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Damaged articular cartilage typically fails to heal on its own and can be associated with pain, loss of function, and disability, and may lead to debilitating osteoarthritis over time. These manifestations can severely impair an individual's activities of daily living and adversely affect quality of life. Conventional treatment options include debridement, subchondral drilling, microfracture, and abrasion arthroplasty. Debridement involves the removal of synovial membrane, osteophytes, loose articular debris, and diseased cartilage, and is capable of producing symptomatic relief. Subchondral drilling, microfracture, and abrasion arthroplasty attempt to restore the articular surface by inducing the growth of fibrocartilage into the chondral defect. Compared to the original hyaline cartilage, fibrocartilage has less capability to withstand shock or shearing force and can degenerate over time, often resulting in the return of clinical symptoms. Osteochondral grafts and ACI attempt to regenerate hyaline-like cartilage and thereby restore durable function. Osteochondral grafts for the treatment of articular cartilage defects are discussed in the Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions medical policy.

With autologous chondrocyte implantation, a region of healthy articular cartilage is identified and biopsied through arthroscopy. The tissue is sent to a facility licensed by the U.S. Food and Drug Administration (FDA) 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 patient 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. ACI may be considered more effective for larger lesions than microfracture or osteochondral grafts, but it is technically difficult, requiring two procedures and harvesting of periosteum. In addition, use of the FDA-indicated periosteal cover may result in hypertrophy as well as donor site morbidity.

Methods to improve the ACI procedure are being investigated, including the use of a scaffold or matrix-induced ACI (MACI) composed of biocompatible carbohydrates, protein polymers, or synthetics. Desired features of articular cartilage repair procedures are the ability to 1) be implanted easily, 2) reduce surgical morbidity, 3) not require harvesting of other tissues, 4) enhance cell proliferation and maturation, 5) maintain the phenotype, and 6) integrate with the surrounding articular tissue. In addition to the potential to improve the formation and distribution of hyaline cartilage, use of a scaffold with MACI eliminates the need for harvesting and suture of a periosteal patch. A scaffold without cells may also support chondrocyte growth.

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 CarticelTM (Genzyme) has received FDA approval for the culturing of chondrocytes through a biologics license. In 1997, Carticel received FDA approval for the repair of clinically significant, "...symptomatic cartilaginous defects of the femoral condyle (medial lateral or trochlear) caused by acute or repetitive trauma.…" The labeled indication was revised in October 1999 to read as follows:

"Carticel is indicated for the repair of symptomatic cartilagenous defects of the femoral condyle (medial, lateral, or trochlear), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure."  Thus the revised labeling suggests a more restricted use of autologous chondrocytes, i.e., as a second-line therapy after failure of initial arthroscopic or surgical repair.

“Carticel is not indicated for the treatment of cartilage damage associated with osteoarthritis. Carticel should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. Data regarding functional outcomes beyond 3 years of autologous cultured chondrocyte treatment are limited.”

A number of second generation methods for implanting cultured autologous chondrocytes in a biodegradable matrix are currently in development/testing. These include Chondroselect (characterized chondrocyte implantation, TiGenex, Phase III trial), BioCart II (ProChon Biotech, Phase II trial), Cartilix (polymer hydrogel, Cartilix), MACI® (matrix-induced ACI, Verigen, available outside of the United States), Cartipatch (solid scaffold with an agarose-alginate matrix, TBF Tissue Engineering, Phase III trial), NeoCart (ACI with a 3-dimensional chondromatrix, Histogenics, Phase II trial), Hyalograft C (ACI with a hyaluronic acid-based scaffold, Fidia Advanced Polymers), and CAIS (Cartilage Autograft Implantation System, which harvests cartilage and disperses chondrocytes on a scaffold in a single stage treatment, Johnson and Johnson). Although clinical use of these second-generation ACI products has been reported in Europe, none are approved for use in the United States at this time. 

DeNovo NT Graft (Natural Tissue Graft) and DeNovo® ET Live Chondral Engineered Tissue Graft (Neocartilage) are produced by ISTO Technologies with exclusive distribution rights by Zimmer. DeNovo NT consists of manually minced cartilage tissue pieces obtained from juvenile allograft donor joints. The tissue fragments are mixed intra-operatively with fibrin glue before implantation in the prepared lesion. It is thought that mincing the tissue helps with cell migration from the extracellular matrix and with fixation. As there is no use of chemicals and minimal manipulation, the allograft tissue does not require FDA approval for marketing. DeNovo NT is currently available in the U.S. and 4 U.S. sites are participating in a company-sponsored observational study with 25 subjects; the expected completion is 2013. DeNovo® ET graft (Neocartilage) uses juvenile allogeneic cartilage cells engineered by ISTO Technologies. The FDA approved ISTO’s Investigational New Drug (IND) application for Neocartilage in 2006, which allowed them to pursue clinical trials of the product in humans.

Also, see the related medical policies, Continuous Passive Motion (CPM) in the Home Setting and Meniscal Allografts and Collagen Meniscus Implants.

• Adolescent patients should be skeletally mature with documented closure of growth plates (e.g., 15 years or older).  Adult patients 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 at least 1.5cm squared in size
• 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 achieved concurrently with autologous chondrocyte implantation
• Autologous chondrocyte implantation for all other joints, including patellar and talar, and any indications other than those listed above is considered investigational.

