Premera Bluecross Meniscal Allograft Coverage Update

Coverage criteria and medical necessity

Meniscal allograft transplantation (medically necessary)

Covered when ALL of the following are met:

MAT coverage criteria: (1) Age >=15 AND <55 years; (2) Disabling knee pain with activity that is refractory to conservative treatment (e.g., persistent symptoms despite physical therapy and analgesic medications); (3) Absence or near absence (>50%) of the existing meniscus, established by imaging or prior surgery; (4) Documented minimal to absent diffuse degenerative changes in surrounding articular cartilage (e.g., Outerbridge grade II or less, and original joint space decreased by <50%); (5) Normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation.see text

Concomitant procedures to correct alignment or stability may be performed concurrently or sequentially.

MAT with focal cartilage treatment

Covered when performed in combination with focal cartilage procedures:

Concomitant cartilage procedures allowed: Meniscal allograft transplantation may be performed concurrently or sequentially with autologous chondrocyte implantation OR osteochondral allografting OR osteochondral autografting.

These combinations are considered medically necessary when MAT criteria are met.

Other meniscal implants (investigational)

Not covered / investigational:

Other meniscal implants: Use of other meniscal implants incorporating materials such as collagen (e.g., collagen meniscal implant/CMI) is considered investigational due to insufficient evidence of net health benefit.

Radiologic reduction in implant size and low-quality studies limit the evidence; CMS non-coverage for CMI in Medicare population also applies.

Clinical coverage considerations for MAT and CMI

Summary of professional input and consensus statements:

MAT considered medically necessary in selected patients: MAT is considered medically necessary in some patients younger than 55 years who have failed conservative treatment and have symptomatic meniscal deficiency.age <55 and failed conservative treatment

Based on 2011 clinical input and IMREF/consensus statements

Contraindications: Uncorrected instability, uncorrected malalignment, and the presence of significant articular disease are contraindications to MAT.

Reviewers in 2008 and other inputs noted these contraindications

CMI evidence and regulatory stance: Evidence is insufficient to determine that collagen meniscal implants (CMI) improve net health outcome; CMS has issued a national non-coverage determination for CMI in the Medicare population.

Regulatory and evidence concerns noted in professional input and summaries

Age-based applicability and combined procedure context

Policy statements in history indicate coverage when age and procedure context are met:

Age and procedure context: Individuals should be 15 years or older and younger than 55 years of age for applicability; meniscal allograft transplantation may be medically necessary when combined procedures (e.g., ligament repair, osteotomy, cartilage restoration) are performed concurrently or sequentially to address instability, malalignment, or focal cartilage defects.age >=15 AND age <55

Statement derived from policy history and prior updates; combined procedures may be required to correct biomechanical factors.

Meniscal allograft transplantation (MAT) requires appropriate knee biomechanics for successful implantation. Uncorrected malalignment or joint instability are contraindications to MAT unless these problems are addressed. The policy specifies that MAT is covered only when there is normal knee biomechanics, or alignment and stability achieved concurrently with meniscal transplantation, and notes that additional procedures (for example, ligament or tendon repair or an osteotomy for realignment) may be performed at the same time to meet this requirement.

Clinically, providers should document that conservative care has failed and that any biomechanical contributors to meniscal overload have been corrected or will be corrected in the same episode of care. Severe obesity (for example, BMI >35 kg/m2) is also noted as a factor that may adversely affect outcomes and should be considered when assessing candidacy.

The Centers for Medicare & Medicaid Services (CMS) issued a national non‑coverage determination for the collagen meniscus implant (CMI). CMS concluded that the CMI does not improve health outcomes in the Medicare population and determined that the CMI is not reasonable and necessary for treatment of meniscal injury or tear.

Because of this Medicare national non‑coverage decision, providers should anticipate heightened prior‑authorization scrutiny and potential denial for CMI procedures in Medicare patients and consider this determination when planning care for beneficiaries.

Policy vocabulary and historical notes reflect removal of specific device or material names from active coverage language. Historical entries document that material‑specific references (for example, mentions of particular synthetic materials) were removed from the policy vocabulary over time; the policy currently focuses on device categories rather than naming specific proprietary products.

Past policy versions explicitly considered some collagen implants investigational; the current policy treats non‑allograft implants by category (e.g., collagen scaffolds) as investigational, without endorsing specific device or material names in the coverage criteria.

Collagen meniscal implants and other non‑allograft meniscal implants are designated investigational and therefore not medically necessary for coverage. The policy states that use of other meniscal implants incorporating materials such as collagen is considered investigational due to insufficient evidence of net health benefit.

