In Washington, there are ongoing developments concerning a federal rule that intends to simplify the reimbursement process for breakthrough medical devices. This rule is anticipated to be finalized early this summer according to Dora Hughes, the director of the clinical standards center at the Centers for Medicare and Medicaid Services (CMS). Hughes communicated this timeline during her speech at the Medical Device Manufacturers’ Association conference held on Thursday.
The CMS has been under considerable pressure from various device manufacturers who have expressed their dissatisfaction with the protracted nature of Medicare’s reimbursement decisions. In response, AdvaMed, a medical technology lobby group, addressed a forthright letter to CMS in March, querying the delay in mobilizing the breakthrough device program.
Hughes explained that the agency has been deliberate in its approach, taking sufficient time to thoughtfully consider the feedback received during the comment period which concluded in August. Additionally, she shared that the CMS plans to introduce the final rule alongside a companion policy. This accompanying policy aims to elucidate the type of evidence that would be necessary to persuade the agency of a device’s reasonableness and necessity.
These discussions and planned regulations are critical as they affect how quickly and efficiently new medical technologies that qualify as ‘breakthrough devices’ can be reimbursed through Medicare, potentially impacting patient access to the latest medical innovations.
#Medicare #breakthrough #device #reimbursement #rule #summer
