CurrentCapital BluecrossPolicy MP 9.039

Hematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Defines medical necessity and investigational status for allogeneic and autologous hematopoietic cell transplantation (HCT) in members with chronic myeloid leukemia (CML), including use of myeloablative and reduced-intensity conditioning regimens. Applies to Capital Blue Cross products with noted program variations.

Policy Summary

PayerCapital Bluecross

PolicyHematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Policy CodePolicy MP 9.039

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionObtain prior authorization and document diagnostic confirmation of CML (Philadelphia chromosome/BCR-ABL testing) and member eligibility before scheduling transplant services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Allogeneic HCT coveredmyeloablative conditioning considered medically necessary

RIC coveredreduced-intensity conditioning considered medically necessary

Investigationalautologous HCT not supported for CML

2Investigational procedure codes (not covered)

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Coverage Determinations for Hematopoietic Cell Transplantation in CML

Coverage stance

Allogeneic myeloablative HCT: Allogeneic HCT using a myeloablative conditioning regimen may be considered medically necessary as a treatment of chronic myeloid leukemia.

From policy statement

Allogeneic reduced-intensity HCT: Allogeneic HCT using a reduced-intensity conditioning regimen may be considered medically necessary for individuals who meet clinical criteria for an allogeneic HCT but are not candidates for myeloablative conditioning (eg, age typically > 60 years or significant comorbidities such as liver or kidney dysfunction, generalized debilitation, prior intensive chemotherapy, or low Karnofsky Performance Status).

Includes examples of qualifying conditions per policy guidelines

Autologous HCT is investigational for treatment of chronic myeloid leukemia due to insufficient evidence of benefit.

Not recommended/considered investigational

Autologous hematopoietic cell transplantation (HCT) for chronic myeloid leukemia is considered investigational and is therefore excluded from coverage. The policy states there is insufficient evidence to support a general conclusion that autologous HCT improves health outcomes for CML, and requests for autologous HCT may be denied as not medically necessary.

The policy lists procedure codes 38206 and 38241 as investigational and not covered. Use of these codes for services related to HCT in CML will be considered investigational and may result in claim denial.

Conditioning Regimens and Transplant Types

Regimen	Description	Coverage status
Myeloablative conditioning regimens (e.g., high-dose chemotherapy with/without total body irradiation)	High-dose cytotoxic chemotherapy and/or radiation given prior to allogeneic HCT to ablate the recipient marrow and immune system and facilitate engraftment.	Covered when medically necessary (Allogeneic HCT)

Regimen	Description	Coverage status
Reduced-intensity or nonmyeloablative conditioning regimens	Lower-dose cytotoxic or less intense radiotherapy regimens intended to reduce treatment-related morbidity and non-relapse mortality; intensity is tailored for older patients or those with significant comorbidities and may include nearly to minimally myeloablative approaches.	Covered when medically necessary for candidates not eligible for myeloablative conditioning (e.g., older age, significant comorbidities)

Regimen	Description	Coverage status
Autologous hematopoietic cell transplantation (autologous HCT)	Use of the patient’s own hematopoietic stem cells for transplantation in CML; evidence consists primarily of case series with insufficient data to demonstrate benefit.	Investigational — not covered for treatment of chronic myeloid leukemia

Procedure and Diagnosis Codes

Coding information (listed in policy)mixed

No codes listed

Investigational / Not Covered Procedure CodesCPTNot Covered

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

Covered when medically necessary Procedure CodesCPT|HCPCSCovered

38214	Covered when medically necessary (listed as a covered procedure code)
38205	Listed in covered group
38215	Listed in covered group
38207	Listed in covered group
38230	Listed in covered group
38208	Listed in covered group
38240	Listed in covered group
38209	Listed in covered group
S2140	Listed in covered group
38210	Listed in covered group

1–10 of 15

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Relevant 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

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Verify the member's program and product-specific benefit variations and confirm eligibility and medical necessity for hematopoietic cell transplantation on the date of service before scheduling or performing services.

