,,ii #aafth ,,congress #ast ,session ,s4 #cabi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ai1 #bjai,mr4 ,crapo 7for himself1 ,mr4 ,enzi1 ,mr4 ,burr1 ,mr4 ,barrasso1 ,mr4 ,tillis1 and ,mr4 ,risch7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to provide for certain reforms with respect to the ,medicare program under title ,,xviii of the ,social ,security ,act1 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,sec4 #ajf4 ,payment for biosimilar biological products during initial period4,sec4 #ajg4 ,education on biological and biosimilar products4,sec4 #ajh4 ,,gao study and report on average sales price4,subtitle ,b--,medicare ,part ,d ,provisions,sec4 #aaa4 ,medicare part ,d benefit redesign4,sec4 #aab4 ,transitional coverage and retroactive ,medicare part ,d coverage for certain low-income beneficiaries4,sec4 #aac4 ,allowing the offering of additional prescription drug plans under ,medicare part ,d4,sec4 #aad4 ,allowing certain enrollees of prescription drug plans and ,,ma-,,pd plans under the ,medicare program to spread out cost-sharing under certain circumstances4,sec4 #aae4 ,establishing a monthly cap on beneficiary incurred costs for insulin products and supplies under a prescription drug plan or ,,ma-,,pd plan4,sec4 #aaf4 ,growth rate of ,medicare part ,d out-of-pocket cost threshold4,sec4 #aag4 ,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 #aah4 ,requiring prescription drug plans and ,,ma-,,pd plans to report potential fraud1 waste1 and abuse to the ,secretary of ,,hhs4,sec4 #aai4 ,establishment of pharmacy quality measures under ,medicare part ,d4,,title ,,ii--,drug ,price ,transparency,sec4 #bja4 ,reporting on explanation for drug price increases4,sec4 #bjb4 ,public disclosure of drug discounts4,sec4 #bjc4 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program4,sec4 #bjd4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities4,sec4 #bje4 ,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,sec4 #bjf4 ,sense of the ,senate regarding the need to expand commercially available drug pricing comparison platforms4,,title ,,iii--,revenue ,provisions,sec4 #cja4 ,permanent extension of reduction in medical expense deduction floor4,sec4 #cjb4 ,safe harbor for high deductible health plans without deductible for insulin4,sec4 #cjc4 ,inclusion of certain over-the-counter medical products as qualified medical expenses4,,title ,,iv--,miscellaneous,sec4 #dja4 ,improving coordination between the ,food and ,drug ,administration and the ,centers for ,medicare ,medicaid ,services4,sec4 #djb4 ,patient consultation in ,medicare national and local coverage determinations in order to mitigate barriers to inclusion of such perspectives4,sec4 #djc4 ,med,p,a,c report on shifting coverage of certain ,medicare part ,b drugs to ,medicare part ,d4,sec4 #djd4 ,requirement that direct-to-consumer advertisements for prescription drugs and biological products include truthful and non-misleading pricing information4,sec4 #dje4 ,chief ,pharmaceutical ,negotiator at the ,office of the ,united ,states ,trade ,representative4 ,i ,medicare ,parts ,b and ,d ,a ,medicare ,part ,b ,provisions #aja4 ,improvements to ,medicare site-of-service transparency ,section #ahcd7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7t77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in the heading1 by striking ,in general and inserting ,site payment2 7,b7 in the matter preceding subparagraph 7,a7-- 7i7 by striking or to and inserting 1 to2 7ii7 by inserting 1 or to a physician for services furnished in a physician's office after surgical center under this title2 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 clause 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 arrange 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 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 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 or allogeneric 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 or allogeneric 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 ,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 #ajf4 ,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 #ajg4 ,education on biological and biosimilar products 7a7 ,in ,general ,the ,secretary of ,health and ,human ,services 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 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 #ajg7;a7 of the ,lower ,costs1 ,more ,cures ,act of #bjai 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 #ajh4 ,,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 ,b ,medicare ,part ,d ,provisions #aaa4 ,medicare part ,d benefit redesign 7a7 ,benefit structure redesign ,section #ahfj;,d-#b7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a7-- 7i7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb and for costs above the annual deductible specified in paragraph 7#a7 and up to the annual out-of-pocket threshold specified in paragraph 7#d77;,b7 for #bjbb and each subsequent year after paragraph 7#c72 7ii7 in clause 7i71 by inserting after #be percent the following3 7or1 for #bjbb and each subsequent year1 #ae percent72 and 7iii7 in clause 7ii71 by inserting 7or1 for #bjbb and each subsequent year1 #ae percent7 after #be percent2 7,b7 in subparagraph 7,c7-- 7i7 in clause 7i71 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7ii7 in clause 7ii77,,iii71 by striking and each subsequent year and inserting and #bjba2 and 7,c7 in subparagraph 7,d7-- 7i7 in clause 7i7-- 7,i7 in the matter preceding subclause 7,i71 by inserting for a year preceding #bjbb1 after paragraph 7#d712 and 7,,ii7 in subclause 7,i77bb71 by striking a year after #bjah and inserting each of years #bjah through #bjba2 and 7ii7 in clause 7ii77,v71 by striking #bjai and each subsequent year and inserting each of years #bjai through #bjba2 7#b7 in paragraph 7#c77;,a7-- 7,a7 in the matter preceding clause 7i71 by inserting for a year preceding #bjbb1 after and 7#d712 and 7,b7 in clause 7ii71 by striking for a subsequent year and inserting for each of years #bjjg through #bjba2 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 one 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 7#d7 ,clarification regarding exclusion of manufacturer discounts from ,tr,o,o,p ,section #ahfj;,d-#b7;b77#d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;b77#d77 is amended-- 7,a7 in subparagraph 7,c71 by inserting and subject to subparagraph 7,f7 after subparagraph 7,e72 and 7,b7 by adding at the end the following