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Meniscal Allografts and Other Meniscus Implants

Policy Number: MP-158

Latest Review Date: April 2022

Category:  Surgery                                                                 

POLICY:

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:

 

  • Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years).
  • Disabling knee pain with activity that is refractory to conservative therapy * i.e., physical therapy, analgesic medications.
  • Absence or near absence (more than 50%) of the meniscus, established by imaging or prior surgery.
  • Documented minimal to absent diffuse degenerative changes in the surrounding articular cartilage (Outerbridge Grade II or less, <50% joint space narrowing).
  • Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation.

 

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.

 

Meniscal allograft transplantation is contraindicated and is considered not medically necessary for the following:

  • Uncorrected misalignment and instability of the joint
  • Severe obesity, e.g., body mass index (BMI) >35kg/m2, may affect outcomes due to the increased stress on weight bearing surfaces of the joint

 

Other meniscal implants incorporating materials such as collagen and polyurethane are considered not medically necessary and investigational.

 

*Conservative therapy is the use of structured physician-directed modalities which may include: prescription strength analgesics/anti-inflammatory medications if not contraindicated; participation in therapeutic physical medicine modality(ies) and/or manipulations when rendered by an eligible provider (including active exercise).

DESCRIPTION OF PROCEDURE OR SERVICE:

Meniscal allografts and other meniscal implants (e.g., collagen) are intended to improve symptoms and reduce joint degeneration in patients 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 et al (2015) estimated an annual incidence of MAT in the U.S. 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 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 osteoarthrosis that is localized to the meniscus-deficient compartment;
  • Patients undergoing ACL 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 osteoarthritis. 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 the most 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 (Marietta, GA) 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, 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. In a survey conducted by the International Meniscus Reconstruction Experts Forum, when surgeons were asked about type of allograft preference, 68% responded fresh frozen nonirradiated allografts, with 14% responding fresh viable allografts.

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).

Tissue engineering that grows new replacement host tissue is also being investigated. For example, the Collagen Meniscus Implant (Ivy Sports Medicine, 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 own 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 non-porous 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.

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.

KEY POINTS:

The most recent literature update was performed through February 20, 2022.

Summary of Evidence

For individuals who are undergoing partial meniscectomy who receive MAT, the evidence includes systematic reviews of mostly case series and an RCT. The relevant outcomes are symptoms, functional outcomes, and QOL. 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 MAT can delay or prevent the development of knee osteoarthritis. A limitation of the evidence is its reliance primarily on case series. Because of 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 with a concomitant procedure to repair malalignment, focal chondral defects and/or ligamentous insufficiency, who receive MAT, the evidence includes one systematic review of case series as well as several case series published after the systematic review. The relevant outcomes are symptoms, functional outcomes, and QOL. 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 CMIs, the evidence includes two systematic reviews primarily of case series. The relevant outcomes  are symptoms, functional outcomes, and QOL. The reviews reported overall positive results with the CMI, 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.

Practice Guidelines and Position Statements

International Meniscus Reconstruction Experts Forum

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

Select Consensus Statements on the Practice of MAT

Statements

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 vs 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

MAT: meniscal allograft transplantation; OA: osteoarthritis.

 

National Institute for Health and Care Excellence

The guidance from the United Kingdom’s National Institute for Health and Care Excellence (2012) stated that evidence on “partial replacement of the meniscus of the knee using a biodegradable scaffold raised no major safety concerns,” but evidence for any advantage of the procedure over standard surgery was limited.

American Academy of Orthopaedic Surgeons

The American Academy of Orthopaedic Surgeons (2009) updated its  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. The website also notes that “synthetic (artificial) meniscal tissue has been tried, but there is conflicting information at this time.”

 

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Meniscal allograft transplantation (MAT), anterior cruciate ligament (ACL), ReGen Collagen Scaffold, Menaflex, Collagen Meniscal Implant (CMI)

APPROVED BY GOVERNING BODIES:

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 predicate absorbable surgical mesh devices. The ReGen Collagen Scaffold (also known as MenaFlex™ CMI) was the only collagen meniscus implant with the FDA clearance at that time. Amid controversy about the 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 is now called CMI® and manufactured by Ivy Sports Medicine. CMI® is the only FDA-approved collagen meniscus product currently on the market.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational and will be reviewed for medical necessity

CURRENT CODES: 

CPT Codes:

29868

Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral

 

HCPCS:

G0428

Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex)

REFERENCES:

