Medical Policies - Surgery


Meniscal Allografts and Other Meniscal Implants

Number:SUR705.034

Effective Date:10-01-2018

Coverage:

*CAREFULLY CHECK STATE REGULATIONS AND/OR THE MEMBER CONTRACT*

Meniscal allografts of the knee 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:

Adult patient should be too young to be considered an appropriate candidate for a total knee arthroplasty or other reconstructive knee surgery (i.e., < 55 years); and

Disabling knee pain with activity that is refractory to conservative treatment, including physical therapy and analgesic medications; and

Absence or near absence (> 50%) of the meniscus, established by imaging or prior surgery; and

Minimal to absent diffuse degenerative changes in surrounding articular cartilage (Outerbridge grade 0, I, or II, < 50% joint space narrowing); and

Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation; and

There is no infection, inflammatory arthritis (e.g., rheumatoid arthritis [RA]) or synovial disease present; and

The body mass index (BMI) is ≤ 35 kg/m2.

Outerbridge Grading

Grade 0

Normal appearing cartilage

Grade I

Swelling and Softening or Articular Cartilage

Grade II

Fissuring within softened areas

Grade III

Fibrillation

Grade IV

Destruction of articular cartilage and exposed bone

DOCUMENTATION Required for Review of Injury and Prior Treatment/Therapies:

Progress report, history, and/or operative notes confirming injury and prior treatments/therapies; and

Report(s) of standing x-rays documenting normal alignment and stability of the knee and the absence of inflammatory arthritis (e.g., RA); and

Report(s) from knee arthroscopy showing the presence of the cartilage defect and normal cartilage surrounding the defect.

NOTE 1: Additional procedures to correct misalignment or instability of the joint, such as repair of ligaments or tendons or an osteotomy for realignment, may be performed at the same time as the meniscal allografts.

NOTE 2: Meniscal allografts may be performed for treatment of focal articular cartilage lesions in combination (either concurrently or sequentially) with any of the following procedures:

Autologous chondrocyte implantation, or

Osteochondral allografting, or

Osteochondral autografting.

For criteria to determine medical necessity of other concurrent or sequential procedures, please refer to the following medical policies:

SUR705.035, Autologous Chondrocyte Implantation (ACI) for Focal Articular Cartilage Lesions, and/or

SUR705.020, Autografts and Allografts in the Treatment of Focal Articular Cartilage Lesions.

Meniscal allografting of the knee is considered not medically necessary as a treatment for symptomatic patients with partial or complete loss of the meniscus when criteria listed above are not met or as a treatment for asymptomatic patients with partial or complete loss of the meniscus.

Use of meniscal implants that incorporate materials, such as collagen (CMI) and polyurethane (PMI), are considered experimental, investigational and/or unproven.

Description:

Meniscal allografts and other meniscal implants (e.g., 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.

Background

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 (OA). 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. With this greater understanding, the surgical principles of treating torn or damaged menisci evolved to favor repair and preservation whenever possible.

Treatment

Meniscal allograft transplantation (MAT) is intended to restore knee function among patients with injured menisci from arthritis or trauma. 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 (TKA) 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 et al. (2015) estimated an annual incidence of MAT in the U.S. of 0.24 per 100,000. (1) 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 3 general groups of patients who have been treated with MAT:

Young patients with a history of meniscectomy who have symptoms of pain and discomfort associated with early OA that is localized to the meniscus-deficient compartment;

Patients undergoing anterior cruciate ligament reconstruction in whom a concomitant meniscal transplant is intended to provide increased stability;

Young athletes with few symptoms in whom the allograft transplantation is intended to deter the development of OA. Due to the risks associated with this surgical procedure, prophylactic treatment for this purpose is not frequently recommended.

Issues under study include techniques for processing and storing the grafts, proper sizing of the grafts, and appropriate surgical techniques. The 4 primary ways of processing and storing allografts are fresh viable, fresh frozen, cryopreserved, and lyophilized:

Fresh - 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.

Fresh Frozen - After sterile harvest, the harvested meniscus can be fresh frozen for storage until needed/thawed for use. The freezing process may destroy donor cells and decrease the size of the graft.

Cryopreserved - 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.

Freeze Dried (Lyophilized) - Donor tissues may be dehydrated, 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 non-irradiated allografts, with 14% responding fresh viable allografts. (2)

There are several techniques for MAT; 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). (3)

Tissue engineering that grows new replacement host tissue is also being investigated. For example, the Collagen Meniscus Implant (CMI®; Ivy Sports Medicine, formerly the ReGen Collagen Scaffold by ReGen Biologics), which may have been referred to as the Menaflex™, is a resorbable collagen matrix composed 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. 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. Non-absorbable 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 (i.e., 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.

Regulatory Status

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 (CMI) with the FDA clearance at that time. Amid controversy about this 510(k) clearance decision, 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®, is manufactured by Ivy Sports Medicine. CMI® is the only FDA-approved collagen meniscus product currently on the market. FDA product code: OLC. No partial or total meniscal implant is FDA-approved or cleared for marketing in the U.S. Additionally, no polyurethane meniscus implant (PMI) has FDA approval or is available in the European Union for marketing; this includes the Actifit® biodegradable meniscus polyurethane scaffold (Saratoga Partners, LLC; London, U.K., and New York, U.S.; formerly known as Orteq Sports Medicine Ltd.).

Rationale:

This medical policy was created in 1994 and has been updated periodically with literature searches using the MedLine database. The most recent literature update was performed through July 2018.

