Four things to know:
1. CMS, under the previous administration, issued the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” Jan. 12, days before President Joe Biden took office. The final rule aimed to create a new and accelerated Medicare coverage process for innovative devices and technologies deemed “breakthrough,” which the FDA approves on an expedited basis.
2. CMS said it will rescind the rule because of concerns over Medicare patient safety.
“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a Nov. 12 news release.
3. CMS said it will explore different coverage process improvements to enhance Medicare beneficiaries access to breakthrough medical devices.
4. CMS had proposed rescinding the rule Sept. 15 and accepted comments through Oct. 15. CMS also 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.”
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