CurrentAvMedPolicy Pub. 100-2

Omisirge (omidubicel-onlv) prior authorization — one-time medical (J3590)

This form governs prior authorization and step-edit requirements for Omisirge (omidubicel-onlv) as a one-time, medical (J3590) outpatient product for AvMed members; it applies to prescribers requesting coverage for high-risk hematologic malignancy or severe aplastic anemia when used as part of allogeneic hematopoietic stem cell transplantation.

Policy Summary

PayerAvMed

PolicyOmisirge (omidubicel-onlv) prior authorization — one-time medical (J3590)

Policy CodePolicy Pub. 100-2

Change TypeNo material change noted

Effective Date

Next Review Date

Key ActionObtain prior authorization (one-time approval) for Omisirge billed as J3590 and submit required documentation including prescriber signature, labs, diagnostics, chart notes, and bone marrow biopsy/peripheral blood findings where applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

One-timeauthorization intended (not renewable)

≥12 yrsmin age — hematologic malignancy

≥6 yrsmin age — aplastic anemia

1 kitquantity limit

NDC 73441-0800-04product NDC

Policy Summary

PayerAvMed

PolicyOmisirge (omidubicel-onlv) prior authorization — one-time medical (J3590)

Policy CodePolicy Pub. 100-2

Change TypeNo material change noted

Effective Date

Next Review Date

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria

Initial Therapy — High-Risk Hematologic Malignancy

Covered when ALL of the following are met (one-time authorization):

High-Risk Hematologic Malignancy criteria: Member is 12 years of age or older; provider is a specialist (oncologist and/or transplant specialty); member is eligible for allogeneic hematopoietic stem cell transplant (allo-HSCT) and has NOT received a prior allo-HSCT (documentation of medical treatment history verifying prior lines of therapy and/or pre-transplant debulking therapy must be submitted); diagnosis of high-risk hematologic malignancy planned for umbilical cord blood transplantation (UCBT) following myeloablative conditioning; requested medication will be used to reduce the time to neutrophil recovery and incidence of infection; member will receive prophylactic and supportive therapies for prevention or treatment of transplant complications (e.g., GVHD, infections) per institutional guidelines; member does NOT have a readily available matched related donor (MRD), matched unrelated donor (MUD), mismatched (7/8 matched) unrelated donor (MMUD), or haploidentical donor; member does NOT have a known allergy or hypersensitivity to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine material; member does NOT have a clinically significant active/uncontrolled systemic infection; member does NOT have active/symptomatic central nervous system (CNS) disease; quantity limit = single dose (1 kit) as specified by NDC and cell counts (Omisirge, NDC 73441-0800-04).

All checked items and supporting documentation must be provided for approval.

Initial Therapy — Severe Aplastic Anemia

Covered when ALL of the following are met (one-time authorization):

Severe Aplastic Anemia criteria: Member is 6 years of age or older; provider is a specialist (hematologist and/or transplant specialty); member is eligible for allogeneic hematopoietic stem cell transplant (allo-HSCT) and has NOT received a prior allo-HSCT (documentation of medical treatment history verifying prior lines of therapy and/or pre-transplant debulking therapy must be submitted); diagnosis meets bone marrow biopsy criteria (bone marrow cellularity <25%, or 25–50% cellularity if fewer than 30% of remaining cells are hematopoietic) AND presence of at least TWO of the following peripheral blood findings: ANC <0.5 × 10^9/L (500/µL), platelet count <20 × 10^9/L (20,000/µL), absolute reticulocyte count <20 × 10^9/L (or 60 × 10^9/L using an automated analyzer, or <1% manual count); requested medication will be used to reduce the time to neutrophil recovery and incidence of infection; member will receive prophylactic and supportive therapies for prevention or treatment of transplant complications (e.g., GVHD, infections) per institutional guidelines; member does NOT have a readily available MRD, MUD, MMUD, or haploidentical donor; member does NOT have a known allergy or hypersensitivity to dimethyl sulfoxide (DMSO), dextran 40, gentamicin, human serum albumin, or bovine material; member does NOT have a clinically significant active/uncontrolled systemic infection; member had failure to respond to a 6-month regimen of immunosuppressive therapy with Antithymocyte Globulin (ATG) and Cyclosporine A (CsA), or has a contraindication to same (documentation required); failure to respond to eltrombopag as specified (documentation required); quantity limit = single dose (1 kit) as specified by NDC and cell counts (Omisirge, NDC 73441-0800-04).

All specified laboratory, biopsy, and prior therapy documentation must be submitted.

