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Osteochondral grafts are used in repair of full-thickness chondral defects involving a joint. In the case of osteochondral autografts, one or more small osteochondral plugs are harvested from non-weight-bearing sites in the knee and press fit into a prepared site in the lesion. Osteochondral allografts are typically used for larger lesions. Autologous or allogeneic minced cartilage, decellularized osteochondral allograft plugs, and reduced osteochondral allograft discs are also being evaluated as a treatment of articular cartilage lesions.
Damaged articular cartilage can be associated with pain, loss of function, and disability, and can lead to debilitating osteoarthrosis over time. These manifestations can severely impair an individual’s activities of daily living and quality of life. Autologous or allogeneic grafts of osteochondral or chondral tissue have been proposed as treatment alternatives for patients who have clinically significant, symptomatic, focal defects of the articular cartilage. It is hypothesized that the implanted grafts chondrocytes retain features of hyaline cartilage that is similar in composition and property to the original articulating surface of the joint. If true, the restoration of a hyaline cartilage surface might restore the integrity of the joint surface and promote long-term tissue repair, thereby improving function and delaying or preventing further deterioration.
There are two main categories of conventional therapy for patients who have significant focal defects of the articular cartilage: symptom relief and articular surface restoration.
First, there are procedures intended to primarily achieve symptomatic relief: débridement (removal of debris and diseased cartilage); lavage (saline washout); and rehabilitation.
Second, there are procedures intended to restore the articular surface. Treatments may be targeted to the focal cartilage lesion and most such treatments induce local bleeding, fibrin clot formation, and resultant fibrocartilage growth. These include: abrasion arthroplasty, microfracture, and drilling, all of which are considered standard therapies. Fibrocartilage is generally considered to be less durable and mechanically inferior to the original articular cartilage. Thus various strategies for chondral resurfacing with hyaline cartilage have been investigated. Alternatively, treatments of very extensive and severe cartilage defects may resort to complete replacement of the articular surface either by osteochondral allotransplant or artificial knee replacement.
Efficacy of the microfracture technique was examined in a 2009 systematic review. Twenty-eight studies (total N=3122 patients) were selected; 6 studies were randomized controlled trials (RCTs). Microfracture was found to improve knee function in all studies during the first 24 months after the procedure, but the reports on durability were conflicting. A prospective longitudinal study of 110 patients by Solheim and colleagues (2016) found that, at a mean of 12 years (range, 10-14 years) after microfracture, 45.5% of patients had poor outcomes, including 43 patients who required additional surgery.
Both fresh and cryopreserved allogeneic osteochondral grafts have been used with some success, although cryopreservation decreases the viability of cartilage cells, and fresh allografts may be difficult to obtain and create concerns regarding infectious diseases. As a result, autologous osteochondral grafts have been investigated as an option to increase the survival rate of the grafted cartilage and to eliminate the risk of disease transmission. Autologous grafts are limited by the small number of donor sites; thus allografts are typically used for larger lesions. In an effort to extend the amount of the available donor tissue, investigators have used multiple, small osteochondral cores harvested from various non-weight-bearing sites in the knee for treatment of full-thickness chondral defects. Several systems are available for performing this procedure: the Mosaicplasty System (Smith and Nephew), the Osteochondral Autograft Transfer System (OATS, Arthrex), and the COR and COR2 systems (DePuy Mitek). Although mosaicplasty and OATS may use different instrumentation, the underlying mode of repair is similar (i.e., the use of multiple osteochondral cores harvested from a non-weight-bearing region of the femoral condyle and autografted into the chondral defect). These terms have been used interchangeably to describe the procedure.
Preparation of the chondral lesion involves debridement and preparation of recipient tunnels. Multiple individual osteochondral cores are harvested from the donor site, typically from a peripheral non-weight-bearing area of the femoral condyle. Donor plugs range from 6 mm to 10 mm in diameter. The grafts are press fit into the lesion in a mosaic-like fashion into the same-sized tunnels. The resultant surface consists of transplanted hyaline articular cartilage and fibrocartilage, which is thought to provide “grouting” between the individual autografts. Mosaicplasty or OATS may be performed with either an open approach or arthroscopically. Osteochondral autografting has also been investigated as a treatment of unstable osteochondritis dissecans lesions using multiple dowel grafts to secure the fragment. While osteochondral autografting is primarily performed on the femoral condyles of the knee, osteochondral grafts have been used to repair chondral defects of the patella, tibia, and ankle. With osteochondral autografting, the harvesting and transplantation can be performed during the same surgical procedure. Technical limitations of osteochondral autografting are difficulty in restoring concave or convex articular surfaces, incongruity of articular surfaces that can alter joint contact pressures, short-term fixation strength and load-bearing capacity, donor site morbidity, and lack of peripheral integration with peripheral chondrocyte death.
Filling defects with minced articular cartilage (autologous or allogeneic), is another single-stage procedure that is being investigated for cartilage repair. The Cartilage Autograft Implantation System (CAIS, Johnson and Johnson) harvests cartilage and disperses chondrocytes on a scaffold in a single-stage treatment. BioCartilage® (Arthrex) consists of a micronized allogeneic cartilage matrix that is intended to provide a scaffold for microfracture. DeNovo NT Graft (Natural Tissue Graft) is 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 intraoperatively with fibrin glue before implantation in the prepared lesion. It is thought that mincing the tissue helps both with cell migration from the extracellular matrix and with fixation.
A minimally processed osteochondral allograft (Chondrofix®, Zimmer) is now available for use. Chondrofix® is composed of decellularized hyaline cartilage and cancellous bone and can be used “off the shelf” with precut cylinders (7-15 mm). Multiple cylinders may be used to fill a larger defect in a manner similar to OATS or mosaicplasty.
ProChondrix® (AlloSource) and Cartiform® (Arthrex) are wafer-thin allografts where the bony portion of the allograft is reduced. The discs are laser etched or porated and contain hyaline cartilage with chondrocytes, growth factors, and extracellular matrix proteins. ProChondrix® is available in dimensions from 7 to 20 mm and is stored fresh for a maximum of 28 days. Cartiform® is cut to the desired size and shape and is stored frozen for a maximum of 2 years. The osteochondral discs are typically inserted after microfracture and secured in place with fibrin glue and/or sutures.
DeNovo ET graft (ISTO Technologies) uses juvenile allogeneic cartilage cells.
Autologous chondrocyte implantation (ACI) is another method of cartilage repair involving the harvesting of normal chondrocytes from normal non-weight-bearing articular surfaces, which are then cultured and expanded in vitro and implanted back into the chondral defect. ACI is considered separately in the Autologous Chondrocyte Implantation for Focal Articular Cartilage Lesions medical policy.
The U.S. Food and Drug Administration (FDA) considers orthopedic manual surgical instruments as class I devices. If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance were not required before marketing the device in the United States. Harvesting and implantation are surgical procedures and therefore not subject to regulation by FDA.
As there is no use of chemicals and minimal manipulation, the allograft tissue does not require U.S. Food and Drug Administration (FDA) approval for marketing. FDA regulates human cells and tissues intended for implantation, transplantation, or infusion through the Center for Biologics Evaluation and Research, under Code of Federal Regulation (CFR) title 21, parts 1270 and 1271.
DeNovo® ET Live Chondral Engineered Tissue Graft (Neocartilage) is marketed by ISTO Technologies outside of the U.S. FDA approved ISTO’s investigational new drug application for Neocartilage in 2006, which allowed ISTO to pursue phase III clinical trials of the product in humans.
Also, see the Meniscal Allografts and Other Meniscal Implants medical policy.
Osteochondral allografting may be considered medically necessary as a technique to repair full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (eg, microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to the size, location, or depth of the lesion.
Osteochondral allografting for all other joints is considered investigational.
Osteochodral autografting, using 1 or more cores of osteochondral tissue, may be considered medically necessary for the treatment of symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior surgical procedure, when all of the following have been met:
Osteochondral autografting for all other joints, including talar, and any indications other than those listed above, 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 is considered investigational.
