ModifiedUnitedHealthcarePolicy CS068NJ.Y

Surgery of the Knee (New Jersey Only)

This New Jersey–only medical policy governs medical necessity and coverage considerations for knee surgical procedures, including arthroscopy, arthrotomy, and joint replacement, and specifies procedures considered unproven for articular cartilage repair.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (New Jersey Only)

Policy CodePolicy CS068NJ.Y

Change TypeDefinitions addedCPT list updatedevidence sections refreshed

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit complete clinical documentation (imaging reports/images, tests, prior treatments, and treatment plan) to demonstrate InterQual criteria are met for the requested knee procedure.

SourceLink

POLICY UPDATE CHANGES

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

Updated list of applicable CPT codes to reflect annual edits and removed CPT 27445.

Clinical evidence and references sections updated to reflect current literature.

InterQualInterQual referenced

>=1Procedure groups covered

MultipleUnproven cartilage methods

NJNJ-only

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27445CPT code removed

Coverage Criteria

Procedures covered per InterQual

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

InterQual referenced procedures: Coverage follows InterQual CP criteria for: Arthroscopy or Arthroscopically Assisted Surgery, Knee; Arthroscopy or Arthroscopically Assisted Surgery, Knee (Pediatric); Arthroscopy, Diagnostic, +/- Synovial Biopsy, Knee; Arthrotomy, Knee; Arthrotomy, Knee (Pediatric); Removal and Replacement, Total Joint Replacement (TJR), Knee; Total Joint Replacement (TJR), Knee; Unicondylar or Patellofemoral Knee Replacement.

Providers must demonstrate the member meets the cited InterQual criteria via submitted documentation.

Unproven / Not Medically Necessary Cartilage Repair Procedures

Not medically necessary / unproven for articular cartilage repair.

Articular cartilage repair methods considered unproven: The following are considered unproven and not medically necessary due to insufficient evidence of efficacy: Autologous minced or particulated cartilage (e.g., Cartilage Autograft Implantation System [CAIS], Reveille Cartilage Processor); Allogeneic minced or particulated cartilage (e.g., BioCartilage, DeNovo NT/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); and Xenograft implantation.

Evidence includes case series, early-stage reports, and technology assessments concluding insufficient or very-low–quality evidence; randomized controlled trials with adequate sample size are needed.

Technologies with insufficient evidence / requiring further study

Coverage determinations depend on evidence quality and outcomes; the following technologies have insufficient or inconclusive evidence and require further study.

Minced or Particulated Cartilage: Evidence is limited to early-stage reports, in vitro and animal studies, and small case series; available clinical series do not permit conclusions about effects on health outcomes and report potential adverse findings (subchondral edema, nonuniform chondral surface, graft hypertrophy, delamination). Larger randomized controlled trials directly comparing these techniques with established treatments are needed.

BioCartilage and DeNovo NT are specifically noted as having inconclusive or very-low–quality evidence.

Collagen Meniscus Implant (CMI): Evidence is insufficient to demonstrate efficacy as a sole treatment; studies are heterogeneous with frequent concurrent procedures and small sample sizes, limiting interpretation. Further high-quality comparative RCTs and long-term outcomes are required.

Current reviews conclude meniscal scaffolds cannot be recommended routinely as sole therapy due to limited and heterogeneous data.

Decellularized Osteochondral Allografts: Published series report delamination and high failure rates (including a 72% failure in one series within 2 years and 29% revision in another), indicating need for larger trials with longer follow-up to assess safety and effectiveness.

Coverage for surgical treatment of knee articular cartilage pathology follows the referenced InterQual criteria; procedures such as arthroscopy, arthrotomy, and total or unicondylar knee replacement are considered when the member’s presentation and submitted documentation meet the cited InterQual clinical criteria. Providers requesting review must submit the clinical information required to demonstrate that the member satisfies the applicable InterQual criteria for the requested knee procedure.

The following cartilage repair methods are considered unproven and not medically necessary because of insufficient peer‑reviewed evidence demonstrating efficacy: autologous minced or particulated cartilage (e.g., Cartilage Autograft Implantation System/CAIS, Reveille), 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), and xenograft implantation. Available studies are primarily small case series, registry reports, or low‑quality assessments and do not provide sufficient high‑quality comparative data to support routine coverage.

