J1302, Injection, sutimlimab-jome, 10 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Documentation Required
- Evidence that the therapy is effective for the diagnosis (peer‑reviewed literature, professional society guidelines, or major compendia).
- For drug therapy, documentation of proposed dose, frequency, and duration consistent with at least one authoritative source (e.g., FDA labeling or major compendia).
- Supporting references may include MCG care guidelines, DrugDex (IIa+), NCCN Guidelines/Compendia (IIb+), professional society guidelines, CMS coverage policy, and/or FDA‑approved labeling.
- Follow documentation and coverage criteria specified in the applicable separate HCSC Medical Policy for the off-label use.
- If no separate HCSC Medical Policy exists for an off-label drug, follow the documentation and review process outlined in RX503.001.
- Peer-reviewed, well-designed controlled studies demonstrating device efficacy and improved health outcomes are required for HCSC to recognize coverage of FDA-approved devices.
Key Coverage Criteria
- Enjaymo is medically necessary for the treatment of CAD in patients who meet all of the following criteria: For initial therapy, all of the following: Diagnosis of CAD by a hematologist; confirmation of CAD with chronic hemolysis, DAT results including C3d, IgG DAT ≤1+, cold agglutinin titer ≥64 at 4°C; ruled out secondary causes; baseline Hb ≤10 g/dL; prescribed by a hematologist; dosing per FDA labeling; not on certain complement inhibitors; initial authorization ≤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.
- Therapy is medically necessary and covered only when proven effective for the relevant diagnosis per current peer‑reviewed literature and 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.
- Off-label use of equipment, drugs, devices, and supplies may be eligible for coverage when the specific use is addressed in a separate HCSC Medical Policy.
- For off-label drug uses not addressed by a separate HCSC Medical Policy, coverage determinations follow RX503.001: Off-Label Use of Drugs Without a Medical Policy.
18 Active Policies
UHC-POL-enjaymo, Enjaymo (Sutimlimab-Jome)
UHC-POL-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
ADM1001.028, Inside the U.S. Food and Drug Administration (FDA)
BCBSIL-ADM1001.028, Inside the U.S. Food and Drug Administration (FDA)
BCBSIL-ADM1001.034, Specialty Medication Administration Site of Care
BCBSIL-RX501.180, Sutimlimab-jome
BCBSMT-ADM1001.028, Inside the U.S. Food and Drug Administration (FDA)
BCBSMT-ADM1001.034, Specialty Medication Administration Site of Care
BCBSMT-RX501.180, Sutimlimab-jome
BCBSNM-ADM1001.028, Inside the U.S. Food and Drug Administration (FDA)
BCBSNM-ADM1001.034, Specialty Medication Administration Site of Care
BCBSNM-RX501.180, Sutimlimab-jome
BCBSOK-ADM1001.028, Inside the U.S. Food and Drug Administration (FDA)
BCBSOK-ADM1001.034, Specialty Medication Administration Site of Care
BCBSOK-RX501.180, Sutimlimab-jome
UMR-POL-UMR-enjaymo, Enjaymo (Sutimlimab-Jome)
UMR-POL-UMR-provider-administered-drugs-soc, Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-enjaymo, Enjaymo (Sutimlimab-Jome)
Related Codes
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