Treatment of focal articular cartilage lesions with decellularized osteochondral allograft plugs (eg, Chondrofix) is considered investigational.
Treatment of focal articular cartilage lesions with reduced osteochondral allograft discs (eg, ProChondrix, Cartiform) is considered investigational.
POLICY EXCEPTIONSFederal 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 coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
If debridement is the only prior surgical treatment, consideration should be given to marrow-stimulating techniques before osteochondral grafting is performed.
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. In addition, meniscal allograft transplantation may be performed in combination, either concurrently or sequentially, with osteochondral allografting or osteochondral autografting.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY2/2001: Approved by Medical Policy Advisory Committee (MPAC); Mosaicplasty considered investigational
5/2001: Reviewed by MPAC; Mosaicplasty separated from ACT policy, investigational status maintained
8/2001: Reviewed by MPAC; investigational status maintained; no policy exceptions
2/8/2002: Investigational definition added
2/19/2002: 2002 CPT Category III codes added, CPT 0012T, 0013T added
5/2/2002: Type of Service and Place of Service deleted
3/25/2004: Reviewed by MPAC, policy title "Mosaicplasty" renamed "Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions", Mosaicplasty remains investigational, OATS procedure considered investigational, Sources updated
5/19/2004: Code Reference section reviewed, no changes
3/23/2005: Code Reference section updated, CPT code 0012T deletion date of 12/31/2004 and Note: "See CPT code 29866" added, CPT code 0013T deletion date of 12/31/2004 and Note: "See CPT code 27415 and 29867" added, CPT code 27415, 29866, 29867 with effective date of 1/1/2005 added, ICD-9 procedure code 81.47 added
3/9/2006: Coding updated. CPT-4/HCPCS 2006 revisions added to policy
12/19/2007: Coding updated per 2008 CPT/HCPCS revisions
12/5/2008: Policy reviewed, policy statement changed and medically necessary indications included in new policy statement.
12/22/2008: Code Reference section updated; CPT codes 27415-27416, 29866-29867 and ICD-9 procedure code 81.47 moved to covered.
06/03/2010: Policy description and guidelines updated regarding treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Added CPT code 28446.
08/23/2011: Deleted "Absence of meniscal pathology" from the osteochondral autografting coverage criteria. Separated the investigational policy statement for autograft and allograft.
07/17/2012: Policy reviewed; no changes.
10/25/2013: Added the following investigational policy statements: Treatment of focal articular cartilage lesions with autologous minced cartilage is considered investigational. Treatment of focal articular cartilage lesions with allogeneic minced cartilage is considered investigational.
10/30/2014: Policy title changed from "Osteochondral Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions" to "Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions" to reflect the scope of the policy. Policy description updated regarding available grafts. Osteochondral autografting for patellar lesions changed from investigational to medically necessary. Policy guidelines updated regarding meniscal allograft transplantation.
08/25/2015: Code Reference section updated to add ICD-10 codes. Moved CPT code 28446 to the Investigational Codes table.
01/25/2016: Policy description updated. Policy statement revised to state that osteochondral allografting may be considered medically necessary as a technique to repair full-thickness chondral defects of the knee caused by acute or repetitive trauma when other cartilage repair techniques (eg, microfracture, osteochondral autografting or autologous chondrocyte implantation) would be inadequate due to the size, location, or depth of the lesion. It previously stated: Osteochondral allografting may be considered medically necessary as a technique to repair large (e.g., 10 cm squared) full thickness chondral defects of the knee caused by acute or repetitive trauma. Policy guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number A.7.01.78 added.
01/25/2017: Policy description updated regarding categories of conventional therapy, devices, and FDA regulation. Added the following policy statements: 1) Treatment of focal articular cartilage lesions with decellularized osteochondral allograft plugs (eg, Chondrofix) is considered investigational. 2) Treatment of focal articular cartilage lesions with reduced osteochondral allograft discs (eg, ProChondrix, Cartiform) is considered investigational.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.78
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.