The Trump administration has issued a proposed rule that aims to significantly overhaul prior authorization for pharmaceuticals.
Through the Interoperability Standards and Prior Authorization for Drugs rule, the Centers for Medicare & Medicaid Services said it would establish deadlines for payers in government insurance plans, setting the timeline at 24 hours for urgent requests and 72 hours for standard determinations.
In addition, the rule would require insurers to publicly report certain metrics around prior authorization, including approval and denial rates, appeal outcomes and decision timeframes, according to an announcement from the agency.
The rule also builds on a 2024 regulation that took aim at prior authorization for non-drug services as well as payers’ 2025 pledge to significantly overhaul their approach to prior auth, an agreement brokered in part by CMS officials.
“Last year, we got 80% of the insurance industry to agree to eliminate prior authorization for common medical services such as diagnostic imaging, physical therapy, and outpatient surgery,” Department of Health and Human Services Secretary Robert F. Kennedy Jr. said in the announcement. “This rule builds on that agreement by making it easier for patients to get the medications they need by minimizing delays and enabling real-time decisions.”
Beyond greater transparency, the rule also aims to support electronic prior authorization and would require plans to report usage metrics for Application Programming Interfaces (APIs), which would allow CMS to track how these platforms are working and adoption rates.
CMS would also push to adopt Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models, making it easier for real-time electronic workflows to thrive.
These changes would better standardize processes across Medicare Advantage, Medicaid, the Children’s Health Insurance Program, individual Affordable Care Act exchange plans and group exchange plans, per the announcement.
“Patients should not have to wait days or weeks for approval to start the medication their doctor prescribed,” said CMS Administrator Mehmet Oz, M.D., in the release. “This proposal moves prior authorization into the digital age, replacing fax machines and fragmented systems with real-time electronic workflows.”
“We are standardizing the process, increasing transparency, and ensuring providers can focus on caring for patients instead of navigating red tape,” Oz said.
In addition to the new provisions, CMS said it is also seeking feedback on five Requests for Information to inform further reform. Topics include ways to improve electronic notifications for care coordination; better cybersecurity and resiliency; enhanced oversight for insurers’ APIs; ways to streamline step therapy; and strategies to improve prior authorization for lab tests as well as durable medical equipment, prosthetics and other supplies.
Publisher: Source link
