Sec. 30606. Oversight of pharmacy benefit manager services
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Title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg et seq. ), as amended by section 30604, is further 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 January 1, 2023, a group health plan or 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 associated third party that limits the disclosure of information to plan sponsors in such a manner that prevents the plan or issuer, or an entity or subsidiary providing pharmacy benefits management services on behalf of a plan or issuer, from making the reports described in subsection (b).
For plan years beginning on or after January 1, 2023, not less frequently than once every 6 months, a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan or an issuer providing group health insurance coverage shall submit to the plan sponsor (as defined in section 3(16)(B) of the Employee Retirement Income Security Act of 1974) of such group health plan or health insurance coverage a report in accordance with this subsection and make such report available to the plan sponsor in a machine-readable format.
Each such report shall include, with respect to the applicable group health plan or health insurance coverage— as applicable, information collected from drug manufacturers by such issuer or entity on the total amount of copayment assistance dollars paid, or copayment cards applied, that were funded by the drug manufacturer with respect to the participants and beneficiaries in such plan or coverage; a list of each drug covered by such plan, issuer, or entity providing pharmacy benefit management services that was dispensed during the reporting period, including, with respect to each such drug during the reporting period— the brand name, chemical entity, and National Drug Code; the number of participants and beneficiaries for whom the drug was filled during the plan year, the total number of prescription fills for the drug (including original prescriptions and refills), and the total number of dosage units of the drug dispensed across the plan year, including whether the dispensing channel was by retail, mail order, or specialty pharmacy; the wholesale acquisition cost, listed as cost per days supply and cost per pill, or in the case of a drug in another form, per dose; the total out-of-pocket spending by participants and beneficiaries on such drug, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and for any drug for which gross spending of the group health plan or health insurance coverage exceeded $10,000 during the reporting period— a list of all other drugs in the same therapeutic category or class, including brand name drugs and biological products and generic drugs or biosimilar biological products that are in the same therapeutic category or class as such drug; and the rationale for preferred formulary placement of such drug in that therapeutic category or class; a list of each therapeutic category or class of drugs that were dispensed under the health plan or health insurance coverage during the reporting period, and, with respect to each such therapeutic category or class of drugs, during the reporting period— total gross spending by the plan, before manufacturer rebates, fees, or other manufacturer remuneration; the number of participants and beneficiaries who filled a prescription for a drug in that category or class; if applicable to that category or class, a description of the formulary tiers and utilization mechanisms (such as prior authorization or step therapy) employed for drugs in that category or class; the total out-of-pocket spending by participants and beneficiaries, including participant and beneficiary spending through copayments, coinsurance, and deductibles; and for each therapeutic category or class under which 3 or more drugs are included on the formulary of such plan or coverage— the amount received, or expected to be received, from drug manufacturers in rebates, fees, alternative discounts, or other remuneration— to be paid by drug manufacturers for claims incurred during the reporting period; or that is related to utilization of drugs, in such therapeutic category or class; the total net spending, after deducting rebates, price concessions, alternative discounts or other remuneration from drug manufacturers, by the health plan or health insurance coverage on that category or class of drugs; and the net price per course of treatment or single fill, such as a 30-day supply or 90-day supply, incurred by the health plan or health insurance coverage and its participants and beneficiaries, after manufacturer rebates, fees, and other remuneration for drugs dispensed within such therapeutic category or class during the reporting period; total gross spending on prescription drugs by the plan or coverage during the reporting period, before rebates and other manufacturer fees or remuneration; total amount received, or expected to be received, by the health plan or health insurance coverage in drug manufacturer rebates, fees, alternative discounts, and all other remuneration received from the manufacturer or any third party, other than the plan sponsor, related to utilization of drug or drug spending under that health plan or health insurance coverage during the reporting period; the total net spending on prescription drugs by the health plan or health insurance coverage during the reporting period; and amounts paid directly or indirectly in rebates, fees, or any other type of remuneration to brokers, consultants, advisors, or any other individual or firm who referred the group health plan's or health insurance issuer's business to the pharmacy benefit manager.
