Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Composite Tissue Allotransplantation of the Hand(s) and Face

Policy #:11.14.30

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's benefit contract.

Composite tissue allotransplantation of the hand(s) and face is considered experimental/investigational and, therefore, not covered because the safety and/or effectiveness of this service cannot be established by review of the available published peer-reviewed literature.
Guidelines

Subject to the terms and conditions of the applicable benefit contract, composite tissue allotransplantation of the hand and face is not eligible for payment under the medical benefits of the Company’s products because the service is considered experimental/investigational and, therefore, not covered.

Services that are experimental/investigational are a benefit contract exclusion for all products of the Company. Therefore, they are not eligible for reimbursement consideration.

Description

Composite tissue allotransplantation (CTA), also known as reconstructive transplantation or vascularized composite allografts (VCAs), involves multiple tissues (skin, muscle, tendon, bone, cartilage, fat, nerves and blood vessels). The primary applications of this type of transplantation have been of the hand and face (partial and full). Federal regulations for CTA, through the Organ Procurement Transplant Network (OPTN), became effective in July 2014. Composite tissue allotransplantation is not considered life-saving, and its primary goal is to increase the individual's quality of life by providing a more normal appearance and a sense of wholeness.

Hand and face transplants have been shown 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. Facial transplantation has been performed on individuals 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 individuals 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 OF THE HAND(S)

The most comprehensive worldwide experience with hand and upper-limb transplant was published by Shores, et al in 2015. The study involved 72 individuals, 37 of whom received bilateral transplants and 35 unilateral, for a total of 109 transplanted hand/upper extremities. There are 4 known mortalities: 1 occurred after a bilateral hand transplant; the other 3 followed multitype 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 individuals 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 individuals experienced hand loss at 9 months, 2 years, and 4 years post-transplant. There is sparsely reported data on functional outcomes following hand transplantation. The authors noted that there is a lack of agreement on appropriate outcome measures, and the level of transplantation varies greatly among individuals, 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 and reported 39 individuals who underwent hand transplants. 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 individuals 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 (44%) individuals and cytomegalovirus reactivation in 10 (26%) individuals. Ten individuals 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 following transplant. The early (day 5) graft loss occurred in an individual who underwent face and bilateral hand transplant, and this individual died at day 65 from cerebral anoxia. This was the only reported death in this series of individuals. Hand function was reported in the article, but specific numbers (e.g., mean function scores) were not included. No studies comparing health outcomes in individuals undergoing hand transplantation versus those who received hand/upper-limb prostheses were identified.

COMPOSITE TISSUE ALLOTRANSPLANTATION OF THE FACE

The first successful full face transplant occurred in 2010 in Spain, with the first partial face transplant taking place in 2005, in France.

As of December 2015, there have been a total of 31 face allotransplantations reported worldwide. In 2014, Smeets et published a systematic analysis of outcomes involving face allotransplantations. There were a total of 27 face transplantations that took place worldwide. Ten of the 27 face transplants were full face transplantations, with the remainder being partial face transplants. The literature did not report on any cases of graft loss, chronic rejection, or graft-versus-host disease. However, all face transplant individuals who were 1 year post-surgery, reported experiencing 1 episode of an acute rejection following 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 the transplant recipients. One individual died 27 months after surgery due to lack of compliance with immunosuppressive therapy. A second death occurred in an early transplant French recipient who had multidrug-resistant infection and graft necrosis. A third individual died of recurrent cancer.

In regard to function, tactile sensitivity recovered at an average of 4.1 months post-surgery when nerve repair was performed or at an average of 7.3 months, without nerve repair. Temperature sensitivity recovered at an average of 4.3 months with nerve repair and at 12.5 months without nerve repair. Motor recovery began at an average of 7.8 months after surgery. The recovery of motor function started with contractions of single muscles, and complex movements appeared within the first year in a number of the recipients.