Autologous and allogeneic minced/particulated cartilage techniques (including systems such as CAIS and products like BioCartilage® and DeNovo) are specifically identified in the policy as lacking adequate evidence. Published reports are limited to early‑stage studies and case series with potential adverse findings (for example, subchondral edema, graft hypertrophy, delamination) and systematic assessments (ECRI, Hayes) have judged the body of evidence to be inconclusive or very low quality; randomized controlled trials directly comparing these approaches with established treatments are needed before they can be considered medically necessary.

Certain technologies have limited clinical evidence and reported high failure rates in some series, and therefore are not supported as standard treatment pending more robust data. Examples include some decellularized osteochondral allograft plugs, which have been associated with implant delamination and substantial short‑term failure rates in reported series, and synthetic resorbable polymers (eg, TruFit) where human data are limited, reports note early improvement with later deterioration, and biocompatibility and incorporation concerns have been described. These findings warrant caution and further comparative trials.

Coding and Procedure Codes

Applicable Procedure and Supply 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

Updated CPT coding changesCPT

27445

removed from applicable CPT codes

WOMAC thresholds — pain and functional limitation numeric thresholds

WOMAC Pain thresholdWOMAC pain domain score > 40 (defines Disabling Pain)

WOMAC Functional limitation thresholdWOMAC functional limitation domain score > 40 (defines Functional Disability)

WOMAC instrumentWOMAC is a 24-item, disease-specific, self‑administered questionnaire assessing pain, stiffness, and physical function

Provider Actions and Documentation Requirements

Prior Authorization

Preauthorization and clinical documentation requirement

Prior authorization/medical review may be required. Submit requested clinical documentation as part of the authorization or medical record review; failure to provide required information may delay or result in denial of the request.

When requested, submit diagnostic images via the external portal at www.uhcprovider.com/paan; faxes will not be accepted.
Include the applicable case number or member name and ID on submitted images; images must be labeled with the date taken.

Documentation Required

Required medical records/documentation

Provide complete medical records to support the clinical necessity of the procedure. Required documentation includes imaging interpretations, relevant diagnostic test reports, clinical notes, and treatment history. Insufficient documentation may lead to denial or delay in coverage determination.

Complete diagnostic interpretation of imaging findings with relevant clinical information, detailed findings, impression, and specialty(ies) of interpreting provider(s).

Background

Articular cartilage is a specialized, avascular tissue with limited intrinsic healing capacity; focal cartilage defects can cause pain, swelling, mechanical symptoms, and functional limitation. A range of repair strategies exist, including established techniques (microfracture, osteochondral autograft transfer/mosaicplasty, autologous chondrocyte implantation) and newer single‑stage or implant‑based approaches (minced/particulated cartilage, extracellular matrix scaffolds, decellularized allografts, synthetic scaffolds, xenografts). Many of the emerging methods are under active investigation but, to date, evidence is frequently limited to small case series, in vitro or animal studies, and low‑quality comparative data; reported adverse findings in some series (for example subchondral edema, nonuniform chondral surface, graft hypertrophy, delamination, and implant failure) highlight the need for larger randomized trials comparing these technologies with established treatments to determine their effect on clinically meaningful outcomes.

Definitions

BioCartilage — product description and intended use

Product typeBioCartilage: Dehydrated, micronized allograft articular cartilage matrix intended to provide a scaffold for microfracture.

Formulation / usePrepared as small particles that are mixed with a blood solution to create a paste-like consistency applied over a cartilage defect.

Intended purposeProvides a scaffold to support cartilage repair when used adjunctively with marrow stimulation (e.g., microfracture).

Cartilage Autograft Implantation System (CAIS) — system description

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

Procedure characteristicUses autologous cartilage harvested and processed intraoperatively to seed a scaffold for implantation during the same surgical session.

Revision History

2026-03-01definitions_added_and_code_removedLatest

Definitions for Disabling Pain, Functional Disability, Outerbridge Grades, Radiographic Findings of Osteoarthritis, and WOMAC were added; CPT code 27445 was removed from the applicable codes list.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (New Jersey Only)

Policy CodePolicy CS068NJ.Y

Change TypeDefinitions addedCPT list updatedevidence sections refreshed

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit complete clinical documentation (imaging reports/images, tests, prior treatments, and treatment plan) to demonstrate InterQual criteria are met for the requested knee procedure.

SourceLink

On This Page

Reported short-term failure rates raise concern about implant durability.

Reduced Osteochondral Allograft Discs (Cartiform/ProChondrix): Evidence consists of small case series with limited follow-up; insufficient to determine effect on health outcomes. Additional, larger comparative studies are necessary.

Some short-term failures reported; data quality and sample sizes are limited.

