CMS Coverage with Evidence Development Policy Highlights Differences Between FDA and CMS Clinical Evidence Requirements

After much delay, the Centers for Medicare & Medicaid Services (CMS) issued its final policy on Coverage with Evidence Development (CED) on July 12, 2006. The policy revises the controversial draft policy, issued on April 7, 2005, in response to public comments that raised many questions, including when and how CMS will apply CED. In the final policy, CMS outlines eight principles that will govern the application of CED. CMS will apply CED in the context of National Coverage Determinations to require the collection of additional evidence as a condition of Medicare coverage. CMS expects to require CED infrequently. CMS has stated that CED will not duplicate or replace FDA’s authority to regulate the safety and efficacy of drugs, biologicals and medical devices.

The final policy introduces two new concepts: Coverage with Appropriateness Determination (CAD) and Coverage with Study Participation (CSP). CMS interprets section 1862(a)(1) of the Social Security Act to authorize both of these concepts. CAD will be used when there is adequate evidence for Medicare coverage, but CMS believes that additional clinical data is needed, which will be gathered through data submitted by Medicare providers to databases and registries. Medicare will only cover items or services for patients who are included in the data collection. Conversely, when CMS believes that inadequate evidence exists to allow Medicare coverage of certain items or services, under the authority of section 1862(a)(1)(E) of the Social Security Act, CMS may require CSP for further evidence development in a clinical research study, which must be designed to meet standards to be developed in reconsideration of the current Medicare Clinical Trial Policy. Medicare coverage may be extended to patients enrolled in these clinical research studies. The CED also explains how clinical research studies under CSP may qualify for Medicare reimbursement, and how researchers may access CMS’s CED data

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