ModifiedUnitedHealthcarePolicy CS068OH.F

Surgery of the Knee (Ohio)

UnitedHealthcare policy governing medical necessity and coverage for knee surgical procedures for members in Ohio, including arthroscopy, arthrotomy, joint replacement, and guidance on articular cartilage repair techniques.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (Ohio)

Policy CodePolicy CS068OH.F

Change TypeDefinitions addedCPT code removedevidence updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionWhen diagnostic images are requested, submit them via the external portal at www.uhcprovider.com/paan; faxes will not be accepted.

SourceLink

POLICY UPDATE CHANGES

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

Removed CPT code 27445 from the applicable codes list.

Updated clinical evidence and references sections to reflect the most current information.

InterQualclinical criteria source

Ohiogeographic applicability

Multipleunproven cartilage approaches

Imaging checklistrequired documentation

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Coverage Criteria — Knee Surgery and Articular Cartilage Repair

inv-01: General coverage stance and reference guidance

Covered when ALL of the following are met:

Reference-based coverage: Coverage decisions for specific knee procedures follow InterQual CP: Arthroscopy or Arthroscopically Assisted Surgery (Adult and Pediatric), Arthroscopy Diagnostic +/- Synovial Biopsy, Arthrotomy (Adult and Pediatric), Removal and Replacement TJR Knee, Total Joint Replacement Knee, Unicondylar or Patellofemoral Knee Replacement.

See InterQual criteria link in policy.

inv-02: Articular cartilage repair — unproven / not medically necessary

Articular cartilage repair is unproven and not medically necessary for treating individuals with any of the following due to insufficient evidence of efficacy:

Articular cartilage repair techniques considered unproven/ not medically necessary: Autologous minced or particulated cartilage (e.g., CAIS, Reveille); 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); Xenograft implantation; and related techniques.insufficient evidence of efficacy

Policy cites systematic reviews, HTA briefs, and limited/low-quality studies as basis.

inv-03: Collagen Meniscus Implant (CMI) — coverage logic

Use of collagen meniscus implants (CMI) is addressed as follows:

Collagen Meniscus Implant (CMI): Available evidence is insufficient to demonstrate efficacy of collagen meniscus implants as a sole treatment. Studies are heterogeneous, often include concurrent procedures, and have variable outcomes; further high-quality randomized trials and long-term comparative data are needed before routine clinical use can be recommended.

Systematic reviews and single-center series report mixed outcomes and methodological limitations (e.g., retrospective design, small samples, concurrent procedures).

inv-04: Osteochondral Allografts & Discs — coverage logic

Decellularized osteochondral allografts and osteochondral allograft discs are addressed as follows:

Decellularized OC Allografts: Case series report delamination and high short-term failure and revision rates (examples include 72% failure within 2 years and 29% requiring implant removal); evidence is insufficient to establish safety and efficacy and larger comparative trials are needed.

High early failure rates reported in small case series.

Osteochondral Allograft Discs: Evidence limited to small case series with insufficient data to draw conclusions about clinical outcomes; further larger, comparative studies with longer follow-up are required.

Hayes brief and small cohort reports cited.

inv-05: Synthetic Polymers & Xenografts — coverage logic

Synthetic resorbable polymers and xenografts are addressed as follows:

Synthetic Resorbable Polymers: Human evidence is limited and predominantly animal data; reported problems include poor clinical outcomes, persistent pain, functional deficits, and graft incorporation failures. Current evidence is insufficient to support routine clinical use as an alternative to autograft or allograft.

Systematic reviews of products like TruFit report early improvements with deterioration over time and no evidence of superiority to established treatments.

Xenografts: Decellularization and other processing methods remain investigational; safety and efficacy are not established and additional research is required before clinical adoption.

Early-stage investigation of xenograft decellularization noted.