Medical policies assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function--including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

The primary literature consists of retrospective case series and systematic reviews of these case series. Two main issues are investigated:

1. Does meniscal allograft transplantation (MAT) reduce pain and improve function; and

2. Does this procedure reduce joint degeneration?

The following is a summary of key references to date, focusing on graft survival and health outcomes with longer term follow-up.

Meniscal Allograft Transplantation (MAT)

Systematic Reviews

Several systematic reviews of available case series have reported reductions in pain and improvements in function at mid-term follow-up, with failure rates at the time of follow-up ranging from 7% to 35% (see Table 1). Elattar et al. (2011) published a large systematic review with a total of 1136 allografts. (4) Twelve different clinical scoring systems were described, which generally showed reductions in pain and improvements in function. Hergan et al. (2011) conducted a systematic review of the literature to evaluate the characteristics of patients, graft survival, and clinical outcomes. (5) The analysis found that patients with Outerbridge scores of II or less in any area had significantly improved post-treatment Lysholm Knee Score (LKS) and Tegner Activity Scale (TAS) scores, whereas patients with Outerbridge grade III or more in any area (not repaired) did not. Studies that analyzed patients undergoing concomitant procedures did not detect a difference between subgroups compared with MAT alone. Functional outcomes were considered generally good where reported. Rosso et al. (2015) published a systematic review evaluating 55 studies (total n=1623 patients). (6) Data from 37 studies were included in demographic and outcome analyses. Collectively, these systematic reviews, which are based primarily on level IV evidence, summarize the short- to medium-term outcomes of MAT (see Table 1).

Table 1. Summary of Key Systematic Reviews of MAT

Variables

Elattar et al.

(2011) (4)

Hergen et al.

(2011) (5)

Rosso et al.

(2015) (6)

Number and type of studies

44 cohort and case series

14 cohort and case series with minimum 2-year follow-up

55 (2 level II, 7 level III, 46 level IV)

Population

(mean age)

1136 knees

1068 patients (34.8 years)

196 knees

1623 patients

Intervention

4.6-year follow-up (range, 8 months to 20 years)

53.8-months (24-167 months)

53.6-months (12-168 months)

Control

None

None

None

Outcome measures

Pain and function

Pain and function

Pain and function

Review synthesis

Pain and function

All showed clinical improvement

Alleviation of knee pain and improvement in function noted

Weighted pre- or post-measuresa:

VAS pain score decreased from 6.4 to 2.4

LKS increased from 55.5 to 82.7

Failure rate

10.6%

7%-35%

Fresh frozen:

9.9%

Cryopreserved: 18.2%

Complication rate

21.3%

Not Reported

10.6%

Review conclusion

Meniscal allograft improves pain and function

Improvements in both objective and subjective outcome measures were shown in relatively young patients without significant chondromalacia who underwent concomitant procedures for cartilage defects, limb malalignment, and/or limb instability

Agreement in literature on MAT indications:

All studies showed clinical improvement at short- and mid-term follow-ups

Complication and failure rates acceptable

Potential chondro-protective effect of MAT remains unclear

Review limitations

Based primarily on case series

Based primarily on case series and qualitative review only

Based primarily on case series

Table Key:

MAT: meniscal allograft transplantation;

LKS: Lysholm Knee Score;

MAT: meniscal allograft transplantation;

VAS: visual analog scale;

a: Data from 37 of the 55 studies in the systematic review.

Randomized Controlled Trials (RCT)

Smith et al. (2018) reported on the results of a small RCT that randomized 21 patients with a symptomatic meniscal deficient knee to MAT (n=10) or personalized physical therapy (n=11). (7) Another 15 patients who were screened for the RCT decided instead to choose their treatment (referred to as preference group) received MAT (n=6) or personalized physical therapy (n=9). The Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, LKS Scale score, and complications were collected at baseline, 4 and 8 months, and 1 year after the interventions. Trialists reported pooled results from the RCT and preference group, with statistically significant differences in favor of MAT group for KOOS composite score (mean difference, 12; p=0.03) and KOOS subscales of pain (mean difference, 15; p=0.02) and activities of daily living (mean difference, 18; p=0.005). However, pooling data from the RCT and preference group precluded a meaningful interpretation of data.

Case Series

The characteristics and results of several case series with longer-term follow-up are provided in Tables 2 and 3. Verdonk et al. (2005) published a large case series with long-term follow-up from 95% of their first 105 fresh cultured (viable) meniscal allografts. (8) The indication for transplantation was moderate-to-severe pain in patients who had undergone previous total meniscectomy, not old enough to be considered for a knee joint replacement, and with good alignment of the lower limb and a stable joint (some were corrected concomitantly). In the study by Hommen et al. (2007), concomitant procedures were performed in 75% of the patients, including anterior cruciate ligament reconstruction or revision (n=10), high tibial osteotomy (n=2), and lateral retinaculum release (n=3). (9)

At a mean follow-up of 16 years, van der Wal et al. (2009) (10) reported graft survival decreased to 52.5%, while most failures in the study by Vundelinckx et al. (2010) (11) occurred approximately 10 years postoperatively. That said, at an average of 105 months of follow-up, the 34 remaining patients assessed in the Vundelinckx study showed significant reductions in pain and improvements in function relative to preoperative levels. Radiographic evidence reported by van der Wal et al., also showed a slight or moderate increase in osteoarthritis (OA) in 42% of patients (1 or 2 points) and no increase in the other 58%. Of 15 patients with follow-up radiographs in the Hommen study, 10 (67%) had joint space narrowing, and 12 (80%) had progression of the Fairbank degenerative joint disease score in the transplanted tibiofemoral compartment.

