CMS proposes new pathway for reimbursing breakthrough devices
The new rule doesn't explicitly make getting reimbursement easier, but it will accelerate the coverage determination process, and make it more transparent.
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.
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