CurrentCapital BluecrossPolicy MP 9.039

Hematopoietic Cell Transplantation for Chronic Myeloid Leukemia

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Defines medical necessity and coverage stance for allogeneic and autologous hematopoietic cell transplantation (HCT) in individuals with chronic myeloid leukemia (CML), including myeloablative and reduced-intensity conditioning; intended for providers and coverage decision-makers.

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Policy CodePolicy MP 9.039

Change TypeAdministrative update — no material clinical changes

Effective DateMay 1, 2026

Last ReviewJan 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnostic confirmation (BCR-ABL status and HLA typing) before performing allogeneic HCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentCapital BluecrossPolicy MP 9.039

Hematopoietic Cell Transplantation for Chronic Myeloid Leukemia

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Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Policy CodePolicy MP 9.039

Change TypeAdministrative update — no material clinical changes

Effective DateMay 1, 2026

Last ReviewJan 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnostic confirmation (BCR-ABL status and HLA typing) before performing allogeneic HCT.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

may be consideredmyeloablative allogeneic

select candidatesreduced-intensity allogeneic

investigationalautologous HCT

05/01/2026effective

01/15/2026last review

Coverage Criteria for Hematopoietic Cell Transplantation

Allogeneic HCT — myeloablative or reduced-intensity

Covered when specified clinical conditions are met

Overall requirement: Allogeneic HCT (myeloablative or reduced-intensity) may be considered medically necessary for treatment of chronic myeloid leukemia

Myeloablative preferred for candidates without prohibitive comorbidity; RIC for those not candidates for myeloablative due to age or comorbidity.

Indications for allo-HCT: Indications include failure or intolerance of tyrosine kinase inhibitor therapy, presence of TKI-resistant BCR-ABL variants (e.g., T315I), accelerated-phase CML, or blast-phase CML where allo-HCT is potentially curative

TKI therapy (imatinib, dasatinib, nilotinib and others) is first-line for chronic phase; allo-HCT generally indicated for progression on or intolerance to TKIs or for advanced phase disease.

Candidate selection for conditioning intensity: Reduced-intensity conditioning may be used in individuals who meet indications for allogeneic HCT but are not candidates for myeloablative conditioning due to factors such as older age (typically >60 years), organ dysfunction, generalized debilitation, prior intensive chemotherapy, or low Karnofsky Performance Status

For individuals who qualify for myeloablative allogeneic HCT on basis of clinical status, either myeloablative or reduced-intensity conditioning may be considered medically necessary.

Autologous HCT

Stance: Autologous hematopoietic cell transplantation for chronic myeloid leukemia is investigational/insufficient evidence and is not considered medically necessary for general use

Available evidence consists mainly of case series; controlled data are lacking (largest series median survival 36 months in accelerated-phase transplants).

Covered when medically necessary

Coverage is tied to medical necessity and diagnosis-specific indications as referenced by coding lists and guideline sources

Covered conditions overview: Transplantation procedures listed as 'Covered when medically necessary' are covered for the specified CML and atypical CML ICD-10 diagnoses when medical necessity criteria are met and member benefits permit

Policy references NCCN Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia (Version 3.2025) and supporting literature for clinical context.

Autologous hematopoietic cell transplantation (autologous HCT) for chronic myeloid leukemia (CML) is considered investigational/insufficient evidence and is not supported as a general treatment option. The policy notes that while case series (including a largest series with median survival of 36 months for accelerated-phase transplants) have been reported, controlled data are lacking to demonstrate consistent benefit; therefore autologous HCT is not considered medically necessary for CML.

Requests for autologous HCT to treat CML are likely to be denied on the basis of investigational status and insufficient evidence of improved health outcomes compared with established therapies (including tyrosine kinase inhibitors and, when appropriate, allogeneic HCT).

Certain procedural codes associated with hematopoietic cell transplantation are explicitly designated as investigational and not covered. The policy lists procedure codes 38206, 38232, and 38241 as investigational and excluded from coverage.

Providers should verify benefits and prior authorization requirements for covered transplant procedures before scheduling services; use of an excluded/investigational code may result in claim denial.

Coding and Billing

Investigational procedure codesCPTNot Covered

38206	Procedure code listed as investigational; therefore, not covered
38232	Procedure code listed as investigational; therefore, not covered
38241	Procedure code listed as investigational; therefore, not covered

Covered procedure and HCPCS codesmixedCovered

38205	Covered when medically necessary (listed group)
38207	Covered when medically necessary
38208	Covered when medically necessary / maps to S2140 per list
38209	Covered when medically necessary / maps to S2142 per list
38211	Covered when medically necessary / maps to S2150 per list
38212	Covered when medically necessary (entry present but specific mapping blank)
38213	Covered when medically necessary
38214	Covered when medically necessary
38215	Covered when medically necessary
38230	Covered when medically necessary

1–10 of 14

1/2

ICD-10-CM Diagnosis CodesICD-10

C92.10	Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
C92.11	Chronic myeloid leukemia, BCR/ABL-positive, in remission
C92.12	Chronic myeloid leukemia, BCR/ABL-positive, in relapse
C92.20	Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
C92.22	Atypical chronic myeloid leukemia, BCR/ABL-negative, in relapse

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required for allogeneic HCT

Prior authorization is required/expected for allogeneic hematopoietic cell transplantation (allo‑HCT); myeloablative or reduced‑intensity allo‑HCT may be authorized when medical necessity criteria are met.

