ModifiedPremera BluecrossPolicy MEDICAL POLICY 7.01.15

Meniscal allograft transplantation and meniscal implants

Defines medical necessity, site-of-service considerations, documentation, and coding for meniscal allograft transplantation (MAT) and other meniscal implants for individuals with meniscus deficiency of the knee; intended for providers and payers applying Premera coverage policy.

Policy Summary

PayerPremera Bluecross

PolicyMeniscal allograft transplantation and meniscal implants

Policy CodePolicy MEDICAL POLICY 7.01.15

Change TypeRevised

Effective Date

Next Review Date

Key ActionObtain prior authorization for elective meniscal transplantation or repair and document failure of conservative therapy with supporting records.

SourceLink

POLICY UPDATE CHANGES

This policy has been revised.

29868, 29882CPT codes listed

15-55 yrsAge range

>=50% absentMeniscus absent threshold

>10 yrsReported benefit duration

InvestigationalCMI status

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Historical revisions

Coverage Criteria for Meniscal Allograft Transplantation and Meniscal Implants

Medically necessary criteria for MAT

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

Age: Individual is 15 years or older and younger than 55 years15-55 yrs

Reflects skeletal maturity and avoidance of early total knee arthroplasty

Symptoms: Disabling knee pain with activity that is refractory to conservative treatment (e.g., physical therapy, analgesics)documented failure of conservative care

Conservative care must be documented

Meniscal deficiency: Absence or near absence (>50%) of the existing meniscus established by imaging or prior surgery>50% absent meniscus

Imaging or operative documentation required

Cartilage status: Documented minimal to absent diffuse degenerative changes in surrounding articular cartilage: Outerbridge grade II or less and original joint space decreased by less than 50%Outerbridge ≤ II; joint space loss <50%

Severe degenerative change is exclusionary

Knee biomechanics: Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantationalignment/stability present or corrected

Uncorrected malalignment and instability are contraindications; concomitant procedures (eg, osteotomy, ligament repair) may be performed

MAT with concomitant cartilage restoration

Meniscal allograft transplantation may be considered medically necessary when performed with cartilage restoration procedures:

Concomitant cartilage procedures: MAT performed concurrently or sequentially with autologous chondrocyte implantation, osteochondral allografting, or osteochondral autografting is considered medically necessary when other MAT criteria are metconcurrent or sequential permitted

See related cartilage restoration policies

Investigational implants

Not medically necessary / Investigational

Collagen and other meniscal implants: Use of other meniscal implants incorporating materials such as collagen (eg, Collagen Meniscus Implant/CMI, RejuvaKnee) or synthetic total meniscus replacements (eg, NUsurface) is considered investigational due to insufficient evidenceinvestigational

Evidence insufficient to determine improvement in net health outcome

Meniscal allograft transplantation (MAT)

Covered when evidence and guideline-context support:

MAT for symptomatic patients: Systematic reviews and case series (and one small RCT) show improvements in symptoms and function after MAT; benefits may persist >10 years though evidence is limited by predominance of case series and lack of demonstrated delay in osteoarthritis

Supported by consensus indications: symptomatic unicompartmental pain post-meniscectomy; may be combined with ACL reconstruction or cartilage procedures when meniscus-deficient

Collagen meniscus implants (CMI)

Not sufficiently supported / not covered:

Collagen meniscus implants (CMI): Systematic reviews report mixed/low-quality evidence for CMI with frequent radiologic reduction in implant size; CMS issued a national non-coverage determination concluding CMI is not reasonable and necessary for the Medicare population

FDA regulatory history noted (initial 510(k) clearance and later rescission); product names include Menaflex/ReGen and RejuvaKnee/Collagen Matrix

MAT with concomitant cartilage/ligament/malalignment procedures

Covered with consideration when combined procedures are performed:

MAT with concomitant procedures: Evidence from systematic reviews and case series indicates improvements when MAT is performed with realignment osteotomy, cartilage repair/restoration, or ligament reconstruction; some series report implant survivorship (eg, ~9.7 years)

Evidence limited to case series; outcomes may be acceptable even with more severe cartilage damage in select series

Historical coverage considerations

Historical policy scope and statements referenced in these chunks include:

Age and procedure context: Policy scope has historically restricted meniscal allograft consideration to individuals generally 15 years or older and 55 years or younger in multiple revisionsage >=15; age <=55

Referenced across multiple historical entries and annual reviews

Device/implant status changes: Collagen meniscal implants and specific device language (eg, ReGen Collagen Scaffold, polyurethane references) have been added, removed, or classified investigational in prior revisions

See 2010 investigational statement and 2010–2023 regulatory/code edits

Prophylactic meniscal allograft transplantation (MAT) for asymptomatic individuals (for example, young athletes without disabling symptoms) is not routinely recommended. MAT is described in the policy as a salvage procedure reserved for individuals with disabling knee pain after meniscectomy who are considered too young for total knee arthroplasty, and prophylactic use to deter osteoarthritis is infrequent due to surgical risks and limited supportive evidence.

