CurrentAetnaPolicy 0786

Menaflex (collagen meniscus implant)

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Defines Aetna's coverage stance for the Menaflex collagen meniscus implant used for repair/reinforcement of the medial meniscus and related indications; affects providers submitting claims for Menaflex (CMI/Collagen Scaffold) procedures.

Policy Summary

PayerAetna

PolicyMenaflex (collagen meniscus implant)

Policy CodePolicy 0786

Change TypeNo material change

Effective DateJun 19, 2009

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization with documentation of indication, prior treatments, and planned concurrent procedures when requesting coverage for Menaflex.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentAetnaPolicy 0786

Menaflex (collagen meniscus implant)

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Sign up for Aetna Policy 0786 alerts

Get alerted when Policy 0786 changes without checking for updates manually.

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Policy Summary

PayerAetna

PolicyMenaflex (collagen meniscus implant)

Policy CodePolicy 0786

Change TypeNo material change

Effective DateJun 19, 2009

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization with documentation of indication, prior treatments, and planned concurrent procedures when requesting coverage for Menaflex.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA marketing status

9.5% vs 19.7%re-op rate (adj)

87.8%implant survival

Coverage Determinations

Experimental / Investigational (Not Covered)

Covered when ALL of the following are met

Primary coverage stance: Aetna considers the Menaflex device (previously known as the Collagen Meniscal Implant and the Collagen Scaffold device) experimental and investigational for repair and reinforcement of the medial meniscus of the knee and all other indications because of insufficient evidence of its effectiveness.

Policy statement

Coverage considerations and selection criteria

Evidence-based coverage considerations (documented factors associated with outcomes):

General evidence summary: Scaffold implantation (CMI, Actifit, NUsurface) demonstrates short- to mid-term improvements in patient-reported outcomes in some studies, but the overall evidence base is low quality (predominantly Level III–IV), heterogeneous, and frequently confounded by a high volume of concurrent procedures; chondroprotective benefit is unproven.

Supports restrictive coverage or requirement for specific indications

Patient selection factors: Reported predictors of worse outcomes include lateral implants versus medial, higher cartilage damage (Outerbridge grade 3–4), and longer interval from prior meniscectomy (>10 years); these factors were associated with increased hazard of surgical or clinical failure in cohort analyses.Outerbridge grade 3–4 (HR reported up to ~3.8); time from meniscectomy >10 years (HR ~2.8)

Consider excluding or counseling high‑risk patients

Concurrent procedures: A high proportion of patients (approximately 45% in reviewed series) underwent concurrent procedures (eg, ACL reconstruction, high tibial osteotomy), limiting attribution of benefit to the scaffold alone and complicating outcome interpretation.~45% concurrent procedures reported for Actifit and CMI

If concurrent procedures are planned, require documentation and clear rationale

Regulatory context: Menaflex (CMI) previously received 510(k) clearance that was later rescinded by FDA; devices have variable regulatory status internationally, which may impact coverage considerations.

Regulatory history may affect coverage decisions

Coverage stance and evidence-based criteria

Policy summary from the review of evidence:

Overall evidence conclusion: Use of meniscal scaffolds as sole treatment for partial meniscal defects is not recommended based on current evidence because of relatively high failure rates in some series, paucity of comparative data, and frequent concurrent procedures; routine clinical use cannot be endorsed pending higher‑quality data.

Explicit conclusion from systematic reviews and authors' statements

Reported outcomes: Some studies report significant postoperative improvements in clinical scores (eg, VAS, Tegner, Lysholm, ASES) and imaging/histologic findings (including case series of bio‑inductive collagen implants), but heterogeneity, short follow‑up in some reports, and lack of controls limit confidence in these findings.

Improvements noted but confounded by study limitations and concurrent procedures

Evidence gaps and recommendations: Further high‑quality randomized controlled trials without concurrent procedures, standardized outcome measures, and longer follow‑up are needed before meniscal scaffolds can be recommended for routine use; until such evidence is available, coverage is not supported except as investigational.

Aetna considers the Menaflex device (also referred to as the collagen meniscus implant or collagen scaffold) experimental and investigational for repair and reinforcement of the medial meniscus of the knee and all other indications because of insufficient evidence of effectiveness. As such, use of Menaflex is excluded from coverage and may result in claim denial as not medically necessary.

Systematic reviewers and guideline authors have concluded that the current evidence is insufficient to support use of meniscal scaffolds as a sole treatment for partial meniscal defects. High rates of concurrent procedures and heterogeneous study designs limit attribution of benefit to the scaffold itself, and investigators recommend that scaffold implantation not be considered routine until higher‑quality comparative data are available.

For isolated partial meniscal defects, reviewers specifically concluded that implantation of a meniscal scaffold alone is not recommended owing to a relatively high reported failure rate and paucity of clinical data. Available studies are often confounded by concurrent procedures, variable inclusion criteria and outcome reporting, so routine coverage of scaffolds as the sole therapy for partial defects is not supported by the evidence.

