Latest Review Date: August 2024

Category:  Surgery                                                                 

POLICY:

Composite tissue allotransplantation (CTA) of the hand and/or face is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

Composite tissue allotransplantation (also referred to as vascularized composite allotransplantation) is defined as transplantation of histologically different tissues. This type of transplantation is being proposed for facial transplants in individuals with severely disfigured faces, and for hand transplants in individuals dissatisfied 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

Composite tissue allotransplantation refers to the transplantation of histologically different tissue, which 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 hand and face (partial and full), although there are also reported cases of several other CTAs, including that of the larynx, knee and abdominal wall.

Hand and face transplants have been shown to be technically feasible. The first successful partial face transplant was performed in France in 2005, and the first complete facial transplant was performed in Spain in 2010. In the U.S., the first facial transplant was done in 2008; it 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 1999.

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 the 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 (eg, kidney and heart transplants), composite tissue allotransplantation is not life-saving, and its primary aim rests mainly in a patient's cosmetic satisfaction and quality of life. In the case of facial transplantations, there is immense potential for psychosocial benefits when surgery is successful. Moreover, the goal of composite tissue transplantation is to improve function (eg, grasping and lifting after hand transplants, blinking and mouth closure after face transplants) without alternative interventions such as prosthetics. Additionally, in the case of face transplantation, the procedure may be less traumatic than "traditional" facial reconstructive surgery using the individual's own tissue. For example, traditional procedures often involve dozens of operations, whereas facial transplantation only involves a few operations.

Adverse Events

Composite tissue allotransplantation is associated with potential risks and benefits, and individuals who undergo face or hand transplantation must adhere to a lifelong regimen of immunosuppressive drugs. Risks of immunosuppression include acute and chronic rejection, an opportunistic infection that may be life-threatening, and metabolic disorders such as diabetes, kidney damage, and lymphoma. A review of 115 facial or upper extremity transplants found an overall acute rejection rate of 89% with 11% of recipients with chronic rejection. Other challenges include the need to participate actively in intensive physical therapy to restore functionality and the potential for frustration and disappointment if functional improvement does not meet expectations. Moreover, there is the potential for allograft loss, which would lead to additional procedures in hand transplant individuals, and there are limited reconstructive options for facial transplantation. Furthermore, in the case of hand transplants, there is a risk that functional ability (eg, 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.

KEY POINTS:

The most recent literature update was performed through July 1, 2024.

Summary of Evidence

For individual who have a severely disfigured face due to burns or trauma who receive composite tissue allotransplantation, the evidence includes a case series and several systematic reviews of case series. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the face have suggested that the surgery is technically feasible; however, to date, only a limited number of individuals worldwide have undergone the procedure, and the data are not sufficient to determine whether the potential benefits to individuals outweigh the potential risks (e.g., of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individual who have hand and upper-extremity amputation(s) who receive composite tissue allotransplantation, the evidence includes a case series, several systematic reviews of case series, and a nonrandomized comparative study. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the hand have suggested that the surgery is technically feasible. The only study comparing outcomes in individuals who had hand transplants with those who received prostheses included 12 individuals. It found no differences between groups in functional outcomes and little difference in quality of life. Given the limited number of individuals worldwide have undergone the procedure and the limited amount of data comparing outcomes with the best available prosthetics, evidence is not sufficiently robust to determine whether the potential benefits to individuals outweigh the potential risks (e.g., of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

National Institute for Health and Care Excellence

In 2011, the National Institute for Health and Care Excellence published guidance on hand allotransplantation. The guidance stated that the quantity of current evidence on the efficacy and safety of hand allotransplantation was inadequate.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Composite tissue allotransplantation (CTA), Vascularized composite tissue allotransplantation (VCA), Reconstructive transplantation (RT), Facial allograft transplantation, Hand allotransplantation

APPROVED BY GOVERNING BODIES:

Hand and face allotransplantation is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP: Special benefit consideration may apply. Refer to member’s benefit plan.

