,,ii ,calendar ,no4 #aac #aahth ,,congress #ast ,session ,s4 #acci ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,april #bg1 #bjbc,mr4 ,sanders 7for himself1 ,mr4 ,cassidy1 ,mrs4 ,murray1 ,mr4 ,marshall1 and ,mr4 ,braun7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,june #bb1 #bjbc,reported by ,mr4 ,sanders1 with an amendment,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to provide for increased oversight of entities that provide pharmacy benefit management services on behalf of group health plans and health insurance coverage4 #a4 ,short title ,this ,act may be cited as the ,pharmacy ,benefit ,manager ,reform ,act4 #b4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,,phsa ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended-- 7#a7 in part ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by adding at the end the following new section3 #bgii;,a-#aa4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a group health plan or health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of such a plan or issuer shall not enter into a contract with an applicable entity that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 from making the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan shall submit to the plan sponsor of such covered group health plan a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format and1 as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan-- 7,a7 as applicable1 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 participants and beneficiaries in such plan2 7,b7 a list of each drug covered by such plan or entity providing pharmacy benefit management services that was billed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom the drug was billed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan or coverage1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or coverage2 and 7vi7 for any drug for which gross spending by the plan exceeded #aj1jjj and that is one of the #ej prescription drugs for which the group health plan spent the most on prescription drug benefits during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 and 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary2 7,c7 a list of each therapeutic class of drugs that were dispensed under the health plan during the reporting period1 and1 with respect to each such therapeutic class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before rebates1 fees1 alternative discounts1 or other remuneration2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan-- 7,i7 the amount received1 or expected to be received1 by such entity1 from an applicable entity1 in rebates1 fees1 alternative discounts1 or other remuneration that-- 7aa7 has been paid1 or will be paid1 by such an applicable entity for claims incurred during the reporting period2 or 7bb7 is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the health plan on that class of drugs2 and 7,,iii7 the net price per typical course of treatment or #cj-;day supply incurred by the health plan and its participants and beneficiaries1 after rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity1 for drugs dispensed within such therapeutic class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan during the reporting period1 before rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity2 7,e7 the total amount received1 or expected to be received1 by the health plan1 from an applicable entity1 in rebates1 fees1 alternative discounts1 and other remuneration received from any such entities1 related to utilization of drug or drug spending under that health plan during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act of #aigd7 to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's business to the pharmacy benefit manager2 and 7,h7 a summary document that includes such information described in subparagraphs 7,a7 through 7,g7 as the ,secretary determines useful for plan sponsors for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary4 7#b7 ,supplementary reporting for intra-company prescription drug transactions 7,a7 ,in general ,a health insurance issuer offering covered group health insurance coverage or an entity providing pharmacy benefit management services under a covered group health plan or covered group health insurance coverage shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes-- 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries 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 entity providing pharmacy benefit management services under such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and copayment incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan1 coverage1 or participants and beneficiaries 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 benefit management services2 and 7iii7 a list of all drugs dispensed by such wholly or partially-owned pharmacy and charged to the plan or coverage1 or participants and beneficiaries of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7,i7 the amounts charged1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the participants and beneficiaries2 7,,ii7 the median amount charged to the plan or coverage1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 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 7,,iii7 the interquartile range of the costs1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 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 7,,iv7 the lowest cost1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan or coverage2 7,v7 the net acquisition cost per dosage unit and for a #cj day-supply1 and the acquisition cost per typical course of treatment1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit1 per typical course of treatment1 or per #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries among all pharmacies included in the network of the plan or coverage4 7,b7 ,plans and coverage offered by small employers ,a health insurance issuer offering covered group health insurance coverage that is not covered group health insurance coverage or an entity providing pharmacy benefit management services under a group health plan that is not a covered group health plan or under group health insurance coverage that is not covered group health insurance coverage that conducts transactions with a wholly or partially-owned pharmacy shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes the information described in clauses 7i7 and 7ii7 of subparagraph 7,a74 7#c7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the privacy1 security1 breach notification1 and enforcement regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#b7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or group health insurance coverage from placing reasonable restrictions on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#b74 7ii7 ,limitations ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or group health insurance coverage may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#d7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#b7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to the regulations promulgated by the ,secretary of ,health and ,human ,services under part ,c of title ,,xi of the ,social ,security ,act and section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif1 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations7 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#e7 ,additional reporting 7,a7 ,reporting with respect to group health plans offered by small employers ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 and make such report available to the plan sponsor in a machine-readable format1 and such other formats as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may determine4 ,each such report shall include1 with respect to the applicable group health plan1 the information described in subparagraphs 7,a71 7,d71 7,e71 7,f71 7,g71 and 7,h7 of paragraph 7#a74 7,b7 ,opt-in for group health insurance coverage 7i7 ,in general ,a plan sponsor may1 on an annual basis1 beginning with plan years beginning on or after ,january #a1 #bjbe1 elect to require a health insurance issuer offering group health insurance coverage to submit to such plan sponsor a report in accordance with this subsection4 7ii7 ,contents of reports 7,i7 ,covered group health insurance coverage ,in the case of an issuer that offers covered group health insurance coverage1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable covered group health insurance coverage1 the information required under paragraph 7#a7 for covered group health plans4 7,,ii7 ,other group health insurance coverage ,in the case of an issuer that offers group health insurance coverage that is not covered group health insurance1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable group health insurance coverage1 the information described in subparagraphs 7,a71 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a74 7iii7 ,application ,for purposes of reports submitted in accordance with this subparagraph1 paragraph 7#a7 shall be applied by substituting group health insurance coverage or health insurance issuer1 as applicable1 for group health plan1 group plan1 and plan where such terms appear in such paragraph4 7iv7 ,required reporting for all group health insurance coverage ,each health insurance issuer of health insurance coverage shall annually submit the information described in paragraph 7#a77;,h71 regardless of whether the plan sponsor made the election described in clause 7i7 for the applicable year4 7#f7 ,submissions to ,,gao ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan shall submit to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#e7 with respect to such coverage or plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#c71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall specify1 through rulemaking1 standard formats for health insurance issuers and entities providing pharmacy benefit management services to submit reports required under this subsection4 7,b7 ,limited form of report ,the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall define through rulemaking a limited form of the reports under paragraphs 7#a7 and 7#b7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in order to prevent anti-competitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a group health plan or health insurance issuer offering group or individual health insurance coverage shall not charge participants and beneficiaries1 and an entity providing pharmacy benefit management services under such a plan or coverage shall not charge the plan1 issuer1 or participants and beneficiaries1 a price for a prescription drug that exceeds the price paid to the pharmacy for such drug1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan1 issuer1 or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan1 issuer1 or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan1 issuer1 or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan1 issuer1 or entity4 7,c7 ,a penalty paid if the pharmacist services billed to the plan1 issuer1 or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services under such health plan or health insurance coverage shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs under such health plan or health insurance coverage1 to the group health plan2 and 7,b7 ensure that any contract entered into by such third-party administrator1 health insurance issuer1 or entity providing pharmacy benefit management services with an applicable entity remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received to the third-party administrator1 health insurance issuer1 or entity providing pharmacy benefit management services4 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 or group health insurance coverage in a timely fashion after the period for which such rebates1 fees1 alternative discounts1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in paragraphs 7#a7 and 7#d7 of subsection 7b72 7,c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor not 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 third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services under such health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third-party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7#d7 ,auditors ,the applicable plan sponsor may select an auditor for purposes of carrying out audits under paragraphs 7#b77;,c7 and 7#c74 7#e7 ,rule of construction ,nothing in this subsection shall be construed to prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not contemplated by this subsection1 provided that such fees are transparent to group health plans and health insurance issuers4 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 7a7 or fails to provide information required under subsection 7b72 a group health plan1 health insurance issuer1 or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services that violates subsection 7d7 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 ,waivers ,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 permit a health insurance issuer1 group health plan1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,department of ,health and ,human ,services to a report described in subsection 7b77#a7 or information related to compliance with subsection 7a7 by such issuer1 plan1 or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 a drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 group purchasing organization1 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may specify through rulemaking2 7#b7 the term covered group health insurance coverage means health insurance coverage offered in connection with a group health plan maintained by a large employer2 7#c7 the term covered group health plan means a group health plan maintained by a large employer2 7#d7 the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#e7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#f7 the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#g7 the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd2 7#h7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 through notice and comment rulemaking2 7#i7 the term small employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #a but not more than #di employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 and 7#aj7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 2 and 7#b7 in section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7ii7 in paragraph 7#b71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 7ii7 in paragraph 7#b77;,a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7iii7 in paragraph 7#b77;,c77ii71 by inserting 7other than section #bgii;,a-#aa7 after part ,d4 7b7 ,,erisa 7#a7 ,in general ,subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is amended-- 7,a7 in subpart ,b of part #g 7#bi ,u4,s4,c4 #aahe et seq471 by adding at the end the following3 #gbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a group health plan 7or health insurance issuer offering group health insurance coverage in connection with such a plan7 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer shall not enter into a contract with an applicable entity that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 from making the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan shall submit to the plan sponsor of such covered group health plan a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format and1 as the ,secretary may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan-- 7,a7 as applicable1 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 participants and beneficiaries in such plan2 7,b7 a list of each drug covered by such plan or entity providing pharmacy benefit management services that was billed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom the drug was billed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan or coverage1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or coverage2 and 7vi7 for any drug for which gross spending by the plan exceeded #aj1jjj and that is one of the #ej prescription drugs for which the group health plan spent the most on prescription drug benefits during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 and 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary2 7,c7 a list of each therapeutic class of drugs that were dispensed under the health plan during the reporting period1 and1 with respect to each such therapeutic class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before rebates1 fees1 alternative discounts1 or other remuneration2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan-- 7,i7 the amount received1 or expected to be received1 by such entity1 from an applicable entity1 in rebates1 fees1 alternative discounts1 or other remuneration that-- 7aa7 has been paid1 or will be paid1 by such an applicable entity for claims incurred during the reporting period2 or 7bb7 is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the health plan on that class of drugs2 and 7,,iii7 the net price per typical course of treatment or #cj-;day supply incurred by the health plan and its participants and beneficiaries1 after rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity1 for drugs dispensed within such therapeutic class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan during the reporting period1 before rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity2 7,e7 the total amount received1 or expected to be received1 by the health plan1 from an applicable entity1 in rebates1 fees1 alternative discounts1 and other remuneration received from any such entities1 related to utilization of drug or drug spending under that health plan during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa77 to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's business to the pharmacy benefit manager2 and 7,h7 a summary document that includes such information described in subparagraphs 7,a7 through 7,g7 as the ,secretary determines useful for plan sponsors for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary4 7#b7 ,supplementary reporting for intra-company prescription drug transactions 7,a7 ,in general ,a health insurance issuer offering covered group health insurance coverage or an entity providing pharmacy benefit management services under a covered group health plan or covered group health insurance coverage shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes-- 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries 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 entity providing pharmacy benefit management services under such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and copayment incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan1 coverage1 or participants and beneficiaries 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 benefit management services2 and 7iii7 a list of all drugs dispensed by such wholly or partially-owned pharmacy and charged to the plan or coverage1 or participants and beneficiaries of the plan or coverage1 during the applicable quarter1 and1 with respect to each drug-- 7,i7 the amounts charged1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan or coverage1 including amounts charged to the plan or coverage and amounts charged to the participants and beneficiaries2 7,,ii7 the median amount charged to the plan or coverage1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 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 7,,iii7 the interquartile range of the costs1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 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 7,,iv7 the lowest cost1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan or coverage2 7,v7 the net acquisition cost per dosage unit and for a #cj day-supply1 and the acquisition cost per typical course of treatment1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit1 per typical course of treatment1 or per #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries among all pharmacies included in the network of the plan or coverage4 7,b7 ,plans and coverage offered by small employers ,a health insurance issuer offering covered group health insurance coverage that is not covered group health insurance coverage or an entity providing pharmacy benefit management services under a group health plan that is not a covered group health plan or under group health insurance coverage that is not covered group