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BioWorld - Tuesday, March 31, 2026
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Home » CMS managers float advisory hearings, CED for breakthrough device coverage
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CMS managers float advisory hearings, CED for breakthrough device coverage

Oct. 12, 2022
By Mark McCarty
The question of Medicare coverage for breakthrough devices is still in play at CMS, but managers there penned an Oct. 12 editorial that suggests that existing coverage mechanisms may have to suffice. CMS’s Lee Fleisher and Jonathan Blum said in the JAMA Internal Medicine (JAMA: IM) editorial that the agency might respond to the breakthrough device coverage question by applying the coverage with evidence development (CED) mechanism for breakthrough devices, suggesting that the policy might ultimately resemble the coverage mechanisms already available to industry.
Medical technology Regulatory

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