CurrentPremera BluecrossPolicy N/A

Meniscal Allografts and Other Meniscal Implants

Medical necessity and coverage criteria for meniscal allograft transplantation and other meniscal implants (e.g., collagen scaffolds) for knee meniscus deficiencies; includes site-of-service guidance and prior authorization considerations for elective knee arthroscopy and related procedures.

Policy Summary

PayerPremera Bluecross

PolicyMeniscal Allografts and Other Meniscal Implants

Policy CodePolicy N/A

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

Key ActionObtain and document prior authorization with medical records showing age, >50% meniscal deficiency, failed conservative therapy, and cartilage status before scheduling meniscal allograft transplantation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

15-55 yrsAge range

>50%Meniscal deficiency threshold

29882,29868,G0428Key procedure codes

InvestigationalNon-allograft implants status

InsufficientCMI evidence

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Coverage Criteria for Meniscal Allografts and Meniscal Implants

Meniscal allograft transplantation - Medically Necessary

Meniscal allograft transplantation may be considered medically necessary when ALL of the following are met:

Meniscal allograft medical necessity criteria

Individual is at least 15 years of age and younger than 55 years.
Age range reflects policy scope and clinical input.
Disabling knee pain with activity that is refractory to conservative treatment (e.g., documented trial of physical therapy and analgesics).
Conservative treatment must be attempted and documented prior to MAT.
Absence or near absence (more than 50%) of the existing meniscus established by imaging or prior surgery.>50%
Meniscal deficiency should be documented by imaging or prior operative reports.
Documented minimal to absent diffuse degenerative changes in the surrounding articular cartilage (for example, Outerbridge grade II or less and original joint space decreased by less than 50%).
Significant diffuse cartilage disease is a contraindication to isolated MAT.
Normal knee biomechanics, or malalignment/instability corrected concurrently or prior to meniscal transplantation (e.g., realignment osteotomy or ligament repair/reconstruction performed concurrently or sequentially).
Uncorrected misalignment and instability are contraindications to isolated MAT; concomitant procedures may be performed.

Other meniscal implants - Investigational

Other meniscal implants: Use of meniscal implants incorporating non‑allograft materials such as collagen or synthetic components (for example, CMI, RejuvaKnee, NUsurface) is considered investigational.

Insufficient evidence that these implants improve net health outcome; therefore they are not considered medically necessary.

Coverage considerations for MAT and CMI

Summary of stance and conditions described in these sections

MAT candidate considerations: MAT may be beneficial or medically necessary in selected patients, particularly younger individuals (clinical input referenced age <55 years) with symptomatic meniscal deficiency after prior meniscectomy who have failed conservative treatment.age <55 yrs (per clinical input)

Clinical inputs support combined procedures (e.g., MAT with focal cartilage repair or ACL reconstruction) when indicated.

Contraindications to MAT: Uncorrected knee instability OR uncorrected malalignment OR significant articular disease (presence of diffuse moderate to severe degenerative changes).

Mechanical axis alignment should be addressed prior to MAT; consider realignment osteotomy if deviation present (IMREF).

CMI stance: Collagen meniscus implants (CMI) have insufficient evidence to demonstrate improved net health outcome; CMS issued a national non‑coverage determination for CMI in the Medicare population due to increased reoperations and higher serious adverse event rates.

Meniscal allograft transplantation is contraindicated when there is uncorrected knee instability or uncorrected malalignment. The policy specifies that these conditions must be corrected prior to, or at the time of, isolated meniscal allograft transplantation — for example, ligament repair or osteotomy for realignment may be performed concurrently or sequentially. The policy also notes that severe obesity (BMI >35 kg/m2) may adversely affect outcomes because of increased stress on weight-bearing joint surfaces and should be considered when evaluating candidacy.

The Centers for Medicare & Medicaid Services issued a national non-coverage determination for the collagen meniscus implant (CMI) in 2010. CMS concluded that the CMI is not reasonable and necessary for treatment of meniscal injury or tear in the Medicare population, citing concerns including an increased number of reoperations and a higher serious adverse event rate compared with controls.

This policy’s scope is limited to younger patients; it was clarified to apply to individuals who are 55 years of age or younger. The formal medical necessity criteria also reference age thresholds used in candidate selection for meniscal allograft transplantation.

Meniscal implants composed of collagen or synthetic (man-made) materials are considered investigational and not medically necessary due to insufficient evidence of effectiveness. The policy states that use of these other meniscal implants (for example, collagen scaffolds) is unproven and that existing evidence does not demonstrate an improvement in net health outcome.

