Oncology & Hematology Coding Alert

Breast Cancer:

J9035: CMS Avastin Coverage Is Safe for Now

Brush up on Medicare's off-label drug use policy.If you're worried that the FDA's decision to withdraw approval of Avastin for breast cancer treatment means Medicare will stop covering the drug for your patients with breast cancer, take heart."Medicare will continue to cover Avastin," said CMS spokesman Don McLeod in a statement. "CMS will monitor the issue and evaluate coverage options as a result of action by the FDA but has no immediate plans to change coverage policies."Withdrawal explained: FDA Commissioner Margaret A. Hamburg, MD, published a decision involving "Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative," according to an FDA news release (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm280536.htm). "This indication must now be removed from Avastin's product labeling" following the FDA's determination that the drug may pose life threatening side-effects to patients [...]
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