Synthetic Resorbable Polymers (e.g., TruFit, TruGraft): Evidence is mainly from animal studies and small human case series; some reports show early improvement but later deterioration, persistent pain, failure of graft incorporation, and biocompatibility concerns. No data demonstrate superiority or equivalence to established treatments; randomized trials are needed.

TruFit studies show inconsistent longer-term outcomes and lack of evidence for bone ingrowth.

Xenografts: Xenograft approaches and decellularization techniques remain in early investigation; safety and efficacy have not been established and require additional research once reliable decellularization methods are available.

Further studies needed to establish clinical safety and effectiveness.

Reports of recent diagnostic tests (e.g., microbiology, synovial exam, ESR, CRP).

Pertinent physical exam, condition requiring procedure, symptoms, severity of pain, functional disabilities, cause of defect, and comorbid conditions.

Physician treatment plan including pre-op discussion and any additional interventions or products to be used during the procedure.

For revision surgery, include details of the complication and a complete (staged) surgical plan.

If inpatient stay is requested, provide justification such as bilateral surgery, significant comorbidities, or lack of resources for outpatient postoperative care.

Documentation Required

Prior conservative therapy documentation

Document prior conservative therapies tried and failed (or contraindicated) with dates, duration, and reason for discontinuation before requesting advanced surgical or biologic interventions.

List prior nonoperative treatments (e.g., activity modification, physical therapy, analgesics, intra-articular injections) with start/end dates and response.
Include date of failed prior surgery to the same joint, if applicable.
For each therapy, note reason for discontinuation (e.g., lack of efficacy, intolerance, contraindication).

Step Therapy

Implied step preference and evidence consideration

Evidence summaries emphasize the need for comparative trials versus established treatments for many cartilage and meniscal technologies. When applicable, document prior use of standard/established treatments and rationale for choosing experimental or novel devices or tissue products.

Procedures using minced/particulated cartilage products, synthetic resorbable polymers, meniscal scaffolds/CMI, decellularized or reduced osteochondral allografts, and xenografts carry higher evidence-related denial risk; document comparative rationale and prior standard treatment attempts.
Include FDA/HCT/P regulatory status, tissue establishment registration, and donor screening/testing information for donor tissue products where applicable (see Device / tissue regulatory documentation).

Documentation Required

Device / tissue regulatory documentation

Document device and tissue regulatory information for any implanted or grafted products. For donor-derived tissue products, include manufacturer/product name, FDA classification or HCT/P status, tissue establishment registration, and donor screening/testing procedures as applicable.

If a device is used, provide FDA 510(k)/PMA or other approval/clearance status where applicable (note: surgeries themselves are not FDA-regulated, but devices are).
For human-derived products (e.g., DeNovo NT, osteochondral allografts, meniscal allografts), include evidence of tissue establishment registration and infectious disease screening/testing per FDA HCT/P guidance.
For collagen meniscus implants or other scaffold devices, provide product-specific regulatory or premarket documentation when available.

Clinical intentDesigned as a single-stage autologous cartilage repair technique to fill focal chondral defects.

WOMAC thresholds — definitions for Disabling Pain and Functional Disability

Definition of Disabling PainWOMAC pain domain score > 40 defines Disabling Pain.

Definition of Functional DisabilityWOMAC functional limitation domain score > 40 defines Functional Disability.

WOMAC instrument descriptionThe WOMAC is a 24‑item, disease‑specific, self‑administered questionnaire assessing pain, stiffness, and physical function in hip/knee OA.

Outerbridge Grades — grade definitions for cartilage lesions

Grade 0Normal cartilage.

Grade ICartilage with softening and swelling.

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

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

Grade IVExposed subchondral bone.

newly added definitions — Outerbridge Grades, Disabling Pain, Functional Disability, Radiographic Findings of Osteoarthritis, WOMAC

Outerbridge Grades (added)Policy added definitions for Outerbridge Grades (Grade 0 through IV) to specify cartilage lesion severity.

Disabling Pain (added)Defined as WOMAC pain domain > 40 in the updated Definitions section.

Functional Disability (added)Defined as WOMAC functional limitation domain > 40 in the updated Definitions section.

Radiographic Findings of Osteoarthritis (added)Defined as narrowing of joint space, osteophyte formation, subchondral sclerosis, subchondral cysts, deformity of bony end‑plates, and thinning or loss of articular cartilage; policy accepts three or more moderate–severe findings to support severe OA.

WOMAC (added)Added as a defined instrument: Western Ontario and McMaster Universities Arthritis Index, a 24‑item measure of pain, stiffness, and physical function.