CMS moves to scrap MCIT rule due to clinical evidence concerns – MedTech Dive

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 next year as it was recently included in a discussion draft of the legislation.

Dive Insight:

The MCIT rule was part of a raft of regulations from the final days of the Trump presidency that the Biden administration put on hold. Critics such as health insurance association AHIP as well as some doctor groups drove CMS to delay implementation. After the first delay, the agency pushed back the implementation date again and expressed concerns with the impact of the rule. Those concerns ultimately persuaded CMS to kill off the proposal. 

“While the rule tried to address stakeholder concerns about accelerating coverage of new devices, significant concerns persist about the availability of clinical evidence on Breakthrough Devices when used in the Medicare population as well as the benefit or risks of these devices with