ModifiedUnitedHealthcarePolicy 2026T0553HH

Articular cartilage repair and related knee procedures

This policy governs coverage and medical necessity determinations for articular cartilage repair procedures and related knee surgeries (including minced/particulated cartilage, allografts, collagen meniscus implants, synthetic polymers, and xenograft implantation) for UnitedHealthcare Commercial and Individual Exchange plans.

Policy Summary

PayerUnitedHealthcare

PolicyArticular cartilage repair and related knee procedures

Policy CodePolicy 2026T0553HH

Change TypeDefinitions addedsupporting sections updated

Effective DateMar 1, 2026

Next Review Date

Key ActionWhen requesting prior authorization, reference InterQual criteria for knee surgeries and provide member-specific benefit information and supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Added definitions including Disabling Pain, Functional Disability, Outerbridge Grades, Radiographic Findings of Osteoarthritis, and WOMAC.

Supporting Information, Clinical Evidence, and References sections updated to reflect the most current information.

InterQualInterQual referenced

insufficient evidenceTechnologies judged unproven

42 codesCodes provided for reference

BioCartilage/DeNovo/CMICommonly cited devices with limited evidence

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high failureHigh failure rates reported (example)

Coverage and Medical Necessity Criteria

General surgical coverage and reference to InterQual

Coverage follows InterQual clinical criteria for knee surgeries; specific cartilage repair technologies are addressed separately.

Surgery of the knee - general: Surgery of the knee is proven and medically necessary in certain circumstances; for medical necessity clinical coverage criteria, refer to InterQual CP: Procedures for arthroscopy/arthroscopically assisted surgery (knee), arthrotomy (knee), diagnostic arthroscopy, and total joint replacement/unicondylar or patellofemoral knee replacement.

InterQual referenced for determinative criteria.

Not medically necessary: specific cartilage repair technologies

The following cartilage repair approaches are considered unproven and not medically necessary due to insufficient evidence of efficacy:

Unproven/Not Medically Necessary Treatments: Autologous minced or particulated cartilage (e.g., CAIS, Reveille Cartilage Processor); Allogeneic minced or particulated cartilage (e.g., BioCartilage, DeNovo NT/ET); Collagen Meniscus Implant (CMI); 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 explicitly as unproven/not medically necessary in policy.

Investigational / insufficient evidence

Evidence summarized for multiple implant types generally finds insufficient or low-quality evidence; specific coverage criteria are not detailed in this excerpt.

General evidence-based requirements: Use of BioCartilage, DeNovo NT, collagen meniscal implants, decellularized osteochondral allografts, reduced osteochondral discs, osteochondral allograft discs, and synthetic resorbable polymers should be considered investigational or of unproven benefit when current evidence is limited, low-quality, or reports high failure rates (e.g., delamination and 72% failure within 2 years reported for decellularized plugs). Randomized controlled trials with sufficient sample size and longer follow-up are needed to establish safety and efficacy.evidence quality low/insufficient or high failure rate

Randomized controlled trials with larger cohorts and longer follow-up are repeatedly called for in the literature; case series and animal studies predominate.

Articular cartilage repair procedures using the technologies listed in this policy are considered not medically necessary when proposed for routine treatment because current evidence is insufficient to demonstrate consistent clinical benefit. The policy explicitly identifies autologous and allogeneic minced/particulated cartilage, collagen meniscus implants, decellularized osteochondral allografts, reduced osteochondral discs, and synthetic resorbable polymers as unproven approaches that may be denied as not medically necessary.

FDA clearance or approval of a device or tissue product does not, by itself, establish that a surgical procedure using that device or tissue is covered. The policy notes that surgeries are procedures and therefore not regulated by the FDA, while devices, instruments, and certain tissue products have separate regulatory pathways. Providers should document relevant regulatory status (FDA or HCT/P) as part of the clinical record, but coverage determinations are based on the clinical evidence of benefit, not regulatory status alone.

This policy addresses a range of specific cartilage repair technologies that are considered unproven or investigational for routine use. These include autologous minced/particulated cartilage (e.g., CAIS, Reveille Cartilage Processor), allogeneic minced/particulated cartilage (e.g., BioCartilage®, DeNovo NT/ET), collagen meniscus implants, decellularized osteochondral allografts (e.g., Chondrofix), reduced osteochondral discs (e.g., ProChondrix, Cartiform), and synthetic resorbable polymers (e.g., PolyGraft BGS, TruFit, TruGraft).

Examples of interventions discussed in the evidence summary include use of extracellular matrix or particulated allograft products such as BioCartilage and donor-derived products like DeNovo NT, implantation of scaffolds such as collagen meniscus implants, and use of decellularized or reduced osteochondral allograft constructs. The literature reports low-quality or limited clinical data for these approaches, and specific concerns cited include inconclusive outcomes for BioCartilage, insufficient evidence for collagen meniscal scaffolds, reported delamination and high failure rates for decellularized osteochondral allograft plugs, limited small-series data for reduced allograft discs, and predominantly animal or small case-series data with biocompatibility issues for synthetic resorbable polymers

Procedure and Diagnostic Coding

Applicable CPT/HCPCS 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.

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Radiographic Findings of Osteoarthritis

Accepted radiographic findingsNarrowing of joint space; osteophyte formation; subchondral sclerosis; subchondral cysts; deformity of bony end-plates; thinning or complete loss of articular cartilage.

Threshold for severe osteoarthritisUnitedHealthcare will accept three or more moderate to severe radiographic findings to support a diagnosis of severe osteoarthritis.

