Retired - Coverage and Correct Coding of Blincyto™

Joint DME MAC Publication

On December 03, 2014, the FDA gave accelerated approval for Blinatumomab (Blincyto™) for the treatment of Philadelphia negative relapsed/refractory acute lymphoblastic leukemia. Blincyto™ is a bispecific CD19-directed CD3 T-cell engager that activates endogenous T-cells when bound to the CD19-expressing target cell (B cells). Activation of the immune system results in release of inflammatory cytokines. The FDA-approved schedule is for 6-week cycles, for a total 5 cycles.

The Durable Medical Equipment Medicare Administrative Contractors (DME MACs) have evaluated Blincyto™ and determined that it is eligible for inclusion in the Durable Medical Equipment (DME) External Infusion Pump Local Coverage Determination (LCD).

Blincyto™ can be administered in multiple settings including:

  1. Inpatient facility
  2. Rehabilitation facility
  3. Hospital/outpatient infusion facility incident to a physician’s service (supervision)
  4. Home setting every 48 hours under nursing supervision
  5. Home setting every 48 hours, with drug cassette exchanges at a hospital/outpatient infusion facility (without supervision)

The DME MAC will only process claims for Blincyto™ administered in the last scenario.

Please refer to the entire bulletin article referenced above and the External Infusion Pump LCD and related Policy Article for additional information.

Claims for Blincyto™ for dates of service on or after December 03, 2014, must be submitted using the HCPCS code J7799 (NOC DRUGS, OTHER THAN INHALATION DRUGS, ADMINISTERED THROUGH DME). Suppliers are reminded that when submitting claims for items coded J7799, the supplier must include the following information:

  • Name of Drug
  • Dosage Strength
  • Amount Dispensed (e.g., total mg)
  • Administration Instructions

This information must be entered in the narrative field of an electronic claim (NTE 2300 or NTE 2400 of an electronic claim) or Item 19 of a paper claim.

For questions about correct coding, contact the Pricing, Data Analysis and Coding (PDAC) contractor Contact Center 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 Form.


Revision History

Date Update
02/25/2015 Published on PDAC website
01/12/2016 Revised

Last Updated: 02/25/2015