Prior authorization required — check product/program variations and member benefit determination prior to service.
Contact Capital Blue Cross Provider Services or Member Services for questions about coverage and benefit limits.

Denial Risk

Autologous HCT Investigational

Requests for autologous hematopoietic cell transplantation (autologous HCT) for chronic myeloid leukemia are considered investigational and may be denied as not medically necessary.

Autologous HCT investigational — requests may be denied for medical necessity.

When Transplant Is Considered by Line of Therapy

Salvage

Indications for allo-HCT (salvage): Allogeneic HCT may be used as salvage therapy for patients with CML who have disease progression on or intolerance to tyrosine kinase inhibitors, who harbor resistant BCR-ABL variants (eg, T315I), or who present in accelerated or blast phase disease.

TKIs are first-line for chronic-phase CML; allo-HCT is generally reserved for progression/advanced disease

Molecular and Cytogenetic Test Requirements

BCR-ABL (Philadelphia chromosome)

BiomarkerBCR-ABL (Philadelphia chromosome)

Required forDiagnostic confirmation of chronic myeloid leukemia (CML) by cytogenetics or molecular testing

Clinical roleIdentifies presence of constitutive BCR-ABL tyrosine kinase activity that defines typical CML

BCR-ABL T315I variant

VariantBCR-ABL T315I

Required forIdentification of TKI resistance that indicates need for allogeneic HCT or experimental therapy

Clinical implication

Key Definitions and Scales

Karnofsky Performance Status

DefinitionKarnofsky Performance Status is a standard scale measuring the ability of cancer patients to perform ordinary tasks; score ranges from 0 to 100.

Scale interpretationHigher score indicates better ability to carry out daily activities (100 = normal; 0 = dead).

Use in policyRequired for selection of conditioning intensity; poor performance may favor reduced-intensity conditioning

Myeloablative conditioning regimen

DefinitionMyeloablative conditioning regimen: high-dose chemotherapy and/or radiation given before transplant to ablate the bone marrow and immune system.

PurposeEradicate malignant cells and permit engraftment; contributes to graft-versus-malignancy effect when combined with allo-HCT

Clinical Background and Rationale

Chronic myeloid leukemia (CML) is characterized by the presence of the Philadelphia chromosome producing constitutive BCR‑ABL tyrosine kinase activity and typically presents in a chronic phase that can progress to accelerated phase or blast crisis. Tyrosine kinase inhibitors (TKIs) are first‑line therapy for chronic‑phase CML, but a subset of patients fail, develop resistance or intolerance, or present in advanced phase—situations in which hematopoietic cell transplantation is used.

Allogeneic HCT offers the only potentially curative option for patients with TKI failure, intolerant or resistant disease (including certain BCR‑ABL kinase mutations such as T315I) or for patients in accelerated or blast phase. Myeloablative conditioning regimens are typically used in younger, fit patients, while reduced‑intensity conditioning (RIC) regimens can provide reasonable outcomes for older patients or those with significant comorbidities who are not candidates for myeloablative conditioning.

Supporting Evidence and Guidelines

Key references supporting this policy include peer‑reviewed studies and guideline sources demonstrating the role of allogeneic HCT in advanced or TKI‑refractory CML and the limited evidence for autologous HCT. Representative citations in the policy are: Xu et al., Front Med. 2015 (comparative outcomes for accelerated‑phase CML) ; Zhao et al., Am J Med Sci. 2014 (second‑generation TKIs with transplantation) ; Egan et al., Biol Blood Marrow Transplant. 2015 (BCR‑ABL kinase mutation relapse patterns) ; and other case series and outcome analyses summarized in the policy.

The policy cites the NCCN Clinical Practice Guidelines in Oncology: Chronic Myeloid Leukemia (Version 3.2025, updated November 27, 2024) as a compendium guideline supporting the recommendations on the role of HCT in CML and selection of candidates.