,,ii #aahth ,,congress #ast ,session ,s4 #bigc ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #bh 7legislative day1 ,september #bb71 #bjbc,mr4 ,wyden introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend titles ,,xviii and ,,xix of the ,social ,security ,act to establish requirements relating to pharmacy benefit managers under the ,medicare and ,medicaid programs1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,modernizing and ,ensuring ,,pbm ,accountability ,act4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,sec4 #b4 ,arrangements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans4,sec4 #c4 ,ensuring fair assessment of pharmacy performance and quality under ,medicare part ,d4,sec4 #d4 ,promoting transparency for pharmacies under ,medicare part ,d4,sec4 #e4 ,preventing the use of abusive spread pricing in ,medicaid4,sec4 #f4 ,ensuring accurate payments to pharmacies under ,medicaid4,sec4 #g4 ,,oig study and report on drug price mark-ups in ,medicare part ,d4,sec4 #h4 ,resolving ,p,t committee conflicts of interest4,sec4 #i4 ,enhancing ,,pbm transparency requirements4,sec4 #aj4 ,facilitating midyear formulary changes for biosimilars4,sec4 #aa4 ,strengthening pharmacy access for seniors4,sec4 #ab4 ,beneficiary-focused listening sessions to improve prescription drug plan transparency1 access1 and choice4,sec4 #ac4 ,reporting on enforcement and oversight of pharmacy access requirements4,sec4 #ad4 ,,gao study on price-related compensation across the supply chain4,sec4 #ae4 ,reports on inappropriate pharmacy rejections4,sec4 #af4 ,,gao study on drug shortages4,sec4 #ag4 ,report on biosimilar and generic access under ,medicare part ,d4,sec4 #ah4 ,medicare ,improvement ,fund4 #b4 ,arrangements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans 7a7 ,in general 7#a7 ,prescription drug plans ,section #ahfj;,d-#ab of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aab7 is amended by adding at the end the following new subsection3 7h7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbf3 7#a7 ,agreements with pharmacy benefit managers ,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 any pharmacy benefit manager acting on behalf of such sponsor has a written agreement with the ,,pdp sponsor under which the pharmacy benefit manager agrees to meet the following requirements3 7,a7 ,no income other than bona fide service fees 7i7 ,in general ,the pharmacy benefit manager and any affiliate of such pharmacy benefit manager shall not derive any remuneration with respect to any services provided in connection with the utilization of covered part ,d drugs from any entity or individual other than bona fide service fees1 subject to clauses 7ii7 and 7iii74 7ii7 ,incentive payments ,for the purposes of this subsection1 an incentive payment paid by a ,,pdp sponsor to a pharmacy benefit manager that is performing services on behalf of such sponsor shall be deemed a bona fide service fee if such payment is a flat dollar amount1 is consistent with fair market value1 and is related to services actually performed by the pharmacy benefit manager or affiliate of such pharmacy benefit manager in connection with the utilization of covered part ,d drugs4 7iii7 ,clarification on rebates and discounts used to lower costs for covered part d drugs ,rebates1 discounts1 and other price concessions received from manufacturers1 even if such price concessions are calculated as a percentage of a drug's price1 shall not be considered a violation of the requirements of clause 7i7 if they are fully passed through to a ,,pdp sponsor and exclusively used to lower costs for prescription drugs under this part1 including in cases where a ,,pdp sponsor is acting as a pharmacy benefit manager on behalf of a prescription drug plan offered by such ,,pdp sponsor4 7iv7 ,evaluation of remuneration arrangements ,remuneration arrangements between pharmacy benefit managers or affiliates of such pharmacy benefit managers1 as applicable1 and other entities involved in the dispensing or utilization of covered part ,d drugs 7including ,,pdp sponsors1 manufacturers1 pharmacies1 and other entities as determined appropriate by the ,secretary7 shall be subject to review by the ,secretary and the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services4 ,the ,secretary1 in consultation with the ,office of the ,inspector ,general1 shall evaluate whether remuneration under such arrangements is consistent with fair market value through reviews and assessments of such remuneration1 as determined appropriate4 7,b7 ,transparency regarding guarantees and cost performance evaluations ,the pharmacy benefit manager shall-- 7i7 define1 interpret1 and apply1 in a fully transparent and consistent manner for purposes of calculating or otherwise evaluating pharmacy benefit manager performance against pricing guarantees or similar cost performance measurements related to rebates1 discounts1 price concessions1 or net costs1 terms such as-- 7,i7 generic drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,ii7 brand name drug1 in a manner consistent with the definition of the term under section #dbc4d of title #db1 ,code of ,federal ,regulations1 or a successor regulation2 7,,iii7 specialty drug2 7,,iv7 rebate2 and 7,v7 discount2 7ii7 identify any drugs1 claims1 or price concessions excluded from any pricing guarantee or other cost performance calculation or evaluation in a clear and consistent manner2 and 7iii7 where a pricing guarantee or other cost performance measure is based on a pricing benchmark other than the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77;,b77 of a drug1 calculate and provide a wholesale acquisition cost-based equivalent to the pricing guarantee or other cost performance measure in the written agreement4 7,c7 ,provision of information 7i7 ,in general ,not later than ,july #a of each year1 beginning in #bjbf1 the pharmacy benefit manager shall submit to the ,,pdp sponsor1 and to the ,secretary1 a report1 in accordance with this subparagraph1 and shall make such report available to such sponsor at no cost to such sponsor in a format specified by the ,secretary under paragraph 7#d74 ,each such report shall include1 with respect to such ,,pdp sponsor and each plan offered by such sponsor1 the following information with respect to the previous plan year3 7,i7 ,a list of all drugs covered by the plan that were dispensed including1 with respect to each such drug-- 7aa7 the brand name1 generic or non-proprietary name1 and ,national ,drug ,code2 7bb7 the number of plan enrollees for whom the drug was dispensed1 the total number of prescription claims for the drug 7including original prescriptions and refills1 counted as separate claims71 and the total number of dosage units of the drug dispensed2 7cc7 the number of prescription claims described in item 7bb7 by each type of dispensing channel through which the drug was dispensed1 including retail1 mail order1 specialty pharmacy1 long term care pharmacy1 home infusion pharmacy1 or other types of pharmacies or providers2 7dd7 the average wholesale acquisition cost1 listed as cost per day's supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7ee7 the average wholesale price for the drug1 listed as cost per day's supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7ff7 the total out-of-pocket spending by plan enrollees on such drug after application of any benefits under the plan1 including plan enrollee spending through copayments1 coinsurance1 and deductibles2 7gg7 total rebates paid by the manufacturer on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7hh7 all other direct or indirect remuneration on the drug as reported under the ,detailed ,,dir ,report 7or any successor report7 submitted by such sponsor to the ,centers for ,medicare ,medicaid ,services2 7ii7 the average pharmacy reimbursement amount paid by the plan for the drug in the aggregate and disaggregated by dispensing channel