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January 7, 2016

YONDELIS® - Coverage and Correct Coding

Joint DME MAC Publication

On October 23, 2015 the Food and Drug Administration (FDA) gave accelerated approval to YONDELIS® (trabectedin), a chemotherapy treatment for specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have evaluated YONDELIS® and determined that it is not eligible for inclusion in the Durable Medical Equipment (DME) External Infusion Pump Local Coverage Determination (LCD L33794). Claims to the DME MACs for YONDELIS® whose administration is initiated in a provider's office will be rejected as wrong jurisdiction. Please consult with the appropriate A/B MAC for potential reimbursement under part B of the Medicare program.

Please refer to the External Infusion Pump LCDExternal Website and related Policy ArticleExternal Website for additional coverage, coding and documentation requirements.

For questions about correct coding, contact the Pricing, Data Analysis, and Coding contractor (PDAC) at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact FormExternal Website.

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