Policy

CMS finalizes faster prior authorization deadlines, but drugs like GLP-1s are left out

A new federal rule sets 7-day and 72-hour prior authorization deadlines for Medicare Advantage, Medicaid, CHIP and marketplace plans, but it excludes drugs, so GLP-1 requests are not covered.

By the Semaglutides news desk·

On Feb. 8, 2024, the Centers for Medicare & Medicaid Services (CMS) published a final rule that puts firm deadlines on prior authorization decisions in several government insurance programs — but the rule excludes drugs, so its new clocks do not apply to GLP-1 medications [1].

The rule is titled "Advancing Interoperability and Improving Prior Authorization Processes" and carries the agency docket number CMS-0057-F. It appears in the Federal Register at 89 FR 8758 and runs 231 pages, from 8758 to 8988 [1]. It is effective April 8, 2024 [1].

The requirements bind Medicare Advantage organizations, Medicaid managed care plans, state Medicaid agencies, Children's Health Insurance Program (CHIP) agencies and CHIP managed care entities, and issuers of qualified health plans on the Federally-Facilitated Exchanges [1]. Starting Jan. 1, 2026, those plans must decide standard prior authorization requests within 7 calendar days and expedited requests within 72 hours, and must give a specific reason when they deny a request [1].

The rule applies to items and services and excludes drugs, and its own table of contents lists the exclusion of drugs as a distinct topic alongside compliance dates and enforcement [1]. Because of that exclusion, a prior authorization for semaglutide (sold as Ozempic, Wegovy and Rybelsus) or for tirzepatide (sold as Mounjaro and Zepbound) is not covered by the 7-day or 72-hour deadlines the rule creates [1].

The rule also addresses other areas, including a Patient Access API and the prior authorization information plans must make available through it, with compliance dates set separately in the rule [1].

Why it matters for patients

For a patient in Medicare Advantage, Medicaid, CHIP or a Federally-Facilitated Exchange plan, this rule does not create a federal deadline for deciding a prior authorization for a GLP-1 drug [1]. The 7-calendar-day standard clock and 72-hour expedited clock apply to items and services, not to drugs [1].

That means the waiting time a patient experiences after a plan receives a GLP-1 prior authorization request is not governed by the deadlines in this rule. What timeline does apply to a drug request is not set by this rule and has not been reported here.

The rule's other provisions, such as the requirement to give a specific denial reason, are stated for items and services in the affected plans, and the prior authorization decision deadlines begin Jan. 1, 2026 [1].

What happens next

April 8, 2024: the rule takes effect [1].

Jan. 1, 2026: affected plans must begin deciding standard prior authorization requests within 7 calendar days and expedited requests within 72 hours, with specific denial reasons, for items and services [1].

Other compliance dates, including those tied to the rule's API provisions, are set separately within the rule [1].

Whether CMS plans a separate rule to bring prescription drugs, including GLP-1s, under these decision deadlines has not been reported.

Sources

  1. https://www.federalregister.gov/documents/2024/02/08/2024-00895/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-advancing-interoperability

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