08.01.29m, Daratumumab (Darzalex®), Daratumumab and Hyaluronidase-fihj (Darzalex Faspro®)

By September 22, 2025: Billing and prior authorization teams must review and update approval workflows for daratumumab/Darzalex Faspro claims to align with expanded indications. Specifically: (1) Update documentation requirements to capture clinical indication matching the new coverage criteria (smoldering myeloma, POEMS syndrome, newly diagnosed with specific drug combinations, relapsed/progressive/refractory disease combinations, and systemic light chain amyloidosis); (2) Ensure prior authorization templates reflect new eligible regimens including bortezomib/lenalidomide/dexamethasone combinations and carfilzomib/pomalidomide/dexamethasone combinations; (3) Train providers and clinical staff on appropriate diagnosis code selection since ICD-10 codes are no longer listed in the policy—staff must independently identify and report the correct diagnosis code supporting medical necessity; (4) Update claim submission guidance to remove reference to any ICD-10 codes previously listed in version 08.01.29m. Claims submitted for new indications (smoldering myeloma, POEMS, light chain amyloidosis) without supporting diagnosis codes and clinical documentation will be denied or delayed. Coordinate with providers to ensure documentation of frailty assessment (using IMWG Myeloma Frailty Score Calculator) for patients <80 years old in transplant-deferred scenarios.