Medical Policy: 07.01.65
Original Effective Date: May 2014
Reviewed: August 2017
Revised: August 2017
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Cartilage injuries are described and classified based on the location of injury, size of the injury, and the depth of the injury. The type of surgery necessary largely depends on the aforementioned factors.
Osteochondral allografting involves transplantation of a piece of articular cartilage and attached subchondral bone from a cadaver donor to a damaged region of the articular surface of a joint. The use of donor bone is necessary due to the size of lesion, Osteochondral allografting is recommended for lesions 4cm2-10cm2. The goal of this procedure is to provide viable chondrocytes and supporting bone that will be sufficient to maintain the cartilage matrix and thereby relieve pain and reduce further damage. The procedure is performed through an open approach to the knee.The exact area of cartilage that is missing on the patient's femur is mapped out and harvested as a cylinder of cartilage and bone. This cylinder of donor cartilage is then press fit into the patient's femur, completing the cartilage transplant.
Osteochondral autograft transfer, also called OATS or mosaicplasty, involves harvesting cylinders of cartilage and bone from areas of the knee, from the patient, that do not bear much weight. These cylinders are then press fit into the cartilage lesion on the weightbearing surface of the knee. The donor sites are then backfilled with synthetic plugs or left to heal on their own. During the OATS procedure a single plug is taken from the patient versus several plugs being removed during the mosaicplasty. All plugs will be removed from non-weight bearing areas. Osteochondral autograft transfer is indicated for cartilage lesions from 1.5 cm2 to 4 cm2 that have failed microfracture surgery or abrasive arthroplasty.
These techniques are limited by the amount of donor tissue available in the joint. Donor site morbidity increases as more tissue is harvested. Treatment of small lesions may be performed arthroscopically, while treatment of larger lesions is typically performed through an open arthrotomy.
Minced cartilage repair is considered a second generation technique that does not require in vitro cell expansion and is described as a single-staged minimally invasive procedure. The procedure uses minced pieces of cartilage seeded over a scaffold which allows for even distribution of the chondrocytes to expand within the defect providing structural and mechanical protection. The first clinical application of the minced cartilage technique was the cartilage autograft implantation system (CAIS) developed by DePuy Mitek. A second technology, DeNOVO NT Graft ("Natural Tissue Graft"; Zimmer Inc, Warsaw, is another application for cartilage regeneration using minced donated juvenile cartilag.e).
Guidelines from the American College of Rheumatology on management of osteoarthritis (OA) of the hip and knee state that autologous osteochondral plugs (mosaicplasty) is being investigated for repair of focal chondral defects, but that this procedure is “not currently indicated in the treatment of patients with OA” (Altman et al, 2000).
An assessment of mosaicplasty for knee cartilage defects from the National Institute for Health and Clinical Excellence (NICE, 2006) concluded: "Current evidence suggests that there are no major safety concerns associated with mosaicplasty for knee cartilage defects. There is some evidence of short-term efficacy, but data on long-term efficacy are inadequate. In view of the uncertainties about the efficacy of the procedure, it should not be used without special arrangements for consent and audit or research."
In 2010 and 2012 clinical practice guidelines on the diagnosis and treatment of osteochondritis dissecans (OCD), the American Academy of Orthopaedic Surgeons (AAOS) was unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature or mature patients with an unsalvageable OCD lesion.
According to the American Academy of Orthopaedic Surgeons (AAOS), most candidates eligible for articular cartilage restoration are young adults with a single injury or lesion. Older individuals, or those with many lesions in one joint, are less likely to benefit from osteochondral autograft transplantation.
In a Clinical Practice Guideline for the diagnosis and treatment of osteochondritis dissecans, the AAOS states that they unable to recommend for or against a specific cartilage repair technique in symptomatic skeletally immature patients with unsalvageable fragment (AAOS 2010).
An AAOS advisory statement for use of musculoskeletal tissue allografts indicates that the AAOS believes that for appropriate patients musculoskeletal allografts represent a therapeutic alternative. These tissues should be acquired from facilities that demonstrate compliance, use well-accepted banking methodology and follow Food and Drug Administration (FDA) Good Tissue Practices. The AAOS urges all tissue banks to follow rigorous national guidelines and standards and recommends the use of tissue from banks that are accredited by the American Association of Tissue Banks (AAOS 2006).
There is also sufficient evidence to support the use of osteochondral allograft of the knee in patients who are physically active, have failed standard medical and surgical treatments, and are considered too young for total knee arthroplasty.
The clinical evidence was reviewed in August 2014 with no additional information identified that would change the conclusion.
