is in the interest of public health2 and 7iii7 any person who submits data in such comment period shall include a certification that the person has submitted all evidence created1 obtained1 or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section #bja7p77#a74 7#c7 ,hearings2 judicial review 7,a7 ,in general ,only a person who participated in each stage of formal dispute resolution under subclause 7,,iii7 of paragraph 7#b77;,a77iv7 of an administrative order with respect to a drug may request a hearing concerning a final administrative order issued under such paragraph with respect to such drug4 ,if a hearing is sought1 such person must submit a request for a hearing1 which shall be based solely on information in the administrative record1 to the ,secretary not later than #cj calendar days after receiving notice of the final decision of the formal dispute resolution procedure4 7,b7 ,no hearing required with respect to orders relating to certain drugs 7i7 ,in general ,the ,secretary shall not be required to provide notice and an opportunity for a hearing pursuant to paragraph 7#b77;,a77iv7 if the final administrative order involved relates to a drug-- 7,i7 that is described in subsection 7a77#c77;,a72 and 7,,ii7 with respect to which no human or non-human data studies relevant to the safety or effectiveness of such drug have been submitted to the administrative record since the issuance of the most recent tentative final monograph relating to such drug4 7ii7 ,human data studies and non-human data defined ,in this subparagraph3 7,i7 ,the term human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies4 7,,ii7 ,the term non-human data means data from testing other than with human subjects which provides information concerning safety or effectiveness4 7,c7 ,hearing procedures 7i7 ,denial of request for hearing ,if the ,secretary determines that information submitted in a request for a hearing under subparagraph 7,a7 with respect to a final administrative order issued under paragraph 7#b77;,a77iv7 does not identify the existence of a genuine and substantial question of material fact1 the ,secretary may deny such request4 ,in making such a determination1 the ,secretary may consider only information and data that are based on relevant and reliable scientific principles and methodologies4 7ii7 ,single hearing for multiple related requests ,if more than one request for a hearing is submitted with respect to the same administrative order under subparagraph 7,a71 the ,secretary may direct that a single hearing be conducted in which all persons whose hearing requests were granted may participate4 7iii7 ,presiding officer ,the presiding officer of a hearing requested under subparagraph 7,a7 shall-- 7,i7 be designated by the ,secretary2 7,,ii7 not be an employee of the ,center for ,drug ,evaluation and ,research2 and 7,,iii7 not have been previously involved in the development of the administrative order involved or proceedings relating to that administrative order4 7iv7 ,rights of parties to hearing ,the parties to a hearing requested under subparagraph 7,a7 shall have the right to present testimony1 including testimony of expert witnesses1 and to cross-examine witnesses presented by other parties4 ,where appropriate1 the presiding officer may require that cross-examination by parties representing substantially the same interests be consolidated to promote efficiency and avoid duplication4 7v7 ,final decision 7,i7 ,at the conclusion of a hearing requested under subparagraph 7,a71 the presiding officer of the hearing shall issue a decision containing findings of fact and conclusions of law4 ,the decision of the presiding officer shall be final4 7,,ii7 ,the final decision may not take effect until the period under subparagraph 7,d77ii7 for submitting a request for judicial review of such decision expires4 7,d7 ,judicial review of final administrative order 7i7 ,in general ,the procedures described in section #eje7;h7 shall apply with respect to judicial review of final administrative orders issued under this subsection in the same manner and to the same extent as such section applies to an order described in such section except that the judicial review shall be taken by filing in an appropriate district court of the ,united ,states in lieu of the appellate courts specified in such section4 7ii7 ,period to submit a request for judicial review ,a person eligible to request a hearing under this paragraph and seeking judicial review of a final administrative order issued under this subsection shall file such request for judicial review not later than #fj calendar days after the latest of-- 7,i7 the date on which notice of such order is published2 7,,ii7 the date on which a hearing with respect to such order is denied under subparagraph 7,b7 or 7,c77i72 7,,iii7 the date on which a final decision is made following a hearing under subparagraph 7,c77v72 or 7,,iv7 if no hearing is requested1 the date on which the time for requesting a hearing expires4 7#d7 ,expedited procedure with respect to administrative orders initiated by the ,secretary 7,a7 ,imminent hazard to the public health 7i7 ,in general ,in the case of a determination by the ,secretary that a drug1 class of drugs1 or combination of drugs subject to this section poses an imminent hazard to the public health1 the ,secretary1 after first making reasonable efforts to notify1 not later than #dh hours before issuance of such order under this subparagraph1 sponsors who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs-- 7,i7 may issue an interim final administrative order for such drug1 class of drugs1 or combination of drugs under paragraph 7#a71 together with a detailed statement of the reasons for such order2 7,,ii7 shall publish in the ,federal ,register a notice of availability of any such order2 and 7,,iii7 shall provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,nondelegation ,the ,secretary may not delegate the authority to issue an interim final administrative order under this subparagraph4 7,b7 ,safety labeling changes 7i7 ,in general ,in the case of a determination by the ,secretary that a change in the labeling of a drug1 class of drugs1 or combination of drugs subject to this section is reasonably expected to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug1 the ,secretary may-- 7,i7 make reasonable efforts to notify informally1 not later than #dh hours before the issuance of the interim final order1 the sponsors of drugs who have a listing in effect under section #eaj7;j7 for such drug or combination of drugs2 7,,ii7 after reasonable efforts of notification1 issue an interim final administrative order in accordance with paragraph 7#a7 to require such change1 together with a detailed statement of the reasons for such order2 7,,iii7 publish in the ,federal ,register a notice of availability of such order2 and 7,,iv7 provide for a public comment period of at least #de calendar days with respect to such interim final order4 7ii7 ,content of order ,an interim final order issued under this subparagraph with respect to the labeling of a drug may provide for new warnings and other information required for safe use of the drug4 7,c7 ,effective date ,an order under subparagraph 7,a7 or 7,b7 shall take effect on a date specified by the ,secretary4 7,d7 ,final order ,after the completion of the proceedings in subparagraph 7,a7 or 7,b71 the ,secretary shall-- 7i7 issue a final order in accordance with paragraph 7#a72 7ii7 publish a notice of availability of such final administrative order in the ,federal ,register2 and 7iii7 afford sponsors of such drugs that will be subject to such an order the opportunity for formal dispute resolution up to the level of the ,director of the ,center for ,drug ,evaluation and ,research1 which must initially be within #de calendar days of the issuance of the order1 and for subsequent levels of appeal1 within #cj calendar days of the prior decision4 7,e7 ,hearings ,a sponsor of a drug subject to a final order issued under subparagraph 7,d7 and that participated in each stage of formal dispute resolution under clause 7iii7 of such subparagraph may request a hearing on such order4 ,the provisions of subparagraphs 7,a71 7,b71 and 7,c7 of paragraph 7#c71 other than paragraph 7#c77;,c77v77,,ii71 shall apply with respect to a hearing on such order in the same manner and to the same extent as such provisions apply with respect to a hearing on an administrative order issued under paragraph 7#b77;,a77iv74 7,f7 ,timing 7i7 ,final order and hearing ,the ,secretary shall-- 7,i7 not later than #f months after the date on which the comment period closes under subparagraph 7,a7 or 7,b71 issue a final order in accordance with paragraph 7#a72 and 7,,ii7 not later than #ab months after the date on which such final order is issued1 complete any hearing under subparagraph 7,e74 7ii7 ,dispute resolution request ,the ,secretary shall specify in an interim final order issued under subparagraph 7,a7 or 7,b7 such shorter periods for requesting dispute resolution under subparagraph 7,d77iii7 as are necessary to meet the requirements of this subparagraph4 7,g7 ,judicial review ,a final order issued pursuant to subparagraph 7,f7 shall be subject to judicial review in accordance with paragraph 7#c77;,d74 7#e7 ,administrative order initiated at the request of a requestor 7,a7 ,in general ,in issuing an administrative order under paragraph 7#a7 at the request of a requestor with respect to certain drugs1 classes of drugs1 or combinations of drugs-- 7i7 the ,secretary shall1 after receiving a request under this subparagraph1 determine whether the request is sufficiently complete and formatted to permit a substantive review2 7ii7 if the ,secretary determines that the request is sufficiently complete and formatted to permit a substantive review1 the ,secretary shall-- 7,i7 file the request2 and 7,,ii7 initiate proceedings with respect to issuing an administrative order in accordance with paragraphs 7#b7 and 7#c72 and 7iii7 