CMS FDA launch pathway expedites Medicare coverage for breakthrough medical devices, enabling payment within two months of FDA authorization.

Certain breakthrough-designated medical devices that receive market authorization will become eligible for Medicare coverage ...

Last year, the CMS Innovation Center launched the Quality Pathway strategic initiative to strengthen the focus on quality in alternative payment models. Since it was created, the CMS Innovation Center ...

The FDA has released draft guidance outlining an approval pathway for individualized therapies aimed at ultra-rare diseases, building on a framework first outlined by agency leaders in November. The ...