Falling Short – Final Guidance on Coverage With Evidence Development

The Centers for Medicare & Medicaid Services (CMS) has issued final guidance on Medicare coverage determinations conditioned on Coverage with Evidence Development (CED) that improves on the draft guidance but may require further revision. The final guidance issued on July 12, 2006 responds to public comments on the draft guidance, outlines the principles and application of CED, and introduces new concepts of Coverage with Study Participation and Coverage with Appropriateness Determination. However, the final guidance provides no assurance to manufacturers that additional evidence gathered under CED will lead to favorable Medicare coverage of a particular drug or medical device.