new subparagraph3 7,f7 ,clarification regarding exclusion of manufacturer discounts ,in applying subparagraph 7,a71 incurred costs shall not include any manufacturer discounts provided under section #ahfj;,d-#ad;,b4 4 7d7 ,determination of allowable reinsurance costs ,section #ahfj;,d-#ae7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;b77 is amended-- 7#a7 in paragraph 7#b7-- 7,a7 by striking ,costs4--,for purposes and inserting ,costs4-- 7,a7 ,in general ,subject to subparagraph 7,b71 for purposes 2 and 7,b7 by adding at the end the following new subparagraph3 7,b7 ,inclusion of manufacturer discounts on applicable drugs ,for purposes of applying subparagraph 7,a71 the term allowable reinsurance costs shall include the portion of the negotiated price 7as defined in section #ahfj;,d-#ad;,b7g77#f77 of an applicable drug 7as defined in section #ahfj;,d-#ad7;g77#b77 that was paid by a manufacturer under the manufacturer discount program under section #ahfj;,d-#ad;,b4 2 and 7#b7 in paragraph 7#c7-- 7,a7 in the first sentence1 by striking ,for purposes and inserting ,subject to paragraph 7#b77;,b71 for purposes2 and 7,b7 in the second sentence1 by inserting or1 in the case of an applicable drug1 by a manufacturer after by the individual or under the plan4 7e7 ,updating risk adjustment methodologies ,to account for part ,d modernization redesign ,section #ahfj;,d-#ae7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aae7;c77 is amended by adding at the end the following new paragraph3 7#c7 ,updating risk adjustment methodologies to account for part ,d modernization redesign ,the ,secretary shall update the risk adjustment model used to adjust bid amounts pursuant to this subsection as appropriate to take into account changes in benefits under this part pursuant to the amendments made by section #aba of the ,lower ,costs1 ,more ,cures ,act of #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 #aab4 ,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-- 7i7 begins on the date that is the later of-- 7,i7 the date that such individual was first eligible for a low-income subsidy under this part2 or 7,,ii7 the date that is #cf months prior to the date such individual enrolls in a prescription drug plan or ,,ma-,,pd plan2 and 7ii7 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 7dissemination 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 7development and revision by a pharmacy and therapeutic committee2 formulary development74 7iii7 ,paragraphs 7#a77;,c7 and 7#b7 of section #ahfj;,d-#d7;c7 7medication 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 #aac4 ,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 #aad4 ,allowing certain enrollees of prescription drug plans and ,,ma-,,pd plans under the ,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 #aaa1 is 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 shall 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 #aae4 ,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 #aaa and #aad1 is 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 #aaa1 is 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 #aaf4 ,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 #aag4 ,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 of 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 #aah4 ,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 #aai4 ,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 ,,ii ,drug ,price ,transparency #bja4 ,reporting on explanation for drug price increases 7a7 ,in general ,title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acja et seq47 is amended by inserting after section #aabh,k the following new section3 #aabh,l4 ,drug price reporting 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 the ,public ,health ,service ,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 or under a ,state ,medicaid plan under title ,,xix 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;,b74 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 the ,public ,health ,service ,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 the ,public ,health ,service ,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 the ,public ,health ,service ,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 the ,public ,health ,service ,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 the ,public ,health ,service ,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 #cea of the ,public ,health ,service ,act1 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 7h7 ,annual report to ,congress 7#a7 ,in ,general ,subject to paragraph 7#b71 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 this section2 7,b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to this section2 7,c7 detailing the costs and expenditures incurred by the ,department of ,health and ,human ,services in carrying out this section2 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 7#b7 ,protected information ,nothing in this subsection 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 shall take effect on the date of enactment of this ,act4 #bjb4 ,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 #bjc4 ,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 #bjd4 ,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 #bje4 ,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 sponsor or an ,,ma-,,pd plan offered by an ,,ma organization3 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 plan or such ,,ma-,,pd plan4 7,b7 ,information submitted with the bid submitted under section #ahfj;,d-#aa by such ,,pdp sponsor or section #ahed by such ,,ma organization4 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 #bjf4 ,sense of the ,senate regarding the need to expand commercially available drug pricing comparison platforms ,it is the sense of the ,senate 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 ,,iii ,revenue ,provisions #cja4 ,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 #bjah4 #cjb4 ,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 #cjc4 ,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 ,,iv ,miscellaneous #dja4 ,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 #djb4 ,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 #djc4 ,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 #djd4 ,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 #dje4 ,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 #a-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