Regulatory and payer assessments reinforce the evidence concerns: the FDA announced that the Menaflex Collagen Scaffold should not have been cleared for marketing in the United States and initiated rescission of its 510(k) clearance, and the Centers for Medicare & Medicaid Services concluded that the collagen meniscus implant does not improve health outcomes in the Medicare population.

Implantation of meniscal scaffolds solely to provide chondro-protection or to prevent osteoarthritis is not supported by conclusive evidence. Reviewers noted that the putative chondro‑protective effects remain inconclusive and therefore scaffolds should not be used with the primary aim of OA prevention.

The evidence base is heterogeneous and limited in quality: most studies are nonrandomized, many include simultaneous procedures (reported in a high proportion of patients), and outcome measures vary across reports. Because of these limitations and relatively high reported failure rates in some series, meniscal scaffold implantation as sole therapy for partial meniscal defects is considered not supported by sufficient evidence and may be deemed not medically necessary.

Billing and Codes

Not covered / Identified HCPCSHCPCSNot Covered

G0428

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

ICD-10 codes listed in policy (not all-inclusive)ICD-10

M17.0	Osteoarthritis of knee
M17.1	Osteoarthritis of knee
M17.2	Osteoarthritis of knee
M17.3	Osteoarthritis of knee
M17.4	Osteoarthritis of knee
M17.5	Osteoarthritis of knee
M17.6	Osteoarthritis of knee
M17.7	Osteoarthritis of knee
M17.8	Osteoarthritis of knee
M17.9	Osteoarthritis of knee

1–10 of 29

1/3

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior authorization for Menaflex (G0428)

The Menaflex procedure (HCPCS G0428) is identified in the policy and the device is considered experimental and investigational; prior authorization is implied to be required so that coverage determination can be made prior to the procedure.

Prior Authorization

Require indication, failed care, and disclosure of concurrent procedures

Prior authorization should include a clear explanation why a scaffold is being used (for example, to address a partial meniscal deficiency), documentation that conservative care failed or the lesion is unsuitable for repair, and disclosure of any planned concurrent procedures because a high proportion of published scaffold cases included concurrent surgeries.

Indication for scaffold (e.g., partial meniscal deficiency)
Evidence of failed conservative care or why repair is not feasible
List and rationale for planned concurrent procedures

Clinical Background

The menisci are semi-lunar fibrocartilaginous structures that play a central role in knee load bearing, shock absorption, joint stability and lubrication. Loss of meniscal tissue after tear or meniscectomy can cause pain and functional decline and is associated with accelerated degenerative changes in the joint. The Menaflex (collagen meniscus implant) is a porous, crescent-shaped bovine type I collagen scaffold intended to be trimmed and sutured into partial meniscal defects to act as a template for new tissue ingrowth; however, its clinical effectiveness compared with standard repair or partial meniscectomy remains unproven.

Device and Term Definitions

Menaflex / Collagen Meniscus Implant (CMI) — description

Device compositionPorous, crescent-shaped scaffold composed of bovine type I collagen (synthetic resorbable collagen matrix) intended to be trimmed and sutured to the native meniscus

Intended useTemplate and support for generation of new meniscal tissue to replace lost meniscus after partial meniscectomy or irreparable medial meniscal injuries

Implant behaviorSponge-like scaffold that is gradually replaced by the patient’s own meniscal tissue over time

Surgical techniqueArthroscopic implantation: device is trimmed to defect size and sutured to remaining native meniscal tissue

Alternate names/termsAlso known as collagen meniscus implant (CMI) or collagen scaffold; marketed as Menaflex

CMI / Menaflex — regulatory history summary

Policy Summary

PayerAetna

PolicyMenaflex (collagen meniscus implant)

Policy CodePolicy 0786

Change TypeNo material change

Effective DateJun 19, 2009

Last ReviewOct 11, 2023

Next Review DateAug 22, 2024

Key ActionObtain prior authorization with documentation of indication, prior treatments, and planned concurrent procedures when requesting coverage for Menaflex.

SourceLink

On This Page

Authors call for RCTs; current evidence insufficient

Prior Authorization

Prior authorization recommended — document indication and rationale

Because clinical evidence is considered insufficient to recommend meniscal scaffolds as sole treatment, prior authorization should require documentation of the indication, prior treatments, and clinical rationale for using a scaffold rather than standard therapies.

Document prior treatments and alternatives tried
Provide rationale referencing patient-specific factors and expected benefit

Step Therapy

Prefer established standard treatments before scaffold

Providers should consider standard, established treatments (suture repair, meniscal tacks/darts/arrow devices, partial meniscectomy, or meniscal allograft transplantation) as the usual care pathways prior to considering a scaffold implant.

Attempt meniscal repair when feasible (suture/tacks/darts/arrow devices)
Partial meniscectomy for irreparable tears
Consider allograft transplantation where appropriate

Step Therapy

Prefer repair/meniscectomy prior to scaffold implantation

Meniscal repair or partial meniscectomy and other established treatments should generally be considered before scaffold implantation, since repair/preservation is preferred when technically feasible.

