,i #aafth ,,congress #ast ,session ,h4 ,r4 #cidg ,,in ,,the ,,house ,,of ,,representatives ,july #bd1 #bjai,mr4 ,meadows introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 the ,judiciary1 ,armed ,services1 and ,oversight and ,reform1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to lower the cost of prescription drugs1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,competition ,prescription ,act of #bjai4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,,eliminating ,,delays ,,of ,,generic ,,drugs ,,and ,,biosimilar ,,products ,sec4 #aja4 ,actions for delays of generic drugs and biosimilar biological products4 ,sec4 #ajb4 ,,rems approval process for subsequent filers4 ,title ,,ii--,,increasing ,,access ,,to ,,drugs ,,and ,,biosimilar ,,products ,sec4 #bja4 ,expedited development and priority review for generic complex drug products4 ,sec4 #bjb4 ,increasing pharmaceutical options to treat an unmet medical need4 ,sec4 #bjc4 ,preemption of ,state barriers to the substitution of biosimilar products4 ,sec4 #bjd4 ,expedited process for biological products authorized for marketing in ,european ,union4 ,title ,,iii--,,prescription ,,drug ,,pricing ,,and ,,competition ,sec4 #cja4 ,medicare drug coverage4 ,sec4 #cjb4 ,fee transparency between pharmacies and ,p,b,ms4 ,sec4 #cjc4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs4 ,sec4 #cjd4 ,regulation of manufacturer-sponsored copay contributions4 ,title ,,iv--,,patent ,,disclosure ,,requirements ,sec4 #dja4 ,patent disclosure and transparency requirements4 ,sec4 #djb4 ,antitrust exemption for health insurance issuers to negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers4 ,sec4 #djc4 ,fair treatment of ,medicare part ,b billing codes for the prescribing of biosimilars4 ,title ,v--,,fixing ,,global ,,freeloading ,sec4 #eja4 ,chief ,pharmaceutical ,negotiator in the ,office of the ,united ,states ,trade ,representative4 ,i ,,eliminating ,,delays ,,of ,,generic ,,drugs ,,and ,,biosimilar ,,products #aja4 ,actions for delays of generic drugs and biosimilar biological products 7a7 ,definitions ,in this section-- 7#a7 the term commercially reasonable1 market-based terms means-- 7,a7 a nondiscriminatory price for the sale of the covered product at or below1 but not greater than1 the most recent wholesale acquisition cost for the drug1 as defined in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b772 7,b7 a schedule for delivery that results in the transfer of the covered product to the eligible product developer consistent with the timing under subsection 7b77#b77;,a77iv72 and 7,c7 no additional conditions are imposed on the sale of the covered product2 7#b7 the term covered product-- 7,a7 means-- 7i7 any drug approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or biological product licensed under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7ii7 any combination of a drug or biological product described in clause 7i72 or 7iii7 when reasonably necessary to support approval of an application under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as applicable1 or otherwise meet the requirements for approval under either such section1 any product1 including any device1 that is marketed or intended for use with such a drug or biological product2 and 7,b7 does not include any drug or biological product that appears on the drug shortage list in effect under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e71 unless-- 7i7 the drug or biological product has been on the drug shortage list in effect under such section #ejf;,e continuously for more than #f months2 or 7ii7 the ,secretary determines that inclusion of the drug or biological product as a covered product is likely to contribute to alleviating or preventing a shortage2 7#c7 the term device has the meaning given the term in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba72 7#d7 the term eligible product developer means a person that seeks to develop a product for approval pursuant to an application for approval under subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or for licensing pursuant to an application under section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 7#e7 the term license holder means the holder of an application approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or the holder of a license under subsection 7a7 or 7k7 of section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 for a covered product2 7#f7 the term ,,rems means a risk evaluation and mitigation strategy under section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a72 7#g7 the term ,,rems with ,,etasu means a ,,rems that contains elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 7#h7 the term ,secretary means the ,secretary of ,health and ,human ,services2 7#i7 the term single1 shared system of elements to assure safe use means