Specifically for the collagen meniscus implant (CMI), the policy summarizes the evidence as insufficient to determine improvement in net health outcome. In addition to the internal evidence assessment, CMS reviewed the data and found increased reoperations and higher serious adverse event rates, concluding that CMI does not improve health outcomes in the Medicare population; the policy therefore treats CMI as investigational/insufficient evidence.

Coding and Key Clinical Thresholds

Relevant CPT/HCPCS Codesmixed

29882	Arthroscopy, knee, surgical; with meniscus repair (medial OR lateral).
29868	Arthroscopy, knee, surgical meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral.
G0428	Collagen meniscus implant procedure for filling meniscal defects (e.g., CMI, collagen scaffold, Menaflex).

No explicit CPT/ICD codes in these chunksmixed

No codes listed

CPT codes mentioned/editedCPT

29868

CPT code 29868 referenced; note that ReGen Collagen Scaffold was removed from its description (11/01/23).

Meniscal deficiency — key diagnostic threshold

Meniscal deficiency thresholdAbsence or near absence of the existing meniscus (more than 50%) established by imaging or prior surgery

How measuredDetermined by imaging (e.g., MRI) or documented prior surgical resection showing >50% loss

Policy consequenceFailure to demonstrate >50% deficiency may result in denial of medical necessity for MAT

Age range — key age eligibility

Eligible age range15 years or older and younger than 55 years

RationaleRange reflects skeletal maturity (~15 years) and that adults under 55 are generally not candidates for total knee replacement

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for elective knee arthroscopy procedures involving meniscus repair or meniscal transplantation. Requests must include documentation that medical necessity criteria are met and will be reviewed prior to approval.

Prior authorization required for elective knee arthroscopy with meniscus repair or meniscal transplantation (CMI and MAT procedures).
Provider-supplied documentation must accompany the prior authorization request for medical necessity review.

Prior Authorization

Site-of-Service Prior Authorization / Review

Site-of-service will be reviewed as part of the authorization and may affect the determination of medical necessity and coverage. Ambulatory surgical centers (ASCs) are preferred when appropriate; hospital outpatient (on-campus or off-campus) or inpatient settings may be considered when clinically justified.

Site-of-Service review performed for primary knee arthroscopy procedure.
ASC preferred when appropriate and available within reasonable geographic access.

Background and Context

Background: The meniscus is a fibrocartilaginous structure that cushions and stabilizes the knee and acts as a shock absorber. Removal of meniscal tissue (meniscectomy) commonly leads to increased contact stresses across the joint and is associated with progressive osteoarthritic change. Meniscal allograft transplantation (MAT) is used as a salvage option for patients—typically younger individuals who are not candidates for total knee arthroplasty—with symptomatic meniscal deficiency after prior meniscectomy. The rationale for MAT is to restore meniscal tissue and knee biomechanics to reduce pain and potentially slow degenerative changes; by contrast, collagen or synthetic meniscal implants remain investigational because available evidence is inadequate to demonstrate consistent clinical benefit.

Definitions

Meniscal allograft transplantation — definition/key term

DefinitionMeniscal allograft transplantation (MAT) is the surgical transplantation of donor meniscal tissue to replace a deficient meniscus

IndicationsTypically used for symptomatic meniscal deficiency after prior meniscectomy in patients who have failed conservative therapy

Concurrent proceduresMay be performed concurrently or sequentially with procedures to correct alignment, cartilage defects, or ligament instability

Collagen meniscus implant (CMI) — definition and description

DefinitionCollagen meniscus implant (CMI) is a resorbable type I bovine collagen scaffold supplied in a semi-lunar shape and trimmed to fill partial meniscal defects after partial meniscectomy

Mechanism

Policy Summary

PayerPremera Bluecross

PolicyMeniscal Allografts and Other Meniscal Implants

Policy CodePolicy N/A

Change TypeNo material changes noted

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

FDA clearance history and appellate actions are noted in the record, but CMS concluded CMI is not reasonable and necessary for Medicare beneficiaries.

Policy scope notePolicy applies to individuals 55 years or younger

Cartilage status — minimal degenerative changes threshold

Cartilage status requirementDocumented minimal to absent diffuse degenerative changes (e.g., Outerbridge grade II or less)

Joint space thresholdOriginal joint space decreased by less than 50%

Contraindication if advanced diseaseSignificant articular disease beyond these thresholds is a contraindication to isolated MAT

If no qualifying ASC is accessible or physician privileges are unavailable, hospital outpatient settings may be authorized with supporting justification.

Denial Risk

Triggers for Denial

Certain clinical and procedural features may trigger denial of authorization. Cases that do not meet established selection criteria or lack required documentation are at higher risk for denial.