health insurance coverage that conducts transactions with a wholly or partially-owned pharmacy shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes the information described in clauses 7i7 and 7ii7 of subparagraph 7,a74 7#c7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the privacy1 security1 breach notification1 and enforcement regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#b7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or group health insurance coverage from placing reasonable restrictions on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#b74 7ii7 ,limitations ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or group health insurance coverage may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#d7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#b7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to the regulations promulgated by the ,secretary of ,health and ,human ,services under part ,c of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 and section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b71 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations7 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#e7 ,additional reporting 7,a7 ,reporting with respect to group health plans offered by small employers ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 and make such report available to the plan sponsor in a machine-readable format1 and such other formats as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor may determine4 ,each such report shall include1 with respect to the applicable group health plan1 the information described in subparagraphs 7,a71 7,d71 7,e71 7,f71 7,g71 and 7,h7 of paragraph 7#a74 7,b7 ,opt-in for group health insurance coverage 7i7 ,in general ,a plan sponsor may1 on an annual basis1 beginning with plan years beginning on or after ,january #a1 #bjbe1 elect to require a health insurance issuer offering group health insurance coverage to submit to such plan sponsor a report in accordance with this subsection4 7ii7 ,contents of reports 7,i7 ,covered group health insurance coverage ,in the case of an issuer that offers covered group health insurance coverage1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable covered group health insurance coverage1 the information required under paragraph 7#a7 for covered group health plans4 7,,ii7 ,other group health insurance coverage ,in the case of an issuer that offers group health insurance coverage that is not covered group health insurance1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable group health insurance coverage1 the information described in subparagraphs 7,a71 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a74 7iii7 ,application ,for purposes of reports submitted in accordance with this subparagraph1 paragraph 7#a7 shall be applied by substituting group health insurance coverage or health insurance issuer1 as applicable1 for group health plan1 group plan1 and plan where such terms appear in such paragraph4 7iv7 ,required reporting for all group health insurance coverage ,each health insurance issuer of health insurance coverage shall annually submit the information described in paragraph 7#a77;,h71 regardless of whether the plan sponsor made the election described in clause 7i7 for the applicable year4 7#f7 ,submissions to ,,gao ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan shall submit to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#e7 with respect to such coverage or plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#c71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall specify1 through rulemaking1 standard formats for health insurance issuers and entities providing pharmacy benefit management services to submit reports required under this subsection4 7,b7 ,limited form of report ,the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall define through rulemaking a limited form of the reports under paragraphs 7#a7 and 7#b7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in order to prevent anti-competitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a group health plan or health insurance issuer offering group health insurance coverage shall not charge participants and beneficiaries1 and an entity providing pharmacy benefit management services under such a plan or coverage shall not charge the plan1 issuer1 or participants and beneficiaries1 a price for a prescription drug that exceeds the price paid to the pharmacy for such drug1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan1 issuer1 or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan1 issuer1 or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan1 issuer1 or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan1 issuer1 or entity4 7,c7 ,a penalty paid if the pharmacist services billed to the plan1 issuer1 or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services under such health plan or health insurance coverage shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other applicable remuneration received from any applicable entity that are related to utilization of drugs under such health plan or health insurance coverage1 to the group health plan2 and 7,b7 ensure that any contract entered into by such third-party administrator1 health insurance issuer1 or entity providing pharmacy benefit management services with an applicable entity remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received to the third-party administrator1 health insurance issuer1 or entity providing pharmacy benefit management services4 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 or group health insurance coverage in a timely fashion after the period for which such rebates1 fees1 alternative discounts1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in paragraphs 7#a7 and 7#d7 of subsection 7b72 7,c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor not 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 third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services under such health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third-party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7#d7 ,auditors ,the applicable plan sponsor may select an auditor for purposes of carrying out audits under paragraphs 7#b77;,c7 and 7#c74 7#e7 ,rule of construction ,nothing in this subsection shall be construed to prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not contemplated by this subsection1 provided that such fees are transparent to group health plans and health insurance issuers4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,health and ,human ,services 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 7a7 or fails to provide information required under subsection 7b72 a group health plan1 health insurance issuer1 or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services that violates subsection 7d7 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 ,waivers ,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 permit a health insurance issuer1 group health plan1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,department of ,labor to a report described in subsection 7b77#a7 or information related to compliance with subsection 7a7 by such issuer1 plan1 or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 a drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 group purchasing organization1 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may specify through rulemaking2 7#b7 the term covered group health insurance coverage means health insurance coverage offered in connection with a group health plan maintained by a large employer2 7#c7 the term covered group health plan means a group health plan maintained by a large employer2 7#d7 the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#e7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#f7 the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#g7 the term plan sponsor has the meaning given such term in section #c7af77;,b72 7#h7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury1 through notice and comment rulemaking2 7#i7 the term small employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #a but not more than #di employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 and 7#aj7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 and 7,b7 in section #ejb7;b77#c7 7#bi ,u4,s4,c4 #aacb7;b77#c771 by inserting 7other than section #gbf7 after part #g4 7#b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gbe the following new item3 ,sec4 #gbf4 ,oversight of entities that provide pharmacy benefit management services4 4 7c7 ,internal ,revenue ,code 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following3 #ihbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a group health plan or an entity providing pharmacy benefit management services on behalf of such a plan shall not enter into a contract with an applicable entity that limits the disclosure of information to plan sponsors in such a manner that prevents the plan1 or an entity providing pharmacy benefit management services on behalf of a plan1 from making the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan shall submit to the plan sponsor of such covered group health plan a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format and1 as the ,secretary may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan-- 7,a7 as applicable1 information collected from drug manufacturers by such 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 participants and beneficiaries in such plan2 7,b7 a list of each drug covered by such plan or entity providing pharmacy benefit management services that was billed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom the drug was billed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug dispensed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days supply1 cost per dosage unit1 and cost per typical course of treatment 7as applicable72 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles1 but not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted to the plan2 and 7vi7 for any drug for which gross spending by the plan exceeded #aj1jjj and that is one of the #ej prescription drugs for which the group health plan spent the most on prescription drug benefits during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class1 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 and 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary2 7,c7 a list of each therapeutic class of drugs that were dispensed under the health plan during the reporting period1 and1 with respect to each such therapeutic class of drugs1 during the reporting period-- 7i7 total gross spending by the plan1 before rebates1 fees1 alternative discounts1 or other remuneration2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries1 including participant and beneficiary spending through copayments1 coinsurance1 and deductibles2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan-- 7,i7 the amount received1 or expected to be received1 by such entity1 from an applicable entity1 in rebates1 fees1 alternative discounts1 or other remuneration that-- 7aa7 has been paid1 or will be paid1 by such an applicable entity for claims incurred during the reporting period2 or 7bb7 is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the health plan on that class of drugs2 and 7,,iii7 the net price per typical course of treatment or #cj-;day supply incurred by the health plan and its participants and beneficiaries1 after rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity1 for drugs dispensed within such therapeutic class during the reporting period2 7,d7 total gross spending on prescription drugs by the plan during the reporting period1 before rebates1 fees1 alternative discounts1 or other remuneration provided by an applicable entity2 7,e7 the total amount received1 or expected to be received1 by the health plan1 from an applicable entity1 in rebates1 fees1 alternative discounts1 and other remuneration received from any such entities1 related to utilization of drug or drug spending under that health plan during the reporting period2 7,f7 the total net spending on prescription drugs by the health plan during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,a777 to brokers1 consultants1 advisors1 or any other individual or firm who referred the group health plan's business to the pharmacy benefit manager2 and 7,h7 a summary document that includes such information described in subparagraphs 7,a7 through 7,g7 as the ,secretary determines useful for plan sponsors for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary4 7#b7 ,supplementary reporting for intra-company prescription drug transactions 7,a7 ,in general ,an entity providing pharmacy benefit management services under a covered group health plan shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes-- 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order1 specialty1 or retail pharmacies that are wholly or partially-owned by that entity providing pharmacy benefit management services under such plan1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and copayment incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan or participants and beneficiaries in the plan1 that were dispensed by mail order1 specialty1 or retail pharmacies that are wholly or partially-owned by the entity providing pharmacy benefit management services2 and 7iii7 a list of all drugs dispensed by such wholly or partially-owned pharmacy and charged to the plan1 or participants and beneficiaries of the plan1 during the applicable quarter1 and1 with respect to each drug-- 7,i7 the amounts charged1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan1 including amounts charged to the plan and amounts charged to the participants and beneficiaries2 7,,ii7 the median amount charged to the plan1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not wholly or partially-owned by the entity and that are included in the pharmacy network of that plan2 7,,iii7 the interquartile range of the costs1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not wholly or partially-owned by the entity and that are included in the pharmacy network of that plan2 7,,iv7 the lowest cost1 per dosage unit1 per course of treatment1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan2 7,v7 the net acquisition cost per dosage unit and for a #cj day-supply1 and the acquisition cost per typical course of treatment1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit1 per typical course of treatment1 or per #cj-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries among all pharmacies included in the network of the plan4 7,b7 ,plans offered by small employers ,an entity providing pharmacy benefit management services under a group health plan that is not a covered group health plan that conducts transactions with a wholly or partially-owned pharmacy shall submit1 together with the report under paragraph 7#a71 a supplementary report every #f months to the plan sponsor that includes the information described in clauses 7i7 and 7ii7 of subparagraph 7,a74 7#c7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the privacy1 security1 breach notification1 and enforcement regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#b7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents an entity providing pharmacy benefit management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#b74 7ii7 ,limitations ,an entity providing pharmacy benefit management services on behalf of a group health plan or group health insurance coverage may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#d7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#b7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#b7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to the regulations promulgated by the ,secretary of ,health and ,human ,services under part ,c of title ,,xi of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d et seq47 and section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b71 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations7 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#e7 ,reporting with respect to group health plans offered by small employers ,for plan years beginning on or after ,january #a1 #bjbe1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 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 plan1 the information described in subparagraphs 7,a71 7,d71 7,e71 7,f71 7,g71 and 7,h7 of paragraph 7#a74 7#f7 ,submissions to ,,gao ,an entity providing pharmacy benefit management services on behalf of a group health plan shall submit to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#e7 with respect to such plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#c71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor shall specify1 through rulemaking1 standard formats for health insurance issuers and entities providing pharmacy benefit management services to submit reports required under this subsection4 7,b7 ,limited form of report ,the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor shall define through rulemaking a limited form of the reports under paragraphs 7#a7 and 7#b7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in order to prevent anti-competitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,a group health plan shall not charge participants and beneficiaries1 and an entity providing pharmacy benefit management services under such a plan shall not charge the plan or participants and beneficiaries1 a price for a prescription drug that exceeds the price paid to the pharmacy for such drug1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan1 issuer1 or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan or entity4 7,c7 ,a penalty paid if the pharmacist services billed to the plan or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-,through to plan 7#a7 ,in general ,for plan years beginning on or after ,january #a1 #bjbe1 a third-party administrator of a group health plan or an entity providing pharmacy benefit management services under such health plan shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs under such health plan1 to the group health plan2 and 7,b7 ensure that any contract entered into by such third-party administrator or entity providing pharmacy benefit management services with an applicable entity remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received to the third-party administrator or entity providing pharmacy benefit management services4 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 alternative discounts1 or other remuneration is calculated1 and in no case later than #ij days after the end of such period2 7,b7 fully disclosed and enumerated to the group health plan sponsor1 as described in paragraphs 7#a7 and 7#d7 of subsection 7b72 7,c7 available for audit by the plan sponsor1 or a third-party designated by a plan sponsor not 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 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 third-party administrator of a group health plan or an entity providing pharmacy benefit management services under such health plan shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by such plan sponsor or designated third-party1 subject to confidentiality agreements to prevent re-disclosure of such contracts4 7#d7 ,auditors ,the applicable plan sponsor may select an auditor for purposes of carrying out audits under paragraphs 7#b77;,c7 and 7#c74 7#e7 ,rule of construction ,nothing in this subsection shall be construed to prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not contemplated by this subsection1 provided that such fees are transparent to group health plans4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary1 in consultation with the ,secretary of ,labor and the ,secretary of ,health and ,human ,services1 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 7a7 or fails to provide information required under subsection 7b72 a group health plan or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan or an entity providing pharmacy benefit management services that violates subsection 7d7 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 ,an 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 ,waivers ,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 permit a group health plan