45 CFR Part 184 — Pharmacy Benefit Manager Standards Under the Affordable Care Act

PART 184—PHARMACY BENEFIT MANAGER STANDARDS UNDER THE AFFORDABLE CARE ACT Authority: 42 U.S.C. 1302, 1320b-23. Source: 86 FR 24295, May 5, 2021, unless otherwise noted. § 184.10 Basis and scope. (a) Basis. (2) [Reserved] (b) Scope. § 184.20 Definitions. The following definitions apply to this part, unless the context indicates otherwise: Health insurance issuer Plan year Qualified health plan Qualified health plan issuer § 184.50 Prescription drug distribution and cost reporting by pharmacy benefit managers. (a) General requirement. (1) The percentage of all prescriptions that were provided under the QHP through retail pharmacies compared to mail order pharmacies, and the percentage of prescriptions for which a generic drug was available and dispensed compared to all drugs dispensed; (2) The aggregate amount, and the type of rebates, discounts or price concessions (excluding bona fide (i) Bona fide (ii) [Reserved] (3) The aggregate amount of the difference between the amount the QHP issuer pays its contracted PBM and the amounts that the PBM pays retail pharmacies, and mail order pharmacies, and the total number of prescriptions that were dispensed. (b) Limitations on disclosure. (1) As HHS determines to be necessary to carry out section 1150A or part D of title XVIII of the Act; (2) To permit the Comptroller General to review the information provided; (3) To permit the Director of the Congressional Budget Office to review the information provided; or (4) To States to carry out section 1311 of the Affordable Care Act. (c) Penalties.

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