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Meniscal allografts and other meniscal implants (eg, collagen or polyurethane) are intended to improve symptoms and reduce joint degeneration in patients who have had a total or partial resection of the meniscus.
Historically, the role of normal meniscal cartilage was greatly under appreciated, and until some 30 years ago, torn and damaged menisci were routinely excised. However, it is now known that the menisci are an integral structural component of the human knee, functioning to absorb shocks and providing load sharing, joint stability, congruity, proprioception, and lubrication and nutrition of the cartilage surfaces. Total and partial meniscectomy frequently result in degenerative osteoarthritis. The integrity of the menisci is particularly important in knees in which the anterior cruciate ligament (ACL) has been damaged. In these situations, the menisci act as secondary stabilizers of anteroposterior and varus-valgus translation. With this greater understanding, the surgical principles of treating torn or damaged menisci evolved to favor repair and preservation whenever possible.
Meniscal allograft transplantation has been investigated in patients with a previous meniscectomy, or in patients who require a total or near total meniscectomy for irreparable tears. There are three (3) general groups of patients who have been treated with meniscal allograft transplantation:
Issues under study include techniques for processing and storing the grafts, proper sizing of the grafts, and the most appropriate surgical techniques (eg, suturing or anchored with bone plugs). Four primary ways of processing and storing allografts (fresh, fresh frozen, cryopreserved, lyophilized) have been reported. Fresh implants, harvested under sterile conditions, are less frequently used because the grafts must be used within a couple of days to maintain viability. Alternatively, the harvested meniscus can be fresh frozen for storage until needed. Another commonly used method, cryopreservation, freezes the graft in glycerol, which aids in preserving the cell membrane integrity and donor fibrochondrocyte viability. Cryolife (Marietta, GA) is a commercial supplier of such grafts. In addition to freezing, donor tissue may be dehydrated (freeze-dried or lyophilized), permitting storage at room temperature. Lyophilized grafts have been shown to be prone to reduced tensile strength, graft shrinkage, poor rehydration, post-transplantation joint effusion, and synovitis and are no longer used in the clinical setting. Several secondary sterilization techniques may be used, with gamma irradiation the most common. The dose of radiation considered effective has been shown to change the mechanical structure of the allograft; therefore, non-irradiated grafts from screened donors are most frequently used.
Tissue engineering that grows new replacement host tissue for individual patients is also being investigated. For example, the ReGen Collagen Scaffold (Ivy Sports Medicine, formerly ReGen Biologics), which may also be referred to as the MenaflexTM collagen meniscus implant or CMITM, is a resorbable collagen matrix comprised primarily of type I collagen from bovine Achilles tendons. The implant is provided in a semilunar shape and trimmed to size for suturing to the remaining meniscal rim. The implant provides an absorbable collagen scaffold that is replaced by the patient's own soft tissue; it is not intended to replace normal body structure. In addition, because it requires a meniscal rim for attachment, it is intended to fill meniscus defects after a partial meniscectomy. Other scaffold materials and cell-seeding techniques are being investigated. For example, Actifit® (Orteq) is a biodegradable polyurethane scaffold that is currently being studied in Europe. Nonabsorbable and nonporous synthetic implants for total meniscus replacement are in development. One total meniscus replacement that is in early phase clinical testing is NUsurface® (Active Implants), which is composed of a polyethylene reinforced polycarbonate urethane.
The ReGen Collagen Scaffold (CS) received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) in 2008. The marketing clearance was based on the decision that this collagen scaffold was substantially equivalent to existing predicate absorbable surgical mesh devices. The ReGen Collagen Scaffold (also known as Menaflex™ CMI) was the only CMI with FDA clearance at that time. Amid controversy about the 510(k) clearance for the ReGen Collagen Scaffold, FDA initiated a review of the clearance process for this device. In September 2009, FDA issued a preliminary report on the review of the ReGen Menaflex®: Departure from Processes, Procedures, and Practices Leave the Basis for a Review Decision in Question. This preliminary report documents findings and recommendations concerning FDA’s review and clearance of the ReGen Biologics, CS device for meniscal repair, marketed as Menaflex™. In October 2010, FDA announced that the device should not have been cleared for marketing, as the Menaflex™ device is intended to be used for different purposes and is technologically dissimilar from devices already on the market (predicate devices).