a single1 shared system of elements to assure safe use under section #eje-a7;f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7;f772 and 7#aj7 the term sufficient quantities means an amount of a covered product that the eligible product developer determines allows it to-- 7,a7 conduct testing to support an application under-- 7i7 subsection 7b77#b7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee72 or 7ii7 section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k772 and 7,b7 fulfill any regulatory requirements relating to approval of such an application4 7b7 ,civil action for failure ,to provide sufficient quantities of a covered product 7#a7 ,in general ,an eligible product developer may bring a civil action against the license holder for a covered product seeking relief under this subsection in an appropriate district court of the ,united ,states alleging that the license holder has declined to provide sufficient quantities of the covered product to the eligible product developer on commercially reasonable1 market-based terms4 7#b7 ,elements 7,a7 ,in general ,to prevail in a civil action brought under paragraph 7#a71 an eligible product developer shall prove1 by a preponderance of the evidence-- 7i7 that-- 7,i7 the covered product is not subject to a ,,rems with ,,etasu2 or 7,,ii7 if the covered product is subject to a ,,rems with ,,etasu-- 7aa7 the eligible product developer has obtained a covered product authorization from the ,secretary in accordance with subparagraph 7,b72 and 7bb7 the eligible product developer has provided a copy of the covered product authorization to the license holder2 7ii7 that1 as of the date on which the civil action is filed1 the product developer has not obtained sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7iii7 that the eligible product developer has requested to purchase sufficient quantities of the covered product from the license holder2 and 7iv7 that the license holder has not delivered to the eligible product developer sufficient quantities of the covered product on commercially reasonable1 market-based terms-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ca days after the date on which the license holder received the request for the covered product2 and 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by #ca days after the later of-- 7aa7 the date on which the license holder received the request for the covered product2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with subparagraph 7,b74 7,b7 ,authorization for covered product subject to a ,,rems with ,,etasu 7i7 ,request ,an eligible product developer may submit to the ,secretary a written request for the eligible product developer to be authorized to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu4 7ii7 ,authorization ,not later than #abj days after the date on which a request under clause 7i7 is received1 the ,secretary shall1 by written notice1 authorize the eligible product developer to obtain sufficient quantities of an individual covered product subject to a ,,rems with ,,etasu for purposes of-- 7,i7 development and testing that does not involve human clinical trials1 if the eligible product developer has agreed to comply with any conditions the ,secretary determines necessary2 or 7,,ii7 development and testing that involves human clinical trials1 if the eligible product developer has-- 7aa7 7,,aa7 submitted protocols1 informed consent documents1 and informational materials for testing that include protections that provide safety protections comparable to those provided by the ,,rems for the covered product2 or 7,,bb7 otherwise satisfied the ,secretary that such protections will be provided2 and 7bb7 met any other requirements the ,secretary may establish4 7iii7 ,notice ,a covered product authorization issued under this subparagraph shall state that the provision of the covered product by the license holder under the terms of the authorization will not be a violation of the ,,rems for the covered product4 7#c7 ,affirmative defense ,in a civil action brought under paragraph 7#a71 it shall be an affirmative defense1 on which the defendant has the burden of persuasion by a preponderance of the evidence-- 7,a7 that1 on the date on which the eligible product developer requested to purchase sufficient quantities of the covered product from the license holder-- 7i7 neither the license holder nor any of its agents1 wholesalers1 or distributors was engaged in the manufacturing or commercial marketing of the covered product2 and 7ii7 neither the license holder nor any of its agents1 wholesalers1 or distributors otherwise had access to inventory of the covered product to supply to the eligible product developer on commercially reasonable1 market-based terms2 7,b7 that-- 7i7 the license holder sells the covered product through agents1 distributors1 or wholesalers2 