or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,department of the ,treasury to a report described in subsection 7b77#a7 or information related to compliance with subsection 7a7 by such plan or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 a drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 group purchasing organization1 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor may specify through rulemaking2 7#b7 the term covered group health insurance coverage means health insurance coverage offered in connection with a group health plan maintained by a large employer2 7#c7 the term covered group health plan means a group health plan maintained by a large employer2 7#d7 the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#e7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#f7 the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of manufacturer rebates1 fees1 alternative discounts1 or other remuneration2 7#g7 the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b772 7#h7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services1 through notice and comment rulemaking2 7#i7 the term small employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #a but not more than #di employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 and 7#aj7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new item3 ,sec4 #ihbf4 ,oversight of entities that provide pharmacy benefit management services4 4 7d7 ,funding 7#a7 ,for purposes of carrying out the amendments made by subsection 7a71 there are appropriated to the ,centers for ,medicare ,medicaid ,services1 out of amounts in the ,treasury not otherwise appropriated1 #hj1jjj1jjj for fiscal year #bjbd4 7#b7 ,for purposes of carrying out the amendments made by subsection 7b71 there are appropriated to the ,department of ,labor1 out of amounts in the ,treasury not otherwise appropriated1 #dc1gej1jjj for fiscal year #bjbd4 7e7 ,,aspe ,study ,the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services shall conduct or commission a study on how the ,united ,states health care market would be impacted by potential regulatory changes disallowing manufacturer rebates in the manner and to the extent allowed on the date of enactment of this ,act1 with a focus on the impact to stakeholders in the commercial insurance market1 and1 not later than #a year after the date of enactment of this ,act1 submit a report to ,congress on the results of such study4 ,such study and report shall consider the following3 7#a7 ,the impact on the impact of making no such regulatory changes1 as well as potential behavioral changes by plan sponsors1 members1 and pharmaceutical manufacturers1 such as tighter formularies1 changes to price concessions1 changes in utilization1 if such regulatory changes are made4 7#b7 ,the mechanics needed in the pharmaceutical supply chain 7whether existing or not7 to move a manufacturer rebate to the point of sale4 7#c7 ,the feasibility of a partial point-of-sale manufacturer rebate versus a full point-of-sale manufacturer rebate4 7#d7 ,the impact on patient out-of-pocket costs1 premiums1 and other cost-sharing4 7#e7 ,possible behavioral changes by other third parties in the pharmaceutical supply chain including drug manufacturer1 distributor1 wholesaler1 rebate aggregators1 pharmacy services administrative organizations1 or group purchasing organizations4 7#f7 ,behavioral changes between entities that contract with pharmaceutical manufacturers and pharmaceutical supply chain4 7#g7 ,alternative price negotiation mechanisms1 including the impact of the ,act of ,june #ai1 #aicf 7commonly known as the ,robinson-,patman ,act2 #di ,stat4 #aebf1 chapter #eib2 #ae ,u4,s4,c4 #ac;a et seq471 and the amendments made by that ,act1 on drug pricing negotiations4 7#h7 ,the impact on pharmacies1 including pharmacy rebates1 pharmacy fees1 and dispensing channels4 7f7 ,,gao study 7#a7 ,in general ,not later than ,january #a1 #bjbi1 the ,comptroller ,general of the ,united ,states shall report to ,congress on-- 7,a7 pharmacy networks of group health plans1 health insurance issuers1 and entities providing pharmacy benefit management services under such group health plan or group or individual health insurance coverage1 including networks that have pharmacies that are under common ownership 7in whole or part7 with group health plans1 health insurance issuers1 or entities providing pharmacy benefit management services or pharmacy benefit administrative services under group health plan or group or individual health insurance coverage2 7,b7 as it relates to pharmacy networks that include pharmacies under common ownership described in subparagraph 7,a7-- 7i7 whether such networks are designed to encourage participants and beneficiaries of a plan or coverage to use such pharmacies over other network pharmacies for specific services or drugs1 and if so1 the reasons the networks give for encouraging use of such pharmacies2 and 7ii7 whether such pharmacies are used by participants and beneficiaries disproportionately more in the aggregate or for specific services or drugs compared to other network pharmacies2 7,c7 whether group health plans and health insurance issuers offering group or individual health insurance coverage have options to elect different network pricing arrangements in the marketplace with entities that provide pharmacy benefit management services1 the prevalence of electing such different network pricing arrangements2 7,d7 pharmacy network design parameters that encourage participants and beneficiaries 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 and 7,e7 the degree to which mail order1 specialty1 or retail pharmacies that dispense prescription drugs to participants and beneficiaries in a group health plan or health insurance coverage that are under common ownership 7in whole or part7 with group health plans1 health insurance issuers1 or entities providing pharmacy benefit management services or pharmacy benefit administrative services under group health plan or group or individual health insurance coverage receive reimbursement that is greater than the median price charged to the group health plan or health insurance issuer when the same drug is dispensed to participants and beneficiaries in the plan or coverage by other pharmacies included in the pharmacy network of that plan1 issuer1 or entity that are not wholly or partially owned by the health insurance issuer or entity providing pharmacy benefit management services4 7#b7 ,requirement ,in carrying out paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall not disclose-- 7,a7 information that would allow for identification of a specific individual1 plan sponsor1 health insurance issuer1 plan1 or entity providing pharmacy benefit management services2 or 7,b7 commercial or financial information that is privileged or confidential4 7#c7 ,definitions ,in this subsection1 the terms group health plan1 health insurance coverage1 and health insurance issuer have the meanings given such terms in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 #a4 ,short title ,this ,act may be cited as the ,pharmacy ,benefit ,manager ,reform ,act4 #b4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,public ,health ,service ,act ,title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended-- 7#a7 in part ,d 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 by adding at the end the following new section3 #bgii;,a-#aa4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan or health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of such a plan or issuer shall not enter into a contract with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 from making the reports described in subsection 7b72 and 7#b7 provide the group health plan or health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan or group health insurance coverage 7regardless of whether such coverage is covered group health insurance coverage as defined in subsection 7g77#c77 shall submit to the plan sponsor of such covered group health plan or issuer of such health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor or issuer in plain language1 in a machine-readable format1 and1 as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan or health insurance coverage-- 7,a7 as applicable1 information collected from drug manufacturers by such entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by such drug manufacturers with respect to the participants and beneficiaries in such plan or coverage2 7,b7 a list of each drug covered by the plan1 coverage1 or entity providing pharmacy benefit management services for which a claim was filed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom a claim for the drug was filed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug for which a claim was filed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days' supply and cost per dosage unit2 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan or coverage-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or coverage2 and 7vi7 for each of the #ej prescription drugs with the highest gross spending under the group health plan or health insurance coverage during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class 7as defined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury71 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 7,c7 a list of each therapeutic class of drugs for which a claim was filed under the group health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic class 7as defined as described in subparagraph 7,b77vi77,i77 of drugs1 during the reporting period-- 7i7 total gross spending by the plan or by the issuer offering such coverage2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries on drugs in such therapeutic class1 after application of any benefits under the plan or coverage-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or issuer2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan or coverage-- 7,i7 the amount received1 or expected to be received1 by such entity1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the plan or by the issuer with respect to such coverage on that class of drugs2 and 7,,iii7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or by the issuer with respect to such coverage during the reporting period2 7,e7 the total amount received1 or expected to be received1 by the group health plan or health insurance issuer1 from applicable entities1 in rebates1 fees1 alternative discounts1 and other remuneration received from such entities1 related to utilization of drugs or drug spending under that group health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the group health plan or health insurance issuer with respect to the coverage during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act of #aigd7 to brokers1 consultants1 advisors1 or any other individual or firm for-- 7i7 referral of the group health plan's or health insurance issuer's business to the pharmacy benefit manager2 7ii7 consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer2 or 7iii7 the retention of the entity by the group health plan or health insurance issuer2 7,h7 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services on behalf of such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan1 issuer1 or participants and beneficiaries in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services2 and 7iii7 a list of all drugs dispensed by such affiliated pharmacy or pharmacy under common ownership and charged to the plan1 issuer1 or participants and beneficiaries of the plan or coverage1 during the applicable period1 and1 with respect to each drug-- 7,i7 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan or coverage1 to the plan or issuer2 and 7bb7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply to participants and beneficiaries2 7,,ii7 the median amount charged to the plan or issuer1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan or coverage2 7,,iii7 the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan or coverage2 7,,iv7 the lowest cost1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan or coverage2 7,v7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit or per #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries among all pharmacies included in the network of the plan or coverage2 7,i7 a summary document for plan sponsors or issuers that includes the information described in subparagraphs 7,a7 through 7,h7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury determine useful to plan sponsors and health insurance issuers for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 and 7,j7 a summary document for participants or beneficiaries1 which shall be made available to participants or beneficiaries upon request to the plan sponsor1 that contains the information described in subparagraphs 7,d7 through 7,g7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury determine useful to participants or beneficiaries in better understanding their plan or benefits1 except that such summary document for participants or beneficiaries shall contain only aggregate information4 7#b7 ,regulations ,not later than #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall1 through notice and comment rulemaking1 promulgate final regulations to implement the requirements of this subsection4 ,in promulgating such regulations1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall1 to the extent practicable1 align the reporting requirements under this subsection with the reporting requirements under section #bgii;,a-#aj4 7#c7 ,additional reporting 7,a7 ,reporting with respect to group health plans offered by small employers ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 and make such report available to the plan sponsor in a machine-readable format1 and such other formats as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may specify4 ,each such report shall include1 with respect to the applicable group health plan-- 7i7 the information described in subparagraphs 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a72 7ii7 as applicable1 information collected from drug manufacturers by such plan on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by applicable drug manufacturers with respect to the participants and beneficiaries in such plan1 except that such information shall not identify any drug manufacturer2 and 7iii7 a summary document that includes the information described in clauses 7i7 and 7ii7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury determine useful for plan sponsors for purposes of selecting pharmacy benefit management services1 provided that such summary documents include only aggregate information4 7,b7 ,opt-in for group health insurance coverage 7i7 ,in general ,a plan sponsor of group health insurance coverage offered in connection with a group health plan may1 on an annual basis1 for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 elect to require an entity providing pharmacy benefit management services on behalf of a health insurance issuer offering group health insurance coverage to submit to such plan sponsor a report in accordance with this subsection4 7ii7 ,contents of reports 7,i7 ,covered group health insurance coverage ,in the case of an entity providing pharmacy benefit management services on behalf of an issuer that offers covered group health insurance coverage1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable covered group health insurance coverage1 the information required under paragraph 7#a7 for covered group health plans4 7,,ii7 ,other group health insurance coverage ,in the case of an entity providing pharmacy benefit management services on behalf of an issuer that offers group health insurance coverage that is not covered group health insurance1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable group health insurance coverage-- 7aa7 the information described in subparagraphs 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a72 and 7bb7 as applicable1 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 applicable drug manufacturers with respect to the participants and beneficiaries in such plan1 except that such information shall not identify any drug manufacturer4 7iii7 ,required reporting for covered group health insurance coverage ,each health insurance issuer that offers covered group health insurance coverage shall annually submit to the plan sponsor the information described in paragraph 7#a77;,i71 regardless of whether the plan sponsor made the election described in clause 7i7 for the applicable year4 7iv7 ,required reporting for other group health insurance coverage ,each health insurance issuer that offers group health insurance coverage that is not covered group health insurance shall annually submit a summary document that includes such information described in items 7aa7 and 7bb7 of clause 7ii77,,ii7 as the ,secretary and the ,secretary of ,labor determine useful for plan sponsors for purposes of selecting pharmacy benefit management services1 provided that such summary documents include only aggregate information4 7#d7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act4 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#c7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from placing reasonable restrictions 7as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may determine7 on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#c74 7ii7 ,limitations ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#e7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#c7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 and as a term of the contract1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to the ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act1 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations promulgated under section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif7 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,written notice ,plan sponsors of group health plans and group health insurance coverage shall provide to each employee written notice informing the employee of the requirement for health insurance issuers or entities providing pharmacy benefit management services on behalf of the plan or coverage to submit reports to plan sponsors under paragraphs 7#a7 and 7#c71 as applicable1 which may include incorporating such notification in plan documents provided to the employee1 an employee handbook provided to the employee1 or individual notification4 7,e7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#f7 ,submissions to ,,gao ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan shall submit1 upon request1 to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#c7 with respect to such coverage or plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#d71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall specify1 through rulemaking1 standard formats for entities providing pharmacy benefit management services to submit reports required under this subsection4 ,such secretaries may provide for separate standard formats for reports to plan sponsors of group health plans and reports to plan sponsors of group health insurance coverage offered in connection with a group health plan4 7,b7 ,form of report ,the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall define through rulemaking a form of the reports under paragraphs 7#a7 and 7#c7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in the case that such secretaries determine that changes to the standard format are necessary to prevent anticompetitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan or health insurance issuer offering group or individual health insurance coverage shall ensure that the amount required to be paid by a participant1 beneficiary1 or enrollee for a prescription drug covered under the plan or coverage1 and a third-party administrator or an entity providing pharmacy benefit management services on behalf of such a plan or coverage shall ensure that the total amount required to be paid by the plan or issuer and participant1 beneficiary1 or enrollee for a prescription drug covered under the plan or coverage1 does not exceed the price paid to the pharmacy1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan1 issuer1 or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan1 issuer1 or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan1 issuer1 