Autologous Hematopoietic Stem Cell Transplant* Printer-Friendly Version   

Medical Policy: 08.01.03 
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: 

Autologous hematopoietic stem cell transplant involves re-infusing a portion of the patient’s own stem cells to rescue the patient by re-establishing his or her bone marrow which has been eradicated after high dose chemotherapy (HDC) and /or total body irradiation.  Autologous stem cells can be harvested from bone marrow through direct aspiration or from circulating blood through the process of pheresis. To increase the number of stem cells in the peripheral circulation, autologous donors may be pre-treated with a course of hematopoietic growth factors.

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.

Policy: 

Prior Approval is recommended for all transplant services. Contact:

Transplant Nurse Case Managers
1-800-552-3993 phone
1-515-235-4449 fax

Autologous 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 indications:

• Acute Lymphoblastic Leukemia (ALL)
  • Adults and children in first complete remission at high risk of relapse
  • Adults and children in second or greater remission
  • Adults and children with relapsed or refractory ALL

  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)
  • AML in any stage for patients who have not had previous HDC with stem cell support 
• Chronic Myelogenous Leukemia (CML)
  • For patients who have failed Gleevec, or similar agents, and are in morphologic and cytogenic/molecular remission.
• Pediatric Neuroblastoma
  • Initial treatment of high-risk neuroblastoma (Definition of high-risk is based on the stage of the tumor and the number of copies of the oncogene N-myc).
  • Primary refractory or recurrent neuroblastoma in patients who have not been treated with high dose chemotherapy with stem cell support.
• Ewing's Sarcoma
  • Recurrent or refractory
• Primitive Neuroectodermal Tumors (PNET)
  • Recurrent or refractory medulloblastoma and other PNETS (tumors arising from the neuroepithelium, including central nervous system neuroblastoma, ependymoblastoma, and pinealoblastoma)
• Germ Cell Tumors (testicular, mediastinal, retroperitoneal, ovarian)
  • Refractory germ cell tumors or those exhibiting a partial response
  • Second complete remission or second relapse
  • For testicular cancer only, tandem high dose chemotherapy and autologous stem cell support
• Multiple Myeloma
  • Single or tandem transplant for newly diagnosed or responsive multiple myeloma (tumor shows complete or partial remission with at least a 50% reduction in tumor burden)
• Primary Amyloidosis-Patients in whom the following criteria is met:
  • Two or fewer organs involved with amyloid deposits
  • Serum creatinine of 2.0 mg/dL or less
  • No evidence of advanced cardiomyopathy as evidenced by ejection fraction of 45% or greater

• Lymphoma (Hodgkin's Disease)
  • Primary refractory
  • Relapsing after an initial course of chemotherapy
• 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 the 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.

• Breast Cancer
  • Chemosensitive Stage IV disease
  • Stage IV disease that has relapsed after a complete response to first line therapy for metastatic disease

Autologous hematopoietic stem cell transplant associated with a myeloablative conditioning regimen consisting of high-dose chemotherapy with or without total body irradiation is considered investigational for the following indications:

• Epithelial ovarian cancer
• Malignant astrocytomas and gliomas
• Autoimmune diseases including, but not limited to:
  • Multiple Sclerosis
  • Systemic Lupus Erythematosus
  • Aplastic Anemia
  • Rheumatoid and Juvenile idiopathic arthritis
• Stage I, II, III, or refractory Stage IV breast cancer, single or tandem transplant
• Initial therapy of all non-Hodgkin's lymphomas
• Initial treatment of germ cell tumors or as treatment following a first relapse
• Tandem transplants for all germ cell tumors except testicular cancer
• Ependymoma
• Initial treatment of low or intermediate risk Ewing sarcoma
• Wilms' tumor
• Retinoblastoma
• Osteosarcoma
• Rhabdomyosarcoma
• Refractory multiple myeloma
• Amyloidosis with involvement of greater than two organ systems and/or advanced cardiac involvement as evidenced by an ejection fraction less than 55%
• Chronic myelogenous leukemia in patients not meeting the criteria identified above
• Adults with acute lymphocytic leukemia in second or greater remission or those with refractory disease.
• Repair of damaged myocardium

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Procedure Codes and Billing Guidelines: 

