The decision by CMS in June 2010 to launch an investigation
into whether Medicare should cover Dendreon
Corp.'s Provenge sipuleucel-T created fear in the biopharmaceutical
industry that it signaled an intention to routinely second-guess FDA approvals
of new, expensive biological drugs.
While CMS initially gave a
variety of reasons for why it launched the National Coverage Determination
(NCD), comments by senior agency officials and internal documents released
under the Freedom of Information Act show the explanations did not include the
most important factor: Congress. The decision was made to avoid a political
firestorm, which was fueled by local Medicare contractors that were confused by
unusual terminology and novel technology.