except as provided in paragraph 7#f71 if the ,secretary determines that a request does not meet the requirements for filing or is not sufficiently complete and formatted to permit a substantive review1 the requestor may demand that the request be filed over protest1 and the ,secretary shall initiate proceedings to review the request in accordance with paragraph 7#b77;,a74 7,b7 ,request to initiate proceedings 7i7 ,in general ,a requestor seeking an administrative order under paragraph 7#a7 with respect to certain drugs1 classes of drugs1 or combinations of drugs1 shall submit to the ,secretary a request to initiate proceedings for such order in the form and manner as specified by the ,secretary4 ,such requestor may submit a request under this subparagraph for the issuance of an administrative order-- 7,i7 determining whether a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje2 or 7,,ii7 determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section #bja7p77#a71 exempt from section #ejc7;b77#a71 and not required to be the subject of an approved application under section #eje1 if1 absent such a changed condition of use1 such drug is-- 7aa7 generally recognized as safe and effective under section #bja7p77#a7 in accordance with subsection 7a77#a71 7a77#b71 or an order under this subsection2 or 7bb7 subject to subsection 7a77#c71 but only if such requestor initiates such request in conjunction with a request for the ,secretary to determine whether such drug is generally recognized as safe and effective under section #bja7p77#a71 which is filed by the ,secretary under subparagraph 7,a77ii74 7ii7 ,exception ,the ,secretary is not required to complete review of a request for a change described in clause 7i77,,ii7 if the ,secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section #bja7p77#a7 under paragraph 7#a7 and issues a final order announcing that determination4 7iii7 ,withdrawal ,the requestor may withdraw a request under this paragraph1 according to the procedures set forth pursuant to subsection 7d77#b77;,b74 ,notwithstanding any other provision of this section1 if such request is withdrawn1 the ,secretary may cease proceedings under this subparagraph4 7,c7 ,exclusivity 7i7 ,in general ,a final administrative order issued in response to a request under this section shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such order71 for a period of #ah months following the effective date of such final order and beginning on the date the requestor may lawfully market such drugs pursuant to the order1 to market drugs-- 7,i7 incorporating changes described in clause 7ii72 and 7,,ii7 subject to the limitations under clause 7iv74 7ii7 ,changes described ,a change described in this clause is a change subject to an order specified in clause 7i71 which-- 7,i7 provides for a drug to contain an active ingredient 7including any ester or salt of the active ingredient7 not previously incorporated in a drug described in clause 7iii72 or 7,,ii7 provides for a change in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor 7or for which the requestor has an exclusive right of reference7 were essential to the issuance of such order4 7iii7 ,drugs described ,the drugs described in this clause are drugs-- 7,i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7,,ii7 subject to a final order issued under this section2 7,,iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a772 or 7,,iv7 described in subsection 7m77#a71 other than drugs subject to an active enforcement action under chapter ,,iii of this ,act4 7iv7 ,limitations on exclusivity 7,i7 ,in general ,only one #ah-month period under this subparagraph shall be granted1 under each order described in clause 7i71 with respect to changes 7to the drug subject to such order7 which are either-- 7aa7 changes described in clause 7ii77,i71 relating to active ingredients2 or 7bb7 changes described in clause 7ii77,,ii71 relating to conditions of use4 7,,ii7 ,no exclusivity allowed ,no exclusivity shall apply to changes to a drug which are-- 7aa7 the subject of a ,tier #b ,,otc monograph order request 7as defined in section #gdd,l72 7bb7 safety-related changes1 as defined by the ,secretary1 or any other changes the ,secretary considers necessary to assure safe use2 or 7cc7 changes related to methods of testing safety or efficacy4 7v7 ,new human data studies defined ,in this subparagraph1 the term new human data studies means clinical trials of safety or effectiveness 7including actual use studies71 pharmacokinetics studies1 or bioavailability studies1 the results of which-- 7,i7 have not been relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje2 and 7,,ii7 do not duplicate the results of another study that was relied on by the ,secretary to support-- 7aa7 a proposed or final determination that a drug described in subclause 7,i71 7,,ii71 or 7,,iii7 of clause 7iii7 is generally recognized as safe and effective under section #bja7p77#a72 or 7bb7 approval of a drug that was approved under section #eje4 7#f7 ,information regarding safe nonprescription marketing and use as condition for filing a generally recognized as safe and effective request 7,a7 ,in general ,in response to a request under this section that a drug described in subparagraph 7,b7 be generally recognized as safe and effective1 the ,secretary-- 7i7 may file such request1 if the request includes information specified under subparagraph 7,c7 with respect to safe nonprescription marketing and use of such drug2 or 7ii7 if the request fails to include information specified under subparagraph 7,c71 shall refuse to file such request and require that nonprescription marketing of the drug be pursuant to a new drug application as described in subparagraph 7,d74 7,b7 ,drug described ,a drug described in this subparagraph is a nonprescription drug which contains an active ingredient not previously incorporated in a drug-- 7i7 specified in subsection 7a77#a71 7a77#b71 or 7a77#c72 7ii7 subject to a final order under this section2 or 7iii7 subject to a final sunscreen order 7as defined in section #ehf7b77;,a774 7,c7 ,information demonstrating prima facie safe nonprescription marketing and use ,information specified in this subparagraph1 with respect to a request described in subparagraph 7,a77i71 is-- 7i7 information sufficient for a prima facie demonstration that the drug subject to such request has a verifiable history of being marketed and safely used by consumers in the ,united ,states as a nonprescription drug under comparable conditions of use2 7ii7 if the drug has not been previously marketed in the ,united ,states as a nonprescription drug1 information sufficient for a prima facie demonstration that the drug was marketed and safely used under comparable conditions of marketing and use in a country listed in section #hjb7;b77#a77;,a7 or designated by the ,secretary in accordance with section #hjb7;b77#a77;,b7-- 7,i7 for such period as needed to provide reasonable assurances concerning the safe nonprescription use of the drug2 and 7,,ii7 during such time was subject to sufficient monitoring by a regulatory body considered acceptable by the ,secretary for such monitoring purposes1 including for adverse events associated with nonprescription use of the drug2 or 7iii7 if the ,secretary determines that information described in clause 7i7 or 7ii7 is not needed to provide a prima facie demonstration that the drug can be safely marketed and used as a nonprescription drug1 such other information the ,secretary determines is sufficient for such purposes4 7,d7 ,marketing pursuant to new drug application ,in the case of a request described in subparagraph 7,a77ii71 the drug subject to such request may be resubmitted for filing only if-- 7i7 the drug is marketed as a nonprescription drug1 under conditions of use comparable to the conditions specified in the request1 for such period as the ,secretary determines appropriate 7not to exceed #e consecutive years7 pursuant to an application approved under section #eje2 and 7ii7 during such period1 #a1jjj1jjj retail packages of the drug1 or an equivalent quantity as determined by the ,secretary1 were distributed for retail sale1 as determined in such manner as the ,secretary finds appropriate4 7,e7 ,rule of application ,except in the case of a request involving a drug described in section #ehf7i71 as in effect on ,january #a1 #bjag1 if the ,secretary refuses to file a request under this paragraph1 the requestor may not file such request over protest under paragraph 7#e77;,a77iii74 7#g7 ,packaging ,an administrative order issued under paragraph 7#b71 7#d77;,a71 or 7#e7 may include requirements for the packaging of a drug to encourage use in accordance with labeling4 ,such requirements may include unit dose packaging1 requirements for products intended for use by pediatric populations1 requirements to reduce risk of harm from unsupervised ingestion1 and other appropriate requirements4 ,this paragraph does not authorize the ,food and ,drug ,administration to require standards or testing procedures as described in part #agjj of title #af1 ,code of ,federal ,regulations4 7#h7 ,final and tentative final monographs for category ,i drugs deemed final administrative orders 7,a7 ,in general ,a final monograph or tentative final monograph described in subparagraph 7,b7 shall be deemed to be a final administrative order under this subsection and may be amended1 revoked1 or otherwise modified in accordance with the procedures of this subsection4 7,b7 ,monographs described ,for purposes of subparagraph 7,a71 a final monograph or tentative final monograph is described in this subparagraph if it-- 7i7 establishes conditions of use for a drug described in paragraph 7#a7 or 7#b7 of subsection 7a72 and 7ii7 represents the most recently promulgated version of such conditions1 including as modified1 in whole or in part1 by any proposed or final rule4 7,c7 ,deemed orders include harmonizing technical amendments ,the deemed establishment of a final administrative order under