,,ii #aafth ,,congress #ast ,session ,s4 #cgg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,february #g1 #bjai,mr4 ,brown 7for himself1 ,ms4 ,baldwin1 and ,ms4 ,klobuchar7 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 require the ,secretary of ,health and ,human ,services to negotiate prices of prescription drugs furnished under part ,d of the ,medicare program4 #a4 ,short title ,this ,act may be cited as the ,medicare ,negotiation and ,competitive ,licensing ,act of #bjai4 #b4 ,requiring the ,secretary of ,health and ,human ,services to negotiate prices of prescription drugs furnished under part ,d of the ,medicare program ,section #ahfj;,d-#aa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aaa7 is amended by striking subsection 7i7 and inserting the following new subsection3 7i7 ,negotiation of lower drug prices 7#a7 ,in general ,notwithstanding any other provision of law1 the ,secretary shall1 for plan years beginning on or after the date of the enactment of this subsection1 negotiate with pharmaceutical manufacturers the prices 7including discounts1 rebates1 and other price concessions7 that may be charged to ,,pdp sponsors and ,,ma organizations during a negotiated price period 7as specified by the ,secretary7 for covered part ,d drugs for part ,d eligible individuals who are enrolled under a prescription drug plan or under an ,,ma-,,pd plan4 ,in negotiating such prices under this section1 the ,secretary shall take into account the following factors3 7,a7 ,the comparative clinical effectiveness and cost effectiveness1 when available from an impartial source1 of such drug4 7,b7 ,the budgetary impact of providing coverage of such drug4 7,c7 ,the number of similarly effective drugs or alternative treatment regimens for each approved use of such drug4 7,d7 ,the associated financial burden on patients that utilize such drug4 7,e7 ,the associated unmet patient need for such drug4 7,f7 ,the total revenues from global sales obtained by the manufacturer for such drug and the associated investment in research and development of such drug by the manufacturer4 7#b7 ,finalization of negotiated price ,the negotiated price of each covered part ,d drug for a negotiated price period shall be finalized not later than #cj days before a ,,pdp sponsor is required to submit information described in subsection 7b77#b7 for the first plan year in such negotiated price period4 7#c7 ,competitive licensing authority 7,a7 ,in general ,notwithstanding any exclusivity under clause 7iii7 or 7iv7 of section #eje7;j77#e77;,f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 clause 7iii7 or 7iv7 of section #eje7;c77#c77;,e7 of such ,act1 section #cea7k77#g77;,a7 of the ,public ,health ,service ,act1 or section #ebg7;a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 or by an extension of such exclusivity under section #eje;,a of such ,act or section #eje;,e of such ,act1 and any other provision of law that provides for market exclusivity 7or extension of market exclusivity7 with respect to a drug1 in the case that the ,secretary is unable to successfully negotiate an appropriate price for a covered part ,d drug for a negotiated price period1 the ,secretary shall authorize the use of any patent1 clinical trial data1 or other exclusivity granted by the ,federal ,government with respect to such drug as the ,secretary determines appropriate for purposes of manufacturing such drug for sale under a prescription drug plan or ,,ma-,,pd plan4 ,any entity making use of a competitive license to use patent1 clinical trial data1 or other exclusivity under this section shall provide to the manufacturer holding such exclusivity reasonable compensation1 as determined by the ,secretary based on the following factors3 7i7 ,the risk-adjusted value of any ,federal ,government subsidies and investments in research and development used to support the development of such drug4 7ii7 ,the risk-adjusted value of any investment made by such manufacturer in the research and development of such drug4 7iii7 ,the impact of the price1 including license compensation payments1 on meeting the medical need of all patients4 7iv7 ,the relationship between the price of such drug1 including compensation payments1 and the health benefits of such drug4 7v7 ,other relevant factors determined appropriate by the ,secretary to provide reasonable compensation4 7,b7 ,reasonable compensation ,the manufacturer described in subparagraph 7,a7 may seek recovery against the ,united ,states in the ,united ,states ,court of ,federal ,claims4 7,c7 ,interim period 7i7 ,in general ,until #a year after a drug described in subparagraph 7,a7 is approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7k7 of the ,public ,health ,service ,act and is provided under license issued by the ,secretary under such subparagraph1 ,,pdp plans and ,,ma-,,pd plans shall not pay more for such drug than the average of the prices available1 during the most recent #ab-month period for which data is available prior to the beginning of such negotiated price period1 from the manufacturer to any wholesaler1 retailer1 provider1 health maintenance organization1 nonprofit entity1 or governmental entity in the ten ,,oecd 7,organization for ,economic ,cooperation and ,development7 countries that have the largest gross domestic product with a per capita income that is not less than half the per capita income of the ,united ,states1 as reported by the manufacturer to the ,secretary4 7ii7 ,federal program licensing ,if such drug is not made available at the price determined1 the ,secretary shall authorize such entities to use any patent1 clinical trial data1 or other exclusivity granted by the ,federal ,government with respect to such drug as the ,secretary determines appropriate for purposes of manufacturing such drug for sale under any ,federal program1 including those provided by ,medicare1 ,medicaid1 ,veterans ,affairs1 the ,department of ,defense1 and the ,coast ,guard4 7,d7 ,authorization for secretary to procure drugs directly 7i7 ,in general ,the ,secretary may procure a drug manufactured pursuant to a competitive license under subparagraph 7,a7 for purposes of this part or pursuant to a ,federal program license under subparagraph 7,c77ii7 for purposes of a ,federal program directly from the entity manufacturing the drug pursuant to such a license4 7ii7 ,clarification regarding application of ,buy ,american ,act ,in the case where the ,secretary procures a drug under this subparagraph1 the provisions of chapter #hc of title #da1 ,united ,states ,code 7commonly referred to as the ,buy ,american ,act7 shall apply4 7,e7 ,priority for ,u4,s4 manufacturers in authorizing competitive licenses ,in authorizing a competitive license under this paragraph1 the ,secretary-- 7i7 shall give preference to entities that the ,secretary determines have the highest safety and security standards2 and 7ii7 may give priority to entities that will manufacture such drug in the ,united ,states4 7#d7 ,,fda review of licensed drug applications ,the ,secretary shall prioritize review of applications under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act for drugs licensed under paragraph 7#c77;,a74 7#e7 ,prohibition of anticompetitive behavior ,no drug manufacturer may engage in anticompetitive behavior with another manufacturer that may interfere with the issuance and implementation of a competitive license or run contrary to public policy4 7#f7 ,required reporting ,the ,secretary may require drug manufacturers to disclose to the ,secretary such information that the ,secretary determines necessary for purposes of carrying out this subsection4 7#g7 ,clarification ,nothing in this subsection shall be construed as preventing the sponsor of a prescription drug plan or an organization offering an ,,ma-,,pd plan from obtaining a discount or reduction of the price for a covered part ,d drug below the price negotiated by the ,secretary4 4