James Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”

James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Law360 Healthcare Authority, in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy,” by Theresa Schliep. (Read the full version – subscription required.)

Following is an excerpt:

The Centers for Medicare and Medicaid Services recently finalized highly anticipated guidance providing a new pathway for Medicare coverage of breakthrough medical devices, but attorneys worry the agency's plans to accept just five products each year will blunt the program's impact.

The final CMS notice, released Aug. 7, lays out the Transitional Coverage for Emerging Technologies coverage pathway for products deemed "breakthrough devices" by the U.S. Food and Drug Administration that treat or diagnose serious or life-threatening conditions better than currently available products.

The new coverage pathway is intended to expedite access to new, innovative treatments by Medicare patients, since it can otherwise take about five years for medical products to achieve comprehensive coverage following FDA approval, according to a study by the Stanford Byers Center for Biodesign. Recent devices given "breakthrough" status by the FDA include an artificial intelligence-assisted cardiac examination device from Ultromics Limited and an Abbott Laboratories blood test for identifying traumatic brain injuries.

As of December 2023, the FDA had granted breakthrough designation to 933 products. But CMS, citing resource constraints, said it anticipates being able to accept at most five breakthrough devices into the new coverage pathway annually, to the chagrin of industry. ...

James A. Boiani, a member of Epstein Becker & Green PC, called the guidance a "step in the right direction," but said, "There are a lot of products competing for these slots each year."

The new coverage pathway is designed to provide temporary Medicare coverage for three to five years while further evidence develops, after which time the device would move to post-TCET coverage. ...