CMS wants to rescind a rule introduced by former President Donald Trump’s administration that lets Medicare cover medical devices that the FDA designates as “breakthrough” technologies, according to a proposed rule scheduled to be filed in the Federal Register Sept. 15.
1. CMS issued the Medicare Coverage of Innovative Technology final rule Jan. 12 with the intention to create a new, accelerated Medicare coverage process for innovative devices and technologies the FDA calls “breakthrough,” which the agency approves on an expedited basis.
2. CMS delayed the final rule twice, first in March and again in May, so the agency could “address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment,” CMS wrote in an interim final rule published May 18.
3. The proposed rule addresses safety concerns associated with speeding up coverage of new devices.
“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 respect to use in the Medicare population upon receipt of coverage,” the proposed rule states.
4. Comments on CMS’ proposal to withdraw the final rule are due Oct. 15.