CurrentCentenePolicy CP.MP.108

Allogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β-Thalassemia

Defines medical necessity criteria, contraindications, and investigational statements for allogeneic hematopoietic cell transplantation (HCT) in individuals with sickle cell anemia or homozygous β-thalassemia for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β-Thalassemia

Policy CodePolicy CP.MP.108

Change TypeClarified criteria and contraindications

Effective Date

Next Review Date

Key ActionDocument that all required medical necessity criteria and absence of absolute contraindications are met, including donor availability, age ≤45, indication-specific evidence, conditioning regimen plan, and specialist consultation when required, when requesting authorization for allogeneic HCT.

SourceLink

POLICY UPDATE CHANGES

Added contraindication criteria I.C.1 through I.C.4 and removed prior criterion related to lack of adequate support system.

Expanded criteria II.A and II.B to specify autologous HCT not in the context of gene therapy.

≤45Maximum age allowed for transplant candidacy

First-degreeRequired donor relationship for sickle cell indication

Transfusion-dependentRequired status for homozygous β-thalassemia

38205,38240,S2150CPT/HCPCS codes referenced

Policy Summary

PayerCentene

PolicyAllogeneic Hematopoietic Cell Transplants for Sickle Cell Anemia and β-Thalassemia

Policy CodePolicy CP.MP.108

Change TypeClarified criteria and contraindications

Effective Date

Next Review Date

SourceLink

On This Page

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Medical Necessity Criteria for Allogeneic HCT

Medically necessary 2D Allogeneic HCT for Sickle Cell Anemia

Covered when ALL of the following are met:

ALL of the following

Age ≤ 45 years (children and young adults)
HLA-matched, first-degree relative donor is available
- One of
  - Prior stroke
  - Recurrent acute chest syndrome
  - Recurrent vasoocclusive crises
  - Red blood cell alloimmunization on chronic transfusion therapy

Medically necessary 2D Allogeneic HCT for Homozygous -Thalassemia

Covered when ALL of the following are met:

Absolute contraindications (Exclusion criteria)

Allogeneic HCT is not medically necessary when ANY of the following absolute contraindications are present:

ANY of the following

Infections with highly virulent and/or resistant microbes that are poorly controlled pre-transplant
Inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support
Active substance use or dependence including current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), or IV drug use without convincing evidence of risk reduction behaviors
Serial blood and urine testing may be used to verify abstinence from substances that are of concern; exceptions may be made for urgent transplants with a commitment to reduce behaviors

Insufficient evidence / Not covered (Investigational) 2D Autologous HCT and other indications

There is insufficient evidence regarding safety and efficacy for the following (not supported):

ANY of the following

Autologous hematopoietic cell transplant for sickle cell anemia not in the context of gene therapy
Autologous hematopoietic cell transplant for β-thalassemia not in the context of gene therapy
Allogeneic hematopoietic cell transplants for sickle cell anemia or homozygous β-thalassemia for any other indications than those specified in the medically necessary criteria above

Relevant CPT/HCPCS Codes

Informational CPT codes (referenced)CPT/HCPCS

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor
S2150	Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; bundled HCPCS

Authorization, Documentation, and Specialist Requirements

Prior Authorization

Medical necessity documentation for allogeneic HCT

Document that all required medical necessity criteria are met when requesting authorization for allogeneic hematopoietic cell transplantation, including age ≤ 45 years; HLA‑matched donor availability and type; indication‑specific evidence (e.g., prior stroke, recurrent acute chest syndrome, recurrent vasoocclusive crises, or transfusion‑dependence for thalassemia); planned conditioning regimen (standard myeloablative when required for thalassemia); and that the request is made by or in consultation with a provider specializing in thalassemia when applicable.

38205
38240
S2150

Documentation Required

Contraindication verification

Document the absence of any absolute contraindications prior to transplant authorization: uncontrolled infections with highly virulent or resistant microbes, inability to adhere to the post‑transplant regimen even with caregiver support, and active substance use or dependence (including current tobacco, vaping, non‑prescribed marijuana, or IV drug use) without convincing evidence of risk‑reduction.

Numeric / Clinical Thresholds

Key thresholds and quick stats

Maximum age for candidacy≤ 45 years

Maximum age allowed for transplant candidacy (stat)Age ≤ 45 years

Required donor relationship for sickle cell indication (stat)HLA-matched, first-degree relative

Required status for homozygous β-thalassemia (stat)Transfusion-dependent

CPT/HCPCS codes referenced (stat)38205, 38240, S2150

Clinical Background

Allogeneic hematopoietic cell transplantation (HCT) is the only curative therapy for sickle cell disease and homozygous β-thalassemia. Success with HCT varies by indication, donor match, conditioning regimen, and patient factors; reported survival and disease‑free survival across studies and patient groups range broadly (for some pediatric cohorts, reported success rates are as high as 85–90%, while overall survival and thalassemia‑free survival have been reported in the approximate 65–90% range).

HCT carries important procedure‑related risks that must be weighed against potential benefit. Major complications include graft‑versus‑host disease, graft rejection, and transplant‑related organ toxicities. Additionally, HCT may result in long‑term morbidities such as infertility/gonadal failure. Donor availability and degree of HLA matching are also key determinants of outcome.

Defined Terms

Definitions

Transfusion-dependent (thalassemia)Requirement for ongoing red blood cell transfusions to manage anemia related to β-thalassemia (as used in policy to define transplant candidacy).

HLA-matched, first-degree relative donorA sibling or parent who is HLA-matched and first-degree relative used as donor for allogeneic HCT (required for sickle cell indication in this policy).

Policy Changes and Review Log

2023-10-23Annual review / RevisionLatest

Annual review: added note regarding Zynteglo criteria; removed criterion related to lack of adequate support system (I.C.3); expanded Criteria II.A and II.B to specify autologous HCT is not in the context of gene therapy; background updated (no impact on criteria).

2023-02-23Revision

Added contraindication criteria I.C.1 through I.C.4 and removed prior ICD-10 code table from the policy.

2022-10