Ring-fence for Provenge

Last week's decision by the Centers for Medicare and Medicaid Services to establish a national coverage policy for Provenge sipuleucel-T from Dendreon Corp. is likely to lead to a decision that bars Medicare reimbursement for off-label uses, or could result in a restriction of coverage to patients who are enrolled in a registry, according to Medicare reimbursement specialists.

CMS's decision to conduct a National Coverage Analysis, the first step in developing a National Coverage Determination (NCD), was "precedent-setting because it comes so soon after the drug was approved, and because it is a cancer drug," Jayson Slotnik, an attorney at Foley Hoag LLP who specializes in federal reimbursement issues, told BioCentury...