FDA approval should mean access, but TRICARE’s opaque process leaves patients & providers struggling with unexpected denials.

How Coverage Decisions Shape Access & Outcomes 

FDA approval doesn’t guarantee insurance coverage, but most payers recognize it as proof of a drug’s safety and efficacy. TRICARE, the Department of Defense’s health plan, takes a different approach—labeling certain FDA-approved drugs as “unproven therapy” and denying coverage, often without warning to patients or providers. 

Why it matters:

• Patients left in the dark: TRICARE covers 9.5 million active-duty personnel, veterans, and their families. When a treatment is denied, they may be forced to pay out of pocket or forgo critical care, putting their health at risk 

• Providers & manufacturers blindsided: TRICARE doesn’t publish a list of “unproven” drugs, hold open meetings, or offer clear guidance. Doctors may prescribe treatments only to have claims unexpectedly denied, while drug manufacturers are left guessing how TRICARE reaches its conclusions 

• A flawed process: TRICARE relies on the Hayes Report, a subscription-based publication that summarizes existing studies but does not conduct independent research. Even the Hayes Report itself states it should not be the sole basis for coverage decisions 

The bigger picture: Congress entrusted the FDA with ensuring drug safety and efficacy, yet TRICARE is applying its own undefined standard—one that lacks transparency and appears to be based on a single, noncomprehensive source. The result? Patients lose access to treatments, and pharmaceutical companies face millions in lost revenue. 

What you can do: If TRICARE designates your product as “unproven,” you can appeal—but expect a long, complex process involving multiple committees and extensive documentation. Seeking expert guidance can help navigate the red tape and push back against denials that hurt both patients and the healthcare industry. 

Having an expert on your side can make all the difference. Our federal market access team is comprised of former VA and Department of Defense decision makers who understand how to best optimize federal market outcomes providing the support you need. Get in touch to learn how we can help.