ModifiedCignaPolicy IP0817

Omisirge

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This policy governs prior authorization and medical-necessity coverage for Omisirge (omidubicel-onlv) intravenous infusion for umbilical cord blood transplantation in hematologic malignancy or treatment of severe aplastic anemia.

Policy Summary

PayerCigna

PolicyOmisirge

Policy CodePolicy IP0817

Change TypeModified

Effective DateNov 1, 2026

Last ReviewNov 1, 2026

Next Review DateNot specified

Key ActionObtain prior authorization and document that the patient meets the applicable indication criteria for one intravenous dose.

SourceLink

POLICY UPDATE CHANGES

HCPCS code J3406 was added for Omisirge, effective October 1, 2026.

The descriptions for HCPCS codes C9399, J3490, and J3590 were updated to state that the codes are effective through September 30, 2026.

The revision details state that no coverage criteria changes were made.

1 doseApproval quantity

6 monthsApproval duration

2Covered indications

3Covered CPT codes

4Covered HCPCS codes

Coverage Criteria

FDA-Approved Indications

Omisirge is considered medically necessary when ONE of the following FDA-approved indications is met. For either indication, approve one dose.

ONE of

Umbilical Cord Blood Transplantation
Aplastic Anemia

Umbilical Cord Blood Transplantation

Approve one dose if the patient meets ALL of the following criteria:

ALL of

Patient is ≥ 12 years of age.
Patient has a hematologic malignancy.
Examples include acute myelogenous leukemia, acute lymphoblastic leukemia, and chronic myeloid leukemia.
Omisirge is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.
Omisirge is given as a single dose by intravenous infusion.
Omisirge is provided in two separate bags containing the two cryopreserved cell fractions: the cultured fraction and the non-cultured fraction.

Aplastic Anemia

Approve one dose if the patient meets ALL of the following criteria:

ALL of

Patient is ≥ 6 years of age.
Patient has undergone reduced intensity conditioning treatment.
ONE of
- Patient has tried at least one immunosuppressant therapy.
  Examples include cyclosporine, Atgam (lymphocyte immune globulin, anti-thymocyte globulin [equine] sterile solution for intravenous use only), mycophenolate mofetil, or sirolimus.
- Patient has an intolerance to immunosuppressant therapy.
Omisirge is prescribed by or in consultation with a hematologist.
Omisirge is given as a single dose by intravenous infusion.
Omisirge is provided in two separate bags containing the two cryopreserved cell fractions: the cultured fraction and the non-cultured fraction.

Omisirge for uses other than the FDA-approved indications listed above is not medically necessary.

Use outside the covered umbilical cord blood transplantation and aplastic anemia indications is not covered.

Use that does not meet the specified criteria for a covered indication is not medically necessary.

Any other use of Omisirge is considered not medically necessary.

Billing and Coding

Medically Necessary CPT CodesCPTCovered

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition.
38208	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

Medically Necessary HCPCS CodesHCPCSCovered

C9399	Unclassified drugs or biologicals (Code effective until 09/30/2026).
J3406	Injection, omidubicel-onlv, per therapeutic dose (Code effective 10/1/2026).
J3490	Unclassified drugs (Code effective until 09/30/2026).
J3590	Unclassified biologics (Code effective until 09/30/2026).

Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omisirge. Approvals are limited to one dose, with a six-month approval duration to allow time to prepare and administer therapy.

One dose per approval
Approval duration: 6 months

Documentation Required

Confirm Indication and Specialist Involvement

Confirm the covered indication and document that Omisirge is prescribed by or in consultation with an applicable specialist.

Umbilical cord blood transplantation: hematologist, oncologist, transplant specialist physician, or physician associated with a transplant center
Aplastic anemia: hematologist

Documentation Required

Document Immunosuppressant Therapy History

For aplastic anemia, document that the patient has tried at least one immunosuppressant therapy.

Examples include cyclosporine, Atgam (equine anti-thymocyte globulin), mycophenolate mofetil, or sirolimus

Documentation Required

Document Prior Therapy or Intolerance

For aplastic anemia, document the applicable alternative pathway when the patient has an intolerance to immunosuppressant therapy rather than a documented treatment trial.