7ii7 the license holder has placed no restrictions1 explicit or implicit1 on its agents1 distributors1 or wholesalers to sell covered products to eligible product developers2 and 7iii7 the covered product can be purchased by the eligible product developer in sufficient quantities on commercially reasonable1 market-based terms from the agents1 distributors1 or wholesalers of the license holder2 or 7,c7 that the license holder made an offer to sell sufficient quantities of the covered product to the eligible product developer at commercially reasonable market-based terms-- 7i7 for a covered product that is not subject to a ,,rems with ,,etasu1 by the date that is #ad days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #g days after the date on which the eligible product developer received such offer from the license holder2 or 7ii7 for a covered product that is subject to a ,,rems with ,,etasu1 by the date that is #bj days after the date on which the license holder received the request for the covered product1 and the eligible product developer did not accept such offer by the date that is #aj days after the date on which the eligible product developer received such offer from the license holder4 7#d7 ,methods for transmission of requests for covered products ,a written request for a covered product1 offer to sell a covered product1 or acceptance of such an offer between the eligible product developer and the license holder shall be made by-- 7,a7 certified or registered mail with return receipt requested2 7,b7 personal delivery2 or 7,c7 electronic means4 7#e7 ,remedies 7,a7 ,in general ,if an eligible product developer prevails in a civil action brought under paragraph 7#a71 the court shall-- 7i7 order the license holder to provide to the eligible product developer without delay sufficient quantities of the covered product on commercially reasonable1 market-based terms2 7ii7 award to the eligible product developer reasonable attorney's fees and costs of the civil action2 and 7iii7 award to the eligible product developer a monetary amount sufficient to deter the license holder from failing to provide eligible product developers with sufficient quantities of a covered product on commercially reasonable1 market-based terms1 if the court finds1 by a preponderance of the evidence-- 7,i7 that the license holder delayed providing sufficient quantities of the covered product to the eligible product developer without a legitimate business justification2 or 7,,ii7 that the license holder failed to comply with an order issued under clause 7i74 7,b7 ,maximum monetary amount ,a monetary amount awarded under subparagraph 7,a77iii7 shall not be greater than the revenue that the license holder earned on the covered product during the period-- 7i7 beginning on-- 7,i7 for a covered product that is not subject to a ,,rems with ,,etasu1 the date that is #ca days after the date on which the license holder received the request2 or 7,,ii7 for a covered product that is subject to a ,,rems with ,,etasu1 the date that is #ca days after the later of-- 7aa7 the date on which the license holder received the request2 or 7bb7 the date on which the license holder received a copy of the covered product authorization issued by the ,secretary in accordance with paragraph 7#b77;,b72 and 7ii7 ending on the date on which the eligible product developer received sufficient quantities of the covered product4 7,c7 ,avoidance of delay ,the court may issue an order under subparagraph 7,a77i7 before conducting further proceedings that may be necessary to determine whether the eligible product developer is entitled to an award under clause 7ii7 or 7iii7 of subparagraph 7,a71 or the amount of any such award4 7c7 ,limitation of liability ,a license holder for a covered product shall not be liable for any claim under ,federal1 ,state1 or local law arising out of the failure of an eligible product developer to follow adequate safeguards to assure safe use of the covered product during development or testing activities described in this section1 including transportation1 handling1 use1 or disposal of the covered product by the eligible product developer4 7d7 ,no violation of ,,rems ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a7 is amended by adding at the end the following new subsection3 7l7 ,provision of samples not a violation of strategy ,the provision of samples of a covered product to an eligible product developer 7as those terms are defined in section #b7;a7 of the ,creating and ,restoring ,equal ,access to ,equivalent ,samples ,act of #bjai7 shall not be considered a violation of the requirements of any risk evaluation and mitigation strategy that may be in place under this section for such drug4 4 7e7 ,rule of construction 7#a7 ,definition ,in this subsection1 the term antitrust laws-- 7,a7 has the meaning given the