WASHINGTON (Reuters) - A new process to review medical products at the U.S. Food and Drug Administration in tandem with the nation’s Medicare insurance program could help speed up coverage decisions, the FDA said in announcing the move on Thursday.
Under the proposal, the FDA would review and make approval decisions alongside the Centers for Medicare and Medicaid Services, which decides whether and how to pay for new medical products for its elderly and disabled patients once they are approved for the U.S. market.
To start, the agencies proposed a pilot project for devices after both FDA and CMS had time to review public comments on the proposal.
More than 45 million people are covered under the Medicare program. Private insurers often weigh CMS’s coverage decisions when setting their own reimbursement policies, and a decision by Medicare to cover a new product can speed its adoption in the wider marketplace.
Reporting by Susan Heavey; Editing by Maureen Bavdek