Blinatumomab Medicare Guidelines
Blinatumomab requires one of the below qualifying diagnoses:
- Relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL)
- B-cell precursor ALL in first or second remission with minimal residual disease (MRD) greater than or equal to 0.1%.
- Documentation outlining ALL history supported by bone marrow biopsy report.
Chartwell reviews all eligible Medicare patients for infusion qualification based on the Noridian LCD found at: External Infusion Pumps LCD and PA (noridianmedicare.com). Noridian has the most current and up to date information. Please refer to the Noridian site for clarification of any content on this site.
Some therapies will have fill and total dose limitations with each qualifying diagnosis. Some therapies will require an electronic external infusion pump, while others will prohibit use of an electronic pump based on the LCD. Medicare covers home infusion under their external infusion pump coverage within the Durable Medical Equipment benefit.
For qualification, provider documentation requires diagnostic testing to support diagnosis for all therapies requiring Medicare qualification. Additionally:
Some therapies will have fill and total dose limitations with each qualifying diagnosis. Some therapies will require an electronic external infusion pump, while others will prohibit use of an electronic pump based on the LCD. Medicare covers home infusion under their external infusion pump coverage within the Durable Medical Equipment benefit.
For qualification, provider documentation requires diagnostic testing to support diagnosis for all therapies requiring Medicare qualification. Additionally:
- The patient must be eligible for a defined Medicare benefit category.
- Therapy must be reasonable and necessary for the diagnosis and supported in medical documentation.
- The case must meet all other applicable Medicare statutory and regulatory requirements.