CurrentArizona Complete HealthPolicy CP.MP.108

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

Defines medical necessity criteria for non‑Medicare health plans affiliated with Centene for allogeneic hematopoietic cell transplants to treat sickle cell anemia and homozygous β-thalassemia and summarizes indications, contraindications, and unsupported scenarios.

Policy Summary

PayerArizona Complete Health

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

Policy CodePolicy CP.MP.108

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document HLA-matching, donor source, and evidence supporting the transplant indication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

85-90%reported HCT success rate in specific pediatric groups

≈90%three-year survival rate after HCT reported

38205,38240,S2150example procedure/billing codes listed

Coverage and Medical Necessity Criteria

Insufficient evidence / not supported

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.

Insufficient evidence categories: The following are considered to have insufficient evidence regarding safety and efficacy and therefore are not supported: autologous hematopoietic cell transplant for sickle cell anemia when not part of gene therapy; autologous hematopoietic cell transplant for β-thalassemia when not part of gene therapy; allogeneic hematopoietic cell transplants for sickle cell anemia or homozygous β-thalassemia for indications other than those specified in the policy.

Candidate Selection

Candidate selection

Candidate selection requirements for non-Medicare plans:

Candidate criteria: Candidates must meet one of the disease-specific indications, have an appropriate HLA-matched donor (with specified source allowances for β-thalassemia), be transfusion-dependent if applicable for thalassemia, and be planned to receive a standard myeloablative conditioning regimen; candidates must not have any of the listed absolute contraindications.

Contraindications

Absolute contraindications that must be absent for coverage include: infections with highly virulent and/or resistant microbes that are poorly controlled pretransplant and an inability to adhere to the regimen necessary to preserve the transplant, even with caregiver support.

Active substance use or dependence is an absolute contraindication unless there is convincing evidence of sustained risk-reduction behaviors. This includes current tobacco use, vaping, marijuana use (unless prescribed by a licensed practitioner), or IV drug use. An exception may be considered if urgent transplant timelines exist and the patient commits to risk-reduction behaviors.

Pre-Transplant Evaluation Requirements

Documentation Required

Document donor HLA match and stem cell source

Documentation of donor HLA-matching and specification of the stem cell source (cord blood, bone marrow, or peripheral blood when donor unable/refuses bone marrow) must be provided as part of the evaluation.

For homozygous β-thalassemia the donor must be HLA-matched and the stem cell source must be specified: cord blood, bone marrow, or peripheral blood only if donor unable/refuses bone marrow.
For sickle cell anemia an HLA-matched, first‑degree relative donor must be documented.

Provider Actions, Authorization, and Documentation

Prior Authorization

Obtain prior authorization and include referenced codes

Prior authorization is required for allogeneic hematopoietic cell transplant procedures; submit requests referencing the informational procedure codes listed in the policy.

Informational CPT codes: 38205, 38240.
Informational HCPCS code: S2150 (describes comprehensive transplant-related services).

Note

Check Medicare and state Medicaid rules before authorization

Verify applicable Medicare NCDs/LCDs and state Medicaid coverage rules before applying this clinical policy or finalizing prior authorization decisions.

For Medicaid members, state Medicaid provisions take precedence—refer to the state Medicaid manual.
For Medicare members, review all applicable NCDs, LCDs, and Medicare Coverage Articles on the CMS website prior to applying these criteria.

Step Therapy

No step therapy required — coverage based on meeting criteria

No step therapy sequencing is prescribed by this policy; coverage is contingent on meeting the transplant indications and absence of absolute contraindications listed.

Ensure patient meets one of the specified disease indications and planned conditioning regimen is standard myeloablative.
Confirm absence of absolute contraindications (e.g., uncontrolled virulent/resistant infection, inability to adhere, active substance use without risk reduction).

Documentation Required

Include required clinical documentation to support indication and regimen

Clinical documentation submitted for authorization must support the specific indication and treatment plan, including HLA match/donor source, history of stroke or high stroke risk or recurrent complications for sickle cell, transfusion dependence for β-thalassemia, and the planned conditioning regimen.

Document evidence of prior stroke, recurrent acute chest syndrome, recurrent vaso-occlusive crises, or RBC alloimmunization when indicating stroke/high risk in sickle cell anemia.
Document transfusion dependence when indicating transplant for β-thalassemia.
Document planned use of a standard myeloablative conditioning regimen.

