CurrentViva HealthPolicy IC-0707

Omisirge (omidubicel-onlv) — Coverage Criteria for Hematopoietic Stem Cell Transplant Indications

Defines prior authorization, coverage criteria, dosing, billing codes, and documentation requirements for Omisirge (omidubicel-onlv) when used for umbilical cord blood transplantation after myeloablative conditioning for high-risk hematologic malignancies and for severe aplastic anemia following reduced intensity conditioning. Applies to Viva Health members and providers requesting prior authorization.

Policy Summary

PayerViva Health

PolicyOmisirge (omidubicel-onlv) — Coverage Criteria for Hematopoietic Stem Cell Transplant Indications

Policy CodePolicy IC-0707

Change TypeNo material changes

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for a single treatment course (one dose); renewals are not allowed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1maximum doses authorized

≥12×10^8minimum total live cells

≥12 / ≥6minimum ages (malignancy / SAA)

J3590 / C9399billing codes listed

73441-0800-xxlisted NDC

Policy Summary

PayerViva Health

PolicyOmisirge (omidubicel-onlv) — Coverage Criteria for Hematopoietic Stem Cell Transplant Indications

Policy CodePolicy IC-0707

Change TypeNo material changes

Effective Date

Next Review DateMay 5, 2026

Key ActionObtain prior authorization for a single treatment course (one dose); renewals are not allowed.

SourceLink

On This Page

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Coverage Criteria

UCBT after myeloablative conditioning

Covered when ALL of the following are met for UCBT after myeloablative conditioning:

UCBT for hematologic malignancy criteria: Member is at least 12 years of age; member is eligible for allogeneic hematopoietic stem cell transplant and has not received a prior allo‑HSCT; member has a diagnosis of a high‑risk hematologic malignancy and is planned for an umbilical cord blood transplantation (UCBT) following myeloablative conditioning; therapy is intended to reduce time to neutrophil recovery and incidence of infection; member has no readily available matched related donor (MRD), matched unrelated donor (MUD), mismatched (7/8 matched) unrelated donor (MMUD), or haploidentical related donor; member does not have any FDA‑labeled contraindications to the requested agent; member will receive prophylactic and supportive therapies for prevention or treatment of transplant complications according to institutional guidelinesage >= 12

Documentation of diagnosis, donor search results, and transplant plan required

Severe aplastic anemia following reduced intensity conditioning

Covered when ALL of the following are met for severe aplastic anemia (SAA) after reduced intensity conditioning:

SAA criteria: Member is at least 6 years of age; member has a diagnosis of severe aplastic anemia (SAA) with severe neutropenia (ANC < 1000 cells/µL) following reduced intensity conditioning; member has tried and failed or is intolerant to standard immunosuppressive therapy; member has an ECOG performance status ≤ 1; member has no readily available HLA identical (12/12) matched related or unrelated donor; member does not have any FDA‑labeled contraindications to the requested agent; member will receive prophylactic and supportive therapies according to institutional guidelinesage >= 6; ANC < 1000; ECOG <= 1

Documentation of prior therapy failure/intolerance, ANC, ECOG, and donor search results required

Coverage for Omisirge (omidubicel-onlv) is limited to members who do not have a readily available alternative donor. Specifically, members with a readily available HLA-matched related or unrelated donor (12/12), a matched unrelated donor (MUD), a mismatched 7/8 unrelated donor (MMUD), or a haploidentical related donor are excluded from coverage when such donors are available. Documentation of donor search results and the absence of a readily available alternative donor must be provided with the authorization request.

Prior authorization is required and will be issued for a single treatment course consisting of one dose of Omisirge. Renewal requests are not allowed and continued therapy beyond the authorized single dose is not covered. Authorization validity must comply with the initial length of authorization and renewal criteria described in the policy, and required supporting clinical documentation must be submitted with the initial request.

Coding and Billing

HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals (Hospital Outpatient Use ONLY)

NDCNDC

73441-0800-xx

Omisirge single-use cryopreserved cell fractions (NDC)

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D61.9	Aplastic anemia, unspecified
Z94.81	Bone marrow transplant status

Cell counts per dose

Minimum total live cells per single doseSingle-use culture containing at least 12 × 10^8 live cells total

Cultured Fraction (CF) minimumAt least 8.0 × 10^8 total viable cells (≥8.7% CD34+; at least 9.2 × 10^7 CD34+ cells)

Non‑cultured Fraction (NF) minimumAt least 4.0 × 10^8 total viable cells with a minimum of 2.4 × 10^7 CD3+ cells

Provider Actions and Requirements

Prior Authorization

Prior Authorization Validity

Prior authorization is required and, when approved, is valid for a single treatment course (one dose). Renewals of prior authorization for additional doses or courses are not permitted.