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  2. American Academy of Orthopaedic Surgeons. OrthoInfo: Meniscal transplant surgery. 2014; https://orthoinfo.aaos.org/en/treatment/meniscal-transplant-surgery/.
  3. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Meniscal Allograft Transplantation. TEC Assessments 1997; Volume 12, Tab14.
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  40. 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.
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  42. Rath E, et al. Meniscal allograft transplantation: Two-to-eight year results. American Journal of Sports Medicine, July 2001.
  43. 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 2008; 90(7):1413-1426.
  44. Rosso F, Bisicchia S, Bonasia DE, et al. Meniscal allograft transplantation: a systematic review. Am J Sports Med. Apr 2015; 43(4):998-1007.
  45. 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 2008; 36(9):1770-1778.
  46. Ryu RK, et al. Meniscal allograft replacement: A 1 year to 6 year experience. Arthroscopy, November 2002; 18(9): 989-994.
  47. Schuttler KF, Haberhauer F, Gesslein M, et al. Midterm follow-up after implantation of a polyurethane meniscal scaffold for segmental medial meniscus loss: maintenance of good clinical and MRI outcome. Knee Surg Sports Traumatol Arthrosc. May 2016; 24(5):1478-1484.
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  49. Sekiya JK, et al. Clinical outcomes after combined meniscal allograft transplantation and anterior cruciate ligament reconstruction. American Journal of Sports Medicine, November-December 2003.
  50. Sekiya JK, West RV, Groff YJ, et al. Clinical outcomes following isolated lateral meniscal allograft transplantation. Arthroscopy, July 2006; 22(7): 771-780.
  51. 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.
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  53. 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 2010; 92(7):941-948.
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POLICY HISTORY:

Medical Policy Group, May 2004 (1)

Medical Policy Administration Committee, May 2004

Available for comment May 17-June 30, 2004

Medical Policy Group, May 2006 (1)

Medical Policy Group, August 2008 (1)

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, February 2009

Available for comment February 6-March 23, 2009

Medical Policy Group, November 2009 (3)

Medical Policy Administration Committee, January 2010

Available for comment January 26-March 11, 2010

Medical Policy Group, October 2010 (1) Added info regarding Menaflex having clearance rescinded from the FDA (see Approved by Governing Bodies)

Medical Policy Group, November 2010 Updated References

Medical Policy Group, May 2011; Updates to Policy, Key Points, & References

Medical Policy Administration Committee June 2011

Available for comment June 8 – July 25

Medical Policy Group, March 2012 (3): 2012 Updates: Key Points, & References

Medical Policy Panel, March 2013

Medical Policy Group, September 2013 (1): Change in Title replacing collagen with other; replaced the word collagen with other in investigational policy statement, no change in coverage; update to Key Points, Governing Bodies and References

Medical Policy Administration Committee, September 2013

Medical Policy Panel, March 2014

Medical Policy Group, March 2014 (3): 2014 Updates to Key Points & References; no change in policy statement

Medical Policy Panel, March 2015

Medical Policy Group, March 2015 (2): 2015 Updates to Key Points and References, removed coverage statement from policy section - effective for dates of service prior to March 24, 2010, no change in policy statement

Medical Policy Panel, April 2017

Medical Policy Group, April 2017 (7): 2017 Updates to Description, Key Points, Approved by Governing Bodies & References. Policy statement updated- removed “six months” time frame for conservative therapy and added definition of conservative therapy; removed old policy statements effective March 24, 2010 – July 25, 2011 and dates prior to July 26, 2011.

Medical Policy Administration Committee; May 2017

Available for comment April 28 through June 11, 2017

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (7): Updates to Description, Key Points and References. Previous Coding Section removed. No change in Policy Statement.

Medical Policy Panel, July 2019

Medical Policy Group, July 2019 (7): Minor updates to Key Points. No change in Policy Statement.

Medical Policy Panel, July 2020

Medical Policy Group, July 2020 (7): Literature review. No new references added. Removed previous Policy Statement prior to April 30, 2017. No change in policy intent.

Medical Policy Panel, April 2021

Medical Policy Group, April 2021 (7): Literature reviewed. No new references added. Removed not medically necessary statement from Policy Section. No change in policy intent.

Medical Policy Panel, April 2022

Medical Policy Group, April 2022 (7): Literature reviewed. No new references added.  No change in policy intent.

 

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

  1. The technology must have final approval from the appropriate government regulatory bodies;
  2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
  3. The technology must improve the net health outcome;
  4. The technology must be as beneficial as any established alternatives;
  5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

  1. In accordance with generally accepted standards of medical practice; and
  2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
  3. Not primarily for the convenience of the patient, physician or other health care provider; and
  4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.