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

• 38206 Blood-derived hematopoietic progenitor cell harvesting for transplantation, per collection; autologous
• 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
• 38241 Bone marrow or blood-derived peripheral stem cell transplantation; autologous

The following HCPCS code may be used to report autologous peripheral blood stem cell support or bone marrow 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.
• Attal M, Harousseau JL, Facon T, et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 2003 Dec 25: 349(26):2495-502.
• Tallman MS, Gray R, Robert NJ, et al. Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell transplantation in high-risk breast cancer. N Engl J med. 2003 Jul 3; 349(1):17-26.
• Federico M, Bellei M, Brice P, et al. High-dose therapy and autologous stem cell transplantation versus conventional therapy for patients with advanced Hodgkin's lymphoma responding to front line therapy. J Clin Oncol. 2003 Jun 15; 21(12):2320-5. Comment in: Cancer Treat Rev 2003 Dec; 29(6):555-9.
• Kaiser U, Uebelacker I, Abel U, et al. Randomized study to evaluate the use of high-dose therapy as part of primary treatment for “aggressive” lymphoma. J Clin Oncol. 2002 Nov 15; 20(22): 4413-9.
• Kottaridis PD, Peggs K, Schmitz N, et al. Survival and freedom from progression in autotransplant lymphoma patients is independent of stem cell source: further follow up from the original randomized study to assess engraftment. Leuk Lymphoma. 2002 Mar; 43(3):531-6.
• Marcus KJ, Shamberger R, Litman H, et al. Primary tumor control in patients with stage ¾ unfavorable neuroblastoma treated with tandem double autologous stem cell transplants. J Pediatr Hematol Oncol. 2003 Dec; 25(12):934-40.
• Imrie K, Esmail R, Meyer RM, et al. The role of high-dose chemotherapy and stem-cell transplantation in patients with multiple myeloma: a practice guideline of the Cancer Care Ontario Practice Guidelines Initiative. Ann Intern Med. 2002 Apr 16; 136(8): 619-29.
• Bhatia R, Verfaillie CM, Miller JS et al. Autologous Transplantation Therapy for Chronic Myelogenous Leukemia. Blood. The Journal of the American Society of Hematology. 1997; 89(8):2623-34.
• Chronic Myelogenous Leukemia. National Comprehensive Cancer Network Clinical Practice Guidelines. v.2.2005.
• Skinner M et al. High-dose melphalan and autologous stem cell transplantation in patients with AL amyloidosis: an 8 year study. Ann Intern Med. 2004 Jan 20; 140(2):85-93.
• ECRI. High-Dose Chemotherapy with Autologous Bone marrow or peripheral Stem Cell Transplant for Epithelial Ovarian Cancer. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2004. Windows on Medical Technology No. 117.
• ECRI. High-dose chemotherapy (immunosuppression) with stem cell transplantation for treatment of multiple sclerosis. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2005. Health Technology Forecast.
• ECRI Autologous stem cell transplantation for myocardial repair. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Services; 2005. Health Technology Forecast.
• Abbott JD, Giordano FJ. Stem cells and cardiovascular disease. J Nucl Cardiol 2003: 10(4):403-12.
• Smits PC, van Geuns RJ, Poldermans D et al. Catheter-based intramyocardial  injection of autologous skeletal myoblasts as a primary treatment of ischemic heart failure: clinical experience with six-month follow-up. J Am Coll Cardiol 2003; 42(12):2063-9.
• 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.
• Einhorn LH, Williams SD, Chamness A et al. High-dose chemotherapy and stem cell rescue for metastatic germ-cell tumors. N Engl J Med 2007;357:340-8.
• Abdelkefi A, Ladeb S, Torjman L et al. Single autologous stem-cell transplantation followed by maintenance therapy with thalidomide is superior to double autologous transplantation in multiple myeloma: results of a multicenter randomized clinical trial. Blood 2008; 111(4):1805-10.
• Gill P, Litzow M, Buckner J et al. High-dose chemotherapy with autologous stem cell transplantation in adults with recurrent embryonal tumors of the central nervous system. Cancer 2008 Apr 15;112-(8):1805-11.
• Shih CS, Hale GA, Gronewald L et al. High-dose chemotherapy with autologous stem cell rescue for children with recurrent malignant brain tumors.   

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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.