Medical Policies - Surgery


Composite Tissue Allotransplantation of the Hand and Face

Number:SUR703.052

Effective Date:10-15-2017

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

CAREFULLY REVIEW the member’s benefit plan, summary plan description or contract for transplant coverage provisions. If there is a discrepancy between a Medical Policy and a member’s benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Composite tissue allotransplantation of the hand is considered experimental, investigational and/or unproven.

Composite tissue allotransplantation of the face is considered experimental, investigational and/or unproven.

Description:

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 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.

Background

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 United States, 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 United States took place in Louisville, Kentucky, in 1999. Several more hand and/or face transplantations have occurred within the last several years, including as recently as 2015, in the United States.

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, chin) and in some cases the forehead, eyelids and scalp. (1) 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 has typically lasted between 8 and 12 hours. Bone fixation occurred first, and this was 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, e.g., 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 challenges and risks, as well as potential 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 obtain functionality and the potential for frustration and disappointment if 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 patients. 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.

Rationale:

The policy was created in January 2016 with a search of the MedLine database through December 16, 2015. Following is a summary of the key literature to date.

Hand Transplantation

The most comprehensive reporting of the worldwide experience with hand/upper limb transplant was published by Shores et al. in 2014. (2) The authors identified 72 patients: 37 received bilateral transplants and 35 unilateral, for a total of 107 transplanted hand/upper extremities. There are 4 known mortalities: 1 occurred after a bilateral hand transplant, and the other 3 followed multi-type composite tissue allotransplantations, CTAs (i.e., combined upper- and lower-limb or combined upper-limb and face transplants). Twenty-four graft losses have been reported; 8 of these were also associated with multiple CTA procedures and another 7 occurred in China during their early experience with hand transplantation. In the United States, 21 known patients have undergone isolated upper limb transplantation; 13 were unilateral and 8 were bilateral (limb or digit) procedures. There was 1 immediate graft loss of the bilateral transplanted limb/digit. An additional 3 patients experienced hand loss at approximately 9 months, 2 years, and 4 years post-transplant, respectively. Few data on functional outcomes after hand transplantation have been reported. The authors noted that there is a lack of agreement on appropriate outcome measures, and the level of transplantation varies greatly among patients, making it difficult to compare functional improvement.

An article describing data from the International Registry on Hand and Composite Tissue Allotransplantation was published in 2011. (3) At the time data were prepared for the article, hand transplants had been reported to the registry in a total of 39 patients. The article stated that 85% of transplant recipients experienced at least 1 episode of acute rejection in the first year after transplant. Acute rejection episodes were reversible in all patients who were compliant with treatment. The most commonly reported complications were metabolic complications (35/39 [90%]) and opportunistic infections (30/39 [77%]). Transient hyperglycemia occurred in 17 patients (44%) and cytomegalovirus reactivation in 10 patients (26%). Ten patients required surgery for complications (2 arterial thromboses, 1 venous thrombosis, 6 small area of skin necrosis, 1 venous fistula). Five cases of graft loss were reported between day 5 and day 275 after transplant. The early (day 5) graft loss occurred in a patient who underwent face and bilateral hand transplant, and this patient died at day 65 from cerebral anoxia. This was the only reported death in this series of patients. Hand function was reported in figures included in the article, but specific numbers, e.g., mean function scores, were not included in the text of the article.

No studies comparing health outcomes in patients undergoing hand transplantation versus receiving hand/lower-limb prostheses were identified.

Face Transplantation

In 2014, Smeets et al. systematically reviewed published reports of face transplants. (4) The authors included English language articles published through September 15, 2013, that provided data on at least 1 face transplant in humans. A total of 36 articles reported on 27 worldwide face transplantations. University Hospital Henri Mondor in Creteil, France, and Brigham and Women’s Hospital in Boston, Massachusetts, were the centers with the most experience. Ten of the 27 cases were full face transplants (the first successful full face transplant was in 2010) and the remainder were partial face transplants. The literature did not report any case of graft loss, hyper-acute (within the first 48 hours) or chronic rejection, or graft-versus-host disease. However, all of the face transplant recipients with at least 1-year postsurgical follow-up were reported to experience at least 1 episode of acute rejection days or months after the procedure. Other common complications were related to drug toxicity from immunosuppressive therapy, leading to opportunistic infections, metabolic disorders, and increased incidence of malignancy. There have been 3 reported cases of malignancy to date. Three deaths occurred in transplant recipients. One patient died 27 months after surgery due to lack of compliance with immunosuppressive therapy. A second death occurred in a French recipient who had multi-drug-resistant infection and graft necrosis (an early transplant in France). The third patient died of recurrent cancer.