CURRENT CODING: 

Currently, there are no specific CPT codes for this procedure; however, should the procedure receive a code, it is likely that a combination of existing codes or the unlisted code for the anatomic area would be used (e.g., 26989 unlisted procedure, hands or fingers).

REFERENCES:

1. American Society for Surgery of the Hand Council. ASSH position statement on hand transplantation 2013. J Hand Surg Am. Nov 2013; 38(11): 2234-5.
2. Fischer S, Kueckelhaus M, Pauzenberger R, et al. Functional Outcomes of Face Transplantation. Am J Transplant. Jan 2015; 15(1):220-233. 
3. Hadjiandreou M, Pafitanis G, Butler PM. Outcomes in facial transplantation - a systematic review. Br J Oral MaxillofacSurg. Jun 2024; 62(5): 404-414.
4. Infante-Cossio P, Barrera-Pulido F, Gomez-Cia T et al. Facial transplantation: a concise update. Med Oral Patol Oral Cir Bucal. Mar 2013; 18(2):e263-271.
5. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
6. Milek D, Reed LT, Echternacht SR, et al. A Systematic Review of the Reported Complications Related to Facial and Upper Extremity Vascularized Composite Allotransplantation. J Surg Res. Jan 2023; 281: 164-175.
7. National Institute for Health and Care Excellence (NICE). Hand allotransplantation [IPG383]. 2011; www.nice.org.uk/guidance/ipg383.
8. Petruzzo P, Dubernard JM. The International Registry on Hand and Composite Tissue allotransplantation. Clin Transpl 2011:247-253.
9. Salminger S, Sturma A, Roche AD, et al. Functional and psychosocial outcomes of hand transplantation compared with prosthetic fitting in below-elbow amputees: a multicenter cohort study. PLoS One. 2016; 11(9):e0162507.
10. Shores JT, Brandacher G, Lee WP. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. Feb 2015; 135(2):351e-360e.
11. Smeets R, Rendenbach C, Birkelbach M, et al. Face transplantation: on the verge of becoming clinical routine? Biomed Res Int. 2014; 2014:907272.

POLICY HISTORY:

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (3):  New Policy adopted; investigational per policy statement

Medical Policy Administration Committee, March 2013

Available for comment March 12 through April 25, 2013

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (3):  2014 Updates to Key Points & References; no change in policy statement

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (2): 2015 Updates to Key Points, Practice Guidelines and Position Statements, and References, no change to policy statement.

Medical Policy Panel, February 2016

Medical Policy Group, February (2): 2016 Updates to Key Points, Approved by Governing Bodies, and References; no change to policy statement.

Medical Policy Panel, August 2017

Medical Policy Group, August 2017 (7): Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, August 2018

Medical Policy Group, August 2018 (3): Updates to Description and Key Points. No changes in policy statement or intent.

Medical Policy Panel, August 2019

Medical Policy Group, September 2019 (3): 2019 Updates to Key Points. No changes to policy statement or intent.

Medical Policy Panel, August 2020

Medical Policy Group, August 2020 (3): 2020 Updates to Key Points and References. No changes to policy statement or intent.

Medical Policy Panel, August 2021

Medical Policy Group, August 2021 (3): 2021 Updates to Key Points. Policy statement updated to remove “not medically necessary”, no other changes to policy statement or intent.

Medical Policy Panel, August 2022

Medical Policy Group, August 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, and References. Removed references for American Society for Reconstructive Microsurgery (ASRM) policy guidelines for facial transplantation from 2006. No changes to policy statement or intent.

Medical Policy Panel, August 2023

Medical Policy Group, October 2023 (5): Updates to Description, Key Points, Benefit Application, and References. No change to Policy Statement.

Medical Policy Panel, August 2024

Medical Policy Group, August 2024 (3): Updates to Description, Key Points, and References. No change to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.