Prior Authorization

Verify benefits and prior authorization for covered transplant procedure codes

Verify member benefits and obtain prior authorization for the specific transplantation procedure codes listed as “Covered when medically necessary” (e.g., 38205, 38207, 38208, 38209, 38211, 38212, 38213, 38214, 38215, 38230, 38240, S2140, S2142, S2150) before scheduling the service.

Check member benefit limitations and eligibility on the date of service.
Obtain prior authorization when medical necessity criteria are met for the applicable CPT/HCPCS code.

Conditioning Regimens and Regimen Coverage

Regimen	Description	Coverage Status
Myeloablative conditioning (high-dose chemotherapy with or without total body irradiation)	Conventional myeloablative regimens include high-dose cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation sufficient to cause marrow ablation before allogeneic HCT.	Covered
Indications and candidate selection	Allogeneic HCT with myeloablative conditioning may be considered medically necessary for treatment of chronic myeloid leukemia in eligible patients; myeloablative regimens are used in younger patients without significant comorbidities.	Covered

Regimen	Description	Coverage Status
Reduced-intensity conditioning (RIC)	Pretransplant regimens using lower doses of cytotoxic drugs or less intense radiotherapy intended to reduce morbidity and non-relapse mortality while relying on graft-versus-malignancy effects; intensity tailored for older or comorbid patients.	Covered
Indications and candidate selection for RIC	RIC may be considered medically necessary for individuals who meet indications for allogeneic HCT but are not candidates for myeloablative conditioning due to age (typically >60 years), organ dysfunction, generalized debilitation, prior intensive chemotherapy, or low Karnofsky Performance Status.	Covered

Procedure	Description	Coverage Status
Autologous hematopoietic cell transplantation (autologous HCT)	Autologous HCT involves harvesting and reinfusing the patient’s own hematopoietic stem cells; typically performed as consolidation when disease is in complete remission. Evidence for autologous HCT in CML is limited to case series and is insufficient to determine benefit.	not covered
Rationale for investigational stance	Autologous HCT for CML is considered investigational/insufficient evidence; largest series reported median survival of 36 months in accelerated-phase transplants and controlled data are lacking.	not covered

Line of Therapy and Salvage Indications

salvage

Salvage-line (when allo-HCT considered): Allogeneic HCT is considered for salvage when disease progresses on or the patient is intolerant to TKIs, when TKI-resistant BCR-ABL variants such as T315I are present, or when disease is in accelerated or blast phase requiring potentially curative therapy

TKIs are first-line in chronic phase; allo-HCT remains the primary potentially curative option in TKI-refractory disease or advanced phases. Prior attempts at alternative TKIs or dose adjustment should be documented unless immediate transplant is clinically indicated.

Biomarker Requirements (BCR-ABL and Mutations)

inv-24: BCR-ABL (including T315I)

BiomarkerBCR-ABL (including detection of specific kinase-domain variants such as T315I)

Clinical implicationPresence of T315I indicates resistance to all currently available TKIs and supports consideration of allogeneic HCT or experimental therapy

Use in decision-makingDetection of BCR-ABL variants helps determine alternative TKIs versus referral for allo-HCT

inv-25: BCR-ABL — biomarker entry listing tests/considerations

Diagnostic testsCytogenetics (Philadelphia chromosome), FISH, or molecular testing for BCR-ABL (quantitative PCR and sequencing for kinase-domain mutations)

Variant assessmentSequence-based assays to identify kinase-domain mutations (e.g., T315I) when clinical resistance to TKIs is suspected

Definitions and Clinical Measures

inv-18: Karnofsky Performance Status

DefinitionKarnofsky Performance Status (KPS): a standard way of measuring the ability of cancer patients to perform ordinary tasks; score ranges from 0 to 100

Interpretation — higher scoreHigher scores indicate better functional status and greater ability to carry out daily activities

Use in transplant selectionKPS is considered in selection of conditioning intensity; lower KPS may favor reduced-intensity conditioning

inv-19: Reduced-intensity conditioning (RIC)

DefinitionReduced-intensity conditioning (RIC): pretransplant regimens using lower doses of cytotoxic drugs or less intense radiotherapy than traditional myeloablative regimens

GoalTo reduce treatment-related morbidity and non-relapse mortality while relying on graft-versus-malignancy effects to control disease

Background

Chronic myeloid leukemia (CML) is a Philadelphia-chromosome–positive myeloproliferative disorder driven by the BCR-ABL tyrosine kinase. Disease typically follows a course from chronic phase to accelerated phase and, if untreated or refractory, to blast crisis.

