Parallel Reviews Should Lead To Local Coverage, Coding Decisions, Firms Say

Article preview from "The Gray Sheet" - January 3, 2010

Device makers say that for FDA and CMS parallel reviews to be successful, they must enable local coverage determinations and coding decisions, not just national coverage decisions.

Parallel Reviews Should Lead To Local Coverage, Coding Decisions, Firms Say

Article preview from "The Gray Sheet" - January 3, 2010

Device makers say that for FDA and CMS parallel reviews to be successful, they must enable local coverage determinations and coding decisions, not just national coverage decisions.

FDA and CMS are preparing to test the concept of joint pre-market review and reimbursement decision-making with a pilot project for devices. The voluntary program will speed market uptake of new technologies, the agencies say.

As envisioned, parallel review would allow CMS to initiate a national coverage determination (NCD) for products still under FDA review, once FDA had a good sense that the product would ultimately be approved or cleared.

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