No partial or total meniscal implant is approved or cleared for marketing in the U.S.
Meniscal allograft transplantation may be considered medically necessary in patients who have had a prior meniscectomy and have symptoms related to the affected side, when all of the following criteria are met:
Meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with treatment of focal articular cartilage lesions using any of the following procedures:
Use of other meniscal implants incorporating materials such as collagen and polyurethane are considered investigational.
Patients should exhibit symptoms of persistent disabling knee pain that has not shown an adequate response to physical therapy and analgesic medications. Uncorrected 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.
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. Meniscal allograft transplantation is typically recommended for young, active patients who are too young for total knee arthroplasty.
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.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
11/1998: Approved by Medical Policy Advisory Committee (MPAC)
11/2001: Reviewed by MPAC; investigational status remains
2/21/2002: Investigational definition added, Code Reference section updated, CPT 0014T added, HCPCS S9085 deletion date of 12/31/2001 added
5/1/2002: Type of Service and Place of Service deleted
3/22/2005: Code Reference section updated, CPT code 0014T deletion date of 12/31/2004 and Note: "See CPT code 29868" added, CPT code 29868 with effective date of 1/1/2005 added, ICD-9 procedure code 81.47 added, HCPCS S9085 deleted
3/16/2006: Policy reviewed, no changes
1/9/2007: Policy reviewed, no changes
5/15/2007: Policy reviewed, description section rewritten. No change to policy statement
12/4/2008: Policy reviewed, policy section re-written with medically necessary conditions as noted
12/15/2008: Code Reference section updated, covered table added.
05/28/2010: Title changed from "Meniscal Allograft Transplantation" to "Meniscal Allografts and Collagen Meniscus Implants." Description section revised; Policy Statement revised to include "Collagen meniscus implants are considered investigational"; Policy Guidelines section revised; and Code Reference section revised to add the following ICD-9 diagnosis codes to the Covered Codes Table: 717.0 - 717.5; 836.0; 836.1 and 836.2.
06/21/2011: Policy statement revised to state that meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation or osteochondral allografting or osteochondral autografting for focal articular cartilage lesions. Policy guidelines revised to remove "lasting at least 6 months" and to add information regarding uncorrected misalignment and instability of the joint.
04/26/2012: Policy reviewed; no changes.
09/01/2013: Policy title was updated to change "Collagen" to "Other." The investigational policy statement, which previously stated that collagen meniscus implants are considered investigational was expanded to state that use of other meniscal implants incorporating materials such as collagen and polyurethane are considered investigational. Deleted outdated references from the Sources section. Added HCPCS G0428 to the Code Reference section as an investigational procedure.
04/30/2014: Policy title updated to change "Meniscus Implants" to "Meniscal Implants." Policy description revised and updated to add that no partial or total meniscal implant is approved or cleared for marketing in the U.S. Deleted the sentence "Adolescent patients should be skeletally mature with documented closure of growth plates (e.g., 15 years or older)" from the first bullet point in the first medically necessary policy statement. Added "< 50% joint space narrowing" to the first medically necessary policy statement criteria. Second policy statement revised to list the procedures that may be used with treatment of focal articular cartilage lesions. It previously stated: Meniscal allograft transplantation may be considered medically necessary when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation or osteochondral allografting or osteochondral autografting for focal articular cartilage lesions.
08/26/2015: Code Reference section updated for ICD-10.
11/10/2015: Policy description updated. Policy statements unchanged. Policy guidelines updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
Blue Cross Blue Shield policy # 7.01.15
This 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.
Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex)
Supplement Right Knee Joint with Synthetic Substitute, Open Approach
Supplement Left Knee Joint with Synthetic Substitute, Open Approach