CMS proposes new pathway for reimbursing breakthrough devices

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. 

The goal is to finalize coverage for the medical device no later than six months after FDA clearance. Then, ideally, the device would generate enough evidence on the market to achieve a longer-term Medicare coverage determination. 

“The goal of the TCET pathway is to develop reliable evidence for patients and their physicians to make health care decisions and ensure that people with Medicare receive high-quality care,” the CMS leaders wrote in the announcement.