identified in item 7cc72 7jj7 the average ,national ,average ,drug ,acquisition ,cost 7,,nadac7 for retail community pharmacies2 and 7kk7 total manufacturer-derived revenue1 inclusive of bona fide service fees1 retained by the pharmacy benefit manager and any affiliate of such pharmacy benefit manager attributable to the drug4 7,,ii7 ,in the case of a pharmacy benefit manager that has an affiliate that is a retail1 mail order1 or specialty pharmacy1 with respect to drugs covered by such plan that were dispensed1 the following information3 7aa7 ,the percentage of total prescriptions that were dispensed by pharmacies that are an affiliate of the pharmacy benefit manager for each drug4 7bb7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are not an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7cc7 ,the interquartile range of the total combined costs paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply for each drug dispensed by pharmacies that are an affiliate of the pharmacy benefit manager and that are included in the pharmacy network of such plan4 7dd7 ,the lowest total combined cost paid by the plan and plan enrollees1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for each drug that is available from any pharmacy included in the pharmacy network of such plan4 7ee7 ,the difference between the average acquisition cost of the affiliate1 such as a pharmacy or other entity that acquires prescription drugs1 that initially acquires the drug and the amount reported under subclause 7,i77jj7 for each drug4 7ff7 ,a list of covered part ,d drugs subject to an agreement with a covered entity under section #cdj;,b of the ,public ,health ,service ,act for which the pharmacy benefit manager or an affiliate of the pharmacy benefit manager had a contract or other arrangement with such a covered entity in the service area of such plan4 7,,iii7 ,where a drug approved under section #eje7;c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7referred to in this subclause as the listed drug7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the listed drug1 or are subject to utilization management that the listed drug is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the listed drug4 7cc7 ,where a generic drug listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the listed drug1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the generic drugs described in item 7aa71 had the plan provided coverage for such drugs on the same formulary tier as the listed drug4 7dd7 ,a written justification for providing more favorable coverage of the listed drug than the generic drugs described in item 7aa74 7ee7 ,the number of currently marketed generic drugs approved under section #eje7;j7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act pursuant to an application that references such listed drug4 7,,iv7 ,where a reference product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act7 is covered by the plan1 the following information3 7aa7 ,a list of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act pursuant to an application that refers to such reference product that are not covered by the plan1 are covered on the same formulary tier or a formulary tier typically associated with higher cost-sharing than the reference product1 or are subject to utilization management that the reference product is not subject to4 7bb7 ,the estimated average beneficiary cost-sharing under the plan for a #cj-;day supply of the reference product4 7cc7 ,where a biosimilar biological product listed under item 7aa7 is on a formulary tier typically associated with higher cost-sharing than the listed drug1 the estimated average cost-sharing that a beneficiary would have paid for a #cj-;day supply of each of the biosimilar biological products described in item 7aa71 had the plan provided coverage for such products on the same formulary tier as the reference product4 7dd7 ,a written justification for providing more favorable coverage of the reference product than the biosimilar biological product described in item 7aa74 7ee7 ,the number of currently marketed biosimilar biological products licensed under section #cea7k7 of the ,public ,health ,service ,act1 pursuant to an application that refers to such reference product4 7,v7 ,total gross spending on covered part ,d drugs by the plan1 not net of rebates1 fees1 discounts1 or other direct or indirect remuneration4 7,,vi7 ,the total amount retained by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in revenue related to utilization of prescription drugs under that plan1 inclusive of bona fide service fees4 7,,vii7 ,the total spending on covered part ,d drugs net of rebates1 fees1 discounts1 or other direct and indirect remuneration by the plan4 7,,viii7 ,an explanation of any benefit design parameters under such plan that encourage plan enrollees to fill prescriptions at pharmacies that are an affiliate of such pharmacy benefit manager1 such as mail and specialty home delivery programs1 and retail and mail auto-refill programs4 7,,ix7 ,a list of all brokers1 consultants1 advisors1 and auditors that receive compensation from the pharmacy benefit manager or an affiliate of such pharmacy benefit manager for referrals1 consulting1 auditing1 or other services offered to ,,pdp sponsors related to pharmacy benefit management services4 7,x7 ,a list of all affiliates of the pharmacy benefit manager4 7,,xi7 ,a summary document submitted in a standardized template developed by the ,secretary that includes such information described in subclauses 7,i7 through 7,x74 7ii7 ,written explanation of contracts or agreements with drug manufacturers 7,i7 ,in general ,the pharmacy benefit manager shall1 not later than #cj days after the finalization of any contract or agreement between such pharmacy benefit manager or an affiliate of such pharmacy benefit manager and a drug manufacturer 7or subsidiary1 agent1 or entity affiliated with such drug manufacturer7 that makes rebates1 discounts1 payments1 or other financial incentives related to one or more prescription drugs of the manufacturer directly or indirectly contingent upon coverage1 formulary placement1 or utilization management conditions on any other prescription drugs1 submit to the ,,pdp sponsor a written explanation of such contract or agreement4 7,,ii7 ,requirements ,a written explanation under subclause 7,i7 shall-- 7aa7 include the manufacturer subject to the contract or agreement1 all prescription drugs subject to the contract or agreement and the manufacturers of such drugs1 and a high-level description of the terms of such contract or agreement and how such terms apply to such drugs2 and 7bb7 be certified by the ,chief ,executive ,officer1 ,chief ,financial ,officer1 or ,general ,counsel of such pharmacy benefit manager1 affiliate of such pharmacy benefit manager1 or an individual delegated with the authority to sign on behalf of one of these officers1 who reports directly to the officer4 7,d7 ,audit rights 7i7 ,in general ,not less than once a year1 at the request of the ,,pdp sponsor1 the pharmacy benefit manager shall allow for an audit of the pharmacy benefit manager to ensure compliance with all terms and conditions under the written agreement and the accuracy of information reported under subparagraph 7,c74 7ii7 ,auditor ,the ,,pdp sponsor shall have the right to select an auditor4 ,the pharmacy benefit manager shall not impose any limitations on the selection of such auditor4 7iii7 ,provision of information ,the pharmacy benefit manager shall make available to such auditor all records1 data1 contracts1 and other information necessary to confirm the accuracy of information provided under subparagraph 7,c71 subject to reasonable restrictions on how such information must be reported to prevent redisclosure of such information4 7iv7 ,timing ,the pharmacy benefit manager must provide information under clause 7iii7 and other information1 data1 