Omidubicel-onlv (Omisirge) — CPB 1032 | AETNA Coverage Update

Aetna modified CPB 1032 for omidubicel-onlv (Omisirge), effective December 4, 2025. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated its Omisirge coverage policy under CPB 1032 Aetna system. This change defines the specific medical necessity criteria for omidubicel-onlv (Omisirge) in umbilical cord blood transplantation. The primary affected codes include CPT 38240, HCPCS S2142, and infusion codes 96365 and 96366. If your team handles hematology/oncology billing or stem cell transplant billing, this policy directly affects your prior authorization workflow and claim submission.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Omidubicel-onlv (Omisirge) — CPB 1032
Policy Code	CPB 1032
Change Type	Modified
Effective Date	December 4, 2025
Impact Level	High
Specialties Affected	Hematology/Oncology, Bone Marrow Transplant, Stem Cell Transplant Programs
Key Action	Verify all three medical necessity criteria are met and precertification is obtained through NME before administering Omisirge

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Aetna Omidubicel-onlv (Omisirge) Coverage Criteria and Medical Necessity Requirements 2025

The Aetna Omisirge coverage policy under CPB 1032 sets a narrow, three-part medical necessity standard. All three criteria must be met — this is not a checklist where two out of three passes.

The member must:

#	Covered Indication Copy
1	Be 12 years of age or older
2	Have a hematologic malignancy (ICD-10 range C81.00–C96.9, selected D46 codes, or D47.1)
3	Receive myeloablative conditioning before the transplant

The medication must also be used specifically to reduce the time to neutrophil recovery and the incidence of infection. That's the clinical rationale Aetna requires documentation for — not just the diagnosis.

Omidubicel-onlv billing under this policy covers one dose total. There is no continuation of therapy criteria beyond what the dosage and administration guidance specifies. If your team is accustomed to multi-dose biologics with monthly prior authorization renewals, this one works differently. One dose, one authorization request.

Precertification is mandatory. Contact National Medical Excellence (NME) at 877-212-8811 before treatment. This is not a standard prior authorization through a normal PA queue. NME handles complex medical procedures separately from routine prior auth. If your precertification coordinator routes this through a standard channel, expect a denial. Route it correctly from the start.

This coverage policy applies to commercial medical plans only. For Medicare patients receiving Omisirge, Aetna directs you to their Medicare Part B criteria separately. Don't assume this policy covers your Medicare Advantage patients — verify independently.

The reimbursement pathway for Omisirge runs through CPT 38240 (allogeneic HPC transplantation) and HCPCS S2142 (cord blood-derived stem-cell transplantation, allogeneic). Both codes need to appear in your claim alongside the correct ICD-10 diagnosis. An Omisirge claim without S2142 or 38240 will not reflect the full clinical encounter — and a missing code often becomes the basis for a claim denial.

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Aetna Omisirge Exclusions and Non-Covered Indications

Aetna's position here is clear: everything outside the three criteria above is experimental, investigational, or unproven. There are no gray zones in this policy.

If a member is under 12, Omisirge is not covered. If the member's condition is a non-malignant hematologic disorder — even a serious one — coverage does not apply. If the conditioning regimen is reduced-intensity rather than myeloablative, the claim will not meet medical necessity under this policy.

The myeloablative conditioning requirement is where denials will concentrate. Reduced-intensity conditioning (RIC) regimens are common in older or frailer patients who can't tolerate full myeloablation. Aetna's policy explicitly covers only myeloablative conditioning. If your clinical team uses a RIC protocol and someone bills Omisirge under this policy, that claim will be denied. The clinical rationale for the exception doesn't exist under CPB 1032.

Don't assume Aetna will cover off-label use in pediatric patients under 12 through a case-by-case exception process without strong clinical justification documented upfront. The policy language calls it experimental and unproven — not "requires additional documentation."

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Coverage Indications at a Glance

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Aetna Omisirge Billing Guidelines and Action Items 2025

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Omidubicel-onlv (Omisirge) Under CPB 1032

Covered CPT Codes (When Medical Necessity Criteria Are Met)

Covered HCPCS Codes (When Medical Necessity Criteria Are Met)

Code	Type	Description Copy
S2142	HCPCS	Cord blood-derived stem-cell transplantation, allogeneic

Key ICD-10-CM Diagnosis Codes

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A few notes on the ICD-10 coding here. The D46 series covers myelodysplastic syndromes (MDS). The source policy lists D46.0 through D46.9 with a unified group description of "Myelodysplastic syndromes" — use the most specific code the documentation supports, and don't let a coder default to D46.9 when the chart supports a more specific subtype. Specificity matters at claim review.

D47.1 covers chronic myeloproliferative disease. This is a less common path to cord blood transplant, but it's explicitly included. If you see it, make sure the myeloablative conditioning documentation is airtight — this is the kind of diagnosis where a reviewer will scrutinize the conditioning regimen carefully.

The C81.00–C96.9 range covers the full spectrum of lymphomas, leukemias, and related malignancies. When using codes from this range, use the most specific code the documentation supports. Unspecified codes in a claim for a high-cost biologic like Omisirge are an audit flag.

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