RETIRED - Billing Instruction - Blinatumomab Blincyto - Revised - JD DME

Article retired due to content incorporation into the applicable Local Coverage Determination or related Policy Article.

DME MAC Joint Publication

Originally Published: March 26, 2015.

Revised: November 22, 2017.

*This revision clarifies that the Unit of Service (UOS) is 1 microgram and not 1 vial, and provides information regarding additional indications.

Blinatumomab was approved for use by the Food and Drug Administration, and has been included in the DME MAC External Infusion Pumps LCD as a covered drug for the treatment of Philadelphia negative relapsed/refractory acute lymphoblastic leukemia. Coverage was effective for claims with dates of service on or after December 03, 2014. On July 11, 2017, the United States (US) Food and Drug Administration (FDA) expanded approval of BLINCYTO® for the treatment of adult and pediatric patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). Coverage is effective for claims with dates of service on or after July 11, 2017.

On January 01, 2016, blinatumomab received a unique HCPCS code J9039 (INJECTION, BLINATUMOMAB, 1 MICROGRAM). On January 07, 2016, a joint DME MAC correct coding article was posted noting that for all claims with dates of service on or after 01/01/2016, one unit of service (UOS) equals one (1) microgram.

Blinatumomab is supplied in 35 mcg (lyophilized powder) single-use vials. A single cycle of treatment of induction or consolidation consists of 28 days of continuous intravenous infusion of 28 micrograms of blinatumomab per day.

Medicare encourages physicians, hospitals, other providers and suppliers to administer medication to beneficiaries in such a way that they use the drugs most efficiently, and in a clinically appropriate manner.

The dose or quantity of medication necessary to administer the prescribed amount is covered based upon the payment rules in the applicable medical policy. When the remainder of a single use vial or other single use package must be discarded after administering a dose of the drug to a Medicare patient, the program provides payment for the amount discarded as well as the dose administered, up to the amount of the drug or biological as indicated on the vial or package label.

The External Infusion Pumps LCD (L33794) indicates that usual utilization is 25 vials per month, which is equivalent to 875 UOS per month. Claims that exceed 875 UOS per month will be denied as not reasonable and necessary.

48 hour Infusion

The drug is reconstituted with sterile water in a USP <797> compliant facility, and placed in a bag coated with an IV Solution Stabilizer, which can be subsequently refrigerated (2°C to 8°C) for up to eight-days.  Each bag must be prepared using the combination of vials that result in the least amount of wastage for the dosage amount being administered.

For beneficiaries requiring a 48-hour infusion, five vials should be used to reconstitute three bags, each containing 56 mcg of blinatumomab, which is infused at a rate of 5 mL/hour. The bags can be refrigerated and used within six-days, leading to the least amount of wastage.

7 day Infusion

The drug is reconstituted with sterile water in a USP <797> compliant facility, and placed in a bag containing an IV Solution Stabilizer, which can be subsequently administered over 7 days.  Each bag must be prepared using the combination of vials that result in the least amount of wastage for the dosage amount being administered.

For beneficiaries requiring a 7-day infusion, six vials should be used to reconstitute one bag, each containing 210 mcg of blinatumomab, which is infused at a rate of 0.6 mL/hour over 7 days – leading to the least amount of wastage.

Suppliers must not bill claims for blinatumomab using vials as the UOS.  Billing UOS as vials will result in improper payments for blinatumomab.  Suppliers should refer to the External Infusion Pumps LCD and related Policy Articles 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 Form.

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