Sutimlimab-jome (Enjaymo) (CPB 1006, reviewed 2025-12-03)

By 2025-12-03: Billing team must implement the following: (1) Update billing system to require precertification for all claims with HCPCS code J1302 on Aetna commercial plans before claim submission—contact Aetna at (866) 752-7021 or fax (888) 267-3277 for prior authorization; (2) Ensure providers document all required diagnostic criteria in the medical record before submitting claims: confirmed primary CAD diagnosis, evidence of hemolysis (elevated LDH and low haptoglobin), positive polyspecific DAT result, monospecific DAT strongly positive for C3d, cold agglutinin titer ≥1:64 at 4°C, DAT result for IgG ≤1+, and confirmation that secondary CAD has been ruled out; (3) Verify patient has received vaccination against encapsulated bacteria (Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae) at least 2 weeks prior to first Enjaymo dose; (4) For continuation of therapy requests, confirm documentation of positive response (improved hemoglobin, improved hemolysis markers, reduced transfusions) and absence of unacceptable toxicity; (5) Add site-of-care utilization management requirements to pre-authorization process per Aetna's specialty drug infusion policy; (6) Update encounter forms and billing software templates to capture required diagnostic codes (D59.12) and supporting lab codes (82247, 82248, 83010, 83615, 85044, 85045, 86156, 86157, 86880); (7) Flag for claims denial any J1302 claims submitted without completed precertification, required diagnostic documentation, or proper vaccination verification. Failure to obtain prior authorization will result in automatic claim denial.