CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Meniscal Allografts and Other Meniscal Implants

Defines medical necessity and coverage stance for meniscal allograft transplantation (MAT) and other meniscal implants (e.g., collagen meniscal implants) for Medicare Advantage and Commercial products offered by Blue Cross Blue Shield - Rhode Island.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMeniscal Allografts and Other Meniscal Implants

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 10, 2003

Next Review DateMay 6, 2024

Key ActionVerify member benefits and eligibility with the provider call center prior to providing services.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

29868CPT code referenced

G0428HCPCS not covered

M23.*, S83.*ICD-10 ranges

Outerbridge IIMax cartilage grade

>50% absentMeniscus deficiency

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Coverage Criteria

MAT combined procedures

MAT may be considered medically necessary when performed concurrently or sequentially with treatment of focal articular cartilage lesions using any of the following:

Allowed concurrent cartilage procedures: Autologous chondrocyte implantation OR osteochondral allografting OR osteochondral autografting

Collagen meniscal implants (CMI) coverage stance

CMI - Medicare Advantage: Collagen meniscal implants are not covered for Medicare Advantage Plans

CMI - Commercial products: Collagen meniscal implants are considered not medically necessary for Commercial products due to insufficient evidence of improved net health outcome

The HCPCS procedure code G0428 (Collagen Meniscus Implant procedure) is explicitly listed in the policy as not covered for Medicare Advantage Plans and as not medically necessary for Commercial products. Claims reporting G0428 for these products may be denied.

Services that are determined to be not medically necessary or that are non-covered benefits are excluded from payment under the member’s benefits unless a prior written agreement with the member is obtained. Providers should verify member benefits and follow the member’s certificate or employer agreement to determine coverage.

Use of collagen meniscal implants (CMIs) is considered not medically necessary for Commercial products due to insufficient evidence of improved net health outcome, and CMIs are not covered for Medicare Advantage Plans. The policy cites limited-quality evidence (systematic reviews and case series) and concludes the evidence is insufficient to establish improved net health outcome for CMIs in the indicated population.

The policy reiterates that services determined to be not medically necessary are not payable under the member’s benefit plan. If a provider plans to deliver care that may be non-covered or not medically necessary, the provider must obtain a written agreement from the member in advance if the member will be billed directly.

Coding

Covered CPT Codes (may be medically necessary when criteria met)CPTCovered

29868

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

Not covered / Not medically necessary HCPCSHCPCSNot Covered

G0428

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

ICD-10 Diagnosis Codes that may support medical necessityICD-10

M23.000-M23.92	Internal derangement of knee (range of codes listed)
S83.200-S83.289	Dislocation and sprain of joints and ligaments of knee (range)
S83.30-S83.32	Tear of meniscus, current injury codes (range)

Cartilage degeneration grade — Outerbridge II or less

Required cartilage gradeDiffuse degenerative changes must be minimal to absent (Outerbridge II or less)

Supporting descriptionDocumented minimal to absent diffuse degenerative changes in surrounding articular cartilage (example: Outerbridge II or less; ~50% joint space narrowing)

Assessment methodDetermined by imaging or intraoperative assessment recorded in the medical record

Meniscal tissue remaining — Absence or near absence (>50%) of the meniscus documented by imaging or surgery

Required meniscal deficiencyAbsence or near absence (>50%) of the meniscus established by imaging or surgery

Documentation to submit

Provider Actions & Requirements

Prior Authorization

Prior Authorization Requirement

Prior authorization is not applicable for this policy per the source.

Note

Verify Benefits / Prior Authorization

Providers must verify member benefits and eligibility with the payer prior to providing services. Contact the provider call center for member-specific benefit information; the member's certificate/employer agreement governs coverage determinations.

Verify benefits and eligibility with the provider call center.
Benefits and eligibility are determined by the member's certificate/subscriber agreement or employer agreement.

Background

Meniscal allograft transplantation (MAT) and meniscal implants are intended to improve symptoms and reduce joint degeneration in patients after total or partial meniscectomy. MAT is generally reserved for relatively young patients with symptomatic meniscal deficiency who are considered too young for total knee arthroplasty or who have irreparable meniscal loss. Collagen meniscal implants are resorbable collagen scaffolds intended to fill partial meniscal defects and be replaced by host tissue; evidence cited in the policy consists largely of case series and systematic reviews with limited-quality data.