Softening and swelling
Fragmentation and fissures in area less than 0.5 inch in diameter
Fragmentation and fissures in area larger than 0.5 inch in diameter
Exposed subchondral bone
Source: Campbell's Operative Orthopaedics, 2007 External Site
Minced cartilage repair is considered a second generation technique that does not require in vitro cell expansion and is described as a single-staged minimally invasive procedure. The procedure uses minced pieces of cartilage seeded over a scaffold which allows for even distribution of the chondrocytes to expand within the defect providing structural and mechanical protection. The first clinical application of the minced cartilage technique was the cartilage autograft implantation system (CAIS) developed by DePuy Mitek. A second technology, DeNOVO NT Graft ("Natural Tissue Graft"; Zimmer Inc, Warsaw, is another application for cartilage regeneration using minced donated juvenile cartilage.
Note: The DeNovo® NT Natural Tissue Graft is a tissue based articular cartilage graft that is processed from healthy donors less than 13 years of age and greater than 6 lbs. in weight. Donors are sourced through appropriate Organ and Tissue Procurement Organizations (OTPOs). BioCartilage® (Arthrex)/ArthrexOATS consists of a micronized allogeneic cartilage matrix that is intended to provide a scaffold for microfracture.
Allograft Discs (H3)
ProChondrix® (AlloSource) and Cartiform® (Arthrex) are wafer-thin allografts where the bony portion of the allograft is reduced. The discs 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.
All of the following criteria must be found in the pre-op notes to determine medical necessity of the procedure.
Osteochondral allografting may be considered medically necessary as a technique to repair large (4cm2-10 cm2) full-thickness chondral defects of the medial or lateral femoral condyles, patellar or trochlear region caused by acute or repetitive trauma when ALL of the following have been met:
Osteochondral allografting for all other joints, including but not limited to talar, shoulder, and elbow is considered investigational.
Osteochondral autografting, using one or more cores of osteochondral tissue, may be considered medically necessary for the treatment of symptomatic full-thickness cartilage defects of the medial or lateral femoral condyles, patellar or trochlear region caused by acute or repetitive trauma when ALL of the following have been met:
Inadequate response to a prior surgical procedure (microfracture or abrasive arthroplasty). The success rate and surgical ease of microfracture and abrasive arthroplasty are such that they should be used as first line therapy before osteochondral autografting.
Adolescent patients should be skeletally mature with documented closure of growth plates). Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery. Age of patient will be 15-50 years old.
Body Mass Index < 35 kg/m2. The outcomes with increased BMI have not been as favorable due to increased stress at the donor site.
Focal, full-thickness (grade III or IV) unipolar lesions on the weight-bearing surface of the femoral condyles, patella, or trochlea that are between 1.5cm2-4cm2 in size
Documented minimal to absent degenerative changes (no osteoarthritis) in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect
Either normal knee biomechanics, or alignment and stability achieved concurrently with osteochondral grafting planned (ie meniscus repair planned during procedure)
Normal joint space is present
Symptoms currently significantly limiting ambulation
Osteochondral autografting/allografting for the knee is considered investigational when the above criteria is not met.
Osteochondral autografting for all other joints, including but not limited to: shoulder, elbow, and talar, and any indications other than those listed above, is considered investigational. The success rate and longevity in other joints have not been proven at this time. There is limited evidence in the form of randomized control studies to demonstrate the benefit for treating any other joint problems except those of the articular surfaces of the knee.
Treatment of focal articular cartilage lesions with autologous minced cartilage is considered investigational (for example CAIS).
Treatment of focal articular cartilage lesions with allogeneic minced cartilage/biopaste is considered investigational (for example DeNOVO NT, BioCartilage® (Arthrex)/Arthrex OATS).
Treatment of cartilage lisions using reduced osteochondral disc (e.g., Prochondrix, Cartiform) is considered investigational.
Non-autologous mosaicplasty using resorbable synthetic bone filler materials (including but not limited to plugs and granules) to repair osteochondral defects of the knee or ankle is considered investigational. (for example PolyGraft, TruFit BGS Plugs or granules)
Use of minced articular cartilage (whether synthetic, allograft or autograft) to repair osteochondral defects is considered investigational. Randomized trials that compare the outcomes of minced articular cartilage repair with standard methods have not been published. Clinical studies are needed to establish the safety and outcome benefit of this technique over standard methods of cartilage repair.
Hybrid technique of autologous chondrocyte implantation/osteochondral autograft transfer system (OATS) technique for the treatment of osteochondral defects is considered investigational.
27415 Osteochondral allograft, knee, open
27416 Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s])
27599 Unlisted procedure, femur or knee
27899 Unlisted procedure, leg or ankle
28446 Open osteochondral autograft, talus (includes obtaining graft[s])
29866 Arthroscopy, knee, surgical; osteochondral autograft(s) (e.g., mosaicplasty) (includes harvesting of the autograft[s])
29867 Arthroscopy, knee, surgical; osteochondral allograft (e.g., mosaicplasty)
29885 Arthroscopy, knee, surgical; drilling for osteochondritis dissecans with bone grafting, with or without internal fixation (including debridement of base of lesion)
29892 Arthroscopically aided repair of large osteochondritis dissecans lesion, talar dome fracture, or tibial plafond fracture, with or without internal fixation (includes arthroscopy)
L8699 Prosthetic implant, not otherwise specified
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
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