,,ii #aafth ,,congress #ast ,session ,s4 #ii ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #aj1 #bjai,mr4 ,sanders 7for himself1 ,mr4 ,booker1 ,mrs4 ,gillibrand1 ,ms4 ,harris1 ,mr4 ,leahy1 ,mr4 ,reed1 ,ms4 ,smith1 and ,ms4 ,warren7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to provide for the negotiation of lower covered part ,d drug prices on behalf of ,medicare beneficiaries and the establishment and application of a formulary by the ,secretary of ,health and ,human ,services under ,medicare part ,d1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,medicare ,drug ,price ,negotiation ,act4 #b4 ,negotiation of lower covered part ,d drug prices on behalf of ,medicare beneficiaries2 ,establishment and application of formulary by the ,secretary of ,health and ,human ,services under ,medicare part ,d 7a7 ,in general ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended by striking subsection 7i7 7relating to noninterference7 and inserting the following3 7i7 ,negotiation of ,lower ,drug ,prices2 establishment and application of formulary 7#a7 ,negotiation 7,a7 ,in general ,notwithstanding any other provision of law1 subject to subparagraph 7,b71 the ,secretary shall1 with respect to an applicable period 7as defined in subparagraph 7,h77-- 7i7 during the negotiation year 7as defined in such subparagraph7 for such period1 negotiate with pharmaceutical manufacturers the prices 7including discounts1 rebates1 and all other price concessions7 that may be charged to ,,pdp sponsors and ,,ma organizations for applicable covered part ,d drugs 7as defined in such subparagraph7 furnished to enrollees during such period2 and 7ii7 complete such negotiations not less than #cj days before the first day of the application review process for the first plan year during the applicable period for new contracts or expanding existing contracts with ,,pdp sponsors and ,,ma organizations to offer prescription drug plans or ,,ma-,,pd plans1 respectively4 7,b7 ,use of fallback if negotiations fail 7i7 ,in general ,if1 after negotiations under subparagraph 7,a7 with respect to an applicable period1 the ,secretary is not successful in obtaining an appropriate price for applicable covered part ,d drugs in accordance with clause 7ii71 the price that may be charged to ,,pdp sponsors and ,,ma organizations for applicable covered part ,d drugs furnished to enrollees during such period shall be the lowest of the following3 7,i7 ,the contract price applied pursuant to section #habf of title #ch1 ,united ,states ,code1 for such drug for the contract year 7as defined in such section #habf74 7,,ii7 ,the average of the prices available1 during the most recent #ab-month period for which data is available from the manufacturer to any wholesaler1 retailer1 provider1 health maintenance organization1 nonprofit entity1 or governmental entity in ,canada1 the ,united ,kingdom1 ,germany1 ,france1 and ,japan4 7,,iii7 ,the best price determined under section #aibg7;c77#a77;,c7 for such drug for the most recent rebate period 7as defined in section #aibg7k77#h77 applicable to such first plan year of the applicable period4 7ii7 ,guidance ,not later than #f months before the ,secretary begins negotiations under subparagraph 7,a7 with respect to the first applicable period1 the ,secretary shall issue guidance on criteria to be considered for purposes of determining under clause 7i7 whether or not the ,secretary is successful in obtaining an appropriate price for an applicable covered part ,d drug4 ,such criteria shall include at least the following3 7,i7 ,the comparative clinical effectiveness and cost effectiveness1 if available1 of such covered part ,d drug4 7,,ii7 ,the budgetary impact of providing coverage under this part for such covered part ,d drug4 7,,iii7 ,the number of similarly effective drug or alternative treatment regimens for each approved use of such covered part ,d drug4 7,,iv7 ,associated unmet need or severity of illness4 7,c7 ,identification of applicable covered part ,d drugs 7i7 ,in general ,the ,secretary shall1 for each applicable period1 in accordance with the subsequent clauses of this subparagraph1 and pursuant to rulemaking1 identify applicable covered part ,d drugs for which negotiations under subparagraph 7,a7 shall be conducted during the negotiation year for such period4 ,in this paragraph1 all such covered part ,d drugs so identified for an applicable period are