Initial approval: single treatment course (1 dose)
Renewal: not allowed

Documentation Required

Documentation Submission Required

Submission of supporting clinical documentation (including but not limited to medical records, chart notes, laboratory results, and confirmatory diagnostics) is REQUIRED on all authorization requests. Records will be reviewed at the time of submission to establish medical necessity. Provide documentation addressing diagnosis, step therapy, and relevant clinical markers (e.g., genetic and mutational testing) when applicable. Upload documentation via the PA web portal or fax. Failure to submit required records may result in denial.

Required documents: medical records, chart notes, labs, confirmatory diagnostics
Failure to submit may result in denial due to inability to establish medical necessity

Documentation Required

Administration and Identity Verification

Administration must occur at qualified centers with hematopoietic stem cell transplant expertise and under the supervision of a physician experienced in treating hematologic malignancies or severe aplastic anemia. Verify the member's identity upon receipt, prior to thaw, and prior to infusion. Thawing should occur immediately prior to use and follow product-specific handling (two infusion solution bags; begin NF infusion within 1 hour after CF infusion completion). Do NOT use a leukodepleting filter.

Verify identity: upon receipt, prior to thaw, prior to infusion
Thaw immediately prior to use; infusion sequence and timing per prescribing information
Administration setting: centers with hematopoietic stem cell transplant expertise; physician experienced in hematologic malignancies or SAA
Do NOT use leukodepleting filter

Step Therapy

SAA Step Therapy Requirement

For severe aplastic anemia (SAA) indications, members must have tried and failed standard immunosuppressive therapy or have documented intolerance to it before authorization will be granted.

Applies to SAA: trial and failure or intolerance to standard immunosuppressive therapy required
Member must meet other eligibility criteria (e.g., age, ECOG, donor availability) as specified in policy

Candidate Selection and Eligibility

Candidate selection

Candidate eligibility criteria are indication‑specific and must be documented.

Allo‑HSCT candidate for Omisirge (hematologic malignancy): Eligible for allogeneic hematopoietic stem cell transplant; no prior allo‑HSCT for the hematologic malignancy indication; planned umbilical cord blood transplantation (UCBT) following myeloablative conditioning; no readily available MRD/MUD/MMUD/haploidentical related donor; age ≥ 12 yearsage >= 12

Document transplant eligibility and donor search results

SAA candidate for Omisirge: Diagnosis of severe aplastic anemia with severe neutropenia (ANC < 1000 cells/µL) following reduced intensity conditioning; has tried and failed or is intolerant to standard immunosuppressive therapy; ECOG performance status ≤ 1; no readily available HLA identical (12/12) matched related or unrelated donor; age ≥ 6 yearsage >= 6; ANC < 1000; ECOG <= 1

Document prior therapies, evidence of failure/intolerance, ANC, ECOG, and donor availability

Evaluation Requirements

Documentation Required

Evaluation documentation required prior to approval

Provide documentation of the diagnosis, transplant eligibility and plan, donor search results, prior therapies for SAA, absolute neutrophil count (ANC), ECOG performance status, and the planned conditioning regimen as part of the authorization request.

Diagnosis and indication (hematologic malignancy or SAA)
Transplant eligibility and planned conditioning (myeloablative or reduced intensity)
Donor search results (availability of MRD/MUD/MMUD/haplo donors)
Prior therapies for SAA (evidence of failure or intolerance to standard immunosuppression)
ANC value and ECOG score

Center and Administration Requirements

Note

Administer only at transplant centers with HSCT expertise and experienced physicians

Omisirge must be administered at centers with hematopoietic stem cell transplant expertise and under the supervision of physicians experienced in transplant care; thawing and infusion procedures require specialized handling.

Administration and thawing should occur at centers with HSCT expertise.
Supervision by physicians experienced in hematologic malignancies or SAA is required.
Thaw immediately prior to use and follow prescribed infusion timing for CF and NF.

Definitions

Umbilical cord blood transplantation (UCBT)

Short nameUCBT (Umbilical cord blood transplantation)

DefinitionTransplantation using hematopoietic stem cells derived from umbilical cord blood; used here following myeloablative conditioning to reduce time to neutrophil recovery and incidence of infection

Typical indication in policyPlanned for high‑risk hematologic malignancies when no readily available matched related or unrelated donor exists

Allogeneic hematopoietic stem cell transplant (Allo‑HSCT)

Short nameAllo‑HSCT (Allogeneic hematopoietic stem cell transplant)

DefinitionHematopoietic stem cell transplantation using donor (allogeneic) stem cells; member must be eligible for allo‑HSCT and not have received a prior allo‑HSCT for the hematologic malignancy indication

Context in policyAllo‑HSCT is the transplant setting for which Omisirge (UCBT) is considered when alternative matched donors are not readily available

OpenPayer

Omisirge (omidubicel-onlv) — Coverage Criteria for Hematopoietic Stem Cell Transplant Indications

Coverage Criteria

Coding and Billing

Provider Actions and Requirements

Candidate Selection and Eligibility

Evaluation Requirements

Center and Administration Requirements

Post-Transplant Coverage

Contraindications

Definitions

Background