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DESCRIPTIONComposite tissue allotransplantation is defined as transplantation of histologically different tissues. This type of transplantation is being proposed for facial transplants in patients with severely disfigured faces, and for hand transplants in patients unsatisfied with prosthetic hands. The treatment has potential benefits in terms of improving functional status and psychosocial well-being. It also has potential risks, most notably those associated with a lifelong regimen of immunosuppressive drugs.
Composite tissue allotransplantation refers to the transplantation of histologically different tissue that may include skin, connective tissue, blood vessels, muscle, bone and nerve tissue. The procedure is also known as reconstructive transplantation. To date, primary applications of this type of transplantation have been of the hand and face (partial and full), although there are also reported cases of several other composite tissue allotransplantations, including that of the larynx, knee and abdominal wall.
The first successful partial face transplant was performed in France in 2005. The first complete facial transplant was performed in Spain in 2010. In the U.S., the first facial transplant was done in 2008 at the Cleveland Clinic; this was a near-total face transplant and included the midface, nose and bone. The first hand transplant with short-term success occurred in 1998 in France. However, the patient failed to follow the immunosuppressive regimen which led to graft failure and removal of the hand 29 months after transplantation. The first hand transplantation in the U.S. took place in Louisville, KY in 1999.
Hand and face transplants have been found to be technically feasible. The most commonly performed face transplant procedure has been to restore the lower two-thirds of facial structure, especially the perioral area (i.e., lips, cheeks and chin) and in some cases, the forehead, eyelids and scalp. Facial transplantation has been performed on patients whose faces have been disfigured by trauma, burns, disease or birth defects and who are unable to benefit from traditional surgical reconstruction. Hand transplantations have been done in patients who lost a hand due to trauma or life-saving interventions that caused permanent injury to the hand. To date, hand transplants have not been performed for congenital anomalies or loss of a limb due to cancer.
Composite tissue allotransplantation procedures are complex and involve a series of operations using a rotating team of specialists. For face transplantation, the surgery may last 8 to 15 hours. Hand transplant surgery typically lasts between 8 and 12 hours. Bone fixation occurs first, and this is generally followed by artery and venous repair and then by suture of nerves and/or tendons. In all surgeries performed to date, the median and ulnar nerves were repaired. The radial nerve was reconstructed in about half of the procedures.
Unlike most solid organ transplantations (e.g., kidney and heart transplants), composite tissue allotransplantation is not life-saving, and its primary aim is to increase a patient’s quality of life, e.g., by having a more normal appearance and a sense of wholeness. In the case of facial transplantations in particular, there is a large potential psychosocial benefit of successful surgery. Moreover, it is hoped that function, eg, grasping and lifting after hand transplants and blinking and mouth closure after face transplants, may be better after composite tissue transplantation than with alternative interventions. Additionally, in the case of face transplantation, the procedure may be less traumatic than “traditional” facial reconstructive surgery using the patient’s own tissue. For example, traditional procedures often involve dozens of operations, whereas facial transplantation involves only a few operations.
Composite tissue allotransplantation is associated with potential risks and benefits. Patients who undergo face or hand transplantation must adhere to a lifelong regimen of immunosuppressive drugs. Risks of immunosuppression include acute and chronic rejection, opportunistic infection that may be life-threatening and metabolic disorders such as diabetes, kidney damage and lymphoma. There are also potential adverse impacts on quality of life, including the need to commit to the immunosuppression regimen. Other challenges include the need to actively participate in intensive physical therapy to restore functionality and the potential for frustration and disappointment if level of functionality does not meet expectations. Moreover, there is the potential for allograft loss, which would lead to additional procedures in hand transplant patients, and there are limited reconstructive options for facial transplantation. Furthermore, in the case of hand transplants, there is a risk that functional ability (e.g., grasping and lifting objects) may be lower than with a prosthetic hand, especially compared with newer electronic prosthetic devices. Due to the importance of selecting candidates who can withstand these physical and mental challenges, potential hand and face transplant recipients undergo extensive screening for both medical and psychosocial suitability.
POLICYComposite tissue allotransplantation of the hand and/or face is considered investigational.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY07/18/2013: Approved by Medical Policy Advisory Committee.
03/17/2014: Policy reviewed; no changes.
03/17/2015: Policy description updated. Policy statement unchanged.
07/13/2015: Code Reference section updated for ICD-10.
04/14/2016: Policy description updated. Policy statement unchanged. Investigative definition updated in Policy Guidelines section.
06/01/2016: Policy number added.
SOURCE(S)Blue Cross and Blue Shield Association Policy # 7.03.13
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.