Medicare Finalizes Pathway for Speedy Medical Device Coverage

Manufacturers of certain breakthrough medical devices may start notifying the Medicare program of their interest in a new voluntary program aimed at providing earlier coverage for devices used to support the treatment or diagnosis of certain diseases.

The Centers for Medicare & Medicaid Services on Wednesday issued a final procedural notice on the Transitional Coverage for Emerging Technologies (TCET) pathway for certain devices granted breakthrough designation by the Food and Drug Administration. The voluntary program is aimed at improving patient care and access and will accept up to five device candidates each year, the CMS said in a fact sheet ...