Sec. 106. Pharmacy benefits price transparency
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Title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg et seq. ) is amended— in part D ( 42 U.S.C. 300gg–111 et seq. ), by adding at the end the following new section: For plan years beginning on or after the date that is 2 years after the date of enactment of this section, a group health plan or a health insurance issuer offering group health insurance coverage, or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan or issuer, shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any other third party that limits (or delays beyond the applicable reporting period described in subsection (b)(1)) the disclosure of information to plan sponsors in such a manner that prevents such plan, issuer, or entity from making the reports described in subsection (b).
With respect to plan years beginning on or after the date that is 2 years after the date of enactment of this section, not less frequently than every 6 months (or at the request of a plan sponsor, not less frequently than quarterly, but under the same conditions, terms, and cost of the semiannual report under this subsection), a group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such a plan or issuer, shall submit to the plan sponsor (as defined in section 3(16)(B) of the Employee Retirement Income Security Act of 1974) of such plan or coverage a report in accordance with this section.
Each such report shall be made available to such plan sponsor in a machine-readable format and shall include the information described in paragraph (2). For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or health insurance issuer offering group health insurance coverage during each reporting period— a list of drugs for which a claim was filed and, with respect to each such drug on such list— the brand name, chemical entity, and National Drug Code; the type of dispensing channel used to furnish such drug, including retail, mail order, or specialty pharmacy; with respect to each drug dispensed under each type of dispensing channel (including retail, mail order, or specialty pharmacy)— whether such drug is a brand name drug or a generic drug, and— in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and the total number of— prescription claims (including original prescriptions and refills); participants, beneficiaries, and enrollees for whom a claim for such drug was filed; dosage units per fill of such drug; and days supply of such drug per fill; the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after manufacturer rebates, fees, and other remuneration or adjustments; the total amount of out-of-pocket spending by participants, beneficiaries, and enrollees on such drug, including spending through copayments, coinsurance, and deductibles; the total net spending by the plan or coverage; total amount received, or expected to be received, by the plan or coverage from any entity in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from an entity or any third party (including group purchasing organizations) other than the plan sponsor; the total amount received, or expected to be received by the plan or issuer, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration— that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; and that is related to utilization rebates for such drug; and to the extent feasible, information on the total amount of remuneration, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copay assistance on behalf of such drug manufacturer) to the participants, beneficiaries, and enrollees enrolled in such plan or coverage; for each category or class of drugs for which a claim was filed, a breakdown of the total gross spending on drugs in such category or class before rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, and the net spending after such rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, including— the number of participants, beneficiaries, and enrollees who filled a prescription for a drug in such category or class, including the National Drug Code for each such drug; if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class; and the total out-of-pocket spending under the plan or coverage by participants, beneficiaries, and enrollees, including spending through copayments, coinsurance, and deductibles; in the case of a drug for which gross spending by such plan, coverage, or entity exceeded $10,000 during the reporting period— a list of all other drugs in the same therapeutic category or class; and the rationale for the formulary placement of such drug in that therapeutic category or class, if applicable; amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act) to brokers, consultants, advisors, or any other individual or firm, for the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefits management services, including the identity of the recipient of such amounts; an explanation of any benefit design parameters that encourage or require participants, beneficiaries, and enrollees in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and in the case of a plan or coverage (or an entity providing pharmacy benefits management services on behalf of such plan or coverage) that has an affiliated pharmacy or pharmacy under common ownership— the percentage of total prescriptions dispensed by such pharmacies to individuals enrolled in such plan or coverage; a list of all drugs dispensed by such pharmacies to individuals enrolled in such plan or coverage, and, with respect to each drug dispensed— the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan or issuer, and to participants, beneficiaries, and enrollees enrolled in such plan or coverage; the median amount charged to such plan or issuer, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants, beneficiaries, and enrollees, 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 such plan or coverage; the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan and participants, beneficiaries, and enrollees, that is available from any pharmacy included in the network of such plan or coverage; and the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount.