Table 2. Summary of Key Case Series Characteristics for MAT

Variables

Verdonk et al.

(2005) (8)

Van der Wal et al. (2009) (10)

Vundelinckx et al. (2010) (11)

Sample size

105

57

34/49

Mean age (range), years

35 (16-50)

39 (26-55)

33 (14-47)

Population

Previous total meniscectomy

Previous total meniscectomy

Patients with intact allograft

Intervention

MAT

MAT

MAT

Control

None

None

None

Length of follow-up (range)

3-15 years

14 years (9-18 years)

105 months

Table Key:

MAT: meniscal allograft transplantation.

Table 3. Summary of Key Case Series Outcomes for MAT

Outcomes

Verdonk et al.

(2005) (8)

Van der Wal et al. (2009) (10)

Vundelinckx et al. (2010) (11)

Base

FU

p

Base

FU

p

Base

FU

p

VAS score

7.0

3.4

<0.001

LKS score

36

61

<0.05

39.7

71.8

<0.001

KOOS score

35.8

60.2

<0.001

Graft survival rate

70%

11 y: 71%

16 y: 52.5%

90%

Mean survival time, years

11.6 y

Table Key:

FU: follow-up;

MAT: meniscal allograft transplantation;

LKS: Lysholm Knee Score;

KOOS: Knee Injury and Osteoarthritis Outcome Score;

MRI: magnetic resonance imaging;

VAS: visual analog scale

y: year(s).

Section Summary: MAT

Evidence for the use of MAT in patients with disabling knee pain and a prior meniscectomy consists of systematic reviews of a large number of case series and an RCT. The reviews have found that MAT is associated with reductions in pain and improvements in function. Longer term studies have indicated that these improvements are maintained in a substantial percentage of patients, up to 10 years and beyond. Because the results of a single RCT, which enrolled a very small number of patients, pooled data from randomized and nonrandomized groups, results cannot be interpreted in a meaningful way. Adverse events, such as graft failure and the need for additional procedures, occur frequently. The strength of the evidence, including accurate estimates of the magnitude of benefit and the complication rates, are limited by the type of data available (case series and systematic reviews of these case series) as well as the heterogeneity in surgical techniques and patient characteristics across the studies.

MAT Plus Articular Cartilage Repair

Patients with malalignment, focal chondral defects, and/or ligamentous insufficiency may require additional surgery combined with MAT. When MAT is combined with osteotomy or articular cartilage repair in a single procedure, MAT should be performed first.

The evidence available for the efficacy of MAT in knees with chondral damage consists of 1 prospective comparative study, case series, most of which are retrospective, and systematic reviews of case series.

Systematic Reviews

Harris et al. (2011) published a systematic review of MAT plus cartilage repair or restoration (see Table 4). (12) Patients underwent MAT with autologous chondrocyte implantation (ACI; n=73), osteochondral allograft (n=20), osteochondral autograft (n=17), or microfracture (n=3). All studies showed improvement in clinical outcomes at final follow-up compared with the preoperative condition. Outcomes were similar to historical outcomes, extracted from mid-term and long-term follow-up studies, of procedures performed in isolation. Additional surgeries are common (nearly 50%) after MAT plus cartilage repair or restoration procedures.

Table 4. Summary of Key Systematic Reviews

Variables

Harris et al. (2011) (12)

Number and type of studies

6 case series

Population

110 patients

Intervention

Meniscal allograft combined with cartilage repair or restoration

Control

Baseline to posttreatment

Historical controls of procedures performed in isolation

Outcome measures

Variable outcome measures of pain and function

Review synthesis

Outcomes improved from baseline to posttreatment

4/6 studies found outcomes equivalent to procedures performed in isolation

2/6 studies found combined surgery not to be as good as historical controls

Review conclusion

Meniscal allograft can improve pain and function when combined with cartilage repair or restoration procedures

Review limitations

Based on case series with historical controls

Table Key:

MAT: meniscal allograft transplantation.

The largest and longest study to report on MAT in patients with significant (grade III and IV) chondral damage is that by Stone et al. (2010) who reported mean allograft survival of 9.9 years (see Table 5). (13) Other prospective studies have reported on graft survival and functional outcomes when MAT has been combined with articular cartilage repair. (14, 15) This includes 1 report, Rue et al. described average 3.1 years of follow-up from a prospective series of 30 patients who had undergone combined MAT with ACI (52%) or osteochondral autograft transplantation (OAT) (48%). (15) The Lysholm score improved in both the ACI and allograft groups; 48% of patients were considered to be normal or nearly normal at the latest follow-up.

Case Series

The following studies were published subsequent to the systematic review (see Table 5). Kempshall et al. (2015) looked at MAT concomitant with cartilage repair procedures on

1. Patients with more knee cartilage damage (grade 3b >1 cm2) and

2. Patients with less knee cartilage damage (grade 3b <1 cm2). (16)

Functional outcomes following the procedures were similar between the 2 groups. However, implant survival (using graft failure as an end point) was lower among those with greater cartilage damage.

Ogura et al. (2016) retrospectively reviewed patients who had undergone ACI and MAT. (17) Seventeen patients were followed for a mean of 7.9 years. Significant improvements in clinical outcomes (visual analog scale [VAS] for pain, Western Ontario and McMaster Universities Arthritis Index, 36-Item Short-Form Health Survey, and modified Cincinnati Knee Rating Scale scores) were reported in 65% of the patients. Of the 6 procedures considered failures, 4 underwent TKA and 2 underwent revision surgery.

