ModifiedUnitedHealthcarePolicy CSNCT0553.08

Surgery of the Knee (for North Carolina Only)

Defines UnitedHealthcare's coverage stance and clinical documentation requirements for knee surgical procedures and cartilage repair interventions for members in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (for North Carolina Only)

Policy CodePolicy CSNCT0553.08

Change TypeDefinitions and applicable codes revised

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit complete medical records and diagnostic images via the external portal when requested to allow InterQual-based review of medical necessity.

SourceLink

POLICY UPDATE CHANGES

Updated definition of 'BioCartilage' and updated list of applicable CPT codes to reflect annual edits; CPT 27445 removed.

Clinical Evidence and References sections updated to reflect most current information.

State-specificPolicy applies to

Articular cartilage repair listUnproven procedures

YesInterQual referenced

Applicable codesCPT/HCPCS codes listed

8.1%

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Minced cartilage study revision rate

72%Decellularized allograft early failure

Coverage Criteria and Policy Position

InterQual-specified procedures

Covered when InterQual clinical criteria are met for the listed procedures.

InterQual-based coverage: Medical necessity determinations for knee surgeries (arthroscopy/arthroscopically assisted surgery, arthrotomy, diagnostic arthroscopy, removal and replacement, total joint replacement, unicondylar or patellofemoral knee replacement) are based on the referenced InterQual CP criteria.

Refer to InterQual CP documents linked in policy for full criteria

Articular cartilage repair — unproven / not medically necessary

Not medically necessary / unproven for treatment of articular cartilage lesions when any of the following techniques/products are used.

Not medically necessary list: Autologous minced or particulated cartilage (e.g., Cartilage Autograft Implantation System, Reveille Cartilage Processor); Allogeneic minced or particulated cartilage (e.g., BioCartilage, DeNovo NT, DeNovo ET); Collagen Meniscus Implant; Decellularized Osteochondral Allografts (e.g., Chondrofix); Reduced osteochondral discs (e.g., ProChondrix, Cartiform); Synthetic resorbable polymers (e.g., PolyGraft BGS, TruFit, TruGraft); Xenograft implantation.

Listed as unproven and not medically necessary due to insufficient evidence of efficacy.

Coverage summaries by implant/technique

Evidence-based coverage stance summaries by implant/technique:

Autologous/Allogeneic Minced or Particulated Cartilage: Evidence includes small prospective and single-arm studies showing short-term clinical improvement (e.g., Schneider 2024: KOOS improvement at 2 years in a 62-patient study) but is limited by lack of control groups, small samples, incomplete imaging follow-up, and absent long-term durability data; controlled trials with longer follow-up are needed.2-year follow-up common

Schneider 2024: KOOS 62.4 to 74.4; revision rate 8.1%

BioCartilage (extracellular matrix): Evidence is inconclusive (ECRI 2019); only limited case-series data identified and randomized trials comparing microfracture with and without BioCartilage are needed.insufficient

ECRI 2019

Collagen Meniscus Implant (CMI): Evidence is insufficient to demonstrate efficacy; some long-term cohort data show comparable outcomes to meniscectomy at 20 years and mixed mid-term benefits, but studies are small, nonrandomized, heterogeneous, and often include concomitant procedures; higher-quality RCTs and long-term comparative studies are required.

Articular cartilage repair procedures that use emerging scaffolds, particulated tissues, or biologic implants are considered unproven and not medically necessary when used to treat cartilage lesions of the knee. Specifically, the following techniques and products are listed as not medically necessary due to insufficient evidence of efficacy: autologous minced or particulated cartilage (e.g., Cartilage Autograft Implantation System, Reveille Cartilage Processor); allogeneic minced or particulated cartilage (e.g., BioCartilage®, DeNovo Natural Tissue, DeNovo Engineered Tissue); collagen meniscus implant; decellularized osteochondral allografts (e.g., Chondrofix); reduced osteochondral discs (e.g., ProChondrix, Cartiform); synthetic resorbable polymers (e.g., PolyGraft BGS, TruFit, TruGraft); and xenograft implantation.