Coverage for Omisirge (omidubicel-onlv) is limited to a one-time authorization and may NOT be renewed. Approval is issued for a single-dose kit as described in the product specifications; subsequent administrations are not covered.

Requests will be denied if they do not meet all listed criteria for the selected diagnosis. Required elements include, but are not limited to, the applicable minimum member age, documentation of specialist provider status, eligibility for allo‑HSCT with no prior allo‑HSCT, absence of a readily available donor (MRD/MUD/MMUD/haploidentical as applicable), no contraindicated allergies or active uncontrolled systemic infection, fulfillment of specified biopsy/laboratory and prior‑therapy requirements for aplastic anemia, and submission of supporting documentation. All specified checklist items and supporting records must be provided for authorization to be approved.

Coding and Product Specifications

Covered Medical HCPCSHCPCSCovered

J3590

Unclassified biologics (medical billing code used here for Omisirge)

Product NDCNDCCovered

NDC 73441-0800-04

Omisirge kit NDC

inv-07: Cultured fraction total viable cells

Cultured fraction total viable cells>= 8.0 × 10^8 total viable cells

Measure contextPart of Omisirge cultured fraction (CF) within single-dose kit

Associated code/NDCNDC 73441-0800-04

inv-08: Cultured fraction CD34+ percentage

Cultured fraction CD34+ percentage>= 8.7% of cultured fraction cells

Measure contextMinimum percentage of CD34+ cells required in the cultured fraction (CF) of the kit

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Omisirge (omidubicel-onlv) billed as J3590 (Medical). Approval is issued as a one-time authorization only; coverage may NOT be renewed. Incomplete, incorrect, or illegible request information (including missing prescriber signature or required documentation) can delay or result in denial of the authorization. Use of samples to initiate therapy does not meet step edit/preauthorization criteria. Prior therapies may be verified through pharmacy paid claims or submitted chart notes.

Prior authorization required for Omisirge (J3590, Medical)
One-time authorization only (coverage not renewable)
Fax completed and signed request to 1-877-535-1391
For Medicare members: comply with Pub. 100-2, Chapter 15, §50 and any applicable NCDs/LCDs
Samples do not meet preauthorization criteria; prior therapies verified via pharmacy claims or chart notes
Provide NPI/DEA of administering location if applicable

Background

Omisirge (omidubicel-onlv) is an allogeneic cellular product supplied as a single-dose kit containing a cultured fraction and a non‑cultured fraction. The kit is intended as a one-time adjunct for allogeneic hematopoietic stem cell transplantation to reduce time to neutrophil recovery and incidence of infection when used with umbilical cord blood transplantation or in severe aplastic anemia. The kit composition and minimum cell-count thresholds are specified in the coding section and must be met for coverage.

Definitions and Kit Composition

inv-18: Omisirge kit composition

Kit components (summary)Single-dose Omisirge kit containing a cultured fraction and a non-cultured fraction with specified minimum viable cell counts

Cultured fraction specificationMinimum 8.0 × 10^8 total viable cells with ≥8.7% CD34+ cells and ≥9.2 × 10^7 CD34+ cells

Non-cultured fraction specificationMinimum 4.0 × 10^8 total viable cells with ≥2.4 × 10^7 CD3+ cells

Product identifierNDC 73441-0800-04 (one kit, single dose)

Line of Therapy

salvage

Line of therapy: Treatment is given as part of planned allogeneic hematopoietic stem cell transplant using umbilical cord blood (for high-risk hematologic malignancy) or as allo-HSCT for severe aplastic anemia; product is a single-use adjunct to transplantation (not a repeated systemic line of therapy).

Covered Regimens

Regimen	Indication / Key criteria	Quantity limit / Product ID
One-time Omisirge kit administered per institutional transplant protocols
Reduce time to neutrophil recovery and incidence of infection when used with umbilical cord blood transplantation for high‑risk hematologic malignancy or as adjunct to allo‑HSCT for severe aplastic anemia; patient and provider must meet listed authorization criteria (age ≥12 yrs for malignancy, ≥6 yrs for aplastic anemia; specialist prescriber; eligible for allo‑HSCT with no prior allo‑HSCT; no readily available MRD/MUD/MMUD/haploidentical donor; absence of listed allergies, uncontrolled systemic infection, or active CNS disease).
Single dose, 1 kit — NDC 73441-0800-04 (Cultured fraction: ≥8.0 × 10^8 total viable cells with ≥8.7% CD34+ and ≥9.2 × 10^7 CD34+ cells; Non‑cultured fraction: ≥4.0 × 10^8 total viable cells with ≥2.4 × 10^7 CD3+ cells)