Zaffagnini et al. (2016) reviewed 147 patients undergoing arthroscopic bone plug-free MAT, with 48% of patients having concomitant procedures (mostly high tibial osteotomy and anterior cruciate ligament reconstruction). (18) Two survival analyses were conducted, one with the end point of surgical failure (need for revision procedures related to initial MAT) and the other with the end point of clinical failure (same revision procedures as a surgical failure or LKS less than 65 at final follow-up). Mean overall survival time with the surgical failure end point was 9.7 years (95% confidence interval, 9.1 to 10.3 years) and mean overall survival with the clinical failure end point was 8.0 years (95% confidence interval, 7.1 to 8.8 years). Logistic regression analysis did not reveal any variables (including concomitant procedures) affecting the surgical or clinical failure end points.

Table 5. Series of MAT with Articular Cartilage Damage

Variables

Stone et al. (2010) (13)

Kempshall et al. (2015) (16)

Ogura et al. (2016) (17)

Zaffagnini et al. (2016) (18)

Sample size

115

99

17

147

Population

Consecutive patients with grade III-IV chondral damage

Prospective series

Grade 3b <1 cm2

Grade 3c >1 cm2

Retrospective series

Retrospective series

Intervention

MAT

MACI and microfracture more common if chondral damage was 3c >1 cm2

ACI with MAT

MAT

Control

None

None

None

None

Outcome measures

Allograft survival

Allograft survival

KOOS, Tegner, LKS, IKDC scores

MAT survival

MCKRS, WOMAC, VAS, SF-36

MAT survival

KOOS, LKS, VAS

Length of follow-up

5.8 years (range, 2 months to 12.3 years)

2 years

5-10 years

4 years

Results

Mean allograft

survival was 9.9 years 47% required additional operations

Similar outcomes on KOOS, Tegner, LKS, IKDC scores for 2 groups

Allograft survival was 97.9% if 3b <1 cm2 and 78% if 3c >1 cm2

Mean MAT survival rate, 75% at 5- and 10-year follow-up

67% (12/18) required additional surgery

Mean MAT survival range, 8-9.7 years

17% required additional surgery

Table Key:

MAT: meniscal allograft transplantation;

ACI: autologous chondrocyte implantation;

IKDC: International Knee Documentation Committee;

KOOS: Knee Injury and Osteoarthritis Outcome Score;

LSK: Lysholm Knee Score;

MACI: matrix-assisted ACI;

MCKRS: modified Cincinnati Knee Rating Scale;

OAT: osteochondral autograft transplantation

SF-36: 36-Item Short-Form Health Survey;

TAS: Tegner Activity Scale;

VAS: visual analog scale;

WOMAC: Western Ontario and McMaster Universities Arthritis Index.

Section Summary: Combined Meniscus Transplantation and Articular Cartilage Repair

There is a limited amount of low-quality evidence on combined MAT and articular cartilage repair. The available literature has reported reductions in pain and improvements in functioning following these procedures, though studies have reported graft failures and the need for additional surgeries.

Collagen Meniscus Implants (CMI)

A CMI is sutured into place on a meniscal rim and is intended for use with a partial meniscectomy. Therefore, the literature search focused on controlled trials comparing health outcomes for CMI with partial meniscectomy alone. The literature to date consists of case series, a large RCT sponsored by a CMI manufacturer, a smaller RCT from Germany, and a small prospective comparative cohort study.

Systematic Reviews

Two systematic reviews, one by Harston et al. (2012) (19) and the other by Warth et al. (2015), (20) are summarized in Table 6. A third, by Zaffagnini et al. (2015), (21) focused only on studies assessing postoperative magnetic resonance imaging evaluations, which included 6 studies, none of which was an RCT and all of which were included in the Warth review. We do not discuss the Zaffagnini review further.

Table 6. Summary of Key Systematic Reviews of CMI

Variables

Harston et al. (2012) (19)

Warth et al. (2015) (20)

Search date

May 2011

March 2014

Number and type of studies

11

13

Population

520

674

Intervention

321 patients received a CMI

41.1% of these patients had concomitant procedures

439 patients received CMI

32.3% patients had concomitant procedures

Control

Partial meniscectomy alone

Not Reported

Outcome measures

LKS, TAS, pain scales

8/11 studies provided postoperative imaging data

LKS, TAS, pain scales

11/13 studies provided postoperative imaging data

Length of follow-up

6-135 months

3-152 months

Review synthesis

66%-70% patients who receiving CMI had satisfactory outcomes

Outcomes in studies with control or comparison groups, reported improvement in both groups

Reduced CMI size at last follow-up reported in 6 (54.5%) of 11 studies

CMI showed superior clinical outcomes versus partial meniscectomy alone

Several studies reported that meniscus scaffold decreased in volume over time

Second-look arthroscopy showed presence of newly formed meniscus-like tissue in area of the scaffold

Review limitations

Based on low-quality evidence

Mostly level IV evidence

No meta-analysis due to differing methodologies and data reporting across studies

Table Key:

CMI: collagen meniscus implant;

LSK: Lysholm Knee Score;

TAS: Tegner Activity Scale.

The quality of the studies included in the systematic reviews was generally rated as low. Tables 7 and 8 summarize select studies (2 RCTs, 2 cohort) included in the systematic reviews. A large RCT from the manufacturers of MenaFlex™ (Rodkey et al. [2008] [23]) was conducted under a U.S. Food and Drug Administration (FDA) investigational device exemption. Only TAS scores in the chronic arm (but not the acute arm) differed significantly between the CMI and partial meniscectomy only groups. Kaplan-Meier analysis suggested a modest 10% increase in survival in the chronic CMI group.

