Sutimlimab-jome (Enjaymo) — CPB 1006 | AETNA Coverage Update

Aetna modified CPB 1006 for sutimlimab-jome (Enjaymo), effective December 4, 2025. Here's what billing teams need to know.

Aetna, a CVS Health company, updated its sutimlimab-jome coverage policy under CPB 1006 Aetna system. This policy governs HCPCS J1302 (injection, sutimlimab-jome, 10 mg) for cold agglutinin disease (CAD). The update tightens the diagnostic criteria required to establish medical necessity before your precertification request goes anywhere. If you bill J1302 for infusion patients, this change affects your prior authorization documentation starting December 4, 2025.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Sutimlimab-jome (Enjaymo) — CPB 1006
Policy Code	CPB 1006
Change Type	Modified
Effective Date	December 4, 2025
Impact Level	High
Specialties Affected	Hematology, Infusion Therapy, Oncology
Key Action	Update your prior auth packets to include all five diagnostic lab criteria before submitting precertification for J1302

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Aetna Sutimlimab-jome Coverage Criteria and Medical Necessity Requirements 2025

The Aetna sutimlimab-jome coverage policy under CPB 1006 sets a high bar for initial approval. Aetna requires that your patient meet every single one of five diagnostic criteria — not most of them, all of them. If even one lab value is missing from your prior authorization submission, expect a denial.

Here's what Aetna requires to establish medical necessity for initial approval. The patient must have a confirmed primary CAD diagnosis supported by the following:

Hemolysis must be documented with two lab values:

#	Covered Indication Copy
1	Lactate dehydrogenase (LDH) — CPT 83615 or 83625 — above the upper limit of normal
2	Haptoglobin — CPT 83010 or 83012 — below the lower limit of normal

Immunologic testing must show:

#	Covered Indication Copy
1	Positive polyspecific direct antiglobulin test (DAT) — CPT 86880
2	Monospecific DAT strongly positive for C3d — CPT 86880
3	DAT for IgG of 1+ or less — CPT 86880

Cold agglutinin titer must meet the threshold:

#	Covered Indication Copy
1	Cold agglutinin titer of 1:64 or higher measured at 4°C — CPT 86157

That's five distinct requirements. All five must be documented. "Consistent with CAD" in a clinical note is not enough. Aetna wants the lab values, and your precertification packet needs to show them.

The policy also requires that secondary CAD has been ruled out. Secondary CAD — cold agglutinin syndrome caused by infection, rheumatologic disease, or active hematologic malignancy — is not a covered indication. Your submitting physician needs to explicitly document that these causes have been excluded.

Precertification is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal. Do not submit J1302 claims without precertification in place.

Also flag the site of care requirement. Aetna's Site of Care Utilization Management Policy applies to sutimlimab-jome infusions. This is the same pattern Aetna uses for other high-cost specialty drug infusions — they want infusions in lower-cost settings where clinically appropriate. Review your site-of-service setup before December 4, 2025, or your reimbursement will be at risk even if the drug itself is authorized.

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Aetna Sutimlimab-jome Exclusions and Non-Covered Indications

Aetna is explicit here: all indications outside primary CAD are experimental, investigational, or unproven. Full stop.

If your patient has secondary cold agglutinin syndrome — whether triggered by infection, a rheumatologic condition like lupus or Sjögren's, or an active hematologic malignancy — sutimlimab-jome is not covered under this policy. The clinical distinction between primary and secondary CAD is the entire hinge point of this coverage policy.

Billing J1302 for secondary CAD will result in claim denial. Make sure your documentation explicitly supports primary CAD and excludes secondary causes before any authorization request goes out.

For autoimmune hemolytic anemia managed with rituximab, Aetna's related policy is CPB 0314. These are two separate coverage determinations. Don't conflate them.

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Coverage Indications at a Glance

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Aetna Sutimlimab-jome Billing Guidelines and Action Items 2025

The effective date is December 4, 2025. Here's what your billing and revenue cycle team needs to do before that date — and after.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Sutimlimab-jome Under CPB 1006

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J1302	HCPCS	Injection, sutimlimab-jome, 10 mg

CPT Codes Related to CPB 1006

These codes support diagnosis, monitoring, and infusion administration for sutimlimab-jome billing.

Key ICD-10-CM Diagnosis Code

Code	Description Copy
D59.12	Cold autoimmune hemolytic anemia

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A practical note on the lab codes: CPT 83615 (LDH) and CPT 83010 (haptoglobin quantitative) are the two you'll most often need to reference in prior authorization documentation. Make sure these results are dated within a clinically reasonable window relative to the authorization request. Stale labs are a common reason Aetna's precertification reviewers push back on CAD requests.

The cold agglutinin titer code — CPT 86157 — is specific to titer measurement. CPT 86156 is a screen only. If you need to document the 1:64 threshold for Aetna's criteria, you need 86157, not 86156.

The infusion administration codes (96365–96368 for standard IV infusion, 96413–96417 for chemotherapy administration) reflect the dual-classification nature of sutimlimab-jome infusions in practice. Confirm with your clinical team which code set applies to your setting and your payer contract terms.

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