CMS Finalizes Breakthrough Device Rule

CMS has finalized regulations aimed at improving access to innovative medical devices for Medicare beneficiaries.

The Transitional Coverage for Emerging Technologies Pathway program will accelerate coverage for certain breakthrough devices approved by the FDA, according to an Aug. 8 news release from the agency.

CMS will accept up to five TCET candidates each year and intends to finalize a decision on national inclusion within six months of a device receiving FDA market authorization.

The TCET pathway is voluntary and will include evidence review and development planning stages, allowing manufacturers to address evidence gaps through studies tailored to the needs of the Medicare population. The pathway will also help determine the appropriate Medicare benefit category for the device, the release said.