Medicare's coverage of colorectal cancer drugs: a case study in evidence development and policy.

Payers point to the lack of unbiased evidence for making coverage decisions for new and often costly technologies. This paper provides a case study of a new approach to developing information to meet the needs of a payer: Medicare's coverage with evidence development (CED) policy. Medicare's decision to condition coverage of cancer therapies on clinical trial participation is an early application of CED and signals Medicare's interest in developing evidence on new technologies for beneficiaries. This paper reviews the rationale and challenges Medicare faces in applying its CED policy and discusses the implications of payers' using and generating evidence.