Evidence for decellularized osteochondral allograft plugs and reduced osteochondral discs is limited and raises safety concerns. Case series and cohort reports describe implant delamination and high early failure rates; for decellularized plugs, studies reported up to a 29% revision rate (Johnson et al., 2017) and a 72% failure rate within the first 2 years (Farr et al., 2016). The literature for osteochondral discs is limited to small case series with short follow-up, and therefore the available data are inadequate to support routine coverage.

The policy explicitly reiterates that articular cartilage repair using the listed products and techniques is unproven and not medically necessary for treatment of individuals with cartilage lesions when any of the following are used: autologous or allogeneic minced/particulated cartilage (including BioCartilage and DeNovo products), collagen meniscus implant, decellularized osteochondral allografts, reduced osteochondral discs, synthetic resorbable polymers, or xenograft implantation.

Specific products and device classes identified in the evidence reviews are considered investigational or insufficiently proven. For example, the evidence for BioCartilage is inconclusive with only limited case-study data and no randomized trials comparing microfracture with and without BioCartilage. Collagen meniscus implants (CMI) lack robust randomized data and long-term comparative outcomes. Studies of synthetic resorbable polymers are largely preclinical or small series with reports of persistent pain and graft incorporation failures. The safety and efficacy of xenografts remain unproven, with mixed outcomes and high nonintegration and persistent pain reported in some series; therefore these approaches are considered investigational pending higher-quality evidence.

Procedure and Billing Codes

Applicable procedure codesmixed

0737T	Xenograft implantation into the articular surface.
27412	Autologous chondrocyte implantation, knee.
27415	Osteochondral allograft, knee, open.
27416	Osteochondral autograft(s), knee, open (e.g., mosaicplasty) (includes harvesting of autograft[s]).
27418	Anterior tibial tubercleplasty (e.g., Maquet type procedure).
27437	Arthroplasty, patella; without prosthesis.
27438	Arthroplasty, patella; with prosthesis.
27440	Arthroplasty, knee, tibial plateau.
27441	Arthroplasty, knee, tibial plateau; with debridement and partial synovectomy.
27442	Arthroplasty, femoral condyles or tibial plateau(s), knee.

1–10 of 43

1/5

Applicable CPT/HCPCS codes (policy note)mixed

0737T	notation: CPT/HCPCS code listed in policy (not on NC Medicaid Fee Schedule)
29868	notation: CPT/HCPCS code listed in policy (not on NC Medicaid Fee Schedule)
G0428	notation: CPT/HCPCS code listed in policy (not on NC Medicaid Fee Schedule)
J7330	notation: CPT/HCPCS code listed in policy (not on NC Medicaid Fee Schedule)
S2112	notation: CPT/HCPCS code listed in policy (not on NC Medicaid Fee Schedule)
27445	removed from list of applicable CPT codes

WOMAC thresholds for disability/pain

Disabling PainWOMAC pain domain > 40

Functional DisabilityWOMAC functional limitation domain > 40

WOMAC instrument24-item self-administered questionnaire assessing pain, stiffness, and physical function for hip/knee OA

Follow-up duration reported in studies

Common follow-up duration in studies2 years (typical reporting period in clinical series)

Longer-term reportsSome studies/report series include follow-up up to 10–20 years (where available for certain implants)

Documentation, Submission, and Provider Requirements

Note

InterQual-based requirements

Coverage determinations follow InterQual clinical criteria for specified knee procedures (e.g., arthroscopy, arthrotomy, total joint replacement, unicondylar/patellofemoral replacement). Medical necessity reviews may require comparison to InterQual CP: Procedures — Arthroscopy or Arthroscopically Assisted Surgery, Knee; Arthrotomy, Knee; Total Joint Replacement (TJR), Knee; Unicondylar or Patellofemoral Knee Replacement; and related pediatric and diagnostic variants.