Table 7. Summary of Key Study Characteristics for CMI

Variables

Rodkey et al. (2008) (23)

Link et al. (2006) (24)

Zaffagnini et al. (2011) (25)

Bulgheroni et al. (2014) (26)

Study design

Randomized controlled trial

Randomized controlled trial

Controlled cohort

Retrospective cohorts

Sample size

311

60

36

34

Population

Acute and chronic partial meniscectomy

Patient choice

Matched controls

Intervention

CMI

Osteotomy plus CMI

CMI

CMI

Control

Partial meniscectomy alone

Osteotomy alone

Partial meniscectomy

alone

Partial meniscectomy

alone

Length of follow-up

59 month (16-92 months)

8-18 months

133 months (120-152 months)

9.6 years

Table Key:

CMI: collagen meniscus implant.

Table 8. Summary of Key Study Results for CMI

Outcomes

Rodkey et al. (2008) (23)

Link et al. (2006) (24)

Zaffagnini et al. (2011) (25)

Bulgheroni et al. (2014) (26)

CMI

Ctrl

p

CMI

Ctrl

p

CMI

Ctrl

p

CMI

Ctrl

p

Survival rate

90%a

80%a

65%

89%

VAS pain

19/100a

21/100a

2.2/10

1.5/10

NS

1.2/10

3.3/10

<0.004

14.7/100

13.5/100

LKS score

79a

78a

NS

93.6

91.0

NS

»86

»80

NS

94.1

95.5

NS

IKDC score

83.0

77.0

NS

<0.001b

85.7

88.1

NS

TAS score

42%a

29%a

<0.02

75

50

<0.026

6 5-6

6 5-6

NS

Table Key:

CMI: collagen meniscus implant;

Ctrl: control;

VAS: Visual Analog Scale;

LSK: Lysholm Knee Score;

IKDC: International Knee Documentation Committee;

NS: Not significant;

a: Chronic only;

b: Higher scores reported by CMI group versus control group.

Section Summary: Collagen Meniscus Implants

Evidence for the use of CMI in patients undergoing partial meniscectomies consists of 2 systematic reviews, the most recent including 674 patients. The reviews reported overall positive results with CMI, but the quality of the included studies (RCTs and observational studies) was low. Radiologic evaluation showed destruction and/or absorption of the implant in a very large portion of patients.

Polyurethane Meniscal Implant (PMI)

Evidence on the PMI includes 3 prospective multicenter series from the Actifit® Study Group and an independently conducted pragmatic trial (see Table 9). Verdonk et al. reported positive results for 1-year tissue ingrowth and 2-year clinical outcomes in patients who received a PMI at the time of partial meniscectomy (34 medial, 18 lateral). (27, 28) Interpretation of these results is limited by the absence of a control group undergoing partial meniscectomy without the scaffold. Another report from this group evaluated the Actifit® biodegradable polyurethane scaffold for the lateral meniscus in patients with post-meniscectomy syndrome. (29) Using last observation carried forward for missing data, clinical outcomes were found to improve over the course of the study. This study is also limited by the lack of a control group. In contrast with the positive results found in the case series, a controlled pragmatic trial found no benefit of inserting an Actifit® at the time of high tibial osteotomy compared with benefit in patients who were left with a meniscus defect. (30) Additional controlled trials are needed to determine the efficacy of the polyurethane meniscal scaffold. It is also noted that the Actifit® meniscal scaffold is not currently approved for marketing in the U.S, nor in the European Union.

Table 9. Summary of Key Study Characteristics for PMI

Variables

Verdonk

et al. (2011) (27)

Verdonk

et al. (2012) (28)

Bouyarmane

et al. (2014) (29)

Gelber

et al. (2015) (30)

Actifit® Study Group

Yes

Yes

Yes

No

Study design

Prospective multicenter series

Prospective multicenter series

Prospective multicenter series

Pragmatic comparative trial

Sample size

44/52

39/52

54

60

Inclusion

Undergoing partial meniscectomy

Undergoing partial meniscectomy

Post-meniscectomy syndrome

Symptomatic varus knees with defect >25 mm

Intervention

PMI at the time of meniscectomy

Follow-up of subjects from Verdonk et al. (2011) (18)

PMI of the lateral meniscus

HTO with PMI

Control

None

None

None

HTO without PMI

Length of follow-up

1 year

24 months

24 months

31.2 months

Table Key:

Polyurethane Meniscal Implant (PMI);

HTO: high tibial osteotomy;

Table 10. Summary of Key Study Results for PMI

Outcomes

Verdonk

et al. (2011) (27)

Verdonk

et al. (2012) (28)

Bouyarmane

et al. (2014) (29)

Gelber et al. (2015) (30)

BL

FU

p

BL

FU

p

BL

FU

p

BL

FU

p

VAS score

45.7/100

20.3/100

<0.001

5.5/10

2.9/10

<0.001

5.9*

4.7*

0.006

IDKC

45.4

70.1

<0.001

47.0

67.0

<0.001

56.7*

50.3*

NS

LKS score

60.1

80.7

<0.001

WOMAT score

53.4*

42.4*

0.002

Overall results

5 scaffold-related AEs

9 serious AEs

17.3% failure rate

Study limitations

No control group

No control group

No control group

Nonrandomized

Table Key:

AEs: adverse events;

BL: baseline;

FU: follow-up;

*: shows improvement;

VAS: visual analog score;

IKDC: International Knee Documentation Committee;

LKS: Lysholm Knee Score;

WOMET: Western Ontario Meniscal Evaluation Tool.