Definitions

Meniscal allograft transplantation (MAT) — Surgical transplantation of donor meniscal tissue to restore meniscal function in a meniscus-deficient compartment.

DefinitionSurgical transplantation of donor meniscal tissue to restore meniscal function in a meniscus-deficient compartment

Indication summaryIntended for adult patients with disabling knee symptoms after meniscectomy who are too young for total knee arthroplasty and have minimal surrounding cartilage degeneration

TechniquesMost techniques are arthroscopically assisted or all-arthroscopic; fixation may be all-suture or bone fixation (plugs or bone bridge)

Collagen Meniscus Implant (CMI) — A resorbable collagen scaffold (e.g., MenaFlex/ReGen Collagen Scaffold) trimmed and sutured to the meniscal rim to fill partial meniscal ...

DefinitionA resorbable collagen scaffold (e.g., MenaFlex/ReGen Collagen Scaffold) trimmed and sutured to the remaining meniscal rim to fill partial meniscal defects

Revision History

2003-02-10policy_effective

Policy effective date as listed in policy metadata.

2024-05-06policy_reviewLatest

Most recent policy review completed on this date.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMeniscal Allografts and Other Meniscal Implants

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateFeb 10, 2003

Next Review DateMay 6, 2024

Key ActionVerify member benefits and eligibility with the provider call center prior to providing services.

SourceLink

On This Page

Imaging reports or operative notes demonstrating >50% meniscal loss or nonfunctional remnant

Temporal contextDeficiency should be current and related to symptoms prompting consideration of MAT

Billing Rule

Not Covered HCPCS

Use of HCPCS code G0428 (Collagen Meniscus Implant procedure for meniscal defects — e.g., CMI, collagen scaffold, Menaflex) is not covered for Medicare Advantage plans and is considered not medically necessary for Commercial products.

HCPCS G0428 — Not covered for Medicare Advantage; Not medically necessary for Commercial.

Step Therapy

Conservative Therapy Prerequisite

Meniscal allograft transplantation (MAT) and meniscal implants are intended for patients with disabling knee symptoms that are refractory to conservative treatment. MAT is reserved for patients who have failed conservative therapies.

Conservative therapy failure is required — disabling knee activity refractory to conservative treatment.

Documentation Required

Required Clinical Documentation

Document clinical information to support medical necessity, including prior meniscectomy and current symptoms, imaging or operative evidence showing absence or near-absence (>50%) of the meniscus, minimal diffuse degenerative change in articular cartilage (e.g., Outerbridge II or less, ~50% joint space narrowing), and any concurrent procedures performed to restore alignment/biomechanics or treat focal cartilage lesions.

Documentation should support prior meniscectomy and symptoms related to the affected side.
Imaging or surgical evidence showing absence or near-absence (>50%) of the meniscus.
Documentation of minimal to absent diffuse degenerative changes (Outerbridge II or less).
If applicable, document concurrent or sequential procedures (e.g., autologous chondrocyte implantation, osteochondral allograft/autograft).

Denial Risk

Denial Risk / Member Billing

If services are determined to be not medically necessary or non-covered benefits, providers may not bill the member unless the member was informed in advance and agreed in writing to pay out-of-pocket. Refer to your participation agreement for applicable provisions.

Do not bill member for non-covered/not medically necessary services unless there is a documented written agreement in advance.
Contact the provider call center for member-specific coverage questions.

Material and purposeComposed primarily of type I bovine collagen; provides an absorbable scaffold intended to be replaced by the patient’s soft tissue

Use caseIntended to fill defects after partial meniscectomy where a meniscal rim remains for attachment

Collagen Meniscus Implant (CMI) — A resorbable collagen scaffold used for partial meniscal replacement; discussed in randomized trials and systematic reviews cited in the ...

Device descriptionA resorbable collagen scaffold used for partial meniscal replacement; provided semilunar and trimmed to size for suturing to the meniscal rim

Regulatory historyReGen Collagen Scaffold (MenaFlex) received 510(k) clearance in 2008; FDA later rescinded then reinstated its decision after appeal (discussion in policy)

Evidence summaryRandomized trials and systematic reviews (mostly case series) have reported symptom and function improvements, but evidence is insufficient to demonstrate delay or prevention of knee osteoarthritis