Long-term results are still forthcoming in most face allotransplantations. After 5 years of follow-up, the first face transplant recipient was able to fully open her mouth, smile, speak, chew, and swallow.

Another published study in 2015, by Fischer et al, reported on 29 face transplants performed through 2013. The study reported on the functional outcomes on five of those 29 face transplants before and after the face transplantation. Prior to surgery, all 5 individuals had compromised respiratory status, sensations, and facial expression. Following the surgery, they had considerable improvement in breathing post-surgery, speech improvement 3 to 9 months after surgery, as well as response to light touch and distinguishing between hot and cold. All 5 of the recipients being followed were capable of oral food intake, 3-29 days following surgery, with no restrictions from 3 to 12 months after surgery. However, all 5 individuals did develop opportunistic infections following the face transplantation.

SUMMARY

There are ongoing clinical trials involving composite tissue allotransplantation for face and hand/upper limbs. To date, the sparsity of evidence is based on small case series and systematic reviews of case studies worldwide. Although the studies on composite tissue allotransplantation reveal the surgery is technically feasible, the functional outcomes and data for improvement on quality of life are lacking. Composite tissue allotransplantation is associated with potential risks and benefits. Individuals 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. Therefore, the data has not proven whether the benefits outweigh the risk. The evidence is insufficient to determine the effects of the technology; composite tissue allotransplantation for face and hand(s) on health outcomes.
References


American Society for Reconstructive Microsurgery (ASRM) and the American Society of Plastic Surgeons (ASPS). Facial Transplantation-ASRM/ASPS Guiding Principles. http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/guiding-principles/Facial-Transplantation-ASRM-ASPS-Guiding-Principals.pdf. Accessed April 12, 2018.

American Society for Surgery of the Hand. ASSH position statement on hand transplantation 2013. J Hand Surg Am. 2013;38(11):2234-2235.

Donate Life America. 2017. Vascularized Composite Allografts. Available at:
https://www.donatelife.net/types-of-donation/vca/?gclid=CNz-srW429ICFdiKswodbEkOYw Accessed March 20, 2017.

Fischer S, Kueckelhaus M, Pauzenberger R, et al. Functional outcomes of face transplantation. Am J Transplant. 2015;15(1):220-233.

Infante-Cossio P, Barrera-Pulido F, Gomez-Cia T, et al. Facial transplantation: a concise update. Med Oral Patol Oral Cir Bucal. 2013;18(2):e263-271.

National Institute for Health and Clinical Excellence (NICE). Hand Allotransplantation.
Published date: March 2011. https://www.nice.org.uk/guidance/ipg383. Accessed April 12, 2018.

Petruzzo P, Dubernard JM. The International Registry on Hand and Composite Tissue allotransplantation. Clin Transpl. 2011:247-253.

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. PMID 27589057

Shores JT, Brandacher G, Lee WP. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. 2015;135(2):351e-360e.

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

Sosin M, Rodriguez ED. The face transplantation update: 2016. Plast Reconstr Surg. Jun 2016;137(6):1841-1850. PMID 27219239.

Wo L, Bueno E, Pomahac B. Facial transplantation: worth the risks? A look at evolution of indications over the last decade. Curr Opin Organ Transplant. 2015;20(6):615-620.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

THE FOLLOWING CODE IS USED TO REPRESENT COMPOSITE TISSUE ALLOTRANSPLANTATION OF THE HAND

26989


THE FOLLOWING CODE(S) ARE USED TO REPRESENT COMPOSITE TISSUE ALLOTRANSPLANTATION OF THE FACE

21499, 21299


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

N/A


HCPCS Level II Code Number(s)

N/A


Revenue Code Number(s)

N/A

Coding and Billing Requirements



Policy History

11.14.30
04/25/2018This new policy has been developed to address the emerging technology of composite tissue allotransplantation of the hand(s) and face.

Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 06/02/2017
Version Issued Date: 06/02/2017
Version Reissued Date: 04/25/2018

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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.