Health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph
(1)in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 13402(a) of the Health Information Technology for Clinical Health Act, and shall restrict the use and disclosure of such information according to such privacy regulations. A plan sponsor receiving a report under paragraph
(1)may disclose such information only to the entity from which the report was received, the group health plan for which the report pertains, or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E). Nothing in this section shall prevent a group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such a plan or coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or the Comptroller General of the United States. The Secretary shall define through rulemaking a limited form of the report under paragraph
(1)required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior. A group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such plan or coverage, shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph
(1)and other such reports as requested, in accordance with the privacy requirements under paragraph (3), the disclosure and redisclosure standards under paragraph (4), the standards specified pursuant to paragraph (6), and such other information that the Comptroller General determines necessary to carry out the study under section 106(d) of the Lower Costs, More Transparency Act. Not later than 1 year after the date of enactment of this section, the Secretary shall specify through rulemaking standards for group health plans, health insurance issuers offering group health insurance coverage, and entities providing pharmacy benefits management services on behalf of such plans or coverage, required to submit reports under paragraph
(1)to submit such reports in a standard format. The Secretary shall enforce this section. A health insurance issuer or an entity providing pharmacy benefits management services on behalf of such plan or coverage that violates sub-section
(a)or fails to provide the information required under subsection
(b)shall be subject to a civil monetary penalty in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported. A health insurance issuer or an entity providing pharmacy benefits management services on behalf of such a plan or coverage that knowingly provides false information under this section shall be subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalty shall be in addition to other penalties as may be prescribed by law. The provisions of section 1128A of the Social Security Act, other than subsections
(a)and
(b)and the first sentence of subsection (c)(1) 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 such section. The Secretary may waive penalties under paragraph (2), or extend the period of time for compliance with a requirement of this section, for an entity in violation of this section that has made a good-faith effort to comply with the requirements in this section. Nothing in this section shall be construed to permit a group health plan, health insurance issuer, or entity providing pharmacy benefits management services on behalf of such plan or coverage, to restrict disclosure to, or otherwise limit the access of, the Department of Health and Human Services to a report described in subsection (b)(1) or information related to compliance with subsection
(a)or
(b)by entities subject to such subsection. In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act. ; and in section 2723 ( 42 U.S.C. 300gg–22 )— in subsection (a)— in paragraph (1), by inserting (other than subsections
(a)and
(b)of section 2799A–11) after part D ; and in paragraph (2), by inserting (other than subsections
(a)and
(b)of section 2799A–11) after part D ; and in subsection (b)— in paragraph (1), by inserting (other than subsections
(a)and
(b)of section 2799A–11) after part D ; in paragraph (2)(A), by inserting (other than subsections
(a)and
(b)of section 2799A–11) after part D ; and in paragraph (2)(C)(ii), by inserting (other than subsections
(a)and
(b)of section 2799A–11) after part D . Subtitle B of title I of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1021 et seq. ) is amended— in subpart B of part 7 ( 29 U.S.C. 1185 et seq. ), by adding at the end the following: For plan years beginning on or after the date that is 2 years after the date of enactment of this section, a group health plan or a health insurance issuer offering group health insurance coverage, or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan or issuer, shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any other third party that limits (or delays beyond the applicable reporting period described in subsection (b)(1)) the disclosure of information to plan sponsors in such a manner that prevents such plan, issuer, or entity from making the reports described in subsection (b). With respect to plan years beginning on or after the date that is 2 years after the date of enactment of this section, not less frequently than every 6 months (or at the request of a plan sponsor, not less frequently than quarterly, but under the same conditions, terms, and cost of the semiannual report under this subsection), a group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such a plan or issuer, shall submit to the plan sponsor (as defined in section 3(16)(B)) of such plan or coverage a report in accordance with this section. Each such report shall be made available to such plan sponsor in a machine-readable format and shall include the information described in paragraph (2). For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan or health insurance issuer offering group health insurance coverage during each reporting period— a list of