or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan1 issuer1 or entity4 7,c7 ,a penalty paid if the pharmacist services for which a claim was filed with the plan1 issuer1 or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-through to plan or health insurance issuer 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs under such group health plan or health insurance coverage1 to the group health plan or health insurance issuer offering group health insurance coverage2 and 7,b7 ensure that any contract entered into1 by such third-party administrator or entity providing pharmacy benefit management services on behalf of such a plan or coverage1 with rebate aggregators 7or other purchasing entity designed to aggregate rebates71 applicable group purchasing organizations1 or any subsidiary1 parent1 affiliate1 or subcontractor of the plan1 entity1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or applicable group purchasing organization remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received that are related to utilization of drugs under such group health plan or health insurance coverage1 to the third-party administrator or entity providing pharmacy benefit management services4 7#b7 ,form and manner of remittance ,with respect to such rebates1 fees1 alternative discounts1 and other remuneration-- 7,a7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,a7 shall be-- 7i7 remitted-- 7,i7 on a quarterly basis1 to the group health plan or the group health insurance issuer1 not later than #ij days after the end of each quarter2 or 7,,ii7 in the case of an underpayment in a remittance for a prior quarter1 as soon as practicable1 but not later than #ij days after notice of the underpayment is first given2 7ii7 fully disclosed and enumerated to the group health plan or health insurance issuer1 as described in paragraphs 7#a7 and 7#c7 of subsection 7b72 and 7iii7 returned to the issuer or entity providing pharmacy benefit management services on behalf of the group health plan if an audit by a plan sponsor1 or a third party designated by a plan sponsor1 indicates that the amounts received are incorrect after such amounts have been paid to the group health plan or health insurance issuer2 7,b7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,b7 shall be remitted in accordance with such procedures as the ,secretary1 ,secretary of ,labor1 and ,secretary of the ,treasury establish2 and 7,c7 the records of such rebates1 fees1 alternative discounts1 and other remuneration shall be available for audit by the plan sponsor1 issuer1 or a third party designated by a plan sponsor1 not less than once per plan year4 7#c7 ,audit of rebate contracts ,a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such group health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by the plan sponsor or designated third party1 subject to reasonable restrictions 7as determined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury7 on confidentiality to prevent re-disclosure of such contracts4 7#d7 ,auditors ,audits carried out under paragraphs 7#b77;,c7 and 7#c7 shall be performed by an auditor selected by the applicable plan sponsor4 7#e7 ,rule of construction ,nothing in this subsection shall be construed to-- 7,a7 prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subsection1 provided that such fees are transparent to group health plans and health insurance issuers2 7,b7 require a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering health insurance coverage to remit bona fide service fees to group health plans or health insurance issuers2 or 7,c7 limit the ability of a group health plan or health insurance issuer to pass through rebates1 fees1 alternative discounts1 and other remuneration to the participant or beneficiary4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary shall enforce this section4 7#b7 ,violations ,a group health plan1 a health insurance issuer1 or an entity providing pharmacy benefit management services that violates subsection 7a72 an entity providing pharmacy benefit management services that fails to provide information required under subsection 7b72 a group health plan1 health insurance issuer1 or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan1 a health insurance issuer1 or an entity providing pharmacy benefit management services that violates subsection 7d7 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 group health plan1 a health insurance issuer1 an entity providing pharmacy benefit management services1 or a third-party administrator 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 subsection 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 ,waivers ,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 permit a health insurance issuer1 group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 or the ,secretary of the ,treasury to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 7c71 or 7d7 by such issuer1 plan1 or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury may specify through rulemaking2 7#b7 the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services2 7#c7 the term covered group health insurance coverage means health insurance coverage offered in connection with a group health plan maintained by a large employer2 7#d7 the term covered group health plan means a group health plan maintained by a large employer2 7#e7 the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#f7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#g7 the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#h7 the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd2 7#i7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of the ,treasury1 through rulemaking1 which shall be reevaluated by such secretaries every #e years2 and 7#aj7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act4 2 7#b7 in section #bgbc 7#db ,u4,s4,c4 #cjj;gg-#bb7-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7ii7 in paragraph 7#b71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 7,b7 in subsection 7b7-- 7i7 in paragraph 7#a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 7ii7 in paragraph 7#b77;,a71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7iii7 in paragraph 7#b77;,c77ii71 by inserting 7other than section #bgii;,a-#aa7 after part ,d2 and 7#c7 in section #bgii;,a-#aj 7#db ,u4,s4,c4 #cjj;gg-#abj71 by adding at the end the following3 7d7 ,entities providing pharmacy benefit management services ,beginning #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 entities providing pharmacy benefit management services shall report to plan sponsors of group health plans or group health insurance coverage information required under paragraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 and 7#g77;,b7 of subsection 7a74 4 7b7 ,employee ,retirement ,income ,security ,act of #aigd 7#a7 ,in general ,subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajba et seq47 is amended-- 7,a7 in subpart ,b of part #g 7#bi ,u4,s4,c4 #aahe et seq471 by adding at the end the following3 #gbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan 7or health insurance issuer offering group health insurance coverage in connection with such a plan7 or an entity providing pharmacy benefit management services on behalf of such a plan or issuer shall not enter into a contract with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 from making the reports described in subsection 7b72 and 7#b7 provide the group health plan or health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of a plan or issuer1 relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan or group health insurance coverage 7regardless of whether such coverage is covered group health insurance coverage as defined in subsection 7g77#c77 shall submit to the plan sponsor of such covered group health plan or issuer of such health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor or issuer in plain language1 in a machine-readable format1 and1 as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan or health insurance coverage-- 7,a7 as applicable1 information collected from drug manufacturers by such entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by such drug manufacturers with respect to the participants and beneficiaries in such plan or coverage2 7,b7 a list of each drug covered by the plan1 coverage1 or entity providing pharmacy benefit management services for which a claim was filed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom a claim for the drug was filed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug for which a claim was filed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days' supply and cost per dosage unit2 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan or coverage-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or coverage2 and 7vi7 for each of the #ej prescription drugs with the highest gross spending under the group health plan or health insurance coverage during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class 7as defined by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury71 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 7,c7 a list of each therapeutic class 7as defined as described in subparagraph 7,b77vi77,i77 of drugs for which a claim was filed under the group health plan or health insurance coverage during the reporting period1 and1 with respect to each such therapeutic class of drugs1 during the reporting period-- 7i7 total gross spending by the plan or by the issuer offering such coverage2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries on drugs in such therapeutic class1 after application of any benefits under the plan or coverage-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or coverage or for which no claim is submitted to the plan or issuer2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan or coverage-- 7,i7 the amount received1 or expected to be received1 by such entity1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the plan or by the issuer with respect to such coverage on that class of drugs2 and 7,,iii7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan or by the issuer with respect to such coverage and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,d7 total gross spending on prescription drugs by the plan or coverage during the reporting period2 7,e7 the total amount received1 or expected to be received1 by the group health plan or health insurance issuer1 from applicable entities1 in rebates1 fees1 alternative discounts1 and other remuneration received from such entities1 related to utilization of drugs or drug spending under that group health plan or health insurance coverage during the reporting period2 7,f7 the total net spending on prescription drugs by the group health plan or health insurance issuer with respect to the coverage during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa77 to brokers1 consultants1 advisors1 or any other individual or firm for-- 7i7 referral of the group health plan's or health insurance issuer's business to the pharmacy benefit manager2 7ii7 consideration of the entity providing pharmacy benefit management services by the group health plan or health insurance issuer2 or 7iii7 the retention of the entity by the group health plan or health insurance issuer2 7,h7 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan or coverage to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services on behalf of such plan or coverage1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan1 issuer1 or participants and beneficiaries in the plan or coverage1 that were dispensed by mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services2 and 7iii7 a list of all drugs dispensed by such affiliated pharmacy or pharmacy under common ownership and charged to the plan1 issuer1 or participants and beneficiaries of the plan or coverage1 during the applicable period1 and1 with respect to each drug-- 7,i7 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan or coverage1 to the plan or issuer2 and 7bb7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply to participants and beneficiaries2 7,,ii7 the median amount charged to the plan or issuer1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan or coverage2 7,,iii7 the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan or coverage2 7,,iv7 the lowest cost1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan or coverage2 7,v7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit or per #cj-;day supply1 for such drug1 including amounts charged to the plan or issuer and participants and beneficiaries among all pharmacies included in the network of the plan or coverage2 7,i7 a summary document for plan sponsors or issuers that includes the information described in subparagraphs 7,a7 through 7,h7 that the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury determine useful to plan sponsors and health insurance issuers for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 and 7,j7 a summary document for participants or beneficiaries1 which shall be made available to participants or beneficiaries upon request to the plan sponsor1 that contains the information described in subparagraphs 7,d7 through 7,g7 that the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury determine useful to participants or beneficiaries in better understanding their plan or benefits1 except that such summary document for participants or beneficiaries shall contain only aggregate information4 7#b7 ,regulations ,not later than #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall1 through notice and comment rulemaking1 promulgate final regulations to implement the requirements of this subsection4 ,in promulgating such regulations1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall1 to the extent practicable1 align the reporting requirements under this subsection with the reporting requirements under section #gbe4 7#c7 ,additional reporting 7,a7 ,reporting with respect to group health plans offered by small employers ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 and make such report available to the plan sponsor in a machine-readable format1 and such other formats as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may specify4 ,each such report shall include1 with respect to the applicable group health plan-- 7i7 the information described in subparagraphs 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a72 7ii7 as applicable1 information collected from drug manufacturers by such plan on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by applicable drug manufacturers with respect to the participants and beneficiaries in such plan1 except that such information shall not identify any drug manufacturer2 and 7iii7 a summary document that includes the information described in clauses 7i7 and 7ii7 that the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury determine useful to plan sponsors for purposes of selecting pharmacy benefit management services1 provided that such summary documents include only aggregate information4 7,b7 ,opt-in for group health insurance coverage 7i7 ,in general ,a plan sponsor of group health insurance coverage offered in connection with a group health plan may1 on an annual basis1 for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 elect to require an entity providing pharmacy benefit management services on behalf of a health insurance issuer offering group health insurance coverage to submit to such plan sponsor a report in accordance with this subsection4 7ii7 ,contents of reports 7,i7 ,covered group health insurance coverage ,in the case of an entity providing pharmacy benefit management services on behalf of an issuer that offers covered group health insurance coverage1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable covered group health insurance coverage1 the information required under paragraph 7#a7 for covered group health plans4 7,,ii7 ,other group health insurance coverage ,in the case of an entity providing pharmacy benefit management services on behalf of an issuer that offers group health insurance coverage that is not covered group health insurance1 a report provided pursuant to clause 7i7 shall include1 with respect to the applicable group health insurance coverage-- 7aa7 the information described in subparagraphs 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a72 and 7bb7 as applicable1 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 applicable drug manufacturers with respect to the participants and beneficiaries in such plan1 except that such information shall not identify any drug manufacturer4 7iii7 ,required reporting for covered group health insurance coverage ,each health insurance issuer that offers covered group health insurance coverage shall annually submit to the plan sponsor the information described in paragraph 7#a77;,i71 regardless of whether the plan sponsor made the election described in clause 7i7 for the applicable year4 7iv7 ,required reporting for other group health insurance coverage ,each health insurance issuer that offers group health insurance coverage that is not covered group health insurance shall annually submit a summary document that includes such information described in items 7aa7 and 7bb7 of clause 7ii77,,ii7 as the ,secretary and the ,secretary of ,health and ,human ,services determine useful for plan sponsors for purposes of selecting pharmacy benefit management services1 provided that such summary documents include only aggregate information4 7#d7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c774 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#c7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage from placing reasonable restrictions 7as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may determine7 on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#c74 7ii7 ,limitations ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#e7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#c7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 and as a term of the contract1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c771 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations promulgated under section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b77 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,written notice ,plan sponsors of group health plans and group health insurance coverage shall provide to each employee written notice informing the employee of the requirement for health insurance issuers or entities providing pharmacy benefit management services on behalf of the plan or coverage to submit reports to plan sponsors under paragraphs 7#a7 and 7#c71 as applicable1 which may include incorporating such notification in plan documents provided to the employee1 an employee handbook provided to the employee1 or individual notification4 7,e7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#f7 ,submissions to ,,gao ,a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefit management services on behalf of a group health plan shall submit1 upon request1 to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#c7 with respect to such coverage or plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#d71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall specify1 through rulemaking1 standard formats for entities providing pharmacy benefit management services to submit reports required under this subsection4 ,such secretaries may provide for separate standard formats for reports to plan sponsors of group health plans and reports to plan sponsors of group health insurance coverage offered in connection with a group health plan4 7,b7 ,form of report ,the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury shall define through rulemaking a form of the reports under paragraphs 7#a7 and 7#c7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in the case that such secretaries determine that changes to the standard format are necessary to prevent anticompetitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan or health insurance issuer offering group health insurance coverage shall ensure that the amount required to be paid by a participant or beneficiary for a prescription drug covered under the plan or coverage1 and a third-party administrator or an entity providing pharmacy benefit management services on behalf of such a plan or coverage shall ensure that the total amount required to be paid by the plan