WASHINGTON — A federal rule aiming to make reimbursement for breakthrough devices easier is slated for early summer, a Centers for Medicare and Medicaid Services official said on Thursday.
The agency has faced intense pressure from device makers frustrated with the slow pace of Medicare reimbursement decisions. Medical technology lobby AdvaMed sent CMS a strongly-worded letter in March asking why it has taken so long to get the breakthrough device program moving.
Dora Hughes, director of the clinical standards center at CMS, told attendees at the Medical Device Manufacturers’ Association conference the agency wanted to take the time to meaningfully address feedback sent during the comment period, which closed in August. She also noted the organization’s goal of releasing the final rule with a slate of other policies, including a rule clarifying the agency’s thinking on what kind of evidence would be needed to convince the agency that a given device is both reasonable and necessary.