Autologous Chondrocyte Implantation (ACI)
DESCRIPTION
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, loss of function, and disability. This can lead to debilitating osteoarthritis over time, severely impairing an individual's activities of daily living, and adversely affecting their quality of life.
The autologous chondrocyte implantation procedure involves a region of healthy articular cartilage being identified and biopsied through arthroscopy. The tissue is sent to an FDA-licensed facility where it is minced and enzymatically digested, and the chondrocytes are separated by filtration. The isolated chondrocytes are cultured for 11-21 days to expand the cell population, tested, and then shipped back for implantation. With the individual under general anesthesia, an arthrotomy is performed, and the chondral lesion is excised up to the normal surrounding cartilage. A periosteal flap is removed from the proximal medial tibia and sutured to the surrounding rim of normal cartilage. The cultured chondrocytes are then injected beneath the periosteal flap.
The culturing of chondrocytes is considered by the U.S. Food and Drug Administration (FDA) to fall into the category of manipulated autologous structural cells (MAS), which are subject to a biologic licensing requirement. At the present time, only Carticel™ (Genzyme) has received FDA approval for the culturing of chondrocytes through a biologics license.
POLICY
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.
Policies with similar titles:
MEDICAL APPROPRIATENESS
Autologous chondrocyte implantation for the treatment of articular cartilage defects of the knee is considered medically appropriate if ALL of the following criteria are met:
The disability is caused by acute or repetitive trauma
The individual has had an inadequate response to a prior surgical procedure
Adolescent individuals should be skeletally mature with documented closure of growth plate (e.g., 15 years or older)
Adult individuals should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years)
Focal, full thickness (grade III or IV) unipolar lesions on the weight bearing surface of the femoral condyles or trochlea are present and at least 1.5 cm2 in size
There is documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less), and normal appearing hyaline cartilage surrounding the boarder of the defect
Normal knee biomechanics, or alignment and stability will be achieved concurrently with autologous chondrocyte implantation
Absence of meniscal pathology
ADDITIONAL INFORMATION
Well-designed, randomized, controlled trials with long-term follow-up are not available to determine long-term benefits of ACI for other conditions / diseases compared to alternative treatments.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (11:2008). Autologous chondrocyte implantation (7.01.48). Retrieved January 20, 2009 from BlueWeb. (26 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Windows on Medical Technology. (2004, August). Autologous chondrocyte implantation for knee cartilage defects. Retrieved November 6, 2007 from ECRI Institute. (71 articles and/or guidelines reviewed)
Gillogly, S., Voight, M., & Blackburn, T. (1998). Treatment of articular cartilage defects of the knee with autologous chondrocyte implantation. Journal of Orthopaedic and Sports Physical Therapy, 28 (4), 241-51.
Hayes. Medical Technology Directory. (2008, October). Autologous chondrocyte implantation of the knee. Retrieved January 20, 2009 from www.Hayes.com/subscribers. (56 articles and/or guidelines reviewed)
Horas, U., Pelinkovic, D., Herr, G., Aigner, T., & Schnettler, R. (2003). Autologous chondrocyte implantation and osteochondral cylinder transplantation in cartilage repair of the knee joint. A prospective, comparative trial. The Journal of Bone and Joint Surgery. American volume, 85-A (2), 185-192. Abstract retrieved April 15, 2003 from PubMed database.
Jobanpatra, P., Parry, D., Fry-Smith, A., & Burls, A. (2001). Effectiveness of autologous chondrocyte transplantation for hyaline cartilage defects in knees: A rapid and systematic review. Health Technology Assessment, 5 (11), 1-63.
Mandelbaum, B. R., Browne, J. E., Fu, F., Micheli, L. Mosely, J. B., Erggelet, C., et al. (1998). Articular cartilage lesions of the knee. The American Journal of Sports Medicine, 26 (6), 853-61.
Micheli, L. J., Browne, J. E., Erggelet, C. Fu, F., Mandelbaum, B., & Moseley, J. B. (2001). Autologous chondrocyte implantation of the knee: multicenter experience and minimum 3-year follow-up. Clinical Journal of Sport Medicine, 11 (4), 223-228. Abstract retrieved April 16, 2003 from PubMed database.
MICROMEDEX Healthcare Series. USP DI Drug Information for the Health Care Professional. (2006). Chondrocytes, autologous cultured (implantation-local). Retrieved January 24, 2006 from MICROMEDEX Healthcare Series.
National Institute for Health and Clinical Excellence. (2005, May). The use of autologous chondrocyte implantation (ACI) for the treatment of cartilage defects in knee joints. Retrieved January 20, 2009 from http://www.nice.org.uk/niceMedia/pdf/2005_009_Launch_ACI.pdf.
Peterson, L., Minas, T., Brittberg, M., & Lindahl, A. ((2003). Treatment of osteochondritis dissecans of the knee with autologous chondrocyte transplantation. Journal of Bone & Joint Surgery, 85-A (Suppl. 2), 17-24.
Sgaglione, N. A., Miniaci, A., Gillogly, S. D., & Carter, T. R. (2002). Update on advanced surgical techniques in the treatment of traumatic focal articular cartilage lesions in the knee. Arthroscopy, 18 (2) (February, Suppl. 1), 9-32.
The Technology Evaluation Center. (2003, June). Autologous chondrocyte transplantation of the knee (Vol. 18, No. 2). Retrieved April 3, 2003 from http://www.bcbs.com/betterknowledge/tec/. (108 articles and/or guidelines reviewed)
U. S. Food and Drug Administration. Center for Biologics Evaluation and Research. Product Approval Information - Licensing action. Autologous cultured chondrocytes. Retrieved January 21, 2009 from http://www.fda.gov/cber/approvltr/autogen082297L.htm.
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 6/13/2009
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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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