Ten U.S. senators are calling on the U.S. Centers for Medicare & Medicaid Services (CMS) to create a new rule allowing government payments for medical devices designated as breakthroughs by the FDA.
CMS said in September that it would not move forward with the Medicare Coverage for Innovative Technologies (MCIT) rule, citing safety concerns for Medicare patients.
In a Nov. 5 letter, the bipartisan group of lawmakers — U.S. Sens. Michael Bennet, John Barrasso, Marsha Blackburn Bill Cassidy, Maggie Hassan, Mark Kelly, Ben Sasse, Jeanne Shaheen, Kyrsten Sinema and Todd Young — urged CMS Administrator Chiquita Brooks-LaSure to propose a new rule.
“We understand that CMS proposed repealing the existing rule after experts raised concerns about operationalization and patient benefit during the comment process,” the letter read. “CMS should address these concerns and move forward with a pathway for coverage that allows for collection of appropriate evidence for Breakthrough Devices. We urge CMS to develop a new rule that addresses coverage for innovative and demonstrably beneficial technologies that balances access with patient protections. Focused improvements to the MCIT pathway will allow for coverage that is flexible, predictable, and evidence-based.”
CMS created the MCIT pathway in the last days of the Trump Administration. It was among a host of regulations the Biden Administration immediately put on hold for further consideration.