Allogeneic Hematopoietic Stem Cell Transplant*

Medical Policy: 08.01.02 
Original Effective Date: March 2004 
Reviewed: July 2008 
Revised: December 2006 

This policy applies to all products unless specific contract limitations, exclusions or exceptions apply. Please refer to the member's coverage manual for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply.

Description: 

Transplantation of allogeneic hematopoietic stem cells, derived from bone marrow or peripheral blood, in conjunction with a myeloablative conditioning regimen, is an established therapy for a variety of malignancies including acute and chronic leukemias, Hodgkin’s lymphoma, and non-Hodgkin’s lymphomas. Immunologic compatibility between donor and patient is a crucial factor in achieving a successful outcome. The harvested stem cells are administered to the patient intravenously following conditioning with myeloablative chemotherapy with or without total body irradiation at high enough doses to cause bone marrow failure. The treatment effect results from chemotherapeutic ablation of malignant cells, as well as an associated immune-mediated graft versus malignancy effect.

In 2001 the World Health Organization (WHO) classified non-Hodgkin’s lymphomas, based on definitions from the Revised European American classification of Lymphoid neoplasms (REAL), published by the International Lymphoma Study Group (ILSG) in 1994.  The WHO classification includes “indolent” lymphomas such as B-cell neoplasms, NK-cell neoplasms, and T-cell neoplasms; “intermediate” lymphomas including follicular lymphoma, diffuse large B-cell lymphoma, anaplastic large-cell lymphoma, and peripheral T-cell lymphoma; and, “aggressive” lymphomas including Burkitt’s lymphoma, precursor B lymphoblastic leukemia, adult T-cell lymphoma, and precursor T lymphoblastic leukemia.

Prior Approval is recommended for all transplant services. Contact:

Transplant Nurse Case Managers

1-800-552-3993 phone

1-515-235-4449 fax

Policy: 

Allogeneic hematopoietic stem cell transplant, in conjunction with a myeloablative conditioning regimen consisting of chemotherapy with or without total body irradiation, may be considered medically necessary for the following conditions:

  • Non-Hodgkin's Lymphoma (NHL)

NHL subtypes classified by the WHO/REAL system as "Intermediate" or "Aggressive" in the following situations:

  • As salvage therapy for patients who do not achieve a complete remission after first-line (induction) treatment with a full course of standard-dose chemotherapy
  • To consolidate a first complete remission for patients with an age-adjusted IPI score that predicts a high or high-intermediate risk of relapse
  • To achieve or consolidate a complete remission for those in a chemosensitive first or subsequent relapse.

NHL subtypes classified by WHO/REAL system as "Indolent" in the following situations:

  • As salvage therapy for patients who do not achieve a complete remission after first-line (induction) treatment with a full course of standard-dose chemotherapy
  • To achieve or consolidate complete remission for those in a first or subsequent chemosensitive relapse, whether or not their lymphoma has undergone transformation to a higher grade.
  • Acute Lymphoblastic Leukemia (ALL)
    • Adults and children in first complete remission at high risk of relapse
    • Adults or children in second or greater remission or refractory ALL
    • Adults with relapsed ALL following conventional-dose chemotherapy

Risk factors associated with high risk of relapse following initial complete remission include:

  • Age > 15 years
  • Leukocyte count > 10 x 109/L
  • Extramedullary disease (especially central nervous system)
  • Chromosomal abnormalities, including Philadelphia chromosome
  • Failure to achieve a complete remission within 6 weeks of the start of induction therapy 
  • Acute Myelogenous Leukemia (AML)
    • Treatment of AML in any stage for individuals who have not had previous high dose chemotherapy with stem cell support.
    • Primary refractory (unable to achieve complete remission after conventional-dose chemotherapy)
    • Relapse after attaining a first complete remission following conventional-dose chemotherapy
  • Chronic Myelogenous Leukemia (CML)
  • Pediatric Neuroblastoma
    • Initial treatment of high-risk neuroblastoma
    • Primary refractory or recurrent neuroblastoma in individuals who have not previously undergone treatment with high dose chemotherapy with stem cell support.
  • Myelodysplastic Diseases
    • Treatment of myelodysplastic syndrome
    • Treatment of myeloproliferative disorders, including Polycythemia Vera; Essential Thrombocytopenia; and, Primary Myelofibrosis.
  • Hodgkin's Disease (Lymphoma)
    • Primary refractory
    • Relapsed after an initial first remission
    • Relapsed after prior therapy with high-dose chemotherapy and autologous stem cell support
  • Genetic Diseases and Acquired Anemias
    • Sickle cell anemia for children or young adults at increased risk of stroke or end-organ damage, and with an HLA-identical, related donor.
      • Factors associated with a high risk of stroke or end-organ damage include recurrent chest syndrome, recurrent vaso-occlusive crisis, and red blood cell alloimmunization on chronic transfusion therapy.
    • Severe aplastic anemia, including congenital (i.e., Fanconi's anemia or Diamond-Blackfan syndrome) or acquired (i.e., secondary to drug or toxin exposure) forms.
    • Homozygous beta-thalassemia
    • Wiskott-Aldrich syndrome
    • Severe combined immunodeficiencies
    • Albers-Schönberg disease
    • Mucopolysaccharidoses (including Hunter's, Hurler's, Sanfilippo, Maroteaux-Lamy variants)
    • Mucolipidoses (including Gaucher's disease, metachromatic leukodystrophy, globoid cell leukodystrophy, adrenoleukodystrophy) for patients who have failed conventional therapies.
    • Kostmann's syndrome
    • Leukocyte adhesion deficiencies
    • X-linked lymphoproliferative syndrome


