CMS To Step Up Enforcement Of AMP Reporting Compliance
Executive Summary
CMS says it plans to step up enforcement against pharmaceutical manufacturers for not complying with Medicaid's average manufacturer prices reporting requirements.
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Medicare and Medicaid In Brief
Provenge review scheduled: The Medicare Evidence Development and Coverage Advisory Committee is scheduled to review Dendreon's novel prostate cancer vaccine Provenge (sipuleucil T) on Nov. 17. CMS says in an Aug. 31 announcement it has called the meeting to "consider the currently available evidence regarding the impact of labeled and unlabeled use of autologous cellular immunotherapy treatment on health outcomes." Provenge is approved for treating asymptomatic or minimally symptomatic prostate cancer that is metastatic and resistant to standard hormone treatment. The potential for use in earlier stages of the disease is the off-label opportunity. The review is part of a national coverage analysis for Provenge 1("The Pink Sheet," Aug. 9, 2010). The NCA recently prompted a letter from Sens. Arlen Specter, R-Penn. and John Kerry, D-Mass., who expressed concern about limiting access to Provenge among Medicare beneficiaries