Healthcare DIVE September 14, 2021
Dive Brief:
- CMS is planning to scrap its contentious breakthrough payment rule after concluding it is not in the best interest of Medicare beneficiaries.
- The Medicare Coverage of Innovative Technology (MCIT) pathway would have allowed medtech companies to secure near-automatic coverage for a period of four years with an FDA breakthrough device designation. However, after buying itself time to review the rule, CMS concluded there are “significant concerns” about the clinical evidence on breakthrough devices in the Medicare population.
- AdvaMed said the proposed repeal is the “wrong decision” and will have the chance to make its case before the action is finalized. Nonetheless, the proposal could yet be resurrected through the second iteration of the 21st Century Cures Act...