Articular cartilage repair techniques listed in this policy are considered unproven and not medically necessary due to insufficient evidence of efficacy. The procedures and products identified include: autologous minced or particulated cartilage (for example, Cartilage Autograft Implantation System [CAIS], Reveille Cartilage Processor); allogeneic minced or particulated cartilage (for example, BioCartilage®, DeNovo NT/ET); Collagen Meniscus Implant (CMI); decellularized osteochondral allografts (for example, Chondrofix); reduced osteochondral discs (for example, ProChondrix, Cartiform); synthetic resorbable polymers (for example, PolyGraft BGS, TruFit, TruGraft); and xenograft implantation.

Additional important considerations supporting the investigational designation include: for Collagen Meniscus Implants (CMI), available studies are heterogeneous, frequently include concurrent procedures, and lack high-quality randomized controlled trials and long-term comparative data to establish safety and efficacy; systematic reviews conclude current evidence is insufficient to recommend routine use. For decellularized osteochondral allografts, case series report delamination and high short-term failure and revision rates, indicating inadequate demonstration of safety and effectiveness. For synthetic resorbable polymers, the human evidence base is limited (mostly animal studies, case reports/series) and reports exist of poor outcomes and graft incorporation failure, supporting continued investigational status.

Consistent with the evidence limitations described above, the policy explicitly states that articular cartilage repair using the listed techniques is unproven and not medically necessary for treatment of cartilage lesions until higher-quality comparative data demonstrate clinical benefit.

Use of the investigational implants and grafts enumerated in this policy (including CMI, decellularized osteochondral allografts and discs, synthetic resorbable polymers, and xenografts) is considered not medically necessary or otherwise unsupported for routine clinical use because of limited data, study heterogeneity, and reported high early failure rates in some series.

Applicable Codes and Coding Notes

Applicable CPT/HCPCS codes listedmixed

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

Removed CPT CodesCPT

27445

CPT code 27445 (removed)

WOMAC threshold

WOMAC threshold (Disabling Pain)WOMAC pain domain > 40 defines disabling pain.

WOMAC threshold (Functional Disability)WOMAC functional limitation domain > 40 defines functional disability.

Source — definition additionsDefinitions for Disabling Pain and Functional Disability were added to the policy on 04/01/2026.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Criteria Use

Prior authorization is required and requests must follow UnitedHealthcare procedures. Use InterQual® criteria as the primary medical/surgical criteria; if InterQual does not have applicable criteria, UnitedHealthcare medical policies, coverage determination guidelines, and/or utilization review guidelines (as approved by the Ohio Department of Medicaid Services) may be used. This Medical Policy applies to Ohio and unproven or limited services will be evaluated for medical necessity using Ohio Administrative Code 5160-101. UnitedHealthcare reserves the right to modify policies as needed.

Prior authorization submissions: follow UnitedHealthcare portal and PA instructions
Clinical criteria reference: InterQual® primary; fallback to UnitedHealthcare medical policies/coverage guidelines

Denial Risk

Documentation Insufficiency May Trigger Denial

Incomplete or missing documentation may result in denial of the request. Failure to provide required imaging, imaging interpretations, or recent diagnostic test reports (e.g., MRI, CT, X-ray, bone scan, microbiology, synovial exam, ESR, CRP) when requested can lead to a denial.

Background — Articular Cartilage and Treatment Approaches

Articular cartilage is a specialized hyaline cartilage with limited intrinsic healing capacity. Focal cartilage defects can cause pain, swelling, mechanical symptoms, and progressive functional impairment. A range of biologic and implant-based approaches have been investigated to restore cartilage structure and function, including autologous or allogeneic minced/particulated cartilage, osteochondral allografts or reduced discs, synthetic resorbable polymer implants, collagen-based scaffolds, and xenografts. Evidence for many of these approaches is currently limited or mixed: human data are often small, uncontrolled, or short-term, and some reports describe poor outcomes such as graft delamination, failure to incorporate, persistent pain, and need for early revision. Given these limitations, comparative high-quality trials and longer-term outcome data are needed to establish the safety and effectiveness of these techniques.

Definitions and Key Terms

BioCartilage

TermBioCartilage

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 (Hayes, 2022).

Intended useScaffold when used with microfracture to fill cartilage defects.