and records relevant to the audit to such auditor within #f months of the initiation of the audit and respond to requests for additional information from such auditor within #cj days after the request for additional information4 7v7 ,information from affiliates ,the pharmacy benefit manager shall be responsible for providing to such auditor information required to be reported under subparagraph 7,c7 that is owned or held by an affiliate of such pharmacy benefit manager4 7,e7 ,enforcement ,the pharmacy benefit manager shall-- 7i7 disgorge to a ,,pdp sponsor 7or1 in a case where the ,,pdp sponsor is an affiliate of such pharmacy benefit manager1 to the ,secretary7 any payment1 remuneration1 or other amount received by the pharmacy benefit manager or an affiliate of such pharmacy benefit manager in violation of subparagraph 7,a7 or the written agreement entered into with such sponsor under this part with respect to a prescription drug plan2 7ii7 reimburse the ,,pdp sponsor for any civil money penalty imposed on the ,,pdp sponsor as a result of the failure of the pharmacy benefit manager to meet the requirements of this paragraph that are applicable to the pharmacy benefit manager under the agreement2 and 7iii7 be subject to punitive remedies for breach of contract for failure to comply with the requirements applicable under this paragraph4 7#b7 ,certification of compliance ,each ,,pdp sponsor shall furnish to the ,secretary 7in a time and manner specified by the ,secretary7 an annual certification of compliance with this subsection1 as well as such information as the ,secretary determines necessary to carry out this subsection4 7#c7 ,rule of construction ,nothing in this subsection shall be construed as prohibiting payments related to reimbursement for ingredient costs to any entity that acquires prescription drugs1 such as a pharmacy or wholesaler4 7#d7 ,standard formats ,not later than ,june #a1 #bjbe1 the ,secretary shall specify standard1 machine-readable formats for pharmacy benefit managers to submit annual reports required under paragraph 7#a77;,c77i74 7#e7 ,confidentiality 7,a7 ,in general ,information disclosed by a pharmacy benefit manager or ,,pdp sponsor under this subsection that is not otherwise publicly available or available for purchase shall not be disclosed by the ,secretary or a ,,pdp sponsor receiving the information1 except that the ,secretary may disclose the information for the following purposes3 7i7 ,as the ,secretary determines necessary to carry out this part4 7ii7 ,to permit the ,comptroller ,general to review the information provided4 7iii7 ,to permit the ,director of the ,congressional ,budget ,office to review the information provided4 7iv7 ,to permit the ,executive ,director of the ,medicare ,payment ,advisory ,commission to review the information provided4 7v7 ,to the ,attorney ,general for the purposes of conducting oversight and enforcement under this title4 7vi7 ,to the ,inspector ,general of the ,department of ,health and ,human ,services in accordance with its authorities under the ,inspector ,general ,act of #aigh 7section #djf of title #e1 ,united ,states ,code71 and other applicable statutes4 7,b7 ,restriction on use of information ,the ,secretary1 the ,comptroller ,general1 the ,director of the ,congressional ,budget ,office1 and the ,executive ,director of the ,medicare ,payment ,advisory ,commission shall not report on or disclose information disclosed pursuant to subparagraph 7,a7 to the public in a manner that would identify a specific pharmacy benefit manager1 affiliate1 manufacturer or wholesaler1 ,,pdp sponsor1 or plan1 or contract prices1 rebates1 discounts1 or other remuneration for specific drugs in a manner that may allow the identification of specific contracting parties4 7#f7 ,definitions ,for purposes of this subsection3 7,a7 ,affiliate ,the term affiliate means any entity that is owned by1 controlled by1 or related under a common ownership structure with a pharmacy benefit manager or ,,pdp sponsor1 or that acts as a contractor or agent to such pharmacy benefit manager or ,,pdp sponsor1 insofar as such contractor or agent performs any of the functions described under subparagraph 7,c74 7,b7 ,bona fide service fee ,the term bona fide service fee means a fee that is reflective of the fair market value for a bona fide1 itemized service actually performed on behalf of an entity1 that the entity would otherwise perform 7or contract for7 in the absence of the service arrangement and that are not passed on in whole or in part to a client or customer1 whether or not the entity takes title to the drug4 ,such fee must be a flat dollar amount and shall not be directly or indirectly based on1 or contingent upon-- 7i7 drug price1 such as wholesale acquisition cost or drug benchmark price 7such as average wholesale price72 7ii7 discounts1 rebates1 fees1 or other direct or indirect remuneration amounts with respect to covered part ,d drugs dispensed to enrollees in a prescription drug plan1 except as permitted pursuant to paragraph 7#a77;,a77ii72 7iii7 coverage or formulary placement decisions or the volume or value of any referrals or business generated between the parties to the arrangement2 or 7iv7 any other amounts or methodologies prohibited by the ,secretary4 7,c7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,,pdp sponsor or prescription drug plan1 or manages the prescription drug benefits provided by such sponsor or plan1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the adjudication of appeals or grievances related to the prescription drug benefit1 contracting with network pharmacies1 controlling the cost of covered part ,d drugs1 or the provision of related services4 ,such term includes any person or entity that carries out one or more of the activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7#b7 ,,ma-,,pd plans ,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 following new subparagraph3 7,f7 ,requirements relating to pharmacy benefit managers ,for plan years beginning on or after ,january #a1 #bjbf1 section #ahfj;,d-#ab7;h74 4 7#c7 ,funding 7,a7 ,secretary ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjbf1 to remain available until expended1 to carry out the amendments made by this subsection4 7,b7 ,,oig ,in addition to amounts otherwise available1 there is appropriated to the ,inspector ,general of the ,department of ,health and ,human ,services1 out of any money in the ,treasury not otherwise appropriated1 #e1jjj1jjj for fiscal year #bjbf1 to remain available until expended1 to carry out the amendments made by this subsection4 7b7 ,,gao study and report on certain reporting requirements 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall conduct a study on ,federal and ,state reporting requirements for health plans and pharmacy benefit managers related to the transparency of prescription drug costs and prices4 ,such study shall include an analysis of the following3 7,a7 ,federal statutory and regulatory reporting requirements for health plans and pharmacy benefit managers related to prescription drug costs and prices4 7,b7 ,selected ,states' statutory and regulatory reporting requirements for health plans and pharmacy benefit managers related to prescription drug costs and prices4 7,c7 ,the extent to which the statutory and regulatory reporting requirements identified in subparagraphs 7,a7 and 7,b7 overlap and conflict4 7,d7 ,the resources required by health plans and pharmacy benefit managers to comply with the reporting requirements described in subparagraphs 7,a7 and 7,b74 7,e7 ,other items determined appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than #b years after the date on which information is first required to be reported under section #ahfj;,d-#ab7;h77#a77;,c7 of the ,social ,security ,act1 as added by subsection 7a77#a71 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for legislation and administrative actions that would