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 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.

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. (2014). Meniscal transplant surgery. Retrieved February 27, 2018 from https://orthoinfo.aaos.org/en/treatment/meniscal-transplant-surgery/.

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Meniscal allografts and other meniscal implants (7.01.15). Retrieved February 27, 2018 from BlueWeb. (34 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.

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.

Palmetto Government Benefit Administrators. (2018). LCD for noncovered services other than CPT  category III noncovered services (L36954). Retrieved February 27, 2018 from www.cms.gov.

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.

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). Technology Brief. Collagen meniscus implant (CMI) (Menaflex; Ivy Sports Medicine LOC) for meniscal repair. Retrieved February 27, 2018 from www.Hayesinccom/subscribers. (37 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  6/1/2000

MOST RECENT REVIEW DATE:  4/12/2018

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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