Documentation Required

Provider responsibility for documentation and medical judgment

This clinical policy is guidance for medical necessity determinations; providers are expected to exercise professional judgment and ensure submitted documentation aligns with standards of medical practice and applicable requirements.

Providers remain responsible for medical judgment and treatment decisions and must ensure documentation aligns with state/federal requirements.
The policy does not dictate care and should not replace clinical decision‑making.

Denial Risk

Incomplete documentation or unmet indications may lead to denial

Requests that do not document that all required indications and absence of absolute contraindications are met risk denial for lack of medical necessity.

Examples of denial triggers include missing documentation of an HLA‑matched donor when required, lack of evidence for stroke/high stroke risk in sickle cell, or presence of uncontrolled infection or active substance use without evidence of risk reduction.

Note

Provider notice regarding policy purpose and plan processes

This clinical policy was developed by experienced professionals to guide medical necessity determinations; providers should note the policy’s purpose and that it does not guarantee payment—follow plan-specific submission and notification requirements.

The policy is a guide to medical necessity and is subject to plan terms, state/federal law, and Health Plan administrative policies.
Providers should follow applicable plan notification and submission processes.

Note

Medicaid precedence — follow state Medicaid provisions

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence; providers should follow state Medicaid manual requirements for Medicaid members.

Failure to follow applicable state Medicaid or Medicare NCD/LCD requirements may affect coverage determinations.

Informational Procedure and Billing Codes

Informational CPT CodesCPT

38205	Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogeneic.
38240	Hematopoietic progenitor cell (HPC); allogeneic transplantation per donor.

Informational HCPCS CodesHCPCS

S2150

Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and posttransplant care in the global definition.

Comprehensive Transplant-Related Services

Comprehensive transplant-related services (S2150)

S2150 global definitionS2150 describes bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre- and posttransplant care in the global definition.

Included servicesHarvesting, pheresis, cell preparation and storage, and marrow ablative therapy are explicitly included.

Care continuumCovers hospitalization, outpatient follow-up, and related medical/surgical, diagnostic, emergency, and rehabilitative services.

Scope of complicationsRelated complications of transplantation are included within the S2150 global definition.

Specifies pre/post care daysDefines inclusion of the number of days of pre- and posttransplant care in the global definition.

Transplant Center Requirements

Note

No center accreditation or volume requirements specified

The policy excerpt does not specify FACT accreditation, center volume, or other formal transplant center requirements in this section.

No explicit accreditation or minimum-volume requirements are stated for centers in this policy portion.

Definitions

Sickle cell anemia — definition and key clinical features

DefinitionA hemoglobinopathy caused by a β-globin mutation (Glu→Val at position 6) resulting in polymerization of deoxygenated hemoglobin and formation of sickled red blood cells.

Key clinical featuresVaso-occlusion leading to pain crises, acute chest syndrome, strokes, tissue infarction, chronic hemolytic anemia, multi-organ injury, reduced quality of life, and shortened lifespan.

GeneticsHomozygous inheritance produces disease phenotype; heterozygous carriers have sickle cell trait and are typically asymptomatic.

β-thalassemia (homozygous) — definition and key clinical features

PathophysiologyReduced β-globin production leads to ineffective erythropoiesis, toxic α-globin aggregates, destruction of erythroid precursors, and severe anemia.

Clinical consequencePatients commonly develop transfusion dependence and shortened red blood cell survival due to ineffective erythropoiesis and hemolysis.

Background and Clinical Context

Sickle cell anemia and homozygous β-thalassemia are monogenic hemoglobinopathies that cause chronic hemolytic anemia and multi-organ complications. Sickle cell disease results from a β-globin mutation leading to sickling of red blood cells with vaso-occlusion, pain crises, and risk of stroke; β-thalassemia major results from mutations that reduce β-globin synthesis, causing ineffective erythropoiesis, severe anemia, and transfusion dependence.

Allogeneic hematopoietic cell transplant is described in the literature as the only curative therapy for these conditions in selected patients, with reported high success rates in specific pediatric cohorts and variable long-term survival in thalassemia series. Clinical selection depends on disease-specific indications, availability of an appropriate HLA-matched donor, stem cell source, and planned use of a standard myeloablative conditioning regimen.

Policy Summary

PayerArizona Complete Health

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

Policy CodePolicy CP.MP.108

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document HLA-matching, donor source, and evidence supporting the transplant indication.

SourceLink

On This Page