Meniscal Allografts and Synthetic Meniscus Implants
The menisci are an integral structural component of the human knee and function to absorb shock, distribute weight, and provide joint stability. Total or partial meniscectomy frequently results in degenerative osteoarthritis. Meniscal allograft transplantation is considered a salvage procedure, reserved for individuals with disabling knee pain following meniscectomy, when there is a clinical determination that the individual is not yet a candidate for total knee arthroplasty. As a result, the population that is intended to receive these transplants is relatively limited.
Meniscal allograft transplantation may be performed in combination, either concurrently or sequentially, with treatment of focal articular cartilage lesions using autologous chondrocyte implantation, osteochondral allografting or osteochondral autografting.
Four primary ways of processing and storing allografts have been reported (fresh, fresh frozen, cryopreserved, freeze-dried or lyophilized). The use of collagen and polyurethane meniscus implants are being investigated outside the United States. Currently, these implants are not FDA approved.
Meniscal allograft transplantation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Meniscal allograft transplantation for all other indications is considered investigational.
Synthetic (e.g., collagen) meniscal implants are considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Meniscal allograft transplantation is considered medically appropriate when ALL of the following criteria are met:
Absence or near absence (more than 50%) of the meniscus, established by imaging or prior surgery
Symptoms are related to the affected side
There is evidence of growth plate closure in adolescents
There is a clinical determination that the individual is not yet a candidate for total knee arthroplasty or other reconstructive knee surgery
Disabling knee pain with activity that is refractory to conservative treatment (e.g., physical therapy, analgesic medications)
Documented minimal to absent diffuse degenerative changes in the surrounding articular cartilage (e.g., Outerbridge grade II or less, less than 50% joint space narrowing)
Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation
No contraindications including ABSENCE of ALL of the following:
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
The collagen and polyurethane meniscus implants do not have FDA approval. Current controlled trials do not report improvements in outcomes for most pain and functional status measures. Therefore, synthetic meniscal implants are considered investigational.
American Academy of Orthopaedic Surgeons. (2014). Meniscal transplant surgery. Retrieved February 27, 2018 from https://orthoinfo.aaos.org/.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Meniscal allografts and other meniscal implants (7.01.15). Retrieved December 27, 2018 from https://www.evidencepositioningsystem.com/. (29 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for collagen meniscus implant (150.12). Retrieved February 5, 2016 from https://www.cms.gov.
CMS.gov. Centers for Medicare & Medicaid Services. Palmetto GBA. (2018, May). LCD for noncovered services other than CPT category III noncovered services (L36954). Retrieved December 27, 2018 from www.cms.gov.
McCormick, F., Harris, J.D., Abrams, G.D., Hussey, K.E., Wilson, H., Frank, R., et al. (2014). Survival and reoperation rates after meniscal allograft transplantation: analysis of failures for 172 consecutive transplants at a minimum 2-year follow-up. The American Journal of Sports Medicine, 42 (4), 892-897. Abstract retrieved January 20, 2017 from PubMed database.
National Institute for Health and Clinical Excellence (NICE). (2012, July). Partial replacement of the meniscus of the knee using a biodegradable scaffold. Retrieved April 30, 2013 from http://www.nice.org.uk/.
Noyes, F.R., & Barber-Westin, S.D. (2015). Meniscal transplantation in symptomatic patients under fifty years of age: survivorship analysis. The Journal of Bone and Joint Surgery, 97 (15), 1209-1219. Abstract retrieved January 20, 2017 from PubMed database.
Parkinson, B., Smith, N., Asplin, L., Thompson, P., Spalding, T. (2016). Factors predicting meniscal allograft transplantation failure. The Orthopaedic Journal of Sports Medicine, 4 (8), 2325967116663185. (Level 3 evidence)
Rosso, F., Bisicchia, S., Bonasia, D.E., & Amendola, A. (2015). Meniscal allograft transplantation: a systematic review. The American Journal of Sports Medicine, 43 (4), 998-1007. Abstract retrieved January 20, 2017 from PubMed database.
Smith, N., MacKay, N., Costa, M., & Spalding, T. (2015). Meniscal allograft transplantation in a symptomatic meniscal deficient knee: a systematic review. Knee Surgery, Sports Traumatology, Arthroscopy, 23 (1), 270-279. Abstract retrieved January 20, 2017 from PubMed database.
Warth, R.J., & Rodkey, W.G. (2015). Resorbable collagen scaffolds for the treatment of meniscus defects: a systematic review. Arthroscopy, 31 (5), 927-941. Abstract retrieved February 27, 2018 from PubMed database.
Winifred S. Hayes, Inc. (2017, February; last update search March 2018). Technology Brief. Collagen meniscus implant (CMI) (Menaflex; Ivy Sports Medicine LOC) for meniscal repair. Retrieved December 27, 2018 from www.Hayesinccom/subscribers. (37 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 2/14/2019
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