Matrix-induced autologous chondrocyte implantation is considered investigational.

Treatment of focal articular cartilage lesions with autologous minced cartilage is considered investigational.

Treatment of focal articular cartilage lesions with allogeneic minced cartilage or cartilage cells is considered investigational.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

The average defect size reported in the literature is about 5 cm2; many studies treated lesions as large as 15 cm2.

Severe obesity, e.g., body mass index (BMI) greater than 35 kg/m2, may affect outcomes due to the increased stress on weight bearing surfaces of the joint.

Misalignment and instability of the joint are contraindications. Therefore additional procedures, such as repair of ligaments or tendons or creation of an osteotomy for realignment of the joint, may be performed at the same time. The charges for the culturing component of the procedure are submitted as part of the hospital bill.

The entire autologous chondrocyte implantation (ACI) procedure consists of 4 steps: (1) the initial arthroscopy and biopsy of normal cartilage; (2) culturing of chondrocytes; (3) a separate arthrotomy to create a periosteal flap and implant the chondrocytes; and (4) post-surgical rehabilitation. The initial arthroscopy may be scheduled as a diagnostic procedure; as part of this procedure a cartilage defect may be identified, prompting biopsy of normal cartilage in anticipation of a possible chondrocyte transplant. The biopsied material is then sent for culturing and returned to the hospital when the implantation procedure (i.e., arthrotomy) is scheduled. At the time of arthrotomy, additional procedures may be done, such as repair of ligaments or tendons or creation of an osteotomy for realignment of the joint. Therefore, it may be difficult to attribute the initial arthroscopy or subsequent arthrotomy entirely to the chondrocyte transplant procedure. The charges for the culturing component of the procedure are submitted as part of the hospital bill. (added 7-15-2004)

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

7/1998: FEP exception added effective January 1, 1998

10/17/2000: TEC source added

2/2001: Reviewed by MPAC; Mosaicplasty considered investigational, HCPCS J7330 added

5/2001: Reviewed by MPAC; Mosaicplasty separated from ACT policy, investigational status maintained

10/4/2001: Clarification of policy exceptions; Document # 00-07IHR takes precedence over Blue Cross Blue Shield Association policy # 7.01.48

2/11/2002: Investigational definition added

4/18/2002: Type of Service and Place of Service deleted

1/17/2003: Policy reviewed; no changes based on Hayes report

4/11/2003: Sources updated

4/25/2003: Code Reference section updated, CPT code 27599 added

8/8/2003: CPT code ranges 27330-27335, 27403, 29870-29887 listed separately, ICD-9 diagnosis code ranges 715-715.99, 717-719.99 listed separately, ICD-9 diagnosis code 715.99 is not a valid code and has been deleted

7/15/2004: Reviewed by MPAC, remains investigational, Description and Policy Guidelines section aligned with BCBSA policy # 7.01.48, Sources updated

10/5/2004: Code Reference section updated, CPT code 20999, 27330-27335, 27403, 29870-29887 deleted, CPT code 29999 added, ICD-9 procedure code 81.47 added, ICD-9 diagnosis code 715.00-715.98, 717.0-719.99, 732.7, 959.7 deleted, HCPCS S2113, S2113 added

3/22/2005: Code Reference section updated, CPT code 27412 with effective date of 1/1/2005 added, CPT code 27599, 29999 Note: "To report services on and after 1/1/2005, see CPT code 27412" added, ICD-9 procedure code 80.16, 80.26 Note: "To report services on and after 1/1/2005, see ICD-9 procedure code 81.47" added, HCPCS S2113 deletion date of 12/31/2004 and Note: "See CPT code 27412" added

3/22/2005: Code Reference section updated, CPT code 27412 with effective date of 1/1/2005 added, CPT code 27599, 29999 Note: "To report services on and after 1/1/2005, see CPT code 27412" added, ICD-9 procedure code 80.16, 80.26 Note: "To report services on and after 1/1/2005, see ICD-9 procedure code 81.47" added, HCPCS S2113 deletion date of 12/31/2004 and Note: "See CPT code 27412" added

12/13/2006: Policy reviewed, no changes

12/12/2007: Code reference section updated per the 2008 CPT/HCPCS revisions.

1/14/2008: Policy reviewed, no changes

12/5/2008: Policy reviewed, policy statement re-written with medically necessary criteria

12/18/2008: Code reference section updated, covered table added

11/11/2009: Policy reviewed, no changes

04/20/2010: Policy title changed from “Autologous Chondrocyte Transplantation” to  “Autologous Chondrocyte Implantation and Other Cell-based Treatments of Focal Articular Cartilage Lesions.” Policy description and guidelines updated extensively due to this expansion.  Two policy statements were added regarding the implantation of autologous minced cartilage, allogeneic minced cartilage, or allogeneic cartilage cells; these procedures are investigational. FEP verbiage added to the Policy Exceptions section.  Outdated references deleted from the Sources section.

08/23/2011:  Deleted "Absence of meniscal pathology" as a coverage criteria from the first policy statement.

07/17/2012: Policy reviewed; no changes.

The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes