Hematopoietic Cell Transplantation for Chronic Myelogenous Leukemia
Customize your policy alerts
Sign up for Aetna Policy 0674 alerts
Get alerted when Policy 0674 changes without checking for updates manually.
Monitor payer policy activity
Defines Aetna's coverage stance for hematopoietic cell transplantation (HCT) in members with chronic myelogenous leukemia (CML), including medical necessity criteria for allogeneic transplants and the noncoverage stance for autologous transplants. Applies to patients being considered for HCT for CML.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical Necessity for Allogeneic HCT
Allogeneic hematopoietic cell transplantation is covered when the following guideline is met:
From policy medical necessity statement
Autologous HCT — Not Covered
Not covered for CML
Aetna considers autologous hematopoietic cell transplantation (auto BM/PSCT) for chronic myelogenous leukemia to be experimental and investigational under all circumstances because its effectiveness for this indication has not been established.
Clinical practice guidelines and evidence summaries do not support routine use of autologous stem cell transplantation for CML. The National Comprehensive Cancer Network’s CML guidance (2009) and recent reviews do not discuss auto‑SCT as a standard treatment option, a meta‑analysis of randomized trials did not find a role for auto‑SCT in initial therapy, and Cancer Care Ontario guidelines state that autologous stem cell transplantation is not recommended for patients with CML.
Candidate Criteria for Allogeneic HCT
Candidate criteria for allo-HCT
When institutional criteria are absent, candidates for allogeneic HCT are typically those who:
Combined policy guidance and cohort study findings
Allo-HSCT candidate considerations
Factors identified in the literature that influence consideration for allo-HSCT in CML:
Derived from cohort analyses noting adverse outcomes with multiple prior TKIs.
From cohort and survivor studies
Provider Actions and Authorization
Prior Authorization Required
Prior authorization is required for listed transplant-related CPT/HCPCS codes when the member meets selection criteria for allogeneic hematopoietic cell transplantation. Ensure prior auth is obtained when institutional eligibility is met or when documentation shows failure, resistance, or intolerance to TKIs and allogeneic transplant is being requested.
Pre-transplant TKI Exposure Risk
Document prior TKI therapy in the medical record. Note that use of three prior TKIs before transplant has been associated with higher non-relapse mortality and worse prognosis; this may influence authorization decisions.
- Prior exposure to 1, 2, or 3 TKIs should be recorded
- Use of 3 TKIs prior to transplant is a documented adverse prognostic factor
Comorbidity Scoring (HCT-CI)
Providers should document comorbidity assessment using a validated tool such as the Hematopoietic Cell Transplantation–Specific Comorbidity Index (HCT-CI). Include the calculated HCT-CI score with the authorization request to support clinical risk evaluation.
- Include HCT-CI score in authorization documentation
- Reference: Hematopoietic Cell Transplantation–Specific Comorbidity Index (HCT-CI)
Document TKI Failure or Institutional Eligibility
Include documentation that the member meets the transplanting institution's written eligibility criteria. If institutional criteria are not available, provide documentation of failure, resistance, or intolerance to tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib) to support medical necessity for allogeneic HCT.
- Attach transplanting institution written eligibility criteria when available
- If no institutional criteria, document TKI failure/resistance/intolerance to imatinib, dasatinib, nilotinib
TKI Therapy Before Transplant
Tyrosine kinase inhibitor (TKI) therapy is the standard first-line treatment for CML. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is generally reserved for patients with disease progression or treatment failure after multiple TKIs. Authorization decisions should reflect prior TKI use and treatment history.
- TKIs are first-line; allo-HSCT considered for progression or failure after multiple TKIs
- Document prior lines of TKI therapy and reasons for discontinuation
Step Therapy Requirements
There are no formal step therapy requirements specified in this policy section beyond documenting prior TKI use and failure/intolerance when applicable. Treat this as informational for authorization reviewers and providers.
- No specific step-therapy sequencing beyond standard practice (document prior TKI attempts)
Supplemental Aetna Resources
Supplemental Aetna resources and external links (glossary, mobile app, program provisions, and notices) may be referenced for member and provider information. Note that external links are provided for convenience and Aetna is not responsible for their content.
- Glossary, Aetna Mobile App, Program Provisions and Notices available via Aetna website
- External site content disclaimer applies
Pre-Transplant Evaluation Requirements
Document TKI failure/resistance/intolerance and institutional organ‑function evaluation
Document failure, resistance, or intolerance to imatinib, dasatinib, or nilotinib if the transplanting institution lacks written eligibility criteria; the institution must also evaluate and document serious organ dysfunction status.
- Provide documentation of TKI failure/resistance/intolerance when institutional criteria are absent.
- Include the transplanting institution's evaluation of organ dysfunction (absence of serious organ dysfunction required when institutional criteria absent).
Document TKI treatment history when no institutional criteria exist
If the transplanting institution has no written eligibility criteria, explicitly document attempts and outcomes with TKIs (failure, resistance, or intolerance) as part of the evaluation for allo‑HCT candidacy.
- Ensure records show TKI treatment history and documented failure/resistance/intolerance where institutional criteria are lacking.
Include HCT‑CI comorbidity assessment in evaluation documentation
Include assessment using the Hematopoietic Cell Transplantation‑Specific Comorbidity Index (HCT‑CI) as part of the pre‑transplant evaluation and documentation.
- HCT‑CI calculator is specifically referenced in the appendix as an assessment tool to evaluate comorbidity burden pre‑transplant.
Coding
| 38204-38215 | Bone Marrow or Stem Cell Services/Procedures. |
| 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 post-transplant care in the global definition. |
| S0088 | Imatinib, 100mg. |
| C92.10 | Chronic myeloid leukemia, BCR/ABL-positive, chronic phase |
| C92.11 | Chronic myeloid leukemia, BCR/ABL-positive, accelerated phase |
Contraindications
When institutional eligibility criteria are not available, the policy requires documentation that the transplanting institution evaluated the member and found no serious organ dysfunction. Serious organ dysfunction as defined by the transplanting institution is a consideration against proceeding with hematopoietic cell transplantation and must be absent for the member to meet the policy’s medical necessity conditions for allogeneic HCT.
The policy does not list specific absolute contraindications to transplantation. However, because available evidence and guidelines do not establish benefit for autologous transplantation in CML, autologous HCT is not recommended and is considered investigational for this indication; autologous transplant codes are therefore not an endorsed treatment option for CML under this policy.
Center Requirements
Provide transplanting institution's written eligibility criteria and organ‑function evaluation
Obtain and document the transplanting institution's written eligibility criteria; when submitting authorization requests, confirm the institution has evaluated the member for serious organ dysfunction per its protocols.
- Transplanting institution's written eligibility criteria are required.
- Transplant center must evaluate for serious organ dysfunction and documentation of that evaluation should be included.
Post-Transplant Coverage
Definitions
Background
Chronic myelogenous leukemia (CML) is a myeloproliferative neoplasm driven by the BCR‑ABL (Philadelphia) fusion, a reciprocal translocation between chromosomes 9 and 22 that produces a constitutively active tyrosine kinase. CML most often presents in a chronic phase that can progress to accelerated or blast phase. Tyrosine kinase inhibitors (e.g., imatinib) are first‑line therapy and have markedly improved outcomes; allogeneic hematopoietic cell transplantation remains the only potentially curative option and is generally reserved for patients with progression or failure of TKI therapy.
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.