subparagraph 7,a7 shall be construed to include any technical amendments to such order as the ,secretary determines necessary to ensure that such order is appropriately harmonized1 in terms of terminology or cross-references1 with the applicable provisions of this ,act 7and regulations thereunder7 and any other orders issued under this section4 7c7 ,procedure for minor changes 7#a7 ,in general ,minor changes in the dosage form of a drug that is described in paragraph 7#a7 or 7#b7 of subsection 7a7 or the subject of an order issued under subsection 7b7 may be made by a requestor without the issuance of an order under subsection 7b7 if-- 7,a7 the requestor maintains such information as is necessary to demonstrate that the change-- 7i7 will not affect the safety or effectiveness of the drug2 and 7ii7 will not materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product2 and 7,b7 the change is in conformity with the requirements of an applicable administrative order issued by the ,secretary under paragraph 7#c74 7#b7 ,additional information 7,a7 ,access to records ,a sponsor shall submit records requested by the ,secretary relating to such a minor change under section #gjd7;a77#d71 within #ae business days of receiving such a request1 or such longer period as the ,secretary may provide4 7,b7 ,insufficient information ,if the ,secretary determines that the information contained in such records is not sufficient to demonstrate that the change does not affect the safety or effectiveness of the drug or materially affect the extent of absorption or other exposure to the active ingredient1 the ,secretary-- 7i7 may so inform the sponsor of the drug in writing2 and 7ii7 if the ,secretary so informs the sponsor1 shall provide the sponsor of the drug with a reasonable opportunity to provide additional information4 7,c7 ,failure to submit sufficient information ,if the sponsor fails to provide such additional information within a time prescribed by the ,secretary1 or if the ,secretary determines that such additional information does not demonstrate that the change does not-- 7i7 affect the safety or effectiveness of the drug2 or 7ii7 materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product1 the drug as modified is a new drug under section #bja7p7 and shall be deemed to be misbranded under section #ejb7;ee74 7#c7 ,determining whether a change will affect safety or effectiveness 7,a7 ,in general ,the ,secretary shall issue one or more administrative orders specifying requirements for determining whether a minor change made by a sponsor pursuant to this subsection will affect the safety or effectiveness of a drug or materially affect the extent of absorption or other exposure to an active ingredient in the drug in comparison to a suitable reference product1 together with guidance for applying those orders to specific dosage forms4 7,b7 ,standard practices ,the orders and guidance issued by the ,secretary under subparagraph 7,a7 shall take into account relevant public standards and standard practices for evaluating the quality of drugs1 and may take into account the special needs of populations1 including children4 7d7 ,confidentiality of information submitted to the ,secretary 7#a7 ,in general ,subject to paragraph 7#b71 any information1 including reports of testing conducted on the drug or drugs involved1 that is submitted by a requestor in connection with proceedings on an order under this section 7including any minor change under subsection 7c77 and is a trade secret or confidential information subject to section #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code1 shall not be disclosed to the public unless the requestor consents to that disclosure4 7#b7 ,public availability 7,a7 ,in general ,except as provided in subparagraph 7,b71 the ,secretary shall-- 7i7 make any information submitted by a requestor in support of a request under subsection 7b77#e77;,a7 available to the public not later than the date on which the proposed order is issued2 and 7ii7 make any information submitted by any other person with respect to an order requested 7or initiated by the ,secretary7 under subsection 7b71 available to the public upon such submission4 7,b7 ,limitations on public availability ,information described in subparagraph 7,a7 shall not be made public if-- 7i7 the information pertains to pharmaceutical quality information1 unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section #bja7p77#a72 7ii7 the information is submitted in a requestor-initiated request1 but the requestor withdraws such request1 in accordance with withdrawal procedures established by the ,secretary1 before the ,secretary issues the proposed order2 7iii7 the ,secretary requests and obtains the information under subsection 7c7 and such information is not submitted in relation to an order under subsection 7b72 or 7iv7 the information is of the type contained in raw datasets4 7e7 ,updates to drug listing information ,a sponsor who makes a change to a drug subject to this section shall submit updated drug listing information for the drug in accordance with section #eaj7;j7 within #cj calendar days of the date when the drug is first commercially marketed1 except that a sponsor who was the order requestor with respect to an order subject to subsection 7b77#e77;,c7 7or a licensee1 assignee1 or successor in interest of such requestor7 shall submit updated drug listing information on or before the date when the drug is first commercially marketed4 7f7 ,approvals under section #eje ,the provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections #eje7;b77#a71 #eje7;b77#b71 and #eje7;j74 ,a determination under this section that a drug is not subject to section #ejc7;b77#a71 is generally recognized as safe and effective under section #bja7p77#a71 and is not a new drug under section #bja7p7 shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section #eje7;b77#b71 so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section4 7g7 ,public availability of administrative orders ,the ,secretary shall establish1 maintain1 update 7as determined necessary by the ,secretary but no less frequently than annually71 and make publicly available1 with respect to orders issued under this section-- 7#a7 a repository of each final order and interim final order in effect1 including the complete text of the order2 and 7#b7 a listing of all orders proposed and under development under subsection 7b77#b71 including-- 7,a7 a brief description of each such order2 and 7,b7 the ,secretary's expectations1 if resources permit1 for issuance of proposed orders over a #c-year period4 7h7 ,development advice to sponsors or requestors ,the ,secretary shall establish procedures under which sponsors or requestors may meet with appropriate officials of the ,food and ,drug ,administration to obtain advice on the studies and other information necessary to support submissions under this section and other matters relevant to the regulation of nonprescription drugs and the development of new nonprescription drugs under this section4 7i7 ,participation of multiple sponsors or requestors ,the ,secretary shall establish procedures to facilitate efficient participation by multiple sponsors or requestors in proceedings under this section1 including provision for joint meetings with multiple sponsors or requestors or with organizations nominated by sponsors or requestors to represent their interests in a proceeding4 7j7 ,electronic format ,all submissions under this section shall be in electronic format4 7k7 ,effect on existing regulations governing nonprescription drugs 7#a7 ,regulations of general applicability to nonprescription drugs ,except as provided in this subsection1 nothing in this section supersedes regulations establishing general requirements for nonprescription drugs1 including regulations of general applicability contained in parts #bja1 #bej1 and #ccj of title #ba1 ,code of ,federal ,regulations1 or any successor regulations4 ,the ,secretary shall establish or modify such regulations by means of rulemaking in accordance with section #eec of title #e1 ,united ,states ,code4 7#b7 ,regulations establishing requirements for specific nonprescription drugs 7,a7 ,the provisions of section #caj4ede of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section1 shall be deemed to be a final order under subsection 7b74 7,b7 ,regulations in effect on the day before the date of the enactment of this section1 establishing requirements for specific nonprescription drugs marketed pursuant to this section 7including such requirements in parts #bja and #bej of title #ba1 ,code of ,federal ,regulations71 shall be deemed to be final orders under subsection 7b71 only as they apply to drugs-- 7i7 subject to paragraph 7#a71 7#b71 7#c71 or 7#d7 of subsection 7a72 or 7ii7 otherwise subject to an order under this section4 7#c7 ,withdrawal of regulations ,the ,secretary shall withdraw regulations establishing final monographs and the procedures governing the over-the-counter drug review under part #ccj and other relevant parts of title #ba1 ,code of ,federal ,regulations 7as in effect on the day before the date of the enactment of this section71 or make technical changes to such regulations to ensure conformity with appropriate terminology and cross references4 ,notwithstanding subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code1 any such withdrawal or technical changes shall be made without public notice and comment and shall be effective upon publication through notice in the ,federal ,register 7or upon such date as specified in such notice74 7l7 ,guidance ,the ,secretary shall issue guidance that specifies-- 7#a7 the procedures and principles for formal meetings between the ,secretary and sponsors or requestors for drugs subject to this section2 7#b7 the format and content of data submissions to the ,secretary under this section2 7#c7 the format of electronic submissions to the ,secretary under this section2 7#d7 consolidated proceedings for appeal and