ModifiedUnitedHealthcarePolicy 2025T0553FF

Surgery of the Knee — cartilage and meniscal implants/patches (coverage criteria)

Defines UnitedHealthcare clinical coverage stance and evidence review for articular cartilage repair techniques and collagen meniscus implants for knee surgery; applies to UnitedHealthcare Commercial and Individual Exchange and Medicare Advantage populations as indicated.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee — cartilage and meniscal implants/patches

Policy CodePolicy 2025T0553FF

Change TypeClarified not-medically-necessary stance for listed cartilage/meniscal technologies

Effective DateAugust 1, 2025

Next Review DateN/A

Key ActionRefer to InterQual clinical policy criteria for medical necessity determinations for knee arthroscopy/arthrotomy and total joint replacement and expect denials for listed unproven cartilage/meniscal implants.

SourceLink

POLICY UPDATE CHANGES

Articular cartilage repair using autologous or allogeneic minced/particulated cartilage, collagen meniscus implants, decellularized osteochondral allografts, reduced osteochondral discs, synthetic resorbable polymers, and xenograft implantation is considered unproven and not medically necessary due to insufficient evidence of efficacy.

8policy pages

Multiplenamed unproven technologies

YesInterQual referenced

Insufficient

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evidence characterization

Yesrevision contains material change

Coverage Criteria — Knee Cartilage and Meniscal Implants

Coverage stance — InterQual governed procedures and not medically necessary technologies

General coverage framework: standard knee surgeries are governed by InterQual criteria; listed cartilage/meniscal scaffold/implant technologies are unproven and not medically necessary.

InterQual governed procedures: Knee arthroscopy/arthrotomy and total joint replacement medical necessity determinations should follow InterQual CP criteria listed in the policy (Arthroscopy or Arthroscopically Assisted Surgery, Knee; Arthrotomy, Knee; Total Joint Replacement, Knee; Unicondylar or Patellofemoral Knee Replacement).

See InterQual reference

Not medically necessary procedures: Autologous minced or particulated cartilage (e.g., CAIS, Reveille), allogeneic minced or particulated cartilage (e.g., BioCartilage, DeNovo NT/ET), collagen meniscus implants, decellularized osteochondral allografts (e.g., Chondrofix), reduced osteochondral discs (e.g., ProChondrix, Cartiform), synthetic resorbable polymers, and xenograft implantation are unproven and not medically necessary due to insufficient evidence of efficacy.

Specific examples listed in policy

Coverage-relevant evidence summaries (insufficient evidence / investigational)

Summary of coverage-relevant evidence

Collagen Meniscus Implant (CMI): Insufficient evidence to demonstrate efficacy for treating meniscus injuries; high heterogeneity and frequent concurrent procedures in published studies limit interpretation. Further high-quality randomized controlled trials and long-term outcomes are needed before routine recommendation.

Supported by Kohli et al. (2022) systematic review and policy summary.

Decellularized Osteochondral Allografts: Reported delamination and high short-term failure and revision rates (e.g., Johnson et al. 2017: 29% required revision; Farr et al. 2016: 72% failure within 2 years). Evidence is insufficient to support routine use; larger comparative trials with longer follow-up are needed.

Supported by Johnson et al. and Farr et al. case series data.

Reduced Osteochondral Allograft Discs: Evidence limited to small case series (e.g., Hayes brief, Mehta et al. 2022) with small samples and short follow-up; insufficient to draw conclusions about clinical benefit. Further larger and comparative studies required.

Supported by Hayes (2023) and Mehta et al. (2022).

Synthetic Resorbable Polymers:

Articular cartilage repair procedures using the technologies listed in this policy are considered unproven and not medically necessary due to insufficient evidence of efficacy. Examples include autologous minced or particulated cartilage (e.g., CAIS, Reveille Cartilage Processor), allogeneic minced or particulated cartilage (e.g., BioCartilage®, DeNovo NT/ET), collagen meniscus implants, decellularized osteochondral allografts (e.g., Chondrofix), and reduced osteochondral discs (e.g., ProChondrix, Cartiform).