collectively referred to as applicable covered part ,d drugs with respect to such period4 7ii7 ,identification of prioritized drugs ,in carrying out clause 7i71 except as provided under clause 7iii71 the ,secretary may not identify a covered part ,d drug that is not a drug prioritized pursuant to subparagraph 7,d7 as an applicable covered part ,d drug until all covered part ,d drugs that are so prioritized have been identified as an applicable covered part ,d drug for the applicable period or for a previous applicable period for which the negotiated price of such drug has not expired4 7iii7 ,drug inclusions for price renegotiations ,in the case of a covered part ,d drug that is identified as an applicable covered part ,d drug for an applicable period1 such covered part ,d drug shall be identified as an applicable covered part ,d drug for each subsequent third negotiation year4 7iv7 ,reasonable notification ,the ,secretary shall carry out this subparagraph in such manner as to provide for public notification of applicable covered part ,d drugs for the applicable period within a reasonable period before the beginning of the negotiation year for such period4 7,d7 ,prioritization of certain covered part ,d drugs ,for purposes of subparagraph 7,c77ii71 the ,secretary shall prioritize covered part ,d drugs-- 7i7 that are among-- 7,i7 the #dj covered part ,d drugs that are utilized by at least #a1jjj ,medicare part ,d beneficiaries and with respect to which there were the highest total expenditures under this part during the most recent #ab-month period for which data is available2 7,,ii7 the #dj covered part ,d drugs that are utilized by at least #a1jjj ,medicare part ,d beneficiaries with respect to whom the total annual spending per such a beneficiary under this part for coverage of such a drug is at least #aj1jjj2 or 7,,iii7 the #bj covered part ,d drugs that are utilized by at least #a1jjj ,medicare part ,d beneficiaries and with respect to which there are unit cost increases at or above the #ieth percentile of overall covered part ,d drug unit cost increases during the most recent #ab-month period prior to the beginning of such negotiation year for which data is available2 7ii7 with respect to which the cost of such a drug to the part ,d eligible individual involved would exceed the annual out-of-pocket threshold applicable under section #ahfj;,d-#b7;b77#d77;,b7 for such negotiation year1 if the drug were prescribed to the individual for the period of the year or with respect to which a single treatment regimen is priced above such annual out-of-pocket threshold applicable under such section #ahfj;,d-#b7;b77#d77;,b7 for the year2 or 7iii7 that are single-source drugs or biologicals 7as defined in section #ahdg;,a7c77#f77;,d77 and that satisfy at least one other criterion described in a previous clause of this subparagraph4 7,e7 ,annual report to ,congress ,not later than #cj days after the date on which the ,secretary completes negotiations under this paragraph for the first negotiation year and each year thereafter1 the ,secretary shall submit to ,congress and make available to the public a report describing the negotiations during the preceding negotiation year1 including-- 7i7 the number of applicable covered part ,d drug prices negotiated2 7ii7 the magnitude of savings achieved as a result of such negotiations2 7iii7 the number of times price negotiations failed 7based on the criteria included in the guidance issued pursuant to clause 7ii7 of subparagraph 7,b77 and resulted in the use of fallback prices under clause 7i7 of such subparagraph1 and the rationale for any such decisions2 7iv7 the progress made toward negotiating the prices of covered part ,d drugs that are prioritized under subparagraph 7,d72 and 7v7 the barriers1 if any1 to achieving savings through negotiations4 7,f7 ,,gao report ,not later than ,december #ca1 #bjbd1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the negotiations conducted by the ,secretary under this paragraph1 including a description and analysis of-- 7i7 the extent to which such price negotiations are achieving lower prices for covered part ,d drugs for enrollees2 7ii7 the parties benefitting from such lower prices1 such as enrollees1 the ,federal ,government1 ,states1 prescription drug plans and ,,ma-,,pd plans1 or other entities2 7iii7 how such price negotiations are affecting-- 7,i7 the list price of covered part ,d