the procedures for such proceedings where appropriate2 and 7#e7 for minor changes in drugs1 recommendations on how to comply with the requirements in orders issued under subsection 7c77#c74 7m7 ,rule of construction 7#a7 ,in general ,this section shall not affect the treatment or status of a nonprescription drug-- 7,a7 that is marketed without an application approved under section #eje as of the date of the enactment of this section2 7,b7 that is not subject to an order issued under this section2 and 7,c7 to which paragraphs 7#a71 7#b71 7#c71 7#d71 or 7#e7 of subsection 7a7 do not apply4 7#b7 ,treatment of products previously found to be subject to time and extent requirements 7,a7 ,notwithstanding subsection 7a71 a drug described in subparagraph 7,b7 may only be lawfully marketed1 without an application approved under section #eje1 pursuant to an order issued under this section4 7,b7 ,a drug described in this subparagraph is a drug which1 prior to the date of the enactment of this section1 the ,secretary determined in a proposed or final rule to be ineligible for review under the ,,otc drug review 7as such phrase ,,otc drug review was used in section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as in effect on the day before the date of the enactment of this section74 7#c7 ,preservation of authority 7,a7 ,nothing in paragraph 7#a7 shall be construed to preclude or limit the applicability of any provision of this ,act other than this section4 7,b7 ,nothing in subsection 7a7 shall be construed to prohibit the ,secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section #bja7p77#a71 as the ,secretary determines appropriate4 7n7 ,investigational new drugs ,a drug is not subject to this section if an exemption for investigational use under section #eje7;i7 is in effect for such drug4 7o7 ,inapplicability of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to collections of information made under this section4 7p7 ,inapplicability of notice and comment rulemaking and other requirements ,the requirements of subsection 7b7 shall apply with respect to orders issued under this section instead of the requirements of subchapter ,,ii of chapter #e of title #e1 ,united ,states ,code4 7q7 ,definitions ,in this section3 7#a7 ,the term nonprescription drug refers to a drug not subject to the requirements of section #ejc7;b77#a74 7#b7 ,the term sponsor refers to any person marketing1 manufacturing1 or processing a drug that-- 7,a7 is listed pursuant to section #eaj7;j72 and 7,b7 is or will be subject to an administrative order under this section of the ,food and ,drug ,administration4 7#c7 ,the term requestor refers to any person or group of persons marketing1 manufacturing1 processing1 or developing a drug4 4 7b7 ,,gao study ,not later than #d years after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit a study to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate addressing the effectiveness and overall impact of exclusivity under section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 and section #ehf;,c of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#c71 including the impact of such exclusivity on consumer access4 ,such study shall include-- 7#a7 an analysis of the impact of exclusivity under such section #eje;,g for nonprescription drug products1 including-- 7,a7 the number of nonprescription drug products that were granted exclusivity and the indication for which the nonprescription drug products were determined to be generally recognized as safe and effective2 7,b7 whether the exclusivity for such drug products was granted for-- 7i7 a new active ingredient 7including any ester or salt of the active ingredient72 or 7ii7 changes in the conditions of use of a drug1 for which new human data studies conducted or sponsored by the requestor were essential2 7,c7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the drug product2 7,d7 an analysis of the implementation of the exclusivity provision in such section #eje;,g1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the nonprescription drug market2 7iii7 the impact of such provision on competition in the nonprescription drug market2 7iv7 the impact of such provision on consumer access to nonprescription drug products2 7v7 the impact of such provision on the prices of nonprescription drug products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient to encourage the development of nonprescription drug products that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #eje;,g have been sufficient incentive to encourage innovation in the nonprescription drug market2 and 7#b7 an analysis of the impact of exclusivity under such section #ehf;,c for sunscreen ingredients1 including-- 7,a7 the number of sunscreen ingredients that were granted exclusivity and the specific ingredient that was determined to be generally recognized as safe and effective2 7,b7 whether1 and to what extent1 the exclusivity impacted the requestor's or sponsor's decision to develop the sunscreen ingredient2 7,c7 whether1 and to what extent1 the sunscreen ingredient granted exclusivity had previously been available outside of the ,united ,states2 7,d7 an analysis of the implementation of the exclusivity provision in such section #ehf;,c1 including-- 7i7 the resources used by the ,food and ,drug ,administration2 7ii7 the impact of such provision on innovation1 as well as research and development in the sunscreen market2 7iii7 the impact of such provision on competition in the sunscreen market2 7iv7 the impact of such provision on consumer access to sunscreen products2 7v7 the impact of such provision on the prices of sunscreen products2 and 7vi7 whether the administrative orders initiated by requestors under such section #eje;,g have been utilized by sunscreen ingredient sponsors and whether such process has been sufficient to encourage the development of sunscreen ingredients that would likely not be otherwise developed1 or developed in as timely a manner2 and 7,e7 whether the administrative orders initiated by requestors under such section #ehf;,c have been sufficient incentive to encourage innovation in the sunscreen market4 7c7 ,conforming amendment ,section #gea7;d77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgir7d77#a77 is amended-- 7#a7 in the matter preceding subparagraph 7,a7-- 7,a7 by striking final regulation promulgated and inserting final order under section #eje;,g2 and 7,b7 by striking and not misbranded2 and 7#b7 in subparagraph 7,a71 by striking regulation in effect and inserting regulation or order in effect4 #cgb4 ,misbranding ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7ee7 ,if it is a nonprescription drug that is subject to section #eje;,g1 is not the subject of an application approved under section #eje1 and does not comply with the requirements under section #eje;,g4 7ff7 ,if it is a drug and it was manufactured1 prepared1 propagated1 compounded1 or processed in a facility for which fees have not been paid as required by section #gdd,m4 4 #cgc4 ,drugs excluded from the over-the-counter drug review 7a7 ,in general ,nothing in this ,act 7or the amendments made by this ,act7 shall apply to any nonprescription drug 7as defined in section #eje;,g7q7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act7 which was excluded by the ,food and ,drug ,administration from the ,over-the-,counter ,drug ,review in accordance with the paragraph numbered #be on page #idff of volume #cg of the ,federal ,register1 published on ,may #aa1 #aigb4 7b7 ,rule of construction ,nothing in this section shall be construed to preclude or limit the applicability of any other provision of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq474 #cgd4 ,treatment of ,sunscreen ,innovation ,act 7a7 ,review of nonprescription sunscreen active ingredients 7#a7 ,applicability of section #eje;,g for pending submissions 7,a7 ,in general ,a sponsor of a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients that1 as of the date of enactment of this ,act1 is subject to a proposed sunscreen order under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 may elect1 by means of giving written notification to the ,secretary of ,health and ,human ,services within #ahj calendar days of the enactment of this ,act1 to transition into the review of such ingredient or combination of ingredients pursuant to the process set out in section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7,b7 ,election exercised ,upon receipt by the ,secretary of ,health and ,human ,services of a timely notification under subparagraph 7,a7-- 7i7 the proposed sunscreen order involved is deemed to be a request for an order under subsection 7b7 of section #eje;,g of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act2 and 7ii7 such order is deemed to have been accepted for filing under subsection 7b77#f77;,a77i7 of such section #eje;,g4 7,c7 ,election not exercised ,if a notification under subparagraph 7,a7 is not received by the ,secretary of ,health and ,human ,services within #ahj calendar days of the date of enactment of this ,act1 the review of the proposed sunscreen order described in subparagraph 7,a7-- 7i7 shall continue under section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c72 and 7ii7 shall not be eligible for review under section #eje;,g1 added by section #ajja of this ,act4 7#b7 ,definitions ,in this subsection1 the terms sponsor1 nonprescription1 sunscreen active ingredient1 and proposed sunscreen order have the meanings given to those terms in section #ehf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff74 7b7 ,amendments to sunscreen provisions 7#a7 ,final sunscreen orders ,paragraph 7#c7 of section #ehf;,c7e7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;e77 is amended to read as follows3 7#c7 ,relationship to orders under section #eje;,g ,a final sunscreen order shall be deemed to be a final order under section #eje;,g4 4 7#b7 ,meetings ,paragraph 7#g7 of section #ehf;,c7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7;b77 