Information about U.S. Food and Drug Administration (FDA) regulation is provided for context only: FDA approval or clearance of a device is informational and is not, by itself, a basis for coverage. Surgical procedures themselves are not regulated by the FDA, although devices and instruments used during knee surgery do require FDA clearance/approval. Clinical coverage determinations should instead follow the criteria and plan-specific requirements described in this policy.

Autologous and allogeneic minced or particulated cartilage techniques are listed as not medically necessary and unproven. Examples specifically named in the policy include Cartilage Autograft Implantation System (CAIS) and the Reveille Cartilage Processor for autologous approaches, and BioCartilage® and DeNovo NT/ET for allogeneic or juvenile particulated cartilage products. The available evidence is limited to early-stage data, case series, and low-quality studies, and randomized controlled trials with larger cohorts are needed to establish clinical benefit.

Use of collagen meniscus implants, decellularized osteochondral allografts, and synthetic resorbable polymers is considered investigational or not medically necessary. The policy notes insufficient evidence of efficacy for collagen meniscus implants and summarizes systematic-review findings showing high heterogeneity, concurrent procedures, and variable failure rates. Decellularized osteochondral allografts have been associated with implant delamination and high short-term failure/revision rates in case series, and synthetic resorbable polymers have predominantly animal and limited human data with reported problems in graft incorporation and biocompatibility.

Procedure and Billing Codes

Applicable Procedure and HCPCS/CPT 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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Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and InterQual® Guidance

UnitedHealthcare may use InterQual® criteria to assist in prior authorization decisions. Providers should submit requests through the plan's prior authorization process and reference the applicable InterQual® procedure criteria (e.g., arthroscopy, arthrotomy, total joint replacement) as appropriate.

Prior authorization may be required — verify with member-specific benefits and plan documents before scheduling.
When submitting prior authorization requests, include the InterQual® criteria name and relevant clinical information to facilitate review.

Documentation Required

Coding and Documentation Note

Coding lists in this policy are provided for reference only. Inclusion of a code does not guarantee coverage or payment. Confirm coverage and coding requirements with the member's benefit plan and submit complete and accurate claims documentation.

Codes listed in this policy are not exhaustive and are for reference only.

Background — Cartilage Biology and Clinical Context

Articular cartilage has a limited intrinsic healing capacity and can be damaged by acute injury or inflammatory conditions, which may lead to persistent pain, swelling, and joint dysfunction. Various biologic and scaffold-based repair approaches (for example, minced cartilage techniques, allograft or xenograft products, collagen scaffolds, and synthetic resorbable implants) have been proposed to restore cartilage, but current evidence for many of these technologies is limited, heterogeneous, and insufficient to demonstrate consistent improvement in long‑term clinical outcomes.

Definitions — Product and Technology Descriptions

BioCartilage definition

TermBioCartilage

DefinitionDehydrated, 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 (Hayes, 2022).

UseApplied as a paste over cartilage defects to augment microfracture procedures.

CAIS definition

TermCAIS (Cartilage Autograft Implantation System)

DefinitionSystem that harvests minced autograft cartilage and disperses chondrocytes on a scaffold in a single‑stage treatment (Farr et al., 2012).

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee — cartilage and meniscal implants/patches

Policy CodePolicy 2025T0553FF

Change TypeClarified not-medically-necessary stance for listed cartilage/meniscal technologies

Effective DateAugust 1, 2025

Next Review DateN/A

SourceLink

On This Page

Predominantly animal data and a small number of human case series; reports of poor clinical outcomes, persistent pain, functional deficits, and graft incorporation failure raise biocompatibility concerns. Current evidence is insufficient to support use as an alternative to autograft/allograft.

Supported by Verhaegen et al. (2015) systematic review and related literature.

Xenografts: Decellularization methods are at an early investigational stage; safety and efficacy have not been established and additional studies are required before clinical use can be supported.

Policy notes ongoing investigation of xenograft decellularization techniques.

Billing and coverage decisions are determined by the member-specific benefit plan document and applicable laws.

Documentation Required

Medical Records Documentation Required for Review

The following medical records and documentation are typically required for review of requests related to articular cartilage or meniscal procedures. Submit complete, legible records; incomplete documentation may delay review or result in denial.