or issuer and participant or beneficiary for a prescription drug covered under the plan or coverage1 does not exceed the price paid to the pharmacy1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan1 issuer1 or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan1 issuer1 or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan1 issuer1 or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan1 issuer1 or entity4 7,c7 ,a penalty paid if the pharmacist services for which a claim was filed with the plan1 issuer1 or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-through to plan or health insurance issuer 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs under such group health plan or health insurance coverage1 to the group health plan or health insurance issuer offering group health insurance coverage2 and 7,b7 ensure that any contract entered into1 by such third-party administrator or entity providing pharmacy benefit management services on behalf of such a plan or coverage1 with rebate aggregators 7or other purchasing entity designed to aggregate rebates71 applicable group purchasing organizations1 or any subsidiary1 parent1 affiliate1 or subcontractor of the plan1 entity1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or applicable group purchasing organization remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received that are related to utilization of drugs under such group health plan or health insurance coverage1 to the third-party administrator or entity providing pharmacy benefit management services4 7#b7 ,form and manner of remittance ,with respect to such rebates1 fees1 alternative discounts1 and other remuneration-- 7,a7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,a7 shall be-- 7i7 remitted-- 7,i7 on a quarterly basis1 to the group health plan or the group health insurance issuer1 not later than #ij days after the end of each quarter2 or 7,,ii7 in the case of an underpayment in a remittance for a prior quarter1 as soon as practicable1 but not later than #ij days after notice of the underpayment is first given2 7ii7 fully disclosed and enumerated to the group health plan or health insurance issuer1 as described in paragraphs 7#a7 and 7#c7 of subsection 7b72 and 7iii7 returned to the issuer or entity providing pharmacy benefit management services on behalf of the group health plan if an audit by a plan sponsor1 or a third party designated by a plan sponsor1 indicates that the amounts received are incorrect after such amounts have been paid to the group health plan or health insurance issuer2 7,b7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,b7 shall be remitted in accordance with such procedures as the ,secretary1 ,secretary of ,health and ,human ,services1 and ,secretary of the ,treasury establish2 and 7,c7 the records of such rebates1 fees1 alternative discounts1 and other remuneration shall be available for audit by the plan sponsor1 issuer1 or a third party designated by a plan sponsor1 not less than once per plan year4 7#c7 ,audit of rebate contracts ,a third-party administrator of a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services on behalf of such group health plan or health insurance coverage shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by the plan sponsor or designated third party1 subject to reasonable restrictions 7as determined by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury7 on confidentiality to prevent re-disclosure of such contracts4 7#d7 ,auditors ,audits carried out under paragraphs 7#b77;,c7 and 7#c7 shall be performed by an auditor selected by the applicable plan sponsor4 7#e7 ,rule of construction ,nothing in this subsection shall be construed to-- 7,a7 prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subsection1 provided that such fees are transparent to group health plans and health insurance issuers2 7,b7 require a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer offering group health insurance coverage to remit bona fide service fees to the group health plans or health insurance issuers2 or 7,c7 limit the ability of a group health plan or health insurance issuer to pass through rebates1 fees1 alternative discounts1 and other remuneration to the participant or beneficiary4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary shall enforce this section4 7#b7 ,violations ,a group health plan1 a health insurance issuer1 or an entity providing pharmacy benefit management services that violates subsection 7a72 an entity providing pharmacy benefit management services that fails to provide information required under subsection 7b72 a group health plan1 health insurance issuer1 or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan1 a health insurance issuer1 or an entity providing pharmacy benefit management services that violates subsection 7d7 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 group health plan1 a health insurance issuer1 an entity providing pharmacy benefit management services1 or a third-party administrator 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 ,secretary shall impose civil monetary penalties under this subsection in the same manner and according to the same procedures as the ,secretary imposes civil monetary penalties as described in section #ejb7;c77#aj74 7#e7 ,waivers ,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 permit a health insurance issuer1 group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan or health insurance issuer1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary of ,labor1 the ,secretary of ,health and ,human ,services1 or the ,secretary of the ,treasury to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 7c71 or 7d7 by such issuer1 plan1 or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury may specify through rulemaking2 7#b7 the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services2 7#c7 the term covered group health insurance coverage means health insurance coverage offered in connection with a group health plan maintained by a large employer2 7#d7 the term covered group health plan means a group health plan maintained by a large employer2 7#e7 the term gross spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#f7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#g7 the term net spending1 with respect to prescription drug benefits under a group health plan or health insurance coverage1 means the amount spent by a group health plan or health insurance issuer on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#h7 the term plan sponsor has the meaning given such term in section #c7af77;,b72 7#i7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of the ,treasury1 through rulemaking1 which shall be reevaluated by such secretaries every #e years2 and 7#aj7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 2 and 7,b7 in section #ejb7;b77#c7 7#bi ,u4,s4,c4 #aacb7;b77#c771 by inserting 7other than section #gbf7 after part #g4 7#b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gbe the following new item3 ,sec4 #gbf4 ,oversight of entities that provide pharmacy benefit management services4 4 7#c7 ,additional reporting requirement ,section #gbe of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahen7 is amended by adding at the end the following3 7d7 ,entities providing pharmacy benefit management services ,beginning #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 entities providing pharmacy benefit management services shall report to plan sponsors of group health plans information required under paragraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 and 7#g77;,b7 of subsection 7a74 4 7c7 ,internal ,revenue ,code of #aihf 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following3 #ihbf4 ,oversight of entities that provide pharmacy benefit management services 7a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan or an entity providing pharmacy benefit management services on behalf of such a plan shall not enter into a contract with an applicable entity unless such applicable entity agrees to-- 7#a7 not limit the disclosure of information to plan sponsors in such a manner that prevents the plan1 or an entity providing pharmacy benefit management services on behalf of a plan1 from making the reports described in subsection 7b72 and 7#b7 provide the group health plan or an entity providing pharmacy benefit management services on behalf of a plan1 relevant information necessary to make the reports described in subsection 7b74 7b7 ,reports 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a covered group health plan shall submit to the plan sponsor of such covered group health plan a report in accordance with this subsection and make such report available to the plan sponsor in plain language1 in a machine-readable format1 and1 as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services may determine1 other formats4 ,each such report shall include1 with respect to the covered group health plan-- 7,a7 as applicable1 information collected from drug manufacturers by such entity on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by such drug manufacturers with respect to the participants and beneficiaries in such plan2 7,b7 a list of each drug covered by the plan or entity providing pharmacy benefit management services for which a claim was filed during the reporting period1 including1 with respect to each such drug during the reporting period-- 7i7 the brand name1 generic or nonproprietary name1 and ,national ,drug ,code2 7ii7 the number of participants and beneficiaries for whom a claim for the drug was filed during the reporting period1 the total number of prescription claims for the drug 7including original prescriptions and refills71 and the total number of dosage units of the drug for which a claim was filed across the reporting period2 7iii7 for each claim or dosage unit described in clause 7ii71 the type of dispensing channel used1 such as retail1 mail order1 or specialty pharmacy2 7iv7 the wholesale acquisition cost1 listed as cost per days' supply and cost per dosage unit2 7v7 the total out-of-pocket spending by participants and beneficiaries on such drug after application of any benefits under the plan-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted to the plan2 and 7vi7 for each of the #ej prescription drugs with the highest gross spending under the group health plan during the reporting period-- 7,i7 a list of all other drugs in the same therapeutic class 7as defined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services71 including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic class as such drug2 7,,ii7 if applicable1 the rationale for preferred formulary placement of such drug in that therapeutic class1 selected from a list of standard rationales established by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services1 in consultation with stakeholders2 and 7,,iii7 any change in formulary placement compared to the prior plan year2 7,c7 a list of each therapeutic class 7as defined as described in subparagraph 7,b77vi77,i77 of drugs for which a claim was filed under the group health plan during the reporting period1 and1 with respect to each such therapeutic class of drugs1 during the reporting period-- 7i7 total gross spending by the plan2 7ii7 the number of participants and beneficiaries who filled a prescription for a drug in that class2 7iii7 if applicable to that class1 a description of the formulary tiers and utilization management mechanisms 7such as prior authorization or step therapy7 employed for drugs in that class2 7iv7 the total out-of-pocket spending by participants and beneficiaries on drugs in such therapeutic class1 after application of any benefits under the plan-- 7,i7 including copayments1 coinsurance1 and deductibles2 and 7,,ii7 not including any amounts spent by participants and beneficiaries on drugs not covered under the plan or for which no claim is submitted to the plan2 and 7v7 for each therapeutic class under which #c or more drugs are included on the formulary of such plan-- 7,i7 the amount received1 or expected to be received1 by such entity1 from applicable entities1 in rebates1 fees1 alternative discounts1 or other remuneration-- 7aa7 for claims incurred during the reporting period2 or 7bb7 that is related to utilization of drugs or drug spending2 7,,ii7 the total net spending by the plan on that class of drugs2 and 7,,iii7 the average net spending per #cj-;day supply and per #ij-;day supply by the plan and its participants and beneficiaries1 among all drugs within the therapeutic class for which a claim was filed during the reporting period2 7,d7 total gross spending on prescription drugs by the plan during the reporting period2 7,e7 the total amount received1 or expected to be received1 by the group health plan1 from applicable entities1 in rebates1 fees1 alternative discounts1 and other remuneration received from such entities1 related to utilization of drugs or drug spending under that group health plan during the reporting period2 7,f7 the total net spending on prescription drugs by the group health plan during the reporting period2 7,g7 amounts paid directly or indirectly in rebates1 fees1 or any other type of compensation 7as defined in section #djh7;b77#b77;,b77ii77dd77,,aa7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77dd77,a777 to brokers1 consultants1 advisors1 or any other individual or firm for-- 7i7 referral of the group health plan's business to the pharmacy benefit manager2 7ii7 consideration of the entity providing pharmacy benefit management services by the group health plan2 or 7iii7 the retention of the entity by the group health plan2 7,h7 7i7 an explanation of any benefit design parameters that encourage or require participants and beneficiaries in the plan to fill prescriptions at mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services on behalf of such plan1 including mandatory mail and specialty home delivery programs1 retail and mail auto-refill programs1 and cost-sharing assistance incentives funded by an entity providing pharmacy benefit management services2 7ii7 the percentage of total prescriptions charged to the plan or participants and beneficiaries in the plan1 that were dispensed by mail order1 specialty1 or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services2 and 7iii7 a list of all drugs dispensed by such affiliated pharmacy or pharmacy under common ownership and charged to the plan1 or participants and beneficiaries of the plan1 during the applicable period1 and1 with respect to each drug-- 7,i7 7aa7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 with respect to participants and beneficiaries in the plan1 to the plan2 and 7bb7 the amount charged1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply to participants and beneficiaries2 7,,ii7 the median amount charged to the plan1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan2 7,,iii7 the interquartile range of the costs1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 including amounts paid by the participants and beneficiaries1 when the same drug is dispensed by other pharmacies that are not affiliated with or under common ownership with the entity and that are included in the pharmacy network of that plan2 7,,iv7 the lowest cost1 per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries1 that is available from any pharmacy included in the network of the plan2 7,v7 the net acquisition cost per dosage unit1 per #cj-;day supply1 and per #ij-;day supply1 if the drug is subject to a maximum price discount2 and 7,,vi7 other information with respect to the cost of the drug1 as determined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services1 such as average sales price1 wholesale acquisition cost1 and national average drug acquisition cost per dosage unit or per #cj-;day supply1 for such drug1 including amounts charged to the plan and participants and beneficiaries among all pharmacies included in the network of the plan2 7,i7 a summary document for plan sponsors that includes the information described in subparagraphs 7,a7 through 7,h7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services determine useful to plan sponsors for purposes of selecting pharmacy benefit management services1 such as an estimated net price to plan sponsor and participant or beneficiary1 a cost per claim1 the fee structure or reimbursement model1 and estimated cost per participant or beneficiary2 and 7,j7 a summary document for participants or beneficiaries1 which shall be made available to participants or beneficiaries upon request to the plan sponsor1 that contains the information described in subparagraphs 7,d7 through 7,g7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services determine useful to participants or beneficiaries in better understanding their plan or benefits1 except that such summary document for participants or beneficiaries shall contain only aggregate information4 7#b7 ,regulations ,not later than #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services shall1 through notice and comment rulemaking1 promulgate final regulations to implement the requirements of this subsection4 ,in promulgating such regulations1 the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services shall1 to the extent practicable1 align the reporting requirements under this subsection with the reporting requirements under section #ihbe4 7#c7 ,additional reporting ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 not less frequently than annually1 an entity providing pharmacy benefit management services on behalf of a group health plan that is not a covered group health plan shall submit to the plan sponsor of such group health plan a report in accordance with this paragraph1 and make such report available to the plan sponsor in a machine-readable format1 and such other formats as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services may specify4 ,each such report shall include1 with respect to the applicable group health plan-- 7,a7 the information described in subparagraphs 7,d71 7,e71 7,f71 and 7,g7 of paragraph 7#a72 7,b7 as applicable1 information collected from drug manufacturers by such plan on the total amount of copayment assistance dollars paid1 or copayment cards applied1 that were funded by applicable drug manufacturers with respect to the participants and beneficiaries in such plan1 except that such information shall not identify any drug manufacturer2 and 7,c7 a summary document that includes that information described in subparagraphs 7,a7 and 7,b7 that the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services determine useful for plan sponsors for purposes of selecting pharmacy benefit management services1 provided that such summary documents include only aggregate information4 7#d7 ,privacy requirements 7,a7 ,relationship to ,,hipaa regulations ,nothing in this section shall be construed to modify the requirements for the creation1 receipt1 maintenance1 or transmission of protected health information under the ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c774 7,b7 ,requirement ,a report submitted under paragraph 7#a7 or 7#c7 shall contain only summary health information1 as defined in section #afd4ejd7;a7 of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7,c7 ,clarification regarding certain disclosures of information 7i7 ,reasonable restrictions ,nothing in this section prevents an entity providing pharmacy benefit management services on behalf of a group health plan from placing reasonable restrictions 7as the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services may determine7 on the public disclosure of the information contained in a report under paragraph 7#a7 or 7#c74 7ii7 ,limitations ,an entity providing pharmacy benefit management services on behalf of a group health plan may not restrict disclosure of such reports to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or any other ,federal agency responsible for enforcement activities under this section for purposes of enforcement under this section or other applicable law1 or to the ,comptroller ,general of the ,united ,states in accordance with paragraph 7#f74 7#e7 ,use and disclosure by plan sponsors 7,a7 ,prohibition ,a plan sponsor may not-- 7i7 fail or refuse to hire1 or discharge1 any employee1 or otherwise discriminate against any employee with respect to the compensation1 terms1 conditions1 or privileges