drugs2 and 7,,ii7 drug prices in the private market2 and 7iv7 recommendations for improving price negotiations1 if applicable4 7,g7 ,definitions ,for purposes of this paragraph3 7i7 ,applicable covered part ,d drugs ,the term applicable covered part ,d drugs means1 for an applicable period1 covered part ,d drugs identified by the ,secretary under subparagraph 7,c7 for such period4 7ii7 ,applicable period ,the term applicable period means1 with respect to a negotiation year and applicable covered part ,d drugs1 the #c-plan year period beginning with the first plan year beginning after the negotiation year for such covered part ,d drugs4 7iii7 ,negotiation year ,the term negotiation year means1 with respect to an applicable period1 a plan year1 beginning with #bjbj1 prior to the first plan year of the applicable period4 7#b7 ,establishment and application of formulary by the ,secretary or changes in formularies to be required by ,secretary 7,a7 ,in general ,the ,secretary shall1 for plan years beginning with plan year #bjbj-- 7i7 subject to subparagraphs 7,b7 and 7,c71 establish and apply a formulary for required use by sponsors of prescription drug plans and organizations offering ,,ma-,,pd plans under this part2 or 7ii7 require changes1 as necessary1 in the covered part ,d drugs included on formularies of ,,pdp sponsors of prescription drug plans 7including changes1 as necessary1 in the preferred or tiered cost-sharing status of such a drug7 to take into account negotiations carried out by the ,secretary pursuant to paragraph 7#a71 regardless of whether such a covered part ,d drug is the subject of such negotiations4 7,b7 ,required inclusion of drugs in all therapeutic categories ,a formulary established and applied under subparagraph 7,a77i7 shall include at least two covered part ,d drugs in each category and class of covered part ,d drugs as described in section #dbc4abj7;b77#b77;i7 of title #db1 ,code of ,federal ,regulations 7as in effect on ,january #a1 #bjag74 7,c7 ,application of development and revision requirements and required inclusion of all drugs in certain categories and classes ,the requirements described in subparagraphs 7,a7 and 7,b7 of section #ahfj;,d-#d7;b77#c7 7relating to development and revision requirements of the formulary7 and subparagraph 7,g7 of such section 7relating to required inclusion of all drugs in certain categories and classes7 shall apply to a formulary established and applied under subparagraph 7,a77i7 of this paragraph4 7#c7 ,plan flexibility to negotiate greater discounts ,nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan1 or an organization offering an ,,ma-,,pd plan1 from obtaining a discount or reduction of the price for a covered part ,d drug below the price negotiated under paragraph 7#a71 if applicable1 including through the use of preferred or tiered cost-sharing status4 7#d7 ,ensuring beneficiary access to needed drugs ,beginning with plan year #bjbj1 each ,,pdp sponsor of a prescription drug plan and organization offering an ,,ma-,,pd plan shall have in place a process under which an enrollee in the plan may request coverage under the plan for a covered part ,d drug that is not on the formulary1 or is subject to utilization management controls1 such as tiered pricing1 prior authorization1 or step therapy4 4 7b7 ,conforming amendments 7#a7 ,in general ,section #ahfj;,d-#d of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7 is amended-- 7,a7 in subsection 7b77#c71 in the matter preceding subparagraph 7,a71 by striking ,if a ,,pdp and inserting ,subject to section #ahfj;,d-#aa7;i77#b71 if a ,,pdp2 7,b7 in subsection 7g7-- 7i7 in paragraph 7#a71 by inserting before the period at the end the following3 1 except that the ,,pdp sponsor of a prescription drug plan shall treat the presentation of a prescription to a participating pharmacy1 which is transmitted to the plan by the pharmacy1 as a request for a coverage determination 7including with respect to prior authorization1 step therapy1 or quantity limits7 and1 in applying such paragraphs of section #aheb7;g71 the response to such transmittal shall be treated as a determination by the sponsor2 and 7ii7 in paragraph 7#b71 in the first sentence1 by inserting 7or a participating pharmacy1 on behalf of such individual1 through transmission of a prescription as described in paragraph 7#a77 after a part ,d eligible individual who is enrolled in the plan2 and 7,c7 