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 264(c) of the Health Insurance Portability and Accountability Act of 1996, and shall restrict the use and disclosure of such information according to such privacy regulations. A group health plan receiving a report under paragraph
(1)may disclose such information only to business associates of such plan as defined in section 160.103 of title 45, Code of Federal Regulations (or successor regulations). Nothing in this section prevents a health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan from placing reasonable restrictions on the public disclosure of the information contained in a report described in paragraph (1), except that such issuer or entity may not restrict disclosure of such report to the Department of Health and Human Services, the Department of Labor, or the Department of the Treasury. 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 health insurance issuer offering group health insurance coverage or an entity providing pharmacy benefits management services on behalf of a group health plan shall submit to the Comptroller General of the United States each of the first 4 reports submitted to a plan sponsor under paragraph
(1)with respect to such coverage or plan, and other such reports as requested, in accordance with the privacy requirements under paragraph
(2)and the disclosure and redisclosure standards under paragraph (3), and such other information that the Comptroller General determines necessary to carry out the study under section 30606(b) of An Act to provide for reconciliation pursuant to title II of S. Con. Res. 14. The Secretary, in consultation with the Secretary of Labor and the Secretary of the Treasury, shall enforce this section. A health insurance issuer or an entity providing pharmacy benefit management services that violates subsection
(a)or fails to provide information required under subsection (b), or a drug manufacturer that fails to provide information under subsection (b)(1)(A) in a timely manner, 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, entity providing pharmacy benefit management services, 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 $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 subsection
(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 section 1128A of the Social Security Act. 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 this section. Nothing in this section shall be construed to permit a health insurance issuer, group health plan, or other entity 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)by such issuer, plan, or entity. 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–12) after part D ; and in paragraph (2), by inserting (other than subsections
(a)and
(b)of section 2799A–12) after part D ; in subsection (b)— in paragraph (1), by inserting (other than subsections
(a)and
(b)of section 2799A–12) after part D ; in paragraph (2)(A), by inserting (other than subsections
(a)and
(b)of section 2799A–12) after part D ; and in paragraph (2)(C)(ii), by inserting (other than subsections
(a)and
(b)of section 2799A–12) after part D . Not later than 3 years after the date of enactment of this Act, the Comptroller General of the United States shall report to Congress on— pharmacy networks of group health plans, health insurance issuers, and entities providing pharmacy benefit management services under such group health plan or group or individual health insurance coverage, including networks that have pharmacies that are under common ownership (in whole or part) with group health plans, health insurance issuers, or entities providing pharmacy benefit management services or pharmacy benefit administrative services under group health plan or group or individual health insurance coverage; as it relates to pharmacy networks that include pharmacies under common ownership described in subparagraph (A)— whether such networks are designed to encourage enrollees of a plan or 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; 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 services, the prevalence of electing such different network pricing arrangements; pharmacy network design parameters that encourage enrollees in the plan or coverage to fill prescriptions at mail order, specialty, or retail pharmacies that are wholly or partially-owned by that issuer or entity; and the degree to which mail order, specialty, or retail pharmacies that dispense prescription drugs to an enrollee in a group health plan or health insurance coverage that are under common ownership (in whole or part) with group health plans, health insurance issuers, 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 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 health insurance issuer or entity providing pharmacy benefit management services. The Comptroller General of the United States shall ensure that the report under paragraph
(1)does not contain information that would allow a reader to identify a specific plan or entity providing pharmacy benefits management services or otherwise contain commercial or financial information that is privileged or confidential. In this subsection, 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 ).
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- 42 USC 300gg–111
- 42 USC 300gg–22
- 42 USC 300gg–91
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Sec. 30606
Oversight of pharmacy benefit manager services
Cite42 USC 300gg–111
Cite42 USC 300gg–22
Cite42 USC 300gg–91
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