Candidates for MAT must meet documented clinical thresholds including failure of conservative treatment (e.g., physical therapy and analgesics), demonstration of absence or near absence of meniscal tissue (>50% absent) by imaging or operative report, and minimal diffuse cartilage degeneration (Outerbridge grade II or less with joint space loss <50%).

Uncorrected joint malalignment or instability are contraindications to isolated MAT; alignment and stability should be normal or addressed concurrently (for example, concomitant realignment osteotomy or ligament repair) to meet coverage considerations.

MAT is intended for symptomatic patients; it is not recommended for asymptomatic meniscus-deficient patients. The policy specifically notes MAT is not recommended for individuals without disabling symptoms related to the meniscus-deficient compartment.

Contraindications to MAT include uncorrected instability and uncorrected malalignment. Specialty input cited in the policy historically emphasized these contraindications when assessing candidate suitability.

Patient selection also incorporates age and functional considerations: the policy frames candidacy generally between 15 and 55 years and expects documentation of persistent, activity-limiting pain despite conservative care before MAT is considered.

Device- and material-specific history is recorded in the policy. Collagen meniscus implants (CMI) such as Menaflex/ReGen and RejuvaKnee/Collagen Matrix have been the subject of systematic reviews and regulatory review; radiologic reduction in implant size is commonly reported and study quality has generally been low.

Regulatory and coverage history noted that CMI initially received 510(k) clearance but later underwent FDA review and rescission activities; CMS issued a national non-coverage determination for CMI in 2010 based on concerns about efficacy and safety.

Other synthetic meniscal replacements (for example, polyethylene-reinforced polycarbonate urethane devices) are described as early-phase or investigational in the policy; the policy classifies use of non-allograft implants incorporating materials such as collagen or certain synthetic constructs as investigational due to insufficient evidence.

Performing an elective meniscal surgical procedure in the inpatient hospital setting when site-of-service criteria are not met is considered not medically necessary and may trigger claim denial. The policy ties site-of-service determination to explicit medical necessity criteria and to listed risk factors that justify higher-acuity settings.

Site-of-service language has been revised over time in the policy history; providers should verify site-of-service requirements and obtain prior authorization as appropriate to avoid inpatient denials for procedures that can be safely performed in outpatient settings.

Evidence for collagen meniscus implants (CMI) is judged insufficient to demonstrate improved net health outcomes. Systematic reviews summarized mostly low-quality studies and reported mixed results, including frequent radiologic shrinkage of the implant.

Consistent with the evidence review, the Centers for Medicare & Medicaid Services issued a national non-coverage determination for CMI, concluding the technology is not reasonable and necessary for the Medicare population.

Historically, the policy has alternated the status of collagen meniscus implants; in the January 2010 update the policy explicitly added the statement that collagen implants were considered investigational. Subsequent revisions documented ongoing literature review and adjustments to device-specific language.

Policy history entries record that CMI and related product names were added, reviewed, and at times reclassified over multiple annual reviews, reflecting evolving evidence and regulatory actions.

Coding and Billing

Covered CPT CodesCPTCovered

29882	Arthroscopy, knee, surgical; with meniscus repair (medial OR lateral).
29868	Arthroscopy, knee, surgical meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral.

Other/Investigational ImplantsHCPCS | neutralExperimental

CMI (HCPCS?)	Collagen meniscus implant procedure for meniscal defects CMI (collagen scaffold, Menaflex/ReGen; RejuvaKnee).
NUsurface	Total meniscus replacement (polyethylene reinforced polycarbonate urethane) — early phase clinical testing.

Policy history references to codingmixed

No codes listed

Referenced CPT codes and editsCPT

CPT 29868

Arthroscopy, knee, surgical; meniscal transplantation (includes arthrotomy for meniscal insertion), medial or lateral. (Note: CPT description and edits as listed in policy; ReGen Collagen Scaffold reference removed from CPT 29868 description per policy history entries.)

inv-18: Meniscal tissue remaining — threshold

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

DocumentationMeniscal deficiency must be established by imaging or operative reports

Clinical contextApplies to patients with prior meniscectomy and persistent disabling knee pain refractory to conservative care

inv-19: Cartilage degeneration — Outerbridge grade and joint space criteria

Outerbridge gradeOuterbridge grade II or less

Joint space

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for elective meniscal procedures, including meniscal repair, meniscal allograft transplantation (MAT), and other implantable meniscal devices when performed on an elective basis.

Elective meniscal procedures require prior authorization before scheduling.
Prior authorization determinations will consider indication, device type, and site of service.

Prior Authorization

Indication- and Device-based Prior Authorization

Prior authorization decisions are based on both the clinical indication and the specific device or procedure requested. Requests should reference guideline-based indications (e.g., symptomatic meniscus deficiency after prior meniscectomy, documented meniscal deficiency >50%, Outerbridge grade of articular cartilage, patient age criteria for MAT). Investigational devices (for example, certain collagen-based meniscal implants or the CMI per Medicare non-coverage) will be reviewed against policy statements.

Indication- and device-specific review will determine medical necessity or investigational status.