term in subsection 7a7 of the first section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab72 and 7,b7 includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent that such section applies to unfair methods of competition4 7#b7 ,antitrust laws ,nothing in this section shall be construed to limit the operation of any provision of the antitrust laws4 #ajb4 ,,rems approval process for subsequent filers ,section #eje-a of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee-a71 as amended by section #aja1 is further amended-- 7#a7 in subsection 7g77#d77;,b7-- 7,a7 in clause 7i7 by striking or after the semicolon2 7,b7 in clause 7ii7 by striking the period at the end and inserting 2 or2 and 7,c7 by adding at the end the following3 7iii7 accommodate different1 comparable aspects of the elements to assure safe use for a drug that is the subject of an application under section #eje7;j71 and the applicable listed drug4 2 7#b7 in subsection 7i77#a71 by striking subparagraph 7,c7 and inserting the following3 7,c7 7i7 ,elements to assure safe use1 if required under subsection 7f7 for the listed drug1 which1 subject to clause 7ii71 for a drug that is the subject of an application under section #eje7;j7 may use-- 7,i7 a single1 shared system with the listed drug under subsection 7f72 or 7,,ii7 a different1 comparable aspect of the elements to assure safe use under subsection 7f74 7ii7 ,the ,secretary may require a drug that is the subject of an application under section #eje7;j7 and the listed drug to use a single1 shared system under subsection 7f71 if the ,secretary determines that no different1 comparable aspect of the elements to assure safe use could satisfy the requirements of subsection 7f74 2 7#c7 in subsection 7i71 by adding at the end the following3 7#c7 ,shared ,,rems ,if the ,secretary approves1 in accordance with paragraph 7#a77;,c77i77,,ii71 a different1 comparable aspect of the elements to assure safe use under subsection 7f7 for a drug that is the subject of an abbreviated new drug application under section #eje7;j71 the ,secretary may require that such different comparable aspect of the elements to assure safe use can be used with respect to any other drug that is the subject of an application under section #eje7;j7 or #eje7;b7 that references the same listed drug4 2 and 7#d7 by adding at the end the following3 7m7 ,separate ,,rems ,when used in this section1 the terms different1 comparable aspect of the elements to assure safe use or different1 comparable approved risk evaluation and mitigation strategies means a risk evaluation and mitigation strategy for a drug that is the subject of an application under section #eje7;j7 that uses different methods or operational means than the strategy required under subsection 7a7 for the applicable listed drug1 or other application under section #eje7;j7 with the same such listed drug1 but achieves the same level of safety as such strategy4 4 ,,ii ,,increasing ,,access ,,to ,,drugs ,,and ,,biosimilar ,,products #bja4 ,expedited development and priority review for generic complex drug products ,subchapter ,a of chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by adding at the end the following3 #ebd;,b4 ,expedited development and priority review for generic complex drug products 7a7 ,establishment of program ,the ,secretary shall establish a program to expedite the development of1 and provide priority review under section #eje7;j7 for1 generic complex drug products4 7b7 ,request for designation ,a sponsor of a generic complex drug product may request that the ,secretary designate such product for expedited development and priority review under this section4 7c7 ,designation process 7#a7 ,in general ,not later than #fj calendar days after the receipt of a request under subsection 7c71 the ,secretary shall determine whether the product that is the subject of the request meets the criteria under subsection 7e7 to be considered a generic complex drug product4 ,if the ,secretary determines that the product meets the criteria1 the ,secretary shall designate the product for expedited development and priority review4 7#b7 ,review ,review of a request under subsection 7b7 shall be undertaken by a team that is composed of experienced staff and senior managers of the ,food and ,drug ,administration4 7#c7 ,withdrawal ,the ,secretary may not withdraw a designation granted under this section on the basis of the criteria under subsection 7e7 no longer applying because of the subsequent clearance or approval of any other product4 7d7 ,expedited development and priority review ,guidance 7#a7 ,content ,not later than ,december #ca1 #bjba1 the ,secretary shall issue guidance on the implementation of this section4 ,such guidance shall-- 7,a7 set forth the process by which a person may seek a designation under subsection 7c72 7,b7 provide a template for