Coverage and Correct Coding of BlincytoTM
Joint DME MAC Publication
On 12/3/2014, the FDA gave accelerated approval for Blinatumomab (BlincytoTM) for the treatment of Philadelphia negative relapsed/refractory acute lymphoblastic leukemia. BlincytoTM 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 DME MACs have evaluated BlincytoTM and determined that it is eligible for inclusion in the DME External Infusion Pump LCD.
BlincytoTM can be administered in multiple inpatient and outpatient settings. However, the DME MACs will only process claims for blinatumomab when it is administered to a Medicare beneficiary every 48 hours in an unsupervised home setting, with drug cassette exchanges that do not require supervision performed at a hospital/outpatient infusion facility. Claims to the DME MACs for BlincytoTM administered in any other setting will be rejected as wrong jurisdiction.
Claims for BlincytoTM for dates of service on or after 12/3/2014, 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.
Please refer to the External Infusion Pump LCD and related Policy Article for additional coverage, coding and documentation requirements.
For questions about correct coding, contact the PDAC at (877) 735-1326 during the hours of 8:30 a.m. to 4:00 p.m. CT, Monday through Friday, or email the PDAC by completing the DME PDAC Contact Form.