Background and Clinical Context

The menisci function as load-distributing cushions and stabilizers for the knee joint. Meniscal deficiency—commonly following partial or total meniscectomy—can produce localized pain and contribute to early joint degeneration, which provides the clinical rationale for reconstructive approaches such as meniscal allograft transplantation (MAT).

MAT is characterized in the policy as a salvage procedure intended for symptomatic, typically younger patients who are not appropriate candidates for total knee arthroplasty. The procedure aims to restore meniscal function in the deficient compartment to relieve pain and improve function.

Available evidence—primarily case series, systematic reviews of observational studies, and one small randomized trial—shows improvements in symptoms and function after MAT with some reports of benefit lasting >10 years; however, the evidence does not demonstrate prevention or delay of osteoarthritis and is limited by study design.

Definitions and Abbreviations

inv-35: ASA score (I–V)

ASA IA normal healthy patient

ASA IIA patient with mild systemic disease

ASA III–VASA III: severe systemic disease; ASA IV: severe disease that is a constant threat to life; ASA V: moribund patient not expected to survive

inv-36: NYHA classification

NYHA Class INo symptoms and no limitation in ordinary physical activity

NYHA Class IIMild symptoms and slight limitation during ordinary activity

NYHA Class III–IV

Policy Revision History

1997-01policy_addition

Policy added to the surgery section (initial policy entry).

1998-04-14revision

Policy reviewed and revised with clarified description and rationale.

1998-06-25revision

Title revised from 'Meniscal Allograft' per history entry.

Policy Summary

PayerPremera Bluecross

PolicyMeniscal allograft transplantation and meniscal implants

Policy CodePolicy MEDICAL POLICY 7.01.15

Change TypeRevised

Effective Date

Next Review Date

Key ActionObtain prior authorization for elective meniscal transplantation or repair and document failure of conservative therapy with supporting records.

SourceLink

On This Page

Original joint space decreased by less than 50%

Exclusionary findingDiffuse or severe degenerative changes (Outerbridge > II or ≥50% joint space loss) are exclusionary

inv-20: Age range

Age range15 to 55 years

RationaleRange reflects skeletal maturity (≈15 years) and typical cutoff for avoiding total knee replacement (<55 years)

Candidate noteIntended for individuals too young for total knee arthroplasty

inv-21: Age limit (policy scope recommendation)

Policy scope recommendationGenerally restricted to individuals under 55 years of age

Historical basisRepeated policy history entries reference age 55 as an upper scope limit

Clinical implicationConsideration emphasizes selection of younger patients for MAT rather than arthroplasty

CMI and other devices with negative coverage determinations may be denied as not reasonable and necessary.

Prior Authorization

Site of Service / Prior Authorization Considerations

Site of service will be considered during prior authorization. The preferred, medically necessary site for many elective meniscal procedures is an ambulatory surgical center when clinically appropriate. Hospital outpatient or inpatient settings may be approved when requisite clinical criteria are met (e.g., concomitant procedures requiring hospital resources, significant comorbidities, anesthesia risk) or when ASC access/privileges are not available.

Preferred site: Ambulatory Surgical Center when safe and cost-effective.
Hospital outpatient may be considered if no ASC within 30 miles or ASC lacks necessary equipment or physician privileges.
Inpatient setting requires documentation of medical necessity (see inpatient indications).

Denial Risk

Site-of-Service Denial Risk

If site-of-service criteria are not met, authorization may be denied or limited. Elective meniscal procedures performed as inpatient without meeting inpatient medical necessity criteria are subject to denial.

Inpatient authorization denied when inpatient criteria (e.g., increased perioperative risk, simultaneous procedures necessitating hospital stay) are not documented.
ASC access, equipment, and physician privilege considerations affect site determination and potential denials.

Denial Risk

Medicare Non-coverage for CMI

The Centers for Medicare & Medicaid Services has issued a national non-coverage determination for the Collagen Meniscal Implant (CMI). For Medicare members, the CMI is considered not reasonable and necessary and will not be covered.

CMS national non-coverage determination for CMI (2010) — CMI considered not reasonable and necessary in the Medicare population.

Note

Benefit Limitations and Member Contract Variability

Coverage is subject to the member's contract. Benefit limitations and differences in member coverage apply; providers must verify benefits and obtain prior authorization when required.

Always confirm coverage and any plan-specific limitations via the member benefit booklet or prior authorization inquiry.
This medical policy is a guide; member contracts may impose additional limits or exclusions.

Documentation Required

Required Documentation for Prior Authorization

Required documentation must be submitted with prior authorization requests. The individual's medical records should document diagnosis, history and physical exam (severity), conservative care attempted with duration, pertinent imaging reports, and, if inpatient requested, specific indications supporting inpatient care.

Diagnosis and clinical history
Physical exam documenting severity
Conservative care attempted and length of time
Pertinent imaging (MRI, radiographs) and prior operative reports if applicable
If inpatient, documentation supporting need for inpatient stay (comorbidities, anesthesia risk, concomitant procedures).

Documentation Required