drugs for which a claim was filed and, with respect to each such drug on such list— the brand name, chemical entity, and National Drug Code; the type of dispensing channel used to furnish such drug, including retail, mail order, or specialty pharmacy; with respect to each drug dispensed under each type of dispensing channel (including retail, mail order, or specialty pharmacy)— whether such drug is a brand name drug or a generic drug, and— in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and the total number of— prescription claims (including original prescriptions and refills); participants, beneficiaries, and enrollees for whom a claim for such drug was filed; dosage units per fill of such drug; and days supply of such drug per fill; the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan or coverage after manufacturer rebates, fees, and other remuneration or adjustments; the total amount of out-of-pocket spending by participants, beneficiaries, and enrollees on such drug, including spending through copayments, coinsurance, and deductibles; the total net spending by the plan or coverage; total amount received, or expected to be received, by the plan or coverage from any entity in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from an entity or any third party (including group purchasing organizations) other than the plan sponsor; the total amount received, or expected to be received by the plan or issuer, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration— that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; and that is related to utilization rebates for such drug; and to the extent feasible, information on the total amount of remuneration, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copay assistance on behalf of such drug manufacturer) to the participants, beneficiaries, and enrollees enrolled in such plan or coverage; for each category or class of drugs for which a claim was filed, a breakdown of the total gross spending on drugs in such category or class before rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, and the net spending after such rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, including— the number of participants, beneficiaries, and enrollees who filled a prescription for a drug in such category or class, including the National Drug Code for each such drug; if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class; and the total out-of-pocket spending under the plan or coverage by participants, beneficiaries, and enrollees, including spending through copayments, coinsurance, and deductibles; in the case of a drug for which gross spending by such plan, coverage, or entity exceeded $10,000 during the reporting period— a list of all other drugs in the same therapeutic category or class; and the rationale for the formulary placement of such drug in that therapeutic category or class, if applicable; amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA)) to brokers, consultants, advisors, or any other individual or firm, for the referral of the group health plan's or health insurance issuer's business to an entity providing pharmacy benefits management services, including the identity of the recipient of such amounts; an explanation of any benefit design parameters that encourage or require participants, beneficiaries, and enrollees in such plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan or coverage, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and in the case of a plan or coverage (or an entity providing pharmacy benefits management services on behalf of such plan or coverage) that has an affiliated pharmacy or pharmacy under common ownership— the percentage of total prescriptions dispensed by such pharmacies to individuals enrolled in such plan or coverage; a list of all drugs dispensed by such pharmacies to individuals enrolled in such plan or coverage, and, with respect to each drug dispensed— the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan or issuer, and to participants, beneficiaries, and enrollees enrolled in such plan or coverage; the median amount charged to such plan or issuer, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants, beneficiaries, and enrollees, 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 such plan or coverage; the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan and participants, beneficiaries, and enrollees, that is available from any pharmacy included in the network of such plan or coverage; and the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount. Health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph
(1)in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 13402(a) of the Health Information Technology for Clinical Health Act, and shall restrict the use and disclosure of such information according to such privacy regulations. A plan sponsor receiving a report under paragraph
(1)may disclose such information only to the entity from which the report was received, the group health plan for which the report pertains, or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E). Nothing in this section shall prevent a group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such a plan or coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or the Comptroller General of the United States. The Secretary shall define through rulemaking a limited form of the report under paragraph
(1)required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior. A group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such plan or coverage, shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph
(1)and other such reports as requested, in accordance with the privacy requirements under paragraph (3), the disclosure and redisclosure standards under paragraph (4), the standards specified pursuant to paragraph (6), and such other information that the Comptroller General determines necessary to carry out the study under section 106(d) of the Lower Costs, More Transparency Act. Not later than 1 year after the date of enactment of this section, the Secretary shall specify through rulemaking standards for group health plans, health insurance issuers offering group health insurance coverage, and entities providing pharmacy benefits management services on behalf of such plans or coverage, required to submit reports under paragraph
(1)to submit such reports in a standard format. Nothing in this section shall be construed to permit a group health plan, health insurance issuer, or entity providing pharmacy benefits management services on behalf of such plan or coverage, to restrict disclosure to, or otherwise limit the access of, the Secretary of Labor to a report described in subsection (b)(1) or information related to compliance with subsection
(a)or
(b)by entities subject to such subsection. In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act. . in section 502 ( 29 U.S.C. 1132 )— in subsection (b)(3), by striking under subsection (c)(9)) and inserting under paragraphs
(9)and
(13)of subsection (c)) ; and in subsection (c), by adding at the end the following new paragraph: The Secretary may impose a penalty against any health insurance issuer or entity providing pharmacy benefits management services that violates section 726(a) or fails to provide information required under section 726(b) in the amount of $10,000 for each day during which such violation continues or such information is not disclosed or reported. The Secretary may impose a penalty against a health insurance issuer or entity providing pharmacy benefits management services that knowingly provides false information under section 726 in an amount not to exceed $100,000 for each item of false information. Such penalty shall be in addition to other penalties as may be prescribed by law. The Secretary may waive penalties under subparagraph (A), or extend the period of time for compliance with a requirement of section 726, for an entity in violation of such section that has made a good-faith effort to comply with such section. . The table of contents in section 1 of the Employee Retirement Income Security Act of 1974 ( 29 U.S.C. 1001 et seq. ) is amended by inserting after the item relating to section 725 the following new item: Sec. 726. Oversight of pharmacy benefits manager services. . Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following: For plan years beginning on or after the date that is 2 years after the date of enactment of this section, a group health plan, or an entity or subsidiary providing pharmacy benefits management services on behalf of such a plan, shall not enter into a contract with a drug manufacturer, distributor, wholesaler, subcontractor, rebate aggregator, or any other third party that limits (or delays beyond the applicable reporting period described in subsection (b)(1)) the disclosure of information to plan sponsors in such a manner that prevents such plan or entity from making the reports described in subsection (b). With respect to plan years beginning on or after the date that is 2 years after the date of enactment of this section, not less frequently than every 6 months (or at the request of a plan sponsor, not less frequently than quarterly, but under the same conditions, terms, and cost of the semiannual report under this subsection), a group health plan, or an entity providing pharmacy benefits management services on behalf of such a plan, shall submit to the plan sponsor (as defined in section 3(16)(B) of the Employee Retirement Income Security Act of 1974) of such plan a report in accordance with this section. Each such report shall be made available to such plan sponsor in a machine-readable format and shall include the information described in paragraph (2). For purposes of paragraph (1), the information described in this paragraph is, with respect to drugs covered by a group health plan during each reporting period— a list of drugs for which a claim was filed and, with respect to each such drug on such list— the brand name, chemical entity, and National Drug Code; the type of dispensing channel used to furnish such drug, including retail, mail order, or specialty pharmacy; with respect to each drug dispensed under each type of dispensing channel (including retail, mail order, or specialty pharmacy)— whether such drug is a brand name drug or a generic drug, and— in the case of a brand name drug, the wholesale acquisition cost, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and in the case of a generic drug, the average wholesale price, listed as cost per days supply and cost per dosage unit, on the date such drug was dispensed; and the total number of— prescription claims (including original prescriptions and refills); participants and beneficiaries for whom a claim for such drug was filed; dosage units per fill of such drug; and days supply of such drug per fill; the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply to the plan after manufacturer rebates, fees, and other remuneration or adjustments; the total amount of out-of-pocket spending by participants and beneficiaries on such drug, including spending through copayments, coinsurance, and deductibles; the total net spending by the plan; total amount received, or expected to be received, by the plan from any entity in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from an entity or any third party (including group purchasing organizations) other than the plan sponsor; the total amount received, or expected to