Meniscal Allografts and Other Meniscal Implants

POLICY NUMBER

A.7.01.15

DESCRIPTION

Meniscal allografts and other meniscal implants (eg, collagen) are intended to improve symptoms and reduce joint degeneration in individuals who have had a total or partial meniscus resection.

Meniscal Cartilage Damage

Meniscal cartilage is 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 has been damaged. In these situations, the menisci act as secondary stabilizers of anteroposterior and varus-valgus translation.

Treatment

Meniscal allograft transplantation (MAT) is considered a salvage procedure, reserved for patients with disabling knee pain following meniscectomy who are considered too young to undergo total knee arthroplasty or in patients who require a total or near total meniscectomy for irreparable tears. As a result, the population intended to receive these transplants is relatively limited. Using a large database of privately insured non-Medicare patients, Cvetanovich and colleagues estimated an annual incidence of MAT in the United States of 0.24 per 100,000. It is not expected that clinical trials will be conducted to compare meniscal allografts with other orthopedic procedures, although trials comparing allograft transplant with medical therapy are possible.

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 appropriate surgical techniques. The four primary ways of processing and storing allografts are fresh viable, fresh frozen, cryopreserved, and lyophilized. Fresh viable 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. Cryopreservation freezes the graft in glycerol, which aids in preserving the cell membrane integrity and donor fibrochondrocyte viability. CryoLife is a commercial supplier of such grafts. Donor tissues may also be dehydrated (freeze-dried or lyophilized), permitting storage at room temperature. Lyophilized grafts are prone to reduced tensile strength, shrinkage, poor rehydration, post-transplantation joint effusion, and synovitis; they 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. In a survey conducted by the International Meniscus Reconstruction Experts Forum, when surgeons were asked about allograft preference, 68% preferred fresh frozen nonirradiated allografts, with 14% responding fresh viable allografts.

There are several techniques for meniscal allograft transplantation; most are arthroscopically assisted or all-arthroscopic. Broadly, the techniques are either all-suture fixation or bone fixation. Within the bone fixation category, the surgeon may use either bone plugs or a bone bridge. Types of bone bridges include keyhole, trough, dove-tail, and bridge-in-slot. The technique used depends on laterality and the need for concomitant procedures. Patients with malalignment, focal chondral defects, and/or ligamentous insufficiency may need concomitant procedures (osteotomy, cartilage restoration, and/or ligament reconstruction, respectively).

Tissue engineering that grows new replacement host tissue is also being investigated. For example, the Collagen Meniscus Implant (CMI®) (by Stryker, formerly the ReGen Collagen Scaffold® by ReGen Biologics), 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 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. A second collagen meniscus implant, RejuvaKnee™ has similar characteristics to CMI; however, the bovine collagen is sourced from the meniscus as opposed to the Achilles tendon. Other scaffold materials and cell-seeding techniques are being investigated. 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); it is composed of a polyethylene reinforced polycarbonate urethane.

Outcome Measures

The outcomes of this treatment (ie, pain, functional status) are subjective, patient-reported outcomes that are prone to placebo effects. On the other hand, the natural history of a severely damaged meniscus is predictable, with progressive joint damage, pain, and loss of function.

Collagen Meniscus Implants

In 2008, the ReGen Collagen Scaffold was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing absorbable surgical mesh devices. The ReGen Collagen Scaffold (also known as MenaFlex™ CMI) was the only collagen meniscus implant with FDA clearance at that time. Amid controversy about this 510(k) clearance, the FDA reviewed its decision. In October 2010, the FDA rescinded the approval, stating that MenaFlex is intended for different purposes and is technologically dissimilar from the predicate devices identified in the approval process. The manufacturer appealed the rescission, and won its appeal in 2014. The product, now called CMI, was manufactured by Ivy Sports Medicine (now Stryker). A second collagen meniscus implant, RejuvaKnee™ (Collagen Matrix, Inc [now Regenity]), was declared substantially equivalent to CMI by the FDA in 2024.

POLICY

Meniscal allograft transplantation may be considered medically necessary in individuals 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:

• autologous chondrocyte implantation, or

• osteochondral allografting, or

• osteochondral autografting.

Use of other meniscal implants incorporating materials such as collagen are considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

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

Individuals should exhibit symptoms of persistent disabling knee pain that has not adequately responded 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 (eg, body mass index 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 individuals 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 Mental Health Disorders, 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 medical necessity, “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 HISTORY

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 A.7.01.15 added.

06/19/2017: Policy description updated regarding meniscal allograft transplantation and devices. Policy statements unchanged.

05/03/2018: Policy description updated to remove information regarding polyurethane. Added information regarding meniscal allograft transplantation treatment and outcomes. Policy statements unchanged.

06/14/2018: Investigational statement updated to remove "polyurethane."

08/14/2019: Policy reviewed; no changes.

08/18/2020: Policy reviewed; no changes.

07/15/2021: Policy description updated regarding devices. Medically necessary criteria updated to change "absent degenerative changes" to "absent diffuse degenerative changes." Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

05/31/2022: Policy reviewed; no changes.

05/12/2023: Policy description updated. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

05/20/2024: Policy reviewed; no changes.

05/09/2025: Policy description updated regarding a second collagen meniscus implant. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield policy # 7.01.15

CODE REFERENCE

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.

Covered Codes

Investigational Codes

CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.