Medical device makers may soon have an easier path to securing health insurance reimbursement for their products, following the notice Thursday of a long-awaited rule by the Centers for Medicare and Medicaid Services.
The program, called Transitional Coverage for Emerging Technologies, would apply to medical products deemed “breakthrough devices” by the Food and Drug Administration. Device makers complain that the process of acquiring Medicare coverage is opaque and complex, creating a “valley of death” between FDA approval and securing coverage from health insurers. The TCET rule is an attempt to make that process more clear.
CMS noted in its announcement that the pathway is voluntary. Participating device makers would get access to CMS officials before FDA market authorization. The officials would review early evidence, help manufacturers design studies that might better address payers’ concerns, and offer guidance on the best existing coverage areas.
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