Document intolerance to immunosuppressant therapy

Documentation Required

Document Umbilical Cord Blood Transplantation Criteria

For umbilical cord blood transplantation, submit documentation of the diagnosis, age, and required specialist involvement.

Patient is ≥ 12 years of age
Patient has a hematologic malignancy
Prescription or consultation by a hematologist, oncologist, transplant specialist physician, or physician associated with a transplant center

Documentation Required

Document Aplastic Anemia Treatment History

For aplastic anemia, submit documentation of prior immunosuppressant treatment or intolerance, as applicable.

Patient is ≥ 6 years of age
Document at least one prior immunosuppressant therapy or intolerance to immunosuppressant therapy

Documentation Required

Umbilical Cord Blood Transplantation Documentation

For umbilical cord blood transplantation, document that the patient meets the age and malignancy requirements and that a qualified specialist is prescribing or consulting.

Age ≥ 12 years
Hematologic malignancy, such as acute myelogenous leukemia, acute lymphoblastic leukemia, or chronic myeloid leukemia
Qualified specialist or transplant-center physician involvement

Documentation Required

Aplastic Anemia Documentation

For aplastic anemia, document the diagnosis, age, conditioning treatment, immunosuppressant treatment history or intolerance, and hematologist involvement.

Age ≥ 6 years
Reduced intensity conditioning treatment completed
At least one immunosuppressant therapy tried or intolerance documented
Prescribed by or in consultation with a hematologist

Unsupported block type: billing_rule

Denial Risk

Unlisted Use Is Not Medically Necessary

Omisirge for any use other than the covered indications is considered not medically necessary.

Covered indications are umbilical cord blood transplantation and aplastic anemia

Denial Risk

Failure to Meet Criteria

Requests are subject to denial when the applicable indication-specific requirements are not met, including required diagnosis, age, treatment history, conditioning, or specialist involvement.

Coverage requires meeting all criteria for the selected indication

Prior Authorization

Nonstandard Dosing Requires Review

Doses outside the single-dose regimen established in this policy require case-by-case review by a clinician, such as a Medical Director or Pharmacist.

Standard approval is for one dose
Nonstandard dosing is not automatically approved

Denial Risk

Noncovered Indication

Uses outside the two covered indications are not medically necessary under this policy.

Covered indications: umbilical cord blood transplantation and aplastic anemia

Denial Risk

Document All Required Criteria

Requests may be denied when documentation does not establish the required age, diagnosis, reduced intensity conditioning where applicable, immunosuppressant treatment or intolerance where applicable, or qualified specialist involvement.

Umbilical cord blood transplantation requires age ≥ 12 years, hematologic malignancy, and qualified specialist or transplant-center involvement
Aplastic anemia requires age ≥ 6 years, reduced intensity conditioning, prior immunosuppressant therapy or intolerance, and hematologist involvement

Clinical Background

Omisirge is a nicotinamide-modified allogeneic hematopoietic progenitor cell therapy derived from umbilical cord blood. It is used for patients with hematologic malignancies undergoing umbilical cord blood transplantation after myeloablative conditioning and for patients with severe aplastic anemia after reduced-intensity conditioning. In the transplantation setting, Omisirge is intended to reduce time to neutrophil recovery and the incidence of infection.

Definitions and Product Details

Aplastic anemia

DefinitionAplastic anemia is a rare and heterogeneous disease defined by pancytopenia with a hypocellular bone marrow, without abnormal infiltrate or marrow fibrosis.

Diagnostic requirementDiagnosis requires at least two of the following: hemoglobin concentration below 100 g/L, platelet count below 50 x 10^9/L, or neutrophil count below 1.5 x 10^9/L.

Severe aplastic anemia

Marrow cellularityBelow 25%; alternatively, 25% to 50% with less than 30% residual hematopoietic cells.

Required cytopeniasAt least two of the following: neutrophil count below 0.5 x 10^9/L, platelet count below 20 x 10^9/L, or reticulocyte count below 60 x 10^9/L.