streamline and reduce the burden associated with the reporting requirements for health plans and pharmacy benefit managers described in paragraph 7#a74 7c7 ,med,p,a,c reports on agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans ,the ,medicare ,payment ,advisory ,commission shall submit to ,congress the following reports3 7#a7 ,not later than ,march #ca1 #bjbg1 a report regarding agreements with pharmacy benefit managers with respect to prescription drug plans and ,,ma-,,pd plans4 ,such report shall include-- 7,a7 a description of trends and patterns1 including relevant averages1 totals1 and other figures for each of the types of information submitted2 7,b7 an analysis of any differences in agreements and their effects on plan enrollee out-of-pocket spending and average pharmacy reimbursement1 and any other impacts2 and 7,c7 any recommendations the ,commission determines appropriate4 7#b7 ,not later than ,march #ca1 #bjbi1 a report describing any changes with respect to the information described in paragraph 7#a7 over time1 together with any recommendations the ,commission determines appropriate4 #c4 ,ensuring fair assessment of pharmacy performance and quality under ,medicare part ,d 7a7 ,standardized pharmacy performance measures ,section #ahfj;,d-#b of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7 is amended by adding at the end the following new subsection3 7f7 ,application of standardized pharmacy performance measures 7#a7 ,measures ,for plan years beginning on or after ,january #a1 #bjbe1 a ,,pdp sponsor offering a prescription drug plan and an ,,ma organization offering an ,,ma-,,pd plan shall1 for purposes of incentive payments1 price concessions1 or any fees or other remuneration paid or charged to a pharmacy based on performance measures1 only use measures that are-- 7,a7 established or adopted by the ,secretary under paragraph 7#b7 and included on the list described in subparagraph 7,b7 of such paragraph2 and 7,b7 relevant to the performance of such pharmacy based on the type of pharmacy 7including retail1 mail order1 specialty1 long term care1 and home infusion or other types of pharmacies71 drugs dispensed by such pharmacy1 and pharmacy services used to dispense and manage drugs by such pharmacy4 7#b7 ,standardized pharmacy performance measures 7,a7 ,measures 7i7 ,in general ,notwithstanding any other provision of law1 the ,secretary shall establish 7or adopt pursuant to clause 7iii77 standardized pharmacy performance measures that may be used by a ,,pdp sponsor offering a prescription drug plan and an ,,ma organization offering an ,,ma-,,pd plan for the purpose of determining incentive payments1 price concessions1 or fees or other remuneration described in paragraph 7#a74 7ii7 ,requirements ,the measures under clause 7i7 shall focus on pharmacy performance and quality of care based on the type of pharmacy1 as determined by the ,secretary4 ,such measures shall be evidence-based1 feasible1 appropriate and reasonable4 7iii7 ,adoption of measure ,in lieu of establishing some or all of the measures under this paragraph1 the ,secretary may adopt measures that are endorsed by one or more multi-stakeholder consensus organizations 7such as the ,pharmacy ,quality ,alliance71 that has participation from pharmacies 7including retail and specialty pharmacies not owned or affiliated with a plan1 pharmacy benefit manager1 or other pharmacy71 health plans1 pharmacy benefit managers1 and the ,centers for ,medicare ,medicaid ,services4 ,any measure adopted under this clause shall be deemed to meet the requirements under clause 7ii74 7,b7 ,maintenance of list 7i7 ,in general ,the ,secretary shall maintain1 and publish on a publicly available internet website1 a list of measures established or adopted under this paragraph4 ,such list shall initially be published no later than ,june #a1 #bjbd4 7ii7 ,update ,the ,secretary shall periodically evaluate measures1 and how measures are applied by type of pharmacy and update the measures on the list under clause 7i7 so that such measures meet the requirements under subparagraph 7,a77ii74 7#c7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary under this subsection4 4 7b7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #d1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out the amendment made by subsection 7a74 #d4 ,promoting transparency for pharmacies under ,medicare part ,d 7a7 ,transparency for pharmacies ,section #ahfj;,d-#b7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajb7;f771 as added by section #c1 is amended by adding at the end the following new paragraph3 7#d7 ,transparency for pharmacies 7,a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a ,,pdp sponsor offering a prescription drug plan and an ,,ma organization offering an ,,ma-,,pd plan1 with respect to payment made by such ,,pdp sponsor or such ,,ma organization to a pharmacy for a covered part ,d drug dispensed by such pharmacy during a plan year1 shall promptly furnish1 upon paying a claim for a covered part ,d drug from a pharmacy1 to such pharmacy information related to such claim1 such as the ,network ,reimbursement ,,id1 fees1 pharmacy price concessions1 discounts1 incentives1 or any other forms of remuneration that affect payment and pricing of the claim4 7,b7 ,standardized format ,the ,,pdp sponsor and the ,,ma organization shall furnish the information described in subparagraph 7,a7 in a standardized format 7as specified by the ,secretary7 that includes all fields needed to price the claim for a covered part ,d drug dispensed by such pharmacy4 7,c7 ,availability of information to the secretary ,a ,,pdp sponsor offering a prescription drug plan or an ,,ma organization offering an ,,ma-,,pd plan shall make the information described in subparagraph 7,a7 available to the ,secretary upon request4 7,d7 ,implementation ,notwithstanding any other provision of law1 the ,secretary shall implement this paragraph by program instruction or otherwise4 4 7b7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,centers for ,medicare ,medicaid ,services ,program ,management ,account1 out of any money in the ,treasury not otherwise appropriated1 #b1jjj1jjj for fiscal year #bjbe1 to remain available until expended1 to carry out the amendment made by subsection 7a74 #e4 ,preventing the use of abusive spread pricing in ,medicaid 7a7 ,in general ,section #aibg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;e77 is amended by adding at the end the following3 7#f7 ,transparent prescription drug pass-through pricing required ,a contract between the ,state and a pharmacy benefit manager 7referred to in this paragraph as a ,,pbm71 or a contract between the ,state and a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d7 and collectively referred to in this paragraph as the entity7 that includes provisions making the entity responsible for coverage of covered outpatient drugs dispensed to individuals enrolled with the entity1 shall require that payment for such drugs and related administrative services 7as applicable71 including payments made by a ,,pbm on behalf of the ,state or entity1 is based on a transparent prescription drug pass-through pricing model under which-- 7,a7 any payment made by the entity or the ,,pbm 7as applicable7 for such a drug-- 7i7 is limited to-- 7,i7 ingredient cost2 and 7,,ii7 a professional dispensing fee that is not less than the professional dispensing fee that the ,state plan or waiver would pay if the plan or waiver was making the payment directly2 7ii7 is passed through in its entirety by the entity or ,,pbm to the pharmacy or provider that dispenses the drug 7and shall not be reduced or denied retroactively under post-adjudication processes72 and 7iii7 is made in a manner that is consistent with sections #ddg4ejb1 #ddg4eab1 #ddg4ead1 and #ddg4eah of title #db1 ,code of ,federal ,regulations 7or any successor regulation7 as if such requirements applied directly to