Source guidance contextThese radiographic features are listed under policy definitions as criteria supporting osteoarthritis severity assessment.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization
Prior Authorization Required
Prior authorization is required. Verify member benefits and eligibility prior to scheduling services. Provide clinical evidence showing that the requested procedure meets InterQual criteria where applicable and include rationale when requesting coverage for procedures that may be considered investigational or not medically necessary under this policy.
Verify member benefits and prior authorization requirements before performing services
Submit supporting clinical documentation demonstrating how patient meets InterQual or plan criteria
For services potentially considered experimental (e.g., minced/particulated cartilage, decellularized osteochondral allografts, synthetic resorbable polymers, collagen meniscus implants), include justification and literature if available

Documentation Required
Medical Records May Be Requested
Medical records and clinical documentation may be requested to substantiate medical necessity. Provide complete operative reports, imaging (MRI/X-ray) reports, prior conservative therapy documentation, prior surgical history, relevant physical exam findings, and specialist consultation notes. Records supplied must support the diagnosis, lesion size/location, symptoms, prior treatments, and functional limitation.

Clinical Background

Articular cartilage is a specialized hyaline tissue that provides a low-friction surface for joint motion and distributes load across the joint. Its intrinsic healing capacity is limited because chondrocytes are relatively avascular and lesions do not readily regenerate native hyaline cartilage. Focal cartilage defects can cause pain, swelling, and functional limitation, and a variety of biologic and scaffold-based repair strategies have been developed; however, many of these approaches lack high-quality comparative evidence demonstrating durable restoration of hyaline cartilage and improved long-term clinical outcomes.

Definitions and Key Terms

BioCartilage — product description and intended use

Product descriptionDehydrated, micronized allograft articular cartilage matrix intended to provide a scaffold for microfracture; small particles are mixed with a blood solution to create a paste-like consistency applied over a cartilage defect.

Intended useUsed as an extracellular matrix scaffold placed over microfracture-treated lesions to support filling of cartilage defects.

Preparation/handlingMixed intraoperatively with a blood solution to form a paste-like consistency before application to the defect.

Cartilage Autograft Implantation System (CAIS) definition

DefinitionCartilage Autograft Implantation System (CAIS) harvests minced autograft cartilage and disperses chondrocytes on a scaffold in a single-stage treatment.

Technique note

Policy Summary

PayerUnitedHealthcare

PolicyArticular cartilage repair and related knee procedures

Policy CodePolicy 2026T0553HH

Change TypeDefinitions addedsupporting sections updated

Effective DateMar 1, 2026

Next Review Date

Key ActionWhen requesting prior authorization, reference InterQual criteria for knee surgeries and provide member-specific benefit information and supporting clinical documentation.

SourceLink

On This Page

Operative reports and procedure notes
Pre- and post-operative imaging reports (including MRI with lesion characterization)
Documentation of prior conservative management (e.g., physical therapy, injections) and duration
Clinical notes detailing symptoms, functional limitation, and failed treatments
Pathology or tissue-bank documentation when applicable

Documentation Required
Regulatory and Documentation Considerations
Document regulatory status and tissue establishment information for implants and biologic products. For human tissue–derived products, include HCT/P status, donor screening/testing, and tissue establishment registration when applicable. Note FDA approval/clearance status for devices and any applicable product codes; FDA clearance alone does not guarantee coverage. When using third‑party tools (e.g., InterQual), indicate which criteria set was applied.
Indicate whether the product is FDA-approved/cleared, HCT/P regulated, or considered minimally processed tissue
Provide tissue establishment registration and donor screening/testing documentation for allograft products (DeNovo NT, osteochondral allografts, meniscal allografts)
For collagen meniscus implants or other scaffold products, include product name, manufacturer, and any available FDA PMA/510(k) or HCT/P information
If InterQual was used to support medical necessity, cite the specific InterQual module and version

Autologous cartilage is minced and applied with a scaffold to allow even distribution of chondrocytes within the defect.

Reference studyDescribed in Farr et al., 2012 as a single-stage autograft cartilage implantation approach.

Outerbridge Grades (grading system summary)

Grade ICartilage with softening and swelling.

Grade IIPartial-thickness defect with fissures on the surface that do not reach subchondral bone or exceed 1.5 cm in diameter.

Grade IIIFissuring to the level of subchondral bone in an area with a diameter more than 1.5 cm.

Grade IVExposed subchondral bone.

WOMAC (measurement instrument) definition

Instrument nameWestern Ontario and McMaster Universities Arthritis Index (WOMAC).

StructureSelf-administered, multidimensional 24-item questionnaire grouped into pain, stiffness, and physical function domains.

Use in policyWOMAC pain and function domain thresholds are referenced in definitions (e.g., Disabling Pain: WOMAC pain > 40; Functional Disability: WOMAC function > 40).

Outerbridge Grades — added definitions in policy history

Added definitions (policy history)Outerbridge Grades added to policy definitions on 03/01/2026.

Purpose of additionDefinitions expanded as part of the 03/01/2026 policy revision to clarify grading of chondral lesions.

Reference entryPolicy History/Revision Information notes the added definition of Outerbridge Grades.

WOMAC — added to policy definitions

Added to definitionsWestern Ontario and McMaster Universities Arthritis Index (WOMAC) was added to the policy definitions on 03/01/2026.

DescriptionThe WOMAC is a disease-specific, self-administered 24-item questionnaire evaluating pain, stiffness, and physical function in hip/knee osteoarthritis.

Policy contextWOMAC domain thresholds (pain and function > 40) are used in the policy definitions for Disabling Pain and Functional Disability.