of employment of the employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee2 or 7ii7 limit1 segregate1 or classify the employees of the employer in any way that would deprive or tend to deprive any employee of employment opportunities or otherwise adversely affect the status of the employee as an employee1 because of information submitted under paragraph 7#a7 or 7#c7 attributed to the employee or a dependent of the employee4 7,b7 ,disclosure and redisclosure ,a plan sponsor shall not disclose the information received under paragraph 7#a7 or 7#c7 except-- 7i7 to an occupational or other health researcher if the research is conducted in compliance with the regulations and protections provided for under part #df of title #de1 ,code of ,federal ,regulations 7or successor regulations72 7ii7 in response to an order of a court1 except that the plan sponsor may disclose only the information expressly authorized by such order2 7iii7 to the ,department of ,health and ,human ,services1 the ,department of ,labor1 the ,department of the ,treasury1 or other ,federal agency responsible for enforcement activities under this section2 or 7iv7 to a contractor or agent for purposes of health plan administration1 if such contractor or agent agrees1 in writing1 and as a term of the contract1 to abide by the same use and disclosure restrictions as the plan sponsor4 7,c7 ,relationship to ,,hipaa regulations ,with respect to the ,,hipaa privacy regulations1 as defined in section #aahj7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c771 subparagraph 7,b7 does not prohibit a covered entity 7as defined for purposes of such regulations promulgated under section #bfd of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b77 from any use or disclosure of health information that is authorized for the covered entity under such regulations4 ,the previous sentence does not affect the authority of such ,secretary to modify such regulations4 7,d7 ,written notice ,plan sponsors of group health plans shall provide to each employee written notice informing the employee of the requirement for entities providing pharmacy benefit management services to submit reports to plan sponsors under paragraphs 7#a7 and 7#c71 as applicable1 which may include incorporating such notification in plan documents provided to the employee1 an employee handbook provided to the employee1 or individual notification4 7,e7 ,enforcement 7i7 ,in general ,the powers1 procedures1 and remedies provided in section #bjg of the ,genetic ,information ,nondiscrimination ,act 7#db ,u4,s4,c4 #bjjj;ff-#f7 to a person alleging a violation of title ,,ii of such ,act shall be the powers1 procedures1 and remedies this subparagraph provides for any person alleging a violation of this paragraph4 7ii7 ,prohibition against retaliation ,no person shall discriminate against any individual because such individual has opposed any act or practice made unlawful by this paragraph or because such individual made a charge1 testified1 assisted1 or participated in any manner in an investigation1 proceeding1 or hearing under this paragraph4 ,the remedies and procedures otherwise provided for under this subparagraph shall be available to aggrieved individuals with respect to violations of this clause4 7#f7 ,submissions to ,,gao ,an entity providing pharmacy benefit management services on behalf of a group health plan shall submit1 upon request1 to the ,comptroller ,general of the ,united ,states each of the first #b reports submitted to a plan sponsor under paragraph 7#a7 or 7#c7 with respect to such plan1 and other such reports as requested1 in accordance with the privacy requirements under paragraph 7#d71 and such other information that the ,comptroller ,general determines necessary to carry out the study under section #b7;f7 of the ,pharmacy ,benefit ,manager ,reform ,act4 7#g7 ,standard formats 7,a7 ,in general ,not later than ,june #a1 #bjbd1 the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor shall specify1 through rulemaking1 standard formats for entities providing pharmacy benefit management services to submit reports required under this subsection4 ,such secretaries may provide for separate standard formats for reports to plan sponsors of group health plans and reports to plan sponsors of group health insurance coverage offered in connection with a group health plan4 7,b7 ,form ,the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor shall define through rulemaking a form of the reports under paragraphs 7#a7 and 7#c7 required to be submitted to plan sponsors who also are drug manufacturers1 drug wholesalers1 entities providing pharmacy benefit management services1 or other direct participants in the drug supply chain1 in the case that such secretaries determine that changes to the standard format are necessary to prevent anticompetitive behavior4 7c7 ,limitations on spread pricing 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a group health plan shall ensure that the amount required to be paid by a participant or beneficiary for a prescription drug covered under the plan1 and a third-party administrator or an entity providing pharmacy benefit management services on behalf of such a plan shall ensure that the total amount required to be paid by the plan and participant or beneficiary for a prescription drug covered under the plan1 does not exceed the price paid to the pharmacy1 excluding penalties paid by the pharmacy 7as described in paragraph 7#b77 to such plan or entity4 7#b7 ,rule of construction ,for purposes of paragraph 7#a71 penalties paid by pharmacies include only the following3 7,a7 ,a penalty paid if an original claim for a prescription drug was submitted fraudulently by the pharmacy to the plan or entity4 7,b7 ,a penalty paid if the original claim payment made by the plan or entity to the pharmacy was inconsistent with the reimbursement terms in any contract between the pharmacy and the plan or entity4 7,c7 ,a penalty paid if the pharmacist services for which a claim was filed with the plan or entity were not rendered by the pharmacy4 7d7 ,full rebate pass-through to plan 7#a7 ,in general ,for plan years beginning on or after the date that is #cj months after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan shall-- 7,a7 remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received from any applicable entity that are related to utilization of drugs under such plan1 to the group health plan2 and 7,b7 ensure that any contract entered into1 by such third-party administrator or entity providing pharmacy benefit management services on behalf of such a plan1 with rebate aggregators 7or other purchasing entity designed to aggregate rebates71 applicable group purchasing organizations1 or any subsidiary1 parent1 affiliate1 or subcontractor of the plan1 entity1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or applicable group purchasing organization remit #ajj percent of rebates1 fees1 alternative discounts1 and other remuneration received that are related to utilization of drugs under such plan1 to the third-party administrator or entity providing pharmacy benefit management services4 7#b7 ,form and manner of remittance ,with respect to such rebates1 fees1 alternative discounts1 and other remuneration-- 7,a7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,a7 shall be-- 7i7 remitted-- 7,i7 on a quarterly basis1 to the group health plan1 not later than #ij days after the end of each quarter2 or 7,,ii7 in the case of an underpayment in a remittance for a prior quarter1 as soon as practicable1 but not later than #ij days after notice of the underpayment is first given2 7ii7 fully disclosed and enumerated to the group health plan1 as described in paragraphs 7#a7 and 7#c7 of subsection 7b72 and 7iii7 returned to the entity providing pharmacy benefit management services on behalf of the group health plan if an audit by a plan sponsor1 or a third party designated by a plan sponsor1 indicates that the amounts received are incorrect after such amounts have been paid to the group health plan2 7,b7 the rebates1 fees1 alternative discounts1 and other remuneration under paragraph 7#a77;,b7 shall be remitted in accordance with such procedures as the ,secretary1 ,secretary of ,health and ,human ,services1 and ,secretary of ,labor establish2 and 7,c7 the records of such rebates1 fees1 alternative discounts1 and other remuneration shall be available for audit by the plan sponsor1 or a third party designated by a plan sponsor1 not less than once per plan year4 7#c7 ,audit of rebate contracts ,a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of such group health plan shall make rebate contracts with rebate aggregators or drug manufacturers available for audit by the plan sponsor or designated third party1 subject to reasonable restrictions 7as determined by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services7 on confidentiality to prevent re-disclosure of such contracts4 7#d7 ,auditors ,audits carried out under paragraphs 7#b77;,c7 and 7#c7 shall be performed by an auditor selected by the applicable plan sponsor4 7#e7 ,rule of construction ,nothing in this subsection shall be construed to-- 7,a7 prohibit payments to entities offering pharmacy benefit management services for bona fide services using a fee structure not described in this subsection1 provided that such fees are transparent to group health plans2 7,b7 require a third-party administrator of a group health plan or an entity providing pharmacy benefit management services on behalf of a group health plan to remit bona fide service fees to plan sponsors of the group health plan2 or 7,c7 limit the ability of a group health plan to pass through rebates1 fees1 alternative discounts1 and other remuneration to the participant or beneficiary4 7e7 ,enforcement 7#a7 ,in general ,the ,secretary shall enforce this section4 7#b7 ,violations ,a group health plan or an entity providing pharmacy benefit management services that violates subsection 7a72 an entity providing pharmacy benefit management services that fails to provide information required under subsection 7b72 a group health plan or entity providing pharmacy benefit management services that violates subsection 7c72 or a third-party administrator of a group health plan or an entity providing pharmacy benefit management services that violates subsection 7d7 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 group health plan1 an entity providing pharmacy benefit management services1 or a third-party administrator 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 subsection 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 ,waivers ,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 permit a group health plan1 entity providing pharmacy benefit management services on behalf of a group health plan1 or other entity to restrict disclosure to1 or otherwise limit the access of1 the ,secretary of the ,treasury to a report described in subsection 7b77#a7 or information related to compliance with subsections 7a71 7b71 7c71 or 7d7 by such plan or entity4 7g7 ,definitions ,in this section-- 7#a7 the term applicable entity means-- 7,a7 an applicable group purchasing organization1 drug manufacturer1 distributor1 wholesaler1 rebate aggregator 7or other purchasing entity designed to aggregate rebates71 or associated third party2 7,b7 any subsidiary1 parent1 affiliate1 or subcontractor of a group health plan1 health insurance issuer1 entity that provides pharmacy benefit management services on behalf of such a plan or issuer1 or any entity described in subparagraph 7,a72 or 7,c7 such other entity as the ,secretary1 the ,secretary of ,health and ,human ,services1 and the ,secretary of ,labor may specify through rulemaking2 7#b7 the term applicable group purchasing organization means a group purchasing organization that is affiliated with or under common ownership with an entity providing pharmacy benefit management services2 7#c7 the term covered group health plan means a group health plan maintained by a large employer2 7#d7 the term gross spending1 with respect to prescription drug benefits under a group health plan1 means the amount spent by a group health plan on prescription drug benefits1 calculated before the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#e7 the term large employer means1 in connection with a group health plan with respect to a calendar year and a plan year1 an employer who employed an average of at least #ej employees on business days during the preceding calendar year and who employs at least #a employee on the first day of the plan year2 7#f7 the term net spending1 with respect to prescription drug benefits under a group health plan1 means the amount spent by a group health plan on prescription drug benefits1 calculated after the application of rebates1 fees1 alternative discounts1 or other remuneration2 7#g7 the term plan sponsor has the meaning given such term in section #c7af77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7af77;,b772 7#h7 the term remuneration has the meaning given such term by the ,secretary1 the ,secretary of ,labor1 and the ,secretary of ,health and ,human ,services1 through rulemaking1 which shall be reevaluated by such secretaries every #e years2 and 7#i7 the term wholesale acquisition cost has the meaning given such term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new item3 ,sec4 #ihbf4 ,oversight of entities that provide pharmacy benefit management services4 4 7#c7 ,additional reporting requirement ,section #ihbe of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following3 7d7 ,entities providing pharmacy benefit management services ,beginning #b years after the date of enactment of the ,pharmacy ,benefit ,manager ,reform ,act1 entities providing pharmacy benefit management services shall report to plan sponsors of group health plans information required under paragraphs 7#d71 7#e71 7#f71 7#g77;,a77iii71 and 7#g77;,b7 of subsection 7a74 4 7d7 ,funding 7#a7 ,for purposes of carrying out the amendments made by subsection 7a7 there is appropriated to the ,centers for ,medicare ,medicaid ,services1 out of amounts in the ,treasury not otherwise appropriated1 #dj1jjj1jjj for fiscal year #bjbc1 to remain available until expended4 7#b7 ,for purposes of carrying out the amendments made by subsection 7b71 there is appropriated to the ,department of ,labor1 out of amounts in the ,treasury not otherwise appropriated1 #d1ejj1jjj for fiscal year #bjbc1 to remain available until expended4 7e7 ,,aspe ,study ,the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services shall conduct or commission a study on how the ,united ,states health care market would be impacted by potential regulatory changes disallowing manufacturer rebates in the manner and to the extent allowed on the date of enactment of this ,act1 with a focus on the impact to stakeholders in the commercial insurance market1 and1 not later than #a year after the date of enactment of this ,act1 submit a report to ,congress on the results of such study4 ,such study and report shall consider the following3 7#a7 ,the impact of making no such regulatory changes1 as well as potential behavioral changes by plan sponsors1 members1 and pharmaceutical manufacturers1 such as tighter formularies1 changes to price concessions1 or changes in utilization1 if such regulatory changes are made4 7#b7 ,the mechanics needed in the pharmaceutical supply chain 7whether existing or not7 to move a manufacturer rebate to the point of sale4 7#c7 ,the feasibility of a partial point-of-sale manufacturer rebate versus a full point-of-sale manufacturer rebate4 7#d7 ,the impact on patient out-of-pocket costs1 premiums1 and other cost-sharing4 7#e7 ,possible behavioral changes by other third parties in the pharmaceutical supply chain including drug manufacturers1 distributors1 wholesalers1 rebate aggregators1 pharmacy services administrative organizations1 or group purchasing organizations4 7#f7 ,behavioral changes between entities that contract with pharmaceutical manufacturers and entities that participate in the pharmaceutical supply chain4 7#g7 ,alternative price negotiation mechanisms1 including the impact of the ,act of ,june #ai1 #aicf 7commonly known as the ,robinson-,patman ,act2 #di ,stat4 #aebf1 chapter #eib2 #ae ,u4,s4,c4 #ac;a et seq471 and the amendments made by that ,act1 on drug pricing negotiations4 7#h7 ,the impact on pharmacies1 including pharmacy rebates1 pharmacy fees1 and dispensing channels4 7#i7 ,the impact of manufacturer rebates on getting insulin products to market1 and the market dynamics and extent to which biosimilar biological product development and competition could increase1 or is increasing1 the number of biological products approved and available to patients1 including by examining barriers to-- 7,a7 placement of biosimilar biological products on health insurance formularies2 7,b7 market entry of insulin products in the ,united ,states1 as compared to other highly developed nations2 and 7,c7 patient and provider education around biosimilar biological products4 7f7 ,,gao study 7#a7 ,in general ,not later than ,january #a1 #bjbi1 the ,comptroller ,general of the ,united ,states shall report to ,congress on-- 7,a7 pharmacy networks of a selection of group health plans1 health insurance issuers1 and entities providing pharmacy benefit management services on behalf of such group health plan or group or individual health insurance coverage1 including networks that have pharmacies that are affiliated with or in common ownership with group health plans1 health insurance issuers1 or entities providing pharmacy benefit management services or pharmacy benefit administrative services under group health plan or group or individual health insurance coverage2 7,b7 as it relates to pharmacy networks that include pharmacies affiliated with or in common ownership with plans1 issuers1 or entities1 as described in subparagraph 7,a7-- 7i7 whether such networks are designed to encourage participants and beneficiaries of a plan or coverage to use such pharmacies over other network pharmacies for specific services or drugs1 and if so1 the reasons the networks give for encouraging use of such pharmacies2 and 7ii7 whether such pharmacies are used by participants and beneficiaries disproportionately more in the aggregate or for specific drugs compared to other network pharmacies2 7,c7 whether group health plans and health insurance issuers offering group health insurance coverage have options to elect different network pricing arrangements in the marketplace with entities that provide pharmacy benefit management services1 and the prevalence of electing such different network pricing arrangements among a selection of such plans and issuers2 7,d7 pharmacy network design parameters that encourage participants and beneficiaries 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 and 7,e7 for a selection of plans and issuers1 the degree to which mail order1 specialty1 or retail pharmacies that dispense prescription drugs to participants and beneficiaries in a group health plan or group health insurance coverage that are affiliated with or in common ownership with group health plans1 health insurance issuers1 or entities providing pharmacy benefit management services or pharmacy benefit administrative services under a group health plan or group health insurance coverage receive reimbursement that is greater than the median price charged to the group health plan or health insurance issuer when the same drug is dispensed to participants and beneficiaries in the plan or coverage by other pharmacies included in the pharmacy network of that plan or issuer that are not affiliated with or in common ownership with the health insurance issuer or entity providing pharmacy benefit management services4 7#b7 ,requirement ,in carrying out paragraph 7#a71 the ,comptroller ,general of the ,united ,states shall not disclose-- 7,a7 information that would allow for identification of a specific individual1 plan sponsor1 health insurance issuer1 group health plan1 or entity providing pharmacy benefit management services2 or 7,b7 commercial or financial information that is privileged or confidential4 7#c7 ,definitions ,in this subsection1 the terms group health plan1 health insurance coverage1 and health insurance issuer have the meanings given such terms in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 #c4 ,reporting on justification