in subsection 7h7-- 7i7 in paragraph 7#a71 in the second sentence1 by inserting 7or a participating pharmacy1 on behalf of such individual7 after the part ,d eligible individual2 and 7ii7 in paragraph 7#b71 by inserting 7or a participating pharmacy1 on behalf of such individual7 after ,a part ,d eligible individual who is enrolled in a prescription drug plan offered by a ,,pdp sponsor4 7#b7 ,effective date ,the amendments made by subparagraphs 7,b7 and 7,c7 of paragraph 7#a7 shall apply to plans years beginning on or after ,january #a1 #bjbj4 #c4 ,requiring drug manufacturers to provide drug rebates for drugs dispensed to low-income individuals 7a7 ,in general ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended-- 7#a7 in subsection 7e77#a71 in the matter preceding subparagraph 7,a71 by inserting and subsection 7f7 after this subsection2 and 7#b7 by adding at the end the following new subsection3 7f7 ,prescription drug rebate agreement for rebate eligible individuals 7#a7 ,requirement 7,a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbj1 in this part1 the term covered part ,d drug does not include any drug or biological product that is manufactured by a manufacturer that has not entered into and have in effect a rebate agreement described in paragraph 7#b74 7,b7 #bjbj plan year requirement ,any drug or biological product manufactured by a manufacturer that declines to enter into a rebate agreement described in paragraph 7#b7 for the period beginning on ,january #a1 #bjbj1 and ending on ,december #ca1 #bjbj1 shall not be included as a covered part ,d drug for the subsequent plan year4 7#b7 ,rebate agreement ,a rebate agreement under this subsection shall require the manufacturer to provide to the ,secretary a rebate for each rebate period 7as defined in paragraph 7#f77;,b77 ending after ,december #ca1 #bjai1 in the amount specified in paragraph 7#c7 for any covered part ,d drug of the manufacturer dispensed after ,december #ca1 #bjai1 to any rebate eligible individual 7as defined in paragraph 7#f77;,a77 for which payment was made by a ,,pdp sponsor or ,,ma organization under this part for such period1 including payments passed through the low-income and reinsurance subsidies under sections #ahfj;,d-#ad and #ahfj;,d-#ae7;b71 respectively4 ,such rebate shall be paid by the manufacturer to the ,secretary not later than #cj days after the date of receipt of the information described in section #ahfj;,d-#ab7;b77#h71 including as such section is applied under section #aheg7;f77#c71 or #cj days after the receipt of information under subparagraph 7,d7 of paragraph 7#c71 as determined by the ,secretary4 ,insofar as not inconsistent with this subsection1 the ,secretary shall establish terms and conditions of such agreement relating to compliance1 penalties1 and program evaluations1 investigations1 and audits that are similar to the terms and conditions for rebate agreements under paragraphs 7#c7 and 7#d7 of section #aibg7;b74 7#c7 ,rebate for rebate eligible ,medicare drug plan enrollees 7,a7 ,in general ,the amount of the rebate specified under this paragraph for a manufacturer for a rebate period1 with respect to each dosage form and strength of any covered part ,d drug provided by such manufacturer and dispensed to a rebate eligible individual1 shall be equal to the product of-- 7i7 the total number of units of such dosage form and strength of the drug so provided and dispensed for which payment was made by a ,,pdp sponsor or an ,,ma organization under this part for the rebate period1 including payments passed through the low-income and reinsurance subsidies under sections #ahfj;,d-#ad and #ahfj;,d-#ae7;b71 respectively2 and 7ii7 the amount 7if any7 by which-- 7,i7 the ,medicaid rebate amount 7as defined in subparagraph 7,b77 for such form1 strength1 and period1 exceeds 7,,ii7 the average ,medicare drug program rebate eligible rebate amount 7as defined in subparagraph 7,c77 for such form1 strength1 and period4 7,b7 ,medicaid rebate amount ,for purposes of this paragraph1 the term ,medicaid rebate amount means1 with respect to each dosage form and strength of a covered part ,d drug provided by the manufacturer for a rebate period-- 7i7 in the case of a single source drug or an innovator multiple source drug1 the amount specified in paragraph 7#a77;,a77ii77,,ii7 or 7#b77;,c7 of section #aibg7;c7 plus the amount1 if any1 specified in subparagraph 7,a77ii7 of