Documentation Required

Required medical records detail

Medical records must include a complete diagnostic interpretation of imaging and supporting documentation to substantiate the clinical indication for surgery. At minimum include relevant clinical information and a detailed imaging report documenting presence/absence of focal full‑thickness articular cartilage defect, size and location of defect, Outerbridge grade, joint space and alignment, ligament tear location and grade, impressions, and the specialty(ies) of the interpreting provider(s). Also include condition requiring procedure, symptoms, severity of pain and functional disability interfering with activities of daily living, cause of defect, pertinent physical exam, comorbid conditions, prior therapies (dates, duration, reason for discontinuation), date of failed prior surgery to the same joint (if applicable), and the physician’s treatment plan (including pre‑op discussion and any additional interventions/products planned). For revision surgery provide details of complication and a complete staged surgical plan. If inpatient stay is requested, document rationale (e.g., bilateral surgery, significant comorbidities, lack of outpatient resources).

Clinical Background and Rationale

Articular cartilage has limited intrinsic healing capacity, and focal cartilage defects may result from acute trauma or degenerative processes. These defects can cause pain, swelling, and functional limitation; multiple novel repair strategies (autologous or allogeneic minced cartilage, extracellular matrix scaffolds, decellularized plugs or discs, collagen scaffolds, synthetic resorbable implants, and xenografts) have been investigated to restore cartilage surface and function. However, available studies are generally small, nonrandomized, and of short duration, limiting conclusions about long-term durability and comparative effectiveness. When donor-derived tissue products are used, product handling and regulatory considerations (e.g., HCT/P registration, donor screening, and infectious disease testing) may be relevant to clinical decision-making and documentation.

Definitions of Key Terms and Devices

BioCartilage

DefinitionExtracellular matrix consisting of cartilage allograft intended to provide a scaffold for microfracture defects

Formulation/UseSmall particles are mixed with a blood solution to create a paste-like consistency applied over a cartilage defect

Reference/updateDescribed in Hayes (2022) with update noted in 2025 per policy definitions

Cartilage Autograft Implantation System

FunctionHarvests minced autograft cartilage and disperses chondrocytes on a scaffold in a single-stage treatment

Technique typeSingle-stage autologous minced cartilage implantation (device/system facilitates processing and reimplantation)

Policy Revision History

2026-06-01material_changeLatest

Updated definition of 'BioCartilage'; updated list of applicable CPT/HCPCS codes to reflect annual edits and removed CPT 27445; added notation that CPT/HCPCS codes 0737T, 29868, G0428, J7330, and S2112 are not on the North Carolina Medicaid Fee Schedule; Clinical Evidence and References sections updated.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (for North Carolina Only)

Policy CodePolicy CSNCT0553.08

Change TypeDefinitions and applicable codes revised

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit complete medical records and diagnostic images via the external portal when requested to allow InterQual-based review of medical necessity.

SourceLink

On This Page

Lucidi 2024; Kohli 2022; Grassi 2021

Decellularized Osteochondral Allografts: Reported short-term high failure and revision rates (e.g., Johnson 2017: 29% revision; Farr 2016: 72% failure within 2 years); evidence insufficient to support clinical effectiveness and larger controlled trials are required.high early failure

Johnson 2017; Farr 2016

Reduced Osteochondral Allograft Discs (e.g., Cartiform, ProChondrix): Evidence limited to small case series and brief research summaries; insufficient peer-reviewed literature to draw conclusions; larger randomized trials with longer follow-up are needed.insufficient

Hayes 2023; Mehta 2022

Synthetic Resorbable Polymers (e.g., TruFit plug): Primarily animal studies and small human case series; early improvements may deteriorate over time and there is no evidence demonstrating equivalence or superiority to established treatments; randomized trials are needed.insufficient

