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Autoimmune diseases represent a heterogeneous group of immune-mediated disorders, with some of the most common types being multiple sclerosis (MS), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis/scleroderma. The National Institutes of Health estimates that 5%–8% of Americans have an autoimmune disorder.

The pathogenesis of autoimmune diseases is not well understood but appears to involve underlying genetic susceptibility and environmental factors that lead to loss of self-tolerance, culminating in tissue damage by the patient’s own immune system (T cells).

Immune suppression is a common treatment strategy for many of these diseases, particularly the rheumatic diseases (e.g., RA, SLE, and scleroderma). Most patients with autoimmune disorders respond to conventional therapies, which consist of antiinflammatory agents, immunosuppressants, and immune-modulating drugs. However, these drugs are not curative, and a proportion of patients will have severe, recalcitrant, or rapidly progressive disease. It is in this group of patients with severe autoimmune disease that alternative therapies have been sought, including hematopoietic stem-cell transplantation (SCT).

SCT in autoimmune disorders raises the question of whether ablating and “resetting” the immune system can alter the disease process and sustain remission and possibly lead to cure. Certain hematologic malignancies, aplastic anemia, and inborn errors of metabolism are treated with SCT. However, its usage in autoimmune diseases has only been performed in approximately 1,000 patients in the last decade.

The rationale for SCT for autoimmune disease is based on studies in experimental animal models, and on observations of remissions of autoimmune disease in patients who received SCT for hematologic malignancies.

Hematopoietic Stem-Cell Transplantation

Hematopoietic stem-cell transplantation (SCT) refers to a procedure in which hematopoietic stem cells are infused to restore bone marrow function in patients who receive bone marrow-toxic doses of cytotoxic drugs with or without whole-body radiation therapy. Stem cells from the bone marrow may be obtained from the transplant recipient (autologous SCT) or from a donor (allogeneic SCT). They can be harvested from bone marrow, peripheral blood, or umbilical cord blood and placenta 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. Cord blood is discussed in greater detail in the Placental and Umbilical Cord Blood as a Source of Stem Cells policy.

Immunologic compatibility between infused stem cells and the recipient is not an issue in autologous SCT. However, immunologic compatibility between donor and patient is a critical factor for achieving a good outcome of allogeneic SCT. 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 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.

Autologous Stem-Cell Transplantation for Autoimmune Diseases

The goal of autologous SCT in patients with autoimmune diseases is to eliminate self-reactive lymphocytes (lymphoablative) and generate new self-tolerant lymphocytes. This approach is in contrast to destroying the entire hematopoietic bone marrow (myeloablative), as is often performed in autologous SCT for hematologic malignancies. However, there is currently no standard conditioning regimen for autoimmune diseases and both lymphoablative and myeloablative regimens are used. The efficacy of the different conditioning regimens has not been compared in clinical trials.

Currently, for autoimmune diseases, autologous transplant is preferred over allogeneic, in part because of the lower toxicity of autotransplant relative to allogeneic, the graft-versus-host disease associated with allogeneic transplant, and the need to administer post-transplant immunosuppression after an allogeneic transplant.

Allogeneic Stem-Cell Transplantation for Autoimmune Diseases

The experience of using allogeneic SCT for autoimmune diseases is currently limited, but has two potential advantages over autologous transplant. First, the use of donor cells from a genetically different individual could possibly eliminate genetic susceptibility to the autoimmune disease and potentially result in a cure. Second, there exists a possible graft-versus-autoimmune effect, in which the donor T cells attack the transplant recipient’s autoreactive immune cells.

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Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

6/25/2004: Code Reference section completed

11/18/2004:  Reviewed by MPAC, no changes

10/19/2005:  Code Reference section updated, codes G0355-G0364 added, 38204, 38205, 38240, 38242, 86812-86822,  J9000-J9999 deleted; ICD9 procedure code 41.01, 41.09 added, 41.05, 41.08, 41.91 deleted; description of ICD9 procedure code 99.79 revised; HCPCS statement added on how to report J9000-J9999 codes.

03/10/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy.

9/18/2007: Policy reviewed, no changes

12/19/2007: Coding updated per 2008 CPT/HCPCS revisions

9/30/2008: Description updated, "high-dose chemotherapy" removed from policy title and statement. "Stem-cell support" wording replaced with "stem-cell transplantation".No changes to policy statement intent.

10/05/2011:  Policy statement revised to add juvenile idiopathic arthritis and type 1 diabetes mellitus as investigational indications.

11/30/2012: Policy reviewed; no changes.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes