Expanded Coverage of Blincyto®

Joint DME MAC Publication

On December 03, 2014, the External Infusion Pump Local Coverage Determination (LCD L33794) was revised to include coverage of BLINCYTO® for the treatment of adults with Philadelphia chromosome negative (Ph-) relapsed/refractory acute lymphoblastic leukemia (ALL). In July of 2017, coverage was expanded for the treatment of adult and pediatric patients with relapsed or refractory (R/R) B-cell precursor ALL. In March of 2018, the policy was revised to extend coverage of BLINCYTO® to include adult and pediatric beneficiaries with B-cell precursor ALL in first or second remission with minimal residual disease (MRD) greater than or equal to 0.1%.

Following an evaluation of the clinical literature, the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) will expand the indications to include coverage for up to four cycles of BLINCYTO® for adults and pediatric patients with B-cell ALL who have achieved complete remission with MRD greater than or equal to 0.1%, and up to 9-cycles of BLINCYTO® for adults and pediatric patients with Relapsed/Refractory B-cell ALL.

As a reminder, BLINCYTO® can be administered in multiple inpatient and outpatient settings. However, the DME MACs will only process claims for BLINCYTO® when it is administered to a Medicare beneficiary in an unsupervised home setting. Claims to the DME MACs for BLINCYTO® initiated in other settings such as a hospital, physician’s office, or an outpatient infusion facility will be rejected as wrong jurisdiction.

The External Infusion Pump policy will be revised to reflect this change. Please refer to the External Infusion Pump policy LCD and related Policy Article (L33794) 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 p.m. CT, Monday through Friday, or e-mail the PDAC by completing the DME PDAC Contact Form.

Publication History

Publication Date: November 8, 2018
Originally Published


Last Updated Nov 08 , 2018