Bipartisan bill requires Medicare to cover breakthrough devices after approval from FDA

Medical device surgeon
New bipartisan legislation aims to require Medicare to cover breakthrough medical devices after they are approved by the FDA, even after the Biden administration delayed a similar regulation. (Getty/A stockphoto)

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.”

The Ensuring Patient Access to Critical Breakthrough Products Act would also give temporary coverage for any breakthrough devices that did not exist or were not considered when Medicare was first created, including digital therapeutics, according to a release on the bill.

RELATED: Insurers slam CMS proposal to hasten Medicare coverage of breakthrough medical devices

Lawmakers say the legislation could help with a problem devicemakers have complained about for some time.

“There are more than 600 medical device companies in our state working to develop innovative and effective products,” said Rep. Gus Bilirakis, R-Florida, one of the co-sponsors, in a statement. “I’ve heard from many of these businesses about how these lengthy and unnecessary Medicare coverage delays create a significant barrier in bringing new products to market.”

The legislation is also part of a discussion draft for the 21st Century Cures Act 2.0, which would build on a 2016 law that boosted medical research funding and included several other initiatives. Inclusion in the discussion draft, which is expected to have wide bipartisan support, could improve prospects for final passage.

The legislation resembles a Trump-era rule that would require temporary Medicare coverage for breakthrough devices. The Biden administration delayed implementation of this rule amid a major pushback from insurers that worry the devices have not been tested for use in the Medicare population.

The CMS rule was expected to go into effect in March but now has been delayed until Dec. 15.

The Biden administration said it will look further into the concerns from insurers and other stakeholders during the delay.