How to collect data for FDA and CMS in the same study

The FDA and CMS perspectives on evidence from clinical trials and suggestions for planning studies that will address the information needs of both agencies are discussed. Planning a trial that can satisfy both FDA and CMS is challenging because the agencies have fundamentally different missions. CMS can grant provisional Medicare coverage for a new procedure contingent on the development and capture of additional patient data to supplement standard claims data. FDA is a regulatory agency with the power to control the marketing of medical products. CMS must examine many other sources of data when formulating the National Coverage Determination (NCD). Careful attention to the design of these reports can facilitate resource coding. Trial designers should address whether including CMS concerns in an FDA submission could muddle the data FDA uses to make the basic regulatory approval. Planning for coverage approval should include supporting studies based on literature synthesis, patient survey research, or economic modeling.