,i #aafth ,,congress #ast ,session ,h4 ,r4 #ecjd ,,in ,,the ,,house ,,of ,,representatives ,december #d1 #bjai,mr4 ,schrader 7for himself and ,mr4 ,gianforte7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend title ,,xxvii of the ,public ,health ,service ,act to require health plan oversight of pharmacy benefit manager services1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,pbm ,transparency in ,prescription ,drug ,costs ,act4 #b4 ,health plan oversight of pharmacy benefit manager services ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following3 #bgbi;,a4 ,health plan oversight of pharmacy benefit manager services 7a7 ,in general ,a group health plan or health insurance issuer offering group or individual health insurance coverage or an entity or subsidiary providing pharmacy benefits management services shall not enter into a contract with a drug manufacturer1 distributor1 wholesaler1 subcontractor1 rebate aggregator1 or any associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or coverage1 or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or coverage from making the reports described in subsection 7b74 7b7 ,reports to group plan sponsors 7#a7 ,in general ,beginning with the first plan year that begins after the date of enactment of this section1 not less frequently than once every six months1 a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the self-funded group health plan and at the request of any other group health plan a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format4 ,each such report shall include1 with respect to the applicable group health plan or health insurance coverage-- 7,a7 information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by the drug manufacturer with respect to the enrollees in such plan or coverage2 7,b7 a list of each covered drug dispensed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 chemical entity1 and ,national ,drug ,code2 7ii7 the number of enrollees for whom the drug was filled during the plan year1 the total number of prescription fills for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the plan year1 including whether the dispensing channel was by retail1 mail order1 or specialty pharmacy2 7iii7 the wholesale acquisition cost1 listed as cost per days supply and cost per pill1 or in the case of a drug in another form1 per dose2 7iv7 the total out-of-pocket spending by enrollees on such drug1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for any drug for which gross spending of the group health plan or health insurance coverage exceeded #aj1jjj during the reporting period-- 7,i7 a list of all other available drugs in the same therapeutic category or class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class2 and 7,,ii7 the rationale for preferred formulary placement of a particular drug or drugs in that therapeutic category or class2 7,c7 a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic category or class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before manufacturer rebates1 fees1 or other manufacturer remuneration2 7ii7 the number of enrollees who filled a prescription for a drug in that category or class2 7iii7 if applicable to that category or class1 a description of the formulary tiers and utilization mechanisms 7such as prior authorization or step therapy7 employed for drugs in that category or class2 7iv7 the total out-of-pocket spending by enrollees1 including enrollee spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic category or class under which three or more drugs are marketed and available-- 7,i7 the amount received1 or expected to be received1 from drug manufacturers in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 to be paid by drug manufacturers for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs1 in such therapeutic category or class2 7,,ii7 the total net spending by the health plan or health insurance coverage on that category or class of drugs2 and 7,,iii7 the net price per dosage unit or course of treatment incurred by the health plan or health insurance coverage and its enrollees1 after manufacturer rebates1 fees1 and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or coverage during the reporting period1 before rebates and other manufacturer fees or remuneration2 7,e7 total amount received1 or expected to be received1 by the health plan or health insurance coverage in drug manufacturer rebates1 fees1 alternative discounts1 and all other remuneration received from the manufacturer or any third party related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period2 and 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of remuneration to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager4 7#b7 ,privacy requirements ,health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph 7#a7 in a manner consistent with the privacy1 security1 and breach notification regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7or successor regulations71 and shall restrict the use and disclosure of such information according to such privacy regulations4 7#c7 ,disclosure and redisclosure 7,a7 ,limitation to business associates ,a group health plan receiving a report under paragraph 7#a7 may disclose such information only to business associates of such plan as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,clarification regarding public disclosure of information ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph 7#a74 7c7 ,limitations on spread pricing 7#a7 ,pass-through offering to plan ,a designated plan administrator of an applicable self-insured health plan1 or an entity providing pharmacy benefit management services to such health plan shall offer at least one contractual arrangement that does not charge the plan or enrollee1 a price for a prescription drug that exceeds the price paid to the pharmacy1 excluding penalties or fees paid by pharmacies to such plan1 issuer1 or entity4 7#b7 ,default to pass-through pricing ,for purposes of paragraph 7#a71 a designated plan administrator of an applicable self-insured health plan1 or an entity providing pharmacy benefit management services to such health plan shall not charge the plan or enrollee an amount for a presciption drug that exceeds the price paid to the pharmacy1 excluding penalties paid by pharmacies to such plan or entity1 without the express permission of the health plan sponsor4 7#c7 ,supplementary reporting for intra-company prescription drug transactions ,a health insurance issuer of group health insurance coverage or an