RETIRED - Blinatumomab - Billing Instructions - JD DME
RETIRED - Blinatumomab (Blincyto) - Billing Instructions
IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
Content Provided on this page contains outdated information and instruction and should not be considered current. Noridian is providing this archived information for research purposes only. This archived article contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.
Article retired due to content incorporation into the applicable Local Coverage Determination or related Policy Article.
DME MAC Joint Publication
Medicare encourages physicians, hospitals, other providers and suppliers to administer medication to patients 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.
Blinatumomab was recently approved for use by the Food and Drug Administration, and has been included in the DME MAC External Infusion Pump LCD as a covered drug for the treatment of Philadelphia negative relapsed/refractory acute lymphoblastic leukemia. Coverage is effective for claims with dates of service on or after December 03, 2014.
Blinatumomab is supplied in 35 mcg (lyophilized powder) single-use vials. 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. A reconstituted bag contains 56 mcg, which is infused over 48 hours.
One unit of service (UOS) equals one (1) vial, and each UOS must be prepared using the combination of vials that result in the least amount of wastage for the dosage amount being administered. Five vials should be used to reconstitute three bags, each containing 56 mcg of blinatumomab, which can be refrigerated and used within six-days, leading to the least amount of wastage.
Using this method, usual utilization is 25 vials per month. Claims that exceed 25 UOS per month will be denied as not reasonable and necessary.
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 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.
