Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy

On July 12, 2006, Medicare finalized its Coverage with Evidence Development policy, which introduces two new concepts: Coverage with Appropriateness Determination and Coverage with Study Participation. Medicare’s Coverage with Study Participation will be of particular interest to clinical trial sponsors. Under Coverage with Study Participation, CMS will require, as a condition of Medicare coverage, the collection of evidence in clinical trials (in addition to clinical investigation for FDA approval) to determine the effectiveness of a particular drug, biologic or medical device on the Medicare population. Medicare Coverage with Evidence Development and Potential Impact on Your Clinical Trial Policy explains the new Medicare coverage policy and provides strategic considerations for Medicare coverage and reimbursement for clinical trial costs.