entity providing pharmacy benefits management services under a group health plan or group health insurance coverage that conducts transactions with a wholly or partially owned pharmacy1 as described in paragraph 7#b71 shall submit1 together with the report under subsection 7b71 a supplementary quarterly report to the plan sponsor that includes-- 7,a7 an explanation of any benefit design parameters that encourage enrollees in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are wholly or partially owned by that issuer or entity2 7,b7 the percentage of total prescriptions charged to the plan1 coverage1 or enrollees in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are wholly or partially owned by the issuer or entity providing pharmacy benefits management services2 and 7,c7 a list of all drugs dispensed by such wholly or partially owned pharmacy and charged to the plan or coverage1 or enrollees of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7i7 the amount charged per dosage unit or course of treatment with respect to enrollees in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the enrollee2 7ii7 the median amount charged to the plan or coverage1 per dosage unit or course of treatment1 and including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 7iii7 the interquartile range of the costs1 per dosage unit or course of treatment1 and including amounts paid by the enrollee1 when the same drug is dispensed by other pharmacies that are not wholly or partially owned by the issuer or entity and that are included in the pharmacy network of that plan or coverage2 and 7iv7 the lowest cost per dosage unit or course of treatment1 for such drug1 including amounts charged to the plan or issuer and enrollee1 that is available from any pharmacy included in the network of the plan or coverage4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall remit #ajj percent of rebates1 fees1 alternative discounts1 and all other remuneration received from a pharmaceutical manufacturer1 distributor or any other third party1 that are related to utilization of drugs under such health plan or health insurance coverage1 to the health plan issuer4 7#b7 ,form and manner of remittance ,such rebates1 fees1 alternative discounts1 and other remuneration shall be-- 7,a7 remitted to the group health plan in a timely fashion after the period for which such rebates1 fees1 or other remuneration is calculated1 and in no case later than #abj days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in 7b77#a72 7,c7 available for audit by the plan sponsor1 or a third party designated by a plan sponsor no less than once per plan year2 and 7,d7 returned to the issuer or entity providing pharmaceutical benefit management services by the group health plan if audits by such issuer or entity indicate that the amounts received are incorrect after such amounts have been paid to the group health plan4 7#c7 ,audit of rebate contracts ,a pharmacy benefits manager1 a third-party administrator of a group health plan1 a health insurance issuer offering a group health insurance coverage1 or an entity providing pharmacy benefits management services under such health plan or health insurance coverage shall make rebate contracts with drug manufacturers available for audit by such plan sponsor or designated third party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of the ,treasury1 shall enforce this section4 7#b7 ,failure ,to provide timely information ,a health insurance issuer or an entity providing pharmacy benefit management services that violates subsection 7a71 fails to provide information required under subsection 7b71 engages in spread pricing as defined in subsection 7c71 or fails to comply with the requirements of subsection 7d71 or a drug manufacturer that fails to provide information under subsection 7b77#a77;,a71 in a timely manner shall be subject to a civil monetary penalty in the amount of #aj1jjj for each day during which such violation continues or such information is not disclosed or reported4 7#c7 ,false information ,a health insurance issuer1 entity providing pharmacy benefit management services1 or drug manufacturer that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalty shall be in addition to other penalties as may be prescribed by law4 7#d7 ,procedure ,the provisions of section #aabh;,a of the ,social ,security ,act1 other than subsections 7a7 and 7b7 and the first sentence of subsection 7c77#a7 of such section shall apply to civil monetary penalties under this subsection in the same manner as such provisions apply to a penalty or proceeding under section #aabh;,a of the ,social ,security ,act4 7#e7 ,safe harbor ,the ,secretary may waive penalties under paragraph 7#b71 or extend the period of time for compliance with a requirement of this section1 for an entity in violation of this section that has made a good-faith effort to comply with this section4 7f7 ,rule of construction ,nothing in this section shall be construed to prohibit entities providing pharmacy benefits management services from retaining bona fide service fees1 provided that such fees are transparent to group health plans and health insurance issuers and are not linked directly to the price or formulary placement or position of a drug4 7g7 ,definitions ,in this section-- 7#a7 the term similarly situated pharmacy means1 with respect to a particular pharmacy1 another pharmacy that is approximately the same size 7as measured by the number of prescription drugs dispensed71 and that serves patients in the same geographical area1 whether through physical locations or mail order2 7#b7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act2 and 7#c7 the term bona fide service fees means fees paid by a manufacturer1 customer1 or client 7other than a group health plan or health insurance issuer7 of an entity providing pharmacy benefit management services1 to an entity providing pharmacy benefit management services1 that represent fair market value for bona fide1 itemized services actually performed on behalf of the manufacturer1 customer1 or client would otherwise perform or contract for in the absence of the service arrangement1 without prior consent for any specific arrangements4 4 #c4 ,third-party administrators ,any obligation on a third-party administrator under this ,act 7including the amendment made by this ,act7 shall not affect any other direct or indirect requirement under any other provision of ,federal law that applies to third-party administrators offering services to group health plans4