BioCentury
ARTICLE | Politics & Policy

Biotech, pharma want CMS to limit CED

January 30, 2013 2:27 AM UTC

Stakeholders are asking CMS to limit use of the agency's coverage with evidence development (CED) mechanism to off-label uses of FDA-approved drugs and biologics, and to limit its use only to the National Coverage Determination (NCD) process. The details came in (see BioCentury Extra, Nov. 30, 2012).

The Biotechnology Industry Organization (BIO) said the CED mechanism should "rarely" be applied to drugs, biologics and diagnostics, noting that the products are already subject to a "rigorous" FDA review process. Both the American Medical Association (AMA) and Personalized Medical Coalition also argued that expanding CED could result in a "duplication of efforts" and "multiple or even conflicting data collection requirements" between CMS and FDA, which the AMA said could create "significant entrance barriers" that may "perversely prevent the entry and uptake of diagnostics and therapeutics that significantly improve patient outcomes." ...