J1307 — Injection, crovalimab-akkz, 10 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Dosing documentation: evidence that the requested product is being prescribed and dosed according to US FDA labeled dosing for the specific indication.
- For Medicare reviews: policy notes to refer to CMS section and applicable LCDs/LCAs for label and off-label uses; 'Preferred therapy criteria is not applicable for Medicare Advantage members.'
- PNH initial therapy: flow cytometry analysis confirming presence of PNH clones; laboratory results, signs and/or symptoms attributed to PNH (examples provided: abdominal pain, anemia, dyspnea, fatigue, unusual thrombosis, hemolysis/hemoglobinuria, kidney disease, pulmonary hypertension); documentation that dosing follows US FDA labeled dosing for PNH.
- General: submission of medical records (chart notes, laboratory values, test results) to support diagnosis and requested indication; prescriber specialty note or documentation of consultation with required specialist (hematologist, nephrologist, neurologist, or oncologist as specified by indication).
Key Coverage Criteria
- Atypical hemolytic uremic syndrome (aHUS) – Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz) when criteria are met
- Paroxysmal nocturnal hemoglobinuria (PNH) – Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), PiaSky (crovalimab-akkz), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz) when criteria are met (PiaSky limited to patients ≥13 years and ≥40 kg per FDA labeling)
- Generalized myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AChR) antibody positive – Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz) when criteria are met
- Neuromyelitis optica spectrum disorder (NMOSD) in anti-aquaporin-4 (AQP4) antibody positive patients – Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh), Soliris (eculizumab), Ultomiris (ravulizumab-cwvz) when criteria are met
- Authorization of hospital outpatient facility infusion services (place of service codes 19 and 22) for specialty medications and IVIG/SCIG when outpatient hospital facility-based administration is medically necessary and the member meets at least one of the criteria below.
- Patient is medically unstable and is at risk of requiring medical services and equipment available only in an outpatient hospital setting (e.g., endotracheal tube, chest tube insertion equipment, cricothyroidotomy set, mechanical ventilator) during administration of the requested drug.
10 Active Policies
UHC-POL-complement-inhibitors — Complement Inhibitors
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-complement-inhibitors — Complement Inhibitors
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-complement-inhibitors
Related Codes
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