C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT › Subpart G—Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage

42 C.F.R. § 423.301

Scope

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This subpart sets forth rules for the calculation and payment of CMS direct and reinsurance subsidies for Part D plans; the application of risk corridors and risk-sharing adjustments to payments; and retroactive adjustments and reconciliations to actual enrollment and interim payments. This subpart does not apply to fallback entities or fallback prescription drug plans.

Notes of Decisions
Cited in 4 cases (4 in the last 5 years), 2025–2025 · leading case: AstraZeneca Pharm. LP v. Sec'y United States Dep't of Health & H, 137 F.4th 116 (3d Cir. 2025).
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AstraZeneca Pharm. LP v. Sec'y United States Dep't of Health & H, 137 F.4th 116 (3d Cir. 2025). “§§ 1395w- 111–1395w-112 (establishing a scheme in which sponsors bid to be accepted into Medicare Part D and enter contracts with CMS for reimbursement); see also 42 C.F.R. § 423.301 et seq. (setting forth rules for reimbursing sponsors).”
Novartis Pharm. Corp v. Sec'y United States Dep't of Health, No. 24-2968 (3d Cir. Sept. 11, 2025). “§§ 1395w-111–1395w-112; see also 42 C.F.R. § 423.301 et seq. (setting forth rules for reimbursing sponsors).”
Novo Nordisk Inc v. Sec'y US Dept & Health & Human Servs., 154 F.4th 105 (3d Cir. 2025). “§§ 1395w-111–1395w-112; see also 42 C.F.R. § 423.301 et seq. (setting forth rules for reimbursing sponsors).”
Teva Pharm. USA, Inc. v. Becerra, No. 2025-0113 (D.D.C. Nov. 20, 2025). “§ 1395w-112; 42 C.F.R. § 423.301 et seq. Prior to 2022, Part D barred CMS from “interfer[ing] with the negotiations between drug manufacturers” and plan sponsors.”
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