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Hematopoietic Cell Transplantation for Chronic Myeloid Leukemia

Policy Number: MP-397

Latest Review Date:  March 2020

Category:  Surgery                                                                 

Policy Grade:  A


Allogeneic hematopoietic cell transplantation using a myeloablative conditioning regimen may be medically necessary for the treatment of chronic myeloid leukemia.

Allogeneic hematopoietic cell transplantation using a reduced-intensity conditioning (RIC) regimen may be medically necessary for the treatment of chronic myeloid leukemia in patients who meet clinical criteria for an allogeneic HCT, but who are not considered candidates for a myeloablative conditioning allogeneic HCT.

Autologous hematopoietic cell transplantation is not medically necessary and is considered investigational as a treatment of chronic myeloid leukemia.


Some patients for whom a conventional myeloablative allotransplant could be curative may be considered candidates for reduced-intensity conditioning allogeneic hematopoietic cell transplantation. They include those patients whose age (typically >60 years) or comorbidities (e.g., liver or kidney dysfunction, generalized debilitation, prior intensive chemotherapy, low Karnofsky Performance Status score) preclude use of a standard myeloablative conditioning regimen.

For patients who qualify for a myeloablative allogeneic hematopoietic cell transplantation on the basis of clinical status, either a myeloablative or a reduced-intensity conditioning regimen may be considered medically necessary.


Chronic myelogenous leukemia (CML) is a hematopoietic stem-cell disorder that is characterized by the presence of a chromosomal abnormality called the Philadelphia chromosome, which results from reciprocal translocation between the long arms of chromosomes 9 and 22. CML most often presents in a chronic phase which it progresses to an accelerated and then a blast phase. Allogeneic hematopoietic stem cell transplant (HSCT) is a treatment option for CML.

Chronic Myelogenous Leukemia

Chronic myelogenous leukemia (CML) is a hematopoietic stem-cell disorder that is characterized by the presence of a chromosomal abnormality called the Philadelphia chromosome, which results from reciprocal translocation between the long arms of chromosomes 9 and 22.  This cytogenetic change results in constitutive activation of BCR-ABL, a tyrosine kinase (TK) that stimulates unregulated cell proliferation, inhibition of apoptosis, genetic instability, and perturbation of the interactions between CML cells and the bone marrow stroma only in malignant cells. CML accounts for about 15% of newly diagnosed cases of leukemia in adults and occurs in about 1 to 2 cases per 100,000 adults.

The natural history of the disease consists of an initial (indolent) chronic phase, lasting a median of three years that typically transforms into an accelerated phase, followed by a "blast crisis," which is usually the terminal event. Most patients present in chronic phase, often with nonspecific symptoms that are secondary to anemia and splenomegaly. CML is diagnosed based on the presence of the Philadelphia chromosome abnormality by routine cytogenetics or by detection of abnormal BCR-ABL products by fluorescence in situ hybridization or molecular studies, in the setting of persistent unexplained leukocytosis.  Conventional-dose chemotherapy regimens used for chronic-phase disease can induce multiple remissions and delay the onset of blast crisis to a median of four to six years.  However, successive remissions are invariably shorter and more difficult to achieve than their predecessors.


Historically, the only curative therapy for CML in blast phase was HCT, and was used more widely earlier in the disease process given the lack of other therapies for chronic phase CML. Drug therapies for chronic phase CML were limited to nonspecific agents including busulfan, hydroxyurea, and interferon-alpha.

Imatinib mesylate (Gleevec®), a selective inhibitor of the abnormal BCR-ABL TK protein), is considered the treatment of choice for newly diagnosed CML.  While imatinib can be highly effective in suppressing CML in most patients, it is not curative and is ineffective in 20% to 30%, initially or due to development of BCR-ABL mutations that cause resistance to the drug. Even so, the overall survival (OS) of patients who present in chronic phase is greater than 95% at two years and 80% to 90% at five years.

Two other TK inhibitors (TKIs, dasatinib, nilotinib) have received marketing approval from the U.S. Food and Drug Administration (FDA) to treat CML as front-line therapy or following failure or patient intolerance of imatinib. Two additional TKIs, bosutinib and ponatinib, have been approved for use for patients resistant or intolerant to prior therapy.

For patients who progress on imatinib, the therapeutic options include increasing the imatinib dose, changing to another TKI, or allo-HSCT. Detection of BCR-ABL mutations may be important in determining an alternative TKI; the presence of T315I mutation is associated with resistance to all TKIs and should indicate the need for allo-HSCT or an experimental therapy. TKIs have been associated with long-term remissions; however, if progression occurs on TKI therapy, allo-HCT is generally indicated and offers the potential for cure.

Hematopoietic Cell Transplantation

Hematopoietic cell transplantation refers to a procedure in which hematopoietic stem cells are infused to restore bone marrow function in cancer patients who receive bone-marrow-toxic doses of cytotoxic drugs with or without whole body radiotherapy. Hematopoietic stem cells may be obtained from the transplant recipient (autologous HCT) or from a donor (allogeneic HCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood shortly after delivery of neonates. Although cord blood is an allogeneic source, the stem cells in it are antigenically “naïve” and thus are associated with a lower incidence of rejection or graft-versus-host disease (GVHD).