In terms of function, tactile sensitivity recovered a mean of 4.1 months after surgery when nerve repair was performed, and a mean of 7.3 months otherwise. Temperature sensitivity recovered a mean of 4.3 months with nerve repair and 12.5 months without nerve repair. Motor recovery began a mean of 7.8 months after surgery. Recovery of motor function has started with contractions of single muscles, and complex movements have appeared within the first year in a number of patients. Long-term results are still pending in most cases. After 5 years of follow-up, the first face transplant recipient was able to fully open her mouth, smile, speak, chew, and swallow.

Also in 2014, Fischer et al. identified a total of 29 face transplants performed through December 2013 and reported functional outcomes in 5 patients treated at their center. (5) The investigators compared each patient’s pre- and postsurgical functioning on various dimensions. Before surgery, all 5 patients had compromised respiration, breathing, sensation, and facial expression. After surgery, they had substantial recovery in all of these areas. In terms of breathing, the 5 patients were able to breathe through their noses post-surgery, and the 2 patients who previously had tracheostomy tubes had them removed. Speech became understandable to an unfamiliar listener 3 to 9 months after surgery. Three to 9 months post surgery, most allografts were responsive to light touch, and patients could distinguish between heat and cold. Facial expression, including the ability to smile, recovered after transplantation in all patients. Three of 5 patients were unable to chew solid food before surgery, and 2 patients had liquid leakage. All patients were capable of oral food intake 3 to 29 days after surgery, and 3 to 12 months after surgery, all had unrestricted or nearly unrestricted eating and drinking. The 2 patients with compromised ability to smell both reported a substantial improvement in smelling, comparable with their functioning before facial trauma. All 5 patients developed opportunistic infections (viral or bacterial) after facial transplantation.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in December 2015 revealed unpublished trials that might influence this policy are listed in Table 1.

Table 1: Ongoing, Unpublished Clinical Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Larger Studies Focused on Risk of Rejection of Allograft

NCT00722280

Human Upper Extremity (Hand and Forearm) Allotransplantation

300

Jan 2018

Smaller Case Series Still Under Investigation

NCT00711373

Allogeneic Hand Transplantation Composite Tissue Allotransplantation (Hand CTA)

10

Jun 2015

NCT01293214

Vascularized Composite Allotransplantation for Multiple Extremity Amputations

10

Dec 2016

NCT01281267

Face Transplantation for Treatment of Severe Facial Deformity

10

Sep 2018

NCT01140087

Face Transplantation

5

Dec 2015

NCT01269164

Face Transplantation Clinical Trial

2

Jul 2015

Table Key:

NCT: national clinical trial.

Practice Guidelines and Position Statements

American Society for Surgery of the Hand (ASSH)

In November 2013, the ASSH published a position statement on hand transplantation. (6) The organization recognized that hand transplantation is an alternative to prostheses and rehabilitation in appropriately selected patients yet continued to consider it an “innovative intervention.” The statement emphasized the need for further advances in the areas of patient selection, surgical technique, and immunosuppression and recommended that, at this time, the procedure be carried out only in centers with extensive experience in both hand surgery and solid organ transplantation.

National Institute for Health and Clinical Excellence (NICE)

In March 2011, the NICE in the United Kingdom published guidance on hand allotransplantation. (7) The guidance stated that current evidence on the efficacy and safety of hand allotransplantation is inadequate in quantity. NICE recommended that the procedure only be available under special arrangements, e.g., in a research setting.

American Society for Reconstructive Microsurgery (ASRM) and American Society of Plastic Surgeons (ASPS)

In 2006, the ASRM and the ASPS published guiding principles on facial transplantation for plastic surgeons. (8) Selected principles follow:

“1. Facial transplantation should only be utilized for patients with severe facial deformities who cannot be helped through traditional reconstructive surgical measures.

