New CMS Proposal to Speed up Patient Access to Drugs

The Centers for Medicare and Medicaid Services (CMS) is proposing changes to reduce long waiting periods for drugs, reducing barriers to timely access to critical treatments. The Interoperability Standards and Prior Authorization for Drugs proposed rule would advance sweeping reforms to modernize prior authorization for drugs by establishing clear decision deadlines for impacted payers — no later than 24 hours for urgent requests and 72 hours for standard requests — and increasing transparency through full disclosure of claims denials and appeals outcomes.

The rule would expand electronic prior authorization requirements to include drugs, aligning processes across Medicare Advantage, Medicaid, the Children’s Health Insurance Program, Qualified Health Plans (QHP) issuers on the Federally-facilitated Exchanges and Small Group Market QHPs on the Federally-facilitated Small Business Health Options Program. 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 usage metrics to CMS, allowing the agency to monitor adoption and performance of electronic systems. These measures would give patients, providers and policymakers clearer insight into how consistently and efficiently prior authorization requests are handled. Public reporting would increase accountability and make it easier to compare how plans handle prior authorization decisions.

The rule also proposes adopting Fast Healthcare Interoperability Resources-based standards to replace the outdated X12N 278 transaction standard currently used by a minority of health plans. This would enable real-time electronic workflows — including streamlined submission of clinical documentation — reducing administrative burden and improving speed and accuracy.