ModifiedAmbetter GeorgiaPolicy CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Customize your policy alerts

Sign up for Ambetter Georgia Policy CP.MP.249 alerts

Get alerted when Policy CP.MP.249 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Defines medical necessity criteria for non-Medicare Ambetter Georgia plans for two FDA‑approved allogeneic hematopoietic progenitor cell therapies (Omisirge/omidubicel and RegeneCyte/HPC cord blood) and summarizes background, evidence, and coding implications. Affects providers requesting coverage for these therapies for eligible members/enrollees.

Policy Summary

PayerAmbetter Georgia

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded Omisirge severe aplastic anemia indicationadded RegeneCyte criteriadescription expanded

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization with documentation showing member age, diagnosis, planned transplant type, and preparative regimen matching product-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added medically necessary indication for Omisirge for severe aplastic anemia (patients age ≥ 6 years) following reduced intensity conditioning.

Added Criteria II to include medically necessary criteria for RegeneCyte (unrelated donor HPC cord blood transplantation).

Expanded policy description to include RegeneCyte in addition to Omisirge and removed Omisirge-specific title language.

2therapies covered

≥12

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedAmbetter GeorgiaPolicy CP.MP.249

Allogeneic Hematopoietic Progenitor Cell Therapy

Customize your policy alerts

Sign up for Ambetter Georgia Policy CP.MP.249 alerts

Get alerted when Policy CP.MP.249 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerAmbetter Georgia

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded Omisirge severe aplastic anemia indicationadded RegeneCyte criteriadescription expanded

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization with documentation showing member age, diagnosis, planned transplant type, and preparative regimen matching product-specific criteria.

SourceLink

POLICY UPDATE CHANGES

Added medically necessary indication for Omisirge for severe aplastic anemia (patients age ≥ 6 years) following reduced intensity conditioning.

Added Criteria II to include medically necessary criteria for RegeneCyte (unrelated donor HPC cord blood transplantation).

Expanded policy description to include RegeneCyte in addition to Omisirge and removed Omisirge-specific title language.

2therapies covered

≥12

Omisirge age threshold (malignancy)

≥6Omisirge age threshold (aplastic anemia)

125pivotal study pts

12d vs 22dmedian neutrophil recovery

2026-08-01effective date

Coverage Criteria

Omisirge medical necessity

Omisirge (omidubicel) is medically necessary for non‑Medicare plans affiliated with Centene when ONE of the following indication-specific groups is met.

Group A: Hematologic malignancies: ALL of: Member/enrollee is ≥ 12 years of age; Member/enrollee is planned for an umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection; Request is for one administration post‑myeloablative conditioning.

Supports faster neutrophil recovery (median ~12 days) and fewer infections vs umbilical cord blood transplantation per randomized study (n=125).

Group B: Severe aplastic anemia: ALL of: Member/enrollee is ≥ 6 years of age; Request is for one administration following reduced intensity conditioning.

Based on single‑arm study in patients ≥6 years showing early and sustained neutrophil engraftment and transfusion independence.

RegeneCyte medical necessity

RegeneCyte (HPC, cord blood) is medically necessary for non‑Medicare plans affiliated with Centene when ALL of the following are met:

RegeneCyte criteria: A. Member/enrollee is planned for an unrelated donor hematopoietic progenitor cell transplantation procedure; B. An appropriate preparative regimen for hematopoietic and immunologic reconstitution will be used in conjunction with the transplantation procedure; C. Member/enrollee has a disorder affecting the hematopoietic system that is inherited, acquired, or a result from myeloablative treatment.

Effectiveness and expected engraftment outcomes are supported by COBLT and other datasets (median neutrophil recovery reported ~22–27 days in cord blood cohorts).

This policy applies to non‑Medicare health plans affiliated with Centene. Medicare‑specific medical necessity criteria are maintained separately; see the Medicare cross‑reference policy MC.CP.MP.249 for coverage rules applicable to Medicare beneficiaries.

Coding and code lists included in this policy are for informational purposes only. Inclusion or exclusion of any code does not guarantee coverage; providers must follow current professional coding guidance and the payer’s coverage determinations. Statements in this policy describing covered services, limitations, or medical necessity criteria guide coverage decisions but do not by themselves constitute a guarantee of payment.

