Health Insurers Criticize CMS Proposal for Breakthrough Device Coverage Pathway

America’s Health Insurance Plans (AHIP), a health insurance company advocacy group, has taken issue with the Centers for Medicare and Medicaid Services’ (CMS) proposed rule for a new Medicare coverage pathway for FDA-cleared breakthrough devices.

AHIP took issue with the proposal because, under the pathway, Medicare coverage would begin the same day a breakthrough device receives FDA clearance and last up to four years. That could result in the coverage of devices that haven’t been adequately evaluated as there’s no requirement for additional clinical studies in the Medicare population during the coverage period, the group contended.

 “We recommended that CMS adapt and streamline existing processes to allow for rapid reviews of breakthrough devices, while still fully considering the evidence needed to ensure their safety and effectiveness,” AHIP said.