12:00 AM
Nov 21, 2011
 |  BioCentury  |  Regulation

CMS aims to revamp CED

CMS revamping coverage with evidence development to generate more clinical data

CMSis revamping its coverage with evidence development program with an eye to using its leverage more broadly to stimulate collection of clinical data where innovations do not neatly fit into coverage mandates.

Coverage with evidence development (CED) is a mechanism for CMS to grant conditional coverage contingent on some form of clinical data collection. CED typically restricts coverage to patients who are in a clinical trial, which is called "coverage with study participation."

Coverage with evidence development is intended to make it possible for Medicare to cover something that wouldn't meet the "reasonable and necessary" criteria mandated by law in the absence of ongoing data collection or the safeguards associated with a clinical trial.

The CED program also allows CMS to restrict coverage to patients enrolled in a registry or database as a way of ensuring that coverage is provided...

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