In the News

New bipartisan legislation aims to require Medicare to cover breakthrough medical devices cleared by the Food and Drug Administration (FDA), which was the subject of a rule delayed by the Biden administration.

The legislation, introduced in the House on Wednesday, would require Medicare to cover all breakthrough products approved by FDA for four years. During that time, the Centers for Medicare & Medicaid Services (CMS) would determine whether coverage should be permanent. Sometimes it can take CMS up to three years after a device is approved to grant a national coverage determination that ensures Medicare reimbursement.

“Guaranteeing the coverage of breakthrough therapies and treatments would encourage future innovation and investment in cutting-edge medical technologies while improving the quality of life for millions of seniors,” said one of the lead sponsors Rep. Suzan DelBene, D-Washington, in a statement. “We can’t let the coverage approval process to be a barrier to life-saving treatments or care.”