for drug price increases ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,drug ,price ,reporting2 ,drug ,value ,fund #cii,,oo4 ,reporting on justification for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the license issued under section #cea of this ,act2 or 7,b7 who is engaged in manufacturing1 preparing1 propagating1 compounding1 processing1 packaging1 repackaging1 or labeling of a prescription drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more per month supply1 or per a course of treatment that lasts less than a month1 and is-- 7i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 not a vaccine2 and 7iii7 not an antibiotic2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales was for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,report required ,the manufacturer of a qualifying drug shall submit a report to the ,secretary for each planned increase in price of a qualifying drug that will result in an increase in the wholesale acquisition cost of that drug that is equal to-- 7,a7 #aj percent or more over a #ab-month period2 or 7,b7 #be percent or more over a #cf-month period4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary not later than #cj days prior to the effective date of such planned increase in price4 7c7 ,contents ,a report under subsection 7b7 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 the percentage by which the manufacturer will raise the wholesale acquisition cost of the drug on the planned effective date of such planned increase in price2 7,b7 a justification for1 and description of1 each manufacturer's planned increase in price that will occur during the #ab-month period described in subsection 7b77#a77;,a7 or the #cf-month period described in subsection 7b77#a77;,b71 as applicable1 that shall be accompanied by information to substantiate the basis for the justification and a certification that1 to the manufacturer's knowledge and belief1 the justification is truthful and nonmisleading and does not describe uses of the drug beyond those listed as an indication or use in its approved labeling2 7,c7 the identity of the initial developer of the drug1 if applicable2 7,d7 a description of the history of the manufacturer's price increases for the drug since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license1 as applicable2 7,e7 the current wholesale acquisition cost of the drug2 7,f7 the total expenditures of the manufacturer for the #c years preceding the planned increase in price on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 the total expenditures of the manufacturer on research and development1 for the #c years preceding the planned increase in price for such drug1 that is necessary to demonstrate that it meets applicable standards for approval under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under such section #cea1 as applicable2 7,i7 the total expenditures of the manufacturer on research and development for such drug that is pursuing new or expanded indications for such drug through supplemental applications under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a7 of this ,act2 7,j7 the total expenditures of the manufacturer on research and development for such drug that is carrying out postmarket requirements related to such drug1 including those under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,k7 the total revenue and the net profit generated from the qualifying drug for each calendar year since the approval of the application for the drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,l7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer-- 7i7 for the #ab-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,a72 7ii7 for the #cf-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,b72 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation-- 7i7 for the #ab-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,a72 or 7ii7 for the #cf-month period preceding the date of the report1 in the case of a report based on an increase described in subsection 7b77#a77;,b72 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials on drugs1 conducted with the intent of using the data to support approval of an application under section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea7;a71 but for which such application was not submitted or filed1 or failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate1 as specified through notice and comment rulemaking4 7d7 ,civil money penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section1 or knowingly provides false information1 shall be subject to a civil money penalty of #ajj1jjj for each day on which the violation continues4 7e7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 not later than #cj days after the submission of a report under subsection 7b71 the ,secretary shall post the report on the public website of the ,department of ,health and ,human ,services1 accompanied by language indicating that such public posting does not represent an endorsement or validation of the report's content by the ,secretary4 7#b7 ,format ,in developing the format of such report for public posting1 the ,secretary shall consult stakeholders1 including beneficiary groups1 and shall seek feedback on the content and format from consumer advocates and readability experts to ensure such public reports are user-friendly to the public and are written in plain language that consumers can readily understand4 7#c7 ,trade secrets and confidential information ,this section does not authorize the disclosure of confidential commercial information or trade secrets4 4 #cii,,oo-#a4 ,use of civil penalty amounts ,the ,secretary shall1 without further appropriation1 collect civil penalties under section #cii,,oo and use the funds derived from such civil penalties1 in addition to any other amounts available to the ,secretary1 to carry out activities described in this part and to improve consumer and provider information about drug value and drug price transparency4 #cii,,oo-#b4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 and post on the public website of the ,department of ,health and ,human ,services in a way that is easy to find1 use1 and understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 and 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to section #cii,,oo4 7b7 ,trade secrets and confidential information ,this section does not authorize the disclosure of confidential commercial information or trade secrets4 4 #d4 ,study on fiduciary duties of pharmacy benefit managers 7a7 ,in general ,the ,secretary of ,labor shall conduct1 and submit to ,congress a report describing the results of1 a study on the impacts of a change in policy described in subsection 7b74 7b7 ,policy described ,under a policy referred to in subsection 7a7-- 7#a7 an entity providing pharmacy benefit management services would be considered a fiduciary within the meaning of section #c7ba7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajjb7ba77 with respect to a group health plan or group health insurance coverage2 and 7#b7 such an entity would-- 7,a7 be subject to the responsibilities1 obligations1 and duties imposed on fiduciaries under part #d of subtitle ,b of title ,i of such ,act 7#bi ,u4,s4,c4 #aaja et seq472 and 7,b7 make the required fiduciary disclosure under section #djh7;b77#b77;,b77iii7 of such ,act 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77iii77 with respect to the pharmacy benefit management services provided to the plan or coverage4 7c7 ,definition of pharmacy benefit management services ,in this section1 the term pharmacy benefit management services means services related to-- 7#a7 negotiating prices with respect to prescription drugs on behalf of a group health plan or health insurance issuer offering group health insurance coverage2 and 7#b7 managing the prescription drug benefits provided by such plan or coverage1 including designing and implementing a drug formulary1 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 prescription drugs1 or the provision of related services4 #e4 ,clarification of requirement to disclose direct and indirect compensation for brokers and consultants to employer-sponsored health plans 7a7 ,in general ,section #djh7;b77#b77;,b77ii77,i77bb7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77 is amended by adding at the end the following3 7,,cc7 ,pharmacy benefit management services provided by pharmacy benefit managers or other service providers and related services provided by third-party administrators 7or other entities providing such services7 for which the covered service provider1 an affiliate1 or a subcontractor reasonably expects to receive indirect compensation or direct compensation described in item 7dd74 4 7b7 ,regulations ,not later than #ah months after the date of enactment of this ,act1 the ,secretary of ,labor shall promulgate regulations1 through notice and comment rulemaking1 clarifying the requirements of section #djh7;b77#b77;,b7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77 with respect to covered service providers providing services described in subitem 7,,cc7 of subclause 7,i77bb7 of such section1 as amended by subsection 7a74 ,such regulations shall apply with respect to any plan year that begins on or after the date that is #f months after such regulations are promulgated4 7c7 ,sense of ,congress ,it is the sense of ,congress that the amendment made by subsection 7a7 clarifies the existing requirement of covered service providers with respect to services described in section #djh7;b77#b77;,b77ii77,i77bb77,,bb7 of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aajh7;b77#b77;,b77ii77,i77bb77,,bb77 that were in effect since the application date described in section #bjb7;e7 of the ,no ,surprises ,act 7,public ,law #aaf-bfj2 #bi ,u4,s4,c4 #aajh note71 and does not impose any additional requirement under section #djh7;b77#b77;,b7 of such ,act4 #f4 ,study on naloxone access 7a7 ,in general ,the ,comptroller ,general of the ,united ,states shall conduct a study on actions that may be taken to ensure appropriate access and affordability of naloxone for individuals seeking to purchase naloxone4 ,such study shall address what is known about-- 7#a7 coverage of naloxone 7in any available form71 including whether naloxone can be covered as an over-the-counter drug under a group health plan or group or individual health insurance coverage 7as such terms are defined in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia772 7#b7 the out-of-pocket cost to consumers purchasing naloxone-- 7,a7 with a prescription1 with and without coverage under any such plan or coverage2 and 7,b7 over the counter1 with and without coverage under any such plan or coverage2 and 7#c7 other factors impacting coverage1 including barriers in covering naloxone as an over-the-counter drug1 the relative net costs of naloxone when purchased over the counter without insurance coverage compared to when purchased with a prescription and covered under a group health plan or health insurance coverage1 and the availability of naloxone purchased and distributed through public health entities4 7b7 ,report ,not later than #b years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report that contains the findings of the study conducted under subsection 7a74 #g4 ,prohibition on blocking consumer decision-support tools 7a7 ,,phsa ,part ,d of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aaa et seq471 as amended by section #b1 is further amended by adding at the end the following3 #bgii;,a-#ab4 ,prohibition on blocking consumer decision-support tools 7a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into a contract with an entity that provides pharmacy benefit management services with respect to such plan or coverage if such contract includes any terms1 conditions1 or costs that would prevent or restrict a covered third party from accessing or using information1 for purposes of the consumer decision-support tool1 relevant to the operability1 implementation1 and utilization of the consumer-decision support tool regarding prescription drug benefits under the plan or coverage that are administered by the entity providing pharmacy benefit management services in contract with the plan or issuer4 7b7 ,definitions ,in this section3 7#a7 ,consumer decision-support tool ,the term consumer decision-support tool means a tool designed to inform enrollees in a group health plan or health insurance coverage about all costs to the enrollee for prescription drugs covered by the plan or coverage1 including out-of-pocket1 copayment1 and coinsurance responsibility1 as well as means for reducing the cost to the enrollee1 such as manufacturer copayment assistance1 purchasing at the cash price1 and purchasing through mail order pharmacy benefits4 7#b7 ,covered third party ,the term covered third party means a third party that is in contract1 as a business associate 7as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations771 with a group health plan or a health insurance issuer offering group or individual health insurance coverage to provide a consumer decision-support tool4 7c7 ,rules of construction regarding privacy 7#a7 ,nothing in this section shall be construed to alter existing obligations of a covered entity or business associate under the privacy1 security1 and breach notification regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7#b7 ,nothing in this section shall be construed to require a group health plan1 a health insurance issuer offering group or individual health insurance coverage1 or an entity providing pharmacy benefit management services to share protected health information1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 with a covered third party4 4 7b7 ,,erisa 7#a7 ,in general ,subpart ,b of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe et seq471 as amended by section #b1 is further amended by adding at the end the following3 #gbg4 ,prohibition on blocking consumer decision-support tools 7a7 ,in general ,a group health plan or a health insurance issuer offering group health insurance coverage shall not enter into a contract with an entity that provides pharmacy benefit management services with respect to such plan or coverage if such contract includes any terms1 conditions1 or costs that would prevent or restrict a covered third party from accessing or using information1 for purposes of the consumer decision-support tool1 relevant to the operability1 implementation1 and utilization of the consumer-decision support tool regarding prescription drug benefits under the plan or coverage that are administered by the entity providing pharmacy benefit management services in contract with the plan or issuer4 7b7 ,definitions ,in this section3 7#a7 ,consumer decision-support tool ,the term consumer decision-support tool means a tool designed to inform participants and beneficiaries in a group health plan or health insurance coverage about all costs to the participant or beneficiary for prescription drugs covered by the plan or coverage1 including out-of-pocket1 copayment1 and coinsurance responsibility1 as well as means for reducing the cost to the participant or beneficiary1 such as manufacturer copayment assistance1 purchasing at the cash price1 and purchasing through mail order pharmacy benefits4 7#b7 ,covered third party ,the term covered third party means a third party that is in contract1 as a business associate 7as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations771 with a group health plan or a health insurance issuer offering group health insurance coverage to provide a consumer decision-support tool4 7c7 ,rules of construction 7#a7 ,nothing in this section shall be construed to alter existing obligations of a covered entity or business associate under the privacy1 security1 and breach notification regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7#b7 ,nothing in this section shall be construed to require a group health plan1 a health insurance issuer offering group health insurance coverage1 or an entity providing pharmacy benefit management services to share protected health information1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 with a covered third party4 4 7#b7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq471 as amended by section #b1 is further amended by inserting after the item relating to section #gbf the following3 ,sec4 #gbg4 ,prohibition on blocking consumer decision-support tools4 4 7c7 ,internal ,revenue ,code 7#a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf1 as amended by section #b1 is further amended by adding at the end the following new section3 #ihbg4 ,prohibition on blocking consumer decision-support tools 7a7 ,in general ,a group health plan offering group health insurance coverage shall not enter into a contract with an entity that provides pharmacy benefit management services with respect to such plan if such contract includes any terms1 conditions1 or costs that would prevent or restrict a covered third party from accessing or using information1 for purposes of the consumer decision-support tool1 relevant to the operability1 implementation1 and utilization of the consumer-decision support tool regarding prescription drug benefits under the plan that are administered by the entity providing pharmacy benefit management services in contract with the plan4 7b7 ,definitions ,in this section3 7#a7 ,consumer decision-support tool ,the term consumer decision-support tool means a tool designed to inform participants and beneficiaries in a group health plan about all costs to the participant or beneficiary for prescription drugs covered by the plan1 including out-of-pocket1 copayment1 and coinsurance responsibility1 as well as means for reducing the cost to the participant or beneficiary1 such as manufacturer copayment assistance1 purchasing at the cash price1 and purchasing through mail order pharmacy benefits4 7#b7 ,covered third party ,the term covered third party means a third party that is in contract1 as a business associate 7as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations771 with a group health plan or a health insurance issuer offering group health insurance coverage to provide a consumer decision-support tool4 7c7 ,rules of construction 7#a7 ,nothing in this section shall be construed to alter existing obligations of a covered entity or business associate under the privacy1 security1 and breach notification regulations in parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7#b7 ,nothing in this section shall be construed to require a group health plan or an entity providing pharmacy benefit management services to share protected health information1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or successor regulations71 with a covered third party4 4 7#b7 ,clerical amendment ,the table of sections for subchapter ,b of chapter #ajj of such ,code1 as amended by section #b1 is further amended by adding at the end the following new item3 ,sec4 #ihbg4 ,prohibition on blocking consumer decision-support tools4 4 7d7 ,application ,the amendments made by subsections 7a71 7b71 and 7c7 shall apply with respect to plan years beginning on or after the date that is #b years after the date of enactment of this ,act4 7e7 ,regulations ,the ,secretary of ,health and ,human ,services1 the ,secretary of ,labor1 and the ,secretary of the ,treasury shall jointly promulgate regulations to carry out the amendments made by subsections 7a71 7b71 and 7c71 and shall issue draft regulations not later than #a year after the date of enactment of this ,act4 #h4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg et seq47 is amended by inserting after section #bgae;,a the following3 #bgae;,b4 ,requirement to provide health claims1 network1 and cost information 7a7 ,in general ,a group health plan or a health insurance issuer offering group or individual health insurance coverage shall make available for access1 exchange1 and use without special effort1 through application programming interfaces 7or successor technology or standards71 consistent with standards and implementation specifications adopted under section #cjjd1 the information described in subsection 7b71 in the manner described in subsection 7b71 as applicable1 and otherwise consistent with this section4 7b7 ,electronic information ,the following electronic information is required to be made available1 as the ,secretary may