Allogeneic hematopoietic stem cell transplant, in conjunction with a myeloablative conditioning regimen consisting of chemotherapy with or without total body irradiation is considered investigational for the following indications: 
  • Acute Lymphocytic Leukemia (ALL)
    • Relapsing after a prior myeloablative conditioning regimen and autologous stem cell support 
  • Acute Myelogenous Leukemia (AML)
    • Relapsing after a prior myeloablative conditioning regimen and autologous stem cell support 
  • Epithelial Ovarian Cancer
  • Breast Cancer
  • Germ Cell Tumors (testicular, mediastinal, retroperitoneal, ovarian)
  • Malignant astrocytomas and gliomas
  • Multiple myeloma
  • Pediatric neuroblastoma 
  • Primitive neuroectodermal tumors (PNET), including medulloblastoma and ependymoma
  • High-risk solid tumors of childhood, including but not limited to:
    • Ewing sarcoma
    • Wilms' tumor
    • Osteosarcoma
    • Retinoblastoma
    • Rhabdomyosarcoma
    • All high-risk pediatric tumors relapsing after a prior myeloablative conditioning regimen and autologous stem cell support 
  • Solid tumors in adults
  • Non-Hodgkin's Lymphoma (NHL)
    • As initial therapy (i.e., without a full course of standard-dose induction chemotherapy) for all NHL's subtypes
  • Hodgkin's lymphoma
    • As initial therapy for newly diagnosed disease
    • To consolidate a first complete remission
  • Auto-immune diseases including, but not limited to:
    • Multiple Sclerosis
    • Rheumatoid Arthritis
    • Systemic Lupus Erythematosus 

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Procedure Codes and Billing Guidelines: 

The following CPT codes may be used to report services/procedures related to allogeneic bone marrow or peripheral stem cell transplant:

  • 38205 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; allogenic
  • 38207 Transplant preparation of hematopoietic progenitor cells; cryopreservation and storage
  • 38208 Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, without washing
  • 38209 Transplant preparation of hematopoietic progenitor cells; thawing of previously frozen harvest, with washing
  • 38210 Transplant preparation of hematopoietic progenitor cells; specific cell depletion within harvest, T-cell depletion
  • 38211 Transplant preparation of hematopoietic progenitor cells; tumor cell depletion
  • 38212 Transplant preparation of hematopoietic progenitor cells; red blood cell removal
  • 38213 Transplant preparation of hematopoietic progenitor cells; platelet depletion
  • 38214 Transplant preparation of hematopoietic progenitor cells; plasma (volume) depletion
  • 38215 Transplant preparation of hematopoietic progenitor cells; cell concentration in plasma, mononuclear, or buffy coat layer
  • 38220 Bone marrow; aspiration only
  • 38221 Bone marrow; biopsy, needle or trocar
  • 38230 Bone marrow harvesting for transplantation
  • 38240 Bone marrow or blood-derived peripheral stem cell transplantation; allogenic
  • 38242 Bone marrow or blood-derived peripheral stem cell transplantation; allogeneic donor lymphocyte infusions

The following HCPCS code may be used to report allogeneic bone marrow or peripheral blood stem cell transplant:

  • S2150 Bone marrow or blood-derived peripheral stem cell harvesting and transplantation, allogenic or autologous, including pheresis, high-dose chemotherapy, and the number of days of post-transplant care in the global definition (including drugs; hospitalization; medical, surgical, diagnostic and emergency services)

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Selected References: 