Immunologic compatibility between infused hematopoietic stem cells and the recipient is not an issue in autologous HCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allogeneic HCT. Compatibility is established by typing of human leukocyte antigens (HLA) using cellular, serologic, or molecular techniques.  HLA refers to the tissue type expressed at the HLA A, B, and DR (antigen-D) loci on each arm of chromosome 6. Depending on the disease being treated, an acceptable donor will match the patient at all or most of the HLA loci.

Conditioning for Hematopoietic Cell Transplantation

Conventional Conditioning

The conventional (“classical”) practice of allo-HCT involves administration of cytotoxic agents (e.g., cyclophosphamide, busulfan) with or without total body irradiation at doses sufficient to cause bone marrow ablation in the recipient. The beneficial treatment effect of this procedure is due to a combination of the initial eradication of malignant cells and subsequent graft-versus-malignancy effect mediated by non-self-immunologic effector cells. While the slower graft-versus-malignancy effect is considered the potentially curative component, it may be overwhelmed by existing disease in the absence of pretransplant conditioning. Intense conditioning regimens are limited to patients who are sufficiently medically fit to tolerate substantial adverse effects. These include opportunistic infections secondary to loss of endogenous bone marrow function and organ damage or failure caused by cytotoxic drugs. Subsequent to graft infusion in allo-HCT, immunosuppressant drugs are required to minimize graft rejection and graft-versus-host disease, which increases susceptibility to opportunistic infections.

The success of autologous HCT is predicated on the potential of cytotoxic chemotherapy, with or without radiotherapy, to eradicate cancerous cells from the blood and bone marrow. This permits subsequent engraftment and repopulation of the bone marrow with presumably normal hematopoietic stem cells obtained from the patient before undergoing bone marrow ablation. Therefore, autologous HCT is typically performed as consolidation therapy when the patient’s disease is in complete remission. Patients who undergo autologous HCT are also susceptible to chemotherapy-related toxicities and opportunistic infections before engraftment, but not graft-versus-host disease.

Reduced-Intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

RIC refers to the pretransplant use of lower doses of cytotoxic drugs or less intense regimens of radiotherapy than are used in traditional full-dose myeloablative conditioning treatments. Although the definition of RIC is variable, with numerous versions employed, all regimens seek to balance the competing effects of relapse due to residual disease and non-relapse mortality. The goal of RIC is to reduce disease burden and to minimize associated treatment-related morbidity and non-relapse mortality in the period during which the beneficial graft-versus-malignancy effect of allogeneic transplantation develops. RIC regimens range from nearly total myeloablative to minimally myeloablative with lymphoablation, with intensity tailored to specific diseases and patient condition. Patients who undergo RIC with allo-HCT initially demonstrate donor cell engraftment and bone marrow mixed chimerism. Most will subsequently convert to full-donor chimerism. In this review, the term reduced-intensity conditioning will refer to all conditioning regimens intended to be nonmyeloablative.


The most recent literature update was performed through November 11, 2019.

Summary of Evidence

For individuals who have CML who receive allo-HCT, the evidence includes systematic reviews, randomized controlled trials (RCTs), and multiple prospective and retrospective series. Relevant outcomes include overall survival, disease-specific survival, and treatment-related morbidity and mortality. The introduction of the tyrosine kinase inhibitors (TKIs) imatinib, dasatinib, nilotinib, bosutinib, and ponatinib, has significantly changed the practice of HCT for CML. TKIs have replaced HCT as initial therapy in patients with chronic phase CML. However a significant proportion of cases fail to respond to TKIs, develop resistance to them, or become unable to tolerate all TKIs and go on to allogeneic HCT. In addition, allogeneic HCT represents the only potentially curative option for those patients in accelerated or blast phase.  The currently-available evidence suggests that TKI-pretreatment does not lead to worse outcomes if HCT is needed. Myeloablative conditioning regimens prior to HCT are used in younger (<60 years) patients without significant comorbidities. However, for patients with more comorbidities and/or more advanced ages in whom myeloablative conditioning regimens would be prohibitively high risk, evidence suggests that reasonable outcomes can be obtained after HCT. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have CML who receive autologous HCT, the evidence includes case series. Relevant outcomes are overall survival, disease-specific survival, and treatment-related morbidity and mortality. In the largest series of 200 patients, median survival was 36 months for patients transplanted during an accelerated phase and median survival data were not available for patients transplanted in chronic phase. Controlled studies are needed to draw conclusions about the impact of autologous HCT on health outcomes in patients with CML. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

National Comprehensive Cancer Network (NCCN)

Current National Comprehensive Cancer Network guidelines (v.1.2020) recommend allogeneic hematopoietic cell transplantation (allo-HCT) as an alternative treatment only for high-risk settings or in patients with advanced phase chronic myeloid leukemia (CML). Relevant recommendations are:

      “Allogeneic HCT is no longer recommended as a first-line treatment option for CP [chronic   

        phase] CML.”