is amended-- 7,a7 by striking ,a sponsor may request and inserting the following3 7,a7 ,in general ,a sponsor may request 2 and 7,b7 by adding at the end the following3 7,b7 ,confidential meetings ,a sponsor may request one or more confidential meetings with respect to a proposed sunscreen order1 including a letter deemed to be a proposed sunscreen order under paragraph 7#c71 to discuss matters relating to data requirements to support a general recognition of safety and effectiveness involving confidential information and public information related to such proposed sunscreen order1 as appropriate4 ,the ,secretary shall convene a confidential meeting with such sponsor in a reasonable time period4 ,if a sponsor requests more than one confidential meeting for the same proposed sunscreen order1 the ,secretary may refuse to grant an additional confidential meeting request if the ,secretary determines that such additional confidential meeting is not reasonably necessary for the sponsor to advance its proposed sunscreen order1 or if the request for a confidential meeting fails to include sufficient information upon which to base a substantive discussion4 ,the ,secretary shall publish a post-meeting summary of each confidential meeting under this subparagraph that does not disclose confidential commercial information or trade secrets4 ,this subparagraph does not authorize the disclosure of confidential commercial information or trade secrets subject to #eeb7;b77#d7 of title #e1 ,united ,states ,code1 or section #aije of title #ah1 ,united ,states ,code4 4 7#c7 ,exclusivity ,section #ehf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#c7 is amended by adding at the end the following3 7f7 ,exclusivity 7#a7 ,in general ,a final sunscreen order shall have the effect of authorizing solely the order requestor 7or the licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 for a period of #ah months1 to market a sunscreen ingredient under this section incorporating changes described in paragraph 7#b7 subject to the limitations under paragraph 7#d71 beginning on the date the requestor 7or any licensees1 assignees1 or successors in interest of such requestor with respect to the subject of such request and listed under paragraph 7#e77 may lawfully market such sunscreen ingredient pursuant to the order4 7#b7 ,changes described ,a change described in this paragraph is a change subject to an order specified in paragraph 7#a7 that permits a sunscreen to contain an active sunscreen ingredient not previously incorporated in a marketed sunscreen listed in paragraph 7#c74 7#c7 ,marketed sunscreen ,the marketed sunscreen ingredients described in this paragraph are sunscreen ingredients-- 7,a7 marketed in accordance with a final monograph for sunscreen drug products set forth at part #ceb of title #ba1 ,code of ,federal ,regulations 7as published at #fd ,fed4 ,reg4 #bgfhg72 or 7,b7 marketed in accordance with a final order issued under this section4 7#d7 ,limitations on exclusivity ,only one #ah-month period may be granted per ingredient under paragraph 7#a74 7#e7 ,listing of licensees1 assignees1 or successors in interest ,requestors shall submit to the ,secretary at the time when a drug subject to such request is introduced or delivered for introduction into interstate commerce1 a list of licensees1 assignees1 or successors in interest under paragraph 7#a74 4 7#d7 ,sunset provision ,subchapter ,i of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff et seq47 is amended by adding at the end the following3 #ehf;,h4 ,sunset ,this subchapter shall cease to be effective at the end of fiscal year #bjbb4 4 7#e7 ,treatment of final sunscreen order ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by striking section #ehf;,e of such ,act 7#ba ,u4,s4,c4 #cfj;fff-#e74 7c7 ,treatment of ,authority ,regarding ,finalization of ,sunscreen ,monograph 7#a7 ,in general 7,a7 ,revision of final sunscreen order ,not later than ,november #bf1 #bjai1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall amend and revise the final administrative order concerning nonprescription sunscreen 7referred to in this subsection as the sunscreen order7 for which the content1 prior to the date of enactment of this ,act1 was represented by the final monograph for sunscreen drug products set forth in part #ceb of title #ba1 ,code of ,federal ,regulations 7as in effect on ,may #ba1 #aiii74 7,b7 ,issuance of revised sunscreen order2 effective date ,a revised sunscreen order described in subparagraph 7,a7 shall be-- 7i7 issued in accordance with the procedures described in section #eje;,g7c77#b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 issued in proposed form not later than ,may #bh1 #bjai2 7iii7 effective not later than ,november #bf1 #bjbj2 and 7iv7 issued by the ,secretary at least #a year prior to the effective date of the revised order4 7#b7 ,reports ,if a revised sunscreen order issued under paragraph 7#a7 does not include provisions related to the effectiveness of various sun protection factor levels1 and does not address all dosage forms known to the ,secretary to be used in sunscreens marketed in the ,united ,states without a new drug application approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 the ,secretary shall submit a report to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate on the rationale for omission of such provisions from such order1 and a plan and timeline to compile any information necessary to address such provisions through such order4 7d7 ,treatment of non-,sunscreen time and extent applications 7#a7 ,in general ,any application described in section #ehf;,f of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;fff-#f7 that was submitted to the ,secretary pursuant to section #ccj4ad of title #ba1 ,code of ,federal ,regulations1 as such provisions were in effect immediately prior to the date of enactment date of this ,act1 shall be extinguished as of such date of enactment1 subject to paragraph 7#b74 7#b7 ,order request ,nothing in paragraph 7#a7 precludes the submission of an order request under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act1 with respect to a drug that was the subject of an application extinguished under paragraph 7#a74 #cge4 ,annual update to ,congress on appropriate pediatric indication for certain ,,otc cough and cold drugs 7a7 ,in general ,subject to subsection 7c71 the ,secretary of ,health and ,human ,services shall1 beginning not later than #a year after the date of enactment of this ,act1 annually submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a letter describing the progress of the ,food and ,drug ,administration-- 7#a7 in evaluating the cough and cold monograph described in subsection 7b7 with respect to children under age #f2 and 7#b7 as appropriate1 revising such cough and cold monograph to address such children through the order process under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7b7 ,cough and cold monograph described ,the cough and cold monograph described in this subsection consists of the conditions under which nonprescription drugs containing antitussive1 expectorant1 nasal decongestant1 or antihistamine active ingredients 7or combinations thereof7 are generally recognized as safe and effective1 as specified in part #cda of title #ba1 ,code of ,federal ,regulations 7as in effect immediately prior to the date of enactment of this ,act71 and included in an order deemed to be established under section #eje;,g7b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by section #ajja of this ,act4 7c7 ,duration of authority ,the requirement under subsection 7a7 shall terminate as of the date of a letter submitted by the ,secretary of ,health and ,human ,services pursuant to such subsection in which the ,secretary indicates that the ,food and ,drug ,administration has completed its evaluation and revised1 in a final order1 as applicable1 the cough and cold monograph as described in subsection 7a77#b74 #cgf4 ,technical corrections 7a7 ,imports and exports ,section #hja7;e77#d77;,e77iii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cha7;e77#d77;,e77iii77 is amended by striking subparagraph each place such term appears and inserting paragraph4 7b7 ,,fda ,reauthorization ,act of #bjag 7#a7 ,in general ,section #ije7;b77#d7 of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb7 is amended by striking ,section #gdd;,h7e77#b77;,b7 and inserting ,section #gdd;,h7f77#b77;,b74 7#b7 ,effective date ,the amendment made by paragraph 7#a7 shall take effect as of the enactment of the ,,fda ,reauthorization ,act of #bjag 7,public ,law #aae-eb74 #b ,user ,fees #cha4 ,short title2 finding 7a7 ,short title ,this part may be cited as the ,over-the-,counter ,monograph ,user ,fee ,act of #bjai4 7b7 ,finding ,the ,congress finds that the fees authorized by the amendments made in this part will be dedicated to ,,otc monograph drug activities1 as set forth in the goals identified for purposes of part #aj of subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 in the letters from the ,secretary of ,health and ,human ,services to the ,chairman of the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,chairman of the ,committee on ,energy and ,commerce of the ,house of ,representatives1 as set forth in the ,congressional ,record4 #chb4 ,fees relating to over-the-counter drugs ,subchapter ,c of chapter ,,vii of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;f et seq47 is amended by inserting after part #i the following3 #aj ,fees ,relating to ,over-the-,counter ,drugs #gdd,l4 ,definitions ,in this part3 7#a7 ,the term affiliate means a business entity that has a relationship with a second business entity if1 directly or indirectly-- 7,a7 one business entity controls1 or has the power to control1 the other business entity2 or 7,b7 a third party controls1 or has power to control1 both of the business entities4 7#b7 ,the term contract manufacturing organization facility means an ,,otc monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the ,,otc monograph drug produced at such facility directly to wholesalers1 retailers1 or consumers in the ,united ,states4 7#c7 ,the term costs of resources allocated for ,,otc monograph drug activities means the expenses in connection with ,,otc monograph drug activities for-- 7,a7 officers and employees of the ,food and ,drug ,administration1 contractors of the ,food and ,drug ,administration1 advisory committees1 and costs related to such officers1 employees1 and committees and costs related to contracts with such contractors2 7,b7 management of information1 and the acquisition1 maintenance1 and repair of computer resources2 7,c7 leasing1 maintenance1 renovation1 and repair of facilities and acquisition1 maintenance1 and repair of fixtures1 furniture1 scientific equipment1 and other necessary materials and supplies2 and 7,d7 collecting fees under section #gdd,m and accounting for resources allocated for ,,otc monograph drug activities4 7#d7 ,the term ,,fda establishment identifier is the unique number automatically generated by ,food and ,drug ,administration's ,field ,accomplishments and ,compliance ,tracking ,system 7,,facts7 7or any successor system74 7#e7 ,the term ,,otc monograph drug means a nonprescription drug without an approved new drug application which is governed by the provisions of section #eje;,g4 7#f7 ,the term ,,otc monograph drug activities means activities of the ,secretary associated with ,,otc monograph drugs and inspection of facilities associated with such products1 including the following activities3 7,a7 ,the activities necessary for review and evaluation of ,,otc monographs and ,,otc monograph order requests1 including-- 7i7 orders proposing or finalizing applicable conditions of use for ,,otc monograph drugs2 7ii7 orders affecting status regarding general recognition of safety and effectiveness of an ,,otc monograph ingredient or combination of ingredients under specified conditions of use2 7iii7 all ,,otc monograph drug development and review activities1 including intra-agency collaboration2 7iv7 regulation and policy development activities related to ,,otc monograph drugs2 7v7 development of product standards for products subject to review and evaluation2 7vi7 meetings referred to in section #eje;,g7i72 7vii7 review of labeling prior to issuance of orders related to ,,otc monograph drugs or conditions of use2 and 7viii7 regulatory science activities related to ,,otc monograph drugs4 7,b7 ,inspections related to ,,otc monograph drugs4 7,c7 ,monitoring of clinical and other research conducted in connection with ,,otc monograph drugs4 7,d7 ,safety activities with respect to ,,otc monograph drugs1 including-- 7i7 collecting1 developing1 and reviewing safety information on ,,otc monograph drugs1 including adverse event reports2 7ii7 developing and using improved adverse event data-collection systems1 including information technology systems2 and 7iii7 developing and using improved analytical tools to assess potential safety risks1 including access to external databases4 7,e7 ,other activities necessary for implementation of section #eje;,g4 7#g7 ,the term ,,otc monograph order request means a request for an order submitted under section #eje;,g7b77#e74 7#h7 ,the term ,tier #a ,,otc monograph order request means any ,,otc monograph order request not determined to be a ,tier #b ,,otc monograph order request4 7#i7 7,a7 ,the term ,tier #b ,,otc monograph order request means1 subject to subparagraph 7,b71 an ,,otc monograph order request for-- 7i7 the reordering of existing information in the drug facts label of an ,,otc monograph drug2 7ii7 the addition of information to the other information section of the drug facts label of an ,,otc monograph drug1 as limited by section #bja4ff7;c77#g7 of title #ba1 ,code of ,federal ,regulations 7or any successor regulations72 7iii7 modification to the directions for use section of the drug facts label of an ,,otc monograph drug1 if such changes conform to changes made pursuant to section #eje;,g7c77#c77;,a72 7iv7 the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph2 7v7 a change to ingredient nomenclature to align with nomenclature of a standards-setting organization2 or 7vi7 addition of an interchangeable term in accordance with section #ccj4a of title #ba1 ,code of ,federal ,regulations 7or any successor regulations74 7,b7 ,the ,secretary may1 based on program implementation experience or other factors found appropriate by the ,secretary1 characterize any ,,otc monograph order request as a ,tier #b ,,otc monograph order request 7including recharacterizing a request from ,tier #a to ,tier #b7 and publish such determination in a proposed order issued pursuant to section #eje;,g4 7#aj7 7,a7 ,the term ,,otc monograph drug facility means a foreign or domestic business or other entity that-- 7i7 is-- 7,i7 under one management1 either direct or indirect2 and 7,,ii7 at one geographic location or address engaged in manufacturing or processing the finished dosage form of an ,,otc monograph drug2 7ii7 includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more ,,otc monograph drugs to manufacture or process such drugs2 and 7iii7 does not include a business or other entity whose only manufacturing or processing activities are one or more of the following3 production of clinical research supplies1 testing1 or placement of outer packaging on packages containing multiple products1 for such purposes as creating multipacks1 when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging4 7,b7 ,for purposes of subparagraph 7,a77i77,,ii71 separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are-- 7i7 closely related to the same business enterprise2 7ii7 under the supervision of the same local management2 and 7iii7 under a single ,,fda establishment identifier and capable of being inspected by the ,food and ,drug ,administration during a single inspection4 7,c7 ,if a business or other entity would meet criteria specified in subparagraph 7,a71 but for being under multiple management1 the business or other entity is deemed to constitute multiple facilities1 one per management entity1 for purposes of this paragraph4 7#aa7 ,the term ,,otc monograph drug meeting means any meeting regarding the content of a proposed ,,otc monograph order request4 7#ab7 ,the term person includes an affiliate of a person4 7#ac7 ,the terms requestor and sponsor have the meanings given such terms in section #eje;,g4 #gdd,m4 ,authority to assess and use ,,otc monograph fees 7a7 ,types of fees ,beginning with fiscal year #bjai1 the ,secretary shall assess and collect fees in accordance with this section as follows3 7#a7 ,facility fee 7,a7 ,in general ,each person that owns a facility identified as an ,,otc monograph drug facility on ,december #ca of the fiscal year or at any time during the preceding #ab-month period shall be assessed an annual fee for each such facility as determined under subsection 7c74 7,b7 ,exceptions 7i7 ,a fee shall not be assessed under subparagraph 7,a7 if the identified ,,otc monograph drug facility-- 7,i7 has ceased all activities related to ,,otc monograph drugs prior to ,january #ca1 #bjai1 for the first program year1 and ,december #ca of the fiscal year for subsequent fiscal years2 and 7,,ii7 has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section #eaj4 7ii7 ,the amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an ,,otc monograph drug facility that is not a contract manufacturing organization facility4 7,c7 ,amount ,the amount of fees established under subparagraph 7,a7 shall be established under subsection 7c74 7,d7 ,due date 7i7 ,for first program year ,for fiscal year #bjai1 the facility fees required under subparagraph 7,a7 shall be due #de calendar days after publication of the ,federal ,register notice provided for under subsection 7c77#d77;,a74 7ii7 ,subsequent fiscal years ,for each fiscal year after fiscal year #bjai1 the facility fees required under subparagraph 7,a7 shall be due on the later of-- 7,i7 the first business day of ,june of such year2 or 7,,ii7 the first business day after the enactment of an appropriations ,act providing for the collection and obligation of fees under this section for such year4 7#b7 ,,otc monograph order request fee 7,a7 ,in general ,each person that submits an ,,otc monograph order request shall be subject to a fee for an ,,otc monograph order request4 ,the amount of such fee shall be-- 7i7 for a ,tier #a ,,otc monograph order request1 #ejj1jjj1 adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b772 and 7ii7 for a ,tier #b ,,otc monograph order request1 #ajj1jjj adjusted for inflation for the fiscal year 7as determined under subsection 7c77#a77;,b774 7,b7 ,due date ,the ,,otc monograph order request fees required under subparagraph 7,a7 shall be due on the date of submission of the ,,otc monograph order request4 7,c7 ,exception for certain safety changes ,a person who is named as the requestor in an ,,otc monograph order shall not be subject to a fee under subparagraph 7,a7 if the ,secretary finds that the ,,otc monograph order request seeks to change the drug facts labeling of an ,,otc monograph drug in a way that would add to or strengthen-- 7i7 a contraindication1 warning1 or precaution2 7ii7 a statement about risk associated with misuse or abuse2 or 7iii7 an instruction about dosage and administration that is intended to increase the safe use of the ,,otc monograph drug4 7,d7 ,refund of fee if order request is recategorized as a ,tier #b ,,otc monograph order request ,if the ,secretary determines that an ,,otc monograph request initially characterized as ,tier #a shall be re-characterized as a ,tier #b ,,otc monograph order request1 and the requestor has paid a ,tier #a fee in accordance with subparagraph 7,a77i71 the ,secretary shall refund the requestor the difference between the ,tier #a and ,tier #b fees determined under subparagraphs 7,a77i7 and 7,a77ii71 respectively4 7,e7 ,refund of fee if order request refused for filing