paragraph 7#b7 of such section1 for such form1 strength1 and period2 or 7ii7 in the case of any other covered outpatient drug1 the amount specified in paragraph 7#c77;,a77i7 of such section for such form1 strength1 and period4 7,c7 ,average ,medicare drug program rebate eligible rebate amount ,for purposes of this subsection1 the term average ,medicare drug program rebate eligible rebate amount means1 with respect to each dosage form and strength of a covered part ,d drug provided by a manufacturer for a rebate period1 the sum1 for all ,,pdp sponsors under part ,d and ,,ma organizations administering an ,,ma-,,pd plan under part ,c1 of-- 7i7 the product1 for each such sponsor or organization1 of-- 7,i7 the sum of all rebates1 discounts1 or other price concessions 7not taking into account any rebate provided under paragraph 7#b7 or any discounts under the program under section #ahfj;,d-#ad;,a7 for such dosage form and strength of the drug dispensed1 calculated on a per-unit basis1 but only to the extent that any such rebate1 discount1 or other price concession applies equally to drugs dispensed to rebate eligible ,medicare drug plan enrollees and drugs dispensed to ,,pdp and ,,ma-,,pd enrollees who are not rebate eligible individuals2 and 7,,ii7 the number of the units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in the prescription drug plans administered by the ,,pdp sponsor or the ,,ma-,,pd plans administered by the ,,ma organization2 divided by 7ii7 the total number of units of such dosage and strength of the drug dispensed during the rebate period to rebate eligible individuals enrolled in all prescription drug plans administered by ,,pdp sponsors and all ,,ma-,,pd plans administered by ,,ma organizations4 7,d7 ,use of estimates ,the ,secretary may establish a methodology for estimating the average ,medicare drug program rebate eligible rebate amounts for each rebate period based on bid and utilization information under this part and may use these estimates as the basis for determining the rebates under this section4 ,if the ,secretary elects to estimate the average ,medicare drug program rebate eligible rebate amounts1 the ,secretary shall establish a reconciliation process for adjusting manufacturer rebate payments not later than #c months after the date that manufacturers receive the information collected under section #ahfj;,d-#ab7;b77#h77;,b74 7#d7 ,length of agreement ,the provisions of paragraph 7#d7 of section #aibg7;b7 7other than clauses 7iv7 and 7v7 of subparagraph 7,b77 shall apply to rebate agreements under this subsection in the same manner as such paragraph applies to a rebate agreement under such section4 7#e7 ,other terms and conditions ,the ,secretary shall establish other terms and conditions of the rebate agreement under this subsection1 including terms and conditions related to compliance1 that are consistent with this subsection4 7#f7 ,definitions ,in this subsection and section #ahfj;,d-#ab7;b77#h73 7,a7 ,rebate eligible individual ,the term rebate eligible individual means-- 7i7 a subsidy eligible individual 7as defined in section #ahfj;,d-#ad7;a77#c77;,a772 7ii7 a ,medicaid beneficiary treated as a subsidy eligible individual under clause 7v7 of section #ahfj;,d-#ad7;a77#c77;,b72 and 7iii7 any part ,d eligible individual not described in clause 7i7 or 7ii7 who is determined for purposes of the ,state plan under title ,,xix to be eligible for medical assistance under clause 7i71 7iii71 or 7iv7 of section #aijb7;a77#aj77;,e74 7,b7 ,rebate period ,the term rebate period has the meaning given such term in section #aibg7k77#h74 4 7b7 ,reporting requirement for the determination and payment of rebates by manufacturers related to rebate for rebate eligible ,medicare drug plan enrollees 7#a7 ,requirements for ,,pdp sponsors ,section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended by adding at the end the following new paragraph3 7#h7 ,reporting requirement for the determination and payment of rebates by manufacturers related ,to rebate for rebate eligible ,medicare drug plan enrollees 7,a7 ,in general ,for purposes of the rebate under section #ahfj;,d-#b7;f7 for contract years beginning on or after ,january #a1 #bjbj1 each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan shall require that the sponsor comply with subparagraphs 7,b7 and 7,c74 7,b7 ,report form and contents ,not later than a date specified by the ,secretary1 