Oncology & Hematology Coding Alert

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 "without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life."

Why coverage remains: "Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme)," according to the FDA announcement.

Additionally, physicians may continue to prescribe Avastin for breast cancer treatment, but the use will now be considered off-label.

Medicare carriers may cover off-label use of drugs in an anti-cancer chemotherapy regimen, according to Medicare Benefit Policy Manual, 100-02, chapter 15, section 50.4.5 (www.cms.gov/manuals/Downloads/bp102c15.pdf).

The manual explains that the use must be supported by one of the following:

• American Hospital Formulary Service-Drug Information (AHFS-DI)
• National Comprehensive Cancer Network (NCCN) Drugs and Biologics Compendium
• Thomson Micromedex DrugDex
• Clinical Pharmacology.

You can learn more about the compendia at www.cms.gov/CoverageGenInfo/02_compendia.asp.

Remember: Private payer policies may vary, so be sure to verify coverage prior to administration. You should report the supply of Avastin using J9035 (Injection, bevacizumab, 10 mg).