Cartilage Autograft Implantation System (CAIS)

TermCartilage Autograft Implantation System (CAIS)

DescriptionSystem 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 (Ohio)

Policy CodePolicy CS068OH.F

Change TypeDefinitions addedCPT code removedevidence updates

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionWhen diagnostic images are requested, submit them via the external portal at www.uhcprovider.com/paan; faxes will not be accepted.

SourceLink

On This Page

When requested, diagnostic images must be submitted via the external portal at www.uhcprovider.com/paan; faxes will not be accepted
Missing reports of recent diagnostic tests or absent imaging interpretation details may result in denial

Denial Risk

High Early Failure — Decellularized OC Allografts & Discs

Decellularized osteochondral allografts and osteochondral discs have been reported with high early failure and implant delamination in available case series. Given the high short-term failure rates reported (including series with 29% revision and reports of up to 72% failure within 2 years), these products have limited/high-risk evidence that may result in noncoverage or denial.

Reported outcomes: implant delamination and high revision/failure rates in short-term series
Coverage implications: limited evidence and high early failure may lead to noncoverage or denial

Documentation Required

Required Medical Record Elements

Medical records must include a complete diagnostic imaging interpretation and a thorough clinical documentation checklist to support medical necessity. Required elements include patient condition, symptoms, severity of pain and functional disability, cause of defect, pertinent physical exam, comorbidities, prior therapies (dates, duration, reasons), physician treatment plan (including pre-op discussion and devices/products to be used), and for revision surgery, details of complication and complete surgical plan.

Imaging interpretation must document: relevant clinical info; detailed findings (presence/absence of full-thickness defect, size/location, Outerbridge grade, joint space/alignment, ligament tear location/grade); impression; specialty of interpreter
Provide reports of recent diagnostic tests (microbiology, synovial exam, ESR, CRP) and date-labeled images with case/member identifiers

Documentation Required

Tissue/Device Documentation

When tissue or device products are used, documentation must include product sourcing and regulatory/tissue-banking information: FDA registration/status where applicable, donor screening/testing and tissue establishment registration, device/implant details, and a description of the procedure including any additional products used.

For donor-derived tissue products: evidence of tissue establishment registration and donor infectious disease screening/testing per FDA HCT/P requirements
For devices/instruments used during surgery: provide FDA 510(k)/PMN/registration details when available and identify the device/product to be used during the procedure

Step Therapy

Synthetic Polymer Requirements

Synthetic resorbable polymer products (e.g., TruFit and similar bi-phasic scaffolds) have limited human evidence, variable outcomes, and potential biocompatibility concerns. There are no specified step-therapy pathways in this policy; evidence is limited and further comparative randomized trials are needed before these products can be considered equivalent to established treatments.

No step therapy specified in policy for synthetic polymers
Clinical evidence: primarily animal studies, few human case series/reports, inconsistent long-term outcomes and reports of graft incorporation failure

Note

Evaluation Standard for Unproven/Limited Services

For services described as unproven or limited, evaluation of medical necessity will follow Ohio Administrative Code 5160-101 in addition to UnitedHealthcare policy and InterQual criteria as applicable.

OAC 5160-101 will be used for medical necessity determinations for Ohio requests involving unproven/limited services
Decisions will reference InterQual® and UnitedHealthcare medical policies where applicable

Single-stage harvest and implantation of autologous minced cartilage onto a scaffold to promote repair.

Disabling Pain / Functional Disability

DefinitionDisabling pain defined as WOMAC pain domain > 40.

Definition (functional)Functional disability defined as WOMAC functional limitation domain > 40.

Policy changeDefinitions for Disabling Pain and Functional Disability were added to the policy on 04/01/2026.

Outerbridge Grades

Grade 0Normal cartilage.

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.

Policy definitions added

Definitions addedDisabling Pain, Functional Disability, Outerbridge Grades, Radiographic Findings of Osteoarthritis, and WOMAC were added to the policy definitions.

Effective dateChanges recorded in policy history on 04/01/2026.

ContextAdded definitions clarify thresholds (WOMAC > 40) and cartilage grading used elsewhere in the policy.