Severity definitionSevere aplastic anemia requires the specified marrow findings plus at least two of the three listed blood-count thresholds.

Omisirge administration

DoseOne single dose of Omisirge.

RouteAdministered by intravenous infusion.

Administration formatThe dose is supplied in two separate bags containing the two cryopreserved cell fractions.

Omisirge product fractions

Cultured fractionA cryopreserved cultured cell fraction.

Non-cultured fractionA cryopreserved non-cultured cell fraction.

PackagingThe cultured and non-cultured cryopreserved cell fractions are provided in two separate bags.

Policy Summary

PayerCigna

PolicyOmisirge

Policy CodePolicy IP0817

Change TypeModified

Effective DateNov 1, 2026

Last ReviewNov 1, 2026

Next Review DateNot specified

Key ActionObtain prior authorization and document that the patient meets the applicable indication criteria for one intravenous dose.

SourceLink

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Omisirge

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Coverage Criteria

FDA-Approved Indications

Omisirge is considered medically necessary when ONE of the following FDA-approved indications is met. For either indication, approve one dose.

ONE of

Umbilical Cord Blood Transplantation
Aplastic Anemia

Umbilical Cord Blood Transplantation

Approve one dose if the patient meets ALL of the following criteria:

ALL of

Patient is ≥ 12 years of age.
Patient has a hematologic malignancy.
Examples include acute myelogenous leukemia, acute lymphoblastic leukemia, and chronic myeloid leukemia.
Omisirge is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.
Omisirge is given as a single dose by intravenous infusion.
Omisirge is provided in two separate bags containing the two cryopreserved cell fractions: the cultured fraction and the non-cultured fraction.

Aplastic Anemia

Approve one dose if the patient meets ALL of the following criteria:

ALL of

Patient is ≥ 6 years of age.
Patient has undergone reduced intensity conditioning treatment.
ONE of
- Patient has tried at least one immunosuppressant therapy.
  Examples include cyclosporine, Atgam (lymphocyte immune globulin, anti-thymocyte globulin [equine] sterile solution for intravenous use only), mycophenolate mofetil, or sirolimus.
- Patient has an intolerance to immunosuppressant therapy.
Omisirge is prescribed by or in consultation with a hematologist.
Omisirge is given as a single dose by intravenous infusion.
Omisirge is provided in two separate bags containing the two cryopreserved cell fractions: the cultured fraction and the non-cultured fraction.

Omisirge for uses other than the FDA-approved indications listed above is not medically necessary.

Use outside the covered umbilical cord blood transplantation and aplastic anemia indications is not covered.

Use that does not meet the specified criteria for a covered indication is not medically necessary.

Any other use of Omisirge is considered not medically necessary.

Billing and Coding

Medically Necessary CPT CodesCPTCovered

38204	Management of recipient hematopoietic progenitor cell donor search and cell acquisition.
38208	Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing, per donor.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor

Medically Necessary HCPCS CodesHCPCSCovered

C9399	Unclassified drugs or biologicals (Code effective until 09/30/2026).
J3406	Injection, omidubicel-onlv, per therapeutic dose (Code effective 10/1/2026).
J3490	Unclassified drugs (Code effective until 09/30/2026).
J3590	Unclassified biologics (Code effective until 09/30/2026).

Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omisirge. Approvals are limited to one dose, with a six-month approval duration to allow time to prepare and administer therapy.

One dose per approval
Approval duration: 6 months

Documentation Required

Confirm Indication and Specialist Involvement

Confirm the covered indication and document that Omisirge is prescribed by or in consultation with an applicable specialist.

Umbilical cord blood transplantation: hematologist, oncologist, transplant specialist physician, or physician associated with a transplant center
Aplastic anemia: hematologist

Documentation Required

Document Immunosuppressant Therapy History

For aplastic anemia, document that the patient has tried at least one immunosuppressant therapy.

Examples include cyclosporine, Atgam (equine anti-thymocyte globulin), mycophenolate mofetil, or sirolimus

Documentation Required

Document Prior Therapy or Intolerance

For aplastic anemia, document the applicable alternative pathway when the patient has an intolerance to immunosuppressant therapy rather than a documented treatment trial.

