Outsourcing global clinical
& medical engagement for accelerated drug approval
& acceptance
AnswerY™, an AI-driven, HIPAA-compliant platform of prescriber-patient conversations that drives next-best actions
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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.
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.
To succeed in the federal market, your team needs to stay up to date on the dynamics of this unique space. Get in touch to learn how we can help.