Healthcare DIVE September 2, 2020
Dive Brief:
- CMS on Monday unveiled a proposed rule outlining a plan to cover FDA-designated breakthrough devices for up to four years from the date they receive U.S. marketing authorization.
- has been under review since March of last year. If finalized in its current form, the new pathway may end up costing the government as much as $291.5 million in its first year, CMS estimates.
- The proposal follows a push by the medical device industry for faster Medicare reimbursement for emerging technologies. AdvaMed has sought immediate Medicare reimbursement for products awarded a breakthrough device designation when approved for marketing by FDA.
Dive Insight:
The product pool eligible for the pathway, restricted to FDA-designated breakthrough devices that then...
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