or withdrawn before filing ,the ,secretary shall refund #ge percent of the fee paid under subparagraph 7,b7 for any order request which is refused for filing or was withdrawn before being accepted or refused for filing4 7,f7 ,fees for order requests previously refused for filing or withdrawn before filing ,an ,,otc monograph order request that was submitted but was refused for filing1 or was withdrawn before being accepted or refused for filing1 shall be subject to the full fee under subparagraph 7,a7 upon being resubmitted or filed over protest4 7,g7 ,refund of fee if order request withdrawn ,if an order request is withdrawn after the order request was filed1 the ,secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed4 ,the ,secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph4 ,a determination by the ,secretary concerning a refund under this subparagraph shall not be reviewable4 7#c7 ,refunds 7,a7 ,in general ,other than refunds provided pursuant to any of subparagraphs 7,d7 through 7,g7 of paragraph 7#b71 the ,secretary shall not refund any fee paid under paragraph 7#a7 except as provided in subparagraph 7,b74 7,b7 ,disputes concerning fees ,to qualify for the return of a fee claimed to have been paid in error under paragraph 7#a7 or 7#b71 a person shall submit to the ,secretary a written request justifying such return within #ahj calendar days after such fee was paid4 7#d7 ,notice ,within the timeframe specified in subsection 7c71 the ,secretary shall publish in the ,federal ,register the amount of the fees under paragraph 7#a7 for such fiscal year4 7b7 ,fee revenue amounts 7#a7 ,fiscal year #bjai ,for fiscal year #bjai1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for fiscal year #bjai 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 and 7,c7 additional direct cost adjustments 7as determined under subsection 7c77#c774 7#b7 ,subsequent fiscal years ,for each of the fiscal years #bjbj through #bjbc1 fees under subsection 7a77#a7 shall be established to generate a total facility fee revenue amount equal to the sum of-- 7,a7 the annual base revenue for the fiscal year 7as determined under paragraph 7#c772 7,b7 the dollar amount equal to the inflation adjustment for the fiscal year 7as determined under subsection 7c77#a772 7,c7 the dollar amount equal to the operating reserve adjustment for the fiscal year1 if applicable 7as determined under subsection 7c77#b772 7,d7 additional direct cost adjustments 7as determined under subsection 7c77#c772 and 7,e7 additional dollar amounts for each fiscal year as follows3 7i7 #g1jjj1jjj for fiscal year #bjbj4 7ii7 #f1jjj1jjj for fiscal year #bjba4 7iii7 #g1jjj1jjj for fiscal year #bjbb4 7iv7 #c1jjj1jjj for fiscal year #bjbc4 7#c7 ,annual base revenue ,for purposes of paragraphs 7#a77;,a7 and 7#b77;,a71 the dollar amount of the annual base revenue for a fiscal year shall be-- 7,a7 for fiscal year #bjai1 #h1jjj1jjj2 and 7,b7 for fiscal years #bjbj through #bjbc1 the dollar amount of the total revenue amount established under this subsection for the previous fiscal year1 not including any adjustments made under subsection 7c77#b7 or 7c77#c74 7c7 ,adjustments2 annual fee setting 7#a7 ,inflation adjustment 7,a7 ,in general ,for purposes of subsection 7b77#b77;,b71 the dollar amount of the inflation adjustment to the annual base revenue for fiscal year #bjbj and each subsequent fiscal year shall be equal to the product of-- 7i7 such annual base revenue for the fiscal year under subsection 7b77#b72 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,b7 ,,otc monograph order request fees ,for purposes of subsection 7a77#b71 the dollar amount of the inflation adjustment to the fee for ,,otc monograph order requests for fiscal year #bjbj and each subsequent fiscal year shall be equal to the product of-- 7i7 the applicable fee under subsection 7a77#b7 for the preceding fiscal year2 and 7ii7 the inflation adjustment percentage under subparagraph 7,c74 7,c7 ,inflation adjustment percentage ,the inflation adjustment percentage under this subparagraph for a fiscal year is equal to-- 7i7 for each of fiscal years #bjbj and #bjba1 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data2 and 7ii7 for each of fiscal years #bjbb and #bjbc1 the sum of-- 7,i7 the average annual percent change in the cost1 per full-time equivalent position of the ,food and ,drug ,administration1 of all personnel compensation and benefits paid with respect to such positions for the first #c years of the preceding #d fiscal years1 multiplied by the proportion of personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years2 and 7,,ii7 the average annual percent change that occurred in the ,consumer ,price ,index for urban consumers 7,washington-,baltimore1 ,,dc-,,md-,,va-,,wv2 ,not ,seasonally ,adjusted2 ,all items2 ,annual ,index7 for the first #c years of the preceding #d years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of ,,otc monograph drug activities for the first #c years of the preceding #d fiscal years4 7#b7 ,operating reserve adjustment 7,a7 ,in general ,for fiscal year #bjai and subsequent fiscal years1 for purposes of subsections 7b77#a77;,b7 and 7b77#b77;,c71 the ,secretary may1 in addition to adjustments under paragraph 7#a71 further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for ,,otc monograph drug activities for not more than the number of weeks specified in subparagraph 7,b74 7,b7 ,number of weeks ,the number of weeks specified in this subparagraph is-- 7i7 #c weeks for fiscal year #bjai2 7ii7 #g weeks for fiscal year #bjbj2 7iii7 #aj weeks for fiscal year #bjba2 7iv7 #aj weeks for fiscal year #bjbb2 and 7v7 #aj weeks for fiscal year #bjbc4 7,c7 ,decrease ,if the ,secretary has carryover balances for such process in excess of #aj weeks of the operating reserves referred to in subparagraph 7,a71 the ,secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than #aj weeks of such operating reserves4 7,d7 ,rationale for adjustment ,if an adjustment under this paragraph is made1 the rationale for the amount of the increase or decrease 7as applicable7 in fee revenue and fees shall be contained in the annual ,federal ,register notice under paragraph 7#d7 establishing fee revenue and fees for the fiscal year involved4 7#c7 ,additional direct cost adjustment ,the ,secretary shall1 in addition to adjustments under paragraphs 7#a7 and 7#b71 further increase the fee revenue and fees for purposes of subsection 7b77#b77;,d7 by an amount equal to-- 7,a7 #ad1jjj1jjj for fiscal year #bjai2 7,b7 #g1jjj1jjj for fiscal year #bjbj2 7,c7 #d1jjj1jjj for fiscal year #bjba2 7,d7 #c1jjj1jjj for fiscal year #bjbb2 and 7,e7 #c1jjj1jjj for fiscal year #bjbc4 7#d7 ,annual fee setting 7,a7 ,fiscal year #bjai ,the ,secretary shall1 not later than the second ,monday in ,march of #bjai-- 7i7 establish ,,otc monograph drug facility fees for fiscal year #bjai under subsection 7a71 based on the revenue amount for such year under subsection 7b7 and the adjustments provided under this subsection2 and 7ii7 publish fee revenue1 facility fees1 and ,,otc monograph order requests in the ,federal ,register4 7,b7 ,subsequent fiscal years ,the ,secretary shall1 not later than the second ,monday in ,march of each fiscal year that begins after ,september #cj1 #bjai-- 7i7 establish for each such fiscal year1 based on the revenue amounts under subsection 7b7 and the adjustments provided under this subsection-- 7,i7 ,,otc monograph drug facility fees under subsection 7a77#a72 and 7,,ii7 ,,otc monograph order request fees under subsection 7a77#b72 and 7ii7 publish such fee revenue amounts1 facility fees1 and ,,otc monograph order request fees in the ,federal ,register4 7d7 ,identification of facilities ,each person that owns an ,,otc monograph drug facility shall submit to the ,secretary the information required under this subsection each year4 ,such information shall1 for each fiscal year-- 7#a7 be submitted as part of the requirements for drug establishment registration set forth in section #eaj2 and 7#b7 include for each such facility1 at a minimum1 identification of the facility's business operation as that of an ,,otc monograph drug facility4 7e7 ,effect of failure ,to pay fees 7#a7 ,,otc ,monograph ,drug ,facility ,fee 7,a7 ,in general ,failure to pay the fee under subsection 7a77#a7 within #bj calendar days of the due date as specified in subparagraph 7,d7 of such subsection shall result in the following3 7i7 ,the ,secretary shall place the facility on a publicly available arrears list4 7ii7 ,all ,,otc monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section #ejb7;ff74 7,b7 ,application of penalties ,the penalties under this paragraph shall apply until the fee established by subsection 7a77#a7 is paid4 7#b7 ,order requests ,an ,,otc monograph order request submitted by a person subject to fees under subsection 7a7 shall be considered incomplete and shall not be accepted for filing by the ,secretary until all fees owed by such person under this section have been paid4 7#c7 ,meetings ,a person subject to fees under this section shall be considered ineligible for ,,otc monograph drug meetings until all such fees owed by such person have been paid4 7f7 ,crediting and availability of fees 7#a7 ,in general ,fees authorized under subsection 7a7 shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations ,acts4 ,such fees are authorized to remain available until expended4 ,such sums as may be necessary may be transferred from the ,food and ,drug ,administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation4 ,the sums transferred shall be available solely for ,,otc monograph drug activities4 7#b7 ,collections and appropriation ,acts 7,a7 ,in general ,subject to subparagraph 7,c71 the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation ,acts1 or otherwise made available for obligation1 for such fiscal year4 7,b7 ,use of fees and limitation ,the fees authorized by this section shall be available to defray increases in the costs of the resources allocated