Utilization management expectations

Part D sponsors may apply utilization management (UM) edits for oral antivirals but should favor soft-reject edits that can be resolved at point-of-sale; UM requirements that cannot be resolved at point-of-sale should be weighed against the need to initiate treatment quickly. CMS prefers that sponsors leverage technology to implement soft reject edits and will not approve UM criteria that are overly restrictive or inconsistent with the product label (these UM edits requiring CMS approval will be reviewed per Chapter 6 § 30.2.2.1 of the Prescription Drug Benefit Manual).

• Soft-reject edits are preferred and must be resolvable at point-of-sale.
• UM criteria that require CMS submission will be reviewed and may be denied if overly restrictive or inconsistent with labeling.

Coverage determination timeframes

Part D sponsors must process coverage determinations as expeditiously as the enrollee's health condition requires and must use expedited timeframes when delay could seriously jeopardize life, health, or ability to regain maximum function; standard decisions are due within 72 hours and expedited initial coverage determinations within 24 hours. Expedited timeframes apply to formulary exceptions and requests to waive UM requirements.

• Standard coverage determinations: decision within 72 hours (42 CFR § 423.568).
• Expedited initial coverage determinations: decision within 24 hours (42 CFR § 423.570).
• Expedited processing required if standard timeframe risks delaying therapy to the point the drugs are no longer indicated.

Formulary exception and prior authorization rules

Part D plans may not impose prior authorization solely to steer enrollees to the standalone USG PAP operated by Pfizer and must process formulary exceptions in accordance with 42 CFR §§ 423.566, 423.568, and 423.570; plans may use message-only alerts or soft rejects to inform pharmacists about the standalone PAP as long as pharmacists can override them.

• Plans that exclude commercial Paxlovid must still process formulary exceptions per 42 CFR timeframes and procedures.
• Plans may not impose PA requirements for the sole purpose of directing enrollees to the standalone USG PAP.
• Pharmacies cannot retroactively bill the standalone USG PAP if drug was dispensed through Part D and later the enrollee learns the plan was not contracted with Pfizer.

Part D coverage requirement for EUA antivirals

EUA oral antivirals for COVID-19 meet the definition of a Part D drug through December 31, 2024 and therefore must be covered by Part D plans either on the formulary or via the formulary exception process consistent with 42 CFR § 423.578(b).

• CMS encourages adding at least one oral antiviral to CY2024 formularies on a preferred or $0 cost-sharing tier where available.
• If a sponsor contracts with Pfizer to facilitate the USG PAP, commercial Paxlovid must be added to the formulary without prior authorization or step therapy (quantity limits for one full course permitted) and in-network/qualifying out-of-network claims processed at $0 cost sharing for Nov 1, 2023–Dec 31, 2024.