2. Facial transplantation should only be undertaken in institutions with appropriate Institutional Review Boards familiar with the many intricacies for approval and application of new clinical procedures and protocols.

3. Facial transplantation should be conducted in the context of a transplant team having appropriate institutional resources and commitment to the project.…

4. Appropriate patient selection criteria should be established and a complete risk/benefit ratio must be considered for each patient on a case-by-case basis.

5. To facilitate informed consent:

a) The physician must provide the patient with the latest and complete information on the risks associated with facial transplant.

b) The preoperative evaluation of potential donors may involve additional considerations as more experience is gained. At this time, the results of facial transplantation are unknown. If early results are less than optimal, potential patients should be informed of any newly identified limitation of the procedure.

c) Patients must demonstrate a thorough understanding of all the known risks and benefits.

d) The physician should regard the facial transplantation procedure as experimental and it should be subjected to the evaluation of an independent research ethics committee.

e) The informed consent should include an alternative and acceptable solution for management of the recipients’ face in the event of transplant failure….”

Summary of Evidence

Preliminary experience with composite tissue allotransplantation of the hand and face suggest that the surgery is technically feasible. To date, however, only a limited number of patients worldwide have undergone such allotransplantation of the hand and/or face. There are insufficient data on whether the procedure improves net health outcome, i.e., whether the potential benefits to patients’ quality of life outweigh the potential risks, e.g., of surgical complications, immunosuppression, and opportunistic infections. In addition, for hand transplantation, no published data are available assessing functional and quality-of-life outcomes compared with use of lower-limb prostheses. Thus, composite tissue allotransplantation of the hand and/or face is considered experimental, investigational and/or unproven.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

There are no specific procedure codes for this type of transplantation. It would be reported using combinations of existing procedure codes and/or the unlisted code for the anatomical area, such as 26989 for hands or fingers. NOTE: There is no unlisted code for the face.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

26989

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Infante-Cossio P, Barrera-Pulido F, Gomez-Cia T, et al. Facial transplantation: A concise update. Med Oral Patol Oral Cir Bucal. Mar 1 2013; 18(2):e263-71. PMID 23229268

2. Shores JT, Brandacher G, Lee WA. Hand and Upper Extremity Transplantation: An Update of Outcomes in the Worldwide Experience. Plast Reconstr Surg. Nov 14 2014:epub ahead of print. PMID 25401735

3. Petruzzo P, Dubernard JM. The International Registry on Hand and Composite Tissue allotransplantation. Clin Transpl. 2011; 247-53. PMID 22755418

4. Smeets R, Rendenbach C, Birkelbach M, et al. Face transplantation: on the verge of becoming clinical routine? Biomed Res Int. 2014; 907272:epub ahead of print. PMID 25009821

5. Fischer S, Kueckelhaus M, Pauzenberger R, et al. Functional Outcomes of Face Transplantation. Am J Transplant. Jan 2015; 15(1):220-33. PMID 25359281

6. American Society for Surgery of the Hand. ASSH position statement on hand transplantation 2013. J Hand Surg. Am. Nov 2013; 38(11):2234-5. PMID 24206988

7. Hand Allotransplantation IPG383 (March 2011). Guidance prepared by the National Institute for Health and Clinical Excellence (NICE). Available at <http://www.nice.org.uk> (accessed on 2015 December 16>.

8. Facial Transplantation-ASRM/ASPS Guiding Principles. Guideline prepared by the American Society for Reconstructive Microsurgery (ASRM) and the American Society of Plastic Surgeons (ASPS). Available at <http://www.plasticsurgery.org> (accessed on 2015 December 16).

9. Composite Tissue Allotransplantation of the Hand and Face. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (February 2016) Surgery 7.03.13.

Policy History:

Date Reason
10/15/2017 Reviewed. No changes.
6/1/2016 New medical document. Composite tissue allotransplantation of the hand is considered experimental, investigational and/or unproven. Composite tissue allotransplantation of the face is considered experimental, investigational and/or unproven.

Archived Document(s):

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