BioCentury
ARTICLE | Regulation

ExCEDing the NCD

Debate over expanding Medicare's Coverage with Evidence Development

April 9, 2012 7:00 AM UTC

Companies are concerned that expanded use of coverage with evidence development by the Centers for Medicare & Medicaid Services could restrict access to new drugs, but not all doctors and policy specialists agree.

Once drugs or devices are approved by FDA, CMS is required by law to cover those that are "reasonable and necessary," although the term itself does not have a precise legal definition...