Relevant clinical history and prior treatments (including conservative therapy details and duration).
Physical examination findings and provider assessment.
Complete diagnostic interpretation of imaging findings including, at a minimum: relevant clinical information, detailed report of imaging findings, impression, and specialty(ies) of the provider(s) who interpreted the images.
Operative reports for prior knee procedures, if applicable.
Progress notes documenting symptoms, functional limitation, and response to prior treatments.
Pathology reports, if applicable.
Consultation notes and correspondence related to the request.

Denial Risk

Denial Risk — Limited Evidence and High Failure Rates

Evidence for some cartilage and meniscal implants is limited and has demonstrated high failure rates in published studies (for example, certain decellularized osteochondral allografts, collagen meniscus implants, and some synthetic resorbable polymers). Due to these limitations and associated risk of poor outcomes or revision surgery, requests for procedures using these implants may be denied as not medically necessary.

High reported failure rates and insufficient high-quality RCT evidence are noted for: collagen meniscus implants (CMI), decellularized osteochondral allografts, and certain synthetic resorbable polymers.
When evidence is insufficient or shows high failure, the procedure using the implant may be considered not medically necessary and denied.
Provide robust supporting clinical evidence and rationale when requesting coverage for procedures involving these implants.

Note

FDA Device and Tissue Information (Informational)

FDA regulation information is provided for informational purposes only. FDA approval, clearance, or registration of a device does not by itself determine coverage. Devices and instruments used in surgical procedures generally require appropriate FDA clearance/approval; tissue products and minimally processed allografts may be subject to different FDA requirements.

Surgeries themselves are not regulated by the FDA, but devices and instruments used during surgery may require FDA clearance/approval.
Meniscal allografts and osteochondral autografts are surgical procedures and not typically subject to FDA premarket review; tissue banking, infectious disease screening, and good tissue practices are regulated.
For device-specific FDA information, consult the FDA databases (e.g., PMN/510(k), PMA) and product-specific approvals.

MechanismUses autologous minced cartilage placed on a scaffold to promote chondral repair.

Collagen Meniscus Implant (CMI) definition

TermCollagen Meniscus Implant (CMI)

DefinitionImplantable porous meniscal scaffold composed of collagen fibers, enriched with glycosaminoglycan, used as a template and support for generation of new meniscal tissue (AAOS, 2023).

CompositionPrimarily collagen fibers forming a porous, bioresorbable scaffold to replace lost meniscus tissue.

Reduced Allograft Discs definition

TermReduced Allograft Discs (e.g., Cartiform, ProChondrix)

DefinitionWafer‑thin allografts in which the bony portion is reduced; discs contain hyaline cartilage with chondrocytes, growth factors, and extracellular matrix proteins and are often used with marrow stimulation to promote chondrogenesis (Hayes, 2018; updated 2021).

ApplicationUsed in conjunction with marrow stimulation to allow host mesenchymal stem cell infiltration and support graft incorporation.

DeNovo NT/ET definition

TermDeNovo NT/ET

DefinitionDeNovo NT: manually particulated juvenile allograft cartilage mixed intraoperatively with fibrin glue before implantation; DeNovo ET: engineered, in‑vitro grown hyaline‑like cartilage tissue created by culturing disaggregated allogeneic juvenile chondrocytes (Farr et al., 2012).

Intended useParticulated or engineered juvenile cartilage tissue used for implantation into prepared cartilage lesions to restore hyaline‑like cartilage.

CMI alternate entry

TermCollagen Meniscus Implant (CMI) — alternate description

DefinitionCollagen meniscus implants (collagen scaffolds) are bioresorbable, primarily bovine type I collagen products designed as a tissue‑engineered scaffold to support generation of new meniscus‑like tissue.

Regulatory noteRefer to FDA Premarket Approval resources (product code OLC) for device information; FDA details are informational and not a basis for coverage determination.

Donor tissue products (HCT/P) — regulatory note

TopicDonor tissue products (HCT/P)

Regulatory noteDonor tissue products derived from human cartilage (e.g., DeNovo NT) are regulated under FDA HCT/P guidance; tissue establishments must register with FDA, screen and test donors, follow procedures to prevent communicable disease, and maintain records (CBER requirements).

Coverage implicationFDA regulation of tissue establishments and HCT/P requirements is informational; transplantation procedures themselves are surgical and not regulated by FDA for coverage determination.