Section Summary: Polyurethane Meniscal Implant

Controlled trials are needed to determine the efficacy of the polyurethane meniscal scaffold with greater certainty. It is also noted that the Actifit® meniscal scaffold is not currently approved for marketing in the U.S. and the European Union.

Ongoing and Unpublished Clinical Trials

Currently ongoing and unpublished trials that might influence this policy are listed in Table 10.

Table 10. Summary of Key Trials

NCT Number

Trial Name

Planned Enrollment

Completion

Date

Ongoing

NCT01712191a

Treatment of the Medial Meniscus with the Treatment of the Medial Meniscus with the NUSurface® Meniscus Implant

150

Jun 2017 (ongoing)

NCT01059409

The Clinical and Medico-economical Evaluation of Meniscal Allografts in the Sequelae of Total or Sub-total Meniscectomy

120

Sep 2017 (ongoing)

NCT02136901a

The VENUS Clinical Study (Verifying the Effectiveness of the NUSurface® System): A Multi-center, Prospective, Randomized, Interventional Superiority Clinical Study

37

Feb 2019

Table Key:

NCT: National Clinical Trial.

Clinical Input Received through Physician Specialty Societies and Academic Medical Centers

In 2008, the Blue Cross Blue Shield Association (BCBSA) requested and received clinical input from 1 physician specialty society and 3 academic medical centers. Although long-term effects on joint space narrowing were unknown, all of the reviewers considered meniscal allograft to be beneficial in selected patients, with evidence of short to intermediate pain relief when performed in younger patients with a prior meniscectomy who have disabling knee pain. Contraindications were noted as uncorrected instability, uncorrected malalignment, and the presence of significant articular disease.

Again in 2011, BCBSA requested and received clinical input from 1 physician specialty society (3 reviewers) and 3 academic medical centers. The input considered combined meniscal allograft transplantation and focal cartilage repair procedures to be medically necessary in patients younger than 55 years of age who have failed conservative treatment. The reviewers agreed that the CMI is investigational, although some considered the implant to be both investigational and medically necessary for some patients.

Practice Guidelines and Position Statements

International Meniscus Reconstruction Experts Forum

In 2015, the International Meniscus Reconstruction Experts Forum published consensus statements on the practice of MAT (see Table 11). (2) The Forum’s statements included guidance on indications, graft procurement and preparation, surgical technique, and rehabilitation.

Table 11. Select Consensus Statements on the Practice of MAT (2)

Statement

“Indications for MAT:

Unicompartmental pain post-meniscectomy;

In combination with anterior cruciate ligament reconstruction when meniscus deficient;

In combination with articular cartilage repair if meniscus deficient.”

“MAT not recommended for asymptomatic meniscus deficient patient.”

“Potentially poorer outcomes expected in patients with moderate to severe OA (Kellgren-Lawrence grade ≥3).”

“Non-irradiated fresh frozen or fresh viable grafts are recommended.”

“Mechanical axis alignment should be performed prior to MAT; if mechanical axis deviation present, consider realignment osteotomy.”

“Based on current evidence, superiority of 1 surgical technique over another (all-suture versus bone) is not established.”

“Outcome scores should include:

Disease-specific: Western Ontario Meniscal Evaluation Tool;

Region-specific: Knee injury and Osteoarthritis Outcome Score;

Activity: Marx Activity Rating Scale;

Quality of life/utility: EuroQoL 5 dimensions questionnaire.”

Table Key:

MAT: meniscal allograft transplantation;

OA: osteoarthritis.

National Institute for Health and Clinical Excellence (NICE)

The 2012 guidance from the NICE stated that the evidence on “partial replacement of the meniscus of the knee using a biodegradable scaffold raises no major safety concerns,” but evidence for any advantage of the procedure over standard surgery was limited. (31)

American Academy of Orthopaedic Surgeons (AAOS)

The AAOS updated its 2009 position in 2014, still recommending MAT for active people younger than 55 years old, with the goal of replacing the meniscus cushion before the articular cartilage is damaged. (32) Their website also notes that “synthetic (artificial) meniscal tissue has been tried, but there is conflicting information at this time.”

Summary of Evidence

For individuals who are undergoing partial meniscectomy who receive meniscal allograft transplantation (MAT), the evidence includes systematic reviews of mostly case series and a randomized controlled trial (RCT). Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic reviews concluded that most studies have shown statistically significant improvements in pain and function following the procedure. The benefits have also been shown to have a long-term effect (>10 years). Reviews have also reported acceptable complication and failure rates. There remains no evidence that meniscal allograft transplantation can delay or prevent the development of knee osteoarthritis (OA). A limitation of the evidence is its reliance primarily on case series. Because the single RCT, which enrolled a very small number of patients, pooled data from randomized and nonrandomized groups, results cannot be interpreted in a meaningful way. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are undergoing partial meniscectomy and concomitant repair of malalignment, focal chondral defects, and/or ligamentous insufficiency who receive MAT, the evidence includes a systematic review of case series as well as case series published after the systematic review. Relevant outcomes are symptoms, functional outcomes, and quality of life. The systematic review concluded that pain and function improved following the procedure. One of the series published after the review showed that patients with more severe cartilage damage experienced favorable outcomes similar to patients with less cartilage damage. Another series published subsequently reported an overall 9.7-year survival of the implant. A limitation of the evidence is its reliance primarily on case series. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who are undergoing partial meniscectomy who receive collagen meniscal implants (CMI), the evidence includes 2 systematic reviews primarily of case series. Relevant outcomes are symptoms, functional outcomes, and quality of life. The reviews reported overall positive results with the collagen meniscus implant, but the quality of the selected studies (RCTs, observational studies) was low. Radiologic evaluations have shown reductions in the size of the implant in a large portion of patients. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who are undergoing partial meniscectomy who receive polyurethane meniscus implant (PMI), the evidence includes 4 clinical trials. Relevant outcomes are symptoms, functional outcomes, and quality of life. The reviews reported overall positive results with the collagen meniscus implant, but the quality of the selected studies (RCTs, observational studies) was low. In addition to the lack of the U.S. Food and Drug Administration (FDA) approval, mid- to long-term follow-up from controlled studies with a larger number of subjects is needed to determine whether implantation of a PMI is able to slow joint degeneration, reduce pain, or otherwise improve the net health outcome. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