Coding and Billing

Referenced HCPCS CodesHCPCS

J3590	Unclassified biologics
C9399	Unclassified drugs or biologicals

Neutrophil recovery timing (median) — Omisirge vs cord blood/RegeneCyte

Omisirge (omidubicel) median time to neutrophil recovery~12 days (87% of subjects attained neutrophil recovery in an average of 12 days in the randomized pivotal study).

Umbilical cord blood (pivotal study comparator) median time to neutrophil recovery~22 days (83% of subjects achieved neutrophil recovery in an average of 22 days in the randomized study).

RegeneCyte (cord blood cohorts) reported median time to neutrophil recovery22–27 days (Study 3 median 22 days; Study 1 median 27 days; Study 2 median 25 days across datasets).

Provider Actions and Prior Authorization

Prior Authorization

Obtain prior authorization with supporting clinical documentation

Prior authorization is required for requests and must be supported by clinical documentation that demonstrates the product‑specific medical necessity criteria (age, diagnosis, planned transplant type, and conditioning regimen). Billing codes referenced in the policy include J3590 (Unclassified biologics) and C9399 (Unclassified drugs or biologicals).

Show member age and qualifying diagnosis (hematologic malignancy or severe aplastic anemia for Omisirge; disorder affecting the hematopoietic system for RegeneCyte).
Document planned transplant type (umbilical cord blood transplantation for Omisirge; unrelated donor HPC transplantation for RegeneCyte).
Document preparative/conditioning regimen type (myeloablative for Omisirge hematologic malignancy indication; reduced intensity for Omisirge severe aplastic anemia; appropriate preparative regimen for RegeneCyte).

Note

Use the policy as a medical‑necessity guide (does not guarantee payment)

This clinical policy is a guide to medical necessity used to assist in making coverage decisions and administering benefits; it does not constitute a contract or guarantee of payment and specific prior authorization procedures or timelines are determined by the Health Plan.

Covered Regimens and Administration

Regimen	Indication / eligibility	Notes	Coverage status
Single administration of Omisirge (omidubicel) given post‑myeloablative conditioning in conjunction with planned umbilical cord blood transplantation	Hematologic malignancies; member/enrollee ≥ 12 years of age; planned for umbilical cord blood transplantation following myeloablative conditioning; request is for one administration post‑myeloablative conditioning	Intended to reduce time to neutrophil recovery and incidence of infection; pivotal randomized data support faster neutrophil recovery (median ~12 days) compared with conventional cord blood cohorts	Covered with criteria

Regimen	Indication / eligibility	Notes	Coverage status
Single administration of Omisirge (omidubicel) given following reduced intensity conditioning	Severe aplastic anemia; member/enrollee ≥ 6 years of age; request is for one administration following reduced intensity conditioning	Effectiveness based on single‑arm study showing early and sustained neutrophil engraftment (median neutrophil recovery ~11 days in study cohort) and high rates of transfusion independence	Covered with criteria

Regimen	Indication / eligibility	Notes	Coverage status
Use of RegeneCyte (HPC, cord blood) in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution as part of an unrelated donor hematopoietic progenitor cell transplantation procedure	Member/enrollee planned for unrelated donor hematopoietic progenitor cell transplantation; has a disorder affecting the hematopoietic system that is inherited, acquired, or resulting from myeloablative treatment; appropriate preparative regimen will be used with the transplantation procedure	RegeneCyte is FDA‑approved for unrelated donor HPC transplantation; clinical datasets (COBLT and others) report median time to neutrophil recovery in cord blood cohorts approximately 22–27 days	Covered with criteria

Line of Therapy

Salvage

Salvage setting: Used in conjunction with a planned umbilical cord blood transplantation (Omisirge) or an unrelated donor hematopoietic progenitor cell transplantation (RegeneCyte) as part of the transplant procedure to accelerate hematopoietic engraftment after conditioning.

Intended for use post‑conditioning (myeloablative for Omisirge hematologic malignancy indication; reduced intensity for Omisirge severe aplastic anemia) or with an appropriate preparative regimen for RegeneCyte.

Definitions

Myeloablative conditioning — definition and expected effects

Definition of myeloablative conditioning (MAC)A regimen (single agent or combination) anticipated to destroy hematopoietic cells in the bone marrow; intended to ablate stem cells that produce new blood cells.

