ModifiedUnitedHealthcarePolicy CS068ID.A

Surgery of the Knee (for Idaho Only)

This policy governs surgical procedures of the knee for members in Idaho (including Idaho Medicaid Plus) and describes clinical coverage rationale, definitions, and coding references for knee surgeries and articular cartilage repair techniques.

Policy Summary

PayerUnitedHealthcare

PolicySurgery of the Knee (for Idaho Only)

Policy CodePolicy CS068ID.A

Change TypeNew Medical Policy

Effective DateJun 1, 2025

Next Review Date

Key ActionReference InterQual CP criteria for medical necessity determinations and obtain any required prior authorization per plan rules.

SourceLink

POLICY UPDATE CHANGES

New Medical Policy

1state-specific application (Idaho)

8+InterQual procedures referenced

7approaches listed as unproven/NMN

40+CPT/HCPCS codes listed

Coverage Criteria and Policy Position

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InterQual-based surgery coverage: Knee surgical procedures are considered proven and medically necessary in certain circumstances; medical necessity clinical coverage criteria are defined by InterQual CP procedures listed (arthroscopy, arthrotomy, total joint replacement, unicondylar/patellofemoral replacement, diagnostic arthroscopy, pediatric variants).

Refer to InterQual criteria for specific indications and required elements.

Articular cartilage repair not medically necessary: The following articular cartilage repair techniques are unproven and not medically necessary due to insufficient evidence of efficacy: 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), and xenograft implantation.

Listed explicitly as unproven/not medically necessary in this policy.

Evidence-based coverage implications

Coverage stance is driven by limited and inconsistent evidence for several implant types; specific implants with high failure or insufficient data are considered unsupported by current evidence.

Decellularized osteochondral allografts: Case series and cohort data report high rates of structural failure and reoperation (e.g., 29% revision in Johnson et al.; 72% failure within 2 years in Farr et al.), indicating insufficient evidence to support routine coverage; larger comparative trials are needed.

References: Johnson et al. (case series), Farr et al. (72% failure).

Osteochondral allograft discs: Evidence is limited to small case series (e.g., ProChondrix study with 18 patients and two failures) with short follow-up and single-surgeon reporting; current data are insufficient to conclude benefit on health outcomes.

Reference: Mehta et al. 2022

Synthetic resorbable polymers: Human evidence is limited (case reports/case series) and mainly animal studies; reports include persistent pain, functional deficits, failure of graft incorporation, and lack of demonstrated bone ingrowth (TruFit systematic review), so evidence is inadequate to support use as an alternative to autograft/allograft.

Includes systematic review of TruFit showing early improvement but later deterioration and no evidence of bone ingrowth.

Xenografts: Decellularization and xenograft approaches remain investigational; decellularization methods are early-stage and additional safety and efficacy studies are required before clinical use can be supported.

Articular cartilage repair using the following technologies is 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 Natural Tissue [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 cylindrical plug, TruGraft granules); and xenograft implantation.

Decellularized osteochondral allograft plugs and certain synthetic resorbable polymer implants have been associated with concerning clinical outcomes and limited human evidence. Case series of decellularized osteochondral plugs report high early failure and revision rates (for example, one series reported 29% revision with implant removal and another reported a 72% failure rate within 2 years), and larger, comparative trials are lacking. For synthetic resorbable polymers, the literature is dominated by animal studies and small case series or reports in humans; reported problems include persistent pain, functional deficits, failure of graft incorporation, and biocompatibility concerns. Overall, evidence is insufficient to support routine use of these implants over established autograft or allograft treatments.

Applicable Codes

Applicable 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 44

1/5

Provider Requirements and Operational Notes

Prior Authorization

Prior authorization / InterQual criteria

InterQual-based medical necessity determinations — Medical necessity determinations should reference InterQual CP criteria for specified knee procedures; providers should obtain any required prior authorization and submit documentation that demonstrates criteria are met.

InterQual CP: Arthroscopy or Arthroscopically Assisted Surgery, Knee
InterQual CP: Arthroscopy or Arthroscopically Assisted Surgery, Knee (Pediatric)
InterQual CP: Arthroscopy, Diagnostic, +/- Synovial Biopsy, Knee
InterQual CP: Arthrotomy, Knee
InterQual CP: Arthrotomy, Knee (Pediatric)
InterQual CP: Removal and Replacement, Total Joint Replacement (TJR), Knee
InterQual CP: Total Joint Replacement (TJR), Knee
InterQual CP: Unicondylar or Patellofemoral Knee Replacement

Documentation Required

FDA / tissue-regulation verification

FDA and tissue-regulation verification — Devices and donor tissue products may require verification of appropriate FDA registration/clearance status. Providers should confirm device 510(k)/PMA or HCT/P status as appropriate and include supporting documentation with any authorization request.

Use FDA 510(k)/PMA databases to verify device clearance (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm).
Confirm whether donor tissue products are regulated as HCT/Ps and that the tissue establishment is registered with FDA.
Provide documentation of FDA clearance/registration when submitting for coverage review.

Documentation Required

Tissue banking and FDA documentation

Tissue banking and FDA-related documentation — Tissue establishments must follow FDA registration, donor screening, infectious disease testing, and recordkeeping requirements per HCT/P regulations. When donor-derived products (e.g., DeNovo NT) are used, include tissue-establishment registration and donor-screening/testing records in the submission.