  • The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
  • Robinet E, Lapierre V, Tayebi H, et al., Blood versus marrow hematopoietic allogeneic graft. Transfus Apheresis Sci. 2003 Aug; 29(1): 53-9.
  • Anagnostopoulos A, Giralt S. Critical review on non-myeloablative stem cell transplantation (NST). Crit Rev Oncol Hematol. 2002;44(2):175-190.
  • Berdeja JG, Jones RJ, et al. Allogeneic bone marrow transplantation in patients with sensitive low-grade lymphoma or mantle cell lymphoma. Biol Blood Marrow Transplant. 2001;7(10):561-567.
  • Bleakley M, Lau L, Shaw PJ, Kaufman A. Bone marrow transplantation for paediatric AML in first remission: a systematic review and meta-analysis. Bone Marrow transplant. 2002 May; 29(10): 843-52.
  • Branson K, Chopra R, et al. Role of nonmyeloablative allogeneic stem-cell transplantation after failure of autologous transplantation in patients with lymphoproliferative malignancies. J Clin Oncol. 2002;20(19):4022-4031.
  • Storek J, Viganego F, Dawson MA, et al. Factors affecting antibody levels after allogeneic hematopoietic cell transplantation. Blood. 2003 Apr 15; 101(8):3319-24. Epub 2002 Dec 27.
  • Levine JE, Uberti JP, Ayash L, et al. Lowered-intensity preparative regimen for allogeneic stem cell transplantation delays acute graft-versus-host disease but does not improve outcome for advanced hematologic malignancy. Biol Blood Marrow Transplant. 2003 Mar; 9(3): 189-97.
  • Passweg JR, Meyer-Monard S, Gregor M, et al. High stem cell dose will not compensate for t-cell depletion in allogeneic non-myeloablative stem cell transplantation. Bone Marrow Transplant. 2002 Sep; 30(5): 267-71.
  • ECRI. High-Dose Chemotherapy (HDC) with Autologous or Allogeneic Stem Cell Transplantation (SCT) or Bone Marrow Transplantation (BMT) for Medulloblastoma. Plymouth Meeting (PA): ECRI Health Technology Information Service; 2002 May 29. (ECRI Hotline Response).
  • Hale GA, Tong X, Benaim E et al. Allogeneic bone marrow transplantation in children failing prior autologous bone marrow transplantation. Bone Marrow Transplant 2001; 27(2):155-62.
  • Acute Myeloid Leukemia. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. v.2.2005.
  • Non-Hodgkin's Lymphoma. National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. v.1.2005.
  • 2000 Technology Evaluation Center Assessments. Tab 9; Salvage HDC/AlloSCS for Relapse or Incomplete Remission Following HDC/AuSCS for Hematologic Malignancies.
  • Perez-Martinez A, Quintero V, Vicent MG et al. High-dose chemotherapy with autologous stem cell rescue as first line of treatment in young children with medulloblastoma and supratentorial primitive neuroectodermal tumors. J Neurooncol. 2004; 67(1-2):101-6.
  • Cogliatti S, Schmid U. Who is WHO and what was REAL? A review of the new WHO classification (2001) for malignant lymphoma. Swiss Med Wkly 2002;132:607-617.
  • Hahn T, Wingard JR, Anderson KC et al. The role of cytotoxic therapy with hematopoietic stem cell transplantation in the therapy of multiple myeloma: an evidence-based review. Biol Blood Marrow Transplant. 2003 Jan;9(1);4-37.
  • Bruno B, Rotta M, Patriarca F et al. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J med 2007;356:1110-20.
  • Kuruvilla J, Shepherd JD, Sutherland HJ et al. Long-term outcome of myeloablative allogeneic stem cell transplantation for multiple myeloma. Biol Blood Marrow Transplant. 2007 Aug;13(8):925-31. E-pub 2007 May 29.
  • Rosinol L, Perez-Simon JA, Sureda A et al. A prosptective pethema study of tandem autologous transplantation versus autograft followed by reduced-intensity conditioning allogeneic transplantation in newly diagnosed multiple myeloma. Blood 2008 Jul 8. [E-pub ahead of print].
  • Chevallier P, Mohty M, Lioure B et al. Allogeneic Hematopoietic Stem Cell Transplantation for Myeloid Sarcoma: A Retrospective Study from the SFGM-TC. J Clin Oncol 2008 Jul 7 [E-pub ahead of print].    

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New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:

Wellmark Blue Cross and Blue Shield
Medical Policy Analyst
Station 304
636 Grand Ave
Des Moines, Iowa 50309

*Current Procedural Terminology © 2008 American Medical Association. All Rights Reserved.

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.