requests under subsection 7b72 7,c7 identify the criteria the ,secretary will use in evaluating a request for designation under this section2 and 7,d7 identify the criteria and processes the ,secretary will use to expedite the development and review of products designated under this section4 7#b7 ,process ,prior to finalizing the guidance under paragraph 7#a71 the ,secretary shall seek public comment on a draft version of that guidance4 7e7 ,generic complex drug product defined ,in this section1 the term generic complex drug product means a product that represents a complex therapy that consists of or includes a drug for approval under section #eje7;j7 and that-- 7#a7 7,a7 contains complex active ingredients 7such as peptides1 polymeric compounds1 complex mixtures of active ingredients1 and naturally sourced ingredients72 7,b7 is composed of complex formulations 7such as liposomes or colloids72 7,c7 requires a complex route of delivery 7such as locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions1 emulsions1 or gels72 or 7,d7 involves a complex dosage form 7such as transdermals1 metered dose inhalers1 or extended release injectables72 7#b7 presents as a complex drug-device combination product 7such as auto injectors or metered dose inhalers72 or 7#c7 is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section #eje7;j74 4 #bjb4 ,increasing pharmaceutical options to treat an unmet medical need ,subsection 7b7 of section #ejf of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef7 is amended by adding at the end the following3 7#d7 ,unmet medical need ,for purposes of paragraph 7#a71 a drug shall be deemed to address an unmet medical need for a disease or condition if fewer than #c available drugs exist for the treatment of such disease or condition4 4 #bjc4 ,preemption of ,state barriers to the substitution of biosimilar products ,no ,state1 or any political subdivision thereof1 may prohibit a pharmacy or pharmacist from dispensing1 in place of a biological reference product1 any product that1 pursuant to section #cea7k7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7k771 has been determined by the ,secretary of ,health and ,human ,services to be interchangeable with the reference product in accordance with subsections 7a7 and 7k77#d7 of such ,act 7#db ,u4,s4,c4 #bfb7;a71 7k77#d774 #bjd4 ,expedited process for biological products authorized for marketing in ,european ,union ,section #cea7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7;a77 is amended by adding at the end the following new paragraph3 7#d7 ,products authorized for marketing in ,european ,union ,in considering whether to license a biological product under this subsection or subsection 7k71 the ,secretary may expedite the licensing process if the biological product has been authorized for marketing by the ,european ,medicines ,agency and such authorization remains in effect4 4 ,,iii ,,prescription ,,drug ,,pricing ,,and ,,competition #cja4 ,medicare drug coverage ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may alter payments for prescription drugs1 including biologicals1 provided through the ,medicare part ,b program by paying at rates that1 based on the average sales price plus #f percent in the year of implementation of this ,act1 grow at the consumer price index 7,,cpi ,prescription ,drugs74 #cjb4 ,fee transparency between pharmacies and ,p,b,ms 7a7 ,prohibiting medicare ,,pdp sponsors and ,,ma-,,pd organizations from retroactively reducing payment on clean claims submitted by pharmacies 7#a7 ,in general ,section #ahfj;,d-#ab7;b77#d77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#d77;,a77 is amended by adding at the end the following new clause3 7iv7 ,prohibiting retroactive reductions in payments on clean claims ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor shall provide that after the date of receipt of a clean claim submitted by a pharmacy1 the ,,pdp sponsor 7or an agent of the ,,pdp sponsor7 may not retroactively reduce payment on such claim directly or indirectly through aggregated effective rate or otherwise except in the case such claim is found to not be a clean claim 7such as in the case of a claim lacking required substantiating documentation7 during the course of a routine audit as permitted pursuant to written agreement between the ,,pdp sponsor 7or such an agent7 and such pharmacy4 ,the previous sentence shall not prohibit any retroactive increase in payment to a pharmacy pursuant to a written agreement between a ,,pdp sponsor 7or an agent of such sponsor7 and such pharmacy4 4 7#b7 ,effective date ,the amendment made by subsection 7a7 shall apply with respect to contracts entered into on or after ,january #a1 #bjba4 7b7 ,elimination of ,,dir fees 7#a7 ,pharmacy benefits manager standards under the ,medicare program for prescription drug plans and ,,ma-,,pd plans 7,a7 ,in general ,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#g7 ,pharmacy benefits manager transparency requirements ,each contract entered into with a ,,pdp sponsor under this part with respect to a prescription drug plan offered by such sponsor or with an ,,ma organization offering an ,,ma-,,pd plan under part ,c shall provide that the sponsor or organization1 respectively1 may not enter into a contract with any pharmacy benefits manager 7referred to in this paragraph as a ,,pbm7 to manage the prescription drug coverage provided under such plan1 or to control the costs of the prescription drug coverage under such plan1 unless the ,,pbm adheres to the following criteria when handling personally identifiable utilization and claims data or other sensitive patient data3 7,a7 ,the ,,pbm may not transmit any personally identifiable utilization1 protected health information1 or claims data1 with respect to a plan enrollee1 to a pharmacy owned by a ,,pbm if the plan enrollee has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at the ,,pbm-owned pharmacy4 7,b7 ,the ,,pbm may not require that a plan enrollee use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 if the incentive is applicable only to such pharmacies4 4 7,b7 ,regular update of prescription drug pricing standard ,paragraph 7#f7 of section #ahfj;,d-#ab7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77 is amended to read as follows3 7#f7 ,regular update of prescription drug pricing standard 7,a7 ,in general ,if the ,,pdp sponsor of a prescription drug plan 7or ,,ma organization offering an ,,ma-,,pd plan7 uses a standard for reimbursement 7as described in subparagraph 7,b77 of pharmacies based on the cost of a drug1 each contract entered into with such sponsor under this part 7or organization under part ,c7 with respect to the plan shall provide that the sponsor 7or organization7 shall-- 7i7 update such standard not less frequently than once every #g days1 beginning with an initial update on ,january #a of each year1 to accurately reflect the market price of acquiring the drug2 7ii7 disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request2 7iii7 if the source for such a standard for reimbursement is not publicly available1 disclose to the applicable pharmacies and the respective contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims2 7iv7 establish a process to appeal1 investigate1 and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug1 which must be adjudicated within #g days of the pharmacy filing its appeal2 and 7v7 provide all such pricing data in an 4xml spreadsheet format or a comparable easily accessible and complete spreadsheet format4 7,b7 ,prescription drug pricing standard defined ,for purposes of subparagraph 7,a71 a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved1 including drug pricing references and amounts that are based upon average wholesale price1 wholesale average cost1 average manufacturer price1 average sales price1 maximum allowable cost 7,,mac71 or other costs1 whether publicly available or not4 4 7,c7 ,effective date ,the amendments made by this section shall apply to plan years beginning on or after ,january #a1 #bjbj4 7#b7 ,regular update of prescription drug pricing standard under ,,tricare retail pharmacy program ,section #ajgd;g7d7 of title #aj1 ,united ,states ,code1 is amended by adding at the end the following new paragraph3 7#c7 ,to the extent practicable1 with respect to the ,,tricare retail pharmacy program described in subsection 7a77#b77;,e77ii71 the ,secretary shall ensure that a contract entered into with a ,,tricare managed care support contractor includes requirements described in section #ahfj;,d-#ab7;b77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7;b77#f77 to ensure the provision of information regarding the pricing standard for prescription drugs4 4 7#c7 ,prescription drug transparency in the ,federal ,employees ,health ,benefits program 7,a7 ,in general ,section #hijb of title #e1 ,united ,states ,code1 is amended by adding at the end the following new subsections3 7p7 ,a contract may not be made or a plan approved under this chapter under which a carrier has an agreement with a pharmacy benefits manager 7in this subsection referred to as a ,,pbm7 to manage prescription drug coverage or to control the costs of the prescription drug coverage unless the carrier and ,,pbm adhere to the following criteria3 7#a7 ,the ,,pbm may not transmit any personally identifiable utilization1 protected health information1 or claims data with respect to an individual enrolled under such contract or plan to a pharmacy owned by the ,,pbm if the individual has not voluntarily elected in writing or via secure electronic means to fill that particular prescription at such a pharmacy4 7#b7 ,the ,,pbm may not require that an individual enrolled under such contract