The Trump administration has announced a proposed rule aimed at overhauling prior drug approvals.
The Centers for Medicare and Medicaid Services announced that it will set deadlines for government insurance plan payers through interoperability standards and drug prior authorization regulations, with timelines ranging from 24 hours for emergency requests to 72 hours for standard decisions.
Additionally, the rule would require insurers to publicly report certain metrics regarding prior approvals, including approval and denial rates. Outcome of the appeal; deadline for the decision, according to an announcement from the authorities.
The rule also builds on 2024 regulations for prior authorization of non-drug services and payers’ 2025 pledge to significantly overhaul their approach to prior authorization, an agreement brokered in part by CMS officials.
“Last year, we received 80 percent agreement from the insurance industry to eliminate prior authorization for common medical services such as diagnostic imaging, physical therapy, and outpatient surgery,” Secretary of Health and Human Services Robert F. Kennedy Jr. said in a statement. “This rule is based on consensus to make it easier for patients to get the medicines they need by minimizing delays and enabling real-time decisions.”
In addition to increasing transparency, this rule also aims to support electronic pre-authorization and requires plans to report usage metrics for application programming interfaces (APIs), allowing CMS to track the performance and adoption rates of these platforms.
CMS will also promote the adoption of Fast Healthcare Interoperability Resources (FHIR)-based standards for the small number of plans still using older models to facilitate the widespread adoption of real-time electronic workflows.
These changes will create more standardized processes across Medicare Advantage, Medicaid, the Children’s Health Insurance Program, Affordable Care Act exchange plans, and group exchange plans, according to the announcement.
“Patients should not have to wait days or even weeks to get approval from their doctor to start taking their prescribed medication,” CMS Administrator Dr. Mehmet Oz said in a release. “This proposal moves pre-approvals into the digital age, replacing fax machines and fragmented systems with real-time electronic workflows.”
“We are standardizing processes, increasing transparency, and freeing providers to focus on patient care without red tape,” Oz said.
In addition to the new provisions, CMS said it is also seeking feedback on five requests for information for further reforms. Topics include how to improve electronic notifications for care coordination; Improving cybersecurity and resilience. Increased oversight of insurance company APIs. How to streamline step therapy. Strategies to improve clinical testing and pre-approval of durable medical equipment, prosthetics, and other supplies.