Document why repair/preservation was not possible if proceeding to scaffold

Step Therapy

Implied stepwise care — attempt alternatives before scaffold

Authors and reviewers recommend that meniscal scaffolds should not be routine and that further high-quality randomized trials are needed — implying a stepwise approach where conservative or alternative treatments are attempted first.

Ensure conservative management or standard surgical options were considered and documented prior to scaffold use

Documentation Required

Pivotal trial follow-up and second-look arthroscopy documented

Clinical trial protocols required second-look arthroscopy at 1 year with biopsy and longitudinal validated outcome assessments; providers should be aware that such follow-up and operative findings were collected in study reports.

Second-look arthroscopy and biopsy at ~1 year were part of pivotal trial follow-up
Validated outcome questionnaires were collected up to 7 years in trials

Documentation Required

Document cartilage status, laterality, timing, and concurrent procedures

Clinical records should document cartilage status (for example, Outerbridge grade), implant laterality (medial versus lateral), time since prior meniscectomy, and any concurrent procedures because these factors were identified as predictors of failure.

Outerbridge grade of articular cartilage
Medial vs lateral implant location
Time from meniscectomy to implantation
Details of concurrent procedures performed

Documentation Required

Suggested supporting documentation: outcomes, imaging, histology

Studies commonly reported clinical outcome measures (e.g., VAS, Tegner, Lysholm, ASES, Constant-Murley), MRI findings, and histology; include these outcome measures and follow-up details in the record to support medical necessity evaluations.

Pre- and post-operative VAS, Lysholm, Tegner, ASES, or Constant-Murley scores
MRI reports describing implant integration or repair status
Histology/biopsy results if available

Denial Risk

Experimental / Investigational device — risk of claim denial

Aetna considers Menaflex experimental and investigational for repair and reinforcement of the medial meniscus and all other indications; submitting claims for this device may trigger denial as not medically necessary.

Denial Risk

Evidence insufficiency for scaffold-alone treatment may trigger denial

Use of meniscal scaffolds as sole treatment for partial meniscal defects is not recommended based on current evidence due to relatively high failure rates and limited clinical data; lack of demonstrated chondro-protective effect may prompt denial.

Denial Risk

Insufficient/heterogeneous evidence and concurrent procedures increase denial risk

High reported failure rates for some scaffolds, heterogeneous and low-quality evidence, and frequent concurrent procedures in the literature may lead to coverage denial or non-coverage determinations when scaffolds are used as sole treatment.

High proportion of cases had concurrent procedures (~45%)
Variable failure rates reported (e.g., Actifit 18%, CMI 6.5% in systematic review)

Initial FDA actionReceived FDA 510(k) marketing clearance in December 2008 for repair and reinforcement of the medial meniscus

Pivotal study510(k) submission included a prospective, randomized, controlled, multicenter study (n = 311) comparing CMI with partial meniscectomy

Regulatory reversalFDA later rescinded the 510(k) clearance after concluding the device was intended for different purposes and technologically dissimilar from predicate devices

Regulatory implicationRescission and subsequent findings (cited by CMS/FDA reviews) contributed to determinations that Menaflex lacks demonstrated improved health outcomes in some populations

Actifit — synthetic scaffold description

MaterialPolyurethane-based synthetic scaffold (Actifit) used for partial meniscal substitution

Regulatory/market statusHas CE mark in Europe; FDA has indicated additional data are needed to confirm efficacy

Clinical evidenceIncluded in systematic reviews and clinical series with reported mid-term outcomes and failure rates (Actifit failure rate ~18% with mean follow-up ~66.8 months)

Comparison to biologic scaffoldsHistological, radiological and clinical evaluations described as equivalent in some reviews but medium- to long-term data remain limited

NUsurface — alternative implant mention

Device typeNUsurface meniscus implant — an alternative meniscal replacement device evaluated in some studies

Evidence availableIncluded in reviews/series; one Level-II study with 12-month follow-up was identified for completeness

Reported short-term outcomeNUsurface failure rate reported as 16.9% at 12 months in pooled review data

Meniscal scaffold — general definition

DefinitionAn implantable scaffold (biologic or synthetic) intended to substitute for or support regeneration of meniscal tissue after partial meniscectomy

ExamplesCommon clinical examples include collagen meniscus implant (CMI/Menaflex), Actifit (polyurethane), and NUsurface

Evidence characteristicsClinical studies report short- to mid-term improvements in patient-reported outcomes but overall evidence is low quality with high rates of concurrent procedures and variable failure rates

Regulatory contextSome scaffolds have CE mark in Europe; FDA has requested additional data and has rescinded clearance for Menaflex

Bio-inductive collagen implant (RACS / Menaflex) — note

Implant typeResorbable type I bovine collagen implant (bio‑inductive collagen) used to augment soft‑tissue repairs

Intended effectAims to stimulate neo‑tissue formation and improve structural integrity of repaired tendon/soft tissue

Relation to Menaflex/CMISimilar bovine type I collagen material has been applied in other applications (e.g., rotator cuff augmentation); histology showed neo‑tendon formation and implant resorption in small series