Proposed Changes Expediting Drug Approvals in Medicare and Medicaid

Federal health officials have proposed significant changes aimed at expediting drug approvals within Medicare, Medicaid, and other government-related health insurance plans. These reforms are intended to address the lengthy delays in insurance approval processes that currently impede patient access to prescribed treatments.

The proposal involves implementing stricter deadlines for insurance plan decisions: urgent drug requests must be addressed within 24 hours, and standard requests within 72 hours. This initiative by the Centers for Medicare & Medicaid Services (CMS) seeks to reduce administrative delays that can obstruct timely medical care.

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized the proposal's goal to simplify the process for obtaining necessary medications, thereby minimizing delays and facilitating real-time decisions. CMS Administrator Dr. Mehmet Oz stated the updates represent necessary modernization, transitioning prior authorization processes to fully electronic systems, aimed at replacing outdated methods with digital solutions that enable instant communication and decision-making.

Under the proposed rules, these electronic requirements would apply to prescription drugs, aligning with current practices for many medical services. CMS highlighted that this would streamline interactions between providers and insurers, allowing medical professionals to devote more time to patient care rather than administrative duties.

The modernization efforts would extend to various health insurance plans, including Medicare Advantage, Medicaid, the Children’s Health Insurance Program (CHIP), and plans under the Affordable Care Act marketplaces. Small group health plans participating in federal exchanges would also need to comply, creating uniformity across public programs and providing consistent experiences for beneficiaries regardless of their insurance source.

Additional aspects of the proposal include mandating insurers to publicly disclose comprehensive prior authorization data. This would encompass approval and denial rates, appeals outcomes, and decision timelines, thus enhancing transparency and enabling comparisons across different plans.

Moreover, the proposal suggests adopting updated data standards that facilitate real-time electronic submissions and efficient clinical information exchange. This change is anticipated to reduce administrative workloads, minimize errors, and expedite decision-making processes by allowing for more comprehensive documentation reviews.

Studies, such as a January 2026 review published in The American Journal of Medicine, indicate that delays due to prior authorization can aggravate health conditions, lead to preventable hospitalizations, and negatively impact survival rates for various diseases. Specifically concerning Medicare, research has shown that prior authorization for essential medications like oral cancer drugs results in treatment discontinuations and delays, which can severely impede timely care.

CMS is open to public comments on the proposal, which also touches on step therapy, cybersecurity, and prior authorization for medical equipment and tests. Most provisions are slated for implementation in 2027, allowing time for feedback from stakeholders, including doctors, insurers, and patient advocacy organizations. A public comment period will precede the final ruling, potentially leading to adjustments based on stakeholder input.