42 CFR 423.2300 : Public Health (Part 1 To Parts 1009-1099) — (§ 414.1 To Parts 427-429) — Centers For Medicare & Medicaid Services, Department Of Health And Human Services (Continued) (§ 414.1 To Parts 427-429) — Medicare Program (Continued) (§ 414.1 To Parts 427-429) — Voluntary Medicare Prescription Drug Benefit (§ 423.1 To § 423.2615) — Medicare Coverage Gap Discount Program (§ 423.2300 To § 423.2345) — Scope.

This subpart implements provisions included in sections 1860D-14A and 1860D-43 of the Act. This subpart sets forth requirements regarding the following:

(a) Condition for coverage of applicable drugs under Part D.

(b) The Medicare Coverage Gap Discount Program Agreement.

(c) Coverage gap discount payment processes for Part D sponsors.

(d) Provision of applicable discounts on applicable drugs for applicable beneficiaries.

(e) Manufacturer audit and dispute resolution processes.

(f) Resolution of beneficiary disputes involving coverage gap discounts.

(g) Compliance monitoring and civil money penalties.

(h) The termination of the Discount Program Agreement.