for ,,otc monograph drug activities 7including increases in such costs for an additional number of full-time equivalent positions in the ,department of ,health and ,human ,services to be engaged in such activities71 only if the ,secretary allocates for such purpose an amount for such fiscal year 7excluding amounts from fees collected under this section7 no less than #ab1jjj1jjj1 multiplied by the adjustment factor applicable to the fiscal year involved under subsection 7c77#a74 7,c7 ,compliance ,the ,secretary shall be considered to have met the requirements of subparagraph 7,b7 in any fiscal year if the costs funded by appropriations and allocated for ,,otc monograph drug activities are not more than #ae percent below the level specified in such subparagraph4 7,d7 ,provision for early payments in subsequent years ,payment of fees authorized under this section for a fiscal year 7after fiscal year #bjai71 prior to the due date for such fees1 may be accepted by the ,secretary in accordance with authority provided in advance in a prior year appropriations ,act4 7#c7 ,authorization of appropriations ,for each of the fiscal years #bjai through #bjbc1 there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section4 7g7 ,collection of unpaid fees ,in any case where the ,secretary does not receive payment of a fee assessed under subsection 7a7 within #cj calendar days after it is due1 such fee shall be treated as a claim of the ,united ,states ,government subject to subchapter ,,ii of chapter #cg of title #ca1 ,united ,states ,code4 7h7 ,construction ,this section may not be construed to require that the number of full-time equivalent positions in the ,department of ,health and ,human ,services1 for officers1 employers1 and advisory committees not engaged in ,,otc monograph drug activities1 be reduced to offset the number of officers1 employees1 and advisory committees so engaged4 #gdd,n4 ,reauthorization2 reporting requirements 7a7 ,performance report ,beginning with fiscal year #bjai1 and not later than #abj calendar days after the end of each fiscal year thereafter for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report concerning the progress of the ,food and ,drug ,administration in achieving the goals identified in the letters described in section #bjja7;b7 of the ,over-the-,counter ,monograph ,safety1 ,innovation1 and ,reform ,act of #bjai during such fiscal year and the future plans of the ,food and ,drug ,administration for meeting such goals4 7b7 ,fiscal report ,not later than #abj calendar days after the end of fiscal year #bjai and each subsequent fiscal year for which fees are collected under this part1 the ,secretary shall prepare and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report on the implementation of the authority for such fees during such fiscal year and the use1 by the ,food and ,drug ,administration1 of the fees collected for such fiscal year4 7c7 ,public availability ,the ,secretary shall make the reports required under subsections 7a7 and 7b7 available to the public on the internet website of the ,food and ,drug ,administration4 7d7 ,reauthorization 7#a7 ,consultation ,in developing recommendations to present to the ,congress with respect to the goals described in subsection 7a71 and plans for meeting the goals1 for ,,otc monograph drug activities for the first #e fiscal years after fiscal year #bjbc1 and for the reauthorization of this part for such fiscal years1 the ,secretary shall consult with-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate2 7,c7 scientific and academic experts2 7,d7 health care professionals2 7,e7 representatives of patient and consumer advocacy groups2 and 7,f7 the regulated industry4 7#b7 ,public review of recommendations ,after negotiations with the regulated industry1 the ,secretary shall-- 7,a7 present the recommendations developed under paragraph 7#a7 to the congressional committees specified in such paragraph2 7,b7 publish such recommendations in the ,federal ,register2 7,c7 provide for a period of #cj calendar days for the public to provide written comments on such recommendations2 7,d7 hold a meeting at which the public may present its views on such recommendations2 and 7,e7 after consideration of such public views and comments1 revise such recommendations as necessary4 7#c7 ,transmittal of recommendations ,not later than ,january #ae1 #bjbc1 the ,secretary shall transmit to the ,congress the revised recommendations under paragraph 7#b71 a summary of the views and comments received under such paragraph1 and any changes made to the recommendations in response to such views and comments4 4 ,i ,other ,provisions #cia4 ,protecting access to biological products ,section #cea7k77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#g77 is amended by adding at the end the following3 7,d7 ,deemed licenses 7i7 ,no additional exclusivity through deeming ,an approved application that is deemed to be a license for a biological product under this section pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji shall not be treated as having been first licensed under subsection 7a7 for purposes of subparagraphs 7,a7 and 7,b74 7ii7 ,application of limitations on exclusivity ,subparagraph 7,c7 shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 7iii7 ,applicability ,the exclusivity periods described in section #ebg1 section #eje;,a7b77#a77;,a77ii71 and section #eje;,a7c77#a77;,a77ii7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection 7a7 pursuant to section #gjjb7;e77#d7 of the ,biologics ,price ,competition and ,innovation ,act of #bjji4 4 #cib4 ,orphan drug clarification ,section #ebg7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;cc7c77 is amended by adding at the end the following3 7#c7 ,applicability ,this subsection applies to any drug designated under section #ebf for which an application was approved under section #eje of this ,act or licensed under section #cea of the ,public ,health ,service ,act after the date of enactment of the ,,fda ,reauthorization ,act of #bjag1 regardless of the date on which such drug was designated under section #ebf4 4 #cic4 ,conditions of use for biosimilar biological products ,section #cea7k77#b77;,a77iii7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k77#b77;,a77iii77 is amended-- 7#a7 in subclause 7,i71 by striking 2 and and inserting a semicolon2 7#b7 in subclause 7,,ii71 by striking the period and inserting 2 and2 and 7#c7 by adding at the end the following3 7,,iii7 may include information to show that the conditions of use prescribed1 recommended1 or suggested in the labeling proposed for the biological product have been previously approved for the reference product4 4 #cid4 ,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 ,provisions #dja4 ,permanent extension of reduction in medical expense deduction floor 7a7 ,in general ,section #bac7;a7 of the ,internal ,revenue ,code of #aihf is amended by striking #aj percent and inserting #g4e percent4 7b7 ,conforming amendments 7#a7 ,section #bac of such ,code is amended by striking subsection 7f74 7#b7 ,section #ef7;b77#a7 of such ,code is amended by striking subparagraph 7,b7 and by redesignating subparagraphs 7,c71 7,d71 7,e71 and 7,f71 as subparagraphs 7,b71 7,c71 7,d71 and 7,e71 respectively4 7c7 ,effective date ,the amendment made by this section shall apply to taxable years ending after ,december #ca1 #bjai4 #djb4 ,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 #djc4 ,inclusion of certain over-the-counter medical products as qualified medical expenses 7a7 ,h,s,as ,section #bbc7;d77#b7 of the ,internal ,revenue ,code of #aihf is amended-- 7#a7 by striking the last sentence of subparagraph 7,a7 and inserting the following3 ,for purposes of this subparagraph1 amounts paid for menstrual care products shall be treated as paid for medical care42 and 7#b7 by adding at the end the following new subparagraph3 7,d7 ,menstrual care product ,for purposes of this paragraph1 the term menstrual care product means a tampon1 pad1 liner1 cup1 sponge1 or similar product used by individuals with respect to menstruation or other genital-tract secretions4 4 7b7 ,archer ,m,s,as ,section #bbj7;d77#b77;,a7 of such ,code is amended by striking the last sentence and inserting the following3 ,for purposes of this subparagraph1 amounts paid for menstrual care products 7as defined in section #bbc7;d77#b77;,d77 shall be treated as paid for medical care44 7c7 ,health flexible spending arrangements and health reimbursement arrangements ,section #ajf of such ,code is amended by striking subsection 7f7 and inserting the following new subsection3 7f7 ,reimbursements for menstrual care products ,for purposes of this section and section #aje1 expenses incurred for menstrual care products 7as defined in section #bbc7;d77#b77;,d77 shall be treated as incurred for medical care4 4 7d7 ,effective dates 7#a7 ,distributions from savings accounts ,the amendment made by subsections 7a7 and 7b7 shall apply to amounts paid after ,december #ca1 #bjai4 7#b7 ,reimbursements ,the amendment made by subsection 7c7 shall apply to expenses incurred after ,december #ca1 #bjai4 ,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 #bjbj1 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 #bjba1 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 #bjba1 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 #eaj4 ,waiving ,medicare coinsurance for colorectal cancer screening tests ,section #ahcc7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77 is amended-- 7#a7 by moving the flush text following paragraph 7#i7 #b ems to the left2 and 7#b7 by adding at the end of such flush text the following new sentence3 ,for items and services furnished on or after ,january #a1 #bjba1 paragraph 7#a77,y7 shall apply with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test1 or for the removal of tissue or other matter or other procedure that is furnished in connection with1 as a result of1 and in the same clinical encounter as the screening test44