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
- Clinical documentation demonstrating the diagnosis and medical necessity for the requested therapy.
- Documentation that proposed drug dose, frequency, and duration align with at least one authoritative source (e.g., FDA labeling, MCG, DrugDex (IIa+), NCCN).
- References or citations to supporting authoritative sources (FDA labeling, major drug compendia, peer-reviewed literature, or professional guidelines).
- Citation(s)/copies of one or more standard medical reference compendia entry(ies) recognizing the off‑label use, if coverage is claimed on that basis.
Key Coverage Criteria
- Medically necessary for initial therapy of aHUS when: documentation ruling out STEC-HUS and TTP; diagnosis with signs of aHUS; treatment-naïve; FDA-labeled dosing for aHUS; prescribed by hematologist/nephrologist; initial authorization up to 12 months. Continuation requires positive clinical response and dosing per FDA labeling, with reauthorization up to 12 months.
- Covered when hospital outpatient facility infusion services for specialty medications and IVIG/SCIG therapy are considered medically necessary and the member meets the specific clinical criteria described in the policy.
- Therapies are covered when proven effective for the relevant diagnosis according to generally accepted standards of practice.
- Drug therapy is covered when the proposed dose, frequency, and duration are consistent with recommendations in at least one authoritative source (e.g., FDA labeling, MCG, DrugDex, NCCN).
- Coverage of any FDA‑approved drug when prescribed for a use recognized as safe and effective in one or more standard medical reference compendia adopted by the U.S. Department of Health and Human Services.
- Coverage of an off‑label FDA‑approved drug use when safety and efficacy are supported by at least two articles from major peer‑reviewed professional medical journals presenting data that the off‑label use is generally safe and effective.
10 Active Policies
UHC-POL-complement-inhibitors, Complement C5 Inhibitors
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
RX501.176, Crovalimab-akkz
BCBSIL-RX501.176, Crovalimab-akkz
BCBSMT-RX501.176, Crovalimab-akkz
Related Codes
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