a ,,pdp sponsor of a prescription drug plan under this part shall report to each manufacturer-- 7i7 information 7by ,national ,drug ,code number7 on the total number of units of each dosage1 form1 and strength of each drug of such manufacturer dispensed to rebate eligible ,medicare drug plan enrollees under any prescription drug plan operated by the ,,pdp sponsor during the rebate period2 7ii7 information on the price discounts1 price concessions1 and rebates for such drugs for such form1 strength1 and period2 7iii7 information on the extent to which such price discounts1 price concessions1 and rebates apply equally to rebate eligible ,medicare drug plan enrollees and ,,pdp enrollees who are not rebate eligible ,medicare drug plan enrollees2 and 7iv7 any additional information that the ,secretary determines is necessary to enable the ,secretary to calculate the average ,medicare drug program rebate eligible rebate amount 7as defined in paragraph 7#c77;,c7 of such section71 and to determine the amount of the rebate required under this section1 for such form1 strength1 and period4 ,such report shall be in a form consistent with a standard reporting format established by the ,secretary4 7,c7 ,submission to ,secretary ,each ,,pdp sponsor shall promptly transmit a copy of the information reported under subparagraph 7,b7 to the ,secretary for the purpose of audit oversight and evaluation4 7,d7 ,confidentiality of information ,the provisions of subparagraph 7,d7 of section #aibg7;b77#c71 relating to confidentiality of information1 shall apply to information reported by ,,pdp sponsors under this paragraph in the same manner that such provisions apply to information disclosed by manufacturers or wholesalers under such section1 except-- 7i7 that any reference to this section in clause 7i7 of such subparagraph shall be treated as being a reference to this section2 7ii7 the reference to the ,director of the ,congressional ,budget ,office in clause 7iii7 of such subparagraph shall be treated as including a reference to the ,medicare ,payment ,advisory ,commission2 and 7iii7 clause 7iv7 of such subparagraph shall not apply4 7,e7 ,oversight ,information reported under this paragraph may be used by the ,inspector ,general of the ,department of ,health and ,human ,services for the statutorily authorized purposes of audit1 investigation1 and evaluations4 7,f7 ,penalties for failure to provide timely information and provision of false information ,in the case of a ,,pdp sponsor-- 7i7 that fails to provide information required under subparagraph 7,b7 on a timely basis1 the sponsor is subject to a civil money penalty in the amount of #aj1jjj for each day in which such information has not been provided2 or 7ii7 that knowingly 7as defined in section #aabh;,a7i77 provides false information under such subparagraph1 the sponsor 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 ,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 4 7#b7 ,application to ,,ma organizations ,section #aheg7;f77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bg7;f77#c77 is amended by adding at the end the following3 7,e7 ,reporting requirement related to rebate for rebate eligible ,medicare drug plan enrollees ,section #ahfj;,d-#ab7;b77#h74 4 7c7 ,deposit of rebates into ,medicare ,prescription ,drug ,account ,section #ahfj;,d-#af7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaf7;c77 is amended by adding at the end the following new paragraph3 7#f7 ,rebate for rebate eligible ,medicare drug plan enrollees ,amounts paid under a rebate agreement under section #ahfj;,d-#b7;f7 shall be deposited into the ,account4 4 7d7 ,exclusion from determination of best price and average manufacturer price under ,medicaid 7#a7 ,exclusion from best price determination ,section #aibg7;c77#a77;,c77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#a77;,c77ii77,i77 is amended by inserting and amounts paid under a rebate agreement under section #ahfj;,d-#b7;f7 after this section4 7#b7 ,exclusion from average manufacturer price determination ,section #aibg7k77#a77;,b77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77#a77;,b77i77 is amended-- 7,a7 in subclause 7,,iv71 by striking and after the semicolon2 7,b7 in subclause 7,v71 by striking the period at the end and inserting 2 and2 and 7,c7 by adding at the end the following3 7,,vi7 amounts paid under a rebate agreement under section #ahfj;,d-#b7;f74 4