the entity or the ,,pbm1 except that any payment by the entity or the ,,pbm for the ingredient cost of such drug purchased by a covered entity 7as defined in subsection 7a77#e77;,b77 may exceed the actual acquisition cost 7as defined in #ddg4ejb of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 for such drug if-- 7,i7 such drug was subject to an agreement under section #cdj;,b of the ,public ,health ,service ,act2 7,,ii7 such payment for the ingredient cost of such drug does not exceed the maximum payment that would have been made by the entity or the ,,pbm for the ingredient cost of such drug if such drug had not been purchased by such covered entity2 and 7,,iii7 such covered entity reports to the ,secretary 7in a form and manner specified by the ,secretary71 on an annual basis and with respect to payments for the ingredient costs of such drugs so purchased by such covered entity that are in excess of the actual acquisition costs for such drugs1 the aggregate amount of such excess2 7,b7 payment to the entity or the ,,pbm 7as applicable7 for administrative services performed by the entity or ,,pbm is limited to the fair market value of such services2 7,c7 the entity or the ,,pbm 7as applicable7 shall make available to the ,state1 and the ,secretary upon request1 all costs and payments related to covered outpatient drugs and accompanying administrative services incurred1 received1 or made by the entity or the ,,pbm1 including ingredient costs1 professional dispensing fees1 administrative fees1 post-sale and post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees1 and any and all other remuneration2 and 7,d7 any form of spread pricing whereby any amount charged or claimed by the entity or the ,,pbm 7as applicable7 that exceeds the amount paid to the pharmacies or providers on behalf of the ,state or entity1 including any post-sale or post-invoice fees1 discounts1 or related adjustments such as direct and indirect remuneration fees or assessments 7after allowing for an administrative fee as described in subparagraph 7,b77 is not allowable for purposes of claiming ,federal matching payments under this title4 4 7b7 ,definition of pharmacy benefit manager ,section #aibg7k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7k77 is amended by adding at the end the following new paragraph3 7#ab7 ,pharmacy benefit manager ,the term pharmacy benefit manager means any person or entity that1 either directly or through an intermediary1 acts as a price negotiator or group purchaser on behalf of a ,state1 managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d771 or manages the prescription drug benefits provided by such ,state1 managed care entity1 or other specified entity1 including the processing and payment of claims for prescription drugs1 the performance of drug utilization review1 the processing of drug prior authorization requests1 the managing of appeals or grievances related to the prescription drug benefits1 contracting with pharmacies1 controlling the cost of covered outpatient drugs1 or the provision of services related thereto4 ,such term includes any person or entity that carries out #a or more of the activities described in the preceding sentence1 irrespective of whether such person or entity calls itself a pharmacy benefit manager4 4 7c7 ,conforming amendments ,section #aijc7m7 of such ,act 7#db ,u4,s4,c4 #acif;b7m77 is amended-- 7#a7 in paragraph 7#b77;,a77xiii7-- 7,a7 by striking and 7,,iii7 and inserting 7,,iii72 7,b7 by inserting before the period at the end the following3 1 and 7,,iv7 if the entity1 or a pharmacy benefit manager acting on behalf of the entity under a contract or other arrangement between the entity and the pharmacy benefit manager1 performs any of the activities described in section #aibg7k77#ab71 such activities shall comply with the requirements of section #aibg7;e77#f72 and 7,c7 by moving the left margin #b ems to the left2 and 7#b7 by adding at the end the following new paragraph3 7#aj7 ,no payment shall be made under this title to a ,state with respect to expenditures incurred by the ,state for payment for services provided by an other specified entity 7as defined in paragraph 7#i77;,d77iii77 unless such services are provided in accordance with a contract between the ,state and such entity which satisfies the requirements of paragraph 7#b77;,a77xiii74 4 7d7 ,effective date ,the amendments made by this section apply to contracts between ,states and managed care entities1 other specified entities1 or pharmacy benefit managers that have an effective date beginning on or after the date that is #ah months after the date of enactment of this ,act4 #f4 ,ensuring accurate payments to pharmacies under ,medicaid 7a7 ,in general ,section #aibg7;f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;f77 is amended-- 7#a7 by striking and after the semicolon at the end of paragraph 7#a77;,a77i7 and all that precedes it through 7#a7 and inserting the following3 7#a7 ,determining pharmacy actual acquisition costs ,the ,secretary shall conduct a survey of retail community pharmacy drug prices to determine the national average drug acquisition cost as follows3 7,a7 ,use of vendor ,the ,secretary may contract services for-- 7i7 with respect to retail community pharmacies1 the determination of retail survey prices of the national average drug acquisition cost for covered outpatient drugs that represent a nationwide average of consumer purchase prices for such drugs1 net of all discounts and rebates 7to the extent any information with respect to such discounts and rebates is available7 based on a monthly survey of such pharmacies2 and 2 7#b7 by adding at the end of paragraph 7#a7 the following3 7,f7 ,survey reporting ,in order to meet the requirement of section #aijb7;a77#ed71 a ,state shall require that any retail community pharmacy in the ,state that receives any payment1 reimbursement1 administrative fee1 discount1 or rebate related to the dispensing of covered outpatient drugs to individuals receiving benefits under this title1 regardless of whether such payment1 reimbursement1 administrative fee1 discount1 or rebate is received from the ,state or a managed care entity or other specified entity 7as such terms are defined in section #aijc7m77#i77;,d77 directly or from a pharmacy benefit manager or another entity that has a contract with the ,state or a managed care entity or other specified entity 7as so defined71 shall respond to surveys of retail prices conducted under this paragraph4 7,g7 ,survey information ,information on national drug acquisition prices obtained under this paragraph shall be made publicly available and shall include at least the following3 7i7 ,the monthly response rate to the survey including a list of pharmacies not in compliance with subparagraph 7,f74 7ii7 ,the sampling frame and number of pharmacies sampled monthly4 7iii7 ,information on price concessions to the pharmacy1 including discounts1 rebates1 and other price concessions1 to the extent that such information may be publicly released and has been collected by the ,secretary as part of the survey4 7,h7 ,penalties ,the ,secretary may enforce non-compliance with this paragraph by a pharmacy through the establishment of penalties or the suspension of payments under this title1 in full or in part1 until compliance with this paragraph has been completed4 2 7#c7 in paragraph 7#b7-- 7,a7 in subparagraph 7,a71 by inserting 1 including payment rates under ,medicaid managed care entities or other specified entities 7as such terms are defined in section #aijc7m77#i77;,d771 after under this title2 and 7,b7 in subparagraph 7,b71 by inserting and the basis for such dispensing fees before the semicolon2 and 7#d7 in paragraph 7#d71 by inserting 1 and #e1jjj1jjj for fiscal year #bjbd and each fiscal year thereafter1 after #bjaj4 7b7 ,effective date ,the amendments made by this section take effect on the first day of the first quarter that