Originally Published MX November/December 2002

GOVERNMENTAL & LEGAL AFFAIRS

Realistically, adoption of IMDMC's proposal to harmonize the FDA approval and Medicare coverage processes is a long-term objective that is unlikely to be completed any time soon. In the meantime, manufacturers of medical devices must have strategies for working appropriately with the two agencies. Those strategies should be built around the following five general principles.

In the Beginning, Stay Local. Manufacturers need not try to achieve a national coverage determination quickly on the heels of FDA approval. In many instances, the local coverage process provides a better, more flexible route to obtaining coverage than would a premature request for a national coverage determination. If the manufacturer decides that local coverage will be sufficient early in a product's life cycle, it may be less important for the company to pursue early coordination activities with FDA and CMS. However, such efforts can still be worthwhile in order to lay the groundwork for an eventual national coverage application.