      “Allogeneic HCT is an appropriate treatment option for the very rare patients presenting        

       with BP [blast phase]-CML at diagnosis, patients with disease that is resistant to TKIs,   

       patients with progression to AP [accelerated phase]-CML or BP-CML while on TKI therapy,

       and for the rare patients intolerant to all TKIs”

      “Evaluation for allogeneic HCT….is recommended for all patients with AP [accelerated

        phase] CML or BP [blast phase] CML”

NCCN guideline states, “Nonmyeloablative allogeneic HCT is a well-tolerated treatment option for patients with a matched donor and the selection of patients is based on their age and presence of comorbidities.

Autologous bone marrow transplant for CML is not addressed in the NCCN guidelines.

American Society for Blood and Marrow Transplantation

In 2015, guidelines by the American Society for Blood and Marrow Transplantation were published on indications for autologous and allogeneic HCT.

Recommendations regarding CML are listed in Table 1.

Table 1. Recommendations on Allogeneic and Autologous HCT for CML


Allogeneic HCT

Autologous HCT




Chronic phase



Accelerated phase



Blast phase






Chronic phase, tyrosine kinase inhibitor intolerant



Chronic phase, tyrosine kinase inhibitor refractory



Chronic phase 2+



Accelerated phase



Blast phase



C: Standard of care, clinical evidence available; S: standard of care; N: Not generally recommended; HCT: hematopoietic cell transplantation

U.S. Preventative Services Task Force Recommendations

Not applicable.


Chronic Myelogenous Leukemia, High-Dose Chemotherapy, Stem-Cell Transplant, Myeloid, CML, HSCT, HCT, allogeneic, allo-HCT, autologous, chronic myeloid leukemia, hematopoietic cell transplantation


The U.S. Food and Drug Administration regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271. Hematopoietic stem cells are included in these regulations.


Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.


CPT Codes:

38204              Management of recipient hematopoietic cell donor search and cell acquisition

38205              Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, allogeneic

38206              Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection, autologous

38208              Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing; per donor

38209              ;thawing of previously frozen harvest, with washing; per donor  

38210              ;specific cell depletion within harvest, T-cell depletion

38211              ;tumor cell depletion

38212              ;red blood cell removal

38213              ;platelet depletion

38214              ;plasma (volume) depletion

38215              ;cell concentration in plasma, mononuclear, or buffy coat


38220              Diagnostic bone marrow; aspiration(s)

38221                   Diagnostic bone marrow; biopsy(ies)

38222              Diagnostic bone marrow; biopsy(ies) and aspiration(s) (Effective 01/01/2018)

38230              Bone marrow harvesting for transplantation; allogeneic

38232              ; autologous

38240              Bone marrow or blood-derived peripheral stem-cell transplantation; allogeneic

38241              Bone marrow or blood-derived peripheral stem-cell transplantation; autologous

38242              Allogeneic donor lymphocyte infusions


S2140              Cord blood harvesting for transplantation, allogeneic

S2142              Cord blood-derived stem-cell transplantation, allogeneic

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


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Medical Policy Group, December 2009 (3)

Medical Policy Administration Committee, February 2010

Available for comment February 5-March 22, 2010

Medical Policy Group, December 2011; Updated Codes 38209, 38210 & 38230 and added Code 38232 – 2012 code updates

Medical Policy Group, December 2011 (4): added Summary section to Key Points and updated References.

Medical Policy Panel, December 2012

Medical Policy Group, December 2012 (3): 2012 update -  NCCN Guidelines section and References.  Policy statement remains unchanged

Medical Policy Panel, December 2013

Medical Policy Group, January 2014 (3):  2013 Updates to Description, Key Points and References; no change in policy statement

Medical Policy Panel, December 2014

Medical Policy Group, January 2015 (3): 2014 Updates to Description, Key Points, and References, no change in policy statement.

Medical Policy Panel, January 2016

Medical Policy Group, March 2016 (2): 2016 Updates Description, Key Points, Approved by Governing Bodies, and References, no change in policy statement.

Medical Policy Panel, January 2017

Medical Policy Group, January 2017 (7): Updates to Description, Key Points, Key Words, and References. Updated policy title and policy statements by removing “stem”, and replaced “myelogenous” with “myeloid” for clarification purposes.

Medical Policy Group, December 2017. Annual Coding Update 2018. Added new CPT code 38222 effective 1/1/18 to the Current Coding section. Updated verbiage for revised CPT codes 38220 and 38221.

Medical Policy Panel, February 2018

Medical Policy Group, March 2018 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, January 2019

Medical Policy Group, February 2019 (3): 2019 Updates to Key Points, Practice Guidelines and Position Statements, References and Key Words: added: hematopoietic cell transplantation. No changes to policy statement or intent.

Medical Policy Panel, January 2020

Medical Policy Group, March 2020 (3): Updates to Description, Key Points, Practice Guidelines and Position Statements. No changes to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.