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New federal prior authorization deadlines start, but pharmacy benefit drugs like GLP-1s are excluded

New federal deadlines give patients faster decisions on medical prior authorization requests, while pharmacy-benefit drugs such as GLP-1s fall outside the rule.

By the Semaglutides news desk·

Federal health plans must now decide standard prior authorization requests within 7 calendar days and expedited requests within 72 hours, under deadlines that took effect January 1 [1][3]. The timelines cover medical items and services. They exclude drugs covered under the pharmacy benefit [2][3].

The requirements come from the Interoperability and Prior Authorization final rule, known as CMS-0057-F, published February 8, 2024, and effective April 8, 2024 [3]. It applies to Medicare Advantage organizations, Medicaid managed care plans, state Medicaid agencies, CHIP agencies and CHIP managed care entities, and issuers of qualified health plans on the federally facilitated exchanges [3].

The rule changed existing Medicaid timeframes. Managed care organizations previously had to decide standard requests within 14 days and expedited requests within 72 hours, and state Medicaid fee-for-service programs had no specific federal decision deadline [1]. The rule shortens the managed care standard window from 14 days to 7 and, for the first time, sets a federal timeframe for fee-for-service decisions [1].

The rule includes a section on the exclusion of drugs [3], and CMS describes the electronic prior authorization effort as covering "medical items and services" [2]. For prescriptions, the agency directs providers to ask their electronic health record vendor whether it supports electronic prior authorization for Part D drugs [2]. CMS has also proposed a separate rule on interoperability standards and prior authorization for drugs [2]. How many prior authorization requests for GLP-1 medications sit under the medical benefit rather than the pharmacy benefit has not been reported, and the rule does not spell out how plans sort a given GLP-1 prescription into one category or the other [3].

Prior authorization has drawn scrutiny. A 2022 report from the U.S. Department of Health and Human Services Office of the Inspector General raised concerns that the process can reduce access to care through delays and denials of medically necessary medications and services [1]. A 2023 survey of adults with Medicaid, Medicare, exchange, or employer-sponsored coverage found that 16 percent had experienced problems with prior authorization in the previous year, sometimes resulting in delayed or denied care and declines in health [1].

CMS estimates that requesting prior authorizations costs providers $20 to $50 per hour and takes an average of 13 hours per week — roughly $34,000 and 700 hours of administrative time per provider each year [2]. The agency says its goals include patients experiencing faster, more predictable access to care when it is medically reasonable and appropriate, plus greater transparency and accountability [2].

Why it matters for patients

The new clock applies to medical requests, not to the pharmacy counter. Medications such as Ozempic, Wegovy, and Rybelsus (semaglutide), Mounjaro and Zepbound (tirzepatide), and Foundayo (orforglipron) are filled as prescriptions, and the rule excludes drugs covered under the pharmacy benefit [3]. Whether a specific GLP-1 prescription is covered under the medical benefit or the pharmacy benefit is not addressed in the rule [3].

Two other features of the process remain. A prior authorization approval is generally not binding and usually states that approval does not guarantee payment, which allows payers to review care afterward and deny payment [1]. A medication may also be approved only for a limited time, requiring additional approval to continue treatment [1].

Beneficiaries keep the right to appeal a denial, and the appeals process may include external medical review or a state fair hearing [1].

What happens next

Starting January 1, 2027, certain health plans regulated by CMS must implement and maintain five application programming interfaces, including a Prior Authorization API, and CMS is urging providers and their EHR vendors to test workflows before then [2].

Organizations that signed a federal industry pledge in 2025 committed to reduce the volume of medical services subject to prior authorization, honor existing authorizations during insurance transitions, expand real-time approvals to minimize delays for most requests by 2027, and ensure medical professionals review all clinical denials [2]. CMS has proposed a separate rule that would address prior authorization for drugs [2].

Sources

  1. https://www.macpac.gov/wp-content/uploads/2024/08/Prior-Authorization-in-Medicaid.pdf
  2. https://www.cms.gov/priorities/electronic-prior-authorization/overview
  3. 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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