begins on or after the date that is #ah months after the date of enactment of this ,act4 #g4 ,,oig study and report on drug price mark-ups in ,medicare part ,d ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb7 is amended by adding at the end the following new subsection3 7e7 ,,oig study and report on drug price mark-,ups under this part 7#a7 ,study ,the ,inspector ,general of the ,department of ,health and ,human ,services 7in this subsection referred to as the ,inspector ,general7 shall conduct a study on the impact of related party transactions within select vertically integrated entities on the negotiated price 7as defined in section #ahfj;,d-#b7;d77#a77;,b77 paid by part ,d plan sponsors for covered part ,d drugs4 ,such study may include an analysis of the following3 7,a7 ,acquisition costs by the affiliate within such vertically integrated entities that initially acquires the prescription drug for a sample of covered part ,d drugs1 including at least #e generic drugs1 brand drugs1 specialty brand drugs1 and specialty generic drugs4 7,b7 ,the methodologies and negotiation processes used to calculate transfer prices or other transactions between related parties with respect to such covered part ,d drugs4 7,c7 ,the impact of the transactions described in subparagraph 7,b7 on the negotiated price1 net of direct and indirect remuneration1 for such covered part ,d drugs4 7,d7 ,the margin captured by different affiliates within such vertically integrated entities through the transactions described in subparagraph 7,b74 7,e7 ,an assessment of the impact of the transactions described in subparagraph 7,b7 on costs to individuals enrolled in a prescription drug plan or an ,,ma-,,pd plan and program spending on prescription drugs under this part4 7,f7 ,other issues determined to be relevant and appropriate by the ,inspector ,general4 7#b7 ,report ,not later than #c years after the date of enactment of this subsection1 the ,inspector ,general shall submit to the ,committee on ,finance of the ,senate and the ,committee on ,energy and ,commerce and the ,committee on ,ways and ,means of the ,house of ,representatives a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,inspector ,general determines appropriate4 7#c7 ,funding ,in addition to amounts otherwise available1 there is appropriated to the ,inspector ,general1 out of any money in the ,treasury not otherwise appropriated1 #e1bjj1jjj for fiscal year #bjbd1 to remain available until expended1 to carry out this subsection4 4 #h4 ,resolving ,p,t committee conflicts of interest ,section #ahfj;,d-#d7;b77#c77;,a77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#c77;,a77ii77,i77 is amended by inserting the following before the semicolon3 7and1 for #bjbe and each subsequent year1 any pharmacy benefit manager acting under contract with such sponsor offering such plan74 #i4 ,enhancing ,,pbm transparency requirements 7a7 ,in general ,section #aaej;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is amended-- 7#a7 by striking subsection 7a7 and inserting the following3 7a7 ,provision of information 7#a7 ,in general ,the following entities shall provide the information described in subsection 7b7 to the ,secretary and1 in the case of an entity described in subparagraph 7,b7 or an affiliate of such entity described in subparagraph 7,c71 to the health benefits plan with which the entity is under contract1 at such times1 and in such form and manner1 as the ,secretary shall specify3 7,a7 ,a health benefits plan4 7,b7 ,any entity that provides pharmacy benefits management services on behalf of a health benefits plan 7in this section referred to as a ,,pbm7 that manages prescription drug coverage under a contract with-- 7i7 a ,,pdp sponsor of a prescription drug plan or an ,,ma organization offering an ,,ma-,,pd plan under part ,d of title ,,xviii2 or 7ii7 a qualified health benefits plan offered through an exchange established by a ,state under section #acaa of the ,patient ,protection and ,affordable ,care ,act4 7,c7 ,any affiliate of an entity described in subparagraph 7,b7 that acts as a price negotiator or group purchaser on behalf of such ,,pbm1 ,,pdp sponsor1 ,,ma organization1 or qualified health benefits plan4 7#b7 ,affiliate defined ,in this section1 the term affiliate means any entity that is owned by1 controlled by1 or related under a common ownership structure with a ,,pbm 7including an entity owned or controlled by the ,,pdp sponsor of a prescription drug plan1 ,,ma organization offering an ,,ma-,,pd plan1 or qualified health benefits plan for which such entity is acting as a price negotiator or group purchaser74 2 7#b7 in subsection 7b7-- 7,a7 in paragraph 7#b71 by inserting and percentage after and the aggregate amount2 and 7,b7 by adding at the end the following new paragraph3 7#d7 ,the amount 7in the aggregate and disaggregated by type7 of all fees the ,,pbm or an affiliate of the ,,pbm receives from all pharmaceutical manufacturers in connection with patient utilization under the plan1 and the amount and percentage 7in the aggregate and disaggregated by type7 of such fees that are passed through to the plan sponsor or issuer4 2 and 7#c7 by adding at the end the following new subsection3 7e7 ,annual report ,the ,secretary shall make publicly available on the internet website of the ,centers for ,medicare ,medicaid ,services an annual report that summarizes the trends observed with respect to data reported under subsection 7b74 4 7b7 ,effective date ,the amendments made by this section shall apply to plan or contract years beginning on or after ,january #a1 #bjbg4 7c7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement the amendments made by this section by program instruction or otherwise4 7d7 ,non-,application of the paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act of #aiie71 shall not apply to the implementation of the amendments made by this section4 #aj4 ,facilitating midyear formulary changes for biosimilars 7a7 ,in general ,section #ahfj;,d-#d7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77 is amended by adding at the end the following new paragraph3 7#e7 ,mid-year changes in formularies permitted for certain biosimilar biological products and the reference product of such biosimilars ,if a ,,pdp sponsor of a prescription drug plan uses a formulary 7including the use of tiered cost-sharing71 the following shall apply3 7,a7 ,in general ,for plan year #bjbe1 and subsequent plan years1 in the case of a covered part ,d drug that is the reference biological product 7as defined in section #cea7;i7 of the ,public ,health ,service ,act7 with respect to a biosimilar biological product 7defined as a biological product licensed under section #cea7k7 of such ,act71 the ,,pdp sponsor may1 with respect to a formulary1 at any time after the first #fj days of the plan year1 subject to paragraph 7#c77;,e71 change the preferred or tiered cost-sharing status of such reference biological product if such ,,pdp sponsor adds1 before or at the same time1 to such formulary such biosimilar biological product at the same or a higher preferred status1 or to the same or lower cost-sharing tier1 as that of such reference biological product immediately prior to such change4 7,b7 ,request for approval of change ,prior to making a change described in subparagraph 7,a71 the ,,pdp sponsor shall submit to the ,secretary a request to make such change4 ,if the ,secretary approves the request or has not provided a decision to the ,,pdp sponsor regarding such request within #cj days of receiving such request1 such ,,pdp sponsor may make such change4 4 7b7 ,administration 7#a7 ,implementation ,notwithstanding any other provision of law1 the ,secretary of ,health and ,human ,services may implement the amendment made by subsection 7a7 by program instruction or otherwise4 7#b7 ,non-application of the ,paperwork ,reduction ,act ,chapter #ce of title #dd1 ,united ,states ,code 7commonly