Medicare Shake-Up: New Rule Could Fast-Track Drug Approvals for Millions

Health & Fitness
16 Apr 2026 • 8:39 PM MYT
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Federal health officials have proposed new rules that would require much faster decisions on prescription drug prior authorization across Medicare, Medicaid, and other federally linked coverage. The plan would also expand electronic approvals and force insurers to disclose how often they deny, delay, or overturn requests.

The proposal, released by the Centers for Medicare & Medicaid Services, targets one of the most persistent complaints in U.S. healthcare: patients waiting days or weeks for insurers to approve medicines already prescribed by their doctors. It would set a 24-hour deadline for urgent requests and a 72-hour deadline for standard ones.

The change would apply across Medicare Advantage, Medicaid, the Children’s Health Insurance Program, and qualified health plans sold through federally facilitated Affordable Care Act exchanges. Small-group exchange plans would also be included, creating a more uniform approval process across public programs.

CMS Aims to Shorten Deadlines and Move Drug Approvals Into Electronic Systems

At the center of the proposed rule is a broad effort to modernize prior authorization for prescription drugs. According to CMS, insurers covered by the rule would have to process urgent drug requests within 24 hours and standard requests within 72 hours, replacing timelines that often stretch far longer in practice.

The agency also wants drug prior authorization handled through electronic systems rather than the fax-based and fragmented processes still used in parts of the industry. Health and Human Services Secretary Robert F. Kennedy Jr. said the proposal builds on earlier insurer commitments to reduce prior authorization for common medical services. CMS Administrator Dr. Mehmet Oz said patients should not have to wait days or weeks to begin medication their physician has already prescribed.

According to the CMS proposal, affected plans would also have to publish approval and denial rates, appeal outcomes, and decision timeframes for prescription drug requests. They would need to report how often electronic systems are being used as well. CMS says the reporting is meant to give patients, doctors, and policymakers a clearer view of how consistently insurers handle drug approvals.

The proposal would also replace an older technical transaction standard still used by some plans with newer Fast Healthcare Interoperability Resources, or FHIR-based, standards. CMS says that shift would support real-time electronic submissions and quicker sharing of clinical information.

Research Cited in the Debate Links Prior Authorization Delays to Measurable Harm

The policy push arrives alongside growing evidence that prior authorization delays are not just an administrative nuisance. According to a January 2026 systematic review published in The American Journal of Medicine, studies across oncology, cardiology, pediatrics, behavioral health, and other specialties linked prior authorization delays to disease exacerbation, preventable hospitalizations, longer hospital stays, and lower disease-free survival in cancer care.

That review examined 25 U.S. studies. Among the examples it cited were delays of 10.2 days and 24.6 days for biologic treatment in patients with inflammatory bowel disease under different prior authorization systems, and a 33.8-day treatment start for proton beam therapy patients facing prior authorization, compared with 20.6 days for those without it.

A separate Harvard-led study of Medicare Part D beneficiaries found similar disruption for patients already taking oral cancer drugs. According to the study, the introduction of a new prior authorization requirement increased the odds of discontinuation within 120 days by more than sevenfold and delayed the next prescription fill by an average of 9.7 days.

CMS is now seeking public input on related issues including step therapy, cybersecurity, payer oversight, lab tests, and medical equipment approvals. The agency says most compliance dates would begin in 2027.

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