Tyrosine kinase inhibitors (TKIs) are the established first-line therapy for chronic-phase CML. Allogeneic hematopoietic cell transplantation (allo-HCT) remains the only potentially curative option for patients with TKI-refractory disease, those with resistant BCR-ABL variants (for example, T315I), or patients presenting in accelerated or blast phase; conditioning intensity (myeloablative versus reduced-intensity) is selected based on patient age, comorbidity, and performance status.

Policy Revision History

2026-01-15Consensus reviewLatest

Consensus review — no changes to the policy statement; removed benefit variations; updated policy formatting, cross-references, product variations, background, definitions, disclaimer, and references; no coding changes.

2025-01-16Consensus review

Consensus review — no changes to the policy statement; coding reviewed.

2024-11-19Administrative update

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Policy CodePolicy MP 9.039

Change TypeAdministrative update — no material clinical changes

Effective DateMay 1, 2026

Last ReviewJan 15, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document diagnostic confirmation (BCR-ABL status and HLA typing) before performing allogeneic HCT.

SourceLink

On This Page

Step Therapy

TKI therapy is standard first‑line before considering HCT

Documented trial of standard first‑line tyrosine kinase inhibitor (TKI) therapy is the expected initial treatment approach; allo‑HCT is generally indicated for progression on or intolerance to TKIs or for accelerated/blast‑phase disease.

Examples of TKIs referenced include imatinib, dasatinib, and nilotinib; presence of T315I mutation supports consideration of allo‑HCT.

Step Therapy

Step‑therapy algorithm not specified in policy

Policy references treatment context with TKIs and transplantation literature but does not provide an explicit step‑therapy algorithm in this document; use clinical judgement and guideline‑directed sequencing of TKIs before considering allo‑HCT per indications.

No explicit step‑therapy algorithm is specified in the policy text.
Consider TKI sequencing, mutation testing, and progression status when evaluating need for transplant.

Documentation Required

Required clinical documentation (diagnosis confirmation and HLA typing)

Provide clinical documentation to support medical necessity: diagnostic confirmation of CML and HLA typing when an allogeneic transplant is planned.

Diagnostic confirmation: Philadelphia chromosome by cytogenetics or detection of BCR‑ABL by FISH or molecular studies.
HLA typing results when allo‑HCT is intended.

Billing Rule

Confirm benefits, eligibility, and medical necessity before proceeding

Verify the member’s benefit program, eligibility on the date of service, and that services meet medical necessity and appropriateness criteria; contact Provider or Member Services with questions.

Coverage determination is subject to the terms of the member’s contract, benefit limitations, and exclusions.
Final claim processing depends on member benefit and medical necessity determination.

Denial Risk

Autologous HCT for CML is investigational and likely to be denied

Requests for autologous HCT for treatment of CML are considered investigational/insufficient evidence and are likely to be denied; do not expect coverage for autologous HCT for CML.

Billing Rule

Investigational procedure codes are not covered and may trigger denial

Procedures listed as investigational (CPT codes 38206, 38232, 38241) are excluded from coverage and may trigger denial if billed; do not submit claims for these investigational procedure codes expecting coverage.

Investigational procedure codes explicitly listed: 38206, 38232, 38241.

RoleDetermines diagnosis (BCR/ABL-positive vs negative variants) and guides TKI selection or need for allo-HCT

ScopeRIC regimens span nearly myeloablative to minimally myeloablative approaches and are tailored to disease and patient condition

inv-20: Myeloablative conditioning regimen

DefinitionMyeloablative conditioning regimen: administration of high-dose chemotherapy (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to cause bone marrow ablation

PurposeTo eradicate malignant cells and permit donor stem cell engraftment; often necessary when disease burden is high

Toxicity considerationsIntense conditioning is limited to medically fit patients due to risks such as opportunistic infections and organ damage

inv-21: Karnofsky Performance Status

Alternate entry — definitionKarnofsky Performance Status: standard measure of cancer patients' ability to perform ordinary tasks; score 0–100 where higher is better

Clinical useUsed to assess functional status for transplant candidacy and to help determine conditioning intensity

Score implicationsLow KPS may lead clinicians to consider reduced-intensity conditioning rather than myeloablative regimens

inv-22: Myeloablative conditioning regimen

Alternate entry — definitionMyeloablative conditioning regimen: high-dose chemotherapy and/or radiation given before transplant sufficient to ablate bone marrow and immune system to facilitate engraftment

Intended effectEnsures transplanted stem cells can engraft and helps prevent rejection

Patient selectionReserved for patients medically fit to tolerate substantial adverse effects from intensive cytotoxic therapy

Administrative update — removed NCCN statement.

2024-02-26Consensus review

Consensus review — updated references; no change to coding.

2023-02-03Consensus review

Consensus review — no changes to policy statement; references reviewed and updated; coding reviewed.

2022-02-08Consensus review

Consensus review — NCCN statement added; no changes to current criteria.

2021-05-26Consensus review

Consensus review — policy unchanged; references and coding reviewed.

2020-04-09Consensus review

Consensus review — policy criteria unchanged; minor revisions under Description/Background section and references updated; coding reviewed.