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 Collagen Meniscal Implant (CMI) (i.e., CMIÒ) is an implant derived from bovine collagen used to treat acute or chronic advanced meniscal loss or damage with the intent of relieving symptoms and preventing joint degeneration. The CMI is a flexible, sickle-shaped disc that mimics the shape of the native meniscus and is attached arthroscopically to native tissue with suture. The porous, collagen-glycosaminoglycan matrix of the CMI is meant to serve as a temporary template to support migration of the host’s cells to the meniscal deficiency, restoring meniscal volume and function. The CMI is resorbable. An intact native meniscal rim must be present so that the surgeon may suture the implant to it. A gradually progressive, 6-month postoperative rehabilitation program designed by the manufacturer includes slow progression to weight bearing and increasing range-of-motion exercises.
POLICY
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.
MEDICAL APPROPRIATENESS
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:
Infection
Inflammatory arthritis
Synovial disease
IMPORTANT REMINDERS
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
There is a lack of high-quality evidence to support synthetic meniscus implants.
SOURCES
American Academy of Orthopaedic Surgeons. (2021). Meniscal transplant surgery. Retrieved August 17, 2021 from https://orthoinfo.aaos.org/.
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Meniscal allografts and other meniscal implants (7.01.15). Retrieved December 1, 2023 from https://www.bcbsaoca.com/eps/. (29 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for collagen meniscus implant (150.12). Retrieved December 19, 2019 from https://www.cms.gov.
Houck, D.A., Kraeutler, M.J., Belk, J.W., McCarty, E., & Bravman, J. (2018). Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review. Knee Surgery, Sports Traumatology, Arthroscopy, 26 (8), 2259-2269. Abstract retrieved October 2, 2020 from PubMed database.
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 December 19, 2019 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.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 1/11/2024
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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