Autologous Chondrocyte Implantation
Autologous chondrocyte implantation (ACI) attempts to treat damaged articular cartilage that fails to heal on its own. Articular cartilage damage can be associated with pain and loss of function. This can lead to debilitating osteoarthritis over time, severely impairing an individual's activities of daily living and adversely affecting their quality of life.
In 2016, MACI® (matrix-induced autologous chondrocyte implantation [ACI]; Vericel Corporation) received FDA approval for the repair of symptomatic, full-thickness cartilage defects of the knee in adults. The first-generation product, Carticel, is being phased out. Matrix-induced ACI consists of four steps: (1) initial arthroscopy and biopsy of normal cartilage, (2) culturing of chondrocytes on an absorbable collagen matrix, (3) a separate arthrotomy to place the implant and (4) postsurgical rehabilitation.
The only matrix-induced autologous chondrocyte implantation product currently approved by the FDA is MACI®.
Autologous chondrocyte implantation for the treatment of articular cartilage defects of the knee is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Autologous chondrocyte implantation for the treatment of other conditions/diseases is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Autologous chondrocyte implantation is considered medically appropriate if ALL of the following are met:
Treatment of articular cartilage defects of the knee when ALL of the following are met:
Presence of focal, full thickness (grade III or IV) unipolar lesions of the patella or the weight bearing surface of the femoral condyles or trochlea that are at least 1.5 cm2 in size
Defect was caused by acute or repetitive trauma
There is evidence of growth plate closure in adolescents
There is a clinical determination that the individual is not yet a candidate for joint replacement
Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less), and normal appearing hyaline cartilage surrounding the border of the defect
Normal knee biomechanics, or alignment and stability will be achieved concurrently with autologous chondrocyte implantation
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.
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of ACI for other conditions / diseases.
American Academy of Orthopaedic Surgeons. (2010, December). The diagnosis and treatment of osteochondritis dissecans: guideline and evidence report. Retrieved October 26, 2018 www.aaos.org.
Basad, E., Wissing, F., Fehrenbach, P., Rickert, M., Steinmeyer, J., & Ishaque, B. (2015). Matrix-induced autologous chondrocyte implantation (MACI) in the knee: clinical outcomes and challenges. Knee Surgery, Sports Traumatology, Arthroscopy, 23 (12), 3729-3735. Abstract retrieved April 21, 2017 from PubMed database.
Biant, L.C., Bentley, G., Vijayan, S., Skinner, J.A., & Carrington, R.W. (2014). Long-term results of autologous chondrocyte implantation in the knee for chronic chondral and osteochondral defects. American Journal of Sports Medicine, 42 (9), 2178-2183. Abstract retrieved October 27, 2015 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (4:2018). Autologous chondrocyte implantation for focal articular cartilage lesions (7.01.48). Retrieved February 28, 2019 from https://www.evidencepositioningsystem.com/. (30 articles and/or guidelines reviewed)
Ebert, J., Smith, A., Fallon, M., Buitler, R., Nairn, R., Breidahl, W., & Wood, D. (2015). Incidence, degree and development of graft hypertrophy 24 months after matrix-induced autologous chondrocyte implantation: association with clinical outcomes. American Journal of Sports Medicine, 43 (9), 2208-2215. Abstract retrieved April 21, 2017 from PubMed database.
ECRI Institute. Hotline Response. (2017, December). Osteochondral allografts and autografts for repairing cartilage in the knee. Retrieved May 11, 2018 from ECRI Institute. (13 articles and/or guideline reviewed)
Li, Z., Zhu, T., & Fan, W. (2016). Osteochondral autograft transplantation or autologous chondrocyte implantation for large cartilage defects of the knee: a meta-analysis. Cell Tissue Bank, 17 (1), 59-67. Abstract retrieved October 3, 2016 from PubMed database.
Micheli, L., Moseley, B., Anderson, A., Browne, J., Erggelet, C., Arciero,R., et al. (2006). Articular cartilage defects of the distal femur in children and adolescents: treatment with autologous chondrocyte implantation. Journal of Pediatric Orthopedics, 26 (4), 455-460.
National Institute for Health and Clinical Excellence (NICE). (2014, March). The use of autologous chondrocyte implantation (ACI) for the treatment of cartilage defects in knee joints. Retrieved October 23, 2015 from http://www.nice.org.uk/guidance/ta89/chapter/1-Guidance.
Niemeyer, P., Albrecht, D., Andereya, S., Angele, P., Ateschrang, A., Aurich, M., et al. (2016). Autologous chondrocyte implantation (ACI) for cartilage defects of the knee: a guideline by the working group “Clinical Tissue Regeneration” of the German Society of Orthopaedics and Trauma (DGOU). The Knee, 426-435. (Level 2 evidence)
Oussedik, S., Tsitskaris, K., & Parker, D. (2015). Treatment of articular cartilage lesions of the knee by microfracture or autologous chondrocyte implantation: a systematic review. Arthroscopy, 31 (4), 732-744. Abstract retrieved September 30, 2016 from PubMed database.
Riboh, J., Cvetanovich, G., Cole, B., & Yanke, A. (2016). Comparative efficacy of cartilage repair procedures in the knee: a network meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy. 2016 Sep 7. [Epub ahead of print] Abstract retrieved September 30, 2016 from PubMed database.
Rosenberger, R., Gomoll, A., Bryant, T., & Minas, T. (2008). Repair of large chondral defects of the knee with autologous chondrocyte implantation in patients 45 years or older. The American Journal of Sports Medicine, 36 (12), 2336-2344. (Level 4 evidence)
U. S. Food and Drug Administration. Vaccines, Blood & Biologics. 2016 Biological License Application Approvals. MACI. Retrieved April 21, 2017 from https://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/ucm482397.htm.
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July; last reviewed July 2018). Comparative effectiveness review of first-generation autologous chondrocyte implantation. Retrieved May 11, 2018 from www.Hayesinc.com/subscribers. (82 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July; last reviewed July 2018). Comparative effectiveness review of second- and third- generation autologous chondrocyte implantation. Retrieved May 11, 2018 from www.Hayesinc.com/subscribers. (84 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 3/28/2019
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.
This document has been classified as public information.