Include tissue establishment FDA registration/listing information.
Include donor screening and infectious disease testing documentation and written procedures for prevention of communicable disease.
Note that transplantation procedures themselves are not FDA-regulated, but the tissue banking processes are subject to FDA oversight.

Documentation Required

Medical records and documentation requirements

Documentation may affect coverage decisions — Medical records documentation may be required to assess whether the member meets clinical criteria for coverage but does not guarantee coverage. Lack of sufficient documentation may result in delay or denial of the request.

Provide complete medical records, imaging, operative reports, and prior treatment history to support medical necessity.
Documentation alone does not guarantee coverage; reviewers will assess records against clinical criteria.

Denial Risk

High failure / limited evidence risk

Failure-related denial risk — Certain implants have reported high early failure rates (for example, decellularized osteochondral allograft plugs with substantial revision/removal rates). High reported failure rates may support denial of coverage for implants lacking durable evidence of safety and effectiveness.

Reported high failure rates (e.g., 72% failure within 2 years for some decellularized osteochondral allografts) may justify denial.
Provide longer-term outcome data and comparative studies to overcome failure-related denial risk.

Note

Prefer established treatments before synthetic implants

Prefer established treatments before synthetic implants — There is no evidence that synthetic resorbable polymer implants (e.g., TruFit plug) are superior to established treatments such as microfracture or mosaicplasty; providers should document prior use of and response to established therapies before seeking coverage for synthetic implants.

Document prior conservative management and established procedural alternatives (microfracture, mosaicplasty) and outcomes.
Randomized controlled trial evidence comparing synthetic implants to established treatments is lacking; include rationale and evidence when requesting coverage.

Clinical Background

Articular cartilage has a limited intrinsic healing capacity and is vulnerable to damage from acute traumatic injury or inflammatory joint conditions. Cartilage defects can cause pain, swelling, and functional impairment, and they frequently do not regenerate effectively without intervention. Numerous biologic and scaffold-based repair approaches have been developed (autograft/allograft particulated cartilage, osteochondral plugs and discs, synthetic resorbable scaffolds, collagen implants, and xenografts), but many of these techniques currently lack sufficient evidence of durable benefit and are considered investigational or not medically necessary in this policy.

Definitions of Techniques and Products

BioCartilage — Key facts

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 and applied over a cartilage defect.

Intended useApplied over cartilage defects to augment microfracture by providing a scaffold for chondrogenesis.

PreparationMixed intraoperatively with a blood solution to form a paste before application.

Source referenceDescribed in Hayes 2022 as an allograft-derived particulate scaffold.

Cartilage Autograft Implantation System (CAIS) — Key facts

DefinitionDevice that harvests minced autograft cartilage and disperses chondrocytes on a scaffold in a single-stage treatment.

Procedure typeSingle-stage autologous cartilage repair using harvested and minced native cartilage placed on a scaffold.

Clinical citationDescribed in Farr et al., 2012 as a system for autograft cartilage implantation.

Collagen Meniscus Implants — Key facts

DefinitionImplantable porous meniscus scaffolds composed of collagen fibers enriched with glycosaminoglycan used as a template and support for generation of new meniscus-like tissue.

MaterialPrimarily bovine type I collagen (bioresorbable) used as a tissue-engineered scaffold.

Regulatory noteCollagen meniscus implants have FDA product code OLC and are subject to PMA/clearance information available via FDA listings.

DeNovo NT / DeNovo ET — Key facts

DeNovo NT (Natural Tissue)Manually particulated juvenile allograft cartilage mixed intraoperatively with fibrin glue before implantation into the prepared lesion.

DeNovo ET (Engineered Tissue)An in vitro grown, 3-dimensional hyaline-like cartilage tissue created by culturing disaggregated allogeneic juvenile chondrocytes.

Source detailsBoth products described in Farr et al., 2012; DeNovo NT is particulate juvenile cartilage, DeNovo ET is cultured engineered tissue.

Reduced Allograft Discs (e.g., Cartiform, ProChondrix CR) — Key facts

DefinitionWafer-thin allografts with reduced bony portion that contain hyaline cartilage along with chondrocytes, growth factors, and extracellular matrix proteins.

Intended mechanismUsed with marrow stimulation to allow host mesenchymal stem cells to infiltrate from underlying bone marrow and promote chondrogenesis.

ExamplesProducts include Cartiform and ProChondrix CR (reduced osteochondral discs).

Xenograft — Key facts

DefinitionGraft of tissue taken from a donor of one species and grafted into a recipient of another species.

StatusDecellularization and xenograft approaches are investigational and early-stage; additional safety and efficacy studies are required before routine clinical use.

HCT/P — Key facts

DefinitionHuman Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P): donor tissue products derived from human cartilage that are subject to FDA HCT/P guidance.

Regulatory requirementsTissue establishments must register with FDA, screen and test donors, follow written procedures to prevent communicable disease, and maintain records per HCT/P rules.

Premarket reviewMinimally processed tissues transplanted for normal structural functions are not subject to FDA premarket review, but tissue establishments remain regulated.

OpenPayer

Surgery of the Knee (for Idaho Only)

Coverage Criteria and Policy Position

Applicable Codes

Provider Requirements and Operational Notes

Clinical Background

Definitions of Techniques and Products

Policy Revision History