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DESCRIPTIONIschemia is the most common cause of cardiovascular disease and myocardial damage in the developed world. Despite impressive advances in treatment, ischemic heart disease is still associated with high morbidity and mortality. Current treatments for ischemic heart disease seek to revascularize occluded arteries, optimize pump function, and prevent future myocardial damage. However, current treatments are not able to reverse existing damage to heart muscle. Treatment with progenitor cells (i.e., stem cells) offers potential benefits beyond those of standard medical care, including the potential for repair and/or regeneration of damaged myocardium.
Various types of autologous cell transplantation have been researched as a technique to either stimulate regeneration of the myocardium or modify ventricular remodeling after infarct. The ideal donor cell is uncertain, and there are scientific as well as ethical concerns involved in choosing the ideal source of donor cells. The range of potential sources of donor cells includes embryonic stem cells, adult stem cell, fetal myocytes, and adult blood progenitor cells.
The mechanism of benefit following treatment with progenitor cells is not entirely understood. Differentiation of progenitor cells into mature myocytes and engraftment of progenitor cells into areas of damaged myocardium has been suggested in animal studies using tagged progenitor cells. However, there is controversy concerning whether injected progenitor cells actually engraft and differentiate into mature myocytes in humans to a degree that might result in clinical benefit.
Other mechanisms of benefit have been hypothesized. Progenitor cells may improve perfusion to areas of ischemic myocardium. Basic scientific research also suggests that injected stem cells secrete cytokines with antiapoptotic and pro-angiogenesis properties. Clinical benefit may result if these paracrine factors are successful at limiting cell death from ischemia. Finally, progenitor cell therapy may activate the intrinsic repair mechanisms of the heart.
There is a variety of potential delivery mechanisms for donor cells, encompassing a wide range of invasiveness. Donor cells can be delivered via thoracotomy and direct injection into areas of damaged myocardium. Injection of progenitor cells into the coronary circulation can also be done using percutaneous, catheter-based techniques. Finally, progenitor cells can be delivered intravenously via a peripheral vein. With this approach, the cells must be able to target damaged myocardium and concentrate at the site of myocardial damage.
Adverse effects of treatment with progenitor cells include the risk of the delivery procedure (e.g., thoracotomy, percutaneous catheter-based, etc.) and the risks of the donor cells themselves. Donor progenitor cells can differentiate into fibroblasts rather than myocytes. This may create a substrate for malignant ventricular arrhythmias. There is also a theoretical risk that tumors, such as teratomas, can arise from progenitor cells, but the actual risk of this occurring in humans is not known at present.
U.S. Food and Drug Administration (FDA) approval is not required in situations in which autologous cells are processed on site with existing laboratory procedures and injected with existing catheter devices. However, there are currently two products that require FDA approval. MyoCell™ consists of patient autologous skeletal myoblasts that are expanded ex vivo and supplied as a cell suspension in a buffered salt solution for injection into the area of damaged myocardium. Since the myoblast isolation and expansion occurs at a single reference laboratory (BioHeart), this process is subject to FDA approval. In addition, implantation may require the use of a unique catheter delivery system (MyoCath™) that also requires FDA approval.
POLICYProgenitor cell therapy, including but not limited to skeletal myoblasts or hematopoietic stem cells, is considered investigational as a treatment of damaged myocardium.
Infusion of growth factors (i.e., granulocyte colony stimulating factor [GCSF]) is considered investigational as a technique to increase the numbers of circulating hematopoietic stem cells as treatment of damaged myocardium.
POLICY GUIDELINESInvestigative 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.
POLICY HISTORY7/15/2004: Approved by Medical Policy Advisory Committee (MPAC)
10/5/2004: Code Reference section completed
3/15/2006: Policy reviewed, no changes
7/22/2008: Policy reviewed, no changes
8/10/2009: Policy Title revised to add "Progenitor" and "due to Ischemia", Policy Description Section updated to add research information on various types of autologous cell tranplantation and adverse effects of treatment with progenitor cells, Verbage, " Investigational for all uses", added to Non-Covered ICD-9 Diagnosis codes Section.
07/16/2010: Policy reviewed; no changes.
08/02/2011: Policy reviewed; no changes.
07/17/2012: Policy reviewed. Deleted "Autologous" from the policy title and statement. Deleted outdated references from the Sources section.
09/03/2013: Policy reviewed; no changes.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.02.18
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
There are no specific codes for this procedure, either describing the laboratory component of processing the harvested autologous cells, or for the implantation procedure. The laboratory component may be reported with the stem cell procedure codes (38204, 38206, 38207, 38208, 38209, 38210, 38211, 38212, 38213, 38214, 38215, 38230, 38241). In some situations, the implantation may be an added component of a scheduled coronary artery bypass graft (CABG), in other situations the implantation may be performed as a unique indication for a cardiac catheterization procedure.