referred to as the ,paperwork ,reduction ,act of #aiie71 shall not apply to the implementation of the amendment made by subsection 7a74 #aa4 ,strengthening pharmacy access for seniors ,section #ahfj;,d-#d7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;b77#a77 is amended by adding at the end the following new subparagraph3 7,f7 ,limited access drugs 7i7 ,limitation on restrictions or limits on access ,for each plan year 7beginning with plan year #bjbf71 a ,,pdp sponsor offering a prescription drug plan-- 7,i7 may not restrict or limit access to any covered part ,d drug to a subset of their network pharmacies1 other than with respect to a limited access drug1 as defined in clause 7v72 and 7,,ii7 shall document the rationale for why a covered part ,d drug meets the definition of a limited access drug under clause 7v71 if such plan restricts or limits access to a limited access drug to a subset of network pharmacies4 7ii7 ,annual submission of information to the secretary on limited access drugs ,for each plan year 7beginning with plan year #bjbf71 each ,,pdp sponsor offering a prescription drug plan shall submit to the ,secretary1 at a time and in a manner specified by the ,secretary1 with respect to each prescription drug plan offered by the sponsor during such plan year-- 7,i7 a list of all covered part ,d drugs that the ,,pdp sponsor designated as a limited access drug2 7,,ii7 for each covered part ,d drug included in the list described in subclause 7,i71 a written rationale for why such drug meets the definition of a limited access drug2 7,,iii7 a summary of the requirements imposed on network pharmacies 7including all accreditation requirements1 if any7 to ensure appropriate handling and dispensing of each covered part ,d drug included in the list described in subclause 7,i72 7,,iv7 the percentages of each covered part ,d drug included in the list described in subclause 7,i7 that is dispensed through retail pharmacies1 specialty pharmacies1 mail order pharmacies1 or other dispensing channels as defined by the ,,pdp sponsor1 respectively2 7,v7 the annual percentage of each covered part ,d drug included in the list described in subclause 7,i7 that is dispensed through a pharmacy that is affiliated with the plan or is an affiliate 7as defined in section #ahfj;,d-#ab7;h77#d77;,a77 of a pharmacy benefit manager acting on behalf of such sponsor or such plan2 and 7,,vi7 any other information determined appropriate by the ,secretary4 7iii7 ,pharmacy access to limited access drug information ,for plan years beginning with plan year #bjbf1 upon the request of a network pharmacy1 a ,,pdp sponsor of a prescription drug plan shall provide such pharmacy1 not later than #ad days after receiving such request1 with the information described in subclauses 7,i71 7,,ii71 and 7,,iii7 of clause 7ii74 7iv7 ,,hhs annual report on limited access drugs ,not later than ,december #ca1 #bjbh1 and annually thereafter1 the ,secretary shall submit to the ,committee on ,finance of the ,senate1 and the ,committee on ,ways and ,means and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report on compliance by ,,pdp sponsors with the requirements under this subparagraph4 ,each such report shall include-- 7,i7 a description of the patterns1 trends1 variations1 and rationales for the designation by ,,pdp sponsors of certain covered part ,d drugs as limited access drugs1 and the implications of such designations on beneficiary access to such covered part ,d drugs2 7,,ii7 a description of the information submitted to the ,secretary under clause 7ii7 7in a manner that does not disclose the identity of a pharmacy1 a ,,pdp sponsor1 a prescription drug plan1 or pharmacy benefit manager1 or any proprietary pricing information72 and 7,,iii7 any other information determined appropriate by the ,secretary4 7v7 ,limited access drug defined ,in this subparagraph1 the term limited access drug means a covered part ,d drug that meets at least one of the following3 7,i7 ,the ,food and ,drug ,administration has restricted distribution of such covered part ,d drug to certain facilities or physicians4 7,,ii7 ,the dispensing of such covered part ,d drug requires extraordinary special handling1 provider coordination1 or patient education that cannot be met by a network pharmacy4 4 7vii7 ,implementation ,notwithstanding any other provision of law1 the ,secretary shall implement this subparagraph by program instruction or otherwise4 7viii7 ,nonapplication of paperwork reduction act ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any data collection undertaken by the ,secretary under this subparagraph4 4 #ab4 ,beneficiary-focused listening sessions to improve prescription drug plan transparency1 access1 and choice ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #g1 is amended by adding at the end the following new subsection3 7f7 ,beneficiary-,focused listening sessions ,to improve prescription drug plan transparency1 access1 and choice 7#a7 ,in general ,not later than ,december #ca1 #bjbd1 the ,secretary shall hold at least one beneficiary-focused listening session to receive input on potential improvements to the experience with1 and transparency of1 prescription drug plans under this part1 as described in paragraph 7#b74 7#b7 ,beneficiary-focused listening sessions ,any beneficiary-focused listening session held under paragraph 7#a7 shall be open to the public1 including beneficiaries1 caregivers of beneficiaries1 consumer and patient advocacy organizations1 health care providers1 and other interested parties4 ,any such listening sessions may include an opportunity for the public to provide input to the ,secretary on potential improvements to-- 7,a7 the information made available by prescription drug plans to individuals2 7,b7 tools and mechanisms to assist enrollees of prescription drug plans in navigating plan complaint systems1 as well as the efficiency and effectiveness of such systems2 7,c7 tools and mechanisms to assist beneficiaries in selecting a prescription drug plan2 7,d7 tools and mechanisms to assist enrollees of prescription drug plans in navigating utilization management requirements of such plans1 such as step therapy and prior authorization2 7,e7 access to1 and effectiveness and utilization of1 electronic real-time benefit tools 7as described in section #dbc4afj7;b77#g7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation7 and beneficiary real-time benefit tools 7as described in section #dbc4abh7;d77#d7 of title #db1 ,code of ,federal ,regulations1 or any successor regulation72 7,f7 formulary management and oversight by prescription drug plans2 and 7,g7 other subjects1 as determined appropriate by the ,secretary4 4 #ac4 ,reporting on enforcement and oversight of pharmacy access requirements ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #ab1 is amended by adding at the end the following new subsection3 7g7 ,biennial report on enforcement and oversight of pharmacy access requirements 7#a7 ,in general ,not later than #b years after the date of enactment of this subsection1 and at least once every #b years thereafter1 the ,secretary shall publish a report on enforcement and oversight actions and activities undertaken by the ,secretary with respect to the requirements under section #ahfj;,d-#d7;b77#a74 7#b7 ,limitation ,a report under paragraph 7#a7 shall not disclose-- 7,a7 identifiable information about individuals or entities unless such information is otherwise publicly available2 or 7,b7 trade secrets with respect to any entities4 4 #ad4 ,,gao study on price-related compensation across the supply chain ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #ac1 is amended by adding at the end the following new subsection3 7h7 ,,gao study and report on price-,related compensation and payment structures in the prescription drug supply chain 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall conduct a study describing the use of compensation