Verhaegen 2015

Xenografts: Safety and efficacy remain unproven with mixed outcomes and high nonintegration and persistent pain rates reported in some series; additional high-quality studies required before routine use.insufficient

Bracey 2020

Limitations notedMany studies have short follow-up and lack long-term durability data; longer controlled trials needed

Documentation Required

Imaging submission requirements

When diagnostic images are requested, submit the specific image(s) that demonstrate the abnormality (MRI, CT, X‑ray, bone scan as applicable). Images must be labeled with the date taken and either the applicable case number obtained at time of notification or the member’s name and ID number. Diagnostic images must be submitted via the external portal at www.uhcprovider.com/paan; faxes will not be accepted. Consultation with the requesting surgeon may help identify the optimal images to submit.

Denial Risk

Documentation-related denial risk

Failure to provide required documentation — including the detailed imaging report elements listed above, diagnostic images when requested, reports of recent diagnostic tests (e.g., microbiology, synovial exam, ESR, CRP), receipts or implant/graft device documentation, or other requested medical records — may result in delay or denial of the request.

Note

Regulatory and coverage & tissue handling considerations

Devices and tissue products used in knee procedures may be subject to FDA or HCT/P requirements even though the surgical procedures themselves are not FDA‑regulated. Tissue establishments supplying donor‑derived products must be registered with the FDA and maintain donor screening/testing and records per HCT/P requirements; documentation of registration and donor testing may be requested as part of coverage review. Note that certain CPT/HCPCS codes listed in the applicable codes section (0737T, 29868, G0428, J7330, S2112) are not on the North Carolina Medicaid Fee Schedule and therefore may not be covered by the State of North Carolina Medicaid Program.

Tissue establishments must register with the FDA and maintain donor screening/testing records for HCT/P products.
Certain CPT/HCPCS codes (0737T, 29868, G0428, J7330, S2112) are not on the North Carolina Medicaid Fee Schedule and may not be covered by NC Medicaid.

Source citationDescribed in Farr et al., 2012 as noted in policy definitions

Collagen Meniscus Implants

CompositionImplantable porous meniscus scaffold composed of collagen fibers, often enriched with glycosaminoglycan

PurposeUsed as a template and support to promote generation of new meniscal tissue to replace lost menisci

Alternate namesAlso referred to as collagen scaffolds (e.g., CMI) in the literature

Decellularized Osteochondral Allograft Plugs

DescriptionCylinder-shaped plug (graft) of healthy cartilage tissue and subchondral bone taken from a non–weight-bearing donor site

PlacementMatched to defect surface area and press-fit (pushed) into place to leave a smooth cartilage surface in the joint

Example productReferenced example: Chondrofix

WOMAC / functional thresholds

WOMAC overview24-item, self-administered questionnaire assessing pain, stiffness, and physical function for hip/knee osteoarthritis

Disabling Pain thresholdWOMAC pain domain > 40

Functional Disability thresholdWOMAC functional limitation domain > 40

Outerbridge Grades

Grade 0Normal

Grade ICartilage with softening and swelling

Grade IIPartial-thickness defect with fissures not reaching subchondral bone or >1.5 cm

Grade IIIFissuring to subchondral bone in area >1.5 cm

Grade IVExposed subchondral bone

Updated definition of 'BioCartilage'

Policy updateUpdated definition of 'BioCartilage' in policy revisions (06/01/2026)

ContextDefinition change reflected in Definitions section; see policy history for annual edits

Supporting referenceDefinition text cites Hayes (2022) with 2025 update per policy document

HCT/P — regulatory note

Regulatory categoryHuman Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P)

Establishment requirementsTissue establishments must register with the FDA and follow donor screening and infectious disease testing requirements

Note on transplantation regulationCBER does not regulate the transplantation of these products per se but requires establishment registration and records maintenance