On April 10, the Centers for Medicare & Medicaid Services (CMS) announced it is proposing changes to slash long waiting periods for drugs, thereby reducing barriers to timely access to critical treatments.

According to a press release, the proposed rule on Interoperability Standards and Prior Authorization for Drugs would advance reforms to modernize prior authorization for drugs by establishing clear decision deadlines for affected payers – no later than 24 hours for urgent requests and 72 hours for standard requests – and by increasing transparency through full disclosure of claims denials and appeals outcomes. 

Building on CMS’s 2024 Interoperability and Prior Authorization final rule, which addressed prior authorization for non-drug items and services, this proposal aims to ensure that patients experience the same streamlined process for medications as for other covered services.

The rule would extend electronic prior authorization requirements to cover drugs, standardizing processes across Medicare Advantage, Medicaid, the Children’s Health Insurance Program (CHIP), Qualified Health Plans (QHP) issuers on the Federally-facilitated Exchanges, and Small Group Market QHPs on the Federally-facilitated Small Business Health Options Program (FF-SHOP).

Impacted payers would also be required to publicly report prior authorization metrics for drugs, including approval and denial rates, appeal outcomes, and decision timeframes.

In addition, plans would report Application Programming Interface (API) usage metrics to CMS, enabling the agency to monitor adoption and performance of electronic systems. These measures would provide patients, providers, and policymakers with insight into the consistency and efficiency with which prior authorization requests are handled.

The rule also proposes adopting Fast Healthcare Interoperability Resources (FHIR®)-based standards to replace the X12N 278 transaction standard currently used by a minority of health plans.

The proposed rule would additionally:

• Update health IT standards and implementation guides to align with current versions adopted by ONC for HHS use
• Expand existing interoperability requirements to small group market QHP issuers on the FF-SHOP
• Add a regulatory definition for “Failure to Report” to strengthen CMS’s oversight authority under the Open Payments program

CMS is seeking public input through five Requests for Information on:

• Improving electronic event notifications for care coordination
• Strengthening healthcare cybersecurity and system resilience
• Enhancing oversight of payer APIs
• Streamlining step therapy processes
• Improving prior authorization for laboratory tests and durable medical equipment, prosthetics, orthotics, and supplies

CMS proposes compliance dates starting in 2027.