or plan use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm or provide an incentive to a plan enrollee to encourage the enrollee to use a retail pharmacy1 mail order pharmacy1 specialty pharmacy1 or other pharmacy entity providing pharmacy services in which the ,,pbm has an ownership interest or that has an ownership interest in the ,,pbm1 if the incentive is applicable only to such pharmacies4 7q7 7#a7 ,if a contract made or plan approved under this chapter provides for a standard for reimbursement 7as described in paragraph 7#b77 with respect to a prescription drug plan1 such contract or plan shall provide that the applicable carrier-- 7,a7 update such standard not less frequently than once every #g days1 beginning with an initial update on ,january #a of each year1 to accurately reflect the market price of acquiring the drug2 7,b7 disclose to applicable pharmacies and the contracting entities of such pharmacies the sources used for making any such update immediately without requirement of request2 7,c7 if the source for such a standard for reimbursement is not publicly available1 disclose to the applicable pharmacies and contracting entities of such pharmacies all individual drug prices to be so updated in advance of the use of such prices for the reimbursement of claims2 7,d7 establish a process to appeal1 investigate1 and resolve disputes regarding individual drug prices that are less than the pharmacy acquisition price for such drug1 which must be adjudicated within #g days of the pharmacy filing its appeal2 and 7,e7 provide all such pricing data in an 4xml spreadsheet format or a comparable easily accessible and complete spreadsheet format4 7#b7 ,for purposes of paragraph 7#a71 a standard for reimbursement of a pharmacy is any methodology or formula for varying the pricing of a drug or drugs during the term of the pharmacy reimbursement contract that is based on the cost of the drug involved1 including drug pricing references and amounts that are based upon average wholesale price1 wholesale average cost1 average manufacturer price1 average sales price1 maximum allowable cost1 or other costs1 whether publicly available or not4 4 7,b7 ,application ,the amendment made by subparagraph 7,a7 shall apply to any contract entered into under section #hijb of title #e1 ,united ,states ,code1 on or after the date of enactment of this section4 #cjc4 ,sunset of limit on maximum rebate amount for single source drugs and innovator multiple source drugs ,section #aibg7;c77#b77;,d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;c77#b77;,d77 is amended by inserting after ,december #ca1 #bjji1 the following3 and before ,december #ca1 #bjbd14 #cjd4 ,regulation of manufacturer-sponsored copay contributions ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may establish a mechanism prohibiting drug manufacturers from contributing financially to patient copays1 and establish a system of penalizing such behavior4 ,,iv ,,patent ,,disclosure ,,requirements #dja4 ,patent disclosure and transparency requirements 7a7 ,in general 7#a7 ,in general ,section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb7 is amended by adding at the end the following3 7o7 ,additional requirements with respect to patents 7#a7 ,publication of information 7,a7 ,in general ,within #a year of the date of enactment of the ,biologic ,patent ,transparency ,act1 the ,secretary shall publish and make available to the public a single1 easily searchable list that includes-- 7i7 the proper and proprietary name of each biological product licensed or deemed to be licensed under subsection 7a7 or 7k72 7ii7 the date of approval and application number for each such biological product2 7iii7 the marketing status1 dosage form1 route of administration1 strength1 and1 if applicable1 reference product1 for each such biological product2 7iv7 the licensure status for each such biological product1 including whether the license at the time of listing is approved1 withdrawn1 or revoked2 7v7 for each such biological product that is a reference product for which an exclusivity period applies1 and for which the ,secretary has determined the dates of such exclusivity period1 under subsection 7k77#g77;,a7 or subsection 7k77#g77;,b7 of this section or under section #ebg of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including any extension of such exclusivity period in accordance with subsection 7m7 of this section1 the date on which such exclusivity period expires2 7vi7 any determination of biosimilarity or interchangeability for each such biological product2 and 7vii7 information regarding approved indications for each such biological product1 in such manner as the ,secretary determines appropriate4 7,b7 ,updates ,every #cj days after the publication of the first list under subparagraph 7,a71 the ,secretary shall revise the list to include-- 