Autologous Chondrocyte Implantation
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. The FDA summary states Carticel™ is indicated for the repair of clinically significant, symptomatic, cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma.
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.
Any device or biologic utilized in this treatment must have FDA approval specific to the indication, otherwise it will be 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:
Presence of focal, full thickness (grade III or IV) unipolar lesions on 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
Individual has had an inadequate response to a prior surgical procedure
Individual is skeletally mature with documented closure of growth plate
Individual is too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years)
Documented minimal to absent degenerative change in the surrounding articular cartilage (Outerbridge Grade II or less), and normal appearing hyaline cartilage surrounds the border of the defect
Normal knee biomechanics, or alignment and stability will be achieved concurrently with autologous chondrocyte implantation
IMPORTANT REMINDER
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.
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. (6:2011). Autologous chondrocyte implantation (7.01.48). Retrieved August 17, 2011 from BlueWeb. (48 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2011). Meniscal allografts and collagen meniscus implants (7.01.15). Retrieved August 18, 2011 from BlueWeb. (35 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Assessment Information Service. Windows on Medical Technology. (2004, July). Autologous chondrocyte implantation for knee cartilage defects. Retrieved November 6, 2007 from ECRI Institute. (71 articles and/or guidelines reviewed)
Gillogly, S., Myers, T., & Reinold, M. (2006). Treatment of full thickness chondral defects in the knee with autologous chondrocyte implantation. Journal of Orthopaedic and Sports Physical Therapy, 36 (10), 751-763.( Level 5-Evidence)
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), 241-251. (Level 5-Evidence)
Halbrecht, J. & Klick, C. (2006). Improvement in bone homeostasis following autologous chondrocyte implantation of the knee. Retrieved October 25, 2010 from http://www.orthosupersite.com/view.aspx?rid=5177. (Level 3 Evidence - Independent)
National Institute for Health and Clinical Excellence. (2008, May). The use of autologous chondrocyte implantation for the treatment of cartilage defects in knee joints. Retrieved October 25, 2010 from http://www.nice.org.uk/nicemedia/live/11556/33036/33036.doc.
Rue, J., Yanke, A., Busam, M., McNickle, A., & Cole, B. (2008). Prospective evaluation of concurrent meniscus transplantation and articular cartilage repair: Minimum 2-year follow-up. American Journal of Sports Medicine, 36 (9), 1770-1778. (Level 4 Evidence - Independent)
U. S. Food and Drug Administration. Center for Biologics Evaluation and Research. Autologous cultured chondrocytes. Retrieved October 26, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM109341.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, October, last update search October 2010). Autologous chondrocyte implantation of the knee. Retrieved January 20, 2009 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
Zaslav, K., Cole, B., Brewster, B., DeBerardino, R., Farr, T., Fowler, J., et al. (2009). A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. American Journal of Sports Medicine, 37 (1), 42-55. (Level 2 Evidence - Independent)
ORIGINAL EFFECTIVE DATE: 10/1998
MOST RECENT REVIEW DATE: 10/13/2011
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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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