Systematic reviews and available studies on collagen implants show low‑quality evidence (predominantly case series), and the policy cites these limitations when classifying such implants as investigational rather than covered alternatives to allograft transplantation.

The evidence base for collagen meniscal implants (CMI) is judged insufficient to establish improvement in net health outcomes. Reviews have noted radiologic reduction in implant size in a large portion of individuals and the included studies are generally low quality, limiting confidence in long‑term benefit.

Concerns raised in regulatory and safety reviews — including increased numbers of reoperations and higher serious adverse event rates reported to CMS — contribute to the conclusion that evidence is insufficient to support routine use of CMI and underpin the investigational designation and related non‑coverage determinations.

Collagen meniscal implants have a complex regulatory and policy history. The ReGen Collagen Scaffold (Menaflex CMI) received FDA 510(k) clearance in 2008, had that determination rescinded in 2010, and the manufacturer later prevailed on appeal. The product has been referenced in prior policy versions and literature reviews.

Policy history entries document that collagen implants were previously flagged as investigational, and in more recent history some device names were removed from CPT descriptors (for example, edits to CPT 29868 description in policy history). These historical notes explain why current policy language emphasizes device categories (allograft vs non‑allograft) rather than specific proprietary product names.

Billing and coding references

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

HCPCS (collagen meniscus implant)HCPCS

G0428

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

ICD-10 and historical coding notesmixed

No codes listed

Meniscal tissue loss threshold — inv-16: More than 50% absence of existing meniscus

ThresholdAbsence or near absence of existing meniscus: more than 50% loss established by imaging or prior surgery

Assessment methodEstablished by imaging (e.g., MRI) or prior operative report documenting meniscectomy

Implication for coverageMAT criteria require >=50% meniscal deficiency to be met for medical necessity

Cartilage degeneration threshold — inv-17: Outerbridge grade II or less; original joint space decreased by less than 50%

Cartilage degeneration ceilingDocumented minimal to absent diffuse degenerative changes: Outerbridge grade II or less

Provider responsibilities, prior authorization, and documentation

Prior Authorization

Prior authorization likely required for CMI/MAT

Prior authorization/review is likely required for collagen meniscus implant (CMI) and meniscal allograft transplantation (MAT). Providers should anticipate prior authorization because CMS has a national non‑coverage determination for CMI in the Medicare population and Premera requires review for elective surgical procedures addressed in this policy.

Prior authorization applies to elective surgical procedures covered by this policy.
CMI has a Medicare national non‑coverage determination — expect payers to require prior review for CMI procedures.

Prior Authorization

Verify site-of-service and authorization

Verify the site‑of‑service requirements and obtain any required authorization prior to scheduling the procedure. Site‑of‑service review criteria have been updated periodically; consult the related Site of Service Ambulatory Service Center (ASC) Select Surgical Procedures policy and check member benefits for any ASC or inpatient limitations.

Site‑of‑service criteria added/updated effective Nov. 7, 2025 (see related policy 11.01.525).

Clinical background and context

The menisci are fibrocartilaginous structures that cushion and stabilize the knee; loss of meniscal tissue reduces load distribution and increases contact stresses, contributing to degenerative changes. The policy recognizes that partial or total meniscectomy frequently leads to symptomatic meniscal deficiency and may accelerate osteoarthritic progression.

Meniscal allograft transplantation (MAT) is described as a salvage option for individuals—typically those who are relatively young and not candidates for total knee arthroplasty—who have symptomatic meniscal deficiency after prior meniscectomy. The policy cites evidence (systematic reviews, case series, and limited RCT data) showing improvements in pain and function after MAT, and supports MAT when strict eligibility criteria are met (for example, symptomatic deficiency >50% meniscal loss, minimal diffuse cartilage degeneration, and corrected biomechanics).

Definitions and acronyms

Meniscal allograft transplantation definition — inv-31: Meniscal allograft (MAT)

TermMeniscal allograft transplantation (MAT)

DefinitionTransplantation using donor meniscal tissue (allograft) to replace absent or near-absent native meniscus

Typical candidatesIndividuals too young for total knee arthroplasty or other reconstructive knee surgery with symptomatic meniscal deficiency

Collagen meniscal implant / scaffold definition — inv-32: Collagen meniscus implant (CMI)

TermCollagen meniscus implant (CMI)

DefinitionA resorbable collagen matrix (scaffold) trimmed and sutured to the remaining meniscal rim to fill partial meniscal defects after partial meniscectomy

OpenPayer

Meniscal Allografts and Other Meniscal Implants

Coverage criteria and medical necessity

Billing and coding references

Provider responsibilities, prior authorization, and documentation

Clinical background and context

Definitions and acronyms