and payment structures related to a prescription drug's price within the retail prescription drug supply chain in this part4 ,such study shall summarize information from ,federal agencies and industry experts1 to the extent available1 with respect to the following3 7,a7 ,the type1 magnitude1 other features 7such as the pricing benchmarks used71 and prevalence of compensation and payment structures related to a prescription drug's price1 such as calculating fee amounts as a percentage of a prescription drug's price1 between intermediaries in the prescription drug supply chain1 including-- 7i7 pharmacy benefit managers2 7ii7 part ,d plan sponsors2 7iii7 drug wholesalers2 7iv7 pharmacies2 7v7 manufacturers2 7vi7 pharmacy services administrative organizations2 7vii7 brokers1 auditors1 consultants1 and other entities that advise part ,d plan sponsors about pharmacy benefits or review part ,d plan sponsor contracts with pharmacy benefit managers2 and 7viii7 other service providers that contract with any of the entities described in clauses 7i7 through 7vii7 that may use price-related compensation and payment structures1 such as rebate aggregators 7or other entities that negotiate or process price concessions on behalf of pharmacy benefit managers1 plan sponsors1 or pharmacies74 7,b7 ,the primary business models and compensation structures for each category of intermediary described in subparagraph 7,a74 7,c7 ,variation in price-related compensation structures between affiliated entities 7such as entities with common ownership1 either full or partial1 and subsidiary relationships7 and unaffiliated entities4 7,d7 ,potential conflicts of interest among contracting entities related to the use of prescription drug price-related compensation structures1 such as the potential for fees or other payments set as a percentage of a prescription drug's price to advantage formulary selection1 distribution1 or purchasing of prescription drugs with higher prices4 7,e7 ,notable differences1 if any1 in the use and level of price-based compensation structures over time and between different market segments1 such as under this part and the ,medicaid program under title ,,xix4 7,f7 ,the effects of drug price-related compensation structures and alternative compensation structures on ,federal health care programs and program beneficiaries1 including with respect to cost-sharing1 premiums1 ,federal outlays1 biosimilar and generic drug adoption and utilization1 drug shortage risks1 and the potential for fees set as a percentage of a drug's price to advantage the formulary selection1 distribution1 or purchasing of drugs with higher prices4 7,g7 ,other issues determined to be relevant and appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than #b years after the date of enactment of this subsection1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 4 #ae4 ,reports on inappropriate pharmacy rejections ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #ad1 is amended by adding at the end the following new subsection3 7i7 ,biennial report on efforts ,to address inappropriate pharmacy rejections and inappropriate coverage denials under ,medicare part ,d 7#a7 ,in general ,not later than ,january #a1 #bjbf1 and at least once every #d years thereafter1 the ,secretary1 in consultation with the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 shall post1 on a publicly available website1 a report related to preventing1 identifying1 or addressing inappropriate pharmacy rejections 7as defined in paragraph 7#b77;,b77 and inappropriate coverage denials 7as defined in paragraph 7#b77;,a77 under this part4 ,such reports shall include-- 7,a7 a description of programs1 reviews1 or initiatives underway to prevent1 identify1 or address such rejections and denials1 in accordance with existing authorities2 7,b7 a summary of data collected or other information available with respect to such rejections and denials1 including-- 7i7 standards 7if any such standards have been adopted7 used by the ,secretary for identifying ,,pdp sponsors and ,,ma organizations with relatively high rates of such rejections or denials2 and 7ii7 notable longitudinal trends or other patterns1 as determined appropriate by the ,secretary2 7,c7 an overview of corrective actions taken and technical assistance provided by the ,secretary in response to violations of existing requirements with respect to such rejections and denials2 and 7,d7 a description of barriers1 if any1 preventing the ,secretary from taking administrative actions sufficient to identify and address such rejections and denials4 7#b7 ,definitions ,for purposes of this subsection3 7,a7 ,inappropriate coverage denial ,the term inappropriate coverage denial means a denial of coverage of a covered part ,d drug claim that violates the requirements of this part4 7,b7 ,inappropriate pharmacy rejections ,the term inappropriate pharmacy rejection means a rejection of a covered part ,d drug claim that violates the requirements of this part1 such as through the application of utilization management requirements that the ,secretary has not approved4 4 #af4 ,,gao study on drug shortages ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #ae1 is amended by adding at the end the following new subsection3 7j7 ,,gao study and report on drug shortages 7#a7 ,study ,the ,comptroller ,general of the ,united ,states 7in this subsection referred to as the ,comptroller ,general7 shall conduct a study on factors contributing to shortages of covered part ,d drugs across the outpatient prescription drug supply chain4 ,such study shall include analysis of-- 7,a7 common features of and trends in covered part ,d drugs that have experienced at least #a shortage 7as defined under section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act72 7,b7 patterns1 trends1 and variations in the duration of shortages experienced by covered part ,d drugs2 7,c7 patterns1 trends1 and variations in the proximate causes and other potential causes of shortages experienced by covered part ,d drugs2 7,d7 effects of such shortages on beneficiaries enrolled in prescription drug plans under this part1 including with respect to access to covered part ,d drugs and out-of-pocket costs2 and 7,e7 other issues determined appropriate by the ,comptroller ,general4 7#b7 ,report ,not later than #b years after the date of enactment of this subsection1 the ,comptroller ,general shall submit to ,congress a report containing the results of the study conducted under paragraph 7#a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4 4 #ag4 ,report on biosimilar and generic access under ,medicare part ,d ,section #ahfj;,d-#db of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#aeb71 as amended by section #af1 is amended by adding at the end the following new subsection3 7k7 ,,oig report on biosimilar and generic access under part d 7#a7 ,study ,the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services 7referred to in this subsection as the ,office of the ,inspector ,general7 shall conduct a study on biosimilar and generic drug access and adoption under prescription drug plans offered under this part1 including with respect to barriers to increased adoption and utilization of lower-priced biosimilar and generic utilization1 plan features that discourage or encourage the utilization of these products1 and the gross and net spending effects of policies that increased adoption of these products under this part4 7#b7 ,report ,not later than #a year after the date of enactment of this subsection1 the ,office of the ,inspector ,general shall publish a report on the study conducted under paragraph 7#a74 4 #ah4 ,medicare ,improvement ,fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is amended by striking during and after fiscal year #bjbb1 #ahj1jjj1jjj and inserting the following3 8during and after-- 7,a7 fiscal year #bjbb1 #ahj1jjj1jjj2 and 7,b7 fiscal year #bjbh1 #a1idg1jjj1jjj 4