7i7 7,i7 each biological product licensed under subsection 7a7 or 7k7 during the #cj-;day period2 and 7,,ii7 with respect to each biological product described in subclause 7,i71 the information described in clauses 7i7 through 7vii7 of subparagraph 7,a72 and 7ii7 any updates to information previously published in accordance with subparagraph 7,a74 4 7#b7 ,public listing of patent information 7,a7 ,in general ,the ,secretary of ,health and ,human ,services shall include in the recommendations transmitted to ,congress under section #gdd;,i7f7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77 recommendations with respect to the collection and publication of patent information in the list described in section #cea7o7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 as added by paragraph 7#a74 7,b7 ,development ,in developing recommendations under subparagraph 7,a71 the ,secretary of ,health and ,human ,services may consult with the ,federal ,trade ,commission1 the ,director of the ,united ,states ,patent and ,trademark ,office1 and the ,federal ,trade ,commission1 in addition to the entities listed in section #gdd;,i7f77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cgi;j-#ec7;f77#a774 7b7 ,rule of construction ,nothing in this section1 including the amendment made by this section1 shall be construed to require or allow the ,secretary of ,health and ,human ,services to delay the review or approval of a biologic license application under section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb74 #djb4 ,antitrust exemption for health insurance issuers ,to negotiate wholesale acquisition prices of prescription drugs purchased from drug manufacturers 7a7 ,exemption ,it shall not be a violation of the antitrust laws for one or more health insurance issuers or their designated agents to jointly negotiate wholesale acquisition prices of a prescription drug with a manufacturer of a prescription drug with regards to the reimbursement policies of the insurers of the manufacturer's drugs so long as no single wholesale acquisition price is jointly determined between the insurance issuers or their designated agents4 7b7 ,definitions ,for purposes of this section3 7#a7 ,antitrust laws ,the term antitrust laws has the meaning given it in subsection 7a7 of the #ast section of the ,clayton ,act 7#ae ,u4,s4,c4 #ab7;a771 except that such term includes section #e of the ,federal ,trade ,commission ,act 7#ae ,u4,s4,c4 #de7 to the extent such section #e applies to unfair methods of competition4 7#b7 ,health insurance issuer ,the term health insurance issuer has the meaning given that term in section #bgia7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia7;b774 7#c7 ,health maintenance organization ,the term health maintenance organization means-- 7,a7 a federally qualified health maintenance organization 7as defined in section #cjj;e7a7 of title #db of the ,code of ,federal ,regulations71 7,b7 an organization recognized under ,state law as a health maintenance organization1 or 7,c7 a similar organization regulated under ,state law for solvency in the same manner and to the same extent as such a health maintenance organization4 7#d7 ,manufacturer ,the term manufacturer means anyone who is engaged in manufacturing1 preparing1 propagating1 compounding1 processing1 packaging1 repackaging1 or labeling of a prescription drug4 7#e7 ,prescription drug ,the term prescription drug means a drug for human use subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;b77#a774 7c7 ,effective date ,this section shall take effect on the date of the enactment of this ,act but shall not apply with respect to conduct that occurs before such date4 #djc4 ,fair treatment of ,medicare part ,b billing codes for the prescribing of biosimilars ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended by adding at the end the following new subsection3 7h7 ,use of certain codes ,notwithstanding any previous provision of this section1 for purposes of payment of biological biosimilar product the ,secretary of ,health and ,human ,services shall assign a uniform ,common ,procedure ,system code to describe all such products that share a common reference product4 4 ,v ,,fixing ,,global ,,freeloading #eja4 ,chief ,pharmaceutical ,negotiator in 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 interests1 including patients and ,united ,states pharmaceutical workers4 ,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 ,code 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 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 ,trade ,representative during the one-year period preceding the submission of the report to ensure the protection of ,united ,states pharmaceutical products and services2 and 7#b7 other actions taken by the ,trade ,representative to advance ,united ,states pharmaceutical products and services4