BlueCross BlueShield of Tennessee Medical Policy Manual

Meniscal Allografts and Synthetic Meniscus Implants

DESCRIPTION

The menisci are an integral structural component of the human knee and function to absorb shocks, 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.

POLICY

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MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

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.

SOURCES

American Academy of Orthopaedic Surgeons. (2015). Surgical management of osteoarthritis of the knee. Evidence-based clinical practice guideline. Retrieved January 20, 2017 from www.aaos.org.

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2015). Meniscal allografts and other meniscal implants (7.01.15). Retrieved February 5, 2016 from BlueWeb. (24 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.

Lee, B., Bin, S., Kim, J., Kim, W., & Choi, J. (2017). Survivorship after meniscal allograft transplantation according to articular cartilage status. The American Journal of Sports Medicine, (Epub ahead of print). (Level 3 evidence)

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/nicemedia/live/13587/60005/60005.pdf.

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.

Smith, N.A., Parkinson, B., Hutchinson, C.E., Costa, M.L., & Spalding, T. (2016). Is meniscal allograft transplantation chondroprotective? A systematic review of radiological outcomes. Knee Surgery, Sports Traumatology, Arthroscopy, 24 (9), 2923-2935. Abstract retrieved January 20, 2017 from PubMed database.

Winifred S. Hayes, Inc., Medical Technology Directory. (2011, December; last update search 2015, November)). Meniscal allograft transplantation. Retrieved February 5, 2016 from www.Hayesinc.com/subscribers  (58 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  6/1/2000

MOST RECENT REVIEW DATE:  6/21/2017

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