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Device Makers Want Say In Medicare 'Coverage-With-Evidence-Development' Policy

Manufacturers seek more input on trial designs and objectives when CMS takes the "coverage-with-evidence-development" route to national Medicare coverage.

As CMS mulls whether to make more use of its "coverage-with-evidence-development" approach, the device industry is stressing the importance of manufacturer input whenever the agency is thinking of employing the special route.

Coverage with evidence development (CED) allows Medicare beneficiaries to receive treatment with a technology that would otherwise be nationally non-covered, due to insufficient supporting evidence, in exchange for their participation in a data-gathering clinical trial or registry. Last fall, the Medicare agency solicited public comments on whether and how to update its policy on the novel coverage approach

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