MedCity News November 12, 2021
Elise Reuter

The agency decided to rescind a rule by the previous administration where Medicare would be required to cover breakthrough devices for up to four years after they receive FDA approval or clearance. CMS said it made the change to address safety concerns with the policy.

Medicare is no longer required to cover “breakthrough” devices after they are cleared or approved by the Food and Drug Administration.  The Centers for Medicare and Medicaid Services rescinded a final rule on Friday, citing safety concerns.

“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...

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