Medicare eliminates key payment pathways for breakthrough devices

Medicare has moved to eliminate flexibilities that allowed devices holding the Food and Drug Administration’s “breakthrough” designation to bypass certain qualification requirements for extra payments, according to a report from STAT News published August 3.

The breakthrough device designation, granted by the FDA, has historically carried a secondary benefit: it let qualifying devices leapfrog standard requirements for securing supplemental Medicare payments. That pathway is now being removed.

The change alters the incentive structure surrounding development of novel medical devices. Manufacturers seeking breakthrough status will no longer be able to rely on that designation alone to shortcut the process for obtaining additional Medicare reimbursement.

STAT News reports the shift as a removal of “key pathways” that breakthrough devices have used for extra payments. The report does not specify a timeline for implementation, nor does it detail the mechanics of the prior payment pathways beyond noting their elimination.

The supplied source material does not include additional detail on CMS’s rationale, on affected device categories, or on responses from device manufacturers or health systems. This bulletin reflects only what the cited report states.