Effective in 2005, CPT category I code 29868 applies specifically to this procedure when performed arthroscopically, either medially or laterally.

There is no CPT code for implantation of the ReGen Collagen Scaffold, but the American Academy of Orthopaedic Surgeons’ Coding, Coverage and Reimbursement Committee feels that the meniscal transplantation CPT code 29868 is appropriate for this procedure.

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage versus. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

29868

HCPCS Codes

G0428

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does have a national Medicare coverage position.

A national coverage position for Medicare may have been changed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

1. Cvetanovich GL, Yanke AB, McCormick F, et al. Trends in meniscal allograft transplantation in the United States, 2007 to 2011. Arthroscopy. Jun 2015; 31(6):1123-7. PMID 25682330

2. Getgood A, LaPrade RF, Verdonk P, et al. International Meniscus Reconstruction Experts Forum (IMREF) 2015 consensus statement on the practice of meniscal allograft transplantation. Am J Sports Med. Aug 25 2017; 45(5):1195-205. PMID 27562342

3. Frank RM, Cole BJ. Meniscus transplantation. Curr Rev Musculoskelet Med. Dec 2015; 8(4):443-50. PMID 26431702

4. Elattar M, Dhollander A, Verdonk R, et al. Twenty-six years of meniscal allograft transplantation: is it still experimental? A meta-analysis of 44 trials. Knee Surg Sports Traumatol Arthrosc. Feb 2011; 19(2):147-57. PMID 21161170

5. Hergan D, Thut D, Sherman O, et al. Meniscal allograft transplantation. Arthroscopy. Jan 2011; 27(1):101-12. PMID 20884166

6. Rosso F, Bisicchia S, Bonasia DE, et al. Meniscal allograft transplantation: a systematic review. Am J Sports Med. Apr 2015; 43(4):998-1007. PMID 24928760

7. Smith NA, Parsons N, Wright D, et al. A pilot randomized trial of meniscal allograft transplantation versus personalized physiotherapy for patients with a symptomatic meniscal deficient knee compartment. Bone Joint J. Jan 2018; 100-B(1):56-63. PMID 29305451

8. Verdonk PC, Demurie A, Almqvist KF, et al. Transplantation of viable meniscal allograft. Survivorship analysis and clinical outcome of one hundred cases. J Bone Joint Surg Am. Apr 2005; 87(4):715-24. PMID 15805198

9. Hommen JP, Applegate GR, Del Pizzo W. Meniscus allograft transplantation: ten-year results of cryopreserved allografts. Arthroscopy. Apr 2007; 23(4):388-93. PMID 17418331

10. van der Wal RJ, Thomassen BJ, van Arkel ER. Long-term clinical outcome of open meniscal allograft transplantation. Am J Sports Med. Nov 2009; 37(11):2134-9. PMID 19542303

11. Vundelinckx B, Bellemans J, Vanlauwe J. Arthroscopically assisted meniscal allograft transplantation in the knee: a medium-term subjective, clinical, and radiographical outcome evaluation. Am J Sports Med. Nov 2010; 38(11):2240-7. PMID 20724642

12. Harris JD, Cavo M, Brophy R, et al. Biological knee reconstruction: a systematic review of combined meniscal allograft transplantation and cartilage repair or restoration. Arthroscopy. Mar 2011; 27(3):409-18. PMID 21030203

13. Stone KR, Adelson WS, Pelsis JR, et al. Long-term survival of concurrent meniscus allograft transplantation and repair of the articular cartilage: a prospective two- to 12-year follow-up report. J Bone Joint Surg Br. Jul 2010; 92(7):941-8. PMID 20595111

14. Farr J, Rawal A, Marberry KM. Concomitant meniscal allograft transplantation and autologous chondrocyte implantation: minimum 2-year follow-up. Am J Sports Med. Sep 2007; 35(9):1459-66. PMID 17435058

15. Rue JP, Yanke AB, Busam ML, et al. Prospective evaluation of concurrent meniscus transplantation and articular cartilage repair: minimum 2-year follow-up. Am J Sports Med. Sep 2008; 36(9):1770-8. PMID 18483199

16. Kempshall PJ, Parkinson B, Thomas M, et al. Outcome of meniscal allograft transplantation related to articular cartilage status: advanced chondral damage should not be a contraindication. Knee Surg Sports Traumatol Arthrosc. Jan 2015; 23(1):280-9. PMID 25432522

17. Ogura T, Bryant T, Minas T. Biological knee reconstruction with concomitant autologous chondrocyte implantation and meniscal allograft transplantation: mid- to long-term outcomes. Orthop J Sports Med. Oct 2016; 4(10):2325967116668490. PMID 27803938

18. Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, et al. Survivorship and clinical outcomes of 147 consecutive isolated or combined arthroscopic bone plug free meniscal allograft transplantation. Knee Surg Sports Traumatol Arthrosc. May 2016; 24(5):1432-9. PMID 26860105

19. Harston A, Nyland J, Brand E, et al. Collagen meniscus implantation: a systematic review including rehabilitation and return to sports activity. Knee Surg Sports Traumatol Arthrosc. Jan 2012; 20(1):135-46. PMID 21695465

20. Warth RJ, Rodkey WG. Resorbable collagen scaffolds for the treatment of meniscus defects: a systematic review. Arthroscopy. May 2015; 31(5):927-41. PMID 25595693

21. Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, et al. MRI evaluation of a collagen meniscus implant: a systematic review. Knee Surg Sports Traumatol Arthrosc. Nov 2015; 23(11):3228-37. PMID 24993568

22. Houck DA, Kraeutler MJ, Belk JW, et al. Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review. Knee Surg Sports Traumatol Arthrosc. Jan 16 2018. PMID 29340746

23. Rodkey WG, DeHaven KE, Montgomery WH, 3rd, et al. Comparison of the collagen meniscus implant with partial meniscectomy. A prospective randomized trial. J Bone Joint Surg Am. Jul 2008; 90(7):1413-26. PMID 18594088

24. Linke RD, Ulmer M, Imhoff AB. [Replacement of the meniscus with a collagen implant (CMI)]. Oper Orthop Traumatol. Dec 2006; 18(5-6):453-62. PMID 17171330

25. Zaffagnini S, Marcheggiani Muccioli GM, Lopomo N, et al. Prospective long-term outcomes of the medial collagen meniscus implant versus partial medial meniscectomy: a minimum 10-year follow-up study. Am J Sports Med. May 2011; 39(5):977-85. PMID 21297005

26. Bulgheroni E, Grassi A, Bulgheroni P, et al. Long-term outcomes of medial CMI implant versus partial medial meniscectomy in patients with concomitant ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. Nov 2015; 23(11):3221-7. PMID 24990662

27. Verdonk R, Verdonk P, Husse W, et al. Tissue ingrowth after implantation of a novel, biodegradable polyurethane scaffold for treatment of partial meniscal lesions. Am J Sports Med. Apr 2011; 39(4):774-82. PMID 21383084

28. Verdonk P, Beaufils P, Bellemans J, et al. Successful treatment of painful irreparable partial meniscal defects with a polyurethane scaffold: two-year safety and clinical outcomes. Am J Sports Med. Apr 2012; 40(4):844-53. PMID 22328711

29. Bouyarmane H, Beaufils P, Pujol N, et al. Polyurethane scaffold in lateral meniscus segmental defects: Clinical outcomes at 24 months follow-up. Orthop Traumatol Surg Res. Feb 2014; 100(1):153-7. PMID 24332925

30. Gelber PE, Isart A, Erquicia JI, et al. Partial meniscus substitution with a polyurethane scaffold does not improve outcome after an open-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. Jan 2015; 23(1):334-9. PMID 25069570

31. NICE – Partial replacement of the meniscus of the knee using a biodegradable scaffold: guidance - IPG430 (2012). National Institute for Health and Clinical Experience. Available at: <http://guidance.nice.org.uk> (last accessed July 16, 2018).

32. AAOS – Meniscal transplant surgery: Your Orthopaedic Connection (2009, updated 2014). American Academy of Orthopaedic Surgeons. Available at: <http://orthoinfo.aaos.org> (last accessed July 16, 2018).

33. Meniscal Allograft Transplantations. Chicago, Illinois: Blue Cross Blue Shield Association Technology Evaluation Assessment Program (1997 August) 12(14):1-7.

34. Meniscal Allograft Transplantation. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2018 April) Surgery 7.01.15.

Policy History:

Date Reason
10/1/2018 Document updated with literature review. Coverage unchanged. References 1-3, 6, 7, 17, 18, 20-22 were added; numerous removed.
7/15/2017 Reviewed. No changes.
9/15/2016 Document updated with literature review. The following criteria changed to: 1) Absence or near absence (> 50%) of the meniscus, established by imaging or prior surgery; and 2) Minimal to absent diffuse degenerative changes in surrounding articular cartilage (Outerbridge grade O, I, or II, < 50% joint space narrowing.
2/1/2015 Document updated with literature review. The following was added: 1) additions to criterion regarding the type of surgery planned, biomechanics, conservative therapies; 2) documentation required for review of procedures; 3) meniscal allograft transplantation (MAT) may be considered medically necessary when performed in combination, either concurrently or sequentially, with autologous chondrocyte implantation, osteochondral allografting, or osteochondral autografting for focal articular cartilage lesions; AND 4) use of other meniscal implants such as collagen and polyurethane are considered experimental, investigational and/or unproven. Description and Rationale substantially revised and reorganized. Title changed from Meniscal Allograft Transplantation. Policy number has been changed from SUR703.011.
2/15/2010 Revised/updated entire document. Coverage added to allow for adolescents ≥ 15 years of age when meeting criteria. This policy is no longer scheduled for routine literature review and update.
8/15/2007 Revised/updated entire document
12/1/2003 Revised/updated entire document
1/1/2000 Revised/updated entire document
7/1/1999 Revised/updated entire document
5/1/1996 Medical policy number changed
4/1/1996 Revised/updated entire document
7/1/1994 New medical document

Archived Document(s):

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