be received, by the plan from drug manufacturers in rebates, fees, alternative discounts, or other remuneration— that has been paid, or is to be paid, by drug manufacturers for claims incurred during the reporting period; and that is related to utilization rebates for such drug; and to the extent feasible, information on the total amount of remuneration, including copayment assistance dollars paid, copayment cards applied, or other discounts provided by each drug manufacturer (or entity administering copay assistance on behalf of such drug manufacturer) to the participants and beneficiaries enrolled in such plan; for each category or class of drugs for which a claim was filed, a breakdown of the total gross spending on drugs in such category or class before rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, and the net spending after such rebates, price concessions, alternative discounts, or other remuneration from drug manufacturers, including— the number of participants and beneficiaries who filled a prescription for a drug in such category or class, including the National Drug Code for each such drug; if applicable, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class; and the total out-of-pocket spending under the plan by participants and beneficiaries, including spending through copayments, coinsurance, and deductibles; in the case of a drug for which gross spending by such plan or entity exceeded $10,000 during the reporting period— a list of all other drugs in the same therapeutic category or class; and the rationale for the formulary placement of such drug in that therapeutic category or class, if applicable; amounts paid directly or indirectly in rebates, fees, or any other type of compensation (as defined in section 408(b)(2)(B)(ii)(dd)(AA) of the Employee Retirement Income Security Act) to brokers, consultants, advisors, or any other individual or firm, for the referral of the group health plan's business to an entity providing pharmacy benefits management services, including the identity of the recipient of such amounts; an explanation of any benefit design parameters that encourage or require participants, beneficiaries, and enrollees in such plan to fill prescriptions at mail order, specialty, or retail pharmacies that are affiliated with or under common ownership with the entity providing pharmacy benefit management services under such plan, including mandatory mail and specialty home delivery programs, retail and mail auto-refill programs, and cost-sharing assistance incentives directly or indirectly funded by such entity; and in the case of a plan (or an entity providing pharmacy benefits management services on behalf of such plan) that has an affiliated pharmacy or pharmacy under common ownership— the percentage of total prescriptions dispensed by such pharmacies to individuals enrolled in such plan; a list of all drugs dispensed by such pharmacies to individuals enrolled in such plan and, with respect to each drug dispensed— the amount charged, per dosage unit, per 30-day supply, or per 90-day supply (as applicable) to the plan and to participants and beneficiaries enrolled in such plan; the median amount charged to such plan, and the interquartile range of the costs, per dosage unit, per 30-day supply, and per 90-day supply, including amounts paid by the participants and beneficiaries, 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 such plan; the lowest cost per dosage unit, per 30-day supply and per 90-day supply, for each such drug, including amounts charged to the plan and to participants and beneficiaries, that is available from any pharmacy included in the network of such plan; and the net acquisition cost per dosage unit, per 30-day supply, and per 90-day supply, if such drug is subject to a maximum price discount. Health insurance issuers offering group health insurance coverage and entities providing pharmacy benefits management services on behalf of a group health plan shall provide information under paragraph
(1)in a manner consistent with the privacy, security, and breach notification regulations promulgated under section 13402(a) of the Health Information Technology for Clinical Health Act, and shall restrict the use and disclosure of such information according to such privacy regulations. A plan sponsor receiving a report under paragraph
(1)may disclose such information only to the entity from which the report was received, the group health plan for which the report pertains, or to that entity’s business associates as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations) or as permitted by the HIPAA Privacy Rule (45 CFR parts 160 and 164, subparts A and E). Nothing in this section shall prevent a group health plan or health insurance issuer offering group health insurance coverage, or an entity providing pharmacy benefits management services on behalf of such a plan or coverage, from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such plan, issuer, or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, the Department of the Treasury, or the Comptroller General of the United States. The Secretary shall define through rulemaking a limited form of the report under paragraph
(1)required of plan sponsors who are drug manufacturers, drug wholesalers, or other direct participants in the drug supply chain, in order to prevent anti-competitive behavior. A group health plan, or an entity providing pharmacy benefits management services on behalf of such plan, shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph
(1)and other such reports as requested, in accordance with the privacy requirements under paragraph (3), the disclosure and redisclosure standards under paragraph (4), the standards specified pursuant to paragraph (6), and such other information that the Comptroller General determines necessary to carry out the study under section 106(d) of the Lower Costs, More Transparency Act. Not later than 1 year after the date of enactment of this section, the Secretary shall specify through rulemaking standards for group health plans, and entities providing pharmacy benefits management services on behalf of such plans, required to submit reports under paragraph
(1)to submit such reports in a standard format. Nothing in this section shall be construed to permit a group health plan or entity providing pharmacy benefits management services on behalf of such plan, to restrict disclosure to, or otherwise limit the access of, the Secretary of Health and Human Services to a report described in subsection (b)(1) or information related to compliance with subsections
(a)or
(b)by entities subject to such subsection. In this section, the term wholesale acquisition cost has the meaning given such term in section 1847A(c)(6)(B) of the Social Security Act. . The table of sections for subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new item: Sec. 9826. Oversight of pharmacy benefits manager services. . Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on— pharmacy networks that have contracted with group health plans, health insurance issuers offering group health insurance coverage, or entities providing pharmacy benefits management services on behalf of such plans or issuers, including networks with pharmacies that are under common ownership (in whole or part) with such plans, issuers, or entities (including entities that provide pharmacy benefits administrative services on behalf of such plans or issuers); pharmacy network design parameters that encourage individuals enrolled in such plans or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are wholly or partially owned by a plan, issuer, or entity; whether such plans and issuers have options to elect different network pricing arrangements in the marketplace with entities that provide pharmacy benefits management services and the prevalence of electing such different network pricing arrangements; with respect to pharmacy networks that include pharmacies under common ownership described in clause (i)— whether such networks are designed to encourage individuals enrolled in a group health plan or health insurance coverage to use such pharmacies over other network pharmacies for specific services or drugs, and if so, the reasons the networks give for encouraging use of such pharmacies; and whether such pharmacies are used by enrollees disproportionately more in the aggregate or for specific services or drugs compared to other network pharmacies; the degree to which mail order, specialty, or retail pharmacies that dispense prescription drugs to an enrollee in a plan or coverage that are under common ownership (in whole or part) with plans, issuers, or entities providing pharmacy benefits management services or pharmacy benefits administrative services on behalf of such plan or coverage receive reimbursement that is greater than the median price charged to the plan or issuer when the same drug is dispensed to enrollees in the plan or coverage by other pharmacies included in the pharmacy network of that plan, issuer, or entity that are not wholly or partially owned by the plan or issuer, or entity providing pharmacy benefits management services on behalf of such plan or issuer. The Comptroller General of the United States shall ensure that the report under subparagraph
(A)does not contain information that would identify a specific group health plan or health insurance issuer (or an entity providing pharmacy benefits management services on behalf of such plan or issuer), or otherwise contain commercial or financial information that is privileged or confidential. In this paragraph, the terms group health plan , health insurance coverage , and health insurance issuer have the meanings given such terms in section 2791 of the Public Health Service Act ( 42 U.S.C. 300gg–91 ). Not later than 18 months after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on what is known about the role of copay assistance programs and the impact of such programs on commercial health insurance, stop loss, and drug prices. Such report shall include to the extent feasible— a description of copay assistance programs, including— the types of programs available and the methods of providing copay assistance through such programs, including cash discounts, copay cards, or drugs provided to an individual at no cost; how such programs are funded; the types of entities that own, operate, or otherwise conduct such programs, the types of information such entities collect, and the direct and indirect contractual relationships between the entities in the drug supply chain that interact with such programs, such as a drug manufacturer, pharmacy, wholesaler, switch, rebate aggregator, pharmacy benefit manager, and other entities in the drug supply chain; the effect of such programs on patient out-of-pocket spending, including for stop-loss insurance, and drug utilization, including drug adherence; and patient eligibility criteria for such programs; and an analysis of— the sources of funding for such programs; and the effects of such programs on Federal health care programs and the individuals enrolled in such Federal health care programs.
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3 references not yet in our index
- 42 USC 300gg–111
- 42 USC 300gg–22
- 42 USC 300gg–91
Citation graph
cites case law
Sec. 106
Pharmacy benefits price transparency
Cite42 USC 300gg–111
Cite42 USC 300gg–22
Cite42 USC 300gg–91
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