Provenge politics

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...