Expected hematologic effectExtensive pancytopenia occurs within one to three weeks after administration and is typically irreversible.

Clinical implicationMAC causes profound cytopenias and major toxicity (mucositis, diarrhea, infection risk) and is used as preparative regimen prior to allogeneic transplantation to allow engraftment of donor cells.

Background and Clinical Context

Allogeneic hematopoietic cell transplantation (HCT) uses hematopoietic progenitor cells from related or unrelated donors to reconstitute hematopoiesis following a preparative conditioning regimen. Donor sources include umbilical cord blood–derived products and unrelated donor hematopoietic progenitor cells. Conditioning regimens range from myeloablative approaches, intended to ablate marrow hematopoiesis, to reduced‑intensity regimens; the chosen regimen determines the degree of marrow ablation and influences engraftment timing and infection risk. The therapies discussed in this policy (Omisirge/omidubicel and RegeneCyte/HPC cord blood) are used as part of the transplant procedure to promote hematopoietic and immunologic reconstitution after conditioning.

Policy Summary

PayerAmbetter Georgia

PolicyAllogeneic Hematopoietic Progenitor Cell Therapy

Policy CodePolicy CP.MP.249

Change TypeAdded Omisirge severe aplastic anemia indicationadded RegeneCyte criteriadescription expanded

Effective DateAug 1, 2026

Last ReviewAug 1, 2026

Next Review DateAug 1, 2026

Key ActionObtain prior authorization with documentation showing member age, diagnosis, planned transplant type, and preparative regimen matching product-specific criteria.

SourceLink

On This Page

Coverage decisions and benefit administration remain subject to plan terms, state/federal requirements, and Health Plan‑level administrative policies.
The policy effective date is determined by the Health Plan and may differ from the posting date.

Documentation Required

Provider responsibility and professional judgment

Providers must exercise professional medical judgment when making treatment decisions and are responsible for submitting claims for services; the policy does not dictate clinical care.

Providers are independent contractors and are responsible for medical advice and treatment of members.
Submitting a claim implies agreement to be bound by the terms and conditions of this policy where a contracting relationship exists.

Billing Rule

Follow plan authorization pathways and coding guidance

Providers should follow Health Plan prior authorization processes and coding guidance when submitting requests and claims; the policy’s inclusion of codes is informational and does not guarantee coverage.

Reference the most up‑to‑date professional coding guidance prior to claim submission.
Plan‑level administrative policies and procedures govern authorization and billing details.

Documentation Required

Required documentation to support medical necessity

Document submission must demonstrate member age, specific diagnosis, planned transplant type, and the preparative/conditioning regimen to support medical necessity under the criteria.

Age evidence: ≥12 years for Omisirge when treating hematologic malignancy; ≥6 years for Omisirge when treating severe aplastic anemia.
Diagnosis: hematologic malignancy or severe aplastic anemia for Omisirge; disorder affecting the hematopoietic system for RegeneCyte.
Transplant plan: umbilical cord blood transplantation for Omisirge; unrelated donor HPC transplantation for RegeneCyte.
Conditioning/preparative regimen: myeloablative conditioning for Omisirge hematologic malignancy indication; reduced intensity conditioning for Omisirge severe aplastic anemia; appropriate preparative regimen for RegeneCyte.

Note

Provider expectations: clinical judgment and claims submission

Providers are expected to exercise professional medical judgment in providing care and must submit claims for services; the policy is a guide to medical necessity and does not replace clinical decision‑making.

The policy is not intended to dictate how providers practice medicine; providers remain solely responsible for member care.
The Health Plan may change, amend, or withdraw the clinical policy and additional administrative policies may apply.

Denial Risk

Denial risk if submitted criteria are not met

Requests that fail to meet the stated age thresholds, indication‑specific transplant plan, or conditioning regimen requirements are likely to be denied.

Example triggers: Omisirge requested for hematologic malignancy in a patient younger than 12 years; Omisirge requested after non‑myeloablative conditioning when myeloablative conditioning is required for that indication; product requested for an indication not listed in the criteria.

Denial Risk

Medicaid precedence: follow state Medicaid provisions

For Medicaid members, applicable state Medicaid coverage provisions take precedence over this clinical policy; failure to adhere to state Medicaid requirements may result in denial.

Refer to the state Medicaid manual for relevant coverage provisions that override this policy when conflicts exist.