J0638, Injection, canakinumab, 1 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 therapy is effective for the relevant diagnosis or procedure.
- For drug therapy, documentation of proposed dose, frequency, and duration and citation showing consistency with at least one authoritative source.
- Supporting references such as FDA-approved labeling, major drug compendia (e.g., DrugDex), MCG care guidelines, NCCN guidelines/compendia, or peer-reviewed literature to justify coverage.
- Provide citation(s) showing the off-label use is listed in one or more HHS-adopted standard medical reference compendia.
Key Coverage Criteria
- Not proven or medically necessary for cardiovascular disease.
- 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.
- Therapy is covered when it is proven effective for the relevant diagnosis or procedure based on generally accepted standards of practice.
- Drug therapy is covered when proposed dose, frequency, and duration are consistent with recommendations in at least one authoritative source.
- Coverage for services and supplies is determined by the member's benefit plan, summary plan description, or contract; consult the plan to determine if a service is covered.
- 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, even if the FDA has not approved the drug for that indication.
14 Active Policies
UHC-POL-ilaris-canakinumab, Ilaris (Canakinumab)
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
RX501.119, Canakinumab
BCBSIL-RX501.119, Canakinumab
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
Related Codes
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