specify3 7#a7 ,historical claims1 provider encounter1 and payment data for each enrollee1 which-- 7,a7 may include adjudicated medical and prescription drug claims and equivalent encounters1 including all data elements contained in such transactions-- 7i7 that were adjudicated by the group health plan or health insurance issuer during the previous #e years or the enrollee's entire period of enrollment in the applicable plan or coverage if such period is less than the previous #e years2 7ii7 that involve benefits managed by any third party1 such as a pharmacy benefits manager or radiology benefits manager that manages benefits or adjudicates claims on behalf of the plan or coverage2 and 7iii7 from any other group health plan or health insurance coverage offered by the same insurance issuer1 in which the same enrollee was enrolled during the previous #e years2 and 7,b7 shall be available to an enrollee or former enrollee1 the enrollee's providers1 and any third-party applications or services authorized by the enrollee-- 7i7 through the application programming interfaces 7or successor technology or standards7 consistent with standards and specifications adopted under section #cjjd1 in a single1 longitudinal format that is easy to understand1 secure1 and that may update automatically2 7ii7 as soon as practicable1 and in no case later than the period of time determined by the ,secretary1 after the claim is adjudicated or the data is received by the group health plan or health insurance issuer2 and 7iii7 for a period of #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer4 7#b7 ,identifying directory information for all in-network providers1 including facilities and practitioners1 that participate in the plan or coverage1 which shall-- 7,a7 include-- 7i7 the national provider identifier for in-network facilities and practitioners2 and 7ii7 the name1 address1 phone number1 and specialty for each such facility and practitioner1 within a timeframe determined by the ,secretary1 from when the plan or coverage receives provider directory information or updates from that facility or practitioner2 7,b7 be capable of returning the information necessary to establish a list of participating in-network facilities and practitioners1 in a given specialty or at a particular facility type1 within a specified geographic radius2 and 7,c7 be capable of returning the network status1 when presented with identifiers for a given enrollee and facility or practitioner4 7#c7 ,estimated enrollee out-of-pocket costs1 including costs expected to be incurred through a deductible1 co-payment1 coinsurance1 or other form of cost-sharing1 for-- 7,a7 a designated set of common services or episodes of care1 to be established by the ,secretary through rulemaking1 including1 at a minimum-- 7i7 in the case of services provided by a hospital1 the #ajj most common diagnosis-related groups1 as used in the ,medicare ,inpatient ,prospective ,patient ,system 7or successor episode-based reimbursement methodology7 at that hospital1 based on claims data adjudicated by the group health plan or health insurance issuer2 7ii7 in the case of services provided in an out-patient setting1 including radiology1 lab tests1 and out-patient surgical procedures1 any service rendered by the facility or practitioner1 and reimbursed by the group health plan or health insurance issuer2 and 7iii7 in the case of post-acute care1 including home health providers1 skilled nursing facilities1 inpatient rehabilitation facilities1 and long-term care hospitals1 the patient out-of-pocket costs for an episode of care1 as the ,secretary may determine1 which permits users to reasonably compare costs across different facility and service types2 and 7,b7 all prescription drugs currently included on any tier of the formulary of the plan or coverage4 7c7 ,availability and access ,subject to all applicable ,federal and ,state privacy1 security1 and breach notification laws1 and within a timeframe determined by the ,secretary1 the application programming interfaces 7or successor technology or standards71 including all data required to be made available through such interfaces1 shall-- 7#a7 be made available by the applicable group health plan or health insurance issuer1 at no charge1 to-- 7,a7 enrollees and prospective enrollees in the group health plan or health insurance coverage2 7,b7 third parties authorized by the enrollee2 7,c7 facilities and practitioners who are under contract with the plan or coverage2 and 7,d7 business associates of such facilities and practitioners1 as defined in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 7#b7 be available to enrollees in the group health plan or health insurance coverage1 and to third-party applications or services facilitating such access by enrollees1 during the enrollment process and for a minimum of #e years after the end date of the enrollee's enrollment in the plan or in any coverage offered by the health insurance issuer2 7#c7 permit persistent access by third-party applications or services authorized by the enrollee1 for a reasonable period of time2 7#d7 employ the applicable content1 vocabulary1 and technical standards1 as determined by the ,secretary pursuant to title ,,xxx2 and 7#e7 employ security and authentication standards1 as the ,secretary determines appropriate4 7d7 ,denial or discontinuance of access ,a group health plan or health insurance issuer offering group or individual health insurance coverage may deny access or discontinue access of the application programming interfaces 7or successor technology or standards7 to third-party applications or services on the basis of reasonable privacy or security concerns1 as determined by the ,secretary1 including at the request of the enrollee4 7e7 ,notification ,when obtaining enrollee authorization to share information with a third party under this section1 a group health plan or a health insurance issuer offering group or individual health insurance coverage shall include a notification for the enrollee that information shared with a third party that is not a covered entity or business associate is not subject to the privacy1 security1 or breach notification rules under parts #afj and #afd of title #de1 ,code of ,federal ,regulations 7or successor regulations74 7f7 ,rule of construction regarding privacy ,nothing in this section shall be construed to alter existing obligations of a covered entity or business associate under the privacy1 security1 and breach notification rules promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act or section #acdjb of the ,,hitech ,act1 or to alter the ,secretary's existing authority to modify such rules1 under part #b of title #db1 ,code of ,federal ,regulations 7or successor regulations71 under section #ddd of the ,general ,education ,provisions ,act 7#bj ,u4,s4,c4 #abcb;g7 7commonly referred to as the ,family ,educational ,rights and ,privacy ,act of #aigd71 under the amendments made by the ,genetic ,information ,nondiscrimination ,act1 or under ,state privacy law4 4 7b7 ,effective date ,section #bgae;,b of the ,public ,health ,service ,act1 as added by subsection 7a71 shall take effect #ah months after the date of enactment of this ,act4 #i4 ,required exceptions process for medication step therapy protocols 7a7 ,short title ,this section may be cited as the ,safe ,step ,act4 7b7 ,required exceptions process for medication step therapy protocols ,the ,employee ,retirement ,income ,security ,act of #aigd is amended by inserting after section #gac of such ,act 7#bi ,u4,s4,c4 #aahe;b7 the following new section3 #gac;,a4 ,required exceptions process for medication step therapy protocols 7a7 ,in general ,in the case of a group health plan or health insurance issuer offering coverage offered in connection with such a plan that provides coverage of a prescription drug pursuant to a medication step therapy protocol1 the plan or issuer shall-- 7#a7 implement a clear1 prompt1 and transparent process for a participant or beneficiary 7or the prescribing health care provider 7referred to in this section as the prescriber7 on behalf of the participant or beneficiary7 to request an exception to such medication step therapy protocol1 pursuant to subsection 7b72 and 7#b7 where the participant or beneficiary or prescriber's request for an exception to the medication step therapy protocols satisfies the criteria and requirements of subsection 7b71 cover the requested drug in accordance with the terms established by the plan or coverage for patient cost-sharing rates or amounts at the beginning of the plan year4 7b7 ,circumstances for exception approval ,the circumstances requiring an exception to a medication step therapy protocol1 pursuant to a request under subsection 7a71 are any of the following3 7#a7 ,any treatments otherwise required under the protocol1 or treatments in the same pharmacological class or having the same mechanism of action1 including treatments provided prior to the effective date of the participant's or beneficiary's coverage under the plan or coverage1 have been ineffective in the treatment of the disease or condition of the participant or beneficiary1 when prescribed consistent with clinical indications1 clinical guidelines1 or other peer-reviewed evidence1 based on the prescribing health care professional's judgement or relevant information provided by the participant or beneficiary 7including the medical records of the participant or beneficiary74 7#b7 ,delay of effective treatment would lead to severe or irreversible consequences1 or worsen disease progression or a comorbidity and the treatment otherwise required under the protocol is reasonably expected by the prescriber to be ineffective based upon the documented physical or mental characteristics of the participant or beneficiary and the known characteristics of such treatment4 7#c7 ,any treatments otherwise required under the protocol are contraindicated for the participant or beneficiary or have caused1 or are likely to cause1 based on clinical1 peer-reviewed evidence1 an adverse reaction or other physical or mental harm to the participant or beneficiary4 7#d7 ,any treatment otherwise required under the protocol has prevented1 will prevent1 or is likely to prevent a participant or beneficiary from achieving or maintaining reasonable and safe functional ability in performing occupational responsibilities or activities of daily living 7as defined in section #dda4eje of title #db1 ,code of ,federal ,regulations 7or successor regulations774 7#e7 ,the participant or beneficiary is stable for his or her disease or condition on the prescription drug or drugs selected by the prescriber and has previously received approval for coverage of the relevant drug or drugs for the disease or condition by any public or private health plan4 7#f7 ,other circumstances1 as determined by the ,secretary4 7c7 ,requirement of a clear process 7#a7 ,in general ,the process required by subsection 7a7 shall-- 7,a7 provide the prescriber or participant or beneficiary an opportunity to present such prescriber's clinical rationale and relevant medical information for the group health plan or health insurance issuer to evaluate such request for exception2 7,b7 develop and use a standard form and instructions for the request of an exception under subsection 7b71 available in paper and electronic forms1 and allow for submission of such form by paper and electronic means2 7,c7 provide both paper and electronic means for the submission of requests for additional information2 7,d7 clearly set forth all required information and the specific criteria that will be used to determine whether an exception is warranted1 which may require disclosure of-- 7i7 the medical history or other health records of the participant or beneficiary demonstrating that the participant or beneficiary seeking an exception-- 7,i7 has tried other drugs included in the drug therapy class without success2 or 7,,ii7 has taken the requested drug for a clinically appropriate amount of time to establish stability1 in relation to the condition being treated and prescription guidelines given by the prescribing physician2 or 7ii7 other clinical information that may be relevant to conducting the exception review2 7,e7 not require the submission of any information or supporting documentation beyond what is strictly necessary 7as determined by the ,secretary7 to determine whether a circumstance listed in subsection 7b7 exists2 7,f7 clearly outline conditions under which an exception request warrants expedited resolution from the group health plan or health insurance issuer1 pursuant to subsection 7d77#b72 and 7,g7 allow a representative of a participant or beneficiary1 which may include a designated third-party advocate1 to act on behalf of the participant or beneficiary4 7#b7 ,availability of process information ,the group health plan or health insurance issuer shall make information regarding the process required under subsection 7a7 readily available in the relevant plan materials1 including the summary of benefits and1 if available1 on the website of the group health plan or health insurance issuer4 ,such information shall include-- 7,a7 the requirements for requesting an exception to a medication step therapy protocol pursuant to this section2 and 7,b7 any forms1 supporting information1 and contact information1 as appropriate4 7d7 ,timing for determination of exception ,the process required under subsection 7a77#a7 shall provide for the disposition of requests received under such paragraph in accordance with the following3 7#a7 ,subject to paragraph 7#b71 not later than #gb hours after receiving an initial exception request1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber with either a determination of exception eligibility or a request for additional required information strictly necessary to make a determination of whether the conditions specified in subsection 7b7 are met4 ,the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a determination of exception eligibility no later than #gb hours after receipt of the additional required information4 7#b7 ,in the case of a request under circumstances in which the applicable medication step therapy protocol may seriously jeopardize the life or health of the participant or beneficiary1 may jeopardize the ability of the participant or beneficiary to regain maximum function1 or may subject the participant or beneficiary to severe pain that cannot be adequately managed without the treatment that is the subject of the request1 the plan or issuer shall conduct a review of the request and respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with either a determination of exception eligibility or a request for additional required information strictly necessary to make a determination of whether the conditions specified in subsection 7b7 are met1 in accordance with the following3 7,a7 ,if the plan or issuer can make a determination of exception eligibility without additional information1 such determination shall be made on an expedited basis1 and no later than #bd hours after receipt of such request4 7,b7 ,if the plan or issuer requires additional information before making a determination of exception eligibility1 the plan or issuer shall respond to the participant or beneficiary and1 if applicable1 the requesting prescriber1 with a request for such information within #bd hours of the request for a determination1 and shall respond with a determination of exception eligibility as quickly as the condition or disease requires1 and no later than #bd hours after receipt of the additional required information4 7e7 ,duration of a grant ,if an exception to a medication step therapy protocol is granted under this section to a participant or beneficiary1 coverage for the requested drug shall remain in effect with respect to such participant or beneficiary for not less than one year4 7f7 ,medication step therapy protocol ,in this section1 the term medication step therapy protocol means a drug therapy utilization management protocol or program under which a group health plan or health insurance issuer offering group health insurance coverage of prescription drugs requires a participant or beneficiary to try an alternative preferred prescription drug or drugs before the plan or health insurance issuer approves coverage for the non-preferred drug therapy prescribed4 7g7 ,clarification ,this section shall apply with respect to any group health plan or health insurance coverage offered in connection with such a plan that provides coverage of a prescription drug pursuant to a policy that meets the definition of the term medication step therapy protocol in subsection 7f71 regardless of whether such policy is described by such group health plan or health insurance coverage as a step therapy protocol4 7h7 ,reporting 7#a7 ,reporting to the ,secretary ,not later than #c years after the date of enactment of the ,safe ,step ,act and not later than ,october #a of each year thereafter1 each group health plan and health insurance issuer offering group health insurance coverage shall report to the ,secretary1 in such manner as the ,secretary shall require1 the following3 7,a7 ,the number of step therapy exception requests received for each exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b71 and the numbers of such requests for each such circumstance that were-- 7i7 approved2 7ii7 deemed approved under subsection 7d77#c7 due to the failure of the plan or issuer to timely respond2 7iii7 denied1 and the reasons for the denials2 7iv7 initially denied and appealed2 and 7v7 initially denied and then subsequently reversed by internal appeals or external reviews4 7,b7 ,the number of times a plan or issuer requested additional information in response to a step therapy exception request1 by exception circumstance described in paragraphs 7#a7 through 7#f7 of subsection 7b74 7,c7 ,the number of exception requests submitted by participants or beneficiaries1 and the number of exception requests submitted by prescribers1 by medical specialty4 7,d7 ,the medical conditions for which participants and beneficiaries were granted exceptions due to the likelihood that switching from a prescription drug will likely cause an adverse reaction by1 or physical or mental harm to1 the participant or beneficiary1 as described in subsection 7b77#c74 7,e7 ,the entities responsible for providing pharmacy benefit management services for the group health plan or health insurance coverage4 7#b7 ,information ,a group health plan or health insurance issuer offering group health insurance coverage shall not enter into a contract with a third-party administrator or an entity providing pharmacy benefit management services on behalf of the plan or coverage that prevents the plan or issuer from obtaining from the third-party administrator or the entity providing pharmacy benefit management services any information needed for the plan or issuer to comply with the reporting requirements under paragraph 7#a74 7#c7 ,reports to ,congress ,not later than #c years after the date of enactment of the ,safe ,step ,act1 and not later than ,october #a of each year thereafter1 the ,secretary shall submit to ,congress1 and make publicly available1 a report that contains a summary and analysis of the information reported under paragraph 7#a71 including an analysis of1 with respect to requests for exceptions under this section1 approvals1 and denials1 including the reasons for denials2 appeals and external reviews2 and trends1 if any1 in exception requests by medical specialty or medical condition4 4 7c7 ,clerical amendment ,the table of contents in section #a of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #ajja et seq47 is amended by inserting after the item relating to section #gac the following new items3 ,sec4 #gac;,a4 ,required exceptions process for medication step therapy protocols4 4 7d7 ,effective date 7#a7 ,in general ,the amendment made by subsection 7b7 applies with respect to plan years beginning with the first plan year that begins at least #f months after the date of the enactment of this ,act4 7#b7 ,regulations ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,labor shall issue final regulations1 through notice and comment rulemaking1 to implement the provisions of section #gac;,a of the ,employee ,retirement ,income ,security ,act of #aigd1 as added by subsection 7b74 ,june #bb1 #bjbc,reported with an amendment