Age outside recommended range (typically <15 years or ≥55 years) unless otherwise justified.
Meniscal deficiency less than the defined threshold (absence/near absence >50% not documented).
Significant diffuse articular cartilage disease (eg, advanced OA) documented on imaging.
Failure to demonstrate adequate conservative therapy attempted and documented.
Uncorrected instability or malalignment without planned correction.

Denial Risk

CMS Non‑coverage Risk for CMI

Centers for Medicare & Medicaid Services (CMS) has issued a national non-coverage determination for the collagen meniscus implant (CMI) for the Medicare population; CMI is considered not reasonable and necessary for Medicare beneficiaries.

CMI (collagen meniscus implant/Collagen scaffold) is non-covered by CMS for Medicare patients due to lack of demonstrated improved health outcomes and higher adverse event/reoperation rates.

Prior Authorization

Site-of-Service Impacts on Authorization

Site-of-service determination can change authorization, including coverage decisions, based on facility availability, clinical necessity for inpatient care, and geographic access to ASCs. Provide indications if inpatient level of care is requested.

If procedure is planned as inpatient, submit documentation supporting need for inpatient setting.
Availability of an ASC within ~30 miles, necessary equipment, or physician privileges may influence site authorization.
Lack of ASC access or other justifying clinical factors should be documented to support hospital outpatient or inpatient authorization.

Note

Recommended Outcome Measures

Recommended outcome measures should be included in the medical record and may be requested during review or follow-up to assess procedure effectiveness.

Disease-specific: Western Ontario Meniscal Evaluation Tool (WOMET).
Region-specific: Knee injury and Osteoarthritis Outcome Score (KOOS).
Activity: Marx Activity Rating Scale.
QOL/utility: EuroQoL 5-Dimensions Questionnaire (EQ-5D).
Other validated measures such as IKDC may also be used.

Documentation Required

Documentation Requirements Exist

Documentation submitted for authorization and medical necessity review must include clear clinical records demonstrating the indication and prior care. Incomplete records may delay or result in denial.

Diagnosis and condition description.
History and physical exam documenting severity and symptoms (disabling knee pain, activity limitation).
Conservative care attempted with duration (eg, physical therapy, analgesics) and response.
Pertinent imaging reports (radiographs, MRI) demonstrating meniscal deficiency and cartilage status.
Operative reports from prior meniscectomy if applicable.
If inpatient setting requested, rationale and supporting clinical indications.

Prior Authorization

Conservative Treatment Prerequisite

Conservative therapy must be attempted and documented prior to consideration of meniscal allograft transplantation (MAT) or other reconstructive procedures. Documentation should specify modalities tried and duration.

Evidence of prior conservative management such as structured physical therapy, activity modification, weight management, and analgesic/anti-inflammatory therapy.
Duration and response to conservative treatment should be documented (eg, failure to improve after an adequate trial).
Persistent disabling knee pain despite conservative measures is required for consideration.

Prior Authorization

Pre‑procedure Correction Requirements

Pre-procedure correction of modifiable contraindications is required or must be planned concurrently. Uncorrected instability, malalignment, or advanced articular disease are contraindications unless corrected at the time of transplantation.

Uncorrected ligamentous instability should be addressed (eg, ACL reconstruction) and may be performed concurrently.
Mechanical axis malalignment should be corrected (eg, osteotomy) prior to or concurrent with MAT when indicated.
Significant diffuse articular cartilage disease (eg, advanced OA) is a contraindication unless appropriately managed or addressed.

Note

Provider Action Note

(Reserved)

Provides an absorbable collagen scaffold intended to be replaced by the individual’s soft tissue; requires an existing meniscal rim for attachment

ExamplesIncludes products formerly called ReGen Collagen Scaffold (Menaflex) and similar devices such as RejuvaKnee

MAT — short definition for meniscal allograft transplantation

Short definitionMAT: transplanting donor meniscus to replace a deficient meniscus

PurposeIntended to improve symptoms and reduce joint degeneration in individuals after total or partial meniscectomy

Typical candidatesPatients with disabling knee pain after prior meniscectomy who meet cartilage and biomechanical criteria

CMI — alternate names and brief description

Alternate namesMenaflex CMI; ReGen Collagen Scaffold; RejuvaKnee

DescriptionBiodegradable collagen scaffold (primarily type I bovine collagen) shaped for suturing to the meniscal rim to fill partial defects

Regulatory/history noteReGen Collagen Scaffold (Menaflex) received 510(k) clearance in 2008; FDA rescinded approval in 2010 and the decision was later appealed and overturned