CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Meniscal Allografts and Other Meniscal Implants

Policy governing medical necessity and coverage stance for meniscal allograft transplantation and collagen meniscal implants for Blue Cross Blue Shield - Rhode Island members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyMeniscal Allografts and Other Meniscal Implants

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 2, 2003

Next Review DateN/A

Key ActionVerify member benefits and document prior meniscectomy, symptoms, imaging or surgical evidence of >50% meniscal loss, and minimal diffuse degenerative changes before pursuing meniscal allograft transplantation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

29868CPT code listed as potentially medically necessary

G0428HCPCS code not covered / not medically necessary

0.24/100kEstimated annual incidence (privately insured)

2022Provider Update through

29Number of references shown

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Coverage Criteria

inv-01: Meniscal allograft transplantation - Medical necessity criteria

Covered when ALL of the following are met:

MAT general criteria: Patient has prior meniscectomy and symptoms related to the affected side; adult patient is too young to be an appropriate candidate for total knee arthroplasty (e.g., younger than 55 years); disabling knee pain with activity refractory to conservative treatment; absence or near absence (>50%) of the meniscus established by imaging or prior surgery; documented minimal to absent diffuse degenerative changes in surrounding articular cartilage (e.g., Outerbridge grade II or less, <50% joint space narrowing); normal knee biomechanics or alignment and stability achieved concurrently with transplantation.

May be performed concurrently or sequentially with treatment of focal articular cartilage lesions.

inv-02: MAT with cartilage procedures

Covered when performed in combination with treatment of focal articular cartilage lesions using one of the following:

Allowed concomitant cartilage procedures: autologous chondrocyte implantation; osteochondral allografting; osteochondral autografting.

May be concurrent or sequential.

inv-03: Collagen meniscal implants - Coverage stance

CMI coverage: Collagen meniscal implants are not covered for Medicare Advantage Plans and are not medically necessary for Commercial products as evidence is insufficient to show improvement in net health outcome.

HCPCS G0428 is listed as not covered/not medically necessary.

Collagen meniscal implants (CMI) are not covered for Medicare Advantage Plans and are considered not medically necessary for Commercial products. The policy conclusion is based on insufficient evidence demonstrating improvement in net health outcome with this technology. The HCPCS code G0428 (Collagen Meniscus Implant procedure) is specifically listed as not covered / not medically necessary.

If services are determined to be not medically necessary (or, in some instances, are medically necessary but are non-covered under a member’s benefit), providers may be unable to bill or collect payment from the member unless the member has been informed and has signed a written agreement to self-pay in advance. Member-specific benefits and eligibility are governed by the member’s subscriber or employer agreement; providers should contact the provider call center for benefit verification.

For Commercial products, collagen meniscal implants are considered not medically necessary. For Medicare Advantage Plans, collagen meniscal implants are not covered. This stance is reflected in the policy because current evidence is insufficient to demonstrate a net health benefit for CMI procedures; accordingly, claims reported with HCPCS G0428 may be denied.

Services that are determined to be not medically necessary or that constitute non-covered benefits may be subject to financial and charge restrictions described in the member’s participation and benefit documents. Providers should review participation agreements and the member’s benefit documents before rendering services that may be non-covered, and obtain a signed advance agreement from the member if the member will be responsible for payment.

Coding

Covered CPT CodesCPTCovered

29868

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

Not covered / Not medically necessaryHCPCSNot Covered

G0428

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

Diagnosis codes that may support medical necessityICD-10

M23.000-M23.92	Disorders of meniscus (range of ICD-10-CM codes listed to support medical necessity)
S83.200-S83.289	Dislocation, sprain and strain of joints and ligaments of knee (specified range)
S83.30-S83.32	Tear of meniscus (range)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization: Not applicable.

Note

Benefit Verification

Benefits may vary between groups/contracts. Verify the member's specific group/contract Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable surgery coverage/benefits prior to proceeding.

Documentation Required

Supporting Clinical Documentation for MAT

Documentation to support medical necessity for meniscal allograft transplantation (MAT) should demonstrate prior meniscectomy and current symptoms related to the affected side, and include imaging or prior surgical documentation showing absence or near absence (>50%) of the meniscus. Also include documentation of refractory disabling knee pain despite conservative treatment, assessment of articular cartilage status (e.g., Outerbridge grade), patient age/appropriateness for arthroplasty, and details of alignment/biomechanics or concurrent procedures to restore stability or address focal cartilage lesions when applicable.

Background

Meniscal allografts and collagen meniscal implants are intended to improve symptoms and reduce joint degeneration following total or partial meniscectomy. Meniscal allograft transplantation (MAT) is typically considered a salvage procedure for patients with disabling post‑meniscectomy pain who are often too young for total knee arthroplasty and may be performed concurrently or sequentially with cartilage restoration procedures. By contrast, collagen scaffolds (CMI) are absorbable matrices intended to fill partial meniscal defects, but current evidence does not demonstrate sufficient improvement in net health outcomes to support coverage for CMI.

Definitions

inv-20: Collagen Meniscus Implant (CMI)

DefinitionA resorbable collagen matrix (primarily type I bovine collagen) provided in a semilunar shape, trimmed and sutured to the remaining meniscal rim to act as an absorbable scaffold replaced by the patient’s tissue. Intended to fill meniscal defects after partial meniscectomy.

Clinical intentPartial meniscal replacement to improve symptoms and reduce joint degeneration in patients with partial meniscectomy defects.

Limitations/evidenceCMS decision memo and systematic reviews referenced; evidence considered insufficient for net health outcome improvement for some products (see coverage stance).

Examples/brands referencedCollagen Meniscus Implant (Ivy Sports Medicine, formerly ReGen Collagen Scaffold); Menaflex-type collagen scaffolds cited in literature.

Regulatory/guidance referencesCMS Decision Memo for Collagen Meniscus Implant (CAG-00414N) and NICE guidance on biodegradable scaffold (IPG430) cited in references.