CMS Dashes Industry Hopes For MCIT Rule Any Time Soon

The Biden administration has put the kibosh on a highly anticipated rule that would’ve given immediate Medicare coverage to breakthrough medical devices. The US Centers for Medicare and Medicaid Services (CMS) says as it stands, the rule would require reimbursement for products not proven to work in patients 65 and older, and for that reason it’s proposing to stop the rule from going into effect.

The Medicare Coverage for Innovative Technologies (MCIT) rule has been touted by industry and other proponents as a critical step to bringing new treatments to elderly patients faster. They have long argued that after the Food and Drug Administration allows a new product on the market under its expedited breakthrough devices program, it can take years to aggregate product data that satisfies the Medicare agency’s reimbursement evidence requirements