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The Alliance of Specialty Medicine submitted formal comments on a CMS proposed rule designed to modernize prior authorization processes for drugs and enhance interoperability across Medicare Advantage, Medicaid, and other health plans. The proposed rule expands a rule CMS finalized in 2024 that applies only to non-drug items and services.  Similar to the 2024 rule, this latest rule would require payers to automate prior authorization for drugs, accelerate decision-making timelines, and improve transparency by providing specific denial reasons and publicly reporting prior authorization-related metrics.

Overall, the Alliance strongly supports expanding these requirements to drugs, but calls on CMS to adopt even shorter—ideally real-time—decision timeframes for both drug and non-drug items and services.   The Alliance also calls for the public reporting of more granular prior-authorization metrics, as well as clear and standardized enforcement mechanisms to ensure that payers comply with the requirements of this rule. In response to an RFI regarding how technology may facilitate step-therapy determinations, the Alliance reiterated its strong opposition to restrictive step-therapy protocols currently employed by insurers.  While the Alliance appreciates CMS and ONC’s effort to improve these processes through technology and data sharing, it urged the agencies to adopt more integrated access to coverage, formulary, and utilization management information across medical and pharmacy benefit systems to support continuity of care. It also emphasized the importance of maintaining appropriate safeguards around automated utilization management.

The Alliance looks forward to working with CMS and ONC to refine prior authorization and other utilization management processes and to ensure that interoperability enhancements improve patient access to appropriate care.  The complete comments can be accessed by clicking on the link below.

Alliance Comments on Interoperability Standards and Prior Auth for Drugs Proposed Rule. June 2026