Document intolerance to immunosuppressant therapy

Documentation Required

Document Umbilical Cord Blood Transplantation Criteria

For umbilical cord blood transplantation, submit documentation of the diagnosis, age, and required specialist involvement.

Patient is ≥ 12 years of age
Patient has a hematologic malignancy
Prescription or consultation by a hematologist, oncologist, transplant specialist physician, or physician associated with a transplant center

Documentation Required

Document Aplastic Anemia Treatment History

For aplastic anemia, submit documentation of prior immunosuppressant treatment or intolerance, as applicable.

Patient is ≥ 6 years of age
Document at least one prior immunosuppressant therapy or intolerance to immunosuppressant therapy

Documentation Required

Umbilical Cord Blood Transplantation Documentation

For umbilical cord blood transplantation, document that the patient meets the age and malignancy requirements and that a qualified specialist is prescribing or consulting.

Age ≥ 12 years
Hematologic malignancy, such as acute myelogenous leukemia, acute lymphoblastic leukemia, or chronic myeloid leukemia
Qualified specialist or transplant-center physician involvement

Documentation Required

Aplastic Anemia Documentation

For aplastic anemia, document the diagnosis, age, conditioning treatment, immunosuppressant treatment history or intolerance, and hematologist involvement.

Age ≥ 6 years
Reduced intensity conditioning treatment completed
At least one immunosuppressant therapy tried or intolerance documented
Prescribed by or in consultation with a hematologist

Unsupported block type: billing_rule

Denial Risk

Unlisted Use Is Not Medically Necessary

Omisirge for any use other than the covered indications is considered not medically necessary.

Covered indications are umbilical cord blood transplantation and aplastic anemia

Denial Risk

Failure to Meet Criteria

Requests are subject to denial when the applicable indication-specific requirements are not met, including required diagnosis, age, treatment history, conditioning, or specialist involvement.

Coverage requires meeting all criteria for the selected indication

Prior Authorization

Nonstandard Dosing Requires Review

Doses outside the single-dose regimen established in this policy require case-by-case review by a clinician, such as a Medical Director or Pharmacist.

Standard approval is for one dose
Nonstandard dosing is not automatically approved

Denial Risk

Noncovered Indication

Uses outside the two covered indications are not medically necessary under this policy.

Covered indications: umbilical cord blood transplantation and aplastic anemia

Denial Risk

Document All Required Criteria

Umbilical cord blood transplantation requires age ≥ 12 years, hematologic malignancy, and qualified specialist or transplant-center involvement
Aplastic anemia requires age ≥ 6 years, reduced intensity conditioning, prior immunosuppressant therapy or intolerance, and hematologist involvement

Clinical Background

Definitions and Product Details

Aplastic anemia

DefinitionAplastic anemia is a rare and heterogeneous disease defined by pancytopenia with a hypocellular bone marrow, without abnormal infiltrate or marrow fibrosis.

Diagnostic requirementDiagnosis requires at least two of the following: hemoglobin concentration below 100 g/L, platelet count below 50 x 10^9/L, or neutrophil count below 1.5 x 10^9/L.

Severe aplastic anemia

Marrow cellularityBelow 25%; alternatively, 25% to 50% with less than 30% residual hematopoietic cells.

Required cytopeniasAt least two of the following: neutrophil count below 0.5 x 10^9/L, platelet count below 20 x 10^9/L, or reticulocyte count below 60 x 10^9/L.

Severity definitionSevere aplastic anemia requires the specified marrow findings plus at least two of the three listed blood-count thresholds.

Omisirge administration

DoseOne single dose of Omisirge.

RouteAdministered by intravenous infusion.

Administration formatThe dose is supplied in two separate bags containing the two cryopreserved cell fractions.

Omisirge product fractions

Cultured fractionA cryopreserved cultured cell fraction.

